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Randomized Controlled Trial Multicenter Study Comparative Study
Invasive Treatment Strategy for Older Patients with Myocardial Infarction.
- Vijay Kunadian, Helen Mossop, Carol Shields, Michelle Bardgett, Philippa Watts, M Dawn Teare, Jonathan Pritchard, Jennifer Adams-Hall, Craig Runnett, David P Ripley, Justin Carter, Julie Quigley, Justin Cooke, David Austin, Jerry Murphy, Damian Kelly, James McGowan, Murugapathy Veerasamy, Dirk Felmeden, Hussain Contractor, Sanjay Mutgi, John Irving, Steven Lindsay, Gavin Galasko, Kelvin Lee, Ayyaz Sultan, Amardeep G Dastidar, Shazia Hussain, Iftikhar Ul Haq, Mark de Belder, Martin Denvir, Marcus Flather, Robert F Storey, David E Newby, Stuart J Pocock, FoxKeith A AKAAFrom the Translational and Clinical Research Institute, Faculty of Medical Sciences (V.K.), the Population Health Sciences Institute (H.M., M.D.T.), and the Newcastle Clinical Trials Unit (C.S., M. Bardgett, P.W., M.D.T., J.P.), Newcastle U, and British Heart Foundation SENIOR-RITA Trial Team and Investigators.
- From the Translational and Clinical Research Institute, Faculty of Medical Sciences (V.K.), the Population Health Sciences Institute (H.M., M.D.T.), and the Newcastle Clinical Trials Unit (C.S., M. Bardgett, P.W., M.D.T., J.P.), Newcastle University, and the Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust (V.K., J.A.H., I.U.H.), Newcastle upon Tyne; Northumbria Healthcare NHS Foundation Trust, Cramlington (C.R., D.P.R.); the Faculty of Health Sciences and Wellbeing, School of Medicine, University of Sunderland Medical School, Sunderland (D.P.R.); North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (J. Carter, J.Q.); Chesterfield Royal Hospital, Chesterfield (J. Cooke); South Tees NHS Foundation Trust, Middlesbrough (D.A.); County Darlington and Durham NHS Foundation Trust, Darlington (J. Murphy); Royal Derby Hospital, Derby (D.K.); University Hospital Ayr, Ayr (J. McGowan); Leeds Teaching Hospital NHS Trust, Leeds (M.V.); Torbay and South Devon NHS Foundation Trust, Torquay (D.F.); Manchester University NHS Foundation Trust, Manchester (H.C.); Epsom and St. Helier University Hospitals, Epsom (S.M.); Ninewells Hospital, Dundee (J.I.); Bradford Royal Infirmary, Bradford (S.L.); Blackpool Victoria Hospital, Blackpool (G.G.); United Lincolnshire Hospitals NHS Trust, Lincoln (K.L.); Wrightington Wigan and Leigh Teaching Hospitals NHS Foundation Trust, Wigan (A.S.); North Bristol NHS Trust, Bristol (A.G.D.); University Hospital of Leicester NHS Trust, Leicester (S.H.); Barts Health NHS Trust (M. Belder) and London School of Hygiene and Tropical Medicine (S.J.P.), London; the Centre for Cardiovascular Science, University of Edinburgh, Edinburgh (M.D., D.E.N., K.A.A.F.); Norwich Medical School, University of East Anglia, Norwich (M.F.); and Sheffield Teaching Hospital, Sheffield (R.F.S.) - all in the United Kingdom.
- N. Engl. J. Med. 2024 Nov 7; 391 (18): 167316841673-1684.
BackgroundWhether a conservative strategy of medical therapy alone or a strategy of medical therapy plus invasive treatment is more beneficial in older adults with non-ST-segment elevation myocardial infarction (NSTEMI) remains unclear.MethodsWe conducted a prospective, multicenter, randomized trial involving patients 75 years of age or older with NSTEMI at 48 sites in the United Kingdom. The patients were assigned in a 1:1 ratio to a conservative strategy of the best available medical therapy or an invasive strategy of coronary angiography and revascularization plus the best available medical therapy. Patients who were frail or had a high burden of coexisting conditions were eligible. The primary outcome was a composite of death from cardiovascular causes (cardiovascular death) or nonfatal myocardial infarction assessed in a time-to-event analysis.ResultsA total of 1518 patients underwent randomization; 753 patients were assigned to the invasive-strategy group and 765 to the conservative-strategy group. The mean age of the patients was 82 years, 45% were women, and 32% were frail. A primary-outcome event occurred in 193 patients (25.6%) in the invasive-strategy group and 201 patients (26.3%) in the conservative-strategy group (hazard ratio, 0.94; 95% confidence interval [CI], 0.77 to 1.14; P = 0.53) over a median follow-up of 4.1 years. Cardiovascular death occurred in 15.8% of the patients in the invasive-strategy group and 14.2% of the patients in the conservative-strategy group (hazard ratio, 1.11; 95% CI, 0.86 to 1.44). Nonfatal myocardial infarction occurred in 11.7% in the invasive-strategy group and 15.0% in the conservative-strategy group (hazard ratio, 0.75; 95% CI, 0.57 to 0.99). Procedural complications occurred in less than 1% of the patients.ConclusionsIn older adults with NSTEMI, an invasive strategy did not result in a significantly lower risk of cardiovascular death or nonfatal myocardial infarction (the composite primary outcome) than a conservative strategy over a median follow-up of 4.1 years. (Funded by the British Heart Foundation; BHF SENIOR-RITA ISRCTN Registry number, ISRCTN11343602.).Copyright © 2024 Massachusetts Medical Society.
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