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.