Bioresorbable Vascular Scaffolds Versus Drug-Eluting Stents for Diffuse Long Coronary Narrowings

Jongkwon Seo, Jung Min Ahn, Sung Jin Hong, Do Yoon Kang, Soon Jun Hong, Ae Young Her, Yong Hoon Kim, Chul Min Ahn, Jung Sun Kim, Byeong Keuk Kim, Young Guk Ko, Donghoon Choi, Yangsoo Jang, Seung Jung Park, Duk Woo Park, Myeong Ki Hong

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Abstract

Clinical benefits of bioresorbable vascular scaffold (BVS) implantation for long coronary lesions were not sufficiently evaluated. The efficacy and safety of BVS and metallic everolimus-eluting stent (EES) were compared for the treatment of long coronary narrowings. A total of 341 patients with diffuse long lesions (requiring device length ≥28 mm) were randomized to receive either BVS (n = 171) or EES (n = 170) implantation. The primary endpoint was major adverse cardiovascular events which included death from cardiac cause, myocardial infarction, device thrombosis, or ischemia-driven target-lesion revascularization at 12 months. The trial was terminated early because the manufacturer stopped supplying BVS. The mean lesion length was 32.2 ± 13.1 mm in the BVS group and 35.3 ± 13.0 mm in the EES group. The 12-month follow-up was completed in 332 patients (97.4%). At 12 months, the primary endpoint events occurred in 2 patients (1.2%) in the BVS group and in 4 patients (2.4%) in the EES group (hazard ratio = 0.49, 95% confidence interval = 0.09 to 2.67, p = 0.398). Definite or probable device thrombosis occurred in 1 patient (0.6%) in the BVS group and 1 patient (0.6%) in the EES group (hazard ratio = 1.00, 95% confidence interval = 0.06 to 15.94, p = 0.998). In conclusion, in patients with long native coronary artery disease, significant differences between BVS and EES were not observed regarding the primary composite endpoint of death from cardiac cause, myocardial infarction, device thrombosis, or target-lesion revascularization at 12 months. However, due to the early termination of this trial and a low number of events, the results cannot be considered clinically relevant (clinicalTrials.gov Identifier: NCT02796157).

Original languageEnglish
JournalAmerican Journal of Cardiology
DOIs
Publication statusAccepted/In press - 2020 Jan 1

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All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Seo, J., Ahn, J. M., Hong, S. J., Kang, D. Y., Hong, S. J., Her, A. Y., Kim, Y. H., Ahn, C. M., Kim, J. S., Kim, B. K., Ko, Y. G., Choi, D., Jang, Y., Park, S. J., Park, D. W., & Hong, M. K. (Accepted/In press). Bioresorbable Vascular Scaffolds Versus Drug-Eluting Stents for Diffuse Long Coronary Narrowings. American Journal of Cardiology. https://doi.org/10.1016/j.amjcard.2020.02.031