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Coronary Artery Disease: HELP
Articles by Marie Claude Morice
Based on 84 articles published since 2008
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Between 2008 and 2019, M-C Morice wrote the following 84 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3 · 4
1 Editorial The Quest for the Perfect Stent for a Given Patient: Drug-Coated Stents for the Treatment of Coronary Disease. 2016

Morice, Marie-Claude / Sawaya, Fadi J. ·Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France. Electronic address: mc.morice@icps.com.fr. · Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France. ·JACC Cardiovasc Interv · Pubmed #26762912.

ABSTRACT: -- No abstract --

2 Editorial Evolving concepts in the management of left main coronary disease. 2014

Morice, Marie-Claude. ·Institut Cardiovasculaire Paris Sud, Générale de Santé, Massy, France. Electronic address: mc.morice@icps.com.fr. ·JACC Cardiovasc Interv · Pubmed #24332417.

ABSTRACT: -- No abstract --

3 Review Current treatment of significant left main coronary artery disease: A review. 2018

Akodad, Mariama / Morice, Marie-Claude. ·Interventional Cardiology Department, Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France. · Interventional Cardiology Department, Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France. Electronic address: mc.morice@icps.com.fr. ·Trends Cardiovasc Med · Pubmed #29336945.

ABSTRACT: Though infrequent, left main stenosis has a major prognostic impact. The management of left main disease has evolved over the last few decades with the growing evidence of the efficacy and safety of percutaneous interventions, as attested by the most recent trials. However, mastery of the technical aspects of left main bifurcation stenting is essential in ensuring optimal results. This review focuses on recent data concerning left main angioplasty results as well as the current technical approaches.

4 Review Clinical outcomes with percutaneous coronary revascularization vs coronary artery bypass grafting surgery in patients with unprotected left main coronary artery disease: A meta-analysis of 6 randomized trials and 4,686 patients. 2017

Palmerini, Tullio / Serruys, Patrick / Kappetein, Arie Pieter / Genereux, Philippe / Riva, Diego Della / Reggiani, Letizia Bacchi / Christiansen, Evald Høj / Holm, Niels R / Thuesen, Leif / Makikallio, Timo / Morice, Marie Claude / Ahn, Jung-Min / Park, Seung-Jung / Thiele, Holger / Boudriot, Enno / Sabatino, Mario / Romanello, Mattia / Biondi-Zoccai, Giuseppe / Cavalcante, Raphael / Sabik, Joseph F / Stone, Gregg W. ·Polo Cardio-Toraco-Vascolare, Policlinico S. Orsola, Bologna, Italy. · International Centre for Circulatory Health, NHLI, Imperial College London, London, United Kingdom. · Department of Cardiothoracic Surgery, Erasmus Medical Center, Rotterdam, the Netherlands. · Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY; Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada; Morristown Medical Center, Morristown, NJ. · Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. · Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark. · Department of Cardiology, Oulu University Hospital, Oulu, Finland. · MC Moriec Ramsay Générale de Santé, ICPS, Massy, France. · The Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. · University Heart Center Lübeck and the German Center for Cardiovascular Research (DZHK), Lübeck, Germany. · Department of Internal Medicine/Cardiology, University Heart Center, Leipzig, Germany. · Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Department of AngioCardioNeurology, IRCCS Neuromed, Pozzilli, Italy. · Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands. · The Cleveland Clinic Foundation, Cleveland, OH. · Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY. Electronic address: gs2184@columbia.edu. ·Am Heart J · Pubmed #28760214.

ABSTRACT: Some but not all randomized controlled trials (RCT) have suggested that percutaneous coronary intervention (PCI) with drug-eluting stents may be an acceptable alternative to coronary artery bypass grafting (CABG) surgery for the treatment of unprotected left main coronary artery disease (ULMCAD). We therefore aimed to compare the risk of all-cause mortality between PCI and CABG in patients with ULMCAD in a pairwise meta-analysis of RCT. METHODS: Randomized controlled trials comparing PCI vs CABG for the treatment of ULMCAD were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. RESULTS: Six trials including 4,686 randomized patients were identified. After a median follow-up of 39 months, there were no significant differences between PCI vs CABG in the risk of all-cause mortality (hazard ratio [HR] 0.99, 95% CI 0.76-1.30) or cardiac mortality. However, a significant interaction for cardiac mortality (P CONCLUSIONS: In patients undergoing revascularization for ULMCAD, PCI was associated with similar rates of mortality compared with CABG at a median follow-up of 39 months, but with an interaction effect suggesting relatively lower mortality with PCI in patients with low SYNTAX score and relatively lower mortality with CABG in patients with high SYNTAX score. Both procedures resulted in similar long-term composite rates of death, myocardial infarction, or stroke, with PCI offering an early safety advantage and CABG demonstrating greater durability.

5 Review Three, six, or twelve months of dual antiplatelet therapy after DES implantation in patients with or without acute coronary syndromes: an individual patient data pairwise and network meta-analysis of six randomized trials and 11 473 patients. 2017

Palmerini, Tullio / Della Riva, Diego / Benedetto, Umberto / Bacchi Reggiani, Letizia / Feres, Fausto / Abizaid, Alexandre / Gilard, Martine / Morice, Marie-Claude / Valgimigli, Marco / Hong, Myeong-Ki / Kim, Byeong-Keuk / Jang, Yangsoo / Kim, Hyo-Soo / Park, Kyung Woo / Colombo, Antonio / Chieffo, Alaide / Sangiorgi, Diego / Biondi-Zoccai, Giuseppe / Généreux, Philippe / Angelini, Gianni D / Pufulete, Maria / White, Jonathon / Bhatt, Deepak L / Stone, Gregg W. ·Dipartimento Cardio-Toraco-Vascolare, University of Bologna, Italy. · Bristol Heart Institute, University of Bristol School of Clinical Sciences, Bristol, Bristol, UK. · Istituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil. · Department of Cardiology, Brest University, Brest, France. · Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France. · Swiss Cardiovascular Center, Bern, Switzerland. · Severance Cardiovascular Hospital and Science Institute, Yonsei University College of Medicine, Seoul, Korea. · Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea. · San Raffaele Scientific Institute, Milan, Italy. · Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, and Department of AngioCardioNeurology, IRCCS Neuromed, Pozzilli, Italy. · Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY. · Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA. ·Eur Heart J · Pubmed #28110296.

ABSTRACT: Aim: We sought to determine whether the optimal dual antiplatelet therapy (DAPT) duration after drug-eluting stent (DES) placement varies according to clinical presentation. Methods and Results: We performed an individual patient data pairwise and network meta-analysis comparing short-term (≤6-months) versus long-term (1-year) DAPT as well as 3-month vs. 6-month vs 1-year DAPT. The primary study outcome was the 1-year composite risk of myocardial infarction (MI) or definite/probable stent thrombosis (ST). Six trials were included in which DAPT after DES consisted of aspirin and clopidogrel. Among 11 473 randomized patients 6714 (58.5%) had stable CAD and 4758 (41.5%) presented with acute coronary syndrome (ACS), the majority of whom (67.0%) had unstable angina. In ACS patients, ≤6-month DAPT was associated with non-significantly higher 1-year rates of MI or ST compared with 1-year DAPT (Hazard Ratio (HR) 1.48, 95% Confidence interval (CI) 0.98-2.22; P = 0.059), whereas in stable patients rates of MI and ST were similar between the two DAPT strategies (HR 0.93, 95%CI 0.65-1.35; P = 0.71; Pinteraction = 0.09). By network meta-analysis, 3-month DAPT, but not 6-month DAPT, was associated with higher rates of MI or ST in ACS, whereas no significant differences were apparent in stable patients. Short DAPT was associated with lower rates of major bleeding compared with 1-year DAPT, irrespective of clinical presentation. All-cause mortality was not significantly different with short vs. long DAPT in both patients with stable CAD and ACS. Conclusions: Optimal DAPT duration after DES differs according to clinical presentation. In the present meta-analysis, despite the fact that most enrolled ACS patients were relatively low risk, 3-month DAPT was associated with increased ischaemic risk, whereas 3-month DAPT appeared safe in stable CAD. Prolonged DAPT increases bleeding regardless of clinical presentation. Further study is required to identify the optimal duration of DAPT after DES in individual patients based on their relative ischaemic and bleeding risks.

