Aortic & peripheral vascular diseaseSecondary analysis
Bempedoic Acid and First and Recurrent Limb Outcomes in Statin-Intolerant Patients With Peripheral Artery Disease: Insights From the CLEAR Outcomes Trial
- Secondary analysis of the CLEAR Outcomes randomised trial
- blinded adjudication of major adverse limb events (MALE)
- PAD subgroup
Authors' conclusion
Patients with PAD are at high risk of MALE and MACE. Bempedoic acid reduces both MACE and MALE in patients with atherosclerotic vascular disease, with notable absolute benefits in patients with PAD.
Study context
- Population
- Statin-intolerant patients with PAD at baseline in the CLEAR Outcomes trialPAD subgroup of 13,970
- Participants
- 1,624 patients
- Comparison
- Bempedoic acid vs placebo
- Primary endpoint
- MACE-4 (trial primary end point): CV death, nonfatal MI, nonfatal stroke or coronary revascularization
Primary result
As reported in the abstract
MALE in patients with PAD · median 40.6 months
Placebo
8.3%
69 events
Bempedoic acid vs PlaceboEstimate (95% CI)P value
first MALE
HR 0.64(0.44–0.93)
P = 0.018total MALE
RR 0.55(0.35–0.85)
P = 0.007Further findings
First MACE-4 or MALE, overall and by PAD (subgroup)
- Overall: HR (95% CI), 13% reduction
- 0.87 (0.80-0.95)
- With PAD: HR (95% CI), not statistically significant
- 0.82 (0.64-1.04)
- Without PAD: HR
- 0.87 (0.79-0.86) (95% CI)
- Pinteraction=NS
Total MACE-4 or MALE, overall and by PAD (subgroup)
- Overall: RR
- 0.81 (0.73-0.90) (95% CI)
- With PAD: RR
- 0.71 (0.54-0.95) (95% CI)
- Without PAD: RR
- 0.82 (0.73-0.92) (95% CI)
- Pinteraction=NS
Original publication
Bempedoic Acid and First and Recurrent Limb Outcomes in Statin-Intolerant Patients With Peripheral Artery Disease: Insights From the CLEAR Outcomes Trial. Circulation. Published 18 August 2026. doi:10.1161/circulationaha.125.078469
Summarised from the published abstract; every number is checked against it