Key result
Ticagrelor alone matches clopidogrel with ticagrelor reload for 24-hour platelet inhibition, achieving faster 2-hour onset.
Why the study?
In the PLATO primary PCI cohort, 40.7% of patients allocated to ticagrelor had received pre-randomization 600 mg of clopidogrel, a scenario frequently employed in real-world practice that warranted a direct pharmacodynamic comparison with ticagrelor alone.
Is a ticagrelor 180 mg loading dose alone non-inferior to a clopidogrel 600 mg loading dose followed 2 hours later by a ticagrelor 180 mg re-loading dose in terms of 24-hour platelet reactivity in P2Y12 inhibitor-naive STEMI patients undergoing primary PCI?
RCT (n=74)
Single-blind
parallel design
Yes
Is a ticagrelor 180 mg loading dose alone non-inferior to a clopidogrel 600 mg loading dose followed 2 hours later by a ticagrelor 180 mg re-loading dose in terms of 24-hour platelet reactivity in P2Y12 inhibitor-naive STEMI patients undergoing primary PCI?
In P2Y12-naive STEMI patients undergoing primary PCI, upfront ticagrelor loading alone achieves similar 24-hour platelet inhibition as clopidogrel pre-treatment followed by ticagrelor re-loading, while providing faster platelet inhibition at 2 hours.
Answers are grounded in this paper and cite their sources.
Simplifies P2Y12 loading in STEMI primary PCI; extends RCT evidence for ticagrelor monotherapy over sequential regimens.
Among patients allocated to ticagrelor in the primary percutaneous coronary intervention (PCI) cohort of Platelet Inhibition and Patient Outcomes (PLATO) trial, 40.7% had received pre-randomization 600 mg of clopidogrel. This scenario is frequently employed in real-world practice. In a prospective, three-center, single-blind, parallel design study, 74 P2Y12 inhibitor-naive patients undergoing primary PCI were randomized (Hour 0) to ticagrelor 180 mg loading dose (LD) vs clopidogrel 600 mg LD followed after 2 h by ticagrelor 180 mg re-LD. Platelet reactivity (VerifyNow, in PRU) was assessed at Hour 0, 2, 4, 6, and 24. The primary comparison was non-inferiority of ticagrelor to clopidogrel followed by ticagrelor re-LD regarding platelet reactivity at 24 h using a prespecified margin of <35 PRU for the upper bound of the one-sided 97.5% confidence interval (CI). Ticagrelor was proven non-inferior to clopidogrel followed by ticagrelor re-LD with a difference between arms of 13.5 PRU (28.8 upper 97.5% CI), p = 0.001. At Hour 2, platelet reactivity was lower in ticagrelor only vs clopidogrel followed by ticagrelor re-LD groups with least square estimate mean difference (95% CI) -105.7 (-140.6 to -70.8), p < 0.001, without significant difference thereafter. In conclusion, in patients undergoing primary PCI, a strategy of ticagrelor LD only was proven non-inferior to clopidogrel LD followed by ticagrelor re-LD, in terms of antiplatelet efficacy at 24 h post-randomization and provided an earlier onset of platelet inhibition.
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Alexopoulos et al. (2016) conducted an RCT in ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention (n=74). Ticagrelor loading dose only vs. Clopidogrel 600 mg loading dose at Hour 0 followed after 2 h by ticagrelor 180 mg re-loading dose was evaluated on Platelet reactivity (VerifyNow, in PRU) at 24 hours (MD 13.5 PRU, 95% CI upper one-sided 97.5% CI 28.8, p=0.001 for noninferiority). Ticagrelor 180 mg LD was non-inferior to clopidogrel 600 mg LD plus ticagrelor re-LD for 24-h platelet reactivity (difference 13.5 PRU; upper 97.5% CI 28.8; p=0.001) with faster inhibition at 2 h.
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