1. Percutaneous complete revascularization strategies using sirolimus-eluting biodegradable polymer-coated stents in patients presenting with acute coronary syndrome and multivessel disease: Rationale and design of the BIOVASC trial
- Author
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Giovanni Esposito, Paul Cummins, Rutger J. van Bommel, Eric Boersma, Matthias Vrolix, BioVasc Trial Investigators, Johan Bennett, Mattie J. Lenzen, Manel Sabaté, Joost Daemen, Roberto Diletti, Nicolas M. Van Mieghem, Felix Zijlstra, Wijnand K den Dekker, Cardiology, den Dekker, W. K., Van Mieghem, N. M., Bennett, J., Sabate, M., Esposito, G., van Bommel, R. J., Daemen, J., Vrolix, M., Cummins, P. A., Lenzen, M. J., Boersma, E., Zijlstra, F., and Diletti, R.
- Subjects
medicine.medical_specialty ,Acute coronary syndrome ,Percutaneous ,Polymers ,medicine.medical_treatment ,Equivalence Trials as Topic ,030204 cardiovascular system & hematology ,Revascularization ,Prosthesis Design ,BioVasc Trial Investigators ,03 medical and health sciences ,0302 clinical medicine ,Percutaneous Coronary Intervention ,Absorbable Implant ,Absorbable Implants ,medicine ,Clinical endpoint ,Drug-Eluting Stent ,Humans ,Multicenter Studies as Topic ,Sirolimu ,030212 general & internal medicine ,Myocardial infarction ,Prospective Studies ,Acute Coronary Syndrome ,Prospective cohort study ,Polymer ,Randomized Controlled Trials as Topic ,Sirolimus ,business.industry ,Percutaneous coronary intervention ,Drug-Eluting Stents ,medicine.disease ,Surgery ,Prospective Studie ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug ,Human - Abstract
BACKGROUND: Complete revascularization in patients with an acute coronary syndrome and multivessel disease is superior compared to culprit-only treatment. However, it is unknown whether direct complete or staged complete revascularization should be pursued. METHODS: The BIOVASC study is an investigator-initiated, prospective, multicenter, randomized, 2-arm, international, open-label, noninferiority trial. We will randomize 1,525 patients 1:1 to immediate complete revascularization (experimental arm) or culprit-only plus staged complete revascularization (control arm). Patients will be enrolled in approximately 30 sites in Belgium, Italy, the Netherlands, and Spain. The primary end point is a composite of all-cause mortality, nonfatal myocardial infarction, any unplanned ischemia-driven revascularization (excluding staged procedures in the control arm at the predetermined time), and cerebrovascular events (MACCE) at 1 year post index procedure. CONCLUSIONS: The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501). ispartof: AMERICAN HEART JOURNAL vol:227 pages:111-117 ispartof: location:United States status: published
- Published
- 2020