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      Ticagrelor Versus Clopidogrel in Patients With Acute Coronary Syndromes and Chronic Obstructive Pulmonary Disease: An Analysis From the Platelet Inhibition and Patient Outcomes (PLATO) Trial

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          Abstract

          Background

          Patients with chronic obstructive pulmonary disease ( COPD) experiencing acute coronary syndromes ( ACS) are at high risk for clinical events. In the Platelet Inhibition and Patient Outcomes ( PLATO) trial, ticagrelor versus clopidogrel reduced the primary endpoint of death from vascular causes, myocardial infarction, or stroke after ACS, but increased the incidence of dyspnea, which may lead clinicians to withhold ticagrelor from COPD patients.

          Methods and Results

          In 18 624 patients with ACS randomized to treatment with ticagrelor or clopidogrel, history of COPD was recorded in 1085 (5.8%). At 1 year, the primary endpoint occurred in 17.7% of patients with COPD versus 10.4% in those without COPD ( P<0.001). The 1‐year event rate for the primary endpoint in COPD patients treated with ticagrelor versus clopidogrel was 14.8% versus 20.6% (hazard ratio [ HR]=0.72; 95% confidence interval [ CI]: 0.54 to 0.97), for death from any cause 8.4% versus 12.4% ( HR=0.70; 95% CI: 0.47 to 1.04), and for PLATO‐defined major bleeding rates at 1 year 14.6% versus 16.6% ( HR=0.85; 95% CI: 0.61 to 1.17). Dyspnea occurred more frequently with ticagrelor (26.1% vs. 16.3%; HR=1.71; 95% CI: 1.28 to 2.30). There was no differential increase in the relative risk of dyspnea compared to non‐ COPD patients ( HR=1.85). No COPD status‐by‐treatment interactions were found, showing consistency with the main trial results.

          Conclusions

          In this post‐hoc analysis, COPD patients experienced high rates of ischemic events. Ticagrelor versus clopidogrel reduced and substantially decreased the absolute risk of ischemic events (5.8%) in COPD patients, without increasing overall major bleeding events. The benefit‐risk profile supports the use of ticagrelor in patients with ACS and concomitant COPD.

          Clinical Trial Registration

          URL: http://www.clinicaltrials.gov. Unique identifier: NCT00391872.

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          Most cited references 14

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          Impaired lung function and mortality risk in men and women: findings from the Renfrew and Paisley prospective population study.

          To assess the relation between forced expiratory volume in one second (FEV1) and subsequent mortality. Prospective general population study. Renfrew and Paisley, Scotland. 7058 men and 8353 women aged 45-64 years at baseline screening in 1972-6. Mortality from all causes, ischaemic heart disease, cancer, hung and other cancers, stroke, respiratory disease, and other causes of death after 15 years of follow up. 2545 men and 1894 women died during the follow up period. Significant trends of increasing risk with diminishing FEV1 are apparent for both sexes for all the causes of death examined after adjustment for age, cigarette smoking, diastolic blood pressure, cholesterol concentration, body mass index, and social class. The relative hazard ratios for all cause mortality for subjects in the lowest fifth of the FEV1 distribution were 1.92 (95% confidence interval 1.68 to 2.20) for men and 1.89 (1.63 to 2.20) for women. Corresponding relative hazard ratios were 1.56 (1.26 to 1.92) and 1.88 (1.44 to 2.47) for ischaemic heart disease, 2.53 (1.69 to 3.79) and 4.37 (1.84 to 10.42) for lung cancer, and 1.66 (1.07 to 2.59) and 1.65 (1.09 to 2.49) for stroke. Reduced FEV1 was also associated with an increased risk for each cause of death examined except cancer for lifelong nonsmokers. Impaired lung function is a major clinical indicator of mortality risk in men and women for a wide range of diseases. The use of FEV1 as part of any health assessment of middle aged patients should be considered. Smokers with reduced FEV1 should form a priority group for targeted advice to stop smoking.
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            Ticagrelor vs. clopidogrel in patients with acute coronary syndromes and diabetes: a substudy from the PLATelet inhibition and patient Outcomes (PLATO) trial

            Aims Patients with diabetes mellitus (DM) have high platelet reactivity and are at increased risk of ischaemic events and bleeding post-acute coronary syndromes (ACS). In the PLATelet inhibition and patient Outcomes (PLATO) trial, ticagrelor reduced the primary composite endpoint of cardiovascular death, myocardial infarction, or stroke, but with similar rates of major bleeding compared with clopidogrel. We aimed to investigate the outcome with ticagrelor vs. clopidogrel in patients with DM or poor glycaemic control. Methods and results We analysed patients with pre-existing DM (n = 4662), including 1036 patients on insulin, those without DM (n = 13 951), and subgroups based on admission levels of haemoglobin A1c (HbA1c; n = 15 150). In patients with DM, the reduction in the primary composite endpoint (HR: 0.88, 95% CI: 0.76–1.03), all-cause mortality (HR: 0.82, 95% CI: 0.66–1.01), and stent thrombosis (HR: 0.65, 95% CI: 0.36–1.17) with no increase in major bleeding (HR: 0.95, 95% CI: 0.81–1.12) with ticagrelor was consistent with the overall cohort and without significant diabetes status-by-treatment interactions. There was no heterogeneity between patients with or without ongoing insulin treatment. Ticagrelor reduced the primary endpoint, all-cause mortality, and stent thrombosis in patients with HbA1c above the median (HR: 0.80, 95% CI: 0.70–0.91; HR: 0.78, 95% CI: 0.65–0.93; and HR: 0.62, 95% CI: 0.39–1.00, respectively) with similar bleeding rates (HR: 0.98, 95% CI: 0.86–1.12). Conclusion Ticagrelor, when compared with clopidogrel, reduced ischaemic events in ACS patients irrespective of diabetic status and glycaemic control, without an increase in major bleeding events.
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              Ticagrelor versus clopidogrel in acute coronary syndromes in relation to renal function: results from the Platelet Inhibition and Patient Outcomes (PLATO) trial.

