Abstract 19109: Adverse Limb Events in Patients With Peripheral Artery Disease Presenting With Acute Coronary Syndrome: Observations From SOLID-TIMI 52
Background: While the presence of vascular disease in multiple beds is associated with a well-established risk of major cardiovascular outcomes, the risk of adverse limb events in patients with PAD post-ACS has not been well described.
Methods: SOLID-TIMI 52 randomized 13,026 patients with recent (≤ 30 days) ACS to darapladib or placebo. Major adverse limb events [MALE; acute limb ischemia (ALI), chronic critical limb ischemia (CLI), or new or worsening PAD] and need for peripheral revascularization were analyzed according to baseline PAD. Cox proportional hazard models were adjusted for baseline factors, ACS event, and treatment arm. Median f/u was 2.5 years.
Results: At baseline, 1,088 (8.4%) had known concomitant PAD and 11,921 (91.6%) had no known PAD. In those with PAD compared to those without, 3-yr KM MALE rates were 15.3% and 1.9%, respectively (p<0.001). PAD at baseline was associated with an increased risk of limb endpoints (Figure), including MALE (adj. HR 7.5, 95% CI 5.9-9.4, p<0.001), ALI or CLI (adj. HR 5.5, 95% CI 3.0-9.9; p<0.001), new or worsening PAD (adj. HR 7.6; 95% CI 5.9-9.6; p<0.001), and the need for revascularization (adj. HR 9.8, 95% CI 7.5-12.9; p<0.001). Treatment with darapladib did not reduce MALE or any of its components.
Conclusion: In patients post-ACS, the presence of PAD at baseline is associated with a heightened risk of MALE and peripheral revascularization. Since few therapies are available to prevent limb events, trials evaluating therapies to reduce CV risk after ACS should also examine limb outcomes.
Author Disclosures: C.L. Fanola: None. E. Braunwald: Research Grant; Modest; AstraZeneca, Merck & Co, GSK, Bristol-Myers Squibb, Beckman Coulter, Roche Diagnostics, Pfizer, Sanofi, Johnson & Johnson. Research Grant; Significant; Daiichi Sankyo. Speakers Bureau; Modest; Uncompensated lectures for Merck and CVRx. Consultant/Advisory Board; Modest; Merck (unpaid consultant). Other; Modest; Lecture fees from Eli Lilly, Menarini, Medscape, and Bayer HealthCare. Consulting fees from Sanofi, Genzyme, Amorcyte, the Medicines Company, and Cardiorentis. C.P. Cannon: Research Grant; Significant; Arisaph, AstraZeneca, Bristol-Myers Squibb, Boehringer-Ingelheim, GlaxoSmithKline, Janssen, Merck, Takeda. Consultant/Advisory Board; Modest; Alnylam, Amgen, Arisaph, Boehringer-Ingelheim, Boehringer-Ingelheim/Lilly, Bristol-Myers Squibb, Kowa, Merck, Takeda, Pfizer. Consultant/Advisory Board; Significant; Lipimedix, Regeneron Pharmaceuticals, Inc., Sanofi, GlaxoSmithKline. J. Zhou: None. M.L. O’Donoghue: Research Grant; Modest; Eisai, Merck, and AstraZeneca. Other Research Support; Modest; Institutional support from GlaxoSmithKline. M.P. Bonaca: Research Grant; Modest; Research Grant from AstraZeneca, Institutional support from GlaxoSmithKline.
- © 2016 by American Heart Association, Inc.