PRIZE
Trial question
What is the role of zibotentan in patients with microvascular angina?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
60.0% female
40.0% male
N = 118
118 patients (71 female, 47 male).
Inclusion criteria: patients with microvascular angina.
Key exclusion criteria: exercise limitation for a noncardiovascular reason; pregnancy; HF; recent MI; disorders of the CNS; significant renal or liver disease.
Interventions
N=59 zibotentan (at a dose of 10 mg daily for 12 weeks).
N=59 placebo (matching placebo daily for 12 weeks).
Primary outcome
Mean exercise duration
124
125
125.0 seconds
93.8 seconds
62.5 seconds
31.3 seconds
0.0 seconds
Zibotentan
Placebo
No significant
difference ↔
No significant difference in mean exercise duration (124 seconds vs. 125 seconds; MD -0.72, 95% CI -3.32 to 1.89).
Secondary outcomes
No significant difference in mean time to 1 mm ST-depression (313 seconds vs. 298 seconds; HR 1.07, 95% CI 0.66 to 1.74).
No significant difference in mean maximum ST-segment deviation (-0.1 mm vs. -0.4 mm; MD 0.29, 95% CI -0.08 to 0.66).
No significant difference in mean Duke Treadmill score (1.7 points vs. 3.5 points; MD -1.78, 95% CI -3.59 to 0.04).
Safety outcomes
Significant difference in adverse events (60.2% vs. 14.4%).
Conclusion
In patients with microvascular angina, zibotentan was not superior to placebo with respect to mean exercise duration.
Reference
Andrew Morrow, Robin Young, George R Abraham et al. Zibotentan in Microvascular Angina: A Randomized, Placebo-Controlled, Crossover Trial. Circulation. 2024 Nov 19;150(21):1671-1683.
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