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Coronary Artery Disease: HELP
Articles by Marie Claude Morice
Based on 101 articles published since 2010
(Why 101 articles?)
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Between 2010 and 2020, M-C Morice wrote the following 101 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3 · 4 · 5
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 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.

8 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.

9 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.

10 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.

11 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.

12 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 / Anonymous2240651. ·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.

13 Article Patients with left main coronary artery disease: stent or surgery? 2020

Morice, Marie-Claude. ·Institut Cardiovasculaire Paris Sud, Ramsay Générale de Santé, 91300 Massy, France. Electronic address: mc.morice@icps.com.fr. ·Lancet · Pubmed #31954444.

ABSTRACT: -- No abstract --

14 Article Cost-Effectiveness of Drug-Eluting Stents in Elderly Patients With Coronary Artery Disease: The SENIOR Trial. 2019

Bulsei, Julie / Butel, Thibault / Varenne, Olivier / Cook, Stéphane / Cuisset, Thomas / Carrié, Didier / Hovasse, Thomas / Morice, Marie-Claude / Sinnaeve, Peter R / Durand-Zaleski, Isabelle / Anonymous7191013. ·AP-HP URC Eco IdF, Unité de recherche clinique en économie de la santé d'Ile de France, Paris, France. Electronic address: julie.bulsei@urc-eco.fr. · AP-HP URC Eco IdF, Unité de recherche clinique en économie de la santé d'Ile de France, Paris, France. · AP-HP Hôpital Cochin, Paris, France; Cardiology Department, Université Paris Descartes, Sorbonne Paris-Cité, Paris, France. · Cardiology Department, University and Hospital of Fribourg, Fribourg, Switzerland. · 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. · Cardiovascular European Research Center, Massy, France. · Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium. ·Value Health · Pubmed #31806191.

ABSTRACT: BACKGROUND: Elderly patients receive bare metal stents instead of drug-eluting stents (DES) to shorten the duration of dual antiplatelet therapy (DAPT). The SENIOR trial compared outcomes between these 2 types of stents combined with a short duration of DAPT. A significant decrease in the number of patients with at least 1 major adverse cardiac and cerebrovascular event (MACCE) was noted in the DES group. OBJECTIVES: The objective of this article was to perform an economic evaluation of the SENIOR trial. METHODS: This evaluation was performed separately in 5 participating countries using pooled patient-level data from all study patients and country-specific unit costs and utility values. Costs, MACCEs, and quality-adjusted life-years (QALYs) were calculated in both arms at 1 year, and an incremental cost-effectiveness ratio was estimated. Uncertainty was explored by probabilistic bootstrapping. RESULTS: A total of 1200 patients underwent randomization. The average total cost per patient was higher in the DES group. The number of MACCEs and average QALYs were not statistically different between the 2 groups. The 1-year incremental cost-effectiveness ratio for each country of reference ranged from €13 752 to €20 511/MACCE avoided and from €42 835 to €68 231/QALY gained. The scatter plots found a wide dispersion, reflecting a large uncertainty surrounding the results. But in each country studied, 90% of the bootstrap replications indicated a higher cost for greater effectiveness for the DES group. Assuming a willingness to pay of €50 000/QALY, there was between a 40% and 50% chance that the use of DES was cost-effective in 4 countries. CONCLUSION: The use of DES instead of bare metal stents combined with a short duration of DAPT in elderly patients induced higher cost for greater effectiveness in each of the 5 countries studied.

