Key result
Ticagrelor shows no efficacy benefit over clopidogrel but increases bleeding by ~76%.
Why the study?
The increased thrombotic risk in patients with acute coronary syndrome and diabetes highlights the need for adequate antithrombotic protection.
Does ticagrelor improve clinical outcomes compared to clopidogrel in Chinese patients with acute coronary syndrome and diabetes?
RCT (n=270)
Open-label, blinded endpoint
1:1
No
Does ticagrelor improve clinical outcomes compared to clopidogrel in Chinese patients with acute coronary syndrome and diabetes?
Effect estimate: HR 0.83 (95% CI 0.44-1.56)
p-value: p=0.561
In Chinese patients with ACS and diabetes, ticagrelor did not improve ischemic outcomes but significantly increased bleeding risk compared to clopidogrel over 6 months.
Background. The increased thrombotic risk in patients with acute coronary syndrome (ACS) and diabetes highlights the need for adequate antithrombotic protection. We aimed to compare the 6-month clinical outcomes between ticagrelor and clopidogrel in patients with ACS and diabetes. Methods and Results. The study was a single-center, prospective, randomized, open-label, blinded endpoint, and controlled registry trial. A total of 270 ACS patients with diabetes were randomly assigned in a 1 : 1 ratio to either the ticagrelor group or the clopidogrel group. Follow-up was performed for 6 months, and the data on efficacy outcomes and bleeding events were collected. At 6 months, complete follow-up data were available for 266 (98.5%) of 270 patients, and 4 were lost to follow-up. There was no significant difference in the survival rate of the effective endpoints between the ticagrelor group ( <a:math xmlns:a="http://www.w3.org/1998/Math/MathML" id="M1"> <a:mi>n</a:mi> <a:mo>=</a:mo> <a:mn>133</a:mn> </a:math> ) and the clopidogrel group ( <c:math xmlns:c="http://www.w3.org/1998/Math/MathML" id="M2"> <c:mi>n</c:mi> <c:mo>=</c:mo> <c:mn>133</c:mn> </c:math> ) (HR 0.83, 95% CI 0.44–1.56, <e:math xmlns:e="http://www.w3.org/1998/Math/MathML" id="M3"> <e:mi>p</e:mi> <e:mo>=</e:mo> <e:mn>0.561</e:mn> </e:math> ), but the incidence of bleeding events in the ticagrelor group was higher than that in the clopidogrel group (HR 1.76, 95% CI 1.00–3.10, <g:math xmlns:g="http://www.w3.org/1998/Math/MathML" id="M4"> <g:mi>p</g:mi> <g:mo>=</g:mo> <g:mn>0.049</g:mn> </g:math> ). Conclusion. Ticagrelor did not improve the composite of nonfatal MI, target vessel revascularization, rehospitalization, stroke, and death from any cause; however, it significantly increased the incidence of bleeding events defined by the Bleeding Academic Research Consortium (BARC) criteria in Chinese patients with ACS and diabetes during the 6-month follow-up compared with clopidogrel.
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He et al. (2021) conducted an RCT in Acute Coronary Syndrome and Diabetes (n=270). Ticagrelor vs. Clopidogrel was evaluated on Composite of nonfatal MI, target vessel revascularization, rehospitalization, stroke, and death from any cause (HR 0.83, 95% CI 0.44-1.56, p=0.561). Ticagrelor did not improve composite efficacy outcomes compared with clopidogrel (HR 0.83; 95% CI 0.44-1.56; p=0.561) but significantly increased bleeding events (HR 1.76; 95% CI 1.00-3.10; p=0.049).
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