老年心肌梗死患者的侵入性治疗策略。
Invasive Treatment Strategy for Older Patients with Myocardial Infarction.
机构信息
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.
出版信息
N Engl J Med. 2024 Nov 7;391(18):1673-1684. doi: 10.1056/NEJMoa2407791. Epub 2024 Sep 1.
BACKGROUND
Whether 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.
METHODS
We 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.
RESULTS
A 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.
CONCLUSIONS
In 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.).
背景
对于年龄在 75 岁及以上的非 ST 段抬高型心肌梗死（NSTEMI）患者，单独采用医学治疗的保守策略与采用医学治疗联合侵入性治疗的策略相比，哪种更有益尚不清楚。
方法
我们开展了一项前瞻性、多中心、随机试验，共纳入英国 48 个地点的年龄在 75 岁及以上的 NSTEMI 患者。将患者按照 1:1 的比例随机分至保守策略组（接受最佳可用的医学治疗）或侵入性策略组（接受冠状动脉造影和血运重建术联合最佳可用的医学治疗）。符合条件的患者为虚弱或存在大量并存疾病的患者。主要终点是心血管原因死亡（心血管死亡）或非致死性心肌梗死的复合终点，采用时间事件分析进行评估。
结果
共有 1518 例患者接受了随机分组；753 例患者分至侵入性策略组，765 例患者分至保守策略组。患者的平均年龄为 82 岁，45%为女性，32%为虚弱患者。侵入性策略组中有 193 例（25.6%）患者发生主要终点事件，保守策略组中有 201 例（26.3%）患者发生主要终点事件（风险比为 0.94；95%置信区间为 0.77 至 1.14；P=0.53）。中位随访 4.1 年后，侵入性策略组中有 15.8%的患者发生心血管死亡，保守策略组中有 14.2%的患者发生心血管死亡（风险比为 1.11；95%置信区间为 0.86 至 1.44）。侵入性策略组中有 11.7%的患者发生非致死性心肌梗死，保守策略组中有 15.0%的患者发生非致死性心肌梗死（风险比为 0.75；95%置信区间为 0.57 至 0.99）。不到 1%的患者发生了手术并发症。
结论
在中位随访 4.1 年后，与保守策略相比，对于年龄在 75 岁及以上的 NSTEMI 患者，采用侵入性策略并未显著降低心血管死亡或非致死性心肌梗死（复合主要终点）的风险。（英国心脏基金会资助；BHF SENIOR-RITA ISRCTN 注册号：ISRCTN85425642。）
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