Effectiveness and safety of the ABSORB bioresorbable vascular scaffold for the treatment of coronary artery disease: systematic review and meta-analysis of randomized clinical trials.

Background: In the last years bioresorbable vascular scaffold (BVS) become a new therapeutic option for interventional cardiologists, with the advantage of a scaffold inducing a possible vessel wall restoration. Nevertheless, several trials tried to prove the safety and efficacy profile of scaffolds, but with conflicting results.

Methods: A systematic review and meta-analysis was performed. The search was carried out in PubMed, Google Scholar, Biomed Central and Cochrane Library between January and March 2017. Inclusion criteria: randomized clinical trials (RCT) comparing the Absorb BVS versus durable polymer cobalt-chromium Everolimus Eluting Stent. The outcomes analysed were all-cause mortality, cardiac death, ischemia-driven target lesion revascularization, target vessel myocardial infarction (MI), target lesion failure (TLF)/device oriented composite endpoints (DOCE), and device thrombosis. Fixed-effect meta-analysis was performed. Data were expressed as odds ratio (OR).

Results: Overall 5,674 patients were included (mean age 62.2±1.31 in drug eluting stents (DES) group 62±1,47 in BVS group; P=0.942). DOCE (OR 1.16, 95% CI: 0.90-1.48; P=0.259, I2=0%), cardiac death (OR 0.86, 95% CI: 0.52-1.40; P=0.537, I=0%) and all-cause death (OR 0.78, 95% CI: 0.53-1.15; P=0.205, I=15%) did not differ between BVS and DES. Conversely, ischemia-driven target lesion revascularization was more frequent in the BVS group (OR 1.32, 95% CI: 1.01-1.73; P=0.039, I=0%), as well as device thrombosis (2.2% 0.6%, OR 2.94, 95% CI: 1.71-5.05, P=0.0001, I=0%) and target-vessel MI (5.4% 3%, OR 1.66, 95% CI: 1.25-2.21, P=0.001, I=0%).

Conclusions: The implantation of BVS is associated with an increased risk of device thrombosis, ischemia-driven target lesion revascularization and target vessel MI. If longer follow-up or different implantation technique may change these findings should be addressed in future trials.