Coronary interventions - Mini focus on bioresorbable scaffolds

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;19:232-239. 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.

Sign in to read and download the full article

Forgot your password?

No account yet?
Sign up for free!

Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from

bioresorbable scaffoldsdiabetesnstemistable angina
Read next article
A prospective study comparing short versus standard dual antiplatelet therapy in patients with acute myocardial infarction: design and rationale of the TARGET-FIRST trial

Latest news