Clinical outcome of patients with de novo coronary bifurcation lesions treated with the Tryton Side Branch Stent. The SAFE-TRY prospective multicenter single arm study

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• 作者：Giuseppe Tarantini ; Luigi La Vecchia ; Mario Galli ; Luca Favero ; Gianpiero D'Amico ; Paolo Buja ; Filippo Russo ; Ester Cabianca ; Massimo Napodano ; Giuseppe Musumeci ; Enrico Franceschini ; Giuseppe Grassi ; Andrea Pavei ; Roberto Bonmassari ; Carlo Cernetti ; Leonardo Spedicato ; Francesco Caprioglio ; Bernhard Reimers ; Giambattista Isabella
• 关键词：Percutaneous coronary intervention ; Coronary artery disease ; Bifurcation lesions ; Dedicated bifurcation device
• 刊名：International Journal of Cardiology
• 出版年：15 October, 2013
• 年：2013
• 卷：168
• 期：6
• 页码：5323-5328
• 全文大小：524 K

文摘

Background

Coronary bifurcation lesions represent a difficult problem regularly confronting interventional cardiologist, in part due to the lack of dedicated device.

Objective

To investigate the feasibility, safety and effectiveness of the Tryton鈩?Side Branch Stent (Tryton Medical, Durham, NC, USA), a dedicated bare metal stent deployed in conjunction with a standard drug-eluting stent to treat bifurcation lesions.

Methods

The SAFE-TRY is a prospective single arm multicenter registry including patients with de novo bifurcation lesions in native coronary arteries and syntax score < 32. The primary endpoint was target vessel failure (TVF) at 30 days that comprised cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization. Secondary endpoints included device, angiographic and procedural success, 9-month major adverse cardiac and cerebrovascular event (MACCE), and stent thrombosis (ST) rates (ClinicalTrials.gov identifier: NCT01174433).

Results

Among 252 enrolled patients, 24% had diabetes and 35.3% unstable angina. True bifurcation lesions involving both branches occurred in 96.8% of cases with Medina classification 1.1.1 in 62%. The left anterior descending artery and the left main were treated in 70% and 8.3% of the patients, respectively. A 6 Fr guide catheter was used in 61% of the cases. Device, angiographic and procedural success rates were 99.6%, 99.6% and 97.2% respectively. The 30-day TVF was 2.8%; the 9-month MACCE rate was 13.7%, with target lesion revascularization being 4.4%. No definite ST occurred.

Conclusions

This prospective, multicenter study confirmed the feasibility, safety and effectiveness of the Tryton Side Branch Stent to treat patients with de novo complex bifurcation lesions.