6 Review Contemporary Approach to Coronary Bifurcation Lesion Treatment. 2016

Sawaya, Fadi J / Lefèvre, Thierry / Chevalier, Bernard / Garot, Phillipe / Hovasse, Thomas / Morice, Marie-Claude / Rab, Tanveer / Louvard, Yves. ·Ramsay-Générale de Santé, Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy and Hôpital Privé Claude Galien, Quincy, France. · Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia. · Ramsay-Générale de Santé, Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy and Hôpital Privé Claude Galien, Quincy, France. Electronic address: y.louvard@angio-icps.com. ·JACC Cardiovasc Interv · Pubmed #27659563.

ABSTRACT: Coronary bifurcations are frequent and account for approximately 20% of all percutaneous coronary interventions. Nonetheless, they remain one of the most challenging lesion subsets in interventional cardiology in terms of a lower procedural success rate and increased rates of long-term adverse cardiac events. Provisional side branch stenting should be the default approach in the majority of cases and we propose easily applicable and reproducible stepwise techniques associated with low risk of failure and complications.

7 Review Why we should never return to bare metal stents? 2008

Morice, Marie-Claude / Thomas, Martyn / Buellesfeld, Lutz / Grube, Eberhard / Colombo, Antonio. ·Institut Hospitalier Jacques Cartier, rue du Noyer Lambert, 91300 Massy, France. mc.morice@icps.com.fr ·EuroIntervention · Pubmed #19112776.

ABSTRACT: -- No abstract --

8 Clinical Trial Does geographical variability influence five-year MACCE rates in the multicentre SYNTAX revascularisation trial? 2017

Roy, Andrew K / Chevalier, Bernard / Lefèvre, Thierry / Louvard, Yves / Segurado, Ricardo / Sawaya, Fadi / Spaziano, Marco / Neylon, Antoinette / Serruys, Patrick A / Dawkins, Keith D / Kappetein, Arie Pieter / Mohr, Friedrich-Wilhelm / Colombo, Antonio / Feldman, Ted / Morice, Marie-Claude. ·Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France. ·EuroIntervention · Pubmed #28320685.

ABSTRACT: AIMS: The use of multiple geographical sites for randomised cardiovascular trials may lead to important heterogeneity in treatment effects. This study aimed to determine whether treatment effects from different geographical recruitment regions impacted significantly on five-year MACCE rates in the SYNTAX trial. METHODS AND RESULTS: Five-year SYNTAX results (n=1,800) were analysed for geographical variability by site and country for the effect of treatment (CABG vs. PCI) on MACCE rates. Fixed, random, and linear mixed models were used to test clinical covariate effects, such as diabetes, lesion characteristics, and procedural factors. Comparing five-year MACCE rates, the pooled odds ratio (OR) between study sites was 0.58 (95% CI: 0.47-0.71), and countries 0.59 (95% CI: 0.45-0.73). By homogeneity testing, no individual site (X2=93.8, p=0.051) or country differences (X2=25.7, p=0.080) were observed. For random effects models, the intraclass correlation was minimal (ICC site=5.1%, ICC country=1.5%, p<0.001), indicating minimal geographical heterogeneity, with a hazard ratio of 0.70 (95% CI: 0.59-0.83). Baseline risk (smoking, diabetes, PAD) did not influence regional five-year MACCE outcomes (ICC 1.3%-5.2%), nor did revascularisation of the left main vs. three-vessel disease (p=0.241), across site or country subgroups. For CABG patients, the number of arterial (p=0.49) or venous (p=0.38) conduits used also made no difference. CONCLUSIONS: Geographic variability has no significant treatment effect on MACCE rates at five years. These findings highlight the generalisability of the five-year outcomes of the SYNTAX study.

9 Clinical Trial The impact of a second arterial graft on 5-year outcomes after coronary artery bypass grafting in the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery Trial and Registry. 2015

Parasca, Catalina A / Head, Stuart J / Mohr, Friedrich W / Mack, Michael J / Morice, Marie-Claude / Holmes, David R / Feldman, Ted E / Colombo, Antonio / Dawkins, Keith D / Serruys, Patrick W / Kappetein, Arie Pieter / Anonymous5470832. ·Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands. · Department of Cardiac Surgery, Herzzentrum Universität Leipzig, Leipzig, Germany. · The Heart Hospital, Baylor Health Care Systems, Plano, Tex. · Department of Cardiology, Institut Cardiovasculaire Paris Sud, Massy, France. · Department of Cardiovascular Disease, Mayo Clinic, Rochester, Minn. · Department of Cardiology, North Shore University Health System, Evanston, Ill. · Department of Cardiology, San Raffaele Scientific Institute, Milan, Italy. · Boston Scientific Corporation, Natick, Mass. · Department of Cardiology, Erasmus University Medical Center, Rotterdam, The Netherlands. · Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands. Electronic address: a.kappetein@erasmusmc.nl. ·J Thorac Cardiovasc Surg · Pubmed #26055439.

ABSTRACT: OBJECTIVE: Despite various evidence supporting the advantages of multiple arterial grafting, inconsistencies in use of the procedure have resulted in high variability in the acceptance and practice of arterial grafting. The purpose of this study was to assess the effects of an arterial versus venous second grafts on outcomes at 5-year follow-up in the coronary artery bypass grafting population from the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial. METHODS: Patients (n = 1419) with an arterial graft to the left anterior descending artery and ≥1 other graft were included and divided according to the second graft's type: 2nd-graft-arterial group (n = 456) and 2nd-graft-venous group (n = 963). Five-year outcomes were compared between subgroups. Event rates were estimated with Kaplan-Meier analyses. Propensity-score matching was used, to control for selection bias due to nonrandom group assignment in a 1:1 manner, resulting in 432 pairs with balanced baseline characteristics. RESULTS: In unmatched groups, the 2nd-graft-arterial group had significantly lower rates of death (8.9% vs 13.1%; P = .02), and composite safety endpoint of death/stroke/myocardial infarction (13.3% vs 18.7%; P = .02), compared with the 2nd-graft-venous group. The rate of major adverse cardiac or cerebrovascular events was similar between groups (22.9% vs 25.5%; P = .30), because it includes the rate of repeat revascularization (12.6% in the 2nd-graft-arterial group vs 9.6% in the 2nd-graft-venous group; P = .10). After propensity-score matching, no statistically significant differences were found between groups. CONCLUSIONS: This study reveals comparable 5-year outcomes with arterial and venous conduits as second grafts after an arterial graft anastomosed to the left anterior descending artery. This study demonstrates the multi-institutional variation in patient selection and operator technique with regard to arterial revascularization, although extended follow-up beyond 5 years is required to estimate its impact on long-term outcomes. CLINICAL TRIAL NUMBER: NCT00114972.

10 Clinical Trial Serial intravascular ultrasound observations from the Tryton first-in-man study. 2014

Maehara, Akiko / van Geuns, Robert Jan / Louvard, Yves / Müller, Ralf / Grube, Eberhard / Morice, Marie-Claude / Davis, H Richard / Kaplan, Aaron V / Onuma, Yoshinobu / Serruys, Patrick W / Mintz, Gary S. ·Cardiovascular Research Foundation, Columbia University Medical Center, New York, NY, USA. ·EuroIntervention · Pubmed #25138185.

