Intensive Blood Pressure Control in Older Patients With Hypertension: 6-Year Results of the STEP Trial
Sustained early intensive systolic BP control reduces cardiovascular events in older hypertensive adults; delaying initiation attenuates benefit. Multicenter randomized controlled trial with extended follow-up; Level 1b (2011 OCEBM).
Background
The durability and timing of benefit from intensive systolic blood pressure targets in older adults have been unclear.
Patients
- 8,511 adults, age 60–80 years, hypertension; China; 42 centers.
- Baseline SBP ~146 mm Hg; groups well balanced.
Intervention
Intensive SBP target 110–<130 mm Hg (sustained from randomization).
Control
Standard SBP target 130–<150 mm Hg during original trial, then switched to intensive in extension (delayed intensive).
Outcome
Primary: composite of stroke, acute coronary syndrome, acute heart failure, coronary revascularization, atrial fibrillation, or cardiovascular death. Safety prespecified (e.g., hypotension).
Follow up period
Median 6.11 years (original trial to Dec 31, 2020; intensive extension Jan 2021–Jul 31, 2023).
Results
| Outcome | Sustained Intensive | Delayed Intensive | Effect (95% CI) | Absolute Difference | NNT/NNH |
|---|---|---|---|---|---|
| Primary composite (primary) | 6.83% | 8.11% | HR 0.82 (0.71–0.96) | −1.28% | NNT 78 (≈6.1 y) |
| Stroke (secondary) | 2.12% | 2.91% | HR 0.72 (0.55–0.94) | −0.79% | NNT 127 |
| Hypotension (safety) | 3.82% | 2.81% | RR 1.36 (1.07–1.72) | +1.01% | NNH 99 |
| Modeled primary risk: start intensive at 0 mo | 7.18% | 8.68% (standard) | RR 0.83 (0.70–0.96) | −1.49% | NNT 68 |
| Modeled primary risk: start at 12 mo | 7.63% | 8.68% (standard) | RR 0.88 (0.76–0.99) | −1.05% | NNT 96 |
Limitations
- Han Chinese cohort; generalizability may be limited.
- Open-label BP targets; potential management bias (endpoints blinded).
- 9% declined extension; selection bias possible.
- g-formula estimates assume no model misspecification.
- No all-cause mortality difference detected; limited power.
Funding
Chinese national and Beijing municipal public grants; minimal commercial bias.
Citation
Song Q, Peng X, Bai J, et al. Intensive Blood Pressure Control in Older Patients With Hypertension: 6-Year Results of the STEP Trial. J Am Coll Cardiol. 2025;86(17):1421–1433. doi:10.1016/j.jacc.2025.06.045.