Preliminary experience with the Tsunami coronary stent: immediate and six-month clinical and angiographic results.

The Tsunami is a new, balloon-expandable, stainless steel, tubular coronary stent whose design is based on a number of radial, diamond-shaped cells joined by double connectors. The aim of this two-centre, prospective, nonrandomized study was to examine the procedural, in-hospital, and long-term clinical and angiographic outcomes of patients undergoing angioplasty with the Tsunami stent. Sixty-one consecutive unselected patients were treated by means of the implantation of 74 Tsunami stents in 72 coronary lesions. Most of the patients (64%) had unstable angina or acute myocardial infarction. The baseline lesion morphology was complex in 76% of cases, and the mean lesion length was 14 +/- 6 mm. The procedural success rate was 98%. Mean percentage diameter of the stenosis decreased after the intervention from 79 +/- 12% to 10 +/- 6%. The in-hospital major adverse cardiac event rate was 3.3%. During the six-month follow-up, there was one cardiac death and nine subjects (14.5%) underwent target vessel revascularization. The six-month event-free survival rate was 80%. The angiographic restenosis rate was 17%: a focal or limited pattern (class I or II) was found in 43% of cases, whereas the remaining 57% had a proliferative morphology (class III or IV). In conclusion, this study indicates the good clinical and angiographic performance of the Tsunami coronary stent system in consecutive unselected patients.