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Coronary Artery Disease: HELP
Articles by Gerrit Anne van Es
Based on 33 articles published since 2010
(Why 33 articles?)
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Between 2010 and 2020, Gerrit A. van Es wrote the following 33 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Review Cardiovascular risk profile of patients included in stent trials; a pooled analysis of individual patient data from randomised clinical trials: insights from 33 prospective stent trials in Europe. 2011

Vranckx, Pascal / Boersma, Eric / Garg, Scot / Valgimigli, Marco / Van Es, Gerrit-Anne / Goedhart, Dick / Serruys, Patrick W. ·Department of Cardiac Intensive Care & Interventional Cardiology, Hartcentrum, Hasselt, Belgium. ·EuroIntervention · Pubmed #22082582.

ABSTRACT: AIMS: Few data document trends in cardiovascular (CV) risk-factors in patients with or without previous symptomatic CV disease. We assessed the prevalence and trends in (non) modifiable CV risk-factors, and the use of cardioprotective therapies in patients enrolled in coronary stent trials. METHODS AND RESULTS: This analysis included prospective data on 10,253 mainly European adults who were enrolled in 32 coronary stent studies between 1995 and 2006. Data was collected at the time of enrolment using a standardised patient clinical record form, and was analysed by considering three consecutive time periods: 1995-1997 (I), 1998-2002 (II) and 2003-2006 (III) rendering approximately equal numbers per period. Overall the proportion of active smokers remained constant (Period I to III: 28%, 27%, 21%, p=0.45), however the proportion increased in females below 50 years (about 2%/ year, R.RR: 1.20, P: 0.05 period III versus I). Prevalent diabetes increased (16%, 17%, 25%; p=0.029). The prevalence of a body-mass index (BMI) ≥25 kg/m² was high, but no trend was observed (69%, 68%, 70%; p=0.24). The proportion of patients with elevated blood pressure (i.e., ≥140/90 mmHg, in diabetes ≥130/80 mmHg) remained unchanged (55%, 50.%, 53%; p=0.22), despite an increase in the number of patients taking anti-hypertensive agents (84%, 89%, 90%; p=0.30). Conversely, the proportion of patients with elevated total cholesterol (i.e., ≥4.5 mmol/L) decreased (80%, 66%, 52%; p=0.002), which was consistent with the increase in patients taking lipid lowering drugs (32%, 62%, 69%; p=0.083). The portion of patients reaching therapeutic targets for blood lipids improved, but no improvement was seen in blood pressure control (p=0.29). CONCLUSIONS: There is an unmet clinical need in primary and secondary CV prevention in Europe. Patients requiring PCI are an important target population in whom lifestyle changes and aggressive secondary preventative measures should be aimed. Ultimately PCI should open the door towards optimising secondary prevention.

2 Guideline Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. 2012

Tearney, Guillermo J / Regar, Evelyn / Akasaka, Takashi / Adriaenssens, Tom / Barlis, Peter / Bezerra, Hiram G / Bouma, Brett / Bruining, Nico / Cho, Jin-man / Chowdhary, Saqib / Costa, Marco A / de Silva, Ranil / Dijkstra, Jouke / Di Mario, Carlo / Dudek, Darius / Falk, Erling / Feldman, Marc D / Fitzgerald, Peter / Garcia-Garcia, Hector M / Gonzalo, Nieves / Granada, Juan F / Guagliumi, Giulio / Holm, Niels R / Honda, Yasuhiro / Ikeno, Fumiaki / Kawasaki, Masanori / Kochman, Janusz / Koltowski, Lukasz / Kubo, Takashi / Kume, Teruyoshi / Kyono, Hiroyuki / Lam, Cheung Chi Simon / Lamouche, Guy / Lee, David P / Leon, Martin B / Maehara, Akiko / Manfrini, Olivia / Mintz, Gary S / Mizuno, Kyiouchi / Morel, Marie-angéle / Nadkarni, Seemantini / Okura, Hiroyuki / Otake, Hiromasa / Pietrasik, Arkadiusz / Prati, Francesco / Räber, Lorenz / Radu, Maria D / Rieber, Johannes / Riga, Maria / Rollins, Andrew / Rosenberg, Mireille / Sirbu, Vasile / Serruys, Patrick W J C / Shimada, Kenei / Shinke, Toshiro / Shite, Junya / Siegel, Eliot / Sonoda, Shinjo / Suter, Melissa / Takarada, Shigeho / Tanaka, Atsushi / Terashima, Mitsuyasu / Thim, Troels / Uemura, Shiro / Ughi, Giovanni J / van Beusekom, Heleen M M / van der Steen, Antonius F W / van Es, Gerrit-Anne / van Soest, Gijs / Virmani, Renu / Waxman, Sergio / Weissman, Neil J / Weisz, Giora / Anonymous6690720. ·The Massachusetts General Hospital and the Wellman Center for Photomedicine, Boston, Massachusetts 02114, USA. gtearney@partners.org ·J Am Coll Cardiol · Pubmed #22421299.

ABSTRACT: OBJECTIVES: The purpose of this document is to make the output of the International Working Group for Intravascular Optical Coherence Tomography (IWG-IVOCT) Standardization and Validation available to medical and scientific communities, through a peer-reviewed publication, in the interest of improving the diagnosis and treatment of patients with atherosclerosis, including coronary artery disease. BACKGROUND: Intravascular optical coherence tomography (IVOCT) is a catheter-based modality that acquires images at a resolution of ~10 μm, enabling visualization of blood vessel wall microstructure in vivo at an unprecedented level of detail. IVOCT devices are now commercially available worldwide, there is an active user base, and the interest in using this technology is growing. Incorporation of IVOCT in research and daily clinical practice can be facilitated by the development of uniform terminology and consensus-based standards on use of the technology, interpretation of the images, and reporting of IVOCT results. METHODS: The IWG-IVOCT, comprising more than 260 academic and industry members from Asia, Europe, and the United States, formed in 2008 and convened on the topic of IVOCT standardization through a series of 9 national and international meetings. RESULTS: Knowledge and recommendations from this group on key areas within the IVOCT field were assembled to generate this consensus document, authored by the Writing Committee, composed of academicians who have participated in meetings and/or writing of the text. CONCLUSIONS: This document may be broadly used as a standard reference regarding the current state of the IVOCT imaging modality, intended for researchers and clinicians who use IVOCT and analyze IVOCT data.

3 Clinical Trial Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 1-year results of the SYNTAX II study. 2017

Escaned, Javier / Collet, Carlos / Ryan, Nicola / De Maria, Giovanni Luigi / Walsh, Simon / Sabate, Manel / Davies, Justin / Lesiak, Maciej / Moreno, Raul / Cruz-Gonzalez, Ignacio / Hoole, Stephan P / Ej West, Nick / Piek, J J / Zaman, Azfar / Fath-Ordoubadi, Farzin / Stables, Rodney H / Appleby, Clare / van Mieghem, Nicolas / van Geuns, Robert Jm / Uren, Neal / Zueco, Javier / Buszman, Pawel / Iñiguez, Andres / Goicolea, Javier / Hildick-Smith, David / Ochala, Andrzej / Dudek, Dariusz / Hanratty, Colm / Cavalcante, Rafael / Kappetein, Arie Pieter / Taggart, David P / van Es, Gerrit-Anne / Morel, Marie-Angèle / de Vries, Ton / Onuma, Yoshinobu / Farooq, Vasim / Serruys, Patrick W / Banning, Adrian P. ·Hospital Cliinico San Carlos IDISSC and Universidad Complutense de Madrid, Madrid, Spain; Calle Profesor Martín Lagos s/n, 28040 Madrid, Spain. · Department of Cardiology, Academic Medical Center of Amsterdam, Cardiology, Amsterdam, the Netherlands; Meibergdreef 9, 1105 AZ Amsterdam-Zuidoost, the Netherlands. · Department of Cardiology, John Radcliffe Hospital, Cardiology, Oxford, UK; Headley Way, Headington, Oxford OX3 9DU, UK. · Department of Cardiology Belfast Health & Social Care Trust, Belfast, UK; Knockbracken Healthcare Park, Saintfield Rd, Belfast BT8 8BH, UK. · Hospital Clinic I Provincial de Barcelona, Barcelona, Spain; Carrer de Villarroel, 170, 08036 Barcelona, Spain. · Department of Cardiology, Imperial College London, London, UK; Kensington, London SW7 2AZ, UK. · 1st Department of Cardiology, University of Medical Sciences, Poznan, Poland; Collegium Maius, Fredry 10, 61-701 Poznan, Poland. · Department of Cardiology, Hospital Universitario la Paz, Madrid, Spain; Paseo de la Castellana, 261, 28046 Madrid, Spain. · Department of Cardiology, Hospital Universitario de Salamanca, IBSAL, Salamanca, Spain; Paseo de San Vicente, 58, 37007 Salamanca, Spain. · Department of Cardiology, Papworth Hospital NHS Foundation Trust, Cambridge, UK; Papworth Everard, Cambridge CB23 3RE, UK. · Department of Cardiology, Freeman Hospital and Newcastle University, Newcastle-upon-Tyne, UK; High Heaton, Newcastle upon Tyne NE7 7DN, UK. · Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals, Manchester, UK; Oxford Rd, Manchester M13 9WL, UK. · Liverpool Heart and Chest Hospital, Liverpool, UK; Thomas Dr, Liverpool L14 3PE, UK. · Thoraxcenter, Erasmus MC, the Netherlands; 's-Gravendijkwal 230, 3015 CE Rotterdam, the Netherlands. · The Royal Infirmary of Edinburgh, Edinburgh, UK; 51 Little France Dr, Edinburgh EH16 4SA, UK. · Department of Cardiology, Hospital Universitario Valdecilla, Cantabria, Spain; Av. Valdecilla, 25, 39008 Santander, Cantabria, Spain. · American Heart of Poland (PAK), Ustrón, Poland; Sanatoryjna 1, 43-450 Ustrón, Poland. · Department of Cardiology, Hospital Meixoeiro, Pontevedra, Spain; Camiño Meixoeiro, s/n, 36214 Vigo, Pontevedra, Spain. · Brighton & Sussex University Hospitals NHS Trust, Brighton, UK; Barry Building, Eastern Rd, Brighton BN2 5BE, UK. · Gornoslaskie Centrum Medycnze, Poland; 45/47, 40-635 Katowice, Poland. · Department of Interventional Cardiology, Jagiellonian University, Krakow, Poland; Gol?bia 24, 31-007 Kraków, Poland. · Cardialysis BV, Rotterdam, the Netherlands; Westblaak 98, 3012 KM, Rotterdam, the Netherlands. · European Cardiovascular Research Institute, Westblaak 98, 3012 KM, Rotterdam, the Netherlands. ·Eur Heart J · Pubmed #29020367.

