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

Int J Cardiovasc Intervent. 2003;5(3):161-5. doi: 10.1080/14628840310017384.

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.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Angina Pectoris / diagnostic imaging*
  • Angina Pectoris / surgery*
  • Angioplasty, Balloon, Coronary / adverse effects
  • Blood Vessel Prosthesis Implantation / adverse effects*
  • Coronary Angiography*
  • Female
  • Follow-Up Studies
  • Graft Occlusion, Vascular / etiology*
  • Humans
  • Male
  • Middle Aged
  • Myocardial Infarction / diagnostic imaging*
  • Myocardial Infarction / surgery*
  • Myocardial Ischemia / diagnostic imaging*
  • Myocardial Ischemia / surgery*
  • Outcome Assessment, Health Care
  • Prospective Studies
  • Stents / adverse effects*
  • Time Factors