Midterm clinical outcomes with everolimus-eluting bioresorbable scaffolds versus everolimus-eluting metallic stents for percutaneous coronary interventions: a meta-analysis of randomised trials.

bioresorbable vascular scaffold (BVS) versus an everolimus-eluting metallic stent (EES) for percutaneous coronary interventions.

METHODS AND RESULTS: We performed a meta-analysis of aggregate data by searching Medline, EMBASE, Cochrane databases and proceedings of international meetings for randomised trials reporting the clinical outcomes beyond one year of patients treated with BVS versus EES. The primary efficacy and safety outcomes were target lesion failure (TLF) and definite/probable stent (scaffold) thrombosis (ST), respectively. Secondary outcomes were the individual components of the primary efficacy outcome (cardiac death, target vessel myocardial infarction [MI], and ischaemia-driven target lesion revascularisation [ID-TLR]). A total of 5,583 patients randomly received BVS (n=3,261) or EES (n=2,322) in seven trials. Weighted median follow-up was 26.6 months. Patients treated with BVS versus EES showed a higher risk of TLF (odds ratio [OR] 1.35, 95% confidence interval [CI]: 1.11-1.65; p=0.0028) due to a higher risk of target vessel MI (OR 1.68, 95% CI: 1.21-2.33; p=0.008) and ID-TLR (OR 1.42, 95% CI: 1.10-1.84; p=0.007) though the risk for cardiac death was not statistically different (OR 0.89, 95% CI: 0.55-1.43; p=0.56). Patients treated with BVS versus EES showed a higher risk of definite/probable ST (OR 3.24, 95% CI: 1.92-5.49; p<0.0001), particularly in the period beyond one year after implantation (OR 4.03, 95% CI: 1.49-10.87; p=0.006).

CONCLUSIONS: At midterm follow-up, patients treated with BVS as compared to those treated with EES display a higher risk of target lesion failure and scaffold thrombosis.