Low rates of angiographic and clinical restenosis with the new flexible MedStent for the treatment of single discrete coronary lesions.

The use of enhanced designs of new coronary stents continues to expand the spectrum of coronary anatomy and clinical settings amenable to nonsurgical revascularization. The objectives of this clinical trial were to demonstrate the safety and late angiographic restenosis rate of the new flexible MedStent. The study included 117 patients with stable or unstable angina pectoris and a discrete de novo lesion of a native coronary artery. Procedural success, 6-month angiographic findings, and 1-year clinical outcomes were determined. The stent was successfully deployed in all but one patient (99.1%). There were no events in any of the patients within the first 2 weeks after the procedure. At 1 year, a total of 12 patients had 16 clinical events related to the stented artery (1 death, 3 non-Q-wave MIs, 10 repeat PTCAs, and 2 CABG procedures). This represents a target vessel revascularization rate (TVR) of 10.3%. The minimal luminal diameter (MLD) at 6 months for the MedStent was 2.04 +/- 0.71 mm. The 6-month binary angiographic restenosis was 20.0% (95% CI, 12.5%-27.5%). The results of the Medstent study in discrete, de novo native coronary lesions demonstrated low incidence of clinical events as well as favorable angiographic restenosis rate.