Meta-Analysis of Bioresorbable Vascular Scaffolds vs. Everolimus Eluting Stents

 Courtesy of Dr. Agustín Vecchia.

The aim of this study was to compare the safety and efficacy of bioresorbable everolimus eluting scaffolds (BVS) vs. everolimus eluting stents (EES) in patients with ischemic heart disease.

Medline, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), was searched for scientific sessions, abstracts, and relevant websites for randomized trials investigating everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents. Efficacy primary end point was target vessel revascularization (TVR) and safety end point was definite/probable stent thrombosis (ST). Secondary end points were target lesion failure (a combination of cardiac death, target vessel infarction, or ischemia driven target vessel revascularization), acute myocardial infarction, death and in device late lumen loss.

The study included six randomized trials with data from 3738 patients: ABSORB China (480 patients), ABSORB II (501), ABSORB III (2008), ABSORB Japan (400), EVERBIO II (158), and TROFI II (191). These trials randomized patients to receive a BVS (n=2337) or an EES (n=1401). Median follow-up was 12 months (IQR 9-12). BVS patients had a similar risk of target lesion revascularization (OR 0.97 [95% CI 0.66-1.43]; p=0·87), target lesion failure (1.20 [0.90-1.60]; p=0.21), myocardial infarction (1.36 [0.98-1.89]; p=0.06), and death (0.95 [0.45-2.00]; p=0.89) as those treated with EES. Patients treated with BVS had a higher risk of definite or probable stent thrombosis (OR 1.99 [95% CI 1.00-3.98]; p=0·05), with the highest risk between 1 and 30 days after implantation (3.11 [1.24-7.82]; p=0.02). Lesions treated with a BVS had greater in-device late lumen loss than those treated with EES (difference 0.08 [95% CI 0.05-0.12]; p<0.0001).

Conclusion
Revascularization rate at one year is similar in both groups with higher late lumen loss and higher definite/probable thrombosis rates in the BVS group. To determine the benefits of BVS, further studies with longer follow up periods are needed.

Editorial Comment
This meta-analysis includes the most relevant studies on this matter and shows higher rates of thrombosis (0.5 vs 1.3%) and late lumen loss in the BVS group, at least in the short term. In theory, the benefits of BVS are expected years after their implantation; however, to date, BVS have not been showed superior to standard EES.

Courtesy of Dr. Agustín Vecchia.

Original Title: Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomized controlled trials.

Reference: Salvatore Cassese et al. 16 Nov 2015 The Lancet http://dx.doi.org/10.1016/S0140-6736(15)00979-4.

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