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ǥ : ȣ - 540294   159 
Comparison of the Efficacy and Safety of Paclitaxel-Eluting CoroflexTM Please Stent versus Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease: The PIPA Randomized Controlled Trial
울산대학교 서울아산병원 ¹ , 한림대학교 성심병원² , 울산대학교 강릉 아산병원³ , 울산대학교병원⁴, 강원대학교병원5, 광주기독병원6, 순천향대학교부속부천병원 7, 서울보훈병원 8
김영학¹, 박승정 ¹ , 박덕우¹ , 안정민¹ , 송혜근 ¹ , 김원장¹ , 이종영¹ , 강수진¹ , 이승환¹ , 이철환¹ , 박성욱¹ , 김현숙² , 정상식³ , 이상곤⁴, 이봉기 5, 이승욱6 , 이내희 7 , 이근 8
BACKGROUND Paclitaxel-eluting CoroflexTM Please stent, compared with bare metal stents, has been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between paclitaxel-eluting CoroflexTM Please stent and first-generation paclitaxel-eluting stents (TAXUS). METHODS We performed a single-blind, multicenter, prospectively randomized trial to compare the safety and efficacy of the CoroflexTM Please stent and TAXUS stent in patients with de novo coronary disease undergoing percutaneous coronary intervention (PCI). The primary end point was an in-segment late luminal loss at 9-months follow-up angiography. Clinical events were also monitored for at least 12 months. RESULTS A total of 319 patients were randomized 1:1 to received CoroflexTM Please stent (n=160) and paclitaxel-eluting stent (n=159). The mean age was 65±11 years and 38% of the patients were women. Twenty-five percent of the patients had diabetes, 55% presented with acute coronary syndrome, and the mean ejection fraction was 61±9%. The proportions of patients with single-vessel disease, two-vessel disease, and three-vessel disease were 56%, 30%, and 14%, respectively. The mean number of lesions stented was 1.3±0.6, the mean number of stents per patient was 1.5±0.8 and total stent length per patient was 34.0±22.9 mm. There were no significant differences of baseline clinical, angiographic, and procedural characteristics between 2 groups. Follow-up angiography was performed in 210 (66%) patients. CONCLUSIONS The final results of the primary study-end point will be available at this-year meeting. This randomized trial will demonstrate a relative safety and efficacy of second-generation paclitaxel-eluting stent, compared with first-generation paclitaxel-eluting stent.


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