Coronary interventions - Mini focus on drug-eluting stents and drug-coated balloons

A prospective, multicentre first-in-man study of the polymer-free ultrathin-strut BIOrapid stent (BIOVITESSE)

EuroIntervention 2022;18:e132-e139. DOI: 10.4244/EIJ-D-21-00537

Lorenz Räber
Lorenz Räber1, MD, PhD; Jonas Dominik Häner1, MD; Thomas F. Lüscher2,3, MD; Marco Moccetti4, MD; Marco Roffi5, MD; Stefan Stortecky1, MD; Olivier Muller6, MD; Hector M. Garcia-Garcia7, MD, PhD; Ron Waksman7, MD; Patrick Siegrist8, MD
1. Cardiology Department, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; 2. Center for Molecular Cardiology, University of Zurich, Schlieren Campus, Zurich, Switzerland; 3. Heart Division, Royal Brompton and Harefield Hospitals, National Heart and Lung Institute, Imperial College London, London, United Kingdom; 4. Instituto CardioCentro Ticino, Lugano, Switzerland; 5. University Hospitals Geneva, Geneva, Switzerland; 6. University Hospital Lausanne, Lausanne, Switzerland; 7. MedStar Health Research Institute, Washington, D.C., USA; 8. University Hospital Zurich, Zurich, Switzerland

Background: Polymer-free drug-coated stents aim to avoid the inflammatory potential of durable polymers, thereby improving the long-term safety profile, and allowing a shorter duration of dual antiplatelet therapy.

Aims: The BIOVITESSE study was conducted to assess the safety and clinical performance of the BIOrapid polymer-free coronary stent system coated with a novel highly lipophilic sirolimus derivate.

Methods: BIOVITESSE was a prospective, multicentre, first-in-man study that enrolled subjects with de novo coronary lesions in two cohorts of 33 patients each. The primary endpoint of the first cohort was strut coverage at one month as assessed by optical coherence tomography. The primary endpoint of the second cohort was late lumen loss at nine-month follow-up.

Results: Patients were on average 63 years old (range: 42-87) and 12% had diabetes. The 66 patients had 70 lesions with an average lesion length of 12.5±5.4 mm. Predilatation was performed in 91.4% and post-dilatation in 87.1% lesions; device success was obtained in 97.4%. At one month, 95.2±5.6% (95% CI: 93.2-97.2) of struts were covered and at nine months, in-stent late lumen loss was 0.31±0.30 mm (95% CI: 0.20-0.42) and in-segment late lumen loss was 0.20±0.29 mm. Two target lesion failures occurred (3.1%): one at day 1 (to cover an asymptomatic stent edge dissection), and one at day 288 post-procedure for restenosis. No stent thrombosis was reported during the 12-month study duration.

Conclusions: The BIOrapid stent system exhibited an excellent safety profile, high strut coverage at one-month, and moderate angiographic efficacy according to the late lumen loss at nine-month angiographic follow-up.

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coronary artery diseasedrug-eluting stentoptical coherence tomographyqca
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