ABSTRACT: Aims: To investigate if recent technical and procedural developments in percutaneous coronary intervention (PCI) significantly influence outcomes in appropriately selected patients with three-vessel (3VD) coronary artery disease. Methods and results: The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in patients with 3VD in 22 centres from four European countries. The SYNTAX-II strategy includes: heart team decision-making utilizing the SYNTAX Score II (a clinical tool combining anatomical and clinical factors), coronary physiology guided revascularisation, implantation of thin strut bioresorbable-polymer drug-eluting stents, intravascular ultrasound (IVUS) guided stent implantation, contemporary chronic total occlusion revascularisation techniques and guideline-directed medical therapy. The rate of major adverse cardiac and cerebrovascular events (MACCE [composite of all-cause death, cerebrovascular event, any myocardial infarction and any revascularisation]) at one year was compared to a predefined PCI cohort from the original SYNTAX-I trial selected on the basis of equipoise 4-year mortality between CABG and PCI. As an exploratory endpoint, comparisons were made with the historical CABG cohort of the original SYNTAX-I trial. Overall 708 patients were screened and discussed within the heart team; 454 patients were deemed appropriate to undergo PCI. At one year, the SYNTAX-II strategy was superior to the equipoise-derived SYNTAX-I PCI cohort (MACCE SYNTAX-II 10.6% vs. SYNTAX-I 17.4%; HR 0.58, 95% CI 0.39-0.85, P = 0.006). This difference was driven by a significant reduction in the incidence of MI (HR 0.27, 95% CI 0.11-0.70, P = 0.007) and revascularisation (HR 0.57, 95% CI 0.37-0.9, P = 0.015). Rates of all-cause death (HR 0.69, 95% CI 0.27-1.73, P = 0.43) and stroke (HR 0.69, 95% CI 0.10-4.89, P = 0.71) were similar. The rate of definite stent thrombosis was significantly lower in SYNTAX-II (HR 0.26, 95% CI 0.07-0.97, P = 0.045). Conclusion: At one year, clinical outcomes with the SYNTAX-II strategy were associated with improved clinical results compared to the PCI performed in comparable patients from the original SYNTAX-I trial. Longer term follow-up is awaited and a randomized clinical trial with contemporary CABG is warranted. ClinicalTrials.gov Identifier: NCT02015832.

4 Clinical Trial Rationale and design of the SYNTAX II trial evaluating the short to long-term outcomes of state-of-the-art percutaneous coronary revascularisation in patients with de novo three-vessel disease. 2016

Escaned, Javier / Banning, Adrian / Farooq, Vasim / Echavarria-Pinto, Mauro / Onuma, Yoshinobu / Ryan, Nicola / Cavalcante, Rafael / Campos, Carlos M / Stanetic, Bojan M / Ishibashi, Yuki / Suwannasom, Pannipa / Kappetein, Arie-Pieter / Taggart, David / Morel, Marie-Angèle / van Es, Gerrit-Anne / Serruys, Patrick W. ·Hospital Clinico San Carlos/Faculty of Medicine Complutense University, Madrid, Spain. ·EuroIntervention · Pubmed #27290681.

ABSTRACT: AIMS: The applicability of the results of the SYNTAX trial comparing percutaneous coronary intervention (PCI) using first-generation drug-eluting stents (DES) with coronary artery bypass graft (CABG) surgery for the treatment of patients with complex coronary artery disease (CAD) has been challenged by recent major technical and procedural developments in coronary revascularisation. Functional assessment of coronary lesions has contributed to marked improvements in both safety and efficacy of DES implantation. In addition, the recent development of the SYNTAX score II, a clinical tool based on anatomical and clinical factors, allows individualised objective decision making regarding the optimal revascularisation modality in patients with complex CAD. The ongoing SYNTAX II trial is currently evaluating the effectiveness of the clinical and technological advances in the treatment of patients with complex (de novo three-vessel) CAD. METHODS AND RESULTS: The SYNTAX II trial is a multicentre, all-comers, open-label, single-arm trial aiming to recruit 450 patients with de novo three-vessel CAD in approximately 25 European interventional cardiology centres. All patients will be selected and treated following the SYNTAX II strategy, which includes: a) establishing the appropriateness of revascularisation utilising the SYNTAX score II as a clinical tool to allow objective decision making by the Heart Team, b) ischaemia-driven revascularisation based on functional intracoronary assessment, c) implantation of the new-generation everolimus-eluting platinum chromium coronary stent with thin struts and abluminal bioabsorbable polymer coating to promote rapid vessel healing, d) intravascular ultrasound-guided DES implantation, and e) treatment at centres with expertise in CTO recanalisation. The primary endpoint is a composite of the major adverse cardiac and cerebral events (MACCE) rate at one-year follow-up compared to the historical PCI arm of the SYNTAX trial. An exploratory endpoint will be MACCE at five-year follow-up compared to the historical surgical arm of the SYNTAX trial. CONCLUSIONS: The SYNTAX II trial will provide valuable information on outcomes of state-of-the-art PCI for the contemporary management of complex (de novo three-vessel) CAD. SYNTAX II will be of critical value in the design of future trials in this arena.

5 Clinical Trial Intravascular ultrasound radiofrequency analysis after optimal coronary stenting with initial quantitative coronary angiography guidance: an ATHEROREMO sub-study. 2011

Sarno, Giovanna / Garg, Scot / Gomez-Lara, Josep / Garcia Garcia, Hector M / Ligthart, Jurgen / Bruining, Nico / Onuma, Yoshinobu / Witberg, Karen / van Geuns, Robert-Jan / de Boer, Sanneke / Wykrzykowska, Joanna / Schultz, Carl / Duckers, Henricus J / Regar, Evelyn / de Jaegere, Peter / de Feyter, Pim / van Es, Gerrit Anne / Boersma, Eric / van der Giessen, Wim / Serruys, Patrick W / Anonymous150687. ·Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. ·EuroIntervention · Pubmed #21330246.

ABSTRACT: AIMS: To investigate whether the use of intravascular ultrasound virtual histology (IVUS-VH) leads to any improvements in stent deployment, when performed in patients considered to have had an optimal percutaneous coronary intervention (PCI) by quantitative coronary angiography (QCA). METHODS AND RESULTS: After optimal PCI result (residual stenosis by QCA<30%), IVUS-VH was performed in 100 patients by protocol, with the option to use the information left to the discretion of the operators. Patients were categorised as: Group1 (n=54), where the IVUS-VH findings were used to evaluate the need for further optimisation of the stent deployment; and Group2 (n=46), where the IVUS-VH was documentary such that the stenting results were considered optimal according to QCA. Optimal stent deployment on IVUS-VH was defined as: normal stent expansion, absence of stent malapposition, complete lesion coverage as indicated by a plaque burden (PB%) between 30-40% and necrotic core confluent to the lumen<10% or PB%<30% at the 5 mm proximal and distal to the stent. The first IVUS-VH in all patients demonstrated the achievement of optimal stent deployment, incomplete lesion coverage, stent under-expansion and stent-edge dissection in 60%, 31%, 20% and 8% of patients, respectively. There was no stent malapposition. In Group 1, 25 patients had optimal stent deployment and did not require further intervention, whilst in 29 patients further intervention was needed (additional stent, n=18; post-dilatation, n=29). Overall optimal stent deployment was finally achieved in 52/54 patients (96%) in Group 1 and 35/46 (76%) of Group 2, p<0.05. CONCLUSIONS: IVUS-VH may have a role in facilitating optimal stent implantation and complete lesion coverage.

