Background New-generation drug-eluting stents (DES) have been mostly investigated by means of head-to-head non-inferiority trials, which typically showed comparable efficacy and greater safety as compared with early-generation DES. Evidence related to new-generation DES versus bare-metal stents (BMS) is more limited, and there remain uncertainties on their comparative safety profile. Methods We performed an individual patient data (IPD) meta-analysis of randomized trials comparing new-generation DES with BMS among patients undergoing percutaneous coronary intervention. The protocol of the study was registered in PROSPERO (CRD42017060520). The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random effects metaanalysis and examined at maximum follow-up and with 1-year landmark. Risk estimates are reported as hazard ratio (HR) with 95% confidence intervals (95%CI). Findings We obtained IPD data from 20 randomized trials including a total of 26,616 patients, with 3•2±1•8 years mean follow-up. The primary outcome occurred in fewer patients in the DES group than in the BMS group (HR 0•84, 95%CI 0•78 to 0•90, P<0•001) owing to lower risk of myocardial infarction (HR 0•79, 95%CI 0•71 to 0•88, P<0•001) and weaker evidence for a possible cardiac mortality benefit (HR 0•89, 95%CI 0•78 to 1•01, P=0•075). All-cause death was unaffected (HR with DES, 0•96, 95%CI 0•88 to 1•05, P=0•358), but DES reduced the risk of definite stent thrombosis (HR 0•63, 95%CI 0•50 to 0•80, P<0•001) and targetvessel revascularization (HR 0•55, 95%CI 0•50 to 0•60, P<0•001). There was evidence for a time-dependent treatment effect, with DES being associated with lower risks of the primary outcome during the first year followed by a null effect in the subsequent years. Interpretation New-generation DES instead of BMS were associated with sustained reduction of cardiac death or myocardial infarction owing to lower event rates within the first year without offsetting effects thereafter.

clinicaltrials.gov Identifier: NCT00611286.

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Moderate-to-severe CKD did not modify the effect of a prolonged or shortened DAPT duration in largely unselected patients undergoing stent implantation. Our analysis suggests that CKD should not be a major driver in the decision-making on the duration of DAPT after stent implantation. This exploratory study is underpowered and should be considered hypothesis-generating only. © 2017 Wiley Periodicals, Inc.