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经皮腔内血管成形术后血管愈合快速评估(REVEAL)试验:原理、目的和设计。

Rapid Evaluation of Vessel HEaling After AngiopLasty (REVEAL) trial: rationale, objectives and design.

机构信息

Cardiology Department, Ferrarotto Hospital, University of Catania, Italy.

出版信息

J Cardiovasc Med (Hagerstown). 2010 Jan;11(1):53-8. doi: 10.2459/JCM.0b013e32832ffad3.

DOI:10.2459/JCM.0b013e32832ffad3
PMID:19829136
Abstract

BACKGROUND

Novel approaches to modify stents have been developed to address the limitations of bare-metal stents (BMS) and drug-eluting stent (DES), aiming for ideal features, such as decreased restenosis rates with decreased thrombogenicity and without the need for long-term dual antiplatelet therapy.

RATIONALE

The Assessment of The LAtest Non-Thrombogenic Angioplasty Stent (ATLANTA) trial was the first-in-man study to show the safety and efficacy of the Polyzene-F coated CATANIA stent (CeloNova BioSciences, Newnan, Georgia, USA) as an alternative to both BMS and DES. The stent was found to be associated with a good clinical outcome with no vessel thrombosis and a modest growth of late neointima. A subgroup undergoing optical coherence tomography late assessment showed almost complete stent strut coverage at 6 months. However, whether the CATANIA stent is superior in promoting a greater stent strut coverage rate both at 7 and 30 days with respect to DES and BMS is unknown.

METHODS

The Rapid Evaluation of Vessel HEaling After AngiopLasty (REVEAL) trial will be a prospective, randomized study providing new evidence on early vessel healing and thrombus development after stenting with different stent types. Optical coherence tomography examination at 7-10 days or 28-32 days after implantation will evaluate strut coverage and vessel healing. The primary endpoint will be a comparison of the percentage of 'healed stent struts' at 28-32 days, identified by the presence of an evenly apposed rim of tissue on stent struts, and without apposition of thrombotic material, on the total amount of analyzed struts for the stent groups.

摘要

背景

为了解决裸金属支架(BMS)和药物洗脱支架(DES)的局限性,已经开发出了一些新型支架改良方法,旨在实现理想的特性,例如降低再狭窄率、降低血栓形成风险,同时无需长期双联抗血小板治疗。

理由

首个评估最新非血栓性血管成形术支架(ATLANTA)的人体研究显示,Polyzene-F 涂层的 CATANIA 支架(CeloNova BioSciences,美国佐治亚州纽南)作为 BMS 和 DES 的替代物具有安全性和疗效。该支架与良好的临床结果相关,无血管血栓形成,晚期新生内膜适度生长。在晚期接受光学相干断层扫描评估的亚组中,6 个月时几乎完全覆盖支架支柱。然而,与 DES 和 BMS 相比,CATANIA 支架是否在促进更大的支架支柱覆盖率方面具有优势,无论是在 7 天还是 30 天,目前尚不清楚。

方法

血管成形术后血管快速愈合评估(REVEAL)试验将是一项前瞻性、随机研究,为不同支架类型植入后早期血管愈合和血栓形成提供新的证据。在植入后 7-10 天或 28-32 天进行光学相干断层扫描检查,评估支架支柱覆盖率和血管愈合情况。主要终点是比较 28-32 天时“愈合支架支柱”的百分比,通过存在均匀贴壁的组织边缘来识别,并且没有血栓形成物质附着在支架组的总分析支架支柱上。

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