Study Comparison Of Sirolimus-eluting Stent With Biodegradable Polymer Versus Sirolimus-eluting Stent With Durable Polymer For The Treatment Of Acute Coronary Syndrome

Objective: The clinical outcomes of sirolimus-eluting stent with biodegradable polymer were compared with sirolimus-eluting stent with durable polymer for the treatment of acute coronary syndrome (ACS). The safety and efficacy of sirolimus-eluting stent with biodegradable polymer was evaluated and the risk factors of major adverse cardiac events (MACE) after the index procedure were analyzed. Reference for clinic practice to choose better stent was offered.Methods: 442 patients with ACS were randomly treated with sirolimus-eluting stent with biodegradable polymer (Excel group n=246) and sirolimus-eluting stent with durable polymer (Partner group n=196) in The Second Affiliated Hospital of Dalian Medical University between January 2006 and December 2007. Patients were divided into Excel group and Partner group. Clinical follow-up was performed by telephone contact or office visit for 1~3 years after the index procedure. Mean follow-up duration was (24.4±6.9 ) months. The frequency of MACE, angina pectoris reoccurrence, restenosis, stent thrombosis and using of drug during the follow-up period were compared between the two groups. The MACE included cardiac death, nonfatal myocardial infarction or target lesion revascularization (TLR).Results: Baseline clinical and angiographic characteristics were similar in two groups. It was not significantly different of follow-up ratio between two groups (93.1%[229]vs92.3%[181]). Frequency of cardiac death (2 [0.9%] vs 1 [0.6%]) were similar for both stent types in 1 month. Frequency of angina pectoris reoccurrence (22[9.6%]vs16[8.8%]),cardiac death (3[1.3%] vs 2[1.1%]), nonfatal myocardial infarction (1[0.4%] vs 1[0.6%]), TLR(6[2.6%] vs 4[2.2%]), MACE(9[3.9%] vs 6[3.3%]), MACE free survival(220[96.1%] vs 175[96.7%]) were similar in two groups in 1 year. Frequency of angina pectoris reoccurrence (42[18.3%]vs31[17.1%]), cardiac death (4[1.7%] vs 4[2.2%]), nonfatal myocardial infarction (2[0.9%] vs 3[1.7%]), TLR(11[4.8%] vs 7[3.9%]), MACE(16[7.3%] vs 12[6.6%]), MACE free survival(213[92,7%] vs 169[93.4%]), restenosis(13[5.7%] vs 8[4.4%]) were similar for both groups during the follow-up period. No definite stent thrombosis occurred in both group during the period of follow-up. Time for clopidogrel administration was 11.3±6.7 months with Excel group and 16.5±5.1 months with Partner group. Time for clopidogrel administration was significantly different between two groups. The risk factors for MACE were analyzed by a logistic regression model, The risk factors for MACE after the index procedure were age(>70 years ), diabetes mellitus, hypertension, hyperlipidemia, left ventricular ejection fraction (LVEF<45%), MI, multivessel disease.Conclusions: Stent eluting sirolimus from a biodegradable polymer represents a safe and effective alternative to stent eluting sirolimus from a durable polymer in patients with acute coronary syndromes. Clinical outcomes of both stents were similar in 1~3 years. Time of antiplatelet therapy of receiving clopidogrel for stent eluting sirolimus from a biodegradable polymer can be administered shorter than that of stent eluting sirolimus from a durable polymer. Age (>70 years), diabetes mellitus, hypertension, hyperlipidemia, left ventricular ejection fraction (LVEF <45%), MI and multivessel disease were the risk factors of MACE after the index procedure.