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;19:. DOI: 10.4244/EIJ-D-22-01069

Adrian Wlodarczak
Adrian Wlodarczak1, MD; Piero Montorsi2, MD; Jan Torzewski3, MD; Johan Bennett4, MD; Gregory Starmer5, MD; Thomas Buck6, MD; Michael Haude7, MD; Marco Moccetti8, MD; Marcus Wiemer9, MD; Michael-Kang-Yin Lee10, MD; Stefan Verheye11, MD
1. Copper Health Center, Lubin, Poland; 2. Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy and Centro Cardiologico Monzino, IRCCS, Milan, Italy; 3. Cardiovascular Center Oberallgäu-Kempten, Kempten, Germany; 4. Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium; 5. Department of Cardiology, Cairns Hospital, Cairns, QLD, Australia; 6. Department of Cardiology, HerzZentrum Westfalen, Klinikum Westfalen, Dortmund, Germany; 7. Medical Clinic I, Rheinland Klinikum Neuss GmbH, Lukaskrankenhaus, Neuss, Germany; 8. Istituto Cardiocentro Ticino, Lugano, Switzerland; 9. Department of Cardiology and Intensive Care, Johannes Wesling University Hospital, Ruhr University Bochum, Minden, Germany; 10. Division of Cardiology, Queen Elizabeth Hospital, Kowloon, Hong Kong SAR, China; 11. Interventional Cardiology, ZNA Cardiovascular Center Middelheim, Antwerp, Belgium

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.

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