6 Clinical Trial Short- and long-term health related quality-of-life and anginal status of the Arterial Revascularisation Therapies Study part II, ARTS-II; sirolimus-eluting stents for the treatment of patients with multivessel coronary artery disease. 2010

van Domburg, Ron T / Daemen, Joost / Morice, Marie-Claude / de Bruyne, Bernard / Colombo, Antonio / Macaya, Carlos / Richardt, Gert / Fajadet, Jean / Hamm, Christian / van Es, Gerrit-Anne / Wittebols, Kristel / Macours, Nathalie / Stoll, Hans Peter / Serruys, Patrick W. ·Erasmus Medical Center, Rotterdam, The Netherlands. r.vandomburg@erasmusmc.nl ·EuroIntervention · Pubmed #20542782.

ABSTRACT: AIMS: Assessment of health related quality-of-life (HRQL) has become increasingly important as not only the clinician's view of the technical success, but also the patient's perception is being measured. We evaluated the HRQL following sirolimus-eluting coronary stent (SES) (CYPHER(R); Cordis, Johnson & Johnson, Warren, NJ, USA) implantation in patients with multivessel disease, comparing the outcomes with the historical surgical and bare metal stent (BMS) arms of the ARTS-I study. METHODS AND RESULTS: The HRQL outcomes were compared to the outcome of the historical cohorts of the randomised ARTS-I trial using the same inclusion and exclusion criteria. HRQL was evaluated at baseline, at one month and at 6, 12 and 36 months after revascularisation using the SF-36 in patients treated with SES (n=585), BMS (n=483) or coronary artery bypass graft (CABG) (n=492). The HRQL compliance rates varied from 100% at baseline to 92% at 36 months. Both stenting and CABG resulted in significant improvement of HRQL and anginal status. There was a trend towards better HRQL after CABG than BMS beyond six months. Already from the first month up to three years, SES patients had, on average, 10% significantly better HRQL than BMS patients on the HRQL subscales physical functioning, role physical functioning, role emotional functioning and mental health (p<0.01) and a trend towards better HRQL in the other subscales. Up to 12 months, the HRQL was better after SES than CABG and was identical thereafter. At all time points, angina was more prevalent in the BMS group than in both the SES and CABG groups, in which the incidence of angina was similar. At three years, 10% of the SES patients suffered from angina, 13% of the CABG patients and 20% of the BMS patients. CONCLUSIONS: Both stenting and CABG resulted in a significant improvement in HRQL and angina. Along with a substantial reduction of restenosis, HRQL after SES was significantly improved as compared with BMS, and was similar to CABG.

7 Article A prospective multicentre randomised all-comers trial to assess the safety and effectiveness of the thin-strut sirolimus-eluting coronary stent SUPRAFLEX: rationale and design of the Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent (TALENT) trial. 2019

Modolo, Rodrigo / Chichareon, Ply / Kogame, Norihiro / Asano, Taku / Chang, Chun-Chin / de Winter, Robbert J / Kaul, Upendra / Zaman, Azfar / Spitzer, Ernest / Takahashi, Kuniaki / Katagiri, Yuki / Soliman, Osama I I / van Es, Gerrit A / Morel, Marie-Angèle / Onuma, Yoshinobu / Serruys, Patrick W. ·Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. ·EuroIntervention · Pubmed #30066672.

ABSTRACT: AIMS: The aim of this study is to compare the SUPRAFLEX sirolimus-eluting stent (SES) with the XIENCE everolimus-eluting stent (EES) with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real-world" patient population. METHODS AND RESULTS: This is a prospective, randomised, 1:1 balanced, controlled, single-blind, multicentre study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in an "all-comers" patient population, comprising a total of 1,430 enrolled subjects with symptomatic coronary artery disease who qualify for percutaneous coronary interventions at 23 centres in Europe. The primary endpoint is a non-inferiority comparison of the device-oriented composite endpoint target lesion failure (cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation) of the SUPRAFLEX group to the XIENCE group at 12 months post procedure. Secondary endpoints include the patient-oriented composite endpoint, target vessel failure, mortality, myocardial infarction, revascularisation and stent thrombosis rates (ARC classification). CONCLUSIONS: The TALENT trial aims to assess the safety and effectiveness of the thin-strut SUPRAFLEX compared to the current standard of care (XIENCE EES) in patients with atherosclerotic lesions. This will provide valuable information on the impact of this thin-strut device in an all-comers population.

8 Article Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial. 2018

Vranckx, Pascal / Valgimigli, Marco / Jüni, Peter / Hamm, Christian / Steg, Philippe Gabriel / Heg, Dik / van Es, Gerrit Anne / McFadden, Eugene P / Onuma, Yoshinobu / van Meijeren, Cokky / Chichareon, Ply / Benit, Edouard / Möllmann, Helge / Janssens, Luc / Ferrario, Maurizio / Moschovitis, Aris / Zurakowski, Aleksander / Dominici, Marcello / Van Geuns, Robert Jan / Huber, Kurt / Slagboom, Ton / Serruys, Patrick W / Windecker, Stephan / Anonymous28170960. ·Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Hasselt, Belgium. · Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. · Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada. · Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany. · Université Paris-Diderot, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, INSERM U-1148, French Alliance for Cardiovascular Trials, Paris, France; National Heart and Lung Institute, Royal Brompton Hospital, Imperial College London, London, UK. · Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland. · European Cardiovascular Research Institute, Rotterdam, Netherlands. · Cork University Hospital, Cork, Ireland. · Erasmus Medical Center, Rotterdam, Netherlands; Cardialysis, Rotterdam, Netherlands. · Cardialysis, Rotterdam, Netherlands. · Academic Medical Center of Amsterdam, Amsterdam, Netherlands. · Imeldaziekenhuis, Bonheiden, Belgium. · UOC Cardiologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. · American Heart of Poland, Center for Cardiovascular Research and Development, Katowice, Poland. · Azienda Ospedaliera S Maria, Terni, Italy. · Erasmus Medical Center, Rotterdam, Netherlands. · 3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenhospital and Sigmund Freud University, Medical Faculty, Vienna, Austria. · Onze Lieve vrouwe Gasthuis, Amsterdam, Netherlands. · Erasmus Medical Center, Rotterdam, Netherlands; Academic Medical Center of Amsterdam, Amsterdam, Netherlands. Electronic address: patrick.w.j.c.serruys@gmail.com. · Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address: stephan.windecker@insel.ch. ·Lancet · Pubmed #30166073.

ABSTRACT: BACKGROUND: We hypothesised that ticagrelor, in combination with aspirin for 1 month, followed by ticagrelor alone, improves outcomes after percutaneous coronary intervention compared with standard antiplatelet regimens. METHODS: GLOBAL LEADERS was a randomised, open-label superiority trial at 130 sites in 18 countries. Patients undergoing percutaneous coronary intervention with a biolimus A9-eluting stent for stable coronary artery disease or acute coronary syndromes were randomly assigned (1:1) to 75-100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy, or standard dual antiplatelet therapy with 75-100 mg aspirin daily plus either 75 mg clopidogrel daily (for patients with stable coronary artery disease) or 90 mg ticagrelor twice daily (for patients with acute coronary syndromes) for 12 months, followed by aspirin monotherapy for 12 months. Randomisation was concealed, stratified by centre and clinical presentation (stable coronary artery disease vs acute coronary syndrome), and blocked, with randomly varied block sizes of two and four. The primary endpoint at 2 years was a composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction as assessed by a core lab in a blinded manner. The key secondary safety endpoint was site-reported bleeding assessed according to the Bleeding Academic Research Consortium criteria (grade 3 or 5). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01813435, and is closed to new participants, with follow-up completed. FINDINGS: Between July 1, 2013, and Nov 9, 2015, 15 968 participants were randomly assigned, 7980 to the experimental group and 7988 to the control group. At 2 years, 304 (3·81%) participants in the experimental group had died or had a non-fatal centrally adjudicated new Q-wave myocardial infarction, compared with 349 (4·37%) participants in the control group (rate ratio 0·87 [95% CI 0·75-1·01]; p=0·073]). There was no evidence for a difference in treatment effects for the primary endpoint across prespecified subgroups of acute coronary syndromes and stable coronary artery disease (p=0·93). Grade 3 or 5 bleeding occurred in 163 participants in the experimental group and 169 in the control group (2·04% vs 2·12%; rate ratio 0·97 [95% CI 0·78-1·20]; p=0·77). INTERPRETATION: Ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not superior to 12 months of standard dual antiplatelet therapy followed by 12 months of aspirin alone in the prevention of all-cause mortality or new Q-wave myocardial infarction 2 years after percutaneous coronary intervention. FUNDING: AstraZeneca, Biosensors, and The Medicines Company.

