Olivier Varenne1, Stéphane Cook2, Georgios Sideris3, Sasko Kedev4, Thomas Cuisset5, Didier Carrié6, Thomas Hovasse7, Philippe Garot7, Rami El Mahmoud8, Christian Spaulding9, Gérard Helft10, José F Diaz Fernandez11, Salvatore Brugaletta12, Eduardo Pinar-Bermudez13, Josepa Mauri Ferre14, Philippe Commeau15, Emmanuel Teiger16, Kris Bogaerts17, Manel Sabate18, Marie-Claude Morice19, Peter R Sinnaeve20. 1. 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. 2. Cardiology Department, University and Hospital Fribourg, Fribourg, Switzerland. 3. 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. 4. Cardiology Department, University St Cyril and Methodius, Skopje, Macedonia. 5. Département de Cardiologie, Centre hospitalier universitaire Timone, Marseille, France. 6. Service de Cardiologie, Centre hospitalier universitaire Toulouse Rangueil, Université Paul Sabatier, Toulouse, France. 7. Institut Cardiovasculaire Paris-Sud, Ramsay Générale de Santé, Massy and Quincy, France. 8. Hôpital Ambroise Paré Assistance Publique-Hôpitaux de Paris, Université Versailles-Saint Quentin en Yvelines, Versailles, France. 9. 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. 10. 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. 11. Juan Ramón Jiménez University Hospital, Huelva, Spain. 12. Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain. 13. Hospital Universitario Virgen de la Arrixaca, Murcia, Spain. 14. Hospital Universitari Germans Trias i Pujol, Badalona, Spain. 15. Département de Cardiologie Interventionnelle, Polyclinique Les Fleurs, Ollioules, France. 16. Service de Cardiologie, Hôpital Henri Mondor Assistance Publique-Hôpitaux de Paris, Université Paris Est Créteil, Créteil, France. 17. 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. 18. Interventional Cardiology Unit, Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain. 19. Cardiovascular European Research Center, Massy, France. 20. Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.
Abstract
BACKGROUND:Elderly patients regularly receivebare-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 P2Y12 inhibitors; contraindication to P2Y12 inhibitors; and silent ischaemia of less than 10% of the left myocardium with a fractional flow reserve of 0·80 or higher. After the intended duration of DAPT was recorded (1 month for patients with stable presentation and 6 months for those with unstable presentation), patients were randomly allocated (1:1) by a central computer system (blocking used with randomly selected block sizes [two, four, eight, or 16]; stratified by site and antiplatelet agent) to either a DES or similar BMS in a single-blind fashion (ie, patients were masked), but those assessing outcomes were masked. The primary outcome was to compare major adverse cardiac and cerebrovascular events (ie, a composite of all-cause mortality, myocardial infarction, stroke, or ischaemia-driven target lesion revascularisation) between groups at 1 year in the intention-to-treat population, assessed at 30 days, 180 days, and 1 year. This trial is registered with ClinicalTrials.gov, number NCT02099617. 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 ofDAPT 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.
RCT Entities:
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 P2Y12 inhibitors; contraindication to P2Y12 inhibitors; and silent ischaemia of less than 10% of the left myocardium with a fractional flow reserve of 0·80 or higher. After the intended duration of DAPT was recorded (1 month for patients with stable presentation and 6 months for those with unstable presentation), patients were randomly allocated (1:1) by a central computer system (blocking used with randomly selected block sizes [two, four, eight, or 16]; stratified by site and antiplatelet agent) to either a DES or similar BMS in a single-blind fashion (ie, patients were masked), but those assessing outcomes were masked. The primary outcome was to compare major adverse cardiac and cerebrovascular events (ie, a composite of all-cause mortality, myocardial infarction, stroke, or ischaemia-driven target lesion revascularisation) between groups at 1 year in the intention-to-treat population, assessed at 30 days, 180 days, and 1 year. This trial is registered with ClinicalTrials.gov, number NCT02099617. 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.
Authors: Leor Perl; Alfonso Franzé; Fabrizio D'Ascenzo; Noa Golomb; Amos Levi; Hana Vaknin-Assa; Gabriel Greenberg; Abid Assali; Gaetano M De Ferrari; Ran Kornowski Journal: J Clin Med Date: 2021-05-30 Impact factor: 4.241