FIRST INTERNATIONAL NEW INTRAVASCULAR RIGID-FLEX ENDOVASCULAR STENT STUDY (FINESS) - CLINICAL AND ANGIOGRAPHIC RESULTS AFTER ELECTIVE AND URGENT STENT IMPLANTATION

Objectives. The purpose of this study was to determine the feasibility , safety and efficacy of elective and urgent deployment of the new int ravascular rigid flex (NIR) stent in patients with coronary artery dis ease. Background. Stent implantation has been shown to be effective in the treatment of focal, new coronary stenoses and in restoring corona ry flow after coronary dissection and abrupt vessel closure. However, currently available stents either lack flexibility, hindering navigati on through tortuous arteries, or lack axial strength, resulting in sub optimal scaffolding of the vessel. The unique transforming multicellul ar design of the NIR stent appears to provide both longitudinal flexib ility and radial strength. Methods. NIR stent implantation was attempt ed in 255 patients (341 lesions) enrolled prospectively in a multicent er international registry from December 1995 through March 1996. Nine- , 16- and 32-mm long NIR stents were manually crimped onto coronary ba lloons and deployed in native coronary (94%) and saphenous vein graft (6%) lesions. Seventy-four percent of patients underwent elective sten ting for primary or restenotic lesions, 21% for a suboptimal angioplas ty result and 5% for threatened or abrupt vessel closure. Fifty-two pe rcent of patients presented with unstable angina, 48% had a previous m yocardial infarction, and 45% had multivessel disease. Coronary lesion s were frequently complex, occurring in relatively small arteries (mea n [+/-SD] reference diameter 2.8 +/- 0.6 mm). Patients were followed u p for 6 months for the occurrence of major adverse cardiovascular even ts. Results. Stent deployment was accomplished in 98% of lesions. Mean minimal lumen diameter increased by 1.51 +/- 0.51 mm (from 1.09 +/- 0 .43 mm before to 2.60 +/- 0.50 mm after the procedure). Mean percent d iameter stenosis decreased from 61 +/- 13% before to 17 +/- 7% after i ntervention. A successful interventional procedure with <50% diameter stenosis of all treatment site lesions and no major adverse cardiac ev ents within 30 days occurred in 95% of patients. Event-free survival a t 6 months was 82%. Ninety-four percent of surviving patients were eit her asymptomatic or had mild stable angina at 6 month follow-up. Concl usions. Despite unfavorable clinical and angiographic characteristics of the majority of patients enrolled, the acute angiographic results a nd early clinical outcome after NIR stent deployment were very promisi ng. A prospective, randomized trial comparing the NIR stent with other currently available stents appears warranted. (C) 1997 by the America n College of Cardiology.