9 Article Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. 2018

Garcia-Garcia, Hector M / McFadden, Eugène P / Farb, Andrew / Mehran, Roxana / Stone, Gregg W / Spertus, John / Onuma, Yoshinobu / Morel, Marie-Angèle / van Es, Gerrit-Anne / Zuckerman, Bram / Fearon, William F / Taggart, David / Kappetein, Arie-Pieter / Krucoff, Mitchell W / Vranckx, Pascal / Windecker, Stephan / Cutlip, Donald / Serruys, Patrick W / Anonymous3450951. ·Cardialysis, Rotterdam, The Netherlands. · Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. · Interventional Cardiology, Cork University Hospital, Cork, Ireland. · US Food and Drug Administration, Washington, DC, USA. · Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, US. · Clinical Trials Center, Cardiovascular Research Foundation and Division of Cardiology, Columbia University Medical Center, New York, US. · Mid America Heart Institute, University of Missouri, Kansas City, USA. · Stanford University Medical Center, Stanford, CA, USA. · Nuffield Department of Surgery, University of Oxford, Oxford, UK. · Department of Cardiothoracic Surgery, Thoraxcenter, Erasmus Medical Canter, Rotterdam, The Netherlands. · Duke University Medical Center/Duke Clinical Research Institute, Durham, North Carolina, US. · Hartcentrum Hasselt and Faculty of Medicine and Life Sciences University of Hasselt, Hasselt, Belgium. · Bern University Hospital, Bern, Switzerland. · Harvard Clinical Research Institute, Boston, Massachusetts; Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. · Centre for International Cardiovascular Health, Imperial College London UK. ·Eur Heart J · Pubmed #29897428.

ABSTRACT: The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.

10 Article Quality-of-Life After Everolimus-Eluting Stents or Bypass Surgery for Left-Main Disease: Results From the EXCEL Trial. 2017

Baron, Suzanne J / Chinnakondepalli, Khaja / Magnuson, Elizabeth A / Kandzari, David E / Puskas, John D / Ben-Yehuda, Ori / van Es, Gerrit-Anne / Taggart, David P / Morice, Marie-Claude / Lembo, Nicholas J / Brown, W Morris / Banning, Adrian / Simonton, Charles A / Kappetein, A Pieter / Sabik, Joseph F / Serruys, Patrick W / Stone, Gregg W / Cohen, David J / Anonymous5060925. ·Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri. · Piedmont Heart Institute, Atlanta, Georgia. · Mount Sinai Medical Center, New York, New York. · Cardiovascular Research Foundation, New York, New York. · Cardialysis, Rotterdam, the Netherlands. · Oxford University Hospitals, Oxford, United Kingdom. · Ramsay Générale de Santé, Hospital Privé Jacques Cartier, Massy, France. · Abbott Vascular Inc., Abbott Park, Illinois. · Erasmus Medical Center, Rotterdam, the Netherlands. · Cleveland Clinic Foundation, Cleveland, Ohio. · International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, United Kingdom. · Cardiovascular Research Foundation, New York, New York; New York-Presbyterian Hospital, Columbia University Medical Center, New York, New York. · Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri. Electronic address: dcohen@saint-lukes.org. ·J Am Coll Cardiol · Pubmed #29097293.

ABSTRACT: BACKGROUND: The EXCEL (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial compared outcomes in patients with unprotected left main coronary artery disease (LMCAD) treated with coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) using everolimus-eluting stents. Whereas rates of death, stroke, and myocardial infarction were similar at 36 months, event timing and repeat revascularization rates differed by treatment group. OBJECTIVES: To understand the effects of revascularization strategy from the patient's perspective, a prospective quality of life (QoL) substudy was performed alongside the EXCEL trial. METHODS: Between September 2010 and March 2014, 1,905 patients with LMCAD were randomized to undergo CABG or PCI, of whom 1,788 participated in the QoL substudy. QoL was assessed at baseline and 1, 12, and 36 months using the Seattle Angina Questionnaire, the 12-Item Short Form Health Survey, the Rose Dyspnea Scale, the Patient Health Questionnaire-8, and the EQ-5D. Differences between PCI and CABG were assessed using longitudinal random-effect growth curve models. RESULTS: Over 36 months, both PCI and CABG were associated with significant improvements in QoL compared with baseline. At 1 month, PCI was associated with better QoL than CABG. By 12 months though, these differences were largely attenuated, and by 36 months, there were no significant QoL differences between PCI and CABG. CONCLUSIONS: Among selected patients with LMCAD, both PCI and CABG result in similar QoL improvement through 36 months, although a greater early benefit is seen with PCI. Taken together with the 3-year clinical results of EXCEL, these findings suggest that PCI and CABG provide similar intermediate-term outcomes for patients with LMCAD. (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776).

11 Article Design and rationale for a randomised comparison of everolimus-eluting stents and coronary artery bypass graft surgery in selected patients with left main coronary artery disease: the EXCEL trial. 2016

Kappetein, Arie Pieter / Serruys, Patrick W / Sabik, Joseph F / Leon, Martin B / Taggart, David P / Morice, Marie-Claude / Gersh, Bernard J / Pocock, Stuart J / Cohen, David J / Wallentin, Lars / Ben-Yehuda, Ori / van Es, Gerrit-Anne / Simonton, Charles A / Stone, Gregg W. ·Department of Cardiothoracic Surgery, Erasmus Medical Center, Rotterdam, The Netherlands. ·EuroIntervention · Pubmed #27639738.

ABSTRACT: AIMS: Coronary artery bypass graft (CABG) surgery is the standard of care for revascularisation of patients with left main coronary artery disease (LMCAD). Recent studies have suggested that percutaneous coronary intervention (PCI) with drug-eluting stents (DES) may provide comparable outcomes in selected patients with LMCAD without extensive CAD. We therefore designed a trial to investigate whether PCI with XIENCE cobalt-chromium everolimus-eluting stents (CoCr-EES) would result in non-inferior or superior clinical outcomes to CABG in selected patients with LMCAD. METHODS AND RESULTS: The Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is a prospective, open-label, multicentre, international study of 1,900 randomised subjects. Patients with significant LMCAD with a SYNTAX score ≤32 and local Heart Team consensus that the subject is appropriate for revascularisation by both PCI and CABG are consented and randomised 1:1 to undergo PCI using CoCr-EES or CABG. All patients undergo follow-up for five years. The primary endpoint is the three-year composite rate of death, stroke or myocardial infarction, assessed at a median follow-up of at least three years (with at least two-year follow-up in all patients), powered for sequential non-inferiority and superiority testing. CONCLUSIONS: The EXCEL study will define the contemporary roles of CABG and PCI using XIENCE CoCr-EES in patients with LMCAD disease with low and intermediate SYNTAX scores.

12 Article Optical coherence tomography versus intravascular ultrasound in the evaluation of observer variability and reliability in the assessment of stent deployment: the OCTIVUS study. 2015

Magnus, Patrick C / Jayne, John E / Garcia-Garcia, Hector M / Swart, Michael / van Es, Gerrit-Anne / Tijssen, Jan / Kaplan, Aaron V. ·Cardiac Catheterization Laboratories, Heart and Vascular Center, Dartmouth-Hitchcock Medical Center/Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire. · Cardialysis BV, Rotterdam, The Netherlands. ·Catheter Cardiovasc Interv · Pubmed #25620044.

ABSTRACT: OBJECTIVES: To compare the variability in the assessment of coronary stents among interventional cardiologists (readers) using optical coherence tomography (OCT) and intravascular ultrasound (IVUS). BACKGROUND: IVUS is established and validated in the evaluation of coronary stent. For cardiologists without core lab expertise, the utility of IVUS is limited by image quality. OCT yields higher image resolution; however, the consistency with which these readers interpret OCT images has not been fully evaluated or compared with IVUS. METHODS: OCT and IVUS image sets (five pairs) obtained after stent placement were reviewed by readers with clinical experience in both modalities. Parameters assessed included stent expansion and symmetry, reference vessel and in-stent cross-sectional area (CSA) and diameter, and stent strut apposition as well as Multicenter Ultrasound Stenting in Coronaries criteria. These interpretations were compared with core lab readings and examined for interobserver variability. RESULTS: The interobserver variability for measurement of in-stent CSA was 1.34 mm(2) using IVUS compared with 0.85 mm(2) using OCT (P = 0.024). Variation in the deviation from core lab measurement of in-stent CSA for IVUS was 1.48 mm(2) compared with 0.87 mm(2) for OCT (P = 0.042). The interobserver agreement for obtaining the Multicenter Ultrasound Stenting in Coronaries criteria using IVUS was 80.4% compared with 81.1% using OCT (P = 0.78). Compared with the corelab measurement, the readers obtained an agreement of 72.7% using IVUS vs. 67.3% using OCT (P = 0.43). CONCLUSION: In the assessment of deployed coronary stents by practicing cardiologists, OCT images are interpreted more consistently compared with IVUS and can be used to assess stent deployment using IVUS-validated metrics.