15 Article Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease. 2019

Stone, Gregg W / Kappetein, A Pieter / Sabik, Joseph F / Pocock, Stuart J / Morice, Marie-Claude / Puskas, John / Kandzari, David E / Karmpaliotis, Dimitri / Brown, W Morris / Lembo, Nicholas J / Banning, Adrian / Merkely, Béla / Horkay, Ferenc / Boonstra, Piet W / van Boven, Ad J / Ungi, Imre / Bogáts, Gabor / Mansour, Samer / Noiseux, Nicolas / Sabaté, Manel / Pomar, Jose / Hickey, Mark / Gershlick, Anthony / Buszman, Pawel E / Bochenek, Andrzej / Schampaert, Erick / Pagé, Pierre / Modolo, Rodrigo / Gregson, John / Simonton, Charles A / Mehran, Roxana / Kosmidou, Ioanna / Généreux, Philippe / Crowley, Aaron / Dressler, Ovidiu / Serruys, Patrick W / Anonymous7621005. ·From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York · Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands · University Hospitals Cleveland Medical Center, Cleveland (J.F.S.) · the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom · Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.) · Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.) · Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary · Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal · Hospital Clinic, Barcelona (M.S., J. Pomar) · Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek) · University of Campinas, Campinas, Brazil (R. Modolo) · Abbott Vascular, Santa Clara, CA (C.A.S.) · and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.). ·N Engl J Med · Pubmed #31562798.

ABSTRACT: BACKGROUND: Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established. METHODS: We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction. RESULTS: At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], -0.9 to 6.5; P = 0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, -1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, -1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, -1.9 percentage points; 95% CI, -3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, -0.8 percentage points; 95% CI, -2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0). CONCLUSIONS: In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776.).

16 Article Left Main Coronary Artery Disease Revascularization According to the SYNTAX Score. 2019

Shlofmitz, Evan / Généreux, Philippe / Chen, Shmuel / Dressler, Ovidiu / Ben-Yehuda, Ori / Morice, Marie-Claude / Puskas, John D / Taggart, David P / Kandzari, David E / Crowley, Aaron / Redfors, Björn / Mehdipoor, Ghazaleh / Kappetein, Arie Pieter / Sabik, Joseph F / Serruys, Patrick W / Stone, Gregg W. ·Cardiovascular Research Foundation, NY (E.S., P.G., S.C., O.D., O.B.-Y., A.C., B.R., G.M., G.W.S.). · New York-Presbyterian Hospital/Columbia University Medical Center (E.S., O.B.-Y., G.W.S.). · Morristown Medical Center, NJ (P.G.). · Hôpital du Sacré-Coeur de Montréal, Québec, Canada (P.G.). · Institut Cardiovasculaire Paris Sud, Ramsay Générale de Santé, Massy, France (M.-C.M.). · Mount Sinai Saint Luke's, NY (J.D.P.). · John Radcliffe Hospital, Oxford, United Kingdom (D.P.T.). · Piedmont Heart Institute, Atlanta, GA (D.E.K.). · Sahlgrenska University Hospital, Gothenburg, Sweden (B.R.). · Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands (A.P.K.). · UH Cleveland Medical Center, Cleveland, OH (J.F.S.). · Imperial College London, United Kingdom (P.W.S.). ·Circ Cardiovasc Interv · Pubmed #31495220.

ABSTRACT: BACKGROUND: The SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS), a measure of anatomic coronary artery disease (CAD) extent and complexity, has proven useful in past studies to determine the absolute and relative prognosis after revascularization with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). We sought to assess contemporary outcomes after PCI and CABG in patients with left main CAD according to SS and revascularization type from a large randomized trial. METHODS: The EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) randomized patients with left main CAD and site-assessed SS≤32 to PCI with everolimus-eluting stents or CABG. Four-year outcomes were examined according to angiographic core laboratory-assessed SS using multivariable Cox proportional hazards regression. RESULTS: A total of 1840 patients with left main CAD randomized to PCI (n=914) versus CABG (n=926) had angiographic core laboratory SS assessment. The mean SS was 26.5±9.3 (range 5-74); 24.1% of patients had angiographic core laboratory-assessed SS ≥33. The 4-year rate of the primary major adverse cardiac event end point of death, stroke, or myocardial infarction was similar between PCI and CABG (18.6% versus 16.7%, respectively; P=0.40) and did not vary according to SS (P CONCLUSIONS: In the EXCEL trial, the 4-year primary composite major adverse cardiac event end point of death, myocardial infarction, or stroke was similar after PCI with everolimus-eluting stents and CABG and was independent of the baseline anatomic complexity and extent of CAD. In contrast, the relative and absolute hazard of major adverse cardiac or cerebrovascular events with PCI compared with CABG rose progressively with the SS. These data should be considered by the heart team when deciding between PCI versus CABG for revascularization in patients with left main CAD. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier NCT01205776.

