Author + information
- Carlos A. Colleta,b,
- Patrick Serruysa,b,
- Robbert de Wintera,b,
- Taku Asanoa,b,
- Yoshinobu Onumaa,b,
- Yosuke Miyazakia,b,
- Yohei Sotomia,b,
- Erhan Tenekecioglua,b,
- Rafael Cavalcantea,b and
- Davide Capodannoa,b
Background: The development of bioresorbable vascular scaffolds (BVS) aimed at improving the long-term safety profile of PCI. However, there is scarce data on the rate of late and very late thrombosis after BVS implantation.
Methods: A systematic review of the published literature between October 2012 and August 2016 was performed. Randomized clinical trials (RCT), observational registries and case series of patients with obstructive coronary artery disease treated with the BVS that reported the rate of definite or probable scaffold thrombosis according to Academic Research Consortium criteria (i.e., acute, sub-acute, late and very late) were included. Scaffold thrombosis rates were pooled with meta-analysis using a random effect model. Meta-regression was performed to explore the predictors of device thrombosis.
Results: Overall, 16,830 patients treated with ABSORB BVS in 59 studies were included. A total of 261 definite or probable scaffold thrombosis (ScT) were identified and included in the present analysis. The overall rate of definite or probable ScT was 1.8% (CI 95% 1.6% to 2.0%) the median follow-up was 12.0 months (interquartile range 7.5 to 15). The rate of very late definite or probable ScT was 1.1% (95% CI 0.7% to 1.6%; 10 studies, 2,622 patients). A higher rate of definite and probable scaffold thrombosis was found in studies with patients presenting with acute myocardial infarction (3.6% vs. 2.1%, Q=0.436, df=1, p=0.035). In the meta-regression analysis, the residual per cent diameter stenosis was the only factor associated with ST after scaffold implantation (coefficient 0.091, 95% CI -0.0009 to 0.183, p=0.052).
Conclusions: Using the largest available dataset of patients treated in randomized trials and observational registries, the present metaanalysis shows that the overall rate of definite or probable ScT is 1.8%, with a rate of very late ScT of 1.1%. Residual stenosis after implantation was associated with the occurrence of scaffold thrombosis.
Poster Contributions Poster Hall, Hall C
Saturday, March 18, 2017, 3:45 p.m.-4:30 p.m.
Session Title: Coronary Intervention: Drug Eluting Stent & Scaffolds
Abstract Category: 21. Interventional Cardiology: Coronary Intervention: Devices
Presentation Number: 1240-137
- 2017 American College of Cardiology Foundation