Bioresorbable Vascular Scaffolds for the Treatment of Chronic Total Occlusions

Abstract

Background— There are only limited studies reporting clinical outcomes after bioresorbable vascular scaffold (BVS; Absorb; Abbott Vascular, Santa Clara, CA) implantation for coronary chronic total occlusions (CTO). The aim of this study was to evaluate the real-world feasibility and safety of BVS implantation for the treatment of CTO. Methods and Results— We retrospectively evaluated CTO cases treated with BVS from a multicenter registry. The primary end point was target lesion failure defined as a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization. From September 2012 to November 2015, 65 patients with CTO were successfully treated with BVS. The mean age of patients was 60.8±11.0 years; 89.2% were male and 40.0% diabetic. The mean ejection fraction was 57.7±10.8%. The mean reference vessel diameter and CTO lesion length were 3.0±0.4 and 20.2±3.0 mm, respectively. The mean number of BVS deployed per patient was 1.8±0.7, of which mean diameter and total length were 3.0±0.4 and 47.6±19.9 mm, respectively. Postdilatation with noncompliant balloons (mean diameter 3.3±0.3 mm) was performed at high pressures (18.6±5.3 atm) in all cases. Intravascular ultrasound (n=34) or optical coherence tomography (n=31) was performed in all cases. During the follow-up period (median: 453 days, 25th and 75th percentiles: 230 and 703), there were no occurrences of target lesion failure or scaffold thrombosis. Conclusions— BVS implantation for the treatment of CTO seems feasible and safe. Appropriate lesion preparation, high-pressure postdilatation, and the use of intravascular imaging are recommended to obtain the best possible final result.

One Ring to Revascularize Them All: Assessing The End Results of Coronary Bioresorbable Vascular Scaffolds as Revascularization Approach for Chronic Total Occlusions

“…However, in most investigations, this imaging method was performed not in all patients, making the accurate rates of scaffold thrombosis or restenosis to be underestimated. For example, Mitomo et al in 2017 reported that only as much as 33.8% of patients went through the angiographic follow-up [13] while in 2018, Maeremans et al recorded approximately 83% of patients went through the multi-slice computed tomography angiographic follow-up [14]. Despite encouraging ndings, the rst-generation BVS was withdrawn from the guideline for clinical practice in an account of the safety alert issued by Food and Drug Administration to Absorb BVS (Abbott) device owing to its con rmed heightened rates for ST [28].…”

Predictors of early scaffold thrombosis

“…Although a higher risk of thrombotic events for absorb BVS than for metallic DES is well documented [1,3,12, 13], the usage of predilatation or postdilatation could not be differentiated as significant predictors of thrombotic events in a recent meta-analysis including 10 510 patients [14]. In contrast, small, single-center, and multicenter registries reported low rates of thrombotic events [15], even in complex lesions with overlapping scaffolds [16] or chronic total occlusions [17,18].…”

Clinical Outcomes of Successful Revascularization of Chronic Total Coronary Occlusions with Bioresorbable Vascular Scaffolds: A Systematic Review

“…In our systematic review, eight out of 12 studies performed an actual invasive or non-invasive follow-up angiography after BVS implantation, but in the vast majority of those studies, this imaging was done in less than 100% of patients, so the true rates of restenosis or scaffold thrombosis might be underestimated. For instance, Mitomo et al reported that only 33.8% of patients underwent follow-up angiography [13] while Maeremans et al reported about 83% of patients having follow-up multislice computed tomography angiography [14]. Regardless of these promising findings, the first generation BVS was recently removed from clinical practice due to safety alert for Absorb BVS (Abbott) recently issued by Food and Drug Administration due to confirmed higher rates of ST [28].…”