17 Article Percutaneous coronary intervention versus coronary artery bypass grafting in patients with three-vessel or left main coronary artery disease: 10-year follow-up of the multicentre randomised controlled SYNTAX trial. 2019

Thuijs, Daniel J F M / Kappetein, A Pieter / Serruys, Patrick W / Mohr, Friedrich-Wilhelm / Morice, Marie-Claude / Mack, Michael J / Holmes, David R / Curzen, Nick / Davierwala, Piroze / Noack, Thilo / Milojevic, Milan / Dawkins, Keith D / da Costa, Bruno R / Jüni, Peter / Head, Stuart J / Anonymous4281003. ·Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands. Electronic address: d.thuijs@erasmusmc.nl. · Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands; Medtronic, Maastricht, Netherlands. · Department of Cardiology, Imperial College London, London, UK. · University Department of Cardiac Surgery, Heart Centre Leipzig, Leipzig, Germany. · Department of Cardiology, Cardiovascular Institute Paris-Sud, Hopital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France. · Department of Cardiothoracic Surgery, Baylor University Medical Centre, Dallas, TX, USA. · Department of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, MN, USA. · University Hospital Southampton NHS Foundation Trust and School of Medicine, University of Southampton, Southampton, UK. · Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands. · Shockwave Medical Inc, Santa Clara, CA, USA. · Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, University of Toronto, Toronto, ON, Canada; Institute of Primary Health Care, University of Bern, Bern, Switzerland. · Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, University of Toronto, Toronto, ON, Canada; Department of Medicine, Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada. · Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands; Medtronic, Minneapolis, MN, USA. ·Lancet · Pubmed #31488373.

ABSTRACT: BACKGROUND: The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferiority trial that compared percutaneous coronary intervention (PCI) using first-generation paclitaxel-eluting stents with coronary artery bypass grafting (CABG) in patients with de-novo three-vessel and left main coronary artery disease, and reported results up to 5 years. We now report 10-year all-cause death results. METHODS: The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension of follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to the PCI group or CABG group. Patients with a history of PCI or CABG, acute myocardial infarction, or an indication for concomitant cardiac surgery were excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause death, which was assessed according to the intention-to-treat principle. Prespecified subgroup analyses were performed according to the presence or absence of left main coronary artery disease and diabetes, and according to coronary complexity defined by core laboratory SYNTAX score tertiles. This study is registered with ClinicalTrials.gov, NCT03417050. FINDINGS: From March, 2005, to April, 2007, 1800 patients were randomly assigned to the PCI (n=903) or CABG (n=897) group. Vital status information at 10 years was complete for 841 (93%) patients in the PCI group and 848 (95%) patients in the CABG group. At 10 years, 244 (27%) patients had died after PCI and 211 (24%) after CABG (hazard ratio 1·17 [95% CI 0·97-1·41], p=0·092). Among patients with three-vessel disease, 151 (28%) of 546 had died after PCI versus 113 (21%) of 549 after CABG (hazard ratio 1·41 [95% CI 1·10-1·80]), and among patients with left main coronary artery disease, 93 (26%) of 357 had died after PCI versus 98 (28%) of 348 after CABG (0·90 [0·68-1·20], p INTERPRETATION: At 10 years, no significant difference existed in all-cause death between PCI using first-generation paclitaxel-eluting stents and CABG. However, CABG provided a significant survival benefit in patients with three-vessel disease, but not in patients with left main coronary artery disease. FUNDING: German Foundation of Heart Research (SYNTAXES study, 5-10-year follow-up) and Boston Scientific Corporation (SYNTAX study, 0-5-year follow-up).

