title: Preliminary experience with the Tsunami coronary stent: immediate and six-month clinical and angiographic results.
abstract: 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.
authors.affiliation: Poliambulanza Hospital, Brescia, Italy. gbdanzi@mail.com
authors.forename: Gian B
authors.initials: GB
authors.lastname: Danzi
authors.forename: Cinzia
authors.initials: C
authors.lastname: Capuano
authors.forename: Angela
authors.initials: A
authors.lastname: Migliorini
authors.forename: Marco
authors.initials: M
authors.lastname: Sesana
authors.forename: Roberto
authors.initials: R
authors.lastname: Baglini
authors.forename: David
authors.initials: D
authors.lastname: Antoniucci
mesh_terms: D000368:Aged; D000787:Angina Pectoris / Q000000981:diagnostic imaging* / Q000601:surgery*; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects*; D017023:Coronary Angiography; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000209:etiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging* / Q000601:surgery*; D017202:Myocardial Ischemia / Q000000981:diagnostic imaging* / Q000601:surgery*; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D015607:Stents / Q000009:adverse effects*; D013997:Time Factors