Six months' clinical and angiographic follow-up of a flexible, coiled stainless steel stent in long, native coronary artery lesions

This study was conducted to evaluate the short- and long-term clinical and angiographic results of implantation of a flexible, coiled stainless steel stent, the Freedom Coronary Stent. During the study period this stent was u sed as an alternative to the Palmaz-Schatz PS153 coronary stent in long or tortuous lesions: Thr study was designed as a prospectively planned outcome analysis. Implantation of Freedom stents was attempted in 62 consecutive p atients (56% males, mean age 63 +/- 10 years) with a total of 65 coronary l esions. Indications for stent implantation were: restenosis, 8%; recoil, 26 %; visible dissection, 32%; threatening occlusion, 15%; chronic total occlu sion, 18%. The average stent length was 30 +/- 16 mm and 67% of the lesions were type C. Rate of successful stent implantation, acute complications, a ngiographic restenosis after 6 months and major cardiac events (death, myoc ardial infarction, target vessel revascularization) during follow-up were a ssessed. The success rate of stent implantation was 94%. One patient died a fter an emergency bypass operation and one patient suffered a subacute sten t thrombosis, which was successfully treated with re-percutaneous translumi nal coronary angioplasty (M-CA). There were no Q- or non-Q myocardial infar ctions. Clinical follow-up was carried out in 56 patients (97%) and 57 vess els were assessed by angiography (93%). Mean length of the follow-up period was 6.8 +/- 2.3 months. During the 6 months' follow-up period, one patient died, two patients suffered an acute non-Q myocardial infarction and eight patients had revascularization of the target vessel. Major cardiac event r ate for all patients where stent implantation was intended was 23%. Angina CCS class declined from 3.0 +/- 0.9 to 1.1 +/- 0.8 (p < 0.01) before PTCA t o follow-up. Overall restenosis rate was 28%. Tn 14 lesions with a stented segment length of <20 mm, the restenosis rate was 21%; in 31 lesions with a stented segment length greater than or equal to 20 and <30 mm, the resteno sis rate was 26%: and in 13 lesions with a stented segment length of greate r than or equal to 30 mm, the restenosis rate was 42%. Although there was a high procedural success rate after implantation of the Freedom stent in lo ng or tortuous lesions, problems with high restenosis rates in long lesions remain unresolved.