Two-Year Outcomes With the Absorb Bioresorbable Scaffold for Treatment of Coronary Artery Disease: A Systematic Review and Meta-Analysis of Seven Randomized Trials With an Individual Patient Data Substudy

Abstract

there were seven type II endoleaks (12.7%) and a significant reduction in aneurysm maximum transverse diameter in 70.4%. Five limb occlusions occurred at the 1-year and one at the 2-year follow-up (7.0%). Limb occlusions were more common in group 2 (0% vs 12.2%; P ¼ .03 at 1 year), representing the majority of required reinterventions (97.7% vs 77.2%; P ¼ .017 at 2 years). Comments: This real-world experience using the ANACONDA fenestrated endograft provides previously unavailable information on the midterm performance of the device. A technical success of only 80% when treating extensive disease (to the celiac trunk) is concerning, and suggests that improvements are needed for this cohort of patients. The limb occlusion rate is also of concern, and may again reflect pushing the limits of the device in unfavorable anatomic conditions. Lessons learned by these early investigations will undoubtedly allow improvements and refinements in design and patient selection.

Predictors of early scaffold thrombosis

“…In randomized clinical trials and meta-analyses, the risk of thrombotic events after implantation of the absorb BVS was shown to be higher than after implantation of metallic DES [1, [9][10][11]. The risk of absorb scaffold thrombosis has been shown to be significantly higher in lesions with smaller reference diameters and for procedures without postdilatation versus those with balloon postdilatation.…”

Bioresorbable vascular scaffold versus everolimus‐eluting stents or drug eluting balloon for the treatment of coronary in‐stent restenosis: 1‐Year follow‐up of a propensity score matching comparison (the BIORESOLVE‐ISR Study)

“…While initial trials reported similar acute outcomes with BVS compared with DES in simple de‐novo lesions, real world data raised concerns of a high risk of scaffold thrombosis . Long‐term data of randomized trials and meta‐analysis comparing BVS to second generation DES confirmed a higher rate of thrombosis in BVS group and failed to demonstrate BVS non‐inferiority . Consequently, BVS use has been firstly restricted to centers participating in clinical trials and later withdrawn from the market.…”

One‐year clinical performance of ABSORB bioresorbable vascular scaffold in patients presenting with acute coronary syndromes: Results from the RAI registry

“…However long‐term data of randomized trials and meta‐analysis comparing BVS to second generation DES, failed to demonstrate BVS non‐inferiority and showed a higher rate of ScT in BVS group. Finally, a recent meta‐analysis demonstrated the inferiority of BVS compared to DES due to increased rates of DOCE and ScT . Consequently, the company first restricted BVS use to centers participating in clinical trials and subsequently withdrew the scaffold from the market.…”

“…Finally, a recent meta-analysis demonstrated the inferiority of BVS compared to DES due to increased rates of DOCE and ScT. 17 Consequently, the company first restricted BVS use to centers participating in clinical trials and subsequently withdrew the scaffold from the market. Regarding ScT, along with the suboptimal procedural technique (lack of predilation, correct vessel sizing, and postdilation ≥1.1:1 balloonto-nominal BVS diameter), also the immediate angiographic result (RVD <2.4 mm, final MLD < 1.86 mm), and DAPT discontinuation appear to be the principal determinants of 12 months outcomes.…”