Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial

Autor: Norihiro Kogame, Krzysztof J. Filipiak, Mariusz Tomaniak, Franz-Josef Neumann, Osama Ibrahim Ibrahim Soliman, Valeri Gelev, Ply Chichareon, Robert-Jan van Geuns, Jan G.P. Tijssen, Philippe Brunel, Zoltan Jambrik, Yoshinobu Onuma, Global Leaders Study Investigators, Jean-François Morelle, Rodrigo Modolo, Chun Chin Chang, Patrick W. Serruys, Mariana Konteva, Tessa Rademaker-Havinga, Marco Valgimigli, Sylvain Plante, Philippe Gabriel Steg, Stephan Windecker, Ernest Spitzer, Kuniaki Takahashi, Farzin Beygui, Rosana Hernandez Antolin, Robert F. Storey, Christian W. Hamm
Přispěvatelé: Cardiology, Graduate School, ACS - Heart failure & arrhythmias, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, University of Zurich
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Male
Ticagrelor
Time Factors
medicine.medical_treatment
Vascular damage Radboud Institute for Health Sciences [Radboudumc 16]
Coronary Artery Disease
030204 cardiovascular system & hematology
Percutaneous coronary intervention
Pulmonary Disease
Chronic Obstructive
0302 clinical medicine
Risk Factors
Aspirin-free antiplatelet strategies after percutaneous coronary intervention
Clinical endpoint
2736 Pharmacology (medical)
Pharmacology (medical)
Prospective Studies
030212 general & internal medicine
Myocardial infarction
610 Medicine & health
COPD
Dual Anti-Platelet Therapy
Incidence
Chronic obstructive pulmonary disease
Hazard ratio
Middle Aged
Treatment Outcome
Female
Cardiology and Cardiovascular Medicine
medicine.drug
medicine.medical_specialty
Risk Assessment
11171 Cardiocentro Ticino
2705 Cardiology and Cardiovascular Medicine
Drug Administration Schedule
03 medical and health sciences
Internal medicine
medicine
Humans
Aged
business.industry
medicine.disease
Dyspnoea adverse event
Clinical trial
Dyspnea
Conventional PCI
business
Platelet Aggregation Inhibitors
Zdroj: European Heart Journal-Cardiovascular Pharmacotherapy, 6, 222-230
European Heart Journal. Cardiovascular pharmacotherapy, 6(4), 222-230. Oxford University Press
Tomaniak, Mariusz; Chichareon, Ply; Takahashi, Kuniaki; Kogame, Norihiro; Modolo, Rodrigo; Chang, Chun Chin; Spitzer, Ernest; Neumann, Franz-Josef; Plante, Sylvain; Hernández Antolin, Rosana; Jambrik, Zoltan; Gelev, Valeri; Brunel, Philippe; Konteva, Mariana; Beygui, Farzin; Morelle, Jean-Francois; Filipiak, Krzysztof J; van Geuns, Robert-Jan; Soliman, Osama; Tijssen, Jan; ... (2020). Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial. European heart journal. Cardiovascular pharmacotherapy, 6(4), pp. 222-230. Oxford University Press 10.1093/ehjcvp/pvz052
European heart journal. Cardiovascular pharmacotherapy, 6(4), 222-230. Oxford University Press
European Heart Journal-Cardiovascular Pharmacotherapy, 6, 4, pp. 222-230
ISSN: 2055-6837
DOI: 10.1093/ehjcvp/pvz052
Popis: 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.
Databáze: OpenAIRE
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