Key result
Absorb BVS more than doubles the relative change in mean vessel area at 3 years vs DES.
Why the study?
Previous observational studies documented late luminal enlargement and expansive remodeling after bioresorbable vascular scaffold implantation, but no randomized comparison with metallic stents had been conducted.
Does a bioresorbable vascular scaffold improve expansive vessel remodeling compared to a metallic drug-eluting stent in patients with coronary lesions?
RCT (n=359)
randomized
Does a bioresorbable vascular scaffold improve expansive vessel remodeling compared to a metallic drug-eluting stent in patients with coronary lesions?
Absolute Event Rate: 6.7% vs 2.9%
p-value: p=0.003
Bioresorbable vascular scaffolds are associated with more frequent and intense expansive vessel wall remodeling at 3 years compared to metallic drug-eluting stents.
BACKGROUND: Although previous observational studies have documented late luminal enlargement and expansive remodeling following implantation of a bioresorbable vascular scaffold (BVS), no comparison with metallic stents has been conducted in a randomized fashion. OBJECTIVES: This study sought to compare vessel remodeling patterns after either Absorb BVS or Xience metallic drug-eluting stent (DES) implantation (Abbott Vascular, Santa Clara, California) and determine the independent predictors of remodeling. METHODS: In the ABSORB II randomized trial, 383 lesions (n = 359) were investigated by intravenous ultrasound both post-procedure and at 3-year follow-up. According to vessel and lumen area changes over 3 years, we categorized 9 patterns of vessel remodeling that were beyond the reproducibility of lumen and vessel area measurements. RESULTS: The relative change in mean vessel area was significantly greater with the BVS compared to the DES (6.7 ± 12.6% vs. 2.9 ± 11.5%; p = 0.003); the relative change in mean lumen area was significantly different between the 2 arms (1.4 ± 19.1% vs. -1.9 ± 10.5%, respectively; p = 0.031). Multivariate analysis indicated that use of the BVS, female sex, balloon-artery ratio >1.25, expansion index ≥0.8, previous percutaneous coronary intervention, and higher level of low-density lipoprotein cholesterol were independent predictors of expansive remodeling. Furthermore, in the BVS arm, necrotic core pre-procedure was an independent determinant of expansive remodeling. CONCLUSIONS: Expansive vessel wall remodeling was more frequent and intense with the BVS than the metallic DES and could be determined by patient baseline characteristics and periprocedural factors. The clinical effect of the observed lumen and vessel remodeling must be investigated in further large clinical studies to optimize the clinical outcome of patients and lesions treated by bioresorbable scaffolds. (ABSORB II Randomized Controlled Trial; NCT01425281).
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Serruys et al. (2017) conducted an RCT in Coronary artery disease (n=359). Absorb BVS vs. Xience metallic drug-eluting stent (DES) was evaluated on relative change in mean vessel area (p=0.003). Absorb BVS resulted in a significantly greater relative change in mean vessel area compared to metallic DES at 3 years (6.7% vs. 2.9%; p=0.003).
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