P6411Dyspnea in ticagrelor treated patients in the all-comer randomized GLOBAL LEADERS study and its association with clinical outcomes

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Tomaniak ◽  
P Chichareon ◽  
R Modolo ◽  
S Plante ◽  
P Brunel ◽  
...  

Abstract Background Dyspnea represents a drug adverse effect reported with a higher frequency for ticagrelor, as compared with other P2Y12 antagonists. The impact of dyspnea on clinical outcomes has not been yet evaluated in the context of aspirin-free therapies after percutaneous coronary intervention (PCI). Purpose The study aimed to evaluate the incidence of dyspnea and its associations with demographic characteristics and clinical outcomes in patients undergoing PCI treated with ticagrelor either as monotherapy or as a part of a dual antiplatelet therapy (DAPT) in the GLOBAL LEADERS cohort. Methods This is a sub-analysis of the randomized all-comer GLOBAL LEADERS study (n=15991), comparing the experimental strategy of ticagrelor monotherapy following one-month DAPT after PCI with the reference strategy of 12-month DAPT followed by 12-month aspirin monotherapy. The incidence of dyspnea reported as adverse event (AE) and its relation to demographic characteristics and 2-year clinical outcomes was evaluated (intention-to-treat analysis). Multivariable Cox proportional hazards models were performed, including randomized treatment and incidence of first dyspnea event as a time-dependent covariate. The primary endpoint was a composite of 2-year all-cause mortality or centrally adjudicated, new Q-wave myocardial infarction (MI). Patient-oriented clinical endpoints (POCE) comprised all-cause death, any stroke, MI or revascularization, whereas net adverse clinical events (NACE) included POCE and Bleeding Academic Research Consortium (BARC)-defined bleeding type 3 or 5. Results Overall, dyspnea was reported as an AE in 2101 patients (13.2%) up to two years of follow-up, with a higher frequency in the experimental arm (16.4%) as compared with the reference group (11.1%) (hazard ratio [HR]1.70, 95% confidence interval [CI] 1.56–1.86, p=0.001). Predictors of dyspnea AE up to 2 years by multivariate analyses were: chronic obstructive pulmonary disease (HR1.71, 95% CI 1.56–1.87, p=0.001), female gender (HR1.31, 95% CI 1.18–1.44, p=0.001), hypertension (HR1.31, 95% CI 1.19–1.44, p=0.001, prior coronary artery bypass grafting (HR1.30, 95% CI 1.10–1.54, p=0.003), left ventricle ejection fraction below 40% (HR1.22, 95% CI 1.04–1.42, p=0.012), presentation with acute coronary syndrome (HR1.19, 95% CI 1.09–1.29, p=0.001) and body mass index (≥27kg/m2) (HR1.17, 95% CI 1.08–1.28, p=0.001). In patients who reported dyspnea AE, the two-year rates of the efficacy and safety endpoints in the experimental and reference arm were: for the primary endpoint 3.4% vs. 4.3% (p adjusted=0.807), for POCE 15.8% vs. 17.6% (p adjusted=0.218), for NACE 17.2% vs. 19.6% (p adjusted=0.082), for BARC 3 or 5 type bleeding 17.2% vs. 19.6% (p adjusted=0.082), respectively. Conclusions The occurrence of dyspnea AE up to two years after PCI appeared not to affect the safety of the experimental treatment strategy of 23-month ticagrelor monotherapy following one-month DAPT after PCI. Acknowledgement/Funding Study founded by European Cardiovascular Research Institute, which received unrestricted grants from Biosensors Int., AstraZeneca, Medicines Company.

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Tomonori Akasaka ◽  
Seiji Hokimoto ◽  
Noriaki Tabata ◽  
Kenji Sakamoto ◽  
Kenichi Tsujita ◽  
...  

