Dataset Information

Mid-term and long-term safety and efficacy of bioresorbable vascular scaffolds versus metallic everolimus-eluting stents in coronary artery disease: A weighted meta-analysis of seven randomised controlled trials including 5577 patients.

ABSTRACT:

Aims

Mid- and long-term safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) have been studied in randomised trials; however, most were not individually powered for clinical endpoints. We performed a weighted meta-analysis comparing mid- and long-term outcomes in patients treated with the BVS compared with the Xience metallic stent.

Methods and results

Randomised trials comparing the BVS and Xience were identified by searching MEDLINE, EMBASE and conference abstracts. Seven trials were included (BVS n = 3258, Xience n = 2319) with follow-up between 1-3 years. The primary outcome of target lesion failure occurred more frequently in BVS compared with Xience [OR 1.34; 95% CI 1.11-1.62, p = 0.003]. Overall definite or probable device thrombosis occurred more frequently with the BVS [OR 2.86; 95% CI 1.88-4.36, p < 0.001] and this extended beyond 1 year of follow-up [OR 4.13; 95% CI 1.99-8.57, p < 0.001]. Clinically indicated or ischaemia driven target lesion revascularisation [OR 1.43; 95% CI 1.11-1.83, p = 0.005] and myocardial infarction (all MI) [OR 1.64; 95% CI 1.20-2.23, p = 0.002] were more frequently seen in the BVS compared with Xience. Rates of target vessel failure [OR 1.15; 95% CI 0.91-1.46, p = 0.25] and cardiac death [OR 0.91; 95% CI 0.57-1.46, p = 0.71] were not significantly different between BVS and Xience.

Conclusion

This meta-analysis shows a higher rate of target lesion failure and an almost threefold higher rate of device thrombosis in BVS compared with Xience, which extends beyond the first year. Device thrombosis did not lead to an overall increased (cardiac) mortality.

SUBMITTER: Elias J

PROVIDER: S-EPMC5513992 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundEverolimus-eluting bioresorbable vascular scaffolds (BVS), which have the characteristics of scaffold absorption and vascular function recovery, are the latest innovation in the treatment of coronary artery disease. This new concept has become a hot topic in the field of interventional cardiology. Data regarding mid-term clinical outcomes of BVS in acute coronary syndromes are currently scarce. The aim of this systematic review and meta-analysis is to compare mid-term outcome data for BVS and second-generation drug-eluting stents (DES) in the treatment of acute coronary syndromes.MethodsWe searched PubMed, Embase, the Cochrane Library, Web of Science, and relevant web sites for studies with a follow-up of ? 1 years that studied percutaneous coronary interventions with BVS vs second-generation DES in acute coronary syndromes. A meta-analysis was performed with the software RevMan following the standards of the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0.ResultsFive studies, 2 randomized controlled trials, and 3 observational studies, with a total of 1758 patients (BVS n?=?917; DES n?=?841) and a median follow-up duration of 24 months, were included. BVS, when compared with DES, resulted in higher rates of target lesion revascularization (TLR) (OR, 2.20; 95% CI, 1.12-3.64; P?=?.02) and stent/scaffold thrombosis (ST/ScT) (OR?=?2.35, 95% CI: 1.13-4.89, P?=?.02). When TLR due to device thrombosis were excluded, the difference in risk estimates between the 2 groups was no longer significant (OR: 1.67, 95% CI: 0.73-3.82, P?=?.22). The risk for all-cause death (OR?=?1.32 95% CI: 0.61-2.88, P?=?.48), cardiac death (OR?=?1.29, 95% CI: 0.58-2.86 P?=?.52), target vessel myocardial infarction (OR?=?1.50, 95% CI: 0.86-2.61, P?=?.15), and target lesion failure (OR?=?1.34, 95% CI: 0.76-2.35, P?=?.31) did not differ between BVS and DES groups.ConclusionAt mid-term follow-up, BVS had a higher risk of TLR and ST/ScT than the second-generation DES in patients with acute coronary syndromes. ST/ScT was the key factor indicating the decreased safety and effectiveness of BVS relative to DES.