The Safety and Efficacy of Absorb Bioresorbable Vascular Scaffold: A Systematic Review

Abstract

Bioresorbable stents are novel devices designed to overcome the long‐term limitations of permanent stent implantation. The Absorb bioresorbable vascular scaffold (BVS; Abbott Vascular, Santa Clara, CA) was the first bioresorbable stent with Conformité Européenne mark approval in coronary vessels and has been the subject of multiple clinical studies. Despite its potential advantages, the safety and efficacy of BVS remain unclear. To address this, we conducted a systematic review to examine the safety and efficacy of BVS. The MEDLINE, Embase, Current Index to Nursing & Allied Health Literature (CINAHL), Cochrane, and Science Citation Index Expanded (SCIE) databases were searched for studies examining BVS safety and efficacy. Our search was restricted to studies published in English or French. Outcomes of interest include cardiac death, myocardial infarction, target‐lesion revascularization, restenosis, and composite endpoints. Eleven studies met our inclusion criteria (n = 2990), which included 1 randomized controlled trial and 10 cohort studies (2 controlled). These studies varied in size (11–1189) and follow‐up duration (1–60 months). The incidence of major adverse cardiac events ranged from 2.6% to 15.5%, with no statistically significant difference between BVS and control in studies that included a comparison group. Although available data are limited, current evidence is promising and suggests that the use of BVS is not associated with a significant increase in major cardiac events in the short term. Numerous randomized controlled trials are currently in progress that will further improve our understanding of the safety and efficacy of this device.

Fracture‐Resistant and Bioresorbable Drug‐Eluting Poly(glycerol Sebacate) Coils

“…Featuring less thrombosis risk, the biodegradable DESs have recently been employed as the standard choice for percutaneous coronary intervention (PCI). [25][26][27][28][29] Stent fracture is a high-incidence clinical entity with potential conduction to multiple complications, resulting in serious recurrent angina, myocardial infarction, and even sudden death. [15][16][17][18][19][20] The disadvantages have led to the develpment of fully degradable DESs that are fabricated entirely from biodegradable polymers without any metallic backbones.…”

“…[21][22][23][24] Despite resolving the adverse clinical effects of the remaining metallic backbones, the recent designs could not completely fix the fracture and deployment issues due to the inherent mechanical weakness of conventionally adopted biodegradable polymers. [25][26][27][28][29] Stent fracture is a high-incidence clinical entity with potential conduction to multiple complications, resulting in serious recurrent angina, myocardial infarction, and even sudden death. [16,[30][31][32][33] Autopsy studies have demonstrated fracture incidence of 29% in patients, which often cannot be diagnosed and thus express themselves as severe clinical situations.…”

Two-year Optical Coherence Tomography Findings after Balloon-Only Treatment of Bioresorbable Scaffold Restenosis in a Calcified Coronary Lesion: A Case Report

“…The rate of target-lesion revascularization ranges from 1 % to 3.3 % after BRS implantation [3, 4]. The most often used method for the treatment of in-scaffold restenosis is a drug-eluting stent (DES) [5], but there is no sufficient data supporting this approach, and the optimal treatment strategy is still uncertain.…”

Initial experience with bioresorbable vascular scaffolds for percutaneous revascularisation in patients with acute coronary syndrome

“…Several randomised clinical trials and meta-analyses have outlined the usefulness of BVS for coronary revascularisation, [11][12][13] although the clinical benefit for ACS patients has not been well analysed. [14,15] The objective of our study was to report the safety and utility of BVS compared to other stents in a cohort of ACS patients.…”