Purpose: To evaluate and describe in-hospital and 30 days clinical outcomes in a real world population treated with a new BMS design and with multiple vessel disease and/or left main coronary artery disease (CAD). Methods: Since August 2016 to March 2017, 201 consecutive patients undergoing coronary stent implantation in 12 centers in Argentina were included in our registry. Multiple vessel disease and/or unprotected left main disease, acute coronary syndromes , including ST elevation myocardial infarction (MI) and coronary arteries with 70% or more of diameter stenosis, were inclusion criteria. On the other hand, in-stent restenosis, protected left main stenosis or impossibility to receive double antiplatelet therapy for at least one month constitute the exclusion criteria. Primary endpoint was hard clinical end points, defined as any cause of death, MI or cerebrovascular accident. Major adverse cardiac events (MACE) are defined as the incidence of cardiac death, MI, and any ischemic driven lesion revascularization (TLR). Incidence of definitive and possible stent thrombosis (SET) was also analyzed. Baseline and residual Syntax and ERACI score risks were analyzed and compared. Results: The average age was 61.5 +/-12 years, 80.1% were men, with a 31.3% of known coronary artery disease and 24.4% with history of MI. The 67.2% of patients had an ACS, of which 31.8% had ST elevation MI. 46.8% of patients had multiple vessel disease and 1.34 vessels per patient were treated in the index procedure. Dual antiplatelet therapy was used in 100% of patients, 52.3% received clopidogrel as charging dose, 11.4% of prasugrel and 36.3% ticagrelor as preferred thyenopiridines. 30 days MACE was 1.5% and cardiac death or any death was 0.5%.Significant differences in baseline (p=0.001) and residual (p<0.01) between Syntax and ERACI score were found. No patients developed stent thrombosis. Conclusions: In this prospective multicenter observational registry performed in 12 centers of Argentina showed a high 30 days quality PCI performance in a real-world CAD population.
The aim of this study was to evaluate 1-year follow-up results in an all “comers” population treated with a new cobalt chromium bare-metal stent (BMS) design. Since August 2016 to March 2017, 201 (9.7% of screening population) consecutive patients undergoing coronary stent implantation in 11 centers in Argentina were prospectively included in our registry. The inclusion criteria were multiple-vessel disease and/or unprotected left main disease, acute coronary syndromes (ACS) with at least one severe (⩾70%) stenosis in any of major epicardial vessel. In-stent restenosis, protected left main stenosis, or impossibility to receive dual-antiplatelet therapy was an exclusion criterion. Major adverse cardiac events (MACE) were the primary endpoint and included cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR); also, all components of the primary endpoint were separately analyzed. Completeness of revascularization was analyzed as post hoc data using residual SYNTAX or ERACI risk scores. Demographic characteristics showed that 6.5% of patients were very elderly, 22.5% have diabetes, 47% have multiple-vessel disease, 67% have ACS, and 32% have ST elevation MI. At a mean of 376 ± 18.1 days of follow-up, MACE was observed in 10.4% of patients: death + MI + cardiovascular accident (CVA) in 3% (6 of 201) and cardiac death + MI + CVA in 1.5% (3 of 201). Residual ERACI score ⩽5 was associated with 98% of event-free survival ( P < .04). In conclusion, this prospective, multicenter, and observational all-comers registry with this novel BMS design showed a low incidence of adverse events at 1 year mainly due to coronary restenosis.
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