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Effect of Valsartan on Suppression of Restenosis after Drug-Eluting Stents and on Regression of Native Plaque Volume: The Val-SUPPRES Randomized Controlled Trial
서울 아산 병원¹ ,서울 삼성병원² ,아주대학교병원³ ,신촌세브란스병원⁴ ,서울성모병원5
박덕우¹, 안정민¹ ,송혜근 ¹ ,김원장¹ ,이종영¹ ,강수진¹ ,이승환¹ ,김영학¹ ,이철환¹ ,박성욱¹ ,박승정¹,권현철² ,탁승제³ ,장양수⁴ ,승기배5
BACKGROUND Accumulating evidence suggests that angiotensin-converting enzyme (ACE) activity may in part mediate neoinimal hyperplasia after stenting. We hypothesize that use of ACE blocker might suppress intimal hyperplasia after drug-eluting stents, and might influence regression of atheromatous plaque in non-stented vessel. METHODS The Val-SUPPRESS trial is a prospective, randomized, multi-center, open-labeled trial. We randomly assigned a total of 220 patients with de novo coronary disease receiving drug-eluting stents (paclitaxel-eluting or zotarolimus-eluting stents) to receive valsartan 160 mgs daily with open treatment or not. The primary end point was an in-stent late loss of the stented segment at 8-month angiographic follow-up. Secondary end points included percent atheroma volume of non-stented, intermediate lesions by intravascular ultrasound (IVUS), and clinical outcomes including death, myocardial infarction, and repeat revascularization. RESULTS A total of 220 patients were randomized 1:1 to received valsartan treatment (n=108) or not (n=112). The mean age was 59 years and 70% of the patients were men. Twenty-one percent of the patients had diabetes, 37% had hyperlipidemia, 82% presented with acute coronary syndrome, 39% had multivessel disease, and the mean ejection fraction was 60%. The proportions of left anterior descending lesions were 75%, diffuse long lesions (≥20 mm) were 49%, and bifurcation lesions 11%, and ACC/AHA type B2 or C lesions were 52%, respectively. The mean number of stents per patient was 1.6±0.8 and total stent length per patient was 37.5±24.1mm. Paclitaxl-eluting stents and zotarolimus-eluting stents were implanted in 172 (78%) patients and 48 (22%) patients, respectively. Non-target vessel IVUS was performed in 109 (50%) patients. There were no significant differences of baseline clinical, angiographic, and procedural characteristics between the 2 groups. Eight-month follow-up angiography was performed in 184 (84%) patients. CONCLUSIONS The final results of the primary and secondary study-end points will be available at this-year meeting. This pivotal, drug trial will provide a critical appraisal of pleiotropic effects of ACE blockage on neointimal hyperplasia or coronary plaque regression.


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