Abstract 2451: Anti-Ischemic Effects of Ranolazine in Women: Results from the Randomized, Placebo-controlled MERLIN-TIMI 36 Trial
Background: The pathobiologic basis of cardiovascular disease, and thus the response to therapy, can differ between women and men. In prior studies, sex-based treatment differences were observed with ranolazine, with a possibly diminished effect in women. Additionally, it has been proposed that women have similar or possibly more favorable outcomes then men after NSTE ACS.
Methods: We investigated the outcomes over 1 year of women with NSTE ACS randomized to ranolazine or placebo in MERLIN-TIMI 36.
Results: Compared with men (N=4,269), women (N=2,291) were older and had higher rates of diabetes, HTN, prior heart failure, and prior angina (P<0.001). On presentation, women were more likely than men to have ST depression ≥ 0.1 mV (40.9 vs 32.0%, P<0.001) and elevated BNP (47.0 vs 40.2%, P<0.001), yet they were less likely to have evidence of epicardial CAD (no stenosis ≥ 50% on angio: 19.4 vs 8.6%, P<0.001) or elevated troponin (57.1 vs 68.9%, P<0.001). Despite these differences, women were at similar risk for the primary endpoint of CV death, MI, or recurrent ischemia compared with men (adj HR 0.94, 95% CI 0.84 –1.06). Treatment with ranolazine was associated with a significant reduction in recurrent ischemia in women (13.0 vs 18.2%, HR 0.71, 95% CI 0.57– 0.88, P<0.002, Figure⇓). No difference in symptomatic documented arrhythmias was observed in women treated with ranolazine vs placebo (2.6 vs 2.6%, P=0.95).
Conclusions: Women with a clinical syndrome consistent with ACS were less likely than men to have obstructive epicardial CAD but were at a similar risk of CV events, including recurrent ischemia. Notably, our findings provide support for the anti-ischemic efficacy of ranolazine in women.