Study of Two Dose Regimens of Ticagrelor Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention for Stable Coronary Artery Disease

Orme, Rachel; Parker, William A.; Thomas, Mark R.; Judge, Heather M; Baster, Kathleen; Sumaya, Wael; Morgan, K.; McMellon, Hannah; Richardson, J. David; Grech, Ever; Wheeldon, Nigel; Hall, Ian; Iqbal, Javaid; Barmby, David; Gunn, Julian; Storey, Robert F.

doi:10.1161/circulationaha.118.034790

Cited by 69 publications

(63 citation statements)

References 35 publications

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“…In patients with CCS, the experimental strategy resulted in no significant difference in any clinical outcomes, but did lead to numerically higher rates of major bleeding in patients irrespective of their BMI group. Although Orme et al reported that lower platelet activity achieved with ticagrelor, compared with clopidogrel, also occurred in patients with CCS [41], our results might suggest that the anti-ischemic effect of potent P2Y 12 inhibitors may not be required in low ischemic-risk settings such as patients with CCS.…”

Section: Discussioncontrasting

confidence: 57%

The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial

et al. 2020

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Background The efficacy of antiplatelet therapies following percutaneous coronary intervention (PCI) may be affected by body mass index (BMI). Methods and results This is a prespecified subgroup analysis of the GLOBAL LEADERS trial, a prospective, multicenter, open-label, randomized controlled trial in an all-comer population undergoing PCI, comparing the experimental strategy (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with a reference regimen (12-month aspirin monotherapy following 12-month DAPT). A total of 15,968 patients were stratified by baseline BMI with prespecified threshold of 27 kg/m 2 . Of those, 6973 (43.7%) patients with a BMI < 27 kg/m 2 had a higher risk of all-cause mortality at 2 years than those with BMI ≥ 27 kg/m 2 (adjusted HR 1.24, 95% CI 1.02-1.49). At 2 years, the rates of the primary endpoint (all-cause mortality or new Q-wave myocardial infarction) were similar between treatment strategies in either BMI group (p interaction = 0.51). In acute coronary syndrome, however, the experimental strategy was associated with significant reduction of the primary endpoint compared to the reference strategy in patients with BMI < 27 kg/m 2 (HR 0.69, 95% CI 0.51-0.94), but not in the ones with BMI ≥ 27 kg/m 2 (p interaction = 0.047). In chronic coronary syndrome, there was no between-group difference in the efficacy and safety of the two antiplatelet strategies. Conclusions Overall, BMI did not influence the treatment effect seen with ticagrelor monotherapy; however, a beneficial effect of ticagrelor monotherapy was seen in ACS patients with BMI < 27 kg/m 2 . Trial registration The trial has been registered with ClinicalTrials.gov, Number NCT01813435.Masafumi Ono and Ply Chichareon contributed equally to this work. Electronic supplementary materialThe online version of this article (https ://doi.

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Section: Discussioncontrasting

confidence: 57%

The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial

et al. 2020

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“…A total of 80 potential eligible studies were then reviewed for full‐text evaluations, of which 39 articles were excluded because they did not meet the inclusion criteria (Table S1). Finally, 41 RCTs were included in the meta‐analysis with 23 trials comparing ticagrelor with clopidogrel and 18 trials comparing prasugrel with clopidogrel, in which bleeding data from ClinicalTrial.gov were used for the study of Ge 2010 . The selection steps and specific excluding reasons were shown in Figure .…”

Section: Resultsmentioning

confidence: 99%

Systematic review with meta‐analysis: the risk of gastrointestinal bleeding in patients taking third‐generation P2Y₁₂ inhibitors compared with clopidogrel

Guo

Chen

Chan

et al. 2018

Aliment Pharmacol Ther

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Summary Background Ticagrelor and prasugrel are third‐generation oral P2Y12 receptor antagonists with rapid onset and pronounced platelet inhibition. However, higher overall bleeding rates have been reported for these agents when compared with clopidogrel. Aim To compare the risk of gastrointestinal bleeding (GIB) among users of third‐generation P2Y12 inhibitors with clopidogrel. Methods We systematically searched for published randomised controlled trials of ticagrelor or prasugrel versus clopidogrel until September 2018. The primary outcome was the risk of GIB among users of third‐generation P2Y12 inhibitors when compared to clopidogrel, expressed as risk ratio (RR) and 95% confidence interval (CI). The rates of non‐coronary artery bypass graft (CABG) major bleeding, life‐threatening bleeding, fatal bleeding, and intracranial bleeding were analysed as secondary outcomes. Results Forty‐one studies were included in the analysis of non‐CABG major bleeding, of which 12 were included in the analysis of GIB including 58 678 patients. Third‐generation P2Y12 inhibitors were associated with higher risk of GIB as compared with clopidogrel (RR 1.28, 95% CI 1.13‐1.46). The findings were consistent for upper (RR 1.32, 95% CI 1.05‐1.67) and unspecified GIB (RR 1.25, 95% CI 1.01‐1.53), but not lower GIB (RR 1.25, 95% CI 0.95‐1.65). Subgroup analysis showed higher GIB risk in prasugrel studies (RR 1.40, 95% CI 1.10‐1.77) than in ticagrelor studies (RR 1.15, 95% CI 0.94‐1.39). Third‐generation P2Y12 inhibitors also increased the risk of non‐CABG major bleeding (RR 1.18, 95% CI 1.08‐1.28). Conclusion Third‐generation P2Y12 inhibitors were associated with increased risk of GIB and non‐CABG major bleeding when compared with clopidogrel.

