Interventional Cardiology 2015: A Selection of Topical Issues

cyclosporine (2.5 mg/kg body weight) or placebo prior to reperfu- sion of the vessel. The aim was to test the hypothesis that cyclosporine can improve the clinical course and prevent ventricular remodeling in STEMI. The events of the primary end point (a composite of all-cause mortality, heart failure, rehospital- ization, or left ventricular remodeling with an increase in left ventricular end-diastolic volume 15% at 1 year) were recorded in 59.0% and 58.1% of the patients in the cyclosporine and control groups, respectively (odds ratio (OR) = 1.04; 95% confidence interval (95%CI), 0.78-1.39; P = .77). Moreover, treatment with cyclosporine did not reduce the incidence of any of the separate components of the primary end point. The TOTAL trial 4 randomized 10 732 STEMI patients treated with primary PCI to a strategy involving systematic aspiration throm- bectomy vs conventional PCI, to test the hypothesis that manual thromboaspiration could reduce distal embolization and improve microvascular perfusion. The primary outcome was the composite of cardiac death, recurrent myocardial infarction, cardiogenic shock, or severe heart failure at 180 days, and the safety outcome was stroke at 30 days. Primary outcome events were recorded in 6.9% of the patients in the thrombectomy group vs 7.0% of the conventional PCI group (OR = 0.99; 95%CI, 0.85-1.15; P = .86). The rates of cardiac death (thrombectomy vs PCI, 3.1% vs 3.5%; OR = 0.90; 95%CI, 0.73- 1.12; P = .34) and of the primary outcome plus stent thrombosis or revascularization of the target vessel (9.9% vs 9.8%; OR = 1.00; 95%CI, 0.89-1.14; P = .95) were also similar. The rate of stroke within the first 30 days was higher in the aspiration thrombectomy group (0.7% vs 0.3%; OR = 1.13-3.75; P = .02), although the reason for this finding is not clear. Because the same results were obtained in a 1-year follow-up, the investigators in the TOTAL trial do not recommend the systematic use of thrombus aspiration in STEMI, 5 although its role in the cases of certain patients and lesions remains to be defined (Figure 1). The ESTROFA-MI registry, 6 involving patients over 75 years of age, collected retrospective data on the antithrombotic therapy administered to STEMI patients undergoing primary PCI. This registry included 2131 patients: 221 (10.3%) treated with bivalir- udin, 1374 (64.5%) treated with unfractionated heparin only, and 536 (25.2%) treated with abciximab; the mean ages were 81 5, 81.3 4.8, and 79.8 4.0 years, respectively (P 2 according to the BARC (Bleeding Academic Research Consortium) criteria 7 was 0.7%, 1.4%, and 1.0% (P = .8), respectively. On multivariate analysis, none of the strategies proved to be an independent predictor of major cardiac events, although the use of bivalirudin was associated with a lower incidence of cardiac death, without significantly increasing the rate of stent thrombosis. The influence of thrombus aspiration was also analyzed in 2 groups matched for a baseline Thrombolysis In Myocardial Infarction flow grade of 0-1 (560 patients who underwent thrombectomy and 490 who did not), but no significant differences were found in terms of cardiac death, reinfarction, need for repeat revascularization, or stent thrombosis. 6