title: Clinical and angiographic performance of a new-generation modular stent design for treatment of de novo coronary lesions.
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.
authors.affiliation: Department of Cardiology, C.H.U. de Liège, Liège, Belgium. vlegrand@chu.ulg.ac.be
authors.forename: V M
authors.initials: VM
authors.lastname: Legrand
authors.forename: E J
authors.initials: EJ
authors.lastname: Garcia
authors.forename: E
authors.initials: E
authors.lastname: Grube
authors.forename: K
authors.initials: K
authors.lastname: Khalife
authors.forename: H
authors.initials: H
authors.lastname: Bonnier
authors.forename: P
authors.initials: P
authors.lastname: Commeau
authors.forename: T
authors.initials: T
authors.lastname: Przewlocki
authors.forename: C
authors.initials: C
authors.lastname: Macaya
authors.forename: A
authors.initials: A
authors.lastname: Witkowski
mesh_terms: D000368:Aged; D000787:Angina Pectoris / Q000150:complications / Q000000981:diagnostic imaging* / Q000601:surgery*; D019917:Blood Vessel Prosthesis Implantation / Q000295:instrumentation; D017023:Coronary Angiography / Q000295:instrumentation; D023921:Coronary Stenosis / Q000150:complications / Q000000981:diagnostic imaging / Q000601:surgery; D004562:Electrocardiography; D004867:Equipment Design; D005060:Europe / Q000453:epidemiology; D005069:Evaluation Studies as Topic; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome