Article ; Online: DynamX sirolimus-eluting Bioadaptor versus the zotarolimus-eluting Resolute Onyx stent in patients with de novo coronary artery lesions: Design and rationale of the multi-center, international, randomized BIODAPTOR-RCT.
Cardiovascular revascularization medicine : including molecular interventions
2023 Volume 55, Page(s) 76–82
Abstract: Background: Conventional drug-eluting stents achieve good safety and performance outcomes, but the stents permanently cage the vessel, leading to a non-plateauing rate of clinical events. The DynamX Bioadaptor is designed to reduce these long-term ... ...
| Abstract | Background: Conventional drug-eluting stents achieve good safety and performance outcomes, but the stents permanently cage the vessel, leading to a non-plateauing rate of clinical events. The DynamX Bioadaptor is designed to reduce these long-term events through unique design features that permit restoring vessel function and physiology through the disengagement of uncaging elements after the resorption of a biodegradable polymer over six months. Promising initial results have been obtained in the DynamX mechanistic study, with excellent safety and effectiveness, positive arterial remodeling, improved vasomotion, compliance, and cyclic pulsatility. We now aim to confirm these findings randomizing the DynamX Bioadaptor against the Resolute Onyx stent. Methods: This multi-center, international, randomized single-blinded study is conducted in 34 sites across Europe, Japan, and New Zealand and is divided into the European/New Zealand cohort and the Japanese cohort (which includes an imaging subset). It is designed to randomly assign 444 patients (222 per region) in a 1:1 ratio to either the DynamX Bioadaptor or the Resolute Onyx stent. Furthermore, a pharmacokinetic substudy is conducted in 9 patients enrolled in Japan to assess the pharmacokinetics of sirolimus after implantation of the DynamX Bioadaptor. Study follow-up is scheduled at one, six, and 12 months, and annually thereafter for five years; imaging follow-up includes angiographic, intravascular ultrasound, and optical coherence tomography assessments at 12 months in a subset of patients. The primary endpoint is 12-month target lesion failure. Conclusions: This trial will provide valuable insights into the safety and efficacy of this novel bioadaptor when compared to a contemporary drug-eluting stent. Condensed abstract: The DynamX Sirolimus-Eluting Bioadaptor has unique design features aiming to reduce long-term events after percutaneous coronary intervention by permitting the restoration of vessel function through the freeing of uncaging elements. Promising initial results have been obtained in the DynamX mechanistic study. This trial aims to confirm these findings in a randomized setting. The European/ New Zealand and Japanese cohorts were designed to randomly assign 444 subjects in a 1:1 ratio to either the DynamX Bioadaptor or the Resolute Onyx stent. Furthermore, a pharmacokinetic substudy is conducted in 9 patients enrolled in Japan to assess the pharmacokinetics of sirolimus. |
|---|---|
| MeSH term(s) | Humans ; Coronary Artery Disease/diagnostic imaging ; Coronary Artery Disease/therapy ; Coronary Angiography ; Drug-Eluting Stents ; Treatment Outcome ; Sirolimus/adverse effects ; Percutaneous Coronary Intervention/adverse effects ; Prosthesis Design |
| Chemical Substances | zotarolimus (H4GXR80IZE) ; Sirolimus (W36ZG6FT64) |
| Language | English |
| Publishing date | 2023-05-23 |
| Publishing country | United States |
| Document type | Randomized Controlled Trial ; Multicenter Study ; Journal Article |
| ZDB-ID | 2212113-4 |
| ISSN | 1878-0938 ; 1553-8389 |
| ISSN (online) | 1878-0938 |
| ISSN | 1553-8389 |
| DOI | 10.1016/j.carrev.2023.05.010 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
Full text online
More links
Kategorien
In stock of ZB MED Cologne/Königswinter
| Zs.A 5562: Show issues | Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG) |
Order via subito
This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.