MedStar Authors catalog › Details for: A prospective, multicentre first-in-man study of the polymer-free ultrathin-strut BIOrapid stent (BIOVITESSE).
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A prospective, multicentre first-in-man study of the polymer-free ultrathin-strut BIOrapid stent (BIOVITESSE).

by Garcia-Garcia, Hector M; Waksman, Ron.
Citation: Eurointervention. 18(2):e132-e139, 2022 Jun 03..Journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.Published: 2022; ; ; ISSN: 1774-024X.Full author list: Garcia-Garcia HM; Haner JD; Luscher TF; Moccetti M; Muller O; Raber L; Roffi M; Siegrist P; Stortecky S; Waksman R.UI/PMID: 34794936.Subject(s): *Coronary Artery Disease | *Coronary Restenosis | *Percutaneous Coronary Intervention | Coronary Angiography | Coronary Artery Disease/su [Surgery] | Humans | Middle Aged | Polymers | Prospective Studies | Stents | Treatment OutcomeInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal Article | Multicenter StudyDigital Object Identifier: https://dx.doi.org/10.4244/EIJ-D-21-00537 (Click here) Abbreviated citation: EuroIntervention. 18(2):e132-e139, 2022 Jun 03.Abstract: 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.Abstract: 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.Abstract: 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.Abstract: 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.Abstract: 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.

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