1. In comparison to everolimus-eluting metallic stents (EESs), bioresorbable vascular scaffolds (BVSs) increased the chances for thrombotic events at both mid- and long-term follow-up.
2. Compared to patients with EESs, those with BVSs had a heightened risk (that increased over time) of myocardial infarction, target lesion revascularization (TLR), and target lesion failure (TLF).
Evidence Rating Level: 1 (Excellent)
Study Rundown: Compared to bare-metal stents, drug-eluting stents decrease the frequency of in-stent stenosis, TLR, and myocardial infarction for people undergoing percutaneous coronary interventions (PCIs). However, there are still concerns that these drug-eluting stents may be associated with late and very late stent thrombosis. BVSs were designed to combat these problems, but recent data suggests that BVSs may be associated with a higher risk of cardiovascular events compared to EESs. This study sought to estimate how often scaffold thrombosis occurred after BVS implantation and to compare everolimus-eluting BVSs with EESs regarding safety and efficacy in adults who had a PCI. Through a systematic review and meta-analysis, researchers found that in comparison to EESs, BVSs increased the chances for thrombotic events, including scaffold or stent thrombosis, at both mid- and long-term follow-up. The authors suggest that to improve clinical outcomes of BVSs, better scaffold-specific techniques and scaffold designs are necessary.
Considering that long-term safety and efficacy data were not clearly established in previous trials, a strength of this study is that it evaluates mid- and long-term follow-up data. Limitations of the study include unclear quality of the observational studies used and that some data were not published.
In-Depth [systematic review and meta-analysis]: Using PubMed, the Cochrane Library, EMBASE, conference proceedings, and pertinent Web sites, researchers completed a meta-analysis of 7 randomized controlled trials (RCTs) and 38 observational studies that included adults with coronary artery disease who received a BVS or an EES and reported thrombosis or other outcomes such as myocardial infarction, revascularization, or death. At a median follow-up of 1 year and beyond 1 year, the rate of scaffold thrombosis following BVS implantation was 1.8% and 0.8%, respectively. In 7 trials with a direct comparison of BVSs with EESs, there was an increased risk (odds ratio [OR], 3.40 [CI, 2.01 to 5.76]) of scaffold thrombosis with BVSs at 25 months (median follow-up). Compared to patients with EES, those with BVSs had a heightened risk of myocardial infarction (OR, 1.63), TLR (OR, 1.31), and TLF (OR, 1.37). Over time, the odds for these three risk factors all increased.
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