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To the Editor,
I read with great interest Elias and colleagues’ recent meta-analysis in which 2‑year follow-up data were used for all trials with the exception of ABSORB II . 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 . 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 . 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 so, continued long-term follow-up of all relevant RCTs is needed.
Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
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. CrossRefPubMedPubMedCentral
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-bioresorbable-vascular-scaffolds-vs-everolimus. Accessed 11 July 2017.
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-angiographic-results. Accessed 11 July 2017.
- Very-long-term efficacy of bioresorbable vascular scaffolds
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