13 Article Biolimus-eluting stent with biodegradable polymer improves clinical outcomes in patients with acute myocardial infarction. 2015

Zhang, Yao-Jun / Iqbal, Javaid / Windecker, Stephan / Linke, Axel / Antoni, Diethmar / Sohn, Hae Young / Corti, Roberto / van Es, Gerrit-Anne / Copt, Samuel / Eerdmans, Pedro / Saitta, Rana / Morice, Marie-Claude / Di Mario, Carlo / Juni, Peter / Wijns, William / Buszman, Pawel / Serruys, Patrick W. ·Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands Nanjing Medical University, Nanjing First Hospital, Nanjing, China. · Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. · Department of Cardiology, University of Bern, Bern, Switzerland. · Herzzentrum Leipzig, Leipzig, Germany. · Department of Cardiology, Hospital Bogenhausen, Munich, Germany. · Department of Cardiology, University Hospital Munich, Munich, Germany. · HerzKlinik Hirslanden, Zürich, Switzerland. · Cardialysis BV, Rotterdam, The Netherlands. · Biosensors Europe SA, Morges, Switzerland. · Institut Cardiovasculaire Paris-Sud, Institut Hospitalier Jacques-Cartier, Massy, France. · NIHR Cardiovascular Biomedical Research Unit, Royal Brompton Hospital, London, UK. · CTU, University of Bern, Bern, Switzerland. · Department of Cardiology, Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium. · American Heart of Poland, Ustroń, Poland. ·Heart · Pubmed #25423953.

ABSTRACT: OBJECTIVE: To investigate clinical outcomes of coronary intervention using a biolimus-eluting stent (BES) compared with a sirolimus-eluting stent (SES) in patients with acute myocardial infarction (AMI) in the Limus Eluted from A Durable versus ERodable Stent (LEADERS) coating trial at the final 5-year follow-up. METHODS: The LEADERS trial is a multicentre all-comer study, where patients (n=1707) were randomised to percutaneous intervention with either BES containing biodegradable polymer or SES containing durable polymer. Out of 1707 patients enrolled in this trial, 573 patients had percutaneous coronary intervention for AMI (BES=280, SES=293) and were included in the current analysis. Patient-oriented composite endpoint (POCE, including all death, all myocardial infarction (MI) and all revascularisations), major adverse cardiac events (MACE, including cardiac death, MI and clinically indicated target vessel revascularisation) and stent thrombosis were assessed at 5-year follow-up. RESULTS: The baseline clinical, angiographic and procedural characteristics were well matched between BES and SES groups. In all patients with AMI, coronary intervention with a BES, compared with SES, significantly reduced POCE (28.9% vs 42.3%; relative risk (RR) 0.61, 95% CI 0.47 to 0.82, p=0.001) at 5-year follow-up. There was also a reduction in MACE rate in the BES group (18.2% vs 25.9%; RR 0.67, 95% CI 0.47 to 0.95, p=0.025); however, there was no difference in cardiac death and stent thrombosis. In patients with ST-elevation MI (STEMI), coronary intervention with BES significantly reduced POCE (24.4% vs 39.3%; RR 0.55, 95% CI 0.36 to 0.85, p=0.006), MACE (12.6% vs 25.0%; RR 0.47, 95% CI 0.26 to 0.83, p=0.008) and cardiac death (3.0% vs 11.4%; RR 0.25, 95% CI 0.08 to 0.75, p=0.007), along with a trend towards reduction in definite stent thrombosis (3.7% vs 8.6%; RR 0.41, 95% CI 0.15 to 1.18, p=0.088), compared with SES. CONCLUSIONS: BES, compared with SES, significantly improved safety and efficacy outcomes in patients with AMI, especially those with STEMI, at 5-year follow-up. TRIAL REGISTRATION NUMBER: NCT 00389220.

14 Article Temporal evolution of strut light intensity after implantation of bioresorbable polymeric intracoronary scaffolds in the ABSORB cohort B trial-an application of a new quantitative method based on optical coherence tomography. 2014

Nakatani, Shimpei / Onuma, Yoshinobu / Ishibashi, Yuki / Eggermont, Jeroen / Zhang, Yao-Jun / Campos, Carlos M / Cho, Yun Kyeong / Liu, Shengnan / Dijkstra, Jouke / Reiber, Johan H C / Perkins, Laura / Sheehy, Alexander / Veldhof, Susan / Rapoza, Richard / van Es, Gerrit-Anne / Garcia-Garcia, Hector M / van Geuns, Robert-Jan / Serruys, Patrick W / Anonymous5950797. ·Thoraxcenter, Department of Cardiology, Erasmus MC. ·Circ J · Pubmed #24942012.

ABSTRACT: BACKGROUND: Quantitative light intensity analysis of the strut core by optical coherence tomography (OCT) may enable assessment of changes in the light reflectivity of the bioresorbable polymeric scaffold from polymer to provisional matrix and connective tissues, with full disappearance and integration of the scaffold into the vessel wall. The aim of this report was to describe the methodology and to apply it to serial human OCT images post procedure and at 6, 12, 24 and 36 months in the ABSORB cohort B trial. METHODS AND RESULTS: In serial frequency-domain OCT pullbacks, corresponding struts at different time points were identified by 3-dimensional foldout view. The peak and median values of light intensity were measured in the strut core by dedicated software. A total of 303 corresponding struts were serially analyzed at 3 time points. In the sequential analysis, peak light intensity increased gradually in the first 24 months after implantation and reached a plateau (relative difference with respect to baseline [%Dif]: 61.4% at 12 months, 115.0% at 24 months, 110.7% at 36 months), while the median intensity kept increasing at 36 months (%Dif: 14.3% at 12 months, 75.0% at 24 months, 93.1% at 36 months). CONCLUSIONS: Quantitative light intensity analysis by OCT was capable of detecting subtle changes in the bioresorbable strut appearance over time, and could be used to monitor the bioresorption and integration process of polylactide struts.

15 Article Impact of 3-dimensional bifurcation angle on 5-year outcome of patients after percutaneous coronary intervention for left main coronary artery disease: a substudy of the SYNTAX trial (synergy between percutaneous coronary intervention with taxus and cardiac surgery). 2013

Girasis, Chrysafios / Farooq, Vasim / Diletti, Roberto / Muramatsu, Takashi / Bourantas, Christos V / Onuma, Yoshinobu / Holmes, David R / Feldman, Ted E / Morel, Marie-Angele / van Es, Gerrit-Anne / Dawkins, Keith D / Morice, Marie-Claude / Serruys, Patrick W. ·Department of Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands. · Department of Cardiovascular Disease and Internal Medicine, Mayo Clinic, Rochester, Minnesota. · Division of Cardiology, Evanston Hospital, Evanston, Illinois. · Cardialysis B.V., Rotterdam, the Netherlands. · Boston Scientific Corporation, Natick, Massachusetts. · Department of Cardiology, Institut Cardiovasculaire Paris Sud, Massy, France. · Department of Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands. Electronic address: p.w.j.c.serruys@erasmusmc.nl. ·JACC Cardiovasc Interv · Pubmed #24355115.

ABSTRACT: OBJECTIVES: This study sought to investigate the impact of left main coronary artery (LMCA) 3-dimensional (3D) bifurcation angle (BA) parameters on 5-year clinical outcomes of patients randomized to LMCA percutaneous coronary intervention (PCI) in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial. BACKGROUND: BA can affect outcome after bifurcation PCI; 3D angiographic analysis provides reliable BA measurements. METHODS: The diastolic distal BA (between left anterior descending and left circumflex) and its systolic-diastolic range were explored. A stratified post-hoc survival analysis was performed for 5-year major adverse cardiac and cardiovascular events (MACCE) (all-cause death, cerebrovascular accident, myocardial infarction, or repeat revascularization), a safety endpoint (all-cause death, cerebrovascular accident, or myocardial infarction), and repeat revascularization. Analysis was performed in patients where 3D BA was available pre- and post-PCI. RESULTS: Of 266 patients eligible for analysis, 185 underwent bifurcation PCI (group B); 1 stent was used in 75 patients (group B1), whereas ≥2 stents were used in 110 patients (group B2). Stratification across pre-PCI diastolic distal BA tertiles (<82°, 82° to 106°, ≥107°) failed to show any difference in MACCE rates either in the entire study population (p = 0.99) or in group B patients (p = 0.78). Group B patients with post-PCI systolic-diastolic range <10° had significantly higher MACCE rates (50.8% vs. 22.7%, p < 0.001); repeat revascularization and safety endpoint rates were also higher (37.4% vs. 15.5%, p = 0.002, and 25.4% vs. 14.1%, p=0.055, respectively). Post-PCI systolic-diastolic range <10° was an independent predictor of MACCE (hazard ratio: 2.65; 95% confidence interval: 1.55 to 4.52; p < 0.001) in group B patients. CONCLUSIONS: A restricted post-procedural systolic-diastolic distal BA range resulted in higher 5-year adverse event rates after LMCA bifurcation PCI. Pre-PCI BA value did not affect the clinical outcome.

16 Article Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. 2013

Serruys, Patrick W / Farooq, Vasim / Kalesan, Bindu / de Vries, Ton / Buszman, Pawel / Linke, Axel / Ischinger, Thomas / Klauss, Volker / Eberli, Franz / Wijns, William / Morice, Marie Claude / Di Mario, Carlo / Corti, Roberto / Antoni, Diethmar / Sohn, Hae Y / Eerdmans, Pedro / Rademaker-Havinga, Tessa / van Es, Gerrit-Anne / Meier, Bernhard / Jüni, Peter / Windecker, Stephan. ·Thoraxcenter, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands. p.w.j.c.serruys@erasmusmc.nl ·JACC Cardiovasc Interv · Pubmed #23968698.

