Background
Bioresorbable vascular scaffolds (BVS) were designed to reduce the rate of late adverse events observed in conventional drug-eluting stents (DES) by dissolving once they have restored lasting patency.
Objectives
Compare the safety and efficacy after five years, of BVS versus DES in patients receiving percutaneous coronary intervention for coronary artery disease in randomized controlled trials (RCT).
Methods
Data collection: We applied the methods recommended by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. We searched Pubmed, and the Cochrane Central Register for randomized controlled trials (RCT) that evaluated log-term results (at least 60 months) of BVS versus DES in patients underwent percutaneous coronary intervention.
Outcome: The primary outcomes were target lesion failure (TLF), stent thrombosis, myocardial infarction, all-causes mortality, and cardiac mortality
Statistical Analysis: The analyses were performed using RevMan version 5.3. The results are presented odds ratios (OR) for dichotomous outcomes (Generic Inverse Variance random effect model) with 95% confidence interval (CI).
Results
Five full texts met inclusion criteria. A total of 4994 patients were included (2927 patients randomized to BVS and 2067 patients randomized to DES),
Target lesion failure: At five years of follow-up, the number of TLFs was significantly higher in patients randomized to BVS (OR 1.23 (1.04-1.45) p=0.02).
Stent thrombosis: at 5 years the number of stent thrombosis is significantly higher in patients randomized to BVS (OR 3.06 (1.93-4.87) p<0.0001)
Myocardial infarction: also in this case the number of myocardial infarctions is significantly higher in patients with BVS (OR 1.40 (1.13-1.73) p=0.002)
All-cause mortality: there were no differences between the two groups (OR 0.89 (0.71-1.12) p=0.33)
Cardiac mortality: no difference between the two groups (OR 0.81 (0.58-1.13) p=0.21.
Conclusions
Summary evidence from the included RCTs showed that DES are much safer and more effective than BVS in long term follow up.