ABSTRACT: AIMS: To report serial intravascular ultrasound (IVUS) findings of bifurcation lesions treated with the dedicated Tryton Side Branch Stent to assess mechanisms of restenosis. METHODS AND RESULTS: The Tryton FIM study was a multicentre, prospective, single-arm, "first-in-man" study to treat de novo bifurcation lesions. Minimum lumen area (MLA) sites and overall volumes were analysed within main vessels and side branches. Overall, 27 main vessels and 22 side branches had paired baseline and follow-up IVUS. The post-intervention main vessel MLA decreased from 5.3 (4.1, 6.2) to 4.8 (3.4, 5.7) mm2 at follow-up, p=0.02, and the side branch MLA decreased from 3.5 (3.0, 3.8) to 2.5 (2.2, 3.2) mm2, p=0.0005. Stent area at the side branch did not change (mean stent area from 4.0 [3.3, 4.1] to 3.8 [3.4, 4.2] mm3/mm, p=0.95). Neointimal hyperplasia (NIH) net volume obstruction (%) measured 1.8% (0.5, 7.0) for the entire main vessel and 14.9% (2.3, 31.1) for the entire side branch stents. In both main vessel and side branches the decrease in lumen area correlated significantly with NIH. CONCLUSIONS: Serial IVUS analysis of a new side branch Tryton stent showed no chronic stent recoil. Side branch underexpansion was common and along with superimposed NIH contributed to the reduction in lumen dimensions at follow-up.

11 Clinical Trial Rationale and design of the LEADERS FREE trial: A randomized double-blind comparison of the BioFreedom drug-coated stent vs the Gazelle bare metal stent in patients at high bleeding risk using a short (1 month) course of dual antiplatelet therapy. 2013

Urban, Philip / Abizaid, Alex / Chevalier, Bernard / Greene, Samantha / Meredith, Ian / Morice, Marie-Claude / Pocock, Stuart. ·Hôpital de la Tour, Geneva, Switzerland. philip.urban@latour.ch ·Am Heart J · Pubmed #23622906.

ABSTRACT: BACKGROUND AND RATIONALE: Major bleeding is a powerful predictor of morbidity and mortality after percutaneous coronary intervention (PCI). To avoid prolonged dual antiplatelet therapy (DAPT), current guidelines recommend using a bare metal stent when PCI is indicated to treat patients at high risk of bleeding. The Biolimus A9-coated BioFreedom is a new stainless steel drug-coated stent devoid of polymer and has been shown to be associated with a low median late-loss of 0.17 mm at 12 months of follow-up. In an animal model, 98% of the drug has diffused into the vessel wall at 1 month. It is therefore reasonable to consider that such a device may have a potential safety advantage, and a lesser dependence on prolonged DAPT than a polymer-coated drug-eluting stent. TRIAL DESIGN: A total of 2456 patients considered at high risk of bleeding will be randomized in a double-blind fashion to the BioFreedom drug-coated stent or to a control arm (Gazelle bare metal stent). Both groups will be treated with DAPT during 1 month only, followed by long-term aspirin alone. At 1-year follow-up, the primary safety endpoint (a composite of cardiac death, myocardial infarction and stent thrombosis) will be assessed by a non-inferiority analysis, and the primary efficacy endpoint (clinically driven target lesion revascularization) by a superiority analysis. CONCLUSIONS: This trial should help better characterize a neglected subset of PCI patients and quantify both their thrombotic and bleeding risks. It has the potential to decrease the need for target lesion revascularization in patients unable to tolerate a prolonged course of DAPT and will assess the shortest DAPT course ever used with an active stent.

12 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.

13 Clinical Trial 5-year clinical outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the sirolimus-eluting stent in the treatment of patients with multivessel de novo coronary artery lesions. 2010

Serruys, Patrick W / Onuma, Yoshinobu / Garg, Scot / Vranckx, Pascal / De Bruyne, Bernard / Morice, Marie-Claude / Colombo, Antonio / Macaya, Carlos / Richardt, Gert / Fajadet, Jean / Hamm, Christian / Schuijer, Monique / Rademaker, Tessa / Wittebols, Kristel / Stoll, Hans Peter / Anonymous2230651. ·Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. p.w.j.c.serruys@erasmusmc.nl ·J Am Coll Cardiol · Pubmed #20171036.

ABSTRACT: OBJECTIVES: The purpose of this study is to compare the 5-year clinical outcomes, safety, and efficacy of sirolimus-eluting stents (SES) in the ARTS II (Arterial Revascularization Therapies Study II) with the outcomes of coronary artery bypass graft (CABG) and bare-metal stenting (BMS) from the ARTS I. BACKGROUND: The long-term outcomes after SES implantation in patients with multivessel disease remains to be established. METHODS: The ARTS I was a randomized trial of 1,205 patients with multivessel disease comparing CABG and BMS. The ARTS II study was a nonrandomized trial with the Cypher sirolimus-eluting stent (Cordis, a Johnson & Johnson Company, Warren, New Jersey), applying the same inclusion and exclusion criteria, end points, and protocol definitions. The ARTS II trial enrolled 607 patients, with an attempt to enroll at least one-third of patients with 3-vessel disease. RESULTS: At 5-year, the death/stroke/myocardial infarction event-free survival rate was 87.1% in ARTS II SES, versus 86.0% (p = 0.1) and 81.9% (p = 0.007) in ARTS I CABG and BMS cohorts, respectively. The 5-year major adverse cardiac and cerebrovascular event (MACCE) rate in ARTS II (27.5%) was significantly higher than ARTS I CABG (21.1%, p = 0.02), and lower than in ARTS I BMS (41.5%, p < 0.001). The cumulative incidence of definite stent thrombosis was 3.8%. Thirty-two percent (56 of 176) of major adverse cardiac events (MACE) at 5 years were related to possible, probable, or definite stent thrombosis. CONCLUSIONS: At 5 years, SES had a safety record comparable to CABG and superior to BMS, and a MACCE rate that was higher than in patients treated with CABG, and lower than in those treated with BMS. Approximately one-third of the events seen with SES could be prevented through the elimination of early, late, and very late stent thrombosis.

14 Article Racial Differences in Ischaemia/Bleeding Risk Trade-Off during Anti-Platelet Therapy: Individual Patient Level Landmark Meta-Analysis from Seven RCTs. 2019

Kang, Jeehoon / Park, Kyung Woo / Palmerini, Tullio / Stone, Gregg W / Lee, Michael S / Colombo, Antonio / Chieffo, Alaide / Feres, Fausto / Abizaid, Alexandre / Bhatt, Deepak L / Valgimigli, Marco / Hong, Myeong-Ki / Jang, Yangsoo / Gilard, Martine / Morice, Marie-Claude / Park, Duk-Woo / Park, Seung-Jung / Jeong, Young-Hoon / Park, Jiesuck / Koo, Bon-Kwon / Kim, Hyo-Soo. ·Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea. · Dipartimento Cardio-Toraco-Vascolare, University of Bologna, Bologna, Italy. · Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York, United States. · Division of Cardiology, David Geffen School of Medicine at UCLA, University of California, Los Angeles, Los Angeles, California, United States. · San Raffaele Scientific Institute, Milan, Italy. · Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. · Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts, United States. · Swiss Cardiovascular Center, Bern University Hospital, Bern University, Bern, Switzerland. · Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea. · Department of Cardiology, Brest University, Brest, France. · Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France. · The Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, University of Ulsan, Seoul, Republic of Korea. · Department of Internal Medicine, Gyeongsang National University Changwon Hospital, Changwon, Republic of Korea. ·Thromb Haemost · Pubmed #30597509.

ABSTRACT: BACKGROUND:  Prolonged dual anti-platelet therapy (DAPT) is intended to reduce ischaemic events, at the cost of an increased bleeding risk in patients undergoing percutaneous coronary intervention (PCI). In this study, we evaluated whether race influences the ischaemia/bleeding risk trade-off. METHODS:  We searched for randomized clinical trials (RCTs) comparing DAPT duration after PCI. To compare the benefit or harm between DAPT duration by race, individual patient-level landmark meta-analysis was performed after discontinuation of the shorter duration DAPT group in each RCT. The primary ischaemic endpoint was major adverse cardiac events (MACEs), and the primary bleeding endpoint was major bleeding events (clinicaltrials.gov NCT03338335). RESULTS:  Seven RCTs including 16,518 patients (8,605 East Asians, 7,913 non-East Asians) were pooled. MACE occurred more frequently in non-East Asians (0.8% vs. 1.8%, CONCLUSION:  We suggest that the ischaemia/bleeding trade-off may be different between East Asians and non-East Asians. In East Asians, prolonged DAPT may have no effect in reducing the ischaemic risk, while significantly increases the bleeding risk.