18 Article Does an occluded RCA affect prognosis in patients undergoing PCI or CABG for left main coronary artery disease? Analysis from the EXCEL trial. 2019

Chen, Shmuel / Karmpaliotis, Dimitrios / Redfors, Björn / Shlofmitz, Evan / Ben-Yehuda, Ori / Crowley, Aaron / Mehdipoor, Ghazaleh / Puskas, John D / Kandzari, David E / Banning, Adrian P / Morice, Marie-Claude / Taggart, David P / Sabik, Joseph F / Serruys, Patrick W / Kappetein, A Pieter / Stone, Gregg W. ·Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA. ·EuroIntervention · Pubmed #31186220.

ABSTRACT: AIMS: The impact of an occluded right coronary artery (RCA) in patients with left main coronary artery disease (LMCAD) undergoing revascularisation is unknown. We compared outcomes for patients with LMCAD randomised to percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) according to the presence of an occluded RCA in the EXCEL trial. METHODS AND RESULTS: The EXCEL trial randomised 1,905 patients with LMCAD and SYNTAX scores ≤32 to PCI with everolimus-eluting stents versus CABG. Patients were categorised according to whether they had an occluded RCA at baseline, and their outcomes were examined using multivariable Cox proportional hazards regression. The primary endpoint was a composite of death, stroke, or myocardial infarction at three years. Among 1,753 patients with a dominant RCA by core laboratory analysis, the RCA was occluded in 130 (7.4%) at baseline. PCI was attempted in 34 of 65 patients with an occluded RCA (52.3%) and was successful in 27 (79.4% of those attempted; 41.5% of all RCAs recanalised). The RCA was bypassed in 42 of 65 patients with an occluded RCA (64.6%; p=0.0008 versus PCI). The three-year absolute and relative rates of the primary endpoint were similar between PCI and CABG, in patients with or without an occluded RCA (pinteraction=0.92). CONCLUSIONS: In the EXCEL trial, the presence of an occluded RCA at baseline did not confer a worse three-year prognosis in patients undergoing revascularisation for LMCAD and did not affect the relative outcomes of PCI versus CABG in this high-risk patient cohort.

19 Article Absorb Bioresorbable Scaffold Versus Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis: Rationale and Design of the COMPARE ABSORB Trial. 2019

Chang, Chun Chin / Onuma, Yoshinobu / Achenbach, Stephan / Barbato, Emanuele / Chevalier, Bernard / Cook, Stéphane / Dudek, Dariusz / Escaned, Javier / Gori, Tommaso / Kočka, Viktor / Tarantini, Giuseppe / West, Nick E J / Morice, Marie-Claude / Tijssen, Jan G P / van Geuns, Robert-Jan / Smits, Pieter C / Anonymous3600992. ·Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taiwan. · Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Cardialysis Clinical Trials Management and Core Laboratories, Rotterdam, the Netherlands. · Department of Cardiology, Universitätsklinikum Erlangen, Erlangen, Germany. · Cardiovascular Research Center OLV Hospital, Aalst, Belgium. · Ramsay Générale de Santé, ICPS, Hôpital Jacques Cartier, Massy, France. · Department of Cardiology, Hospital and University Fribourg, Switzerland. · 2nd Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland. · Hospital Clinico San Carlos IDISSC, Complutense University, Madrid, Spain. · Center of Cardiology, Cardiology I, University Medical Center of the Johannes Gutenberg-University Mainz and DZHK Standort Rhein-Main, Mainz, Germany. · Third Faculty of Medicine, Charles University and University Hospital Královske Vinohrady, Prague, Czech Republic. · Interventional Cardiology Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy. · Department of Interventional Cardiology, Royal Papworth Hospital, UK. · Ramsay Générale de Santé, Hopital Privé Jacques Cartier, Massy, France. · Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands. · Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Cardiology Department, Radboud UMC, Nijmegen, the Netherlands. · Cardiology Department, Maasstad Hospital, Rotterdam, the Netherlands. Electronic address: SmitsP@maasstadziekenhuis.nl. ·Cardiovasc Revasc Med · Pubmed #31153846.

