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Are coronary revascularization and myocardial infarction a homogeneous combined endpoint in hypertension trials? The Losartan Intervention For Endpoint reduction in hypertension study

Cicala, Silvanaa,b; de Simone, Giovannia,b; Gerdts, Evac; Dahlöf, Björnd; Lindholm, Lars He; Kjeldsen, Sverre Ef; Devereux, Richard Ba

doi: 10.1097/HJH.0b013e328337a9c8
Original papers: Trials

Objective Construction of prognostically relevant endpoints for clinical trials in hypertension has increasingly included coronary revascularization with myocardial infarction (MI) as manifestations of coronary artery disease. However, whether coronary revascularization and MI predict other cardiovascular events similarly is unknown.

Methods We examined risks of cardiovascular death, all-cause death, and stroke following MI or coronary revascularization in hypertensive patients with left ventricular hypertrophy (LVH) enrolled in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE). We studied 9113 patients after excluding those who died within 7 days after MI or underwent coronary revascularization within 24 h after MI.

Results In multivariate Cox regression adjusting for participating countries, time-varying systolic blood pressure, and Framingham risk score, hazard ratios for cardiovascular death, all-cause death, and stroke were, respectively, 4.5 (P < 0.0001), 2.9 (P < 0.0001), and 1.9 (P = 0.003) in 321 patients with MI as first event. In similar models, coronary revascularization as first event (n = 202) was not associated with increased risks of cardiovascular death, all-cause death, and stroke (P = 0.06–0.86).

Conclusion During follow-up of hypertensive patients with LVH, occurrence of MI but not coronary revascularization as first cardiovascular event significantly increased risk of subsequent cardiovascular death, all-cause death, and stroke. In view of differences in prognostic implications, when the goal is to have a prognostically relevant composite endpoint for trials in hypertensive patients, caution should be used in combining coronary revascularization with MI.

aDivision of Cardiology, Weill Cornell Medical College, New York, New York, USA

bDepartment of Clinical and Experimental Medicine, Federico II University of Naples, Naples, Italy

cInstitute of Medicine, University of Bergen and Haukeland University Hospital, Bergen, Norway

dDepartment of Medicine, Sahlgrenska University Hospital/Östra, University of Göteborg, Gothenburg, Sweden

eDepartment of Public Health and Clinical Medicine, Umeå University, Umea, Sweden

fUllevål University Hospital, Oslo, Norway

Received 12 June, 2009

Revised 26 November, 2009

Accepted 18 January, 2010

Correspondence to Dr Richard B. Devereux, MD, Greenberg Division of Cardiology, The New York Presbyterian Hospital–Weill Medical College of Cornell University, 525 East 68th Street, New York, NY 10021, USA Tel: +1 212 746 4655; fax: +1 212 746 8561; e-mail:

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