15 Article Polymer-free drug-coated coronary stents in diabetic patients at high bleeding risk: a pre-specified sub-study of the LEADERS FREE trial. 2019

Richardt, Gert / Maillard, Luc / Nazzaro, Marco Stefano / Abdel-Wahab, Mohamed / Carrié, Didier / Iñiguez, Andres / Garot, Philippe / Abdellaoui, Mohammed / Morice, Marie-Claude / Foley, David / Copt, Samuel / Stoll, Hans-Peter / Urban, Philip. ·Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany. gert.richardt@segebergerkliniken.de. · Clinique Axium, Aix-en-Provence, France. · Azienda Ospedaliera San Camillo Forlanini, Rome, Italy. · Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany. · CHU Toulouse Rangueil, Toulouse, France. · University Hospital Vigo, Vigo, Spain. · Hôpital Privé Claude Galien ICPS, Quincy-Sous-Senart, France. · Groupe Hospitalier Mutualiste de Grenoble (GHM), Grenoble, France. · Cardiovascular European Research Center CERC, Massy, France. · Beaumont Hospital, Dublin, Ireland. · Biosensors Clinical Research, Morges, Switzerland. · Hopital LaTour, Geneva, Switzerland. ·Clin Res Cardiol · Pubmed #29951803.

ABSTRACT: OBJECTIVE: Diabetics are at increased risk after stent implantation and potentially sensitive to the type of stent and dual anti-platelet therapy (DAPT). The randomized, double-blind LEADERS FREE trial compared 2432 patients at high bleeding risk (HBR) receiving either a polymer-free BA9-coated stent (DCS) or a bare metal stent (BMS) with 1 month of DAPT, and showed superior safety and efficacy of the DCS at 2 years. We report outcomes at 2 years of the pre-specified diabetic subgroup. METHODS AND RESULTS: The diabetic sub-group comprised 805 (33.1%) patients; 262 (10.8%) were insulin-dependent (IDDM). Compared to non-diabetics, diabetics were younger and had more risk factors and multi-vessel disease. They suffered higher rates of death (15.6 vs. 12.2%, p = 0.01), cardiac death (8.3 vs. 5.9%, p = 0.02), myocardial infarction (MI) (11.1 vs. 7.8%, p = 0.009) and definite/probable stent thrombosis (3.1 vs. 1.7%, p = 0.01), but rates of clinically-indicated TLR (9.1 vs. 9.5%, p = 0.93) and BARC 3-5 bleeding (10.2 vs. 8.4%, p = 0.20) were comparable. Compared to diabetic patients treated with a BMS, diabetic DCS recipients required less clinically driven TLR (6.3 vs. 12.2%, p = 0.006). The primary safety endpoint (cardiac death, MI, definite/probable stent thrombosis) occurred numerically less frequently in the DCS group (14.9 vs. 19.7%, p = 0.10), and was significantly lower in IDDM patients (13.8 vs. 25.4%, p = 0.03). BARC 3-5 was similar for patients treated with DCS (9.9%) and BMS (10.5%, p = 0.84). CONCLUSIONS: In diabetic HBR patients, DCS significantly reduced re-intervention rates over BMS, and showed a strong trend towards a safety benefit at 2 years. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number: NCT01623180.

16 Article Effect of Increasing Stent Length on 3-Year Clinical Outcomes in Women Undergoing Percutaneous Coronary Intervention With New-Generation Drug-Eluting Stents: Patient-Level Pooled Analysis of Randomized Trials From the WIN-DES Initiative. 2018

Chandrasekhar, Jaya / Baber, Usman / Sartori, Samantha / Stefanini, Giulio G / Sarin, Michele / Vogel, Birgit / Farhan, Serdar / Camenzind, Edoardo / Leon, Martin B / Stone, Gregg W / Serruys, Patrick W / Wijns, William / Steg, Philippe G / Weisz, Giora / Chieffo, Alaide / Kastrati, Adnan / Windecker, Stephan / Morice, Marie-Claude / Smits, Pieter C / von Birgelen, Clemens / Mikhail, Ghada W / Itchhaporia, Dipti / Mehta, Laxmi / Kim, Hyo-Soo / Valgimigli, Marco / Jeger, Raban V / Kimura, Takeshi / Galatius, Søren / Kandzari, David / Dangas, George / Mehran, Roxana. ·The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. · Humanitas Research Hospital, Rozzano, Milan, Italy. · Institut Lorrain du Coeur et des Vaisseaux, Vandoeuvre-lès-Nancy, France. · Columbia University Medical Center, New York, New York. · Imperial College Healthcare NHS Trust, London, United Kingdom. · Cardiovascular Center Aalst, Onze-Lieve-Vrouwziekenhuis Ziekenhuis, Aalst, Belgium. · Département Hospitalo Universitaire, Assistance Publique-Hôpitaux de Paris, Université Paris Diderot, INSERM U114, Paris, France. · Columbia University Medical Center, New York, New York; Shaare Zedek Medical Center, Jerusalem, Israel. · San Raffaele Scientific Institute, Milan, Italy. · Deutsches Herzentrum Munchen, Technische Universitat Munich, Germany. · Bern University Hospital, Bern, Switzerland. · Institut Cardiovasculaire Paris Sud, Ramsay Générale de Santé, Massy, France. · Maasstad Hospital, Rotterdam, the Netherlands. · Thoraxcentrum Twente, Enschede, the Netherlands. · Hoag Memorial Hospital Presbyterian, Newport Beach, California. · Ohio State University Medical Center, Columbus, Ohio. · Seoul National University Hospital, Seoul, Korea. · University of Ferrara, Ferrara, Italy. · University Hospital Basel, Basel, Switzerland. · Kyoto University Graduate School of Medicine, Kyoto, Japan. · Bispebjerg University Hospital, Copenhagen, Denmark. · Piedmont Heart Institute, Atlanta, Georgia. · The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: roxana.mehran@mountsinai.org. ·JACC Cardiovasc Interv · Pubmed #29301648.

ABSTRACT: OBJECTIVES: The aim of this study was to examine whether stent length per patient and stent length per lesion are negative markers for 3-year outcomes in women following percutaneous coronary intervention (PCI) with new-generation drug-eluting stents (DES). BACKGROUND: In the era of advanced stent technologies, whether stent length remains a correlate of adverse outcomes is unclear. METHODS: Women treated with new-generation DES in 14 randomized trials from the WIN-DES (Women in Innovation and Drug-Eluting Stents) pooled database were evaluated. Total stent length per patient, which was available in 5,403 women (quartile 1, 8 to 18 mm; quartile 2, 18 to 24 mm; quartile 3, 24 to 36 mm; quartile 4, ≥36 mm), and stent length per lesion, which was available in 5,232 women (quartile 1, 8 to 18 mm; quartile 2, 18 to 20 mm; quartile 3, 20 to 27 mm; quartile 4, ≥27 mm) were analyzed in quartiles. The primary endpoint was 3-year major adverse cardiovascular events (MACE), defined as a composite of all-cause death, myocardial infarction, or target lesion revascularization. RESULTS: In the per-patient analysis, a stepwise increase was observed with increasing stent length in the adjusted risk for 3-year MACE (p for trend <0.0001), myocardial infarction (p for trend <0.001), cardiac death (p for trend = 0.038), and target lesion revascularization (p for trend = 0.011) but not definite or probable stent thrombosis (p for trend = 0.673). In the per-lesion analysis, an increase was observed in the adjusted risk for 3-year MACE (p for trend = 0.002) and myocardial infarction (p for trend <0.0001) but not other individual endpoints. On landmark analysis for late event rates between 1 and 3 years, stent length per patient demonstrated weak associations with target lesion revascularization (p = 0.0131) and MACE (p = 0.0499), whereas stent length per lesion was not associated with higher risk for any late events, suggesting that risk was established early within the first year after PCI. CONCLUSIONS: In this pooled analysis of women undergoing PCI with new-generation DES, increasing stent length per patient and per lesion were independent predictors of 3-year MACE but were not associated with definite or probable stent thrombosis.

