Arterial Remodeling After Bioresorbable Scaffolds and Metallic Stents.

Serruys, Patrick W; Katagiri, Yuki; Sotomi, Yohei; Zeng, Yaping; Chevalier, Bernard; van der Schaaf, René J; Baumbach, Andreas; Smits, Pieter; van Mieghem, Nicolas M; Bartorelli, Antonio; Barragan, Paul; Gershlick, Anthony; Kornowski, Ran; Macaya, Carlos; Ormiston, John; Hill, Jonathan; Lang, Irene M; Egred, Mohaned; Fajadet, Jean; Lesiak, Maciej; ... (2017). Arterial Remodeling After Bioresorbable Scaffolds and Metallic Stents. Journal of the American College of Cardiology, 70(1), pp. 60-74. Elsevier 10.1016/j.jacc.2017.05.028

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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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