Six-month clinical and angiographic outcomes of the Tecnic Carbostent coronary system: the phantom IV study.

The aim of this multicenter, prospective, non-randomized study was to examine the procedural, in-hospital, and mid-term clinical and angiographic outcome of patients undergoing coronary angioplasty with the Tecnic Carbostent system. Between October 2001 and March 2002, 123 consecutive patients were treated with coronary implantation of the Tecnic Carbostent. Stable angina (54%), unstable angina (37%) and silent ischemia (9%) were clinical indications for revascularisation. The baseline lesion morphology was complex (Type B2 or C) in 59% of the cases, and the mean lesion length was 15+/-8 mm. A total of 179 stents were implanted in 149 lesions. The procedural success rate was 100%. Mean percent diameter of the stenosis decreased after the intervention from 75%+/-11% to 8%+/-4%. The mean cross-sectional area stent recoil was 8.8%+/-7.3%. No in-hospital or 30-day major adverse cardiac events were observed. During the 6-month follow-up period, there were no deaths or myocardial infarctions, whereas the incidence of target lesion revascularisation was 12.7%. The angiographic restenosis rate was 14.1%: a focal or limited pattern (class I or II) was found in 83% of cases, whereas the remaining 17% had a proliferative morphology (class III or IV). In conclusion, this study indicates that a good clinical and angiographic outcome may be obtained with the Tecnic Carbostent coronary system in consecutive patients with de novo coronary lesions.