Implantation of a bioresorbable vascular scaffold in a wider range of coronary lesion types and clinical presentations than seen in randomized trials was feasible and associated with encouraging outcomes, researchers reported.
The researchers conducted a prospective, single-arm, single-center study to evaluate the performance of the bioresorbable vascular scaffold (BVS; Absorb, Abbott Vascular) in complex coronary lesions representative of daily practice.
They implanted the BVS in 180 patients (mean age, 61 years; 74% men) with 249 de novo stenotic coronary lesions of any level of complexity who had stable angina, unstable angina or non-STEMI. They reported procedural results and 12-month clinical outcomes.
Device success per lesion was 99.2%, and 119 calcified lesions were treated, Roberto Diletti, MD, PhD, from Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands, and colleagues wrote.
Percent diameter stenosis was similar in severe lesions (20.3%), moderate lesions (17.8%) and noncalcified lesions (16.8%; P = .112), according to the researchers. The same was true for acute gain (severe, 1.36 mm; moderate, 1.48 mm; noncalcified, 1.56 mm; P = .109).
In 54 lesions that were bifurcated, side-branch ballooning after treatment of the main vessel was performed 33.3% of the time, and the rate of side-branch impairment was 9.3%, the researchers wrote.
Twenty-nine patients had total coronary occlusions, but they did not differ from the rest of the cohort in device success (P = .465), procedure success (P = .393), mean lumen diameter (P = .163) or percent diameter stenosis (P = .78), Diletti and colleagues found.
At 12 months, the rate of target lesion revascularization and target vessel revascularization was 3.3%; the rate of definite scaffold thrombosis was 2.6%, and there were three deaths. In one case of scaffold thrombosis, the Academic Research Consortium (ARC) criteria for stent thrombosis was met, but the finding was not confirmed on OCT, and in the other cases, underexpansion of the BVS was a factor, Diletti and colleagues wrote.
“The implantation of the everolimus-eluting [BVS] in an expanded range of coronary lesion types and clinical presentations was observed to be viable with promising angiographic results and midterm clinical outcomes,” the researchers wrote. “Larger studies with longer follow-up and a direct comparison with currently available metallic drug-eluting stents are needed to fully evaluate the possible additional value of the bioresorbable technologies [in] an all-comers setting.” – by Erik Swain
The researchers report no relevant financial disclosures.