17 Article Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): a randomised single-blind trial. 2018

Varenne, Olivier / Cook, Stéphane / Sideris, Georgios / Kedev, Sasko / Cuisset, Thomas / Carrié, Didier / Hovasse, Thomas / Garot, Philippe / El Mahmoud, Rami / Spaulding, Christian / Helft, Gérard / Diaz Fernandez, José F / Brugaletta, Salvatore / Pinar-Bermudez, Eduardo / Mauri Ferre, Josepa / Commeau, Philippe / Teiger, Emmanuel / Bogaerts, Kris / Sabate, Manel / Morice, Marie-Claude / Sinnaeve, Peter R / Anonymous8010925. ·Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France; Cardiology Department, Université Paris Descartes, Sorbonne Paris-Cité, Paris, France. Electronic address: olivier.varenne@aphp.fr. · Cardiology Department, University and Hospital Fribourg, Fribourg, Switzerland. · Service de Cardiologie-Institut national de la santé et de la recherche médicale U942, Hôpital Lariboisiere, Assistance Publique - Hôpitaux de Paris, Université Paris Diderot, Paris, France. · Cardiology Department, University St Cyril and Methodius, Skopje, Macedonia. · Département de Cardiologie, Centre hospitalier universitaire Timone, Marseille, France. · Service de Cardiologie, Centre hospitalier universitaire Toulouse Rangueil, Université Paul Sabatier, Toulouse, France. · Institut Cardiovasculaire Paris-Sud, Ramsay Générale de Santé, Massy and Quincy, France. · Hôpital Ambroise Paré Assistance Publique-Hôpitaux de Paris, Université Versailles-Saint Quentin en Yvelines, Versailles, France. · Service de Cardiologie, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris Descartes University and Sudden Death Expert Center, Institut national de la santé et de la recherche médicale U990, Paris, France. · Institut de Cardiologie, Hôpital Pitié-Salpétrière, Assistance Publique-Hôpitaux de Paris, Université Pierre et Marie Curie et Institut hospitalo-universitaire, Institute of Cardiometabolism and Nutrition, Hôpital Pitié-Salpétrière, Paris, France. · Juan Ramón Jiménez University Hospital, Huelva, Spain. · Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain. · Hospital Universitario Virgen de la Arrixaca, Murcia, Spain. · Hospital Universitari Germans Trias i Pujol, Badalona, Spain. · Département de Cardiologie Interventionnelle, Polyclinique Les Fleurs, Ollioules, France. · Service de Cardiologie, Hôpital Henri Mondor Assistance Publique-Hôpitaux de Paris, Université Paris Est Créteil, Créteil, France. · Interuniversity Institute for Biostatistics and Statistical Bioinformatics (I-BioStat), Department of Public Health and Primary Care, Katholieke Universiteit Leuven, Leuven, Belgium; Interuniversity Institute for Biostatistics and Statistical Bioinformatics (I-BioStat), University Hasselt, Hasselt, Belgium. · Interventional Cardiology Unit, Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain. · Cardiovascular European Research Center, Massy, France. · Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium. ·Lancet · Pubmed #29102362.

ABSTRACT: BACKGROUND: Elderly patients regularly receive bare-metal stents (BMS) instead of drug-eluting stents (DES) to shorten the duration of double antiplatelet therapy (DAPT). The aim of this study was to compare outcomes between these two types of stents with a short duration of DAPT in such patients. METHODS: In this randomised single-blind trial, we recruited patients from 44 centres in nine countries. Patients were eligible if they were aged 75 years or older; had stable angina, silent ischaemia, or an acute coronary syndrome; and had at least one coronary artery with a stenosis of at least 70% (≥50% for the left main stem) deemed eligible for percutaneous coronary intervention (PCI). Exclusion criteria were indication for myocardial revascularisation by coronary artery bypass grafting; inability to tolerate, obtain, or comply with DAPT; requirement for additional surgery; non-cardiac comorbidities with a life expectancy of less than 1 year; previous haemorrhagic stroke; allergy to aspirin or P2Y FINDINGS: Between May 21, 2014, and April 16, 2016, we randomly assigned 1200 patients (596 [50%] to the DES group and 604 [50%] to the BMS group). The primary endpoint occurred in 68 (12%) patients in the DES group and 98 (16%) in the BMS group (relative risk [RR] 0·71 [95% CI 0·52-0·94]; p=0·02). Bleeding complications (26 [5%] in the DES group vs 29 [5%] in the BMS group; RR 0·90 [0·51-1·54]; p=0·68) and stent thrombosis (three [1%] vs eight [1%]; RR 0·38 [0·00-1·48]; p=0·13) at 1 year were infrequent in both groups. INTERPRETATION: Among elderly patients who have PCI, a DES and a short duration of DAPT are better than BMS and a similar duration of DAPT with respect to the occurrence of all-cause mortality, myocardial infarction, stroke, and ischaemia-driven target lesion revascularisation. A strategy of combination of a DES to reduce the risk of subsequent repeat revascularisations with a short BMS-like DAPT regimen to reduce the risk of bleeding event is an attractive option for elderly patients who have PCI. FUNDING: Boston Scientific.

18 Article The DELTA 2 Registry: A Multicenter Registry Evaluating Percutaneous Coronary Intervention With New-Generation Drug-Eluting Stents in Patients With Obstructive Left Main Coronary Artery Disease. 2017

Chieffo, Alaide / Tanaka, Akihito / Giustino, Gennaro / Briede, Ieva / Sawaya, Fadi J / Daemen, Joost / Kawamoto, Hiroyoshi / Meliga, Emanuele / D'Ascenzo, Fabrizio / Cerrato, Enrico / Stefanini, Giulio G / Capodanno, Davide / Mangiameli, Andrea / Templin, Christian / Erglis, Andrejs / Morice, Marie Claude / Mehran, Roxana / Van Mieghem, Nicolas M / Nakamura, Sunao / De Benedictis, Mauro / Pavani, Marco / Varbella, Ferdinando / Pisaniello, Marco / Sharma, Samin K / Tamburino, Corrado / Tchetche, Didier / Colombo, Antonio / Anonymous531032. ·Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy. Electronic address: chieffo.alaide@hsr.it. · Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy. · Mount Sinai Medical Center, New York, New York. · Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia. · Institut Hospitalier Jacques Cartier, Ramsay Générale de Santé, Massy, France. · Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands. · Interventional Cardiology Unit, New Tokyo Hospital, Chiba, Japan. · Department of Cardiology, Mauriziano Hospital, Turin, Italy. · Department of Internal Medicine, Division of Cardiology, University of Turin, Città della Salute e della Scienza, Turin, Italy. · San Luigi Gonzaga University Hospital, Orbassano and Infermi Hospital, Rivoli, Turin, Italy. · Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy. · Ferrarotto Hospital, University of Catania, Catania, Italy. · Clinique Pasteur, Toulouse, France. · University Hospital of Zurich, Zurich, Switzerland. ·JACC Cardiovasc Interv · Pubmed #29217002.

