Safety and efficacy of second-generation drug-eluting stents compared with bare-metal stents: An updated meta-analysis and regression of 9 randomized clinical trials

Abstract

The efficacy of second-generation drug-eluting stents (DES; eg, everolimus and zotarolimus) compared with bare-metal stents (BMS) in patients undergoing percutaneous coronary intervention was challenged recently by new evidence from large clinical trials. Thus, we aimed to conduct an updated systematic review and meta-analysis of randomized clinical trials (RCTs) evaluating the efficacy and safety of second-generation DES compared with BMS. Electronic databases were systematically searched for all RCTs comparing second-generation DES with BMS and reporting clinical outcomes. The primary efficacy outcome was major adverse cardiac events (MACE); the primary safety outcome was definite stent thrombosis. The DerSimonian and Laird method was used for estimation of summary risk ratios (RR). A total of 9 trials involving 17 682 patients were included in the final analysis. Compared with BMS, second-generation DES were associated with decreased incidence of MACE (RR: 0.78, 95% confidence interval [CI]: 0.69-0.88), driven by the decreased incidence of myocardial infarction (MI) (RR: 0.67, 95% CI: 0.48-0.95), target-lesion revascularization (RR: 0.47, 95% CI: 0.42-0.53), definite stent thrombosis (RR: 0.57, 95% CI: 0.41-0.78), and definite/probable stent thrombosis (RR: 0.54, 95% CI: 0.38-0.80). The incidence of all-cause mortality was similar between groups (RR: 0.94, 95% CI: 0.79-1.10). Meta-regression showed lower incidences of MI with DES implantation in elderly and diabetic patients (P = 0.026 and P < 0.0001, respectively). Compared with BMS, second-generation DES appear to be associated with a lower incidence of MACE, mainly driven by lower rates of target-lesion revascularization, MI, and stent thrombosis. However, all-cause mortality appears similar between groups.

Keywords: Coronary Artery Disease; Drug-Eluting Stents; Percutaneous Coronary Intervention.

Figure 1

Search strategy and selection criteria (PRISMA) figure. Abbreviations: EES, everolimus‐eluting stent; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta‐Analyses

Figure 2

Summary risk ratio of MACE and definite stent thrombosis. The relative size of the data markers indicates the weight of the sample size from each study. P value represents χ² test of heterogeneity. Abbreviations: BASKET‐PROVE, Basel Stent Kosten Effektivitäts Trial–Prospective Validation Examination; BMS, bare‐metal stents; CI, confidence interval; DES, drug‐eluting stents; ENDEAVOR II, Medtronic Endeavor Drug‐Eluting Coronary Stent System in Coronary Artery Lesions; EXAMINATION, Everolimus‐Eluting Stents vs Bare‐Metal Stents in ST‐Segment Elevation Myocardial Infarction; MACE, major adverse cardiac events; NORSTENT, Norwegian Coronary Stent trial; PRODIGY, Prolonging Dual Antiplatelet Treatment After Grading Stent‐Induced Intimal Hyperplasia Study; RR, risk ratio; SPIRIT FIRST, prospective, single‐blind, randomized, multicenter trial comparing outcomes in patients treated with Xience V/Promus vs BMS; XIMA, Xience or Vision Stents for the Management of Angina in the Elderly; ZEUS, Zotarolimus‐Eluting vs Bare‐Metal Stents in Uncertain Drug‐Eluting Stent Candidates

Figure 3

Summary risk ratios of MI, TLR, and all‐cause mortality (secondary efficacy outcomes). The relative size of the data markers indicates the weight of the sample size from each study. P value represents χ² test of heterogeneity. Abbreviations: BASKET‐PROVE, Basel Stent Kosten Effektivitäts Trial–Prospective Validation Examination; BMS, bare‐metal stents; CI, confidence interval; DES, drug‐eluting stents; ENDEAVOR II, Medtronic Endeavor Drug‐Eluting Coronary Stent System in Coronary Artery Lesions; EXAMINATION, Everolimus‐Eluting Stents vs Bare‐Metal Stents in ST‐Segment Elevation Myocardial Infarction; MI, myocardial infarction; NORSTENT, Norwegian Coronary Stent trial; PRODIGY, Prolonging Dual Antiplatelet Treatment After Grading Stent‐Induced Intimal Hyperplasia Study; RR, risk ratio; SPIRIT FIRST, prospective, single‐blind, randomized, multicenter trial comparing outcomes in patients treated with Xience V/Promus vs BMS; TLR, target‐lesion revascularization; XIMA, Xience or Vision Stents for the Management of Angina in the Elderly; ZEUS, Zotarolimus‐Eluting vs Bare‐Metal Stents in Uncertain Drug‐Eluting Stent Candidates