Key result
Ticagrelor monotherapy after 1-month DAPT shows no benefit over standard DAPT for mortality or MI.
Why the study?
To evaluate the long-term safety and efficacy of ticagrelor monotherapy after PCI in relation to baseline COPD and adverse event dyspnoea that may lead to treatment non-adherence.
Does 23-month ticagrelor monotherapy following 1-month DAPT improve clinical outcomes compared to 12-month DAPT followed by 12-month aspirin in PCI patients with and without COPD?
RCT (n=15,991)
Does 23-month ticagrelor monotherapy following 1-month DAPT improve clinical outcomes compared to 12-month DAPT followed by 12-month aspirin in PCI patients with and without COPD?
In patients undergoing PCI, COPD is a strong predictor of mortality, but ticagrelor monotherapy remains safe and its efficacy is not differentially affected by the presence of COPD or the occurrence of dyspnoea.
Answers are grounded in this paper and cite their sources.
COPD independently predicts higher post-PCI mortality; post hoc analysis leaves open ticagrelor monotherapy safety despite excess dyspnoea in this subgroup.
AIMS: To evaluate long-term safety and efficacy of ticagrelor monotherapy in patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary disease (COPD) at baseline and the occurrence of dyspnoea reported as adverse event (AE) that may lead to treatment non-adherence. METHODS AND RESULTS: This is a non-prespecified, post hoc analysis of the randomized GLOBAL LEADERS trial (n = 15 991), comparing the experimental strategy of 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after PCI with the reference strategy of 12-month DAPT followed by 12-month aspirin monotherapy. Impact of COPD and dyspnoea AE (as a time-dependent covariate) on clinical outcomes was evaluated up to 2 years. The primary endpoint was a 2-year all-cause mortality or non-fatal, centrally adjudicated, new Q-wave myocardial infarction. The presence of COPD (n = 832) was the strongest clinical predictor of 2-year all-cause mortality after PCI [hazard ratio (HR) 2.84; 95% confidence interval (CI) 2.21-3.66; P adjusted = 0.001] in this cohort (n = 15 991). No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58-1.35; P = 0.562; P int = 0.952). Overall, at 2 years dyspnoea was reported as an AE in 2101 patients, more frequently among COPD patients, irrespective of treatment allocation (27.2% in experimental arm vs. 14.5% in reference arm, P = 0.001). Its occurrence was not associated with a higher rate of the primary endpoint (P adjusted = 0.640) in the experimental vs. the reference arm. CONCLUSION: In this exploratory analysis, COPD negatively impacted long-term prognosis after PCI. Despite higher incidence of dyspnoea in the experimental arm, in particular among COPD patients, the safety of the experimental treatment strategy appeared not to be affected. CLINICAL TRIAL REGISTRATION UNIQUE IDENTIFIER: NCT01813435.
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Tomaniak et al. (2019) conducted an RCT in percutaneous coronary interventions (PCIs) (n=15,991). 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) vs. 12-month DAPT followed by 12-month aspirin monotherapy was evaluated on 2-year all-cause mortality or non-fatal, centrally adjudicated, new Q-wave myocardial infarction (HR 0.88, 95% CI 0.58-1.35, p=0.562). Ticagrelor monotherapy after 1-month DAPT showed no differential effect on 2-year mortality or new Q-wave MI compared to standard DAPT, irrespective of COPD status (HR 0.88; 95% CI 0.58-1.35).
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