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

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 des ign consisting of interconnected sinusoidal rings allowing improved flexibi lity with good conformability and scaffolding. A total of 285 stents were i mplanted in 267 patients with (un)stable angina pectoris who underwent angi oplasty of a single de novo, lesion in a native coronary artery with a diam eter 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 exp erienced 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. Th ere were no additional events at 1 month. The clinical; endpoints encounter ed at 6 months were Q-wave MI in 1, bypass surgery in 3, and repeat angiopl asty 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 w as 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 wit h (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. (C) 2001 Wiley-Liss, Inc.