Raffaele Piccolo1, Kaare H Bonaa2, Orestis Efthimiou3, Olivier Varenne4, Andrea Baldo5, Philip Urban6, Christoph Kaiser7, Wouter Remkes8, Lorenz Räber5, Adam de Belder9, Arnoud W J van 't Hof10, Goran Stankovic11, Pedro A Lemos12, Tom Wilsgaard2, Jörg Reifart13, Alfredo E Rodriguez14, Expedito E Ribeiro12, Patrick W J C Serruys15, Alex Abizaid16, Manel Sabaté17, Robert A Byrne18, Jose M de la Torre Hernandez19, William Wijns20, Peter Jüni21, Stephan Windecker5, Marco Valgimigli22. 1. Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy. 2. Department of Community Medicine, University of Tromsø-Arctic University of Norway, Tromsø, Norway. 3. Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland. 4. Department of Cardiology, Hôpital Cochin, AP-HP, Paris, France; Université Paris Descartes, Faculté de Médecine, Paris, France. 5. Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland. 6. Hôpital de la Tour, Geneva, Switzerland. 7. Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland. 8. Department of Cardiology, Isala Heart Centre, Zwolle, Netherlands. 9. Department of Cardiology, Sussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton, UK. 10. Department of Cardiology, Isala Heart Centre, Zwolle, Netherlands; Department of Cardiology, Maastricht University Medical Center, Netherlands; Department of Cardiology, Zuyderland Medical Centre Heerlen, Netherlands. 11. Department of Cardiology, Clinical Centre of Serbia, University of Belgrade, Belgrade, Serbia. 12. Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil. 13. Department of Cardiology, Kerckhoff Klinik, Bad Nauheim, Germany. 14. Cardiac Unit, Cardiology Fellow Training Program, Otamendi Hospital, Buenos Aires School of Medicine, Buenos Aires, Argentina. 15. International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College, London, London, UK. 16. Department of Invasive Cardiology, Institute Dante Pazzanese of Cardiology, São Paulo, Brazil. 17. Cardiology Department, Cardiovascular Institute (ICCV), Hospital Clínic, IDIBAPS, University of Barcelona, Barcelona, Spain. 18. Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; German Centre for Cardiovascular Research (DZHK), Munich, Germany; Munich Heart Alliance, Munich, Germany. 19. Hospital Marqués de Valdecilla, Santander, Spain. 20. Lambe Institute for Translational Medicine, Galway, Ireland; Cúram, Biomedical Sciences, National University of Ireland Galway, Galway, Ireland. 21. Applied Health Research Centre of the Li Ka Shing Knowledge Institute, Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, ON, Canada. 22. Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address: marco.valgimigli@insel.ch.
Abstract
BACKGROUND: New-generation drug-eluting stents (DES) have mostly been investigated in head-to-head non-inferiority trials against early-generation DES and have typically shown similar efficacy and superior safety. How the safety profile of new-generation DES compares with that of bare-metal stents (BMS) is less clear. METHODS: We did an individual patient data meta-analysis of randomised clinical trials to compare outcomes after implantation of new-generation DES or BMS among patients undergoing percutaneous coronary intervention. The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random-effects meta-analysis and examined at maximum follow-up and a 1-year landmark. Risk estimates are reported as hazard ratios (HRs) with 95% CIs. This study is registered in PROSPERO, number CRD42017060520. FINDINGS: We obtained individual data for 26 616 patients in 20 randomised trials. Mean follow-up was 3·2 (SD 1·8) years. The risk of the primary outcome was reduced in DES recipients compared with BMS recipients (HR 0·84, 95% CI 0·78-0·90, p<0·001) owing to a reduced risk of myocardial infarction (0·79, 0·71-0·88, p<0·001) and a possible slight but non-significant cardiac mortality benefit (0·89, 0·78-1·01, p=0·075). All-cause death was unaffected (HR with DES 0·96, 95% CI 0·88-1·05, p=0·358), but risk was lowered for definite stent thrombosis (0·63, 0·50-0·80, p<0·001) and target-vessel revascularisation (0·55, 0·50-0·60, p<0·001). We saw a time-dependent treatment effect, with DES being associated with lower risk of the primary outcome than BMS up to 1 year after placement. While the effect was maintained in the longer term, there was no further divergence from BMS after 1 year. INTERPRETATION: The performance of new-generation DES in the first year after implantation means that BMS should no longer be considered the gold standard for safety. Further development of DES technology should target improvements in clinical outcomes beyond 1 year. FUNDING: Bern University Hospital.
BACKGROUND: New-generation drug-eluting stents (DES) have mostly been investigated in head-to-head non-inferiority trials against early-generation DES and have typically shown similar efficacy and superior safety. How the safety profile of new-generation DES compares with that of bare-metal stents (BMS) is less clear. METHODS: We did an individual patient data meta-analysis of randomised clinical trials to compare outcomes after implantation of new-generation DES or BMS among patients undergoing percutaneous coronary intervention. The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random-effects meta-analysis and examined at maximum follow-up and a 1-year landmark. Risk estimates are reported as hazard ratios (HRs) with 95% CIs. This study is registered in PROSPERO, number CRD42017060520. FINDINGS: We obtained individual data for 26 616 patients in 20 randomised trials. Mean follow-up was 3·2 (SD 1·8) years. The risk of the primary outcome was reduced in DES recipients compared with BMS recipients (HR 0·84, 95% CI 0·78-0·90, p<0·001) owing to a reduced risk of myocardial infarction (0·79, 0·71-0·88, p<0·001) and a possible slight but non-significant cardiac mortality benefit (0·89, 0·78-1·01, p=0·075). All-cause death was unaffected (HR with DES 0·96, 95% CI 0·88-1·05, p=0·358), but risk was lowered for definite stent thrombosis (0·63, 0·50-0·80, p<0·001) and target-vessel revascularisation (0·55, 0·50-0·60, p<0·001). We saw a time-dependent treatment effect, with DES being associated with lower risk of the primary outcome than BMS up to 1 year after placement. While the effect was maintained in the longer term, there was no further divergence from BMS after 1 year. INTERPRETATION: The performance of new-generation DES in the first year after implantation means that BMS should no longer be considered the gold standard for safety. Further development of DES technology should target improvements in clinical outcomes beyond 1 year. FUNDING: Bern University Hospital.
Authors: Seng Chan You; Yeunsook Rho; Behnood Bikdeli; Jiwoo Kim; Anastasios Siapos; James Weaver; Ajit Londhe; Jaehyeong Cho; Jimyung Park; Martijn Schuemie; Marc A Suchard; David Madigan; George Hripcsak; Aakriti Gupta; Christian G Reich; Patrick B Ryan; Rae Woong Park; Harlan M Krumholz Journal: JAMA Date: 2020-10-27 Impact factor: 56.272
Authors: Marysia S Tweet; Jennifer Lewey; Nathaniel R Smilowitz; Carl H Rose; Patricia J M Best Journal: Circ Cardiovasc Interv Date: 2020-08-01 Impact factor: 6.546