ABSTRACT: BACKGROUND: The advent of bioresorbable vascular scaffolds (BVS) was considered as a potential improvement in percutaneous coronary intervention (PCI) after the groundbreaking development of drug eluting stents (DES). However, the clinical performance, long-term safety and efficacy of BVS in complex coronary lesions remain uncertain. COMPARE ABSORB, a multicenter, single blind, prospective randomized trial, aims to compare the clinical outcomes between the Absorb BVS and Xience everolimus-eluting metallic stent (EES) in patients with coronary artery disease and a high risk of restenosis. DESIGN: COMPARE ABSORB is designed to enroll 2100 patients at up to 45 European sites. Enrolled patients will possess high risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent PCI. Once included in the study, patients will receive either Absorb BVS or Xience EES. Specific advice on implantation technique including mandatory pre-dilatation, sizing and post-dilatation (PSP), will be used in the Absorb BVS arm. The primary endpoint is target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization). The trial is powered to assess non-inferiority of Absorb BVS compared with Xience EES with a predetermined non-inferiority margin of 4.5% at 1 year after index procedure. The clinical follow-up will continue for 7 years. CONCLUSIONS: The prospective COMPARE ABSORB randomized trial (ClinicalTrials.govNCT02486068) will help to assess the long-term safety and efficacy of Absorb BVS compared with Xience EES in the treatments of patients with complex coronary artery disease and a high attendant risk of restenosis.

20 Article Design and rationale of the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen (MASTER DAPT) Study. 2019

Frigoli, Enrico / Smits, Pieter / Vranckx, Pascal / Ozaki, Yokio / Tijssen, Jan / Jüni, Peter / Morice, Marie-Claude / Onuma, Yoshinobu / Windecker, Stephan / Frenk, Andrè / Spaulding, Christian / Chevalier, Bernard / Barbato, Emanuele / Tonino, Pim / Hildick-Smith, David / Roffi, Marco / Kornowski, Ran / Schultz, Carl / Lesiak, Maciej / Iñiguez, Andrés / Colombo, Antonio / Alasnag, Mirvat / Mullasari, Ajit / James, Stefan / Stankovic, Goran / Ong, Paul J L / Rodriguez, Alfredo E / Mahfoud, Felix / Bartunek, Jozef / Moschovitis, Aris / Laanmets, Peep / Leonardi, Sergio / Heg, Dik / Sunnåker, Mikael / Valgimigli, Marco. ·Clinical Trials Unit, University of Bern, Bern, Switzerland. · Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands. · Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium; Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium. · Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Aichi, Japan. · AMC Heartcenter, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. · University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada. · Cardiovascular European Research Center (CERC), Massy, France. · Thorax Center, Erasmus Medical Center, Rotterdam, the Netherlands. · Department of Cardiology, Bern University Hospital, Bern, Switzerland. · Cardiology department, Hôpital Européen Georges Pompidou, Assistance Publique Hôpitaux de Paris, Sudden Death Expert Center, INSERM U 970, Paris Descartes Université, Paris, France. · Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud, Massy, France. · Cardiovascular Research Center Aalst, Aalst, Belgium; Division of Cardiology, Department of Advanced Biomedical Sciences, University Federico II of Naples, Italy. · Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands. · Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom. · Division of Cardiology, Geneva University Hospitals, Geneva, Switzerland. · Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. · Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia. · 1st Department of Cardiology, University of Medical Sciences, Poznan, Poland. · Hospital Alvaro Cunqueiro, Vigo, Spain. · Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia. · Madras Medical Mission, Chennai, India. · Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden. · Department of Cardiology, Clinical Center of Serbia, and Faculty of medicine, University of Belgrade, Belgrade, Serbia. · Tan Tock Seng Hospital, Singapore, Singapore. · Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (CECI), Buenos Aires, Argentina. · Saarland University Hospital, Homburg, Germany. · Cardiovascular Research Center Aalst, Aalst, Belgium. · North-Estonia Medical Centre Foundation, Tallinn, Estonia. · Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. · Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic address: marco.valgimigli@insel.ch. ·Am Heart J · Pubmed #30703644.

