Analysis of ABSORB Trials Evaluates Effect of Technique on Outcomes After BVS Implantation
December 11, 2017—An analysis of the effect of technique on outcomes after bioresorbable vascular scaffold (BVS) implantation in the ABSORB trials was published by Gregg W. Stone, MD, et al in Journal of the American College of Cardiology (JACC; 2017;70:2863–2874). The ABSORB trials assessed clinical outcomes after implantation of the Absorb everolimus-eluting poly-L-lactic acid–based BVS (Abbott Vascular).
After a multivariable adjustment for baseline patient and lesion characteristics in this present large-scale analysis from the major ABSORB studies, the investigators concluded that vessel sizing and operator technique were strongly associated with BVS-related outcomes during 3-year follow-up.
As summarized in JACC, the study sought to determine whether target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) and scaffold thrombosis rates within 3 years of BVS implantation were affected by operator technique (vessel size selection and pre- and postdilation parameters).
TLF and scaffold thrombosis rates were determined in 2,973 patients with 3,149 BVS-treated coronary artery lesions from five prospective studies (ABSORB II, ABSORB China, ABSORB Japan, ABSORB III, and ABSORB Extend).
Outcomes were assessed through 3 years (and between 0–1 and 1–3 years) according to prespecified definitions of optimal technique (predilation, vessel sizing, and postdilation). Multivariable analysis was used to adjust for differences in up to 18 patient and lesion characteristics.
The investigators found that optimal predilation (balloon to core laboratory–derived reference vessel diameter ratio ≥ 1:1), vessel size selection (reference vessel diameter ≥ 2.25 mm and ≤ 3.75 mm), and postdilation (with a noncompliant balloon at ≥ 18 atm and larger than the nominal scaffold diameter, but not by > 0.5 mm) in all BVS-treated lesions was performed in 59.2%, 81.6%, and 12.4% of patients, respectively.
BVS implantation in properly sized vessels was an independent predictor of freedom from TLF through 1 year (hazard ratio [HR], 0.67; P = .01) through 3 years (HR, 0.72; P = .01), and from scaffold thrombosis through 1 year (HR, 0.36; P = .004). Aggressive predilation was an independent predictor of freedom from scaffold thrombosis between 1 and 3 years (HR, 0.44; P = .03), and optimal postdilation was an independent predictor of freedom from TLF between 1 and 3 years (HR, 0.55; P = .05), reported the investigators in JACC.