Erythropoietin in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a randomized, double-blind trial.

BACKGROUND: Erythropoietin improves myocardial function in experimental models of myocardial infarction. The aim of the present study was to determine the value of erythropoietin in patients with acute ST-elevation myocardial infarction. METHODS AND RESULTS: This randomized, double-blind study included 138 patients admitted with acute ST-elevation myocardial infarction and treated with primary percutaneous coronary intervention. Patients were randomly assigned to receive epoetin-ß (3.33×104 U, n=68) or placebo (n=70) immediately and at 24 and 48 hours after percutaneous coronary intervention. The primary end point was left ventricular ejection fraction after 6 months measured by MRI. Other end points included infarct size at 5 days and 6 months. Clinical adverse events (death, recurrent myocardial infarction, stroke, and infarct-related artery revascularization) were investigated at 30 days and 6 months. Left ventricular ejection fraction at 6-month follow-up was 52.0±9.1% in the erythropoietin group compared with 51.8±9.3% in the placebo group (P=0.92). Five days after percutaneous coronary intervention, left ventricular ejection fraction was 49.4±8.0% in the erythropoietin group and 50.8±7.3% in the placebo group (P=0.32); infarct size was 26.8±20.9% and 28.3±24.4% (P=0.76) and decreased to 17.3±14.3% and 20.9±16.4% at 6-month follow-up (P=0.27). The cumulative 6-month incidence of death, recurrent myocardial infarction, stroke or target vessel revascularization was 13.2% in the erythropoietin group and 5.7% in the placebo group (hazard ratio, 2.36; 95% confidence interval, 0.73 to 7.66; P=0.15). CONCLUSIONS: In patients with acute ST-elevation myocardial infarction treated with primary percutaneous coronary intervention, erythropoietin treatment did not improve left ventricular ejection fraction or reduce infarct size but may increase clinical adverse events. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00390832.

Electrogram-guided substrate ablation with or without pulmonary vein isolation in patients with persistent atrial fibrillation.

AIMS: Ablation of complex fractionated atrial electrograms (CFAEs) is a new approach for the treatment of atrial fibrillation (AF). The purpose of the study was to assess the efficacy of CFAE ablation as a stand-alone strategy in patients with persistent AF and to compare it with a combined approach of CFAE ablation and pulmonary vein isolation (PVI). METHODS AND RESULTS: The study included 77 consecutive patients with persistent AF who underwent radiofrequency (RF) ablation of CFAE as a sole ablation procedure (CFAE group, n = 23 patients) or a combined approach of CFAE ablation and PVI (CFAE plus PVI group, n = 54 patients). Procedures were guided by three-dimensional mapping systems. After the procedure, AF recurrences were evaluated with 7-day Holter recordings at 1, 3, and 6 months and every 6 months thereafter. Treatment failure was defined as >or=1 AF episode lasting >30 s on Holter recordings during follow-up. After a mean follow-up time of 13 +/- 10 months, 2 of 23 patients (9%) with CFAE ablation and 22 of 54 patients (41%) with CFAE plus PVI were in sinus rhythm after a single ablation procedure without anti-arrhythmic medication (P = 0.008). CONCLUSION: Ablation of CFAE as a stand-alone ablation strategy seems insufficient for the treatment of patients with persistent AF. Pulmonary vein isolation plus CFAE ablation significantly increases the mid-term success rate.