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Randomised Placebo-Controlled Pilot Trial Evaluating the Anti-Anginal Efficacy of Ticagrelor in Patients with Angina
Sivabaskari Pasupathy1,2,3,4, Rosanna Tavella1,2,3, Christopher Zeitz1,2,3
1School of Medicine, Faculty of Health and Medical Sciences, The University of Adelaide, Adelaide, SA 5000, Australia.
Insights
Ticagrelor did not significantly reduce angina episodes in patients with coronary slow flow phenomenon (CSFP) and refractory angina. This study found no improvement in angina symptoms or nitrate use compared to placebo.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Coronary slow flow phenomenon (CSFP) presents with delayed contrast passage in coronary arteries without obstructive disease.
- Patients with CSFP experience recurrent angina, lacking effective evidence-based therapies.
- Ticagrelor's potential anti-anginal effects via adenosine-mediated vasodilation were investigated.
Purpose of the Study:
- To assess the anti-anginal efficacy of ticagrelor 90 mg twice daily in patients with refractory angina and CSFP.
- To evaluate ticagrelor's impact on spontaneous angina episodes and related outcomes.
Main Methods:
- A randomized, double-blind, placebo-controlled, cross-over trial involving 20 patients with refractory angina and CSFP.
- Four-week treatment periods with ticagrelor or placebo, with angina episode frequency as the primary endpoint.
- Secondary endpoints included angina severity, duration, nitrate consumption, and health status (SAQ, SF-36).
Main Results:
- Ticagrelor did not significantly reduce the frequency of angina episodes compared to placebo (p > 0.05).
- No significant improvements were observed in angina severity, duration, nitrate consumption, or health status scores.
- No serious adverse events related to ticagrelor were reported.
Conclusions:
- Ticagrelor was not effective in reducing angina episodes or nitrate use in CSFP patients refractory to standard therapy.
- Larger clinical trials are needed to further confirm any potential benefits of ticagrelor in this patient population.
Abstract:
Background: The coronary slow flow phenomenon (CSFP) is an angiographic finding characterised by the delayed passage of contrast through the coronary arteries, despite the absence of obstructive coronary artery disease (defined as less than 50% narrowing of the vessel lumen). Patients with the CSFP experience recurrent angina, for which there are limited evidence-based therapies. Ticagrelor may serve as an effective anti-anginal therapy for these patients by increasing adenosine levels, which could alleviate coronary microvascular dysfunction and its associated angina due to its vasodilatory properties. This study aimed to determine the anti-anginal efficacy of ticagrelor 90 mg taken twice daily on spontaneous angina episodes in patients with refractory angina (i.e., episodes ≥3/week despite two anti-anginals) and documented CSFP. Methods: In a randomised, double-blind, placebo-controlled, cross-over trial, the anti-anginal efficacy of a 4-week ticagrelor therapy regimen was evaluated in 20 patients with refractory angina (mean age 61.5 ± 10.5 years; 40% women) who had documented slow coronary flow. The primary endpoint was the frequency of angina episodes, recorded using an angina diary. Secondary endpoints included the duration and severity of angina episodes, consumption of short-acting nitrates, and health status evaluations using the Seattle Angina Questionnaire (SAQ) and the Short Form-36 (SF-36) indices. Results: During the four weeks of therapy, ticagrelor did not significantly improve angina symptoms compared to the placebo (placebo 25.7 (16.7)) vs. ticagrelor 19.8 (18.1), p > 0.05). Furthermore, it did not impact other patient-related outcome measures, including angina severity, duration, frequency of prolonged angina episodes, nitrate consumption, or the SAQ/SF-36 health outcome indices. No serious adverse events related to the study drug were observed. Conclusions: In patients with documented CSFP who were unresponsive to standard anti-anginal therapy, ticagrelor did not reduce the frequency of spontaneous angina episodes or the consumption of nitrates. Further confirmation of the potential benefits of this therapy may be obtained through a larger clinical trial.
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