ABSTRACT: OBJECTIVES: This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. BACKGROUND: The LEADERS trial is the first randomized study to evaluate biodegradable polymer-based drug-eluting stents (DES) against durable polymer DES. METHODS: The LEADERS trial was a 10-center, assessor-blind, noninferiority, "all-comers" trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The primary endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary endpoints included extending the primary endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. RESULTS: At 5 years, the BES was noninferior to SES for the primary endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority <0.0001, p for superiority = 0.069). The BES was associated with a significant reduction in the more comprehensive patient-orientated composite endpoint of all-cause death, any MI, and all-cause revascularization (297 [35.1%] vs. 339 [40.4%], RR: 0.84 [95% CI: 0.71 to 0.98], p for superiority = 0.023). A significant reduction in very late definite ST from 1 to 5 years was evident with the BES (n = 5 [0.7%] vs. n = 19 [2.5%], RR: 0.26 [95% CI: 0.10 to 0.68], p = 0.003), corresponding to a significant reduction in ST-associated clinical events (primary endpoint) over the same time period (n = 3 of 749 vs. n = 14 of 738, RR: 0.20 [95% CI: 0.06 to 0.71], p = 0.005). CONCLUSIONS: The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220).

17 Article The CABG SYNTAX Score - an angiographic tool to grade the complexity of coronary disease following coronary artery bypass graft surgery: from the SYNTAX Left Main Angiographic (SYNTAX-LE MANS) substudy. 2013

Farooq, Vasim / Girasis, Chrysafios / Magro, Michael / Onuma, Yoshinobu / Morel, Marie Angèle / Heo, Jung Ho / Garcia-Garcia, Hector / Kappetein, Arie Pieter / van den Brand, Marcel / Holmes, David R / Mack, Michael / Feldman, Ted / Colombo, Antonio / Ståhle, Elisabeth / James, Stefan / Carrié, Didier / Fournial, Gerard / van Es, Gerrit-Anne / Dawkins, Keith D / Mohr, Friedrich W / Morice, Marie-Claude / Serruys, Patrick W. ·Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands. ·EuroIntervention · Pubmed #23537954.

ABSTRACT: AIMS: The SYNTAX Score (SXscore) has established itself as an important prognostic tool in patients undergoing percutaneous coronary intervention (PCI). A limitation of the SXscore is the inability to differentiate outcomes in patients who have undergone prior coronary artery bypass graft (CABG) surgery. The CABG SXscore was devised to address this limitation. METHODS AND RESULTS: In the SYNTAX-LE MANS substudy 115 patients with unprotected left main coronary artery disease (isolated or associated with one, two or three-vessel disease) treated with CABG were prospectively assigned to undergo a 15-month coronary angiogram. An independent core laboratory analysed the baseline SXscore prior to CABG. The 15-month CABG SXscore was calculated by a panel of three interventional cardiologists. The CABG SXscore was calculated by determining the standard SXscore in the "native" coronary vessels ("native SXscore") and deducting points based on the importance of the diseased coronary artery segment (Leaman score) that have a functioning bypass graft anastomosed distally. Points relating to intrinsic coronary disease, such as bifurcation disease or calcification, remain unaltered. The mean 15-month CABG SXscore was significantly lower compared to the mean baseline SXscore (baseline SXscore 31.6, SD 13.1; 15-month CABG SXscore 21.2, SD 11.1; p<0.001). Reproducibility analyses (kappa [k] statistics) indicated a substantial agreement between CABG SXscore measurements (k=0.70; 95% CI [0.50-0.90], p<0.001), with the points deducted to calculate the CABG SXscore the most reproducible measurement (k=0.74; 95% CI [0.53-0.95], p<0.001). Despite the limited power of the study, four-year outcome data (Kaplan-Meier curves) demonstrated a trend towards reduced all-cause death (9.1% vs. 1.8%, p=0.084) and death/CVA/MI (16.4% vs. 7.0%, p=0.126) in the low compared to the high CABG SXscore group. CONCLUSIONS: In this pilot study the calculation of the CABG SXscore appeared feasible, reproducible and may have a long-term prognostic role in patients with complex coronary disease undergoing surgical revascularisation. Validation of this new scoring methodology is required.

18 Article Anatomical and clinical characteristics to guide decision making between coronary artery bypass surgery and percutaneous coronary intervention for individual patients: development and validation of SYNTAX score II. 2013

Farooq, Vasim / van Klaveren, David / Steyerberg, Ewout W / Meliga, Emanuele / Vergouwe, Yvonne / Chieffo, Alaide / Kappetein, Arie Pieter / Colombo, Antonio / Holmes, David R / Mack, Michael / Feldman, Ted / Morice, Marie-Claude / Ståhle, Elisabeth / Onuma, Yoshinobu / Morel, Marie-angèle / Garcia-Garcia, Hector M / van Es, Gerrit Anne / Dawkins, Keith D / Mohr, Friedrich W / Serruys, Patrick W. ·Thoraxcenter, Erasmus University Medical Center, Rotterdam, Netherlands. ·Lancet · Pubmed #23439103.

ABSTRACT: BACKGROUND: The anatomical SYNTAX score is advocated in European and US guidelines as an instrument to help clinicians decide the optimum revascularisation method in patients with complex coronary artery disease. The absence of an individualised approach and of clinical variables to guide decision making between coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) are limitations of the SYNTAX score. SYNTAX score II aimed to overcome these limitations. METHODS: SYNTAX score II was developed by applying a Cox proportional hazards model to results of the randomised all comers SYNTAX trial (n=1800). Baseline features with strong associations to 4-year mortality in either the CABG or the PCI settings (interactions), or in both (predictive accuracy), were added to the anatomical SYNTAX score. Comparisons of 4-year mortality predictions between CABG and PCI were made for each patient. Discriminatory performance was quantified by concordance statistics and internally validated with bootstrap resampling. External validation was done in the multinational all comers DELTA registry (n=2891), a heterogeneous population that included patients with three-vessel disease (26%) or complex coronary artery disease (anatomical SYNTAX score ≥33, 30%) who underwent CABG or PCI. The SYNTAX trial is registered with ClinicalTrials.gov, number NCT00114972. FINDINGS: SYNTAX score II contained eight predictors: anatomical SYNTAX score, age, creatinine clearance, left ventricular ejection fraction (LVEF), presence of unprotected left main coronary artery (ULMCA) disease, peripheral vascular disease, female sex, and chronic obstructive pulmonary disease (COPD). SYNTAX score II significantly predicted a difference in 4-year mortality between patients undergoing CABG and those undergoing PCI (p(interaction) 0·0037). To achieve similar 4-year mortality after CABG or PCI, younger patients, women, and patients with reduced LVEF required lower anatomical SYNTAX scores, whereas older patients, patients with ULMCA disease, and those with COPD, required higher anatomical SYNTAX scores. Presence of diabetes was not important for decision making between CABG and PCI (p(interaction) 0·67). SYNTAX score II discriminated well in all patients who underwent CABG or PCI, with concordance indices for internal (SYNTAX trial) validation of 0·725 and for external (DELTA registry) validation of 0·716, which were substantially higher than for the anatomical SYNTAX score alone (concordance indices of 0·567 and 0·612, respectively). A nomogram was constructed that allowed for an accurate individualised prediction of 4-year mortality in patients proposing to undergo CABG or PCI. INTERPRETATION: Long-term (4-year) mortality in patients with complex coronary artery disease can be well predicted by a combination of anatomical and clinical factors in SYNTAX score II. SYNTAX score II can better guide decision making between CABG and PCI than the original anatomical SYNTAX score. FUNDING: Boston Scientific Corporation.

19 Article The negative impact of incomplete angiographic revascularization on clinical outcomes and its association with total occlusions: the SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial. 2013

Farooq, Vasim / Serruys, Patrick W / Garcia-Garcia, Hector M / Zhang, Yaojun / Bourantas, Christos V / Holmes, David R / Mack, Michael / Feldman, Ted / Morice, Marie-Claude / Ståhle, Elisabeth / James, Stefan / Colombo, Antonio / Diletti, Roberto / Papafaklis, Michail I / de Vries, Ton / Morel, Marie-Angèle / van Es, Gerrit Anne / Mohr, Friedrich W / Dawkins, Keith D / Kappetein, Arie-Pieter / Sianos, Georgios / Boersma, Eric. ·Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, the Netherlands. ·J Am Coll Cardiol · Pubmed #23265332.