ABSTRACT: OBJECTIVES: The aim of this study was to evaluate clinical outcomes of unprotected left main coronary artery percutaneous coronary intervention (PCI) with new-generation drug-eluting stents in a "real world" population. BACKGROUND: PCI of the unprotected left main coronary artery is currently recommended as an alternative to coronary artery bypass grafting (CABG) in selected patients. METHODS: All consecutive patients with unprotected left main coronary artery stenosis treated by PCI with second-generation drug-eluting stents were analyzed in this international, all-comers, multicenter registry. The results were compared with those from the historical DELTA 1 (Drug Eluting Stent for Left Main Coronary Artery) CABG cohort using propensity score stratification. The primary endpoint was the composite of death, myocardial infarction (MI), or stroke at the median time of follow-up. RESULTS: A total of 3,986 patients were included. The mean age was 69.6 ± 10.9 years, diabetes was present in 30.8%, and 21% of the patients presented with acute MI. The distal left main coronary artery was involved in 84.6% of the lesions. At a median of 501 days (≈17 months) of follow-up, the occurrence of the primary endpoint of death, MI, or cerebrovascular accident was lower in the PCI DELTA 2 group compared with the historical DELTA 1 CABG cohort (10.3% vs. 11.6%; adjusted hazard ratio: 0.73; 95% confidence interval: 0.55 to 0.98; p = 0.03). Of note, an advantage of PCI was observed with respect to cerebrovascular accident (0.8% vs. 2.0%; adjusted hazard ratio: 0.37; 95% confidence interval: 0.16 to 0.86; p = 0.02), while an advantage of CABG was observed with respect to target vessel revascularization (14.2% vs. 2.9%; adjusted hazard ratio: 3.32; 95% confidence interval: 2.12 to 5.18; p < 0.0001). CONCLUSIONS: After a median follow-up period of 17 months, PCI with new-generation drug-eluting stents was associated with an overall low rate of the composite endpoint of death, MI, or cerebrovascular accident.

19 Article Safety and Efficacy of Polymer-Free Biolimus A9-Coated Versus Bare-Metal Stents in Orally Anticoagulated Patients: 2-Year Results of the LEADERS FREE Oral Anticoagulation Substudy. 2017

Carrié, Didier / Menown, Ian / Oldroyd, Keith / Copt, Samuel / Talwar, Suneel / Maillard, Luc / Morice, Marie-Claude / Teik, Lim Soo / Lang, Irene / Urban, Philip. ·Centre Hospitalier Universitaire, Toulouse, France. Electronic address: carrie.didier@chu-toulouse.fr. · Craigavon Cardiac Centre, Craigavon, United Kingdom. · West of Scotland Regional Heart and Lung Centre, Glasgow, United Kingdom. · Biosensors Europe, Morges, Switzerland. · Dorset Heart Centre, Royal Bournemouth Hospital, Bournemouth, United Kingdom. · Centre de Cardiologie Interventionnelle Axium-Rambot, Aix-en-Provence, France. · Hôpital Privé Jacques Cartier, Massy, France. · National Heart Centre, Singapore, Singapore. · Medical University of Vienna, Vienna, Austria. · Hôpital La Tour, Meyrin, Switzerland. ·JACC Cardiovasc Interv · Pubmed #28838473.

ABSTRACT: OBJECTIVES: The aim of this study was to compare the performance of drug-coated stents (DCS) versus bare-metal stents (BMS) in patients who are candidates for long-term oral anticoagulation (OAC) after percutaneous coronary interventions. BACKGROUND: The randomized controlled LEADERS FREE (A Randomized Clinical Evaluation of the BioFreedom™ Stent) trial demonstrated the superior safety and efficacy of a polymer-free biolimus A9 DCS compared with a similar BMS used with 1 month of dual antiplatelet therapy in 2,466 patients at high bleeding risk. METHODS: The 2 stents were compared in a pre-specified analysis of the 879 LEADERS FREE patients (35.6%) scheduled to remain on OAC after percutaneous coronary intervention. The primary safety endpoint was a composite of cardiac death, myocardial infarction, and stent thrombosis. The primary efficacy endpoint was the incidence of clinically driven target lesion revascularization. RESULTS: Baseline characteristics of 448 DCS and 431 BMS recipients were similar, 78.8% had histories of atrial fibrillation, and 21% presented with acute coronary syndromes. Four hundred patients in the DCS group and 376 in the BMS group were discharged on OAC after percutaneous coronary intervention. At 2 years, for the DCS and BMS recipients, respectively, the incidence of clinically driven target lesion revascularization was 7.5% versus 11.2% (hazard ratio: 0.63; 95% confidence interval: 0.40 to 1.01; p = 0.0514), the safety endpoint was reached by 14.4% and 15.0% (p = NS), and the rates of major bleeding events (Bleeding Academic Research Consortium 3 to 5) were 10.7% and 12.9% (p = NS). CONCLUSIONS: The efficacy advantage of DCS over BMS up to 2 years appears confirmed in patients on long-term OAC. Despite the very short course of dual antiplatelet therapy, both the DCS and BMS groups experienced similarly high rates of major bleeding. (A Randomized Clinical Evaluation of the BioFreedom™ Stent [Leaders Free]; NCT01623180).

20 Article A randomized multicenter trial comparing the XIENCE everolimus eluting stent with the CYPHER sirolimus eluting stent in the treatment of female patients with de novo coronary artery lesions: The SPIRIT WOMEN study. 2017

Franzone, Anna / Zaugg, Serge / Piccolo, Raffaele / Modena, Maria Grazia / Mikhail, Ghada W / Ferré, Josepa Mauri / Strasser, Ruth / Grinfeld, Liliana / Heg, Dik / Jüni, Peter / Windecker, Stephan / Morice, Marie-Claude. ·Department of Cardiology, Bern University Hospital, Bern, Switzerland. · Clinical Trials Unit, Department of Clinical Research, University of Bern, Bern, Switzerland. · Institute of Cardiology, Policlinico Hospital, University of Modena and Reggio Emilia, Modena, Italy. · Imperial College Healthcare NHS Trust, London, United Kingdom. · Hospital Germans Trias I Pujol, Invasive Cardiology Unit, Badalona, Spain. · University of Dresden, Department of Internal Medicine and Cardiology, Heart Centre, University Hospital, Dresden, Germany. · Hospital Italiano, Invasive Cardiology Unit, Buenos Aires, Argentina. · Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland. · Applied Health Research Centre (AHRC), 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, Canada. · Institut Cardiovasculaire Paris Sud, Paris, France. ·PLoS One · Pubmed #28796809.

ABSTRACT: BACKGROUND: The comparative performance of different drug-eluting stents (DES) among female patients has not been assessed in a randomized manner. OBJECTIVES: The SPIRIT Women Clinical Evaluation trial compared the durable polymer everolimus-eluting XIENCE stent (DP-EES) with the durable polymer sirolimus-eluting Cypher stent (DP-SES) in women undergoing percutaneous coronary intervention (PCI). METHODS: A total of 455 female patients with stable CAD were randomly assigned to receive DP-EES (n = 304) or DP-SES (n = 151). The powered angiographic outcome of the trial was in-stent late lumen loss (LLL) at 9 months after the index procedure. Secondary angiographic end points included in-segment LLL, in-stent and in-segment binary restenosis and percent diameter stenosis. The primary clinical outcome was a composite of all-cause death, myocardial infarction (MI) or target vessel revascularization (TVR). RESULTS: At 9-month follow-up, in-stent LLL was 0.19±0.38 mm and 0.11±0.37 mm in patients assigned to DP-EES and DP-SES, respectively. The one-sided upper 95% CI of the difference in in-stent LLL between the groups of 0.08 mm was 0.15 and therefore within the pre-specified non-inferiority margin of 0.17 mm (p for non-inferiority = 0.013). However, the test for superiority showed a borderline significant difference in terms of LLL between DP-EES and DP-SES (p for superiority = 0.044). There were no significant differences in binary restenosis (2.0% vs. 0.72%, p = 0.44) and percent diameter stenosis (14.97±12.17 vs. 13.36±10.82, p = 0.19). The rate of definite stent thrombosis at 12 months was lower in patients treated with DP-EES (0% vs. 2.0%, p = 0.036). CONCLUSIONS: Among women undergoing PCI, DP-EES was associated with a small but probably clinically relevant increase in in-stent LLL at 9 months as compared to DP-SES and with a lower risk of definite stent thrombosis at 12 months. TRIAL REGISTRATION: ClinicalTrials.gov NCT01182428. https://clinicaltrials.gov/.

