Swipe om te navigeren naar een ander artikel
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.
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.
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.
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.
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-up12471_2017_1008_MOESM1_ESM.doc
ESM-Caption 2: Meta-analyses of all secondary endpoints at maximum 1 year follow-up12471_2017_1008_MOESM2_ESM.tif
ESM-Caption 3: Funnel plots of both primary efficacy and safety endpoint at longest follow-up available12471_2017_1008_MOESM3_ESM.tif
ESM-Caption 4: Primary endpoints TLF and definite/probable device thrombosis at longest follow-up available of published trails only12471_2017_1008_MOESM4_ESM.tif
Sabate M, Windecker S, Iniguez A, et al. Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction-TROFI II trial. Eur Heart J. 2016;37:229–40. CrossRefPubMed
Serruys PW, Chevalier B, Dudek D, et al. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1‑year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015;385:43–54. CrossRefPubMed
Serruys PW, Chevalier B, Sotomi Y, et al. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet. 2016;388:2479–91. CrossRefPubMed
Ellis SG. Everolimus-eluting bioresorbable vascular scaffolds in patients with coronary artery disease: aBSORB III trial 2‑year results. American College of Cardiology, Washington DC, 18 March 2017. 2017.
FDA. FDA investigating increased rate of major adverse cardiac events observed in patients receiving Abbott vascular’s absorb GT1 Bioresorbable vascular scaffold (BVS) - letter to health care providers 2017. https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm546808.htm. Accessed: 18 March 2017
Onuma Y, Sotomi Y, Shiomi H, et al. Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimuseluting bioresorbable scaffold and an everolimus-eluting metallic stent: Insights from the randomised ABSORB Japan trial. EuroIntervention. 2016;12:1090–101. CrossRefPubMed
Puricel S. Comparison of everolimus-and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds: 2‑year outcomes of the EVERBIO II trial. Transcatheter Cardiovascular Therapeutics, San Fransisco, 14 October 2015. 2015.
Sabate M. BRS in STEMI: rationale, registry outcomes and Trofi II 2‑year results. Transcatheter Cardiovascular Therapeutics, Washington DC, 31 October 2016. 2016.
Gao R. ABSORB China: two-year clinical results in patients with coronary artery disease randomized to the absorb bioresorbable vascular scaffold versus metallic drug-eluting stents. Transcatheter Cardiovascular Therapeutics, Washington DC, 30 October 2016. 2016.
Sorrentino S, Giustino G, Mehran R, et al. Everolimus-eluting bioresorbable scaffolds versus metallic everolimus-eluting stents: meta-analysis of randomized controlled trials. J Am Coll Cardiol. 2017; doi: 10.1016/j.jacc.2017.04.011.
Stone G. Impact of technique on early and late outcomes following coronary bioresorbable scaffold implantation: analysis from the ABSORB trials. Cardiovasc Res Technol. 2017. Conference Proceedings. 21 February 2017, Washington.
- 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
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
- Bohn Stafleu van Loghum