Clinical and angiographic performance of a new-generation modular stent design for treatment of de novo coronary lesions

Catheter Cardiovasc Interv. 2001 Nov;54(3):276-82. doi: 10.1002/ccd.1284.

Abstract

The objectives of the Race Car study were to assess the safety and efficacy of the Medtronic AVE S670 stent, a new-generation stent with a modular design consisting of interconnected sinusoidal rings allowing improved flexibility with good conformability and scaffolding. A total of 285 stents were implanted in 267 patients with (un)stable angina pectoris who underwent angioplasty of a single de novo lesion in a native coronary artery with a diameter between 3.0 and 4.0 mm. Available stent lengths were 9, 12, and 15 mm. The primary endpoint was the 6-month restenosis rate. Secondary endpoints were device and procedural success and major adverse cardiac event (MACE)-free survival at 1 and 6 months. All patients received the study stents and no other stents were used (angiographic success: 100%). Eight patients experienced a MACE during hospital admission (Q-wave MI in 2, non-Q-wave MI in 4, TLR in 2). A procedural success was obtained in 97% of the patients. There were no additional events at 1 month. The clinical endpoints encountered at 6 months were Q-wave MI in 1, bypass surgery in 3, and repeat angioplasty in 25 (MACE-free survival: 86.5%). Quantitative angiographic results were the minimum lumen diameter increased from 1.05 +/- 0.32 before to 2.73 +/- 0.39 mm after stent implantation. At follow-up, the loss in diameter was 0.74 +/- 0.50 mm. The loss index was 0.45 +/- 0.31 and restenosis rate was 13.4%. This study has demonstrated that the S670 stent in patients with (un)stable angina pectoris requiring intervention of a single lesion has a low acute and 6-month major event rate and a low angiographic restenosis rate.

Publication types

  • Clinical Trial
  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Angina Pectoris / complications
  • Angina Pectoris / diagnostic imaging*
  • Angina Pectoris / surgery*
  • Blood Vessel Prosthesis Implantation / instrumentation
  • Coronary Angiography* / instrumentation
  • Coronary Stenosis / complications
  • Coronary Stenosis / diagnostic imaging
  • Coronary Stenosis / surgery
  • Electrocardiography
  • Equipment Design
  • Europe / epidemiology
  • Evaluation Studies as Topic
  • Female
  • Follow-Up Studies
  • Hospitalization
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Stents*
  • Treatment Outcome