ABSTRACT: BACKGROUND: The optimal duration of antiplatelet therapy in high-bleeding risk (HBR) patients with coronary artery disease treated with newer-generation drug-eluting bioresorbable polymer-coated stents remains unclear. DESIGN: MASTER DAPT (clinicaltrial.govNCT03023020) is an investigator-initiated, open-label, multicenter, randomized controlled trial comparing an abbreviated versus a standard duration of antiplatelet therapy after bioresorbable polymer-coated Ultimaster (TANSEI) sirolimus-eluting stent implantation in approximately 4,300 HBR patients recruited from ≥100 interventional cardiology centers globally. After a mandatory 30-day dual-antiplatelet therapy (DAPT) run-in phase, patients are randomized to (a) a single antiplatelet regimen until study completion or up to 5 months in patients with clinically indicated oral anticoagulation (experimental 1-month DAPT group) or (b) continue DAPT for at least 5 months in patients without or 2 in patients with concomitant indication to oral anticoagulation, followed by a single antiplatelet regimen (standard antiplatelet regimen). With a final sample size of 4,300 patients, this study is powered to assess the noninferiority of the abbreviated antiplatelet regimen with respect to the net adverse clinical and major adverse cardiac and cerebral events composite end points and if satisfied for the superiority of abbreviated as compared to standard antiplatelet therapy duration in terms of major or clinically relevant nonmajor bleeding. Study end points will be adjudicated by a blinded Clinical Events Committee. CONCLUSIONS: The MASTER DAPT study is the first randomized controlled trial aiming at ascertaining the optimal duration of antiplatelet therapy in HBR patients treated with sirolimus-eluting bioresorbable polymer-coated stent implantation.

21 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.

22 Article New-generation drug-eluting stents for left main coronary artery disease according to the EXCEL trial enrollment criteria: Insights from the all-comers, international, multicenter DELTA-2 registry. 2019

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 / Chieffo, Alaide / Anonymous2121017. ·Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy. · The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America. · Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia. · Hopital privé 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. · C.A.S.T., P.O. Gaspare Rodolico, Azienda-Ospedaliero Universitaria "Policlinico-Vittorio Emanuele", Catania, Italy. · Clinique Pasteur, Toulouse, France. · University Hospital of Zurich, Zurich, Switzerland. · Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy. Electronic address: chieffo.alaide@hsr.it. ·Int J Cardiol · Pubmed #30595357.

ABSTRACT: BACKGROUND: Percutaneous coronary intervention (PCI) has been established as an alternative treatment option to coronary artery by-pass graft (CABG) surgery in patients with left main coronary artery disease (LMCAD). Whether the findings of randomized controlled trials are applicable to a real-world patient population is unclear. METHODS: We compared the outcomes of PCI with new-generation DES in the all-comer, international, multicenter DELTA-2 registry retrospectively evaluating mid-term clinical outcomes with the historical CABG cohort enrolled in the DELTA-1 registry according to the EXCEL key inclusion or exclusion criteria. The primary endpoint was the composite of death, myocardial infarction, or stroke at the median time of follow-up time of 501 days. The consistency of the effect of DELTA-2 PCI versus DELTA-1 CABG according to the EXCEL enrollment criteria was tested using propensity score-adjusted Cox regression models. RESULTS: Out of 3986 patients enrolled in the DELTA-2 PCI registry, 2418 were EXCEL candidates and 1568 were not EXCEL candidates. The occurrence of the primary endpoint was higher among non-EXCEL candidates compared with EXCEL candidates (15.4% vs. 6.9%; hazard ratio 2.52; 95% confidence interval 2.00-3.16; p < 0.001). Among 901 patients enrolled in the historical DELTA-1 CABG cohort, 471 were EXCEL candidates and 430 were not EXCEL candidates. When comparing the DELTA-2 PCI with the DELTA-1 CABG cohort, the occurrence of the primary endpoint was lower in the PCI group compared with the historical CABG cohort among EXCEL candidates (6.9% vs. 10.7%; adjusted hazard ratio: 0.65; 95% confidence interval: 0.45-0.92), while no significant difference was observed among non-EXCEL candidates (15.4% vs. 12.5%; adjusted hazard ratio: 0.94; 95% confidence interval: 0.67-1.33) with evidence of statistical interaction (adjusted interaction p-value = 0.002). CONCLUSIONS: In a real-world population, PCI can be selected more favorably as an alternative to CABG in patients fulfilling the enrollment criteria of the EXCEL trial.

