PMID- 25853743 OWN - NLM STAT- MEDLINE DCOM- 20150414 LR - 20220419 IS - 1533-4406 (Electronic) IS - 0028-4793 (Print) IS - 0028-4793 (Linking) VI - 372 IP - 15 DP - 2015 Apr 9 TI - Randomized trial of primary PCI with or without routine manual thrombectomy. PG - 1389-98 LID - 10.1056/NEJMoa1415098 [doi] AB - 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.). FAU - Jolly, Sanjit S AU - Jolly SS AD - 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.); Universite Paris-Diderot, Sorbonne Paris-Cite, INSERM Unite 1148, Hopital Bichat, Assistance Publique-Hopitaux 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, Sao 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 FAU - Cairns, John A AU - Cairns JA FAU - Yusuf, Salim AU - Yusuf S FAU - Meeks, Brandi AU - Meeks B FAU - Pogue, Janice AU - Pogue J FAU - Rokoss, Michael J AU - Rokoss MJ FAU - Kedev, Sasko AU - Kedev S FAU - Thabane, Lehana AU - Thabane L FAU - Stankovic, Goran AU - Stankovic G FAU - Moreno, Raul AU - Moreno R FAU - Gershlick, Anthony AU - Gershlick A FAU - Chowdhary, Saqib AU - Chowdhary S FAU - Lavi, Shahar AU - Lavi S FAU - Niemela, Kari AU - Niemela K FAU - Steg, Philippe Gabriel AU - Steg PG FAU - Bernat, Ivo AU - Bernat I FAU - Xu, Yawei AU - Xu Y FAU - Cantor, Warren J AU - Cantor WJ FAU - Overgaard, Christopher B AU - Overgaard CB FAU - Naber, Christoph K AU - Naber CK FAU - Cheema, Asim N AU - Cheema AN FAU - Welsh, Robert C AU - Welsh RC FAU - Bertrand, Olivier F AU - Bertrand OF FAU - Avezum, Alvaro AU - Avezum A FAU - Bhindi, Ravinay AU - Bhindi R FAU - Pancholy, Samir AU - Pancholy S FAU - Rao, Sunil V AU - Rao SV FAU - Natarajan, Madhu K AU - Natarajan MK FAU - ten Berg, Jurrien M AU - ten Berg JM FAU - Shestakovska, Olga AU - Shestakovska O FAU - Gao, Peggy AU - Gao P FAU - Widimsky, Petr AU - Widimsky P FAU - Dzavik, Vladimir AU - Dzavik V CN - TOTAL Investigators LA - eng SI - ClinicalTrials.gov/NCT01149044 GR - 119992-1/Canadian Institutes of Health Research/Canada PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20150316 PL - United States TA - N Engl J Med JT - The New England journal of medicine JID - 0255562 SB - IM CIN - N Engl J Med. 2015 Apr 9;372(15):1464-5. PMID: 25853751 CIN - Ann Intern Med. 2015 Jun 16;162(12):JC2. PMID: 26075779 CIN - Dtsch Med Wochenschr. 2015 May;140(10):711. PMID: 26171475 CIN - N Engl J Med. 2015 Aug 13;373(7):682-3. PMID: 26267630 CIN - N Engl J Med. 2015 Aug 13;373(7):680. PMID: 26267631 CIN - N Engl J Med. 2015 Aug 13;373(7):680-1. PMID: 26267632 CIN - N Engl J Med. 2015 Aug 13;373(7):681. PMID: 26267633 CIN - N Engl J Med. 2015 Aug 13;373(7):681-2. PMID: 26267634 CIN - N Engl J Med. 2015 Aug 13;373(7):682. PMID: 26267635 MH - Aged MH - Cardiovascular Diseases/mortality/prevention & control MH - Combined Modality Therapy/adverse effects MH - Coronary Thrombosis/complications/*therapy MH - Electrocardiography MH - Female MH - Heart Failure/etiology MH - Humans MH - Kaplan-Meier Estimate MH - Male MH - Microvessels MH - Middle Aged MH - Myocardial Infarction/complications/*therapy MH - *Percutaneous Coronary Intervention/adverse effects MH - Stroke/etiology