Ole Fröbert1, Bo Lagerqvist, Göran K Olivecrona, Elmir Omerovic, Thorarinn Gudnason, Michael Maeng, Mikael Aasa, Oskar Angerås, Fredrik Calais, Mikael Danielewicz, David Erlinge, Lars Hellsten, Ulf Jensen, Agneta C Johansson, Amra Kåregren, Johan Nilsson, Lotta Robertson, Lennart Sandhall, Iwar Sjögren, Ollie Ostlund, Jan Harnek, Stefan K James. 1. From the Department of Cardiology, Örebro University Hospital, Örebro (O.F., F.C.), Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala (B.L., O.O., S.K.J.), Department of Cardiology, Lund University Hospital, Lund (G.K.O., D.E., J.H.), Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (E.O., O.A.), Department of Cardiology, Karolinska Institutet, Sodersjukhuset (M.A.), and Cardiology Unit, Department of Medicine, Karolinska University Hospital (U.J.), Stockholm, Department of Cardiology, Karlstad Hospital, Karlstad (M.D.), Department of Cardiology, Gävle Hospital, Gävle (L.H.), PCI Unit, Sunderby Hospital, Sunderby (A.C.J.), Department of Cardiology, Västerås Hospital, Västerås (A.K.), Department of Cardiology, Heart Center, Umea University, Umea (J.N.), Department of Cardiology, Borås Hospital, Borås (L.R.), Department of Radiology, Helsingborg Hospital, Helsingborg (L.S.), and Department of Cardiology, Falun Hospital, Falun (I.S.) - all in Sweden; Department of Cardiology and Cardiovascular Research Center, Landspitali University Hospital of Iceland, Reykjavik, Iceland (T.G.); and Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark (M.M.).
Abstract
BACKGROUND: The clinical effect of routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) is uncertain. We aimed to evaluate whether thrombus aspiration reduces mortality. METHODS: We conducted a multicenter, prospective, randomized, controlled, open-label clinical trial, with enrollment of patients from the national comprehensive Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and end points evaluated through national registries. A total of 7244 patients with STEMI undergoing PCI were randomly assigned to manual thrombus aspiration followed by PCI or to PCI only. The primary end point was all-cause mortality at 30 days. RESULTS: No patients were lost to follow-up. Death from any cause occurred in 2.8% of the patients in the thrombus-aspiration group (103 of 3621), as compared with 3.0% in the PCI-only group (110 of 3623) (hazard ratio, 0.94; 95% confidence interval [CI], 0.72 to 1.22; P=0.63). The rates of hospitalization for recurrent myocardial infarction at 30 days were 0.5% and 0.9% in the two groups, respectively (hazard ratio, 0.61; 95% CI, 0.34 to 1.07; P=0.09), and the rates of stent thrombosis were 0.2% and 0.5%, respectively (hazard ratio, 0.47; 95% CI, 0.20 to 1.02; P=0.06). There were no significant differences between the groups with respect to the rate of stroke or neurologic complications at the time of discharge (P=0.87). The results were consistent across all major prespecified subgroups, including subgroups defined according to thrombus burden and coronary flow before PCI. CONCLUSIONS: Routine thrombus aspiration before PCI as compared with PCI alone did not reduce 30-day mortality among patients with STEMI. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT01093404.).
RCT Entities:
BACKGROUND: The clinical effect of routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) is uncertain. We aimed to evaluate whether thrombus aspiration reduces mortality. METHODS: We conducted a multicenter, prospective, randomized, controlled, open-label clinical trial, with enrollment of patients from the national comprehensive Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and end points evaluated through national registries. A total of 7244 patients with STEMI undergoing PCI were randomly assigned to manual thrombus aspiration followed by PCI or to PCI only. The primary end point was all-cause mortality at 30 days. RESULTS: No patients were lost to follow-up. Death from any cause occurred in 2.8% of the patients in the thrombus-aspiration group (103 of 3621), as compared with 3.0% in the PCI-only group (110 of 3623) (hazard ratio, 0.94; 95% confidence interval [CI], 0.72 to 1.22; P=0.63). The rates of hospitalization for recurrent myocardial infarction at 30 days were 0.5% and 0.9% in the two groups, respectively (hazard ratio, 0.61; 95% CI, 0.34 to 1.07; P=0.09), and the rates of stent thrombosis were 0.2% and 0.5%, respectively (hazard ratio, 0.47; 95% CI, 0.20 to 1.02; P=0.06). There were no significant differences between the groups with respect to the rate of stroke or neurologic complications at the time of discharge (P=0.87). The results were consistent across all major prespecified subgroups, including subgroups defined according to thrombus burden and coronary flow before PCI. CONCLUSIONS: Routine thrombus aspiration before PCI as compared with PCI alone did not reduce 30-day mortality among patients with STEMI. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT01093404.).
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