A Randomized Non-inferiority Study of Low-dose and Standard-dose Ticagrelor After Intervention for Acute Coronary Syndrome

Abstract BackgroundCurrent 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.MethodsThe study is a prospective, multicenter, randomized, open-label, controlled study involving 2120 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, stroke, and bleeding events of grade 2 or higher according to Bleeding Academic Research Consortium [BARC] criteria at one year. The secondary endpoints are bleeding events of grade 2 or higher according to Bleeding Academic Research Consortium [BARC] criteria at one year.DiscussionRecent 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 one week after successful PCI.Trial registrationClinicaltrials.gov, NCT04255602. Registered on 5 February 2020.

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Efficacy and safety of low dose ticagrelor in patients with acute coronary syndrome: a systematic review and meta-analysis

Postgraduate Medical Journal ◽

10.1136/postgradmedj-2019-137180 ◽

2020 ◽

Vol 96 (1141) ◽

pp. 693-702

Author(s):

Qing Chen ◽

Yuanyuan Zhang ◽

Zhen Wang ◽

Shuai Wang ◽

Hao Zhang ◽

...

Keyword(s):

Acute Coronary Syndrome ◽

Platelet Aggregation ◽

Major Bleeding ◽

Low Dose ◽

Standard Dose ◽

Left Ventricular ◽

Efficacy And Safety ◽

Bleeding Events ◽

Coronary Syndrome ◽

Major Bleeding Events

Our aim was to examine clinical trials, provide guidance to practitioners and estimate the efficacy and safety of two agents by comparing low dose ticagrelor with standard dose clopidogrel in patients with acute coronary syndrome. We systematically looked through Pubmed, Embase, the Cochrane Library, Wanfang data and CNKI for trials comparing low dose ticagrelor with standard dose clopidogrel for the treatment of patients with ACS since the database was created. The primary endpoint for efficacy was the rate of major adverse cardiac events (MACEs). The primary endpoint for safety was the rate of major bleeding events. We also evaluated platelet function between low dose ticagrelor and standard dose clopidogrel in ACS patients. From 6744 articles, 16 studies including 1629 patients met the inclusion criteria. In contrast with standard dose clopidogrel, low dose ticagrelor significantly reduced MACEs (OR 0.39, 95% CI 0.26, 0.58) and the difference was statistically significant (p<0.01). No difference was noted for major bleeding events (OR 1.16, 95% CI 0.43, 3.08) between the two agents (p=0.77). In addition, low dose ticagrelor showed lower platelet aggregation rate than clopidogrel (standardised mean difference (SMD) −0.68, 95% CI −0.83 to 0.53) (p<0.01). Platelet reaction units for low dose ticagrelor were much lower than those for standard dose clopidogrel (SMD −2.46, 95% CI −2.85 to −2.07) (p<0.01). In comparison with standard dose clopidogrel, low dose ticagrelor significantly lowered the incidence of MACEs, improved left ventricular ejection fraction, decreased left ventricular end diastolic dimension and did not expand the risk of major bleeding events or minor or minimal bleeding events in ACS patients with a considerable safety and efficacy profile. In addition, low dose ticagrelor was associated with dramatically lower platelet aggregation compared with standard dose clopidogrel.

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