Low rates of clinical restenosis with the new flexible stainless steel tube intracoronary stent: the R Stent. A six-month safety and feasibility study.

BACKGROUND: Coronary stents have been used with increasing frequency and in increasingly complex coronary lesions for the treatment of symptomatic coronary artery disease. A new stainless steel coronary stent, the R Stent, has been designed to provide maximum flexibility for tracking and high radial strength post-deployment. AIMS: To assess the safety and feasibility of the R Stent in patients with coronary artery disease. Specific objectives were to assess the R Stent's deployment success, angiographic and procedural success (< 20% residual stenosis and TIMI 3 flow), safety (absence of complications), 30-day and six-month clinical follow-up. METHODS: Between April 1998 and January 1999, stent deployment was attempted in 36 lesions in 30 patients with stable (43%) or unstable (57%) angina pectoris and 29/36 of the lesions were anatomically complex. Treated lesions were in the LAD (n = 15), RCA (n = 13) or LCX (n = 8). RESULTS: Stent deployment was achieved in 97% with one crossing failure in a patient with a long, calcified, proximal LAD lesion. After the procedure, patients were scheduled for one- and six-month clinical follow-up. One patient experienced a non-Q-wave myocardial infarction in hospital. At one month, there were no additional complications. Only one patient experienced recurrence of angina (CCS class 2) within the 30 days. At six-month follow-up, one sudden death had occurred. Three (10%) patients had anginal complaints, one of them received target lesion repeat PTCA. All other patients (87%) were event- and angina-free. CONCLUSION: This first clinical experience with the R Stent shows acceptable feasibility and safety with good long-term clinical results.