Clinical and angiographic safety and efficacy trial with a new coronary stent: the RESTOR study of the R Stent.
The RESTOR trial (R Stent Efficacy and Safety Trial by ORBUS) is an efficacy and safety evaluation of the R Stent for treatment of patients with a single de novo coronary lesion < 25 mm in length in a coronary artery of 2.75-4.0 mm diameter. This new stent utilizes a patented dual helix design for radial strength and flexibility. The aim of the study was to assess major adverse cardiac events (MACE) and angiographic outcome at 6 months after implantation. From May to December 2000 a total of 121 patients with symptomatic stable or unstable angina pectoris or documented silent ischemia and a significant single, de novo coronary lesion (average reference vessel diameter 2.84 +/- 0.54 mm, average lesion length 10.53 +/- 3.70 mm) were included in two Dutch centers. All patients were treated with clopidogrel 75 mg/day for 1 month and with aspirin greater than or equal to 100 mg/day. The angiographic success rate (< 30% diameter stenosis post-procedure) was 98.3%. Procedural success (angiographic success without in-hospital MACE) was 95.9%. The 6-month MACE rate was 12.4%. 101 of the 121 patients had an angiographic follow-up at 6 months. Minimal lumen diameter pre-/post-procedure and at follow-up was 0.98 +/- 0.37, 2.64 +/- 0.38 and 1.85 +/- 0.68 mm, respectively. The resulting binary restenosis rate in this population was 20.8%. The coronary R Stent is safe and effective as a primary device for the treatment of native coronary lesions in patients with stable or unstable angina pectoris, and well suitable as a platform for a drug eluting stent.
den Heijer
Peter
P
Amphia Ziekenhuis, Loc. Galderseweg, P.O. Box 90158, 4800 RK Breda, the Netherlands. p.den.heijer@planet.nl
Rensing
Benno J W M
BJ
Foley
David P
DP
van den Bos
Arjan A
AA
Corbeij
Huub M A
HM
Quarles van Ufford
Michael A
MA
te Riele
Johannes A M
JA
Rooset
Paul C H
PC
Serruys
Patrick W
PW
D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012449:Safety; D015607:Stents / Q000592:standards*; D016896:Treatment Outcome