TY - JOUR
T1 - Drug-eluting or bare-metal stents for percutaneous coronary intervention
T2 - a systematic review and individual patient data meta-analysis of randomised clinical trials
AU - Coronary Stent Trialists' Collaboration
AU - Piccolo, Raffaele
AU - Bonaa, Kaare H.
AU - Efthimiou, Orestis
AU - Varenne, Olivier
AU - Baldo, Andrea
AU - Urban, Philip
AU - Kaiser, Christoph
AU - Remkes, Wouter
AU - Räber, Lorenz
AU - de Belder, Adam
AU - van't Hof, Arnoud W.J.
AU - Stankovic, Goran
AU - Lemos, Pedro A.
AU - Wilsgaard, Tom
AU - Reifart, Jörg
AU - Rodriguez, Alfredo E.
AU - Ribeiro, Expedito E.
AU - Serruys, Patrick W.J.C.
AU - Abizaid, Alex
AU - Sabaté, Manel
AU - Byrne, Robert A.
AU - de la Torre Hernandez, Jose M.
AU - Wijns, William
AU - Jüni, Peter
AU - Windecker, Stephan
AU - Valgimigli, Marco
N1 - Publisher Copyright:
© 2019 Elsevier Ltd
PY - 2019/6/22
Y1 - 2019/6/22
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/85067378112
U2 - 10.1016/S0140-6736(19)30474-X
DO - 10.1016/S0140-6736(19)30474-X
M3 - Article
C2 - 31056295
AN - SCOPUS:85067378112
SN - 0140-6736
VL - 393
SP - 2503
EP - 2510
JO - The Lancet
JF - The Lancet
IS - 10190
ER -