ABSTRACT: OBJECTIVES: The study sought to evaluate the clinical impact of angiographic complete (CR) and incomplete (ICR) revascularization and its association with the presence of total occlusions (TO), after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery in the "all-comers" SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial. BACKGROUND: In patients with complex coronary artery disease undergoing PCI or CABG, the long-term prognostic implications of CR versus ICR is unsettled. METHODS: In this post hoc study, consisting of randomized (n = 1,800) and nested PCI (n = 198) and CABG (n = 649) registries, 4-year clinical outcomes were compared in groups, with and without angiographic CR, in the PCI and CABG arms. Clinical outcomes were analyzed with Kaplan-Meier estimates, log-rank comparisons, and Cox regression analyses. Multivariate predictors of ICR were determined. Similar analyses were undertaken in the TO and non-TO treated groups of both study arms. RESULTS: Angiographic CR was achieved in 52.8% of the PCI arm and 66.9% of the CABG arm. Within the PCI and CABG arms, ICR (compared with CR) seemed to be a surrogate marker of a greater burden of anatomical coronary complexity and clinical comorbidity and was associated with significantly higher frequencies of 4-year mortality, all-cause revascularization, stent thrombosis (PCI arm), and major adverse cardiac and cerebrovascular events. The presence of a TO was the strongest independent predictor of ICR after PCI (hazard ratio: 2.70, 95% confidence interval: 1.98 to 3.67, p < 0.001). Eight hundred and forty patients (PCI: 26.3%, CABG: 36.4%, p < 0.001) were identified to have 1,007 TOs, with 68.1% of TOs located in the proximal-mid coronary vasculature. The findings associating ICR (compared with CR) with higher frequencies of 4-year mortality and major adverse cardiac and cerebrovascular events remained consistent in the TO-treated groups in the PCI and CABG arms. CONCLUSIONS: Within the PCI and CABG arms of the all-comers SYNTAX trial, angiographically determined ICR has a detrimental impact on long-term clinical outcomes, including mortality. This effect remained consistent in patients with and without TOs.

20 Article Incidence and multivariable correlates of long-term mortality in patients treated with surgical or percutaneous revascularization in the synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) trial. 2012

Farooq, Vasim / Serruys, Patrick W / Bourantas, Christos / Vranckx, Pascal / Diletti, Roberto / Garcia Garcia, Hector M / Holmes, David R / Kappetein, Arie-Pieter / Mack, Michael / Feldman, Ted / Morice, Marie Claude / Colombo, Antonio / Morel, Marie-angèle / de Vries, Ton / van Es, Gerrit Anne / Steyerberg, Ewout W / Dawkins, Keith D / Mohr, Friedrich W / James, Stefan / Ståhle, Elisabeth. ·Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, s-Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands. ·Eur Heart J · Pubmed #23103663.

ABSTRACT: AIMS: The aim of this investigation was to determine the incidence and multivariable correlates of long-term (4-year) mortality in patients treated with surgical or percutaneous revascularization in the synergy between percutaneous coronary intervention (PCI) with TAXUS Express and Cardiac Surgery (SYNTAX) trial. METHODS AND RESULTS: A total of 1800 patients were randomized to undergo coronary artery bypass graft (CABG) surgery (n = 897) or PCI (n = 903). Prospectively collected baseline and peri- and post-procedural data were used to determine independent correlates of 4-year all-cause death in the CABG and the PCI arms (Cox proportional hazards model). Four-year mortality rates in the CABG and the PCI arms were 9.0% [74 deaths (12 in-hospital)] and 11.8% [104 deaths (16 in-hospital)], respectively (log-rank P-value = 0.063). Censored data comprised 78 patients (8.7%) in the CABG arm, and 24 patients (2.7%) in the PCI arm (log-rank P-value < 0.001). Within the CABG arm, the strongest independent correlates of 4-year mortality were lack of discharge aspirin [hazard ratio (HR) 3.56; 95% CI: 2.04, 6.21; P < 0.001], peripheral vascular disease (PVD) (HR: 2.65; 95% CI: 1.49, 4.72; P = 0.001), chronic obstructive pulmonary disease, age, and serum creatinine. Within the PCI arm, the strongest independent correlate of 4-year mortality was lack of post-procedural anti-platelet therapy (HR: 152.16; 95% CI: 53.57, 432.22; P < 0.001), with 10 reported early (within 45 days) in-hospital deaths secondary to multifactorial causes precluding administration of anti-platelet therapy. Other independent correlates of mortality in the PCI arm included amiodarone therapy on discharge, pre-procedural poor left ventricular ejection fraction, a 'history of gastrointestinal bleeding or peptic ulcer disease', PVD (HR: 2.13; 95% CI: 1.26, 3.60; P = 0.005), age, female gender (HR: 1.60; 95% CI: 1.01, 2.56; P = 0.048), and the SYNTAX score (Per increase in 10 points: HR: 1.25; 95% CI: 1.06, 1.47; P = 0.007). CONCLUSION: Independent correlates of 4-year mortality in the SYNTAX trial were multifactorial. Lack of discharge aspirin and lack of post-procedural anti-platelet therapy were the strongest independent correlates of mortality in the CABG and the PCI arms, respectively. Peripheral vascular disease is a common independent correlate of 4-year mortality and may be a marker of the severity of baseline coronary disease and risk of future native coronary disease (and extra-cardiac disease) progression.

21 Article Different cardiac biomarkers to detect peri-procedural myocardial infarction in contemporary coronary stent trials: impact on outcome reporting. 2012

Vranckx, Pascal / Farooq, Vasim / Garg, Scot / Van Es, Gerrit-Anne / Silber, Sigmund / Windecker, Stephan / Stone, Gregg W / Serruys, Patrick W. ·Department of Cardiac Intensive Care and Interventional Cardiology, Hartcentrum Hasselt, Hasselt, Belgium. ·Heart · Pubmed #22821273.

ABSTRACT: OBJECTIVE: To assess the differential implications of cardiac biomarker type on peri-procedural myocardial infarction (PMI) reporting. SETTING: The Resolute 'All-Comers' stent trial. INTERVENTIONS: Blood samples for creatine kinase (CK), CK-myoband (CK-MB) mass or cardiac troponin (cTn) (optional) were collected before and at 6, 12 and 18 h after the assigned percutaneous coronary intervention or at discharge. PMIs were adjudicated using either the 2007 universal definition of MI (type-4a) or the extended historical definition of MI. PATIENTS: 2121/2292 patients (92.5%) had an analysable dataset for either biomarker. 890/2121 patients (42%) presented with an acute coronary syndrome (ACS). 267/890 patients (30%) were within 24 h of an ST-segment elevation MI. MAIN OUTCOME MEASURES: Type-4a MI was diagnosed in 208/2121 patients (9.8%) when cTn was used (CK-MB mass if cTn not available), and in 93/2121 of patients (4.4%) when CK-MB mass was used (cTn if CK-MB mass not available). With the extended historical CK-based definition of MI, PMI was diagnosed in 65/2121 patients (3.1%). Adjudication of type-4a MI in patients with an ACS was problematic with <10% of the potential type-4a MI being confirmed as an event, as compared with approximately 95% in stable patients undergoing elective PCI. Type-4a MI was not associated with the subsequent hazard for cardiac mortality (p=0.6). CONCLUSIONS: The percentage of adjudicated PMI events is driven by the MI-definition criteria and biomarker type. Type-4a MI may not be a reliable component of the primary composite end point in coronary stent investigations which recruit patients with ACS. TRIAL REGISTRATION NUMBER: http://www.ClinicalTrials.gov; Unique identifier: NCT00617084.

22 Article A global risk approach to identify patients with left main or 3-vessel disease who could safely and efficaciously be treated with percutaneous coronary intervention: the SYNTAX Trial at 3 years. 2012

Serruys, Patrick W / Farooq, Vasim / Vranckx, Pascal / Girasis, Chrysafios / Brugaletta, Salvatore / Garcia-Garcia, Hector M / Holmes, David R / Kappetein, Arie-Pieter / Mack, Michael J / Feldman, Ted / Morice, Marie-Claude / Ståhle, Elisabeth / James, Stefan / Colombo, Antonio / Pereda, Peggy / Huang, Jian / Morel, Marie-Angèle / Van Es, Gerrit-Anne / Dawkins, Keith D / Mohr, Friedrich W / Steyerberg, Ewout W. ·Department of Interventional Cardiology, Erasmus University, Medical Centre, Thoraxcenter, Rotterdam, the Netherlands. p.w.j.c.serruys@erasmusmc.nl ·JACC Cardiovasc Interv · Pubmed #22721655.

ABSTRACT: OBJECTIVES: The aim of this study was to assess the additional value of the Global Risk--a combination of the SYNTAX Score (SXscore) and additive EuroSCORE--in the identification of a low-risk population, who could safely and efficaciously be treated with coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI). BACKGROUND: PCI is increasingly acceptable in appropriately selected patients with left main stem or 3-vessel coronary artery disease. METHODS: Within the SYNTAX Trial (Synergy between PCI with TAXUS and Cardiac Surgery Trial), all-cause death and major adverse cardiac and cerebrovascular events (MACCE) were analyzed at 36 months in low (GRC(LOW)) to high Global Risk groups, with Kaplan-Meier, log-rank, and Cox regression analyses. RESULTS: Within the randomized left main stem population (n = 701), comparisons between GRC(LOW) groups demonstrated a significantly lower mortality with PCI compared with CABG (CABG: 7.5%, PCI: 1.2%, hazard ratio [HR]: 0.16, 95% confidence interval [CI]: 0.03 to 0.70, p = 0.0054) and a trend toward reduced MACCE (CABG: 23.1%, PCI: 15.8%, HR: 0.64, 95% CI: 0.39 to 1.07, p = 0.088). Similar analyses within the randomized 3-vessel disease population (n = 1,088) demonstrated no statistically significant differences in mortality (CABG: 5.2%, PCI: 5.8%, HR: 1.14, 95% CI: 0.57 to 2.30, p = 0.71) or MACCE (CABG: 19.0%, PCI: 24.7%, HR: 1.35, 95% CI: 0.95 to 1.92, p = 0.10). Risk-model performance and reclassification analyses demonstrated that the EuroSCORE-with the added incremental benefit of the SXscore to form the Global Risk-enhanced the risk stratification of all PCI patients. CONCLUSIONS: In comparison with the SXscore, the Global Risk, with a simple treatment algorithm, substantially enhances the identification of low-risk patients who could safely and efficaciously be treated with CABG or PCI.

