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A randomized non-inferiority study of low-dose and standard-dose ticagrelor after intervention for acute coronary
Yanan Pang1, Minglu Ma1, Jiachun Xia1
1The Department of Cardiology, Institute of Cardiovascular Diseases, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, 200336, Shanghai, China.
Insights
This study investigates if a lower dose of ticagrelor with aspirin is as effective as standard dual antiplatelet therapy for acute coronary syndrome patients after PCI, aiming to reduce bleeding risks.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Current guidelines recommend 12 months of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS).
- Long-term DAPT increases bleeding risk, necessitating optimized antiplatelet strategies.
- An optimal strategy balancing ischemic event prevention and reduced bleeding risk is needed.
Purpose of the Study:
- To compare the efficacy and safety of low-dose versus standard-dose ticagrelor combined with aspirin in Chinese ACS patients post-PCI.
- To determine if a reduced ticagrelor dose can maintain anti-ischemic effects while lowering bleeding risk.
Main Methods:
- A prospective, multicenter, randomized, open-label, controlled study involving 2090 ACS patients in China.
- Patients received aspirin and ticagrelor for 1 week, then were randomized to low-dose or standard-dose ticagrelor.
- Primary endpoint: composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, repeat revascularization, and stroke. Secondary endpoints included bleeding events (BARC grade ≥2).
Main Results:
- Primary and secondary endpoint data are pending collection and analysis.
- The study is designed to provide robust evidence on the comparative effectiveness and safety of the two treatment arms.
Conclusions:
- Previous studies suggest ticagrelor monotherapy can reduce bleeding without increasing ischemic events.
- The TIGER study will clarify if low-dose ticagrelor plus aspirin offers a superior risk-benefit profile compared to standard DAPT in Chinese ACS patients.
- This research addresses a critical clinical question regarding antiplatelet therapy optimization post-PCI.
Background:
Current guidelines recommend that patients with acute coronary syndrome (ACS) who have successfully undergone percutaneous coronary intervention (PCI) should continue to use dual antiplatelet therapy (DAPT) for 12 months. The long-term use of standard-dose dual antiplatelet therapy will increase the risk of bleeding. An optimized antiplatelet strategy that can prevent ischemic events and reduce the risk of bleeding remains to be explored.
Methods:
The study is a prospective, multicenter, randomized, open-label, controlled study involving 2090 patients from six clinical centers in China. Through the interactive web response system (IWRS), ACS patients undergoing successful PCI will be randomly divided into the low-dose ticagrelor group or the normal-dose ticagrelor group, after taking 100 mg aspirin and 90 mg ticagrelor bid for 1 week. The primary endpoint is a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, repeat revascularization, and stroke. The secondary endpoints are bleeding events of grade 2 or higher according to Bleeding Academic Research Consortium [BARC] criteria, cardiovascular death, acute myocardium infarction, and coronary revascularization at 1 year.
Discussion:
Recent studies have confirmed that 90 mg ticagrelor alone can safely and effectively reduce bleeding without increasing ischemic events of patients with ACS after PCI. Compared with standard-dose DAPT, whether low-dose ticagrelor combined with aspirin can ensure the anti-ischemic effect while reducing the bleeding risk remains unclear in Chinese patients. The TIGER study will be the first large-scale, multicenter study to compare the efficacy and safety of low-dose and standard-dose ticagrelor combined with aspirin in ACS patients 1 week after successful PCI.
Trial Registration:
Clinicaltrials.gov NCT04255602. Registered on 5 February 2020.
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