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“…Existing studies about the optimal DAPT regimen in stable CAD undergoing PCI are limited. In terms of pharmacodynamic effects, ticagrelor has shown greater platelet inhibition effect than clopidogrel in stable patients [29, 30]. In terms of clinical outcomes, GLOBAL LEADERS trail had evaluated the effects of ticagrelor and clopidogrel in stable CAD patients undergoing PCI.…”

Section: Discussionmentioning

confidence: 99%

Effects of Ticagrelor versus Clopidogrel in Patients with Coronary Bifurcation Lesions Undergoing Percutaneous Coronary Intervention

Zheng

Tian

et al. 2019

BioMed Research International

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Background. Percutaneous treatment of coronary bifurcation lesions can potentially lead to higher risk of ischemic events than the nonbifurcation ones, thus calling for further optimization of dual antiplatelet therapy (DAPT). This study aimed to compare the clinical outcomes from ticagrelor and clopidogrel in bifurcation lesions patients undergoing percutaneous coronary intervention (PCI). Methods. We performed a retrospective cohort study in patients with coronary bifurcation lesions. A total of 553 patients discharged on ticagrelor or clopidogrel combined with aspirin were recruited for 1-year follow-up. The incidences of primary endpoint (major adverse cardiovascular event [MACE]: a composite of cardiac death, myocardial infarction [MI] or stroke), secondary endpoints (the individual component of the primary endpoint or definite/probable stent thrombosis), and major bleeding (Bleeding Academic Research Consortium [BARC]≥3 bleeding events) were evaluated. To minimize the selection bias, a propensity score-matched population analysis was also conducted. Results. The risks of both primary endpoint (8.15% and 12.01% for the ticagrelor and clopidogrel groups, respectively; adjusted hazards ratio [HR]: 0.488, 95% confidence interval [CI]: 0.277-0.861, P=0.013) and MI (4.44% and 8.48% for the ticagrelor and clopidogrel groups, respectively; adjusted HR: 0.341, 95% CI: 0.162-0.719, P=0.005) were significantly reduced in the ticagrelor group as compared with those of the clopidogrel counterpart, whereas the risk of major bleeding was comparable (2.96% and 2.47% for the ticagrelor and clopidogrel groups, respectively; adjusted HR: 0.972, 95% CI: 0.321-2.941, P=0.960). Propensity score-matched analysis confirmed such findings. Conclusions. For patients with bifurcation lesions after PCI, ticagrelor treatment shows lower MACE and MI rates than the clopidogrel one, along with comparable major bleeding.

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Study of Two Dose Regimens of Ticagrelor Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention for Stable Coronary Artery Disease

Abstract: Supplemental Digital Content is available in the text.

Cited by 69 publications

References 35 publications

The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial

The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial

Systematic review with meta‐analysis: the risk of gastrointestinal bleeding in patients taking third‐generation P2Y₁₂ inhibitors compared with clopidogrel

Effects of Ticagrelor versus Clopidogrel in Patients with Coronary Bifurcation Lesions Undergoing Percutaneous Coronary Intervention

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Study of Two Dose Regimens of Ticagrelor Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention for Stable Coronary Artery Disease

Abstract: Supplemental Digital Content is available in the text.

Cited by 69 publications

References 35 publications

The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial

The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial

Systematic review with meta‐analysis: the risk of gastrointestinal bleeding in patients taking third‐generation P2Y12 inhibitors compared with clopidogrel

Effects of Ticagrelor versus Clopidogrel in Patients with Coronary Bifurcation Lesions Undergoing Percutaneous Coronary Intervention

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Systematic review with meta‐analysis: the risk of gastrointestinal bleeding in patients taking third‐generation P2Y₁₂ inhibitors compared with clopidogrel