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

Abstract

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.

Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (BIOSTEMI): a single-blind, prospective, randomised superiority trial

“…Early-generation 17,18 and newer-generation drug-eluting stents 2 have progressively improved safety and efficacy outcomes compared with bare-metal stents in patients with acute STEMI undergoing primary PCI. Newer-generation drug-eluting stents that combine thin strut stent platforms with biocompatible durable polymer coatings were associated with further reductions in the risk of repeat revascularisation and stent thrombosis after primary PCI compared with early-generation thicker strut durable polymer drug-eluting stents.…”

Drug-Coated Balloons versus Everolimus-Eluting Stents in Patients with In-Stent Restenosis: A Pair-Wise Meta-Analysis of Randomized Trials

“…Randomized trials have demonstrated that DCB is associated with comparable angiographic results and clinical events with rst-generation DES [17,18]. EES was a second-generation DES, which was superior to BMS and rst-generation DES in reducing the risk of stent thrombosis and repeat revascularization [1,19]. Several trials compared DCB with EES for the treatment of ISR, but they had small sample sizes and inconsistent outcomes [4,5,[8][9][10][11].…”

“…In-stent restenosis (ISR) is one of the main stumbling blocks for stent implantation in patients with coronary artery disease [1]. Although the medicines and stents had advanced prominently, ISR was still remarkable.…”

“…Although the medicines and stents had advanced prominently, ISR was still remarkable. Repeat revascularization for ISR accounts for 5-10% of patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and for 20-30% a er PCI with bare-metal stents (BMS) [1]. Many repeat revascularization strategies were performed in ISR patients, such as balloon angioplasty, BMS implantation, vascular brachytherapy, rotablation, DES implantation, or drug-coated balloon (DCB) angioplasty [2].…”

Expanding the armamentarium for the treatment of left main disease

“…However, early technical success and a operator‐friendly feature is not enough. Before implementation in routine practice, it will be important to know whether this technology is at least non‐inferior to current, highly performing, new‐generation drug‐eluting stents …”