23 Article Relationship between palpography and virtual histology in patients with acute coronary syndromes. 2012

Brugaletta, Salvatore / Garcia-Garcia, Hector M / Serruys, Patrick W / Maehara, Akiko / Farooq, Vasim / Mintz, Gary S / de Bruyne, Bernard / Marso, Steven P / Verheye, Stefan / Dudek, Dariusz / Hamm, Christian W / Farhat, Nahim / Schiele, Francois / McPherson, John / Lerman, Amir / Moreno, Pedro R / Wennerblom, Bertil / Fahy, Martin / Templin, Barry / Morel, Marie-Angel / van Es, Gerrit Anne / Stone, Gregg W. ·Erasmus University, Thoraxcentrum, Rotterdam, the Netherlands. ·JACC Cardiovasc Imaging · Pubmed #22421227.

ABSTRACT: OBJECTIVES: The purpose of this study was to correlate adverse events at long-term follow-up in patients after an acute coronary syndrome with coronary plaque characteristics derived from simultaneous evaluation of their mechanical and compositional properties using virtual histology (intravascular ultrasound virtual histology) and palpography. BACKGROUND: Fibroatheroma is the plaque morphology with the highest risk of causing adverse cardiac events. Palpography can potentially assess the local mechanical plaque properties with the possibility of identifying fibroatheroma with the highest risk of rupture. METHODS: A total of 114 patients with acute coronary syndrome from the PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) trial underwent a single ultrasound imaging investigation of their 3 coronary vessels with the co-registration of intravascular ultrasound virtual histology and palpography. Major adverse cardiac events (MACE) (cardiac death, cardiac arrest, myocardial infarction, or unstable or progressive angina) were collected up to a median follow-up of 3.4 years and adjudicated to originally treated culprit versus untreated nonculprit lesions. RESULTS: In total, 488 necrotic core-rich plaques were identified and subclassified as thin-cap fibroatheroma (n = 111), calcified thick-cap fibroatheroma (n = 213), and noncalcified thick-cap fibroatheroma (n = 164) and matched to their co-registered palpography data. A total of 16 MACE, adjudicated to untreated nonculprit lesions, were recorded at follow-up. In patients in whom MACE developed, fibroatheroma were larger (plaque area 10.0 mm(2) [range: 8.4 to 11.6 mm(2)] vs. 8.2 mm(2) [range: 7.7 to 8.8 mm(2)] (p = 0.03) compared with patients who were MACE free. By palpography, the maximum and the density strain values did not differ between the varying subtypes of fibroatheroma of patients with or without MACE during follow-up. CONCLUSIONS: In acute coronary syndromes, patients treated with stents and contemporary pharmacotherapy, palpography did not provide additional diagnostic information for the identification of fibroatheroma with a high risk of rupture and MACE during long-term follow-up. (Providing Regional Observations to Study Predictors of Events in the Coronary Tree [PROSPECT]: An Imaging Study in Patients With Unstable Atherosclerotic Lesions; NCT00180466).

24 Article Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial. 2011

Stefanini, Giulio G / Kalesan, Bindu / Serruys, Patrick W / Heg, Dik / Buszman, Pawel / Linke, Axel / Ischinger, Thomas / Klauss, Volker / Eberli, Franz / Wijns, William / Morice, Marie-Claude / Di Mario, Carlo / Corti, Roberto / Antoni, Diethmar / Sohn, Hae Y / Eerdmans, Pedro / van Es, Gerrit-Anne / Meier, Bernhard / Windecker, Stephan / Jüni, Peter. ·Department of Cardiology, University of Bern, Switzerland. ·Lancet · Pubmed #22075451.

ABSTRACT: BACKGROUND: The effectiveness of durable polymer drug-eluting stents comes at the expense of delayed arterial healing and subsequent late adverse events such as stent thrombosis (ST). We report the 4 year follow-up of an assessment of biodegradable polymer-based drug-eluting stents, which aim to improve safety by avoiding the persistent inflammatory stimulus of durable polymers. METHODS: We did a multicentre, assessor-masked, non-inferiority trial. Between Nov 27, 2006, and May 18, 2007, patients aged 18 years or older with coronary artery disease were randomly allocated with a computer-generated sequence to receive either biodegradable polymer biolimus-eluting stents (BES) or durable polymer sirolimus-eluting stents (SES; 1:1 ratio). The primary endpoint was a composite of cardiac death, myocardial infarction, or clinically-indicated target vessel revascularisation (TVR); patients were followed-up for 4 years. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00389220. FINDINGS: 1707 patients with 2472 lesions were randomly allocated to receive either biodegradable polymer BES (857 patients, 1257 lesions) or durable polymer SES (850 patients, 1215 lesions). At 4 years, biodegradable polymer BES were non-inferior to durable polymer SES for the primary endpoint: 160 (18·7%) patients versus 192 (22·6%) patients (rate ratios [RR] 0·81, 95% CI 0·66-1·00, p for non-inferiority <0·0001, p for superiority=0·050). The RR of definite ST was 0·62 (0·35-1·08, p=0·09), which was largely attributable to a lower risk of very late definite ST between years 1 and 4 in the BES group than in the SES group (RR 0·20, 95% CI 0·06-0·67, p=0·004). Conversely, the RR of definite ST during the first year was 0·99 (0·51-1·95; p=0·98) and the test for interaction between RR of definite ST and time was positive (p(interaction)=0·017). We recorded an interaction with time for events associated with ST but not for other events. For primary endpoint events associated with ST, the RR was 0·86 (0·41-1·80) during the first year and 0·17 (0·04-0·78) during subsequent years (p(interaction)=0·049). INTERPRETATION: Biodegradable polymer BES are non-inferior to durable polymer SES and, by reducing the risk of cardiac events associated with very late ST, might improve long-term clinical outcomes for up to 4 years compared with durable polymer SES. FUNDING: Biosensors Europe SA, Switzerland.

25 Article The three year follow-up of the randomised "all-comers" trial of a biodegradable polymer biolimus-eluting stent versus permanent polymer sirolimus-eluting stent (LEADERS). 2011

Wykrzykowska, Joanna / Serruys, Patrick / Buszman, Pawel / Linke, Axel / Ischinger, Thomas / Klauss, Volker / Eberli, Franz / Corti, Roberto / Wijns, William / Morice, Marie-Claude / Di Mario, Carlo / Van Geuns, Robert-Jan / Van Es, Gerrit-Anne / Juni, Peter / Windecker, Stephan. ·Academic Medical Center, Amsterdam, The Netherlands. ·EuroIntervention · Pubmed #22027687.

ABSTRACT: AIMS: The current study reports clinical outcomes at three year follow-up of the LEADERS clinical trial which was the first all-comers trial comparing a new generation biodegradable polymer biolimus drug-eluting stent (BES) with the first generation permanent polymer sirolimus-eluting stent (SES). METHODS AND RESULTS: One thousand seven hundred and seven patients were randomised to unrestricted use of BES (n=857) or SES (n=850) in an all-comers population. Three year follow-up was available in 95% of the patients, 812 treated with BES and 809 treated with SES. At three years, BES remains non-inferior to SES for the primary endpoint of major adverse cardiac events (composite of cardiac death, myocardial infarction (MI), or clinically-indicated target vessel revascularisation (CI-TVR) (BES 15.7% versus SES 19%; HR 0.82 CI 0.65-1.03; p=0.09). The MACE Kaplan Meier event curves increasingly diverge with the difference in events increasing from 1.4% to 2.4% and 3.3% at 1, 2 and 3 years, respectively in favour of BES. The rate of cardiac death was non-significantly lower 4.2% versus 5.2% (HR=0.81 CI 0.52-1.26; p=0.34) and the rate of myocardial infarction was equivalent 7.2% versus 7.1% (HR 1.01 CI 0.70-1.44; p=0.97) for BES versus SES, respectively. Thus BES was non-inferior to SES in all the safety endpoints. Clinically-indicated TVR occurred in 9.4% of BES treated patients versus 11.1% of SES treated patients (HR 0.84 CI 0.62-1.13; p=0.25). Rates of definite stent thrombosis were 2.2% for BES and 2.9% for SES (HR 0.78 CI 0.43-1.43; p=0.43), with the event rate increase of 0.2% from one to three years for BES and 0.9% for SES. For patients presenting with ST-elevation myocardial infarction BES was superior to SES in reducing MACE. CONCLUSIONS: The findings of the three year follow-up support the claim that the biodegradable polymer biolimus-eluting stent has equivalent safety and efficacy to permanent polymer sirolimus-eluting stent in an all-comers patient population. Its performance is superior in some subpopulations such as in ST-elevation MI patients and event rates for BES are overall lower than for SES with a trend toward increasing divergence of outcomes over three years.

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