Background: Based on 2011 ACCF/AHA/SCAI PCI guideline, it is recommended that PCI should be performed at hospital with onsite cardiac surgery. But, recent data suggests that there is no significant difference in clinical outcomes following primary or elective PCI between hospitals with and without onsite cardiac surgery. The proportion of PCI centers without onsite cardiac surgery comprises approximately more than half of all PCI centers in Japan. We examined the impact of with or without onsite cardiac surgery on clinical outcomes following PCI to ACS. Methods: From Aug 2008 to March 2011, subjects (n=2288) were enrolled from the Kumamoto Intervention Conference Study (KICS), which is a multicenter registry, and enrolling consecutive patients undergoing PCI in 15 centers in Japan. Patients were assigned to two groups treated in hospitals with (n=1954) or without (n=334) onsite cardiac surgery. Clinical events were followed up for 12 months. Primary endpoint was in-hospital death, cardiovascular death, myocardial infarction, and stroke. And we monitored other events those were non-cardiovascular deaths, bleeding complications, revascularizations, and emergent CABG. Results: There was no overall significant difference in primary endpoint between hospitals with and without onsite cardiac surgery (9.6%vs9.5%; P=0.737). There was also no significant difference when events in primary endpoint were considered separately. In other events, only revascularization was more frequently seen in hospitals with onsite cardiac surgery (22.1%vs12.9%; P<0.001). Kaplan-Meier analysis for primary endpoint showed that there was no significant difference between two groups (Log Rank P=0.943). By cox proportional hazards model analysis for primary endpoint, without onsite cardiac surgery was not a predictive factor for primary endpoint (HR 0.969, 95%CI 0.704-1.333; P=0.845). We performed propensity score matching analysis to correct for the disparate patient numbers between two groups, and there was also no significant difference for primary endpoint (6.9% vs 8.0%; P=0.544). Conclusions: There is no significant difference in clinical outcomes following PCI for ACS between hospitals with and without onsite cardiac surgery backup in Japan.


2021 ◽  
Vol 8 (1) ◽  
pp. e000840
Author(s):  
Lianne Parkin ◽  
Sheila Williams ◽  
David Barson ◽  
Katrina Sharples ◽  
Simon Horsburgh ◽  
...  

BackgroundCardiovascular comorbidity is common among patients with chronic obstructive pulmonary disease (COPD) and there is concern that long-acting bronchodilators (long-acting muscarinic antagonists (LAMAs) and long-acting beta2 agonists (LABAs)) may further increase the risk of acute coronary events. Information about the impact of treatment intensification on acute coronary syndrome (ACS) risk in real-world settings is limited. We undertook a nationwide nested case–control study to estimate the risk of ACS in users of both a LAMA and a LABA relative to users of a LAMA.MethodsWe used routinely collected national health and pharmaceutical dispensing data to establish a cohort of patients aged >45 years who initiated long-acting bronchodilator therapy for COPD between 1 February 2006 and 30 December 2013. Fatal and non-fatal ACS events during follow-up were identified using hospital discharge and mortality records. For each case we used risk set sampling to randomly select up to 10 controls, matched by date of birth, sex, date of cohort entry (first LAMA and/or LABA dispensing), and COPD severity.ResultsFrom the cohort (n=83 417), we identified 5399 ACS cases during 281 292 person-years of follow-up. Compared with current use of LAMA therapy, current use of LAMA and LABA dual therapy was associated with a higher risk of ACS (OR 1.28 (95% CI 1.13 to 1.44)). The OR in an analysis restricted to fatal cases was 1.46 (95% CI 1.12 to 1.91).ConclusionIn real-world clinical practice, use of two versus one long-acting bronchodilator by people with COPD is associated with a higher risk of ACS.