21 Article 6- Versus 24-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents in Patients Nonresistant to Aspirin: Final Results of the ITALIC Trial (Is There a Life for DES After Discontinuation of Clopidogrel). 2017

Didier, Romain / Morice, Marie Claude / Barragan, Paul / Noryani, Arif A L / Noor, Hussam A / Majwal, Talib / Hovasse, Thomas / Castellant, Philippe / Schneeberger, Michel / Maillard, Luc / Bressolette, Erwan / Wojcik, Jaroslaw / Delarche, Nicolas / Blanchard, Didier / Jouve, Bernard / Ormezzano, Olivier / Paganelli, Franck / Levy, Gilles / Sainsous, Joël / Carrie, Didier / Furber, Alain / Berlan, Jacques / Darremont, Olivier / Le Breton, Hervé / Lyuycx-Bore, Anne / Gommeaux, Antoine / Cassat, Claude / Kermarrec, Alain / Cazaux, Pierre / Druelles, Philippe / Dauphin, Raphael / Armengaud, Jean / Dupouy, Patrick / Champagnac, Didier / Ohlmann, Patrick / Ben Amer, Hakim / Kiss, Robert G / Ungi, Irme / Gilard, Martine. ·Department of Cardiology Brest University, Brest, France. · ICPS, Massy, France. · Clinique des Fleurs, Ollioules, France. · Al Qassimi Hospital, Sharjah, United Arab Emirates. · Bahrain Defence Force, West Riffa, Bahrain. · Dubai Hospital, Dubai, United Arab Emirates. · Hôpital Albert Schweitzer, Colmar, France. · Clinique Axium, Aix en Provence, France. · NCN, Nantes, France. · Klinika Kardiologii SPSK4, Lublin, Poland. · CH Mitterrand, Pau, France. · Clinique St. Gatien, Tours, France. · CH Aix en Provence, Aix en Provence, France. · CHU, Grenoble, France. · CHU Hôpital Nord, Marseille, France. · Clinique du Millénaire, Montpellier, France. · Clinique Rhône Durance, Avignon, France. · CHU, Toulouse, France. · CHU, Angers, France. · Clinique St. Hilaire, Rouen, France. · Clinique Saint Augustin, Bordeaux, France. · CHU, Rennes, France. · CH Compiègne, Compiègne, France. · Polyclinique de Bois, Bernard, France. · CHU, Limoges, France. · CH Vannes, Vannes, France. · CH Lorient, Lorient, France. · Poly de St. Laurent, Rennes, France. · Hôpital de la Croix Rousse, Lyon, France. · Clinique Esquirol, Agen, France. · Hôpital Privé, Antony, France. · Clinique Tonkin, Villeurbanne, France. · CHU, Strasbourg, France. · Hôpital la Roseraie, Aubervilliers, France. · Honvéd Kórház, Budapest, Hungary. · SZTE Szent-Györgyi Albert, Szeged, Hungary. · Department of Cardiology Brest University, Brest, France. Electronic address: martine.gilard@chu-brest.fr. ·JACC Cardiovasc Interv · Pubmed #28641840.

ABSTRACT: OBJECTIVES: The aim of this study was to test the hypothesis that 6-month dual antiplatelet therapy (DAPT) is noninferior to 24-month DAPT in aspirin-sensitive patients. BACKGROUND: The ITALIC (Is There a Life for DES After Discontinuation of Clopidogrel) trial showed that rates of bleeding and thrombotic events at 1 year were much the same with 6 versus 12 months of DAPT after percutaneous coronary intervention with second-generation drug-eluting stents. In this report, 2-year follow-up is presented. METHODS: In a multicenter randomized study, patients with confirmed nonresistance to aspirin undergoing drug-eluting stent implantation were allocated to 6 or 24 months of DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-percutaneous coronary intervention. The secondary endpoints comprised the same composite endpoint at 24 months and each individual component. RESULTS: Overall, 2,031 patients from 70 centers were screened; 926 were randomized to 6-month and 924 to 24-month DAPT. Noninferiority was demonstrated for 6- versus 12-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p = 0.0002). At 2 years, the composite endpoint was unchanged, at 3.5% for 6 months and 3.7% for 24 months (p = 0.79), and rates of myocardial infarction (1.3% vs. 1.0%; p = 0.51), stroke (0.6% vs. 0.8%; p = 0.77), and target vessel revascularization (1.0% vs. 0.3%; p = 0.09) were likewise similar. There was a trend toward higher mortality with longer DAPT (2.2% vs. 1.2%; p = 0.11). Four patients (0.4%) in the 24-month group and none in the 6-month group had major bleeding. CONCLUSIONS: Two-year outcomes in the ITALIC trial confirmed the 1-year results and showed that patients receiving 6-month DAPT after percutaneous coronary intervention with second-generation drug-eluting stent have similar outcomes to those receiving 24-month DAPT.

22 Article Influence of practice patterns on outcome among countries enrolled in the SYNTAX trial: 5-year results between percutaneous coronary intervention and coronary artery bypass grafting. 2017

Milojevic, Milan / Head, Stuart J / Mack, Michael J / Mohr, Friedrich W / Morice, Marie-Claude / Dawkins, Keith D / Holmes, David R / Serruys, Patrick W / Kappetein, Arie Pieter. ·Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, Netherlands. · Department of Cardiovascular Surgery, Heart Hospital Baylor Plano, Baylor Healthcare System, Plano, TX, USA. · Department of Cardiovascular Surgery, Herzzentrum Universität Leipzig, Leipzig, Germany. · Department of Cardiology, Institut Hospitalier Jacques Cartier, Massy, France. · Boston Scientific Corporation, Natick, MA, USA. · Division of Cardiovascular Disease and Internal Medicine, Mayo Clinic, Rochester, MN, USA. · Department of Cardiology, Erasmus University Medical Center, Rotterdam, Netherlands. ·Eur J Cardiothorac Surg · Pubmed #28520861.

ABSTRACT: OBJECTIVES: To examine differences among participating countries in baseline characteristics, clinical practice, medication strategies and outcomes of patients randomized to coronary artery bypass grafting and percutaneous coronary intervention in the SYNTAX trial. METHODS: In SYNTAX, centres in 18 different countries enrolled 1800 patients, of which 8 countries enrolled ≥80 patients, what was projected to be a large enough sample size to be included in the analysis. Baseline characteristics, practice patterns and clinical outcomes were compared between the USA (n = 245), the UK (n = 267), Italy (n = 197), France (n = 208), Germany (n = 179), Netherlands (n = 148), Belgium (n = 91) and Hungary (n = 83). The remaining patients from other participating countries were pooled together (n = 382). RESULTS: Five-year results demonstrated significantly different outcomes between countries. After adjustment, percutaneous coronary intervention patients in France had lower rates of major adverse cardiac and cerebrovascular events [hazard ratio (HR) = 0.60, 95% confidence interval (CI) 0.37-0.98], while the incidence of repeat revascularization was higher in Hungary (HR = 1.89, 95% CI 1.14-3.42). Coronary artery bypass grafting showed the lowest rate of repeat revascularization in the UK (HR = 0.32, 95% CI 0.12-0.85). There were numerous differences in the risk profile of patients between participating countries, as well as marked differences in surgical practice across countries in the use of blood cardioplegia (range 3.1-89.0%; P < 0.001), bilateral internal mammary artery usage (range 7.8-68.2%; P < 0.001) and off-pump procedures (range 3.9-44.4%; P < 0.001). Variation was also found for percutaneous coronary intervention in the number of implanted stents (range 4.0 ± 2.3 to 6.1 ± 2.6; P < 0.001) as well as for the entire stents length (range 69.0 ± 45.1 to 124.1 ± 60.9; P < 0.001). Remarkable differences were observed in the prescription of post-coronary artery bypass grafting medication in terms of acetylsalicylic acid (range 79.6-95.0%; P = 0.004), thienopyridine (6.8-31.1%; P < 0.001) and statins (41.3-89.1%; P < 0.001). CONCLUSIONS: Patient characteristics and clinical patterns are significantly different between countries, resulting in significantly different 5-year outcomes. This article presents specific data that can further improve outcomes in each country. Clinical Trials Registry: NCT00114972.