              Reduced renal function is associated with a poorer prognosis and increased bleeding risk in patients with acute coronary syndromes and may therefore alter the risk-benefit ratio with antiplatelet therapies. In the Platelet Inhibition and Patient Outcomes (PLATO) trial, ticagrelor compared with clopidogrel reduced the primary composite end point of cardiovascular death, myocardial infarction, and stroke at 12 months but with similar major bleeding rates. Central laboratory serum creatinine levels were available in 15 202 (81.9%) acute coronary syndrome patients at baseline, and creatinine clearance, estimated by the Cockcroft Gault equation, was calculated. In patients with chronic kidney disease (creatinine clearance <60 mL/min; n=3237), ticagrelor versus clopidogrel significantly reduced the primary end point to 17.3% from 22.0% (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.65 to 0.90) with an absolute risk reduction greater than that of patients with normal renal function (n=11 965): 7.9% versus 8.9% (HR, 0.90; 95% CI, 0.79 to 1.02). In patients with chronic kidney disease, ticagrelor reduced total mortality (10.0% versus 14.0%; HR, 0.72; 95% CI, 0.58 to 0.89). Major bleeding rates, fatal bleedings, and non-coronary bypass-related major bleedings were not significantly different between the 2 randomized groups (15.1% versus 14.3%; HR, 1.07; 95% CI, 0.88 to 1.30; 0.34% versus 0.77%; HR, 0.48; 95% CI, 0.15 to 1.54; and 8.5% versus 7.3%; HR, 1.28; 95% CI, 0.97 to 1.68). The interactions between creatinine clearance and randomized treatment on any of the outcome variables were nonsignificant. In acute coronary syndrome patients with chronic kidney disease, ticagrelor compared with clopidogrel significantly reduces ischemic end points and mortality without a significant increase in major bleeding but with numerically more non-procedure-related bleeding. URL:http://www.clinicatrials.gov. Unique identifier: NCT00391872.
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                Author and article information

                Journal
                J Am Heart Assoc
                J Am Heart Assoc
                10.1002/(ISSN)2047-9980
                JAH3
                ahaoa
                Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
                John Wiley and Sons Inc. (Hoboken )
                2047-9980
                09 October 2015
                October 2015
                : 4
                : 10 ( doiID: 10.1002/jah3.2015.4.issue-10 )
                Affiliations
                [ 1 ] Department of Cardiology Clinical SciencesLund University LundSweden
                [ 2 ] Department of Medical Sciences Cardiology and Uppsala Clinical Research CenterUppsala University UppsalaSweden
                [ 3 ] Cardiovascular DivisionBrigham and Women's Hospital Boston MA
                [ 4 ]Harvard Clinical Research Institute Boston MA
                [ 5 ] Duke Clinical Research InstituteDuke University Medical Center Durham NC
                [ 6 ]AstraZeneca Research and Development MölndalSweden
                [ 7 ] Medical DepartmentHospital Unit West Herning/HolstebroDenmark
                [ 8 ] Hungarian Institute of CardiologySemmelweis University BudapestHungary
                [ 9 ] Department of Cardiology Vascular Medicine Faculty of Medicine Harapan Kita Hospital National Cardiovascular CenterUniversity of Indonesia JakartaIndonesia
                [ 10 ]INSERM‐Unité 1148 ParisFrance
                [ 11 ] Département Hospitalo‐Universitaire FIRE Assistance Publique‐Hôpitaux de ParisHôpital Bichat ParisFrance
                [ 12 ] Sorbonne‐Paris CitéUniversité Paris‐Diderot ParisFrance
                [ 13 ] NHLI Imperial College ICMSRoyal Brompton Hospital LondonUK
                [ 14 ] Department of Cardiovascular ScienceUniversity of Sheffield Sheffield UK
                Author notes
                [* ] Correspondence to: Pontus Andell, MD, Department of Cardiology, Clinical Sciences, Lund University, Skane University Hospital, Lund; 221 85 Lund, Sweden. E‐mail: pontus.andell@ 123456med.lu.se
                Article
                JAH31153
                10.1161/JAHA.115.002490
                4845124
                26452988
                © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

                This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                Page count
                Pages: 8
                Product
                Funding
                Funded by: AstraZeneca
                Funded by: Uppsala Clinical Research Center
                Funded by: Duke Clinical Research Institute
                Categories
                Original Research
                Original Research
                Custom metadata
                2.0
                jah31153
                October 2015
                Converter:WILEY_ML3GV2_TO_NLMPMC version:4.8.4 mode:remove_FC converted:03.03.2016

                Cardiovascular Medicine

                cardiovascular diseases, lung, myocardial infarction

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