23 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.

24 Article Left Main Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Prior Cerebrovascular Disease: Results From the EXCEL Trial. 2018

Diamond, Jamie / Madhavan, Mahesh V / Sabik, Joseph F / Serruys, Patrick W / Kappetein, Arie Pieter / Leon, Martin B / Taggart, David P / Berland, Jacques / Morice, Marie-Claude / Gersh, Bernard J / Kandzari, David E / Dressler, Ovidiu / Stone, Gregg W. ·NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. · Department of Surgery, UH Cleveland Medical Center, Cleveland, Ohio. · Imperial College of Science, Technology and Medicine, London, United Kingdom. · Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands. · NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. · John Radcliffe Hospital, Oxford, United Kingdom. · Clinique Saint Hilaire, Rouen, France. · Ramsay Générale de Santé - Institut Cardiovasculaire Paris Sud, Massy, France. · Mayo Clinic College of Medicine, Rochester, Minnesota. · Piedmont Heart Institute, Atlanta, Georgia. · Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. · NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. Electronic address: gs2184@columbia.edu. ·JACC Cardiovasc Interv · Pubmed #30573053.

ABSTRACT: OBJECTIVES: The aim of this study was to determine whether high-risk patients with left main coronary artery disease (LMCAD) and prior cerebrovascular disease (CEVD) preferentially benefit from revascularization by percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG). BACKGROUND: Patients with known CEVD requiring revascularization are often referred to PCI rather than CABG. There is a paucity of data regarding the impact of CEVD in patients with LMCAD undergoing revascularization. METHODS: In the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, patients with LMCAD and low or intermediate SYNTAX (Synergy Between PCI with Taxus and Cardiac Surgery) scores were randomized to PCI with everolimus-eluting stents versus CABG. The effects of prior CEVD, defined as prior stroke, transient ischemic attack, or carotid artery disease, on 30-day and 3-year event rates were assessed. RESULTS: Prior CEVD was present in 233 of 1,898 patients (12.3%). These patients were older and had higher rates of comorbidities, including hypertension, diabetes, peripheral vascular disease, anemia, chronic kidney disease, and prior PCI, compared with those without prior CEVD. Patients with prior CEVD had higher rates of stroke at 30 days (2.2% vs. 0.8%; p = 0.05) and 3 years (6.4% vs. 2.2%; p = 0.0003) and higher 3-year rates of the primary endpoint of all-cause death, stroke, or myocardial infarction (25.0% vs. 13.6%; p < 0.0001). The relative effects of PCI versus CABG on the 30-day and 3-year rates of stroke (p CONCLUSIONS: Patients with LMCAD and prior CEVD compared with those without CEVD have higher rates of stroke and reduced event-free survival after revascularization. Data from the EXCEL trial do not a priori support a preferential role of PCI over CABG in patients with known CEVD.

25 Article New-Generation Drug-Eluting Stents for Left Main In-Stent Restenosis: The DELTA-2 Registry. 2018

Giustino, Gennaro / Tanaka, Akihito / Erglis, Andrejs / Morice, Marie Claude / Van Mieghem, Nicolas M / Meliga, Emanuele / D'Ascenzo, Fabrizio / Stefanini, Giulio G / Capodanno, Davide / Chieffo, Alaide / Anonymous6440971. · ·JACC Cardiovasc Interv · Pubmed #30522680.

ABSTRACT: -- No abstract --

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