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BVS confers positive results beyond 1 year in cohort with complex anatomy, lesions
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Researchers reported an acceptable rate of long-term adverse events associated with bioresorbable vascular scaffold implantation in real-world patients with complex coronary lesions.
According to the study background, little is known about medium- to long-term outcomes after implantation with the bioresorbable vascular scaffold (BVS; Absorb, Abbott Vascular), and what is known pertains to simpler lesions.
Cordula M. Felix , MD, from Thoraxcenter, Erasmus Medical Center in Rotterdam, the Netherlands, and colleagues analyzed clinical outcomes beyond 1 year in patients from the BVS Expand registry.
According to the researchers, the patient population of the prospective, single-center, single-arm study included those with more complex characteristics and lesions than seen in randomized controlled trials, including total occlusions, long lesions, calcified lesions and small vessels.
Felix and colleagues analyzed 249 patients with 335 lesions at Erasmus Medical Center from September 2012 to January 2015. The primary endpoint was MACE, defined as cardiac death, MI and target lesion revascularization. The median follow-up period was 622 days (interquartile range, 376-734).
The mean number of scaffolds per patient was 1.79 ± 1.15, whereas invasive imaging was used in 39% of the cohort. The researchers observed American College of Cardiology/American Heart Association classification type B2/C lesions in 38.1% of the patients. The mean lesion length was 22.16 ± 13.79 mm, and postprocedural acute lumen gain was 1.39 ± 0.59 mm.
According to a Kaplan-Meier analysis, the 18-month MACE rate was 6.8%. Also, at 18 months, the cardiac mortality rate was 1.8%, the MI rate was 5.2% and TLR rate was 4%, the researchers wrote.
The rate of definite scaffold thrombosis at 18 months was 1.9%, Felix and colleagues wrote, noting they found that the scaffold was underexpanded in 26% of lesions, and patients who received an underexpanded scaffold were more likely to experience MACE compared with those who did not (8% vs. 3.8%; log-rank P = .15).
“Compared to other BVS registries, [the] rate of post-dilatation in our study is somewhat low (53.3%), and this could partly explain the frequent occurrence of underexpansion,” the researchers wrote. – by James Clark
Disclosure: The study was funded by an unrestricted grant from Abbott Vascular. Felix reports no relevant financial disclosures. Three other researchers report receiving speaker fees from Abbott Vascular.
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