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13-06-2017 | Original Article - E‑Learning | Uitgave 7-8/2017 Open Access

Netherlands Heart Journal 7-8/2017

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

Tijdschrift:
Netherlands Heart Journal > Uitgave 7-8/2017
Auteurs:
J. Elias, I. M. van Dongen, R. P. Kraak, R. Y. G. Tijssen, B. E. P. M. Claessen, J. G. P. Tijssen, R. J. de Winter, J. J Piek, J. J. Wykrzykowska, J. P. S. Henriques
Belangrijke opmerkingen

Electronic supplementary material

The online version of this article (doi: 10.​1007/​s12471-017-1008-x) contains supplementary material, which is available to authorized users.
J. Elias and I.M. van Dongen contributed equally to this paper.

Abstract

Aims

Mid- and long-term safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) have been studied in randomised trials; however, most were not individually powered for clinical endpoints. We performed a weighted meta-analysis comparing mid- and long-term outcomes in patients treated with the BVS compared with the Xience metallic stent.

Methods and results

Randomised trials comparing the BVS and Xience were identified by searching MEDLINE, EMBASE and conference abstracts. Seven trials were included (BVS n = 3258, Xience n = 2319) with follow-up between 1–3 years. The primary outcome of target lesion failure occurred more frequently in BVS compared with Xience [OR 1.34; 95% CI 1.11–1.62, p = 0.003]. Overall definite or probable device thrombosis occurred more frequently with the BVS [OR 2.86; 95% CI 1.88–4.36, p < 0.001] and this extended beyond 1 year of follow-up [OR 4.13; 95% CI 1.99–8.57, p < 0.001]. Clinically indicated or ischaemia driven target lesion revascularisation [OR 1.43; 95% CI 1.11–1.83, p = 0.005] and myocardial infarction (all MI) [OR 1.64; 95% CI 1.20–2.23, p = 0.002] were more frequently seen in the BVS compared with Xience. Rates of target vessel failure [OR 1.15; 95% CI 0.91–1.46, p = 0.25] and cardiac death [OR 0.91; 95% CI 0.57–1.46, p = 0.71] were not significantly different between BVS and Xience.

Conclusion

This meta-analysis shows a higher rate of target lesion failure and an almost threefold higher rate of device thrombosis in BVS compared with Xience, which extends beyond the first year. Device thrombosis did not lead to an overall increased (cardiac) mortality.

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Netherlands Heart Journal

Het Netherlands Heart Journal wordt uitgegeven in samenwerking met de Nederlandse Vereniging voor Cardiologie en de Nederlandse Hartstichting. Het tijdschrift is Engelstalig en wordt gratis beschikbaa ...

Extra materiaal
ESM-Caption 1: Meta-analyses of the primary efficacy endpoint of target lesion failure and the primary safety endpoint of device thrombosis at maximum 1 year follow-up
12471_2017_1008_MOESM1_ESM.doc
ESM-Caption 2: Meta-analyses of all secondary endpoints at maximum 1 year follow-up
12471_2017_1008_MOESM2_ESM.tif
ESM-Caption 3: Funnel plots of both primary efficacy and safety endpoint at longest follow-up available
12471_2017_1008_MOESM3_ESM.tif
ESM-Caption 4: Primary endpoints TLF and definite/probable device thrombosis at longest follow-up available of published trails only
12471_2017_1008_MOESM4_ESM.tif
Literatuur
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