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N Engl J Med. 2015 Apr 9;372(15):1389-98. doi: 10.1056/NEJMoa1415098. Epub 2015 Mar 16.

Randomized trial of primary PCI with or without routine manual thrombectomy.

Author information

1
From the Population Health Research Institute and Department of Medicine, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.S.J., S.Y., B.M., J.P., M.J.R., L.T., M.K.N., O.S., P.G.), University of British Columbia, Vancouver (J.A.C.), London Health Sciences Centre, Department of Medicine, London, ON (S.L.), Southlake Regional Health Centre, Newmarket, ON (W.J.C.), Peter Munk Cardiac Centre, University Health Network (C.B.O., V.D.), and St. Michael's Hospital (A.N.C.), Toronto, Mazankowski Alberta Heart Institute, Department of Medicine, Edmonton (R.C.W.), and Quebec Heart-Lung Institute, Laval University, Quebec, QC (O.F.B.) - all in Canada; University Clinic of Cardiology, Sts. Cyril and Methodius University, Skopje, Macedonia (S.K.); Clinical Center of Serbia and Department of Cardiology, Medical Faculty, University of Belgrade, Belgrade, Serbia (G.S.); University Hospital La Paz, Madrid (R.M.); University Hospitals of Leicester, Department of Cardiovascular Sciences, Leicester (A.G.), and University Hospitals South Manchester, Manchester Academic Health Science Centre, Manchester (S.C.) - both in the United Kingdom; Heart Center, Tampere University Hospital, Tampere, Finland (K.N.); Université Paris-Diderot, Sorbonne Paris-Cité, INSERM Unité 1148, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris (P.G.S.); University Hospital and Faculty of Medicine Pilsen, Pilsen (I.B.), and the Third Faculty of Medicine, Charles University Prague, University Hospital Kralovske Vinohrady, Prague (P.W.) - both in the Czech Republic; the Tenth People's Hospital, Tongji University, Shanghai, China (Y.X.); Department of Cardiology and Angiology, Contilla Heart and Vascular Center, Elisabeth-Krankenhaus, Essen, Germany (C.K.N.); Dante Pazzanese Institute of Cardiology, São Paulo (A.A.); Royal North Shore Hospital, Sydney (R.B.); Northeast Clinical Trials Group, Scranton, PA (S.P.); Duke Clinical Research Institute, Durham, NC (S.V.R.); and Department

Abstract

BACKGROUND:

During primary percutaneous coronary intervention (PCI), manual thrombectomy may reduce distal embolization and thus improve microvascular perfusion. Small trials have suggested that thrombectomy improves surrogate and clinical outcomes, but a larger trial has reported conflicting results.

METHODS:

We randomly assigned 10,732 patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI to a strategy of routine upfront manual thrombectomy versus PCI alone. The primary outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within 180 days. The key safety outcome was stroke within 30 days.

RESULTS:

The primary outcome occurred in 347 of 5033 patients (6.9%) in the thrombectomy group versus 351 of 5030 patients (7.0%) in the PCI-alone group (hazard ratio in the thrombectomy group, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P=0.86). The rates of cardiovascular death (3.1% with thrombectomy vs. 3.5% with PCI alone; hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P=0.34) and the primary outcome plus stent thrombosis or target-vessel revascularization (9.9% vs. 9.8%; hazard ratio, 1.00; 95% CI, 0.89 to 1.14; P=0.95) were also similar. Stroke within 30 days occurred in 33 patients (0.7%) in the thrombectomy group versus 16 patients (0.3%) in the PCI-alone group (hazard ratio, 2.06; 95% CI, 1.13 to 3.75; P=0.02).

CONCLUSIONS:

In patients with STEMI who were undergoing primary PCI, routine manual thrombectomy, as compared with PCI alone, did not reduce the risk of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA class IV heart failure within 180 days but was associated with an increased rate of stroke within 30 days. (Funded by Medtronic and the Canadian Institutes of Health Research; TOTAL ClinicalTrials.gov number, NCT01149044.).

PMID:
25853743
PMCID:
PMC4995102
DOI:
10.1056/NEJMoa1415098
[Indexed for MEDLINE]
Free PMC Article

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