Comparative Efficacy and Safety of Everolimus-Eluting Bioresorbable Scaffold Versus Everolimus-Eluting Metallic Stents: A Systematic Review and Meta-analysis.

ABSTRACT

BACKGROUND: Theoretically, the everolimus-eluting bioresorbable vascular scaffold (BVS) could eliminate stent thrombosis and improve outcomes in patients having percutaneous coronary intervention. PURPOSE: To estimate the incidence of stent thrombosis after BVS implantation and to compare the efficacy and safety of BVSs versus everolimus-eluting metallic stents (EESs) in adults having percutaneous coronary intervention. DATA SOURCES PubMed, EMBASE, Cochrane Central Register of Controlled Trials, conference proceedings, and relevant Web sites from inception through 20 January 2016. STUDY SELECTION 6 randomized, controlled trials and 38 observational studies, each involving at least 40 patients with BVS implantation. DATA EXTRACTION Two reviewers independently extracted study data and evaluated study risk of bias. DATA SYNTHESIS: The pooled incidence of definite or probable stent thrombosis after BVS implantation was 1.5 events per 100 patient-years (PYs) (95% CI, 1.2 to 2.0 events per 100 PYs) (126 events during 8508 PYs). Six randomized trials that directly compared BVSs with EESs showed a non-statistically significant increased risk for stent thrombosis (odds ratio [OR], 2.05 [CI, 0.95 to 4.43]; P = 0.067) and myocardial infarction (OR, 1.38 [CI, 0.98 to 1.95]; P = 0.064) with BVSs. The 6 observational studies that compared BVSs with EESs showed increased risk for stent thrombosis (OR, 2.32 [CI, 1.06 to 5.07]; P = 0.035) and myocardial infarction (OR, 2.09 [CI, 1.23 to 3.55]; P = 0.007) with BVSs. The relative rates of all-cause and cardiac death, revascularization, and target lesion failure were similar for BVSs and EESs. LIMITATION: Scarce comparative data, no published data from large trials with long-term follow-up, and limited quality and incomplete reporting of observational studies. CONCLUSION: Compared with EESs, BVSs do not eliminate and might increase risks for stent thrombosis and myocardial infarction in adults having percutaneous coronary intervention. Results of large trials with long-term follow-up are critically needed to establish the safety or at least the noninferiority of BVSs compared with EESs. PRIMARY FUNDING SOURCE None.