Very-long-term efficacy of bioresorbable vascular scaffolds

Netherlands Heart Journal, Oct 2017

R. Shah

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Very-long-term efficacy of bioresorbable vascular scaffolds

Neth Heart J Very-long-term efficacy of bioresorbable vascular scaffolds R. Shah 0 1 R. Shah 0 1 0 Section of Cardiology, University of Tennessee, School of Medicine , Memphis, TN , USA 1 To the Editor - I read with great interest Elias and colleagues’ recent metaanalysis in which 2-year follow-up data were used for all trials with the exception of ABSORB II [ 1 ]. However, sensitivity analysis using 2-year follow-up data from ABSORB II does not change their summary result for target lesion failure (TLF) (RR 1.31; 95% CI 1.08–1.58; p = 0.004). Thus, based on this meta-analysis, we can conclude that bioresorbable vascular scaffolds (BVSs) are associated with worse safety and efficacy outcomes up to 2 years after implantation; however, it is not clear if this is true beyond 2 years. Since the publication of this work, two randomised controlled trials (RCTs) in addition to ABSORB II have reported 3-year results [ 2, 3 ]. In ABSORB-Japan, only one scaffold thrombosis occurred (0.4%) in the BVS group between years 2 and 3 [3]. The TLF rate was exactly the same (1.6%) for both the BVS and metallic stent groups. In ABSORB-China, no stent thromboses occurred in either group between years 2 and 3 [ 2 ]. A landmark meta-analysis (using TLF between years 2 and 3) of these three trials suggests no statistically significant difference in TLF between the BVS and metallic stent groups (RR 1.78; 95% CI 0.68–4.62; p = 0.237). These new findings suggest that efficacy problems with BVSs might recede 2 years post-implantation. While these findings are encouraging, they are not confirmatory; to be 1. Elias J , van Dongen IM , Kraak RP , et al. Mid-term and long-term safety and efficacy of bioresorbable vascular scaffolds versus metallic everolimus-eluting stents in coronary artery disease: A weighted meta-analysis of seven randomised controlled trials including 5577 patients . Neth Heart J. 2017 ; 25 : 429 - 38 . 2. Gao R. Randomized Comparison of Everolimus-eluting Bioresorbable Vascular Scaffolds vs . Everolimus-eluting Metallic Stents in Patients with Coronary Artery Disease: 3-year Clinical Outcomes from ABSORB China . Presented at: Annual EuroPCR Conference; May 17, 2017 ; Paris, France. Available at: https://www.tctmd.com/ slide/randomized -comparison-everolimus-eluting-bioresorbablevascular-scaffolds-vs-everolimus . Accessed 11 July 2017 . 3. Kozuma K. ABSORB Japan: 3-year Clinical and Angiographic Results of a Randomized trial Evaluating the Absorb Bioresorbable Vascular Scaffoldvs. Metallic Drug eluting Stent in de novo Native Coronary Artery Lesions . Presented at: Annual EuroPCR Conference; May 17, 2017 ; Paris, France. Available at: https://www.tctmd. com/slide/absorb -japan-results-3-year-clinical-and-angiographicresults . Accessed 11 July 2017 .


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R. Shah. Very-long-term efficacy of bioresorbable vascular scaffolds, Netherlands Heart Journal, 2017, 649-649, DOI: 10.1007/s12471-017-1041-9