Bo Lagerqvist1, Ole Fröbert, Göran K Olivecrona, Thórarinn Gudnason, Michael Maeng, Patrik Alström, Jonas Andersson, Fredrik Calais, Jörg Carlsson, Olov Collste, Matthias Götberg, Peter Hårdhammar, Dan Ioanes, Anders Kallryd, Rickard Linder, Anders Lundin, Jacob Odenstedt, Elmir Omerovic, Verner Puskar, Tim Tödt, Eva Zelleroth, Ollie Östlund, Stefan K James. 1. From the Department of Medical Sciences, Cardiology Section, and Uppsala Clinical Research Center, Uppsala University, Uppsala (B.L., O.O., S.K.J.), Department of Cardiology, Örebro University Hospital, Örebro (O.F., F.C.), Department of Coronary Heart Disease, Skane University Hospital, Clinical Sciences Section, Lund University, Lund (G.K.O., M.G., A.L.), Department of Cardiology, Karolinska Institutet, Södersjukhuset (P.A., O.C.), and Department of Cardiology, Karolinska Institutet, Danderyd (R.L.), Stockholm, Department of Cardiology, Umeå University Hospital, Umeå (J.A.), Section of Cardiology, Kalmar County Hospital and Linnaeus University, Kalmar (J.C.), Department of Cardiology, Halmstad Hospital, Halmstad (P.H.), Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., J.O., E.O.), Department of Cardiology, Skaraborgs Hospital, Skövde (A.K.), Department of Radiology, Ryhov Hospital, Jönköping (V.P.), Department of Cardiology, Linköping University Hospital, Linköping (T.T.), and Department of Radiology, Mälarsjukhuset, Eskilstuna (E.Z.) - all in Sweden; Department of Cardiology and Cardiovascular Research Center, Landspitali University Hospital, Reykjavik, Iceland (T.G.); and the Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark (M.M.).
Abstract
BACKGROUND:Routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) has not been proved to reduce short-term mortality. We evaluated clinical outcomes at 1 year after thrombus aspiration. METHODS: We randomly assigned 7244 patients withSTEMI to undergo manual thrombus aspiration followed by PCI or to undergo PCI alone, in a registry-based, randomized clinical trial. The primary end point of all-cause mortality at 30 days has been reported previously. Death from any cause at 1 year was a prespecified secondary end point of the trial. RESULTS: No patients were lost to follow-up. Death from any cause occurred in 5.3% of the patients (191 of 3621 patients) in the thrombus-aspiration group, as compared with 5.6% (202 of 3623) in the PCI-only group (hazard ratio, 0.94; 95% confidence interval [CI], 0.78 to 1.15; P=0.57). Rehospitalization for myocardial infarction at 1 year occurred in 2.7% and 2.7% of the patients, respectively (hazard ratio, 0.97; 95% CI, 0.73 to 1.28; P=0.81), and stent thrombosis in 0.7% and 0.9%, respectively (hazard ratio, 0.84; 95% CI, 0.50 to 1.40; P=0.51). The composite of death from any cause, rehospitalization for myocardial infarction, or stent thrombosis occurred in 8.0% and 8.5% of the patients, respectively (hazard ratio, 0.94; 95% CI, 0.80 to 1.11; P=0.48). The results were consistent across all the major subgroups, including grade of thrombus burden and coronary flow before PCI. CONCLUSIONS: Routine thrombus aspiration before PCI in patients with STEMI did not reduce the rate of death from any cause or the composite of death from any cause, rehospitalization for myocardial infarction, or stent thrombosis at 1 year. (Funded by the Swedish Research Council and others; TASTE ClinicalTrials.gov number, NCT01093404.).
RCT Entities:
BACKGROUND: Routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) has not been proved to reduce short-term mortality. We evaluated clinical outcomes at 1 year after thrombus aspiration. METHODS: We randomly assigned 7244 patients with STEMI to undergo manual thrombus aspiration followed by PCI or to undergo PCI alone, in a registry-based, randomized clinical trial. The primary end point of all-cause mortality at 30 days has been reported previously. Death from any cause at 1 year was a prespecified secondary end point of the trial. RESULTS: No patients were lost to follow-up. Death from any cause occurred in 5.3% of the patients (191 of 3621 patients) in the thrombus-aspiration group, as compared with 5.6% (202 of 3623) in the PCI-only group (hazard ratio, 0.94; 95% confidence interval [CI], 0.78 to 1.15; P=0.57). Rehospitalization for myocardial infarction at 1 year occurred in 2.7% and 2.7% of the patients, respectively (hazard ratio, 0.97; 95% CI, 0.73 to 1.28; P=0.81), and stent thrombosis in 0.7% and 0.9%, respectively (hazard ratio, 0.84; 95% CI, 0.50 to 1.40; P=0.51). The composite of death from any cause, rehospitalization for myocardial infarction, or stent thrombosis occurred in 8.0% and 8.5% of the patients, respectively (hazard ratio, 0.94; 95% CI, 0.80 to 1.11; P=0.48). The results were consistent across all the major subgroups, including grade of thrombus burden and coronary flow before PCI. CONCLUSIONS: Routine thrombus aspiration before PCI in patients with STEMI did not reduce the rate of death from any cause or the composite of death from any cause, rehospitalization for myocardial infarction, or stent thrombosis at 1 year. (Funded by the Swedish Research Council and others; TASTE ClinicalTrials.gov number, NCT01093404.).
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