Please use this identifier to cite or link to this item: https://dora.health.qld.gov.au/qldresearchjspui/handle/1/5338
Title: One- and two-year clinical outcomes of treatment with resorbable magnesium scaffolds for coronary artery disease: the prospective, international, multicentre BIOSOLVE-IV registry
Authors: Wlodarczak, Adrian
Montorsi, Piero
Torzewski, Jan
Bennett, Johan
Starmer, Gregory 
Buck, Thomas
Haude, Michael
Moccetti, Marco
Wiemer, Marcus
Lee, Michael-Kang-Yin
Verheye, Stefan
Issue Date: 2023
Publisher: EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)
Source: Wlodarczak A, Montorsi P, Torzewski J, Bennett J, Starmer G, Buck T, Haude M, Moccetti M, Wiemer M, Lee MK, Verheye S. One- and two-year clinical outcomes of treatment with resorbable magnesium scaffolds for coronary artery disease: the prospective, international, multicentre BIOSOLVE-IV registry. EuroIntervention. 2023 Jun 19;19(3):232-239. doi: 10.4244/EIJ-D-22-01069. PMID: 37226676; PMCID: PMC10266381.
Journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Abstract: Background: Bioresorbable scaffolds have been developed to overcome the limitations of drug-eluting stents and to reduce long-term adverse events. Aims: We aimed to assess the long-term safety and efficacy of a sirolimus-eluting resorbable magnesium scaffold to ensure its safe rollout into clinical routine. Methods: BIOSOLVE-IV is a prospective, international, multicentre registry including more than 100 centres in Europe, Asia, and Asia-Pacific. Enrolment started directly after the commercialisation of the device. Follow-up assessments are scheduled at 6 and 12 months, and annually for up to 5 years; we herein report the 24-month outcomes. Results: Overall, 2,066 patients with 2,154 lesions were enrolled. Patients were 61.9±10.5 years old, 21.6% had diabetes, and 18.5% had non-ST-elevation myocardial infarction (NSTEMI). Lesions were 14.8±4.0 mm long with a reference vessel diameter of 3.2±0.3 mm. Device and procedure success were 97.5%, and 99.1%, respectively. The 24-month target lesion failure (TLF) rate was 6.8%, mainly consisting of clinically driven target lesion revascularisations (6.0%). Patients with NSTEMI had significantly higher TLF rates than those without (9.3% vs 6.2%; p=0.025), whereas there were no significant differences observed for patients with diabetes or with type B2/C lesions (a 24-month TLF rate of 7.0% and 7.9%, respectively). The 24-month rate of definite or probable scaffold thrombosis was 0.8%. Half of the scaffold thromboses occurred after premature discontinuation of antiplatelet/anticoagulation therapy, and only one scaffold thrombosis occurred beyond the 6-month follow-up, on day 391. Conclusions: The BIOSOLVE-IV registry showed good safety and efficacy outcomes, confirming a safe rollout of the Magmaris into clinical practice.
Description: Cairns & Hinterland Hospital and Health Service (CHHHS) affiliated author: Gregory Starmer
DOI: 10.4244/EIJ-D-22-01069
Type: Article
Appears in Sites:Cairns & Hinterland HHS Publications

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