Clinical Outcomes from Unselected Real-World Patients with Acute Myocardial Infarction Receiving Biodegradable Polymer Coated Sirolimus-Eluting Stents
Objectives: To investigate clinical outcomes of acute myocardial infarction population in a real-life setting when treated with Indolimus® biodegradable polymer coated sirolimus-eluting coronary stent.
Background: Drug-eluting stents in acute myocardial infarction are still feared for possible late and very late stent thrombosis. Newer antiproliferative drugs and more biodegradable polymers have shown promise in reducing further the rate of late stent thrombosis in patients with stable angina. However, limited data is available on the safety and efficacy of biodegradable polymer coated drug-eluting stent in acute myocardial infarction patients.
Methods: We studied patients undergoing cardiac catheterization with acute myocardial infarction (n=239) and without acute myocardial infarction (n=291) who had been implanted with Indolimus® sirolimus-eluting stents. The outcomes were reported for 1 and 6-months. The primary endpoint was the composite of major adverse cardiac events at 1 and 6-months after discharge from hospital. The secondary endpoint was stent thrombosis.
Results: A higher proportion of patients in the acute myocardial infarction group had renal insufficiency at screening (p=0.02), but there was a higher proportion of patients with a history of myocardial infarction (p<0.001), previous percutaneous coronary intervention (p=0.01) in the non- myocardial infarction group. The frequency of type B2/C lesions (p<0.001) and chronic total occlusion (p<0.001) was higher in the myocardial infarction group. There was no significant difference in parameters related to target vessel distribution and severity of disease. The six months follow-up was completed for 516 (97.4%) enrolled patients. The incidence of any major adverse cardiac events at 6-months was 2.1% and 4.2% for non-myocardial infarction and myocardial infarction population, respectively. There was no stent thrombosis up to 6-months in both groups.Conclusions: In this all-comer, real-world Indolimus acute myocardial infarction study, major adverse cardiac events rates did not differ between acute myocardial infarction and non-acute myocardial infarction population. Six-month observation of acute myocardial infarction treatment using Indolimus® stent compared with non- acute myocardial infarction has no clinical disadvantage.
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