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ASSURE registry: BVS produced favorable real-world outcomes at 1 year
New 1-year data from the ASSURE registry demonstrate that an everolimus-eluting bioresorbable vascular scaffold was associated with procedural success and positive clinical and functional outcomes in a real-world setting.
The prospective, observational ASSURE registry was established as a postmarketing surveillance registry to monitor use of the Absorb bioresorbable vascular scaffold (BVS; Abbott Vascular) in patients with CAD. The current analysis included 183 consecutive patients (198 lesions) aged 18 to 75 years with ischemic heart disease and one or more de novo coronary artery lesions at six centers in Germany. The primary outcome was procedural success; other outcomes included CV death, MI and ischemia-driven target lesion revascularization. The second-generation Absorb BVS was used to treat lesions with a reference vessel diameter of ≥2 mm and ≤3.8 mm and a percent diameter stenosis of at least 50%. One hundred twenty-eight lesions (64.7%) had complex American College of Cardiology/American Heart Association morphology of B2 or C.
The procedural success rate was 100%. Acute gain was 1.54 ± 0.51 mm. This resulted “in a final minimal lumen diameter, which met the baseline reference vessel diameter, although visual estimates overrated the reference vessel diameter by 0.5 ± 0.5 mm. … In ASSURE, the acute gain of 1.54 mm was higher than known from previous ABSORB clinical studies with 1.1 to 1.25 mm on average. Therefore, the final mean lumen diameter got closer to the target of baseline reference vessel diameter,” the researchers wrote.
Follow-up data through 12 months demonstrated one death due to gastrointestinal bleeding (0.5%), three non-target vessel MIs (1.7%) and five patients required TLR due to restenosis (2.8%). The overall major adverse cardiac event rate at 1 year was 5%; this is comparable to previous BVS and drug-eluting stent studies, according to the researchers. The researchers also observed improvements in angina pectoris. No patient experienced stent thrombosis during the 12-month follow-up in this registry.
“One-year results suggest that bioresorbable vascular scaffolds for de novo CAD are associated with favorable clinical and functional outcomes in routine clinical practice despite a visually overestimated reference vessel diameter,” the researchers concluded.
Disclosure: The researchers report no relevant financial disclosures.