23 Article Geographical Difference of the Interaction of Sex With Treatment Strategy in Patients With Multivessel Disease and Left Main Disease: A Meta-Analysis From SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) Randomized Controlled Trials. 2017

Sotomi, Yohei / Onuma, Yoshinobu / Cavalcante, Rafael / Ahn, Jung-Min / Lee, Cheol Whan / van Klaveren, David / de Winter, Robbert J / Wykrzykowska, Joanna J / Farooq, Vasim / Morice, Marie-Claude / Steyerberg, Ewout W / Park, Seung-Jung / Serruys, Patrick W. ·From the Academic Medical Center, University of Amsterdam, the Netherlands (Y.S., R.J.d.W., J.J.W.) · ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O., R.C.) · Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-M.A., C.W.L., S.-J.P.) · Department of Public Health, Erasmus Medical Centre, Rotterdam, the Netherlands (D.v.K., E.W.S.) · Institute of Cardiovascular Sciences, Manchester Academic Health Sciences Centre, University of Manchester and Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Trust, United Kingdom (V.F.) · Institut Cardiovasculaire Paris Sud, Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France (M.-C.M.) · and International Centre for Circulatory Health, NHLI, Imperial College London, United Kingdom (P.W.S.). ·Circ Cardiovasc Interv · Pubmed #28495897.

ABSTRACT: BACKGROUND: The impact of sex on clinical outcomes of percutaneous coronary intervention and coronary artery bypass graft for patients with multivessel coronary disease and unprotected left main disease could be dissimilar between Western and Asian populations. METHODS AND RESULTS: To assess clinical outcomes after percutaneous coronary intervention or coronary artery bypass graft in women and men with multivessel coronary disease and unprotected left main disease, a pooled analysis (n=3280) was performed using the patient-level data from 3 large randomized trials: SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) trials. The primary end point was all-cause death. Of 3280 patients, 794 patients (24.2%) were women. The median follow-up period was 1806 days (1611-1837 days). In women, a high heterogeneity of the treatment effect among the 3 trials was found for all-cause death ( CONCLUSIONS: The present meta-analysis suggested the presence of the heterogeneous sex-treatment interaction across Asian and Western trials. Considering the ongoing globalization of our medical practice, the heterogeneity of the sex-treatment interaction needs to be well recognized and taken into account during the decision making of the treatment strategy. CLINICAL TRIAL REGISTRATIONS: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT00114972, NCT00997828, NCT00422968.

24 Article Quality of Life After Surgery or DES in Patients With 3-Vessel or Left Main Disease. 2017

Abdallah, Mouin S / Wang, Kaijun / Magnuson, Elizabeth A / Osnabrugge, Ruben L / Kappetein, A Pieter / Morice, Marie-Claude / Mohr, Friedrich A / Serruys, Patrick W / Cohen, David J / Anonymous1031193. ·Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio. · Saint Luke's Mid America Heart Institute, Kansas City, Missouri. · Saint Luke's Mid America Heart Institute, Kansas City, Missouri; University of Missouri-Kansas City School of Medicine, Kansas City, Missouri. · Erasmus University Medical Center, Rotterdam, the Netherlands. · Hôpital Privé Jacques Cartier, Massy, France. · Herzzentrum Universität Leipzig, Leipzig, Germany. · Saint Luke's Mid America Heart Institute, Kansas City, Missouri; University of Missouri-Kansas City School of Medicine, Kansas City, Missouri. Electronic address: dcohen@saint-lukes.org. ·J Am Coll Cardiol · Pubmed #28427580.

ABSTRACT: BACKGROUND: In the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial, patients with 3-vessel or left main coronary artery disease (CAD) had improved long-term outcomes with coronary artery bypass graft (CABG) surgery compared with percutaneous coronary intervention (PCI) with drug-eluting stents (DES), improvements driven mainly by differences in myocardial infarction and repeat revascularization. OBJECTIVES: This study compared the long-term quality-of-life benefits of DES-PCI versus CABG for patients with 3-vessel or left main CAD. METHODS: Between 2005 and 2007, the SYNTAX trial randomized 1,800 patients with 3-vessel or left main CAD to either CABG or DES-PCI. Health status was assessed at baseline and at 1, 6, 12, 36, and 60 months by using the Seattle Angina Questionnaire (SAQ) and the 36-Item Short Form Health Survey. RESULTS: At 5-year follow-up, CABG was superior to DES-PCI on several SAQ domains including angina frequency and physical function, as well as the role physical and role emotional scales of the 36-Item Short Form Health Survey. Subgroup analysis demonstrated a significant interaction between angiographic complexity (as assessed by the SYNTAX score) and angina relief (mean difference in the SAQ angina frequency score for CABG vs. PCI of -0.9, 3.3, and 3.9 points for low, intermediate, and high SYNTAX score patients, respectively; p = 0.048 for interaction). CONCLUSIONS: Among patients with 3-vessel or left main CAD, both CABG and DES-PCI were associated with substantial and sustained quality-of-life benefits over 5 years of follow-up. In general, CABG resulted in greater angina relief, although the absolute treatment benefit was small. Angina relief at 5 years was enhanced with CABG among patients with high SYNTAX scores, a finding reinforcing the recommendation that CABG should be strongly preferred for such patients. (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery [SYNTAX]; NCT00114972).

25 Article Incidence, Characteristics, Predictors, and Outcomes of Repeat Revascularization After Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting: The SYNTAX Trial at 5 Years. 2016

Parasca, Catalina A / Head, Stuart J / Milojevic, Milan / Mack, Michael J / Serruys, Patrick W / Morice, Marie-Claude / Mohr, Friedrich W / Feldman, Ted E / Colombo, Antonio / Dawkins, Keith D / Holmes, David R / Kappetein, Pieter A / Anonymous3770891. ·Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands. · Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands. Electronic address: s.head@erasmusmc.nl. · The Heart Hospital, Baylor Health Care Systems, Plano, Texas. · Department of Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands. · Department of Cardiology, Institut Cardiovasculaire Paris Sud, Hopital Privé Jacques Cartier, Générale de Santé, Massy, France. · Department of Cardiac Surgery, Herzzentrum Universität Leipzig, Leipzig, Germany. · Department of Cardiology, North Shore University Health System, Evanston, Illinois. · Department of Cardiology, San Raffaele Scientific Institute, Milan, Italy. · Boston Scientific Corporation, Natick, Massachusetts. · Department of Cardiovascular Disease, Mayo Clinic, Rochester, Minnesota. ·JACC Cardiovasc Interv · Pubmed #28007201.

ABSTRACT: OBJECTIVES: The study sought to determine the incidence, predictors, characteristics, and outcomes of repeat revascularization during 5-year follow-up of the SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) trial. BACKGROUND: Limited in-depth long-term data on repeat revascularization are available from randomized trials comparing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). METHODS: Incidence and timing of repeat revascularization and its relation to the long-term composite safety endpoint of death, stroke, and myocardial infarction were analyzed in the SYNTAX trial (n = 1,800) using Kaplan-Meier analysis. RESULTS: At 5 years, repeat revascularization occurred more often after initial PCI than after initial CABG (25.9% vs. 13.7%, respectively; p < 0.001), and more often consisted of multiple repeat revascularizations (9.0% vs. 2.8%, respectively; p = 0.022). Significantly more repeat PCI procedures were performed on de novo lesions in patients after initial PCI than initial CABG (33.3% vs. 13.4%, respectively; p < 0.001). At 5-year follow-up, patients who underwent repeat revascularization versus patients not undergoing repeat revascularization had significantly higher rates of the composite safety endpoint of death, stroke, and myocardial infarction after initial PCI (33.8% vs. 16.6%, respectively; p < 0.001), and a trend was found after initial CABG (22.4% vs. 15.8%, respectively; p = 0.07). After multivariate adjustment, repeat revascularization was an independent predictor of the composite safety endpoint after both initial PCI (hazard ratio [HR]: 2.2; 95% confidence interval [CI]: 1.6 to 3.0; p < 0.001) and initial CABG (HR: 1.8; 95% CI: 1.2 to 2.9; p = 0.011). CONCLUSIONS: Repeat revascularization rates are significantly higher after initial PCI than after initial CABG for complex coronary disease. Repeat revascularization is an independent predictor of death, stroke, and myocardial infarction for myocardial revascularization.

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