Site-Specific Antithrombotic Therapy: 24-Month Outcomes of the Randomized DESyne BDS Plus Trial Using a Novel Triple-Drug Eluting Coronary Implant With Two Anticoagulants and Sirolimus

IF 1.9 3区医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

Catheterization and Cardiovascular Interventions Pub Date : 2025-08-28 DOI:10.1002/ccd.70106

Stefan Verheye, Bert Ferdinande, Johan Bennett, Rodolfo Staico, Seif El-Jack, Pim A. L. Tonino, Alexandre Abizaid, Ian Buysschaert, Douglas Scott, Madhav Menon, Gerard Wilkins, Dougal McClean, Tomas Kovarnik, Uwe Christians, Antoinette Neylon, Zlatko Mehmedbegovic, Pieter C. Smits, Marie-Claude Morice, Mark Webster, the DESyne BDS Plus RCT Investigators

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引用次数: 0

Abstract

Background

DESyne BDS Plus represents a novel triple drug therapy (TRx) applied on a coronary stent platform eluting the antiproliferative drug Sirolimus along with two anticoagulants (Rivaroxaban and Argatroban) to reduce the site-specific thrombotic risk.

Aims

To assess the feasibility and safety of this novel device against a contemporary drug-eluting stent.

Methods

This prospective, multicenter randomized (1:1) trial included 202 patients assigned between the device group (DESyne BDS Plus) and the control group (DESyne X2). A subgroup of 58 patients underwent imaging follow-up at 6 months. The blood pharmacokinetics of Sirolimus and both anticoagulants were assessed in 11 nonrandomized patients.

Results

The primary endpoint, target lesion failure (TLF) at discharge or 3-day postprocedure, whichever occurred first, was 0.0% (0/98) in the device and 5.0% (5/100) in the control group (p_{noninferiority} < 0.001). The secondary endpoint, late lumen loss at 6 months, was 0.14 mm [90% CI: 0.06; 0.23] and 0.09 mm [90% CI: 0.01; 0.18] in the device (n = 28) and control group (n = 27), respectively (p_{noninferiority} < 0.001). Through 24 months, stent thrombosis (definite/probable) was 0.0% (0/97) versus 1.0% (1/96) in the control, p = 0.497, and TLF was 2.1% (2/97) versus 11.3% (11/97), p = 0.010, respectively. Optical coherence tomography findings including strut coverage and neointimal hyperplasia thickness/volume were similar between the groups. The pharmacokinetic study indicated median maximum blood concentrations (C_max) of Rivaroxaban and Argatroban of 1.38 ng/mL and 1.99 ng/mL, respectively.

Conclusions

This is the first clinical evidence of the feasibility of site-specific antithrombotic therapeutic with two anticoagulants and an antiproliferative mTOR inhibitor.

Abstract Image

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部位特异性抗血栓治疗：随机DESyne BDS Plus试验使用新型三药洗脱冠状动脉植入物与两种抗凝剂和西罗莫司的24个月结果。

背景：DESyne BDS Plus是一种新型的三联药物治疗（TRx），应用于冠状动脉支架平台，洗脱抗增殖药物西罗莫司和两种抗凝剂（利伐沙班和阿加曲班），以降低部位特异性血栓形成风险。目的：评估这种新型装置与现代药物洗脱支架的可行性和安全性。方法：这项前瞻性、多中心随机（1:1）试验纳入了202例患者，分为装置组（DESyne BDS Plus）和对照组（DESyne X2）。亚组58例患者在6个月时接受影像学随访。对11例非随机患者的西罗莫司和两种抗凝血药的血药代动力学进行了评估。结果：在利伐沙班和阿加托班分别为1.38 ng/mL和1.99 ng/mL的对照组（p非劣效非劣效max）中，主要终点，出院时或术后3天的靶病变失败（TLF）（以先发生者为准）在装置中为0.0%(0/98)，在对照组中为5.0%（5/100）。结论：这是第一个临床证据，证明了两种抗凝剂和一种抗增殖mTOR抑制剂的部位特异性抗血栓治疗的可行性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Catheterization and Cardiovascular Interventions 医学-心血管系统

CiteScore

5.40

自引率

8.70%

发文量

419

审稿时长

2 months

期刊介绍： Catheterization and Cardiovascular Interventions is an international journal covering the broad field of cardiovascular diseases. Subject material includes basic and clinical information that is derived from or related to invasive and interventional coronary or peripheral vascular techniques. The journal focuses on material that will be of immediate practical value to physicians providing patient care in the clinical laboratory setting. To accomplish this, the journal publishes Preliminary Reports and Work In Progress articles that complement the traditional Original Studies, Case Reports, and Comprehensive Reviews. Perspective and insight concerning controversial subjects and evolving technologies are provided regularly through Editorial Commentaries furnished by members of the Editorial Board and other experts. Articles are subject to double-blind peer review and complete editorial evaluation prior to any decision regarding acceptability.