Drug-eluting or bare-metal stents for percutaneous coronary intervention: a systematic review and individual patient data meta-analysis of randomised clinical trials.

Piccolo, Raffaele; Bonaa, Kaare H; Efthimiou, Orestis; Varenne, Olivier; Baldo, Andrea; Urban, Philip; Kaiser, Christoph; Remkes, Wouter; Räber, Lorenz; de Belder, Adam; van 't Hof, Arnoud W J; Stankovic, Goran; Lemos, Pedro A; Wilsgaard, Tom; Reifart, Jörg; Rodriguez, Alfredo E; Ribeiro, Expedito E; Serruys, Patrick W J C; Abizaid, Alex; Sabaté, Manel; ... (2019). Drug-eluting or bare-metal stents for percutaneous coronary intervention: a systematic review and individual patient data meta-analysis of randomised clinical trials. Lancet, 393(10190), pp. 2503-2510. Elsevier 10.1016/S0140-6736(19)30474-X

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology
04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine

UniBE Contributor:

Efthimiou, Orestis; Räber, Lorenz; Windecker, Stephan and Valgimigli, Marco

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

0140-6736

Publisher:

Elsevier

Language:

English

Submitter:

Andrea Flükiger-Flückiger

Date Deposited:

14 May 2019 11:16

Last Modified:

03 Nov 2019 02:31

Publisher DOI:

10.1016/S0140-6736(19)30474-X

PubMed ID:

31056295

BORIS DOI:

10.7892/boris.130655

URI:

https://boris.unibe.ch/id/eprint/130655

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