- Design
- International randomised clinical trial, 55 sites
- Population
- 2,487 men starting androgen deprivation for prostate cancer
- Primary outcome
- Hierarchical composite of CV events and risk-factor control (win ratio)
- Effect
- Win ratio 1.60 (1.42–1.81); CV events sHR 1.08 (0.79–1.49)
This international randomised trial enrolled 2,487 men (mean age 68) at 55 sites who had started, or were about to start, androgen deprivation therapy for prostate cancer. Men already on a statin with systolic pressure of 130 mmHg or lower were excluded. The intervention added referral to an internist or cardiologist who targeted systolic pressure of 130 mmHg or lower, started a statin regardless of cholesterol, and advised on smoking, diet and exercise.
Over a median 5.8 years, the intervention won on a hierarchical composite (win ratio 1.60, 95% CI 1.42–1.81). The win came mostly from total cholesterol 12 mg/dL lower. Blood pressure at close-out barely differed (131 vs 133 mmHg). Cardiovascular death, myocardial infarction, stroke and heart failure did not differ (sHR 1.08, 0.79–1.49).
Men on ADT carry real cardiovascular risk, and this trial shows structured attention improves risk factors. But blanket specialist referral did not prevent events. A more efficient path is for the urology team to check risk factors and hand over to primary care, with statins prescribed by standard risk criteria.
- Assess cardiovascular risk factors in every man starting ADT
- Manage blood pressure and lipids by standard risk criteria, through primary care where possible
- Reserve cardiology referral for established heart disease or uncontrolled risk factors
- Do not assume routine specialist referral will reduce heart attacks or strokes on its own
Why it matters
Separates better risk numbers from fewer heart events, which is what patients care about.
Don't overread it
The composite win was driven by cholesterol; clinical cardiovascular events did not fall.
The statistics, in plain English
A win ratio of 1.60 means that when patients were compared in pairs, the intervention patient fared better more often than worse — but most 'wins' came from cholesterol, the lowest tier of the composite. The hazard ratio for hard events of 1.08, with a confidence interval from 0.79 to 1.49, shows no detectable effect on heart attacks, strokes or deaths.
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