Long-term risk, clinical management, and healthcare resource utilization of stable patients with coronary artery disease and post-myocardial infarction in Greece - TIGREECE study.

BACKGROUND: In light of the scarcity of evidence, TIGREECE evaluated the clinical management and long-term outcomes of patients at high risk for an atherothrombotic event who have suffered a myocardial infarction (MI), managed by cardiologists/internists in routine hospital and private office settings in Greece. METHODS: TIGREECE, a multicenter, 3-year prospective cohort study, enrolled patients ≥50 years old, with a history of MI 1-3 years before enrollment and with at least one of the following risk factors: age ≥65 years, diabetes mellitus requiring medication, second prior MI, multivessel coronary artery disease, and creatinine clearance 15-60 mL/min. The primary outcome was a composite of MI, unstable angina with urgent revascularization, stroke, or all-cause death. RESULTS: Between 5 June 2014 and 25 July 2015, 305 eligible consented patients (median age: 67.3 years; 81.3% males; 14.8% active smokers; 80.7% overweight/obese) were enrolled; 52.5% had ≥2 qualifying risk factors. The median time from the index MI [ST-segment elevation myocardial infarction (STEMI) in 51.1%, non-STEMI in 33.1%] to enrollment was 1.7 years. Of the patients, 65.9% had been discharged on dual antiplatelet therapy. At enrollment, 94.4% were receiving antiplatelets: 60.0% single [acetylsalicylic acid (ASA): 43.3%; clopidogrel: 15.7%] and 34.4% dual (ASA + clopidogrel: 31.8%) therapy. The Kaplan-Meier estimated 3-year primary composite event rate was 9.3% [95% confidence interval (CI): 6.4-13.0), and the ischemic composite event rate was 6.7% (95% CI: 4.2-9.9). CONCLUSIONS: Study results indicate that in the routine care of Greece one in ten patients experience a recurring cardiovascular event or death, mainly of ischemic origin, 1-3 years post-MI.

The incidence of recurrent cardiovascular events among acute coronary syndrome patients treated with generic or original clopidogrel in relation to their sociodemographic and clinical characteristics. The Aegean study.

INTRODUCTION: The use of generic drugs is continuously growing; however, there are limited epidemiological data regarding the therapeutic equivalence of each original drug formulation with its generic counterparts. We evaluated the 12-month composite endpoint of recurrent acute myocardial infarction, ischaemic stroke, cardiac deaths, or hospitalisation due to a major bleeding in acute coronary syndrome (ACS) patients treated with original clopidogrel or a generic clopidogrel formulation, in relation to sociodemographic and clinical characteristics. MATERIAL AND METHODS: Consecutive Greek ACS patients (n = 1194) hospitalised in the Aegean islands and the Attica region were enrolled. Clopidogrel treatment was recorded either as original clopidogrel hydrogen sulphate (Plavix®/Iscover®) or as a generic clopidogrel besylate formulation (Clovelen®). The composite endpoint was recorded at 12-month follow-up. RESULTS: The 12-month composite endpoint was 3.9% (4.6% in the Aegean islands and 3.5% in the Attica area, p > 0.05). The respective incidence in men was 4.0% and in women 3.8% (p > 0.05). Overall, generic and original clopidogrel use was 87% and 13% of patients, respectively. No significant differences were observed between original and generic clopidogrel use and 12-month composite endpoint incidence. Subgroup analysis with gender, region of residence, and clinical and lifestyle factors as strata did not reveal any significant outcomes. Haemorrhage incidence did not exceed 1% in the total sample. CONCLUSIONS: The use of a generic clopidogrel besylate formulation was quite high in both urban and insular areas of Greece and had similar efficacy and safety profile with the original clopidogrel salt, supporting the routine use of this low-cost generic clopidogrel in the management of cardiovascular disease patients.