MH - *Thrombectomy/adverse effects PMC - PMC4995102 MID - CAMS5774 OID - NLM: CAMS5774 FIR - Rahman, A IR - Rahman A FIR - Bhindi, R IR - Bhindi R FIR - Weaver, J IR - Weaver J FIR - Lang, I IR - Lang I FIR - Pourbaix, S IR - Pourbaix S FIR - Tebet, M IR - Tebet M FIR - Kormann, A IR - Kormann A FIR - Zago, A IR - Zago A FIR - Caramori, P IR - Caramori P FIR - Lima, V IR - Lima V FIR - dos Santos, M IR - dos Santos M FIR - Abizaid, A IR - Abizaid A FIR - Jolly, S IR - Jolly S FIR - Fung, A IR - Fung A FIR - Cheema, A IR - Cheema A FIR - Bertrand, O IR - Bertrand O FIR - Dzavik, V IR - Dzavik V FIR - Kassam, S IR - Kassam S FIR - Della Siega, A IR - Della Siega A FIR - Cieza, T IR - Cieza T FIR - Lavi, S IR - Lavi S FIR - Nadeem, S IR - Nadeem S FIR - Welsh, R W IR - Welsh RW FIR - Cantor, W IR - Cantor W FIR - Bilodeau, L IR - Bilodeau L FIR - Leung, R IR - Leung R FIR - Charania, J IR - Charania J FIR - Xu, Y IR - Xu Y FIR - Qiu, J IR - Qiu J FIR - Liu, S IR - Liu S FIR - Luo, Haiming IR - Luo H FIR - Hajek, P IR - Hajek P FIR - Kocka, V IR - Kocka V FIR - Cervinka, P IR - Cervinka P FIR - Horak, D IR - Horak D FIR - Niemela, K IR - Niemela K FIR - Romppanen, H IR - Romppanen H FIR - Sideris, G IR - Sideris G FIR - Steg, P G IR - Steg PG FIR - Delarche, N IR - Delarche N FIR - Schiele, F IR - Schiele F FIR - Marliere, S IR - Marliere S FIR - Werner, N IR - Werner N FIR - Naber, C K IR - Naber CK FIR - Greif, M IR - Greif M FIR - Torzewski, J IR - Torzewski J FIR - Alexopoulos, D IR - Alexopoulos D FIR - Ziakas, A IR - Ziakas A FIR - Ungi, I IR - Ungi I FIR - Merkely, B IR - Merkely B FIR - Kedev, S IR - Kedev S FIR - ten Berg, J M IR - ten Berg J FIR - Devlin, G IR - Devlin G FIR - Stankovic, G IR - Stankovic G FIR - Kim, W IR - Kim W FIR - Shin, W IR - Shin W FIR - Jeong, M IR - Jeong M FIR - Kim, S IR - Kim S FIR - Ferre, J Mauri IR - Ferre J FIR - Vazquez, N IR - Vazquez N FIR - del Blanco, B Garcia IR - del Blanco B FIR - Bethencourt, A IR - Bethencourt A FIR - Moreno-Gomez, R IR - Moreno-Gomez R FIR - Romo, A Iniguez IR - Romo A FIR - Escaned, J IR - Escaned J FIR - Tizon-Marcos, H IR - Tizon-Marcos H FIR - Gershlick, A IR - Gershlick A FIR - Chowdhary, S IR - Chowdhary S FIR - Jain, A IR - Jain A FIR - Curzen, N IR - Curzen N FIR - El-Omar, M IR - El-Omar M FIR - Seddon, M IR - Seddon M FIR - Shannon, J IR - Shannon J FIR - Oliver, R IR - Oliver R FIR - Gunn, J IR - Gunn J FIR - Hetherington, S IR - Hetherington S FIR - Grosser, K IR - Grosser K FIR - Glover, J IR - Glover J FIR - Patel, N IR - Patel N FIR - Sarembock, I IR - Sarembock I FIR - Blankenship, J IR - Blankenship J FIR - Lasorda, D IR - Lasorda D FIR - Sheldon, M IR - Sheldon M FIR - Pancholy, S IR - Pancholy S FIR - Devireddy, C IR - Devireddy C FIR - Singh, S IR - Singh S EDAT- 2015/04/09 06:00 MHDA- 2015/04/15 06:00 PMCR- 2016/08/23 CRDT- 2015/04/09 06:00 PHST- 2015/04/09 06:00 [entrez] PHST- 2015/04/09 06:00 [pubmed] PHST- 2015/04/15 06:00 [medline] PHST- 2016/08/23 00:00 [pmc-release] AID - 10.1056/NEJMoa1415098 [doi] PST - ppublish SO - N Engl J Med. 2015 Apr 9;372(15):1389-98. doi: 10.1056/NEJMoa1415098. Epub 2015 Mar 16.