2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
M Santos ◽  
H Santos ◽  
I Almeida ◽  
H Miranda ◽  
C Sa ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. OnBehalf on behalf of the Investigators of " Portuguese Registry of ACS " Introduction Heart failure (HF) is a frequent complication of acute coronary syndromes (ACS). Therefore, it is important to access its impact on prognosis and identify patients (pts) with higher risk of HF. Objective To evaluate predictors and prognosis of HF in the setting of ACS. Methods Based on a multicenter retrospective study, data collected from admissions between 1/10/2010 and 4/09/2019. Pts without data on cardiovascular history or uncompleted clinical data were excluded. Pts were divided in 2 groups (G): GA – pts without HF; GB - pts with HF during hospitalization. Results HF occurred in 4003 (15.6%) out of 25718 pts with ACS. GB was older (74 ± 12 vs 65 ± 13, p &lt; 0.001), had more females (36.3% vs 26.2%, p &lt; 0.001), had higher rates of arterial hypertension (78.4% vs 69.3%, p &lt; 0.001), dyslipidaemia (64.4% vs 61.1%. p &lt; 0.001), previous ACS (25.6% vs 19.7%, p &lt; 0.001,), previous HF (16.4% vs 4.1%, p &lt; 0.001), previous stroke (11.9% vs 6.4%, p &lt; 0.001), chronic kidney disease (CKD) (17.1% vs 5.5%, p &lt; 0.001), chronic obstructive pulmonary disease (COPD) (7.8% vs 3.8%, p &lt; 0.001) and longer times from first symptoms to admission (268min vs 238min, p &lt; 0.001). GA had higher rate of smokers (28.4% vs 16.2%, p &lt; 0.001) and higher rate of non-ST-elevation myocardial infarction (MI) (46.5% vs 43.0%, p &lt; 0.001). GB had higher rates of ST-elevation MI (STEMI) (49.2% vs 41.1%, p &lt; 0.001), namely anterior STEMI (58.1% vs 44.9%, p &lt; 0.001). GB had lower blood pressure (130 ± 32 vs 140 ± 28, p &lt; 0.001), higher heart rate (86 ± 23 vs 76 ± 18, p &lt; 0.001), Killip-Kimball class (KKC) ≥2 (63.2% vs 6.7%, p &lt; 0.001), atrial fibrillation (AF) (15.4% vs 5.7%, p &lt; 0.001), left bundle branch block (7.5% vs 3.1%, p &lt; 0.001) and were previously treated with diuretics (39.1% vs 22.1%, p &lt; 0.001), amiodarone (2.2% vs 1.4%, p &lt; 0.001) and digoxin (2.8% vs 0.7%, p &lt; 0.001). GB had higher rates of multivessel disease (66.0% vs 49.5%, p &lt; 0.001) and planned coronary artery bypass grafting (7.3% vs 6.0%, p &lt; 0.001), reduced left ventricle function (72.3% vs 33.4%, p &lt; 0.001) and needed more frequently mechanical ventilation (8.2% vs 0.9%, p &lt; 0.001), non-invasive ventilation (8.7% vs 0.5%, p &lt; 0.001) and provisory pacemaker (4.5% vs 1.0%, p &lt; 0.001). Logistic regression confirmed females (p &lt; 0.001, OR 1.42, CI 1.29-1.58), diabetes (p &lt; 0.001, OR 1.43, CI 1.30-1.58), previous ACS (p &lt; 0.001, OR 1.27, CI 1.10-1.47), previous stroke (p &lt; 0.001, OR 1.35, CI 1.16-1.57), CKD (p &lt; 0.001, OR 1.76, CI 1.50-2.05), COPD (p &lt; 0.001, OR 2.15, CI 1.82-2.54), previous usage of amiodarone (p = 0.041, OR 1.35, CI 1.01-1.81) and digoxin (p &lt; 0.001, OR 2.30, CI 1.70-3.16), and multivessel disease (p &lt; 0.001, OR 1.64, CI 1.67-2.32) were predictors of HF in the setting of ACS. Event-free survival was higher in GA than GB (79.5% vs 58.1%, OR 2.3, p &lt; 0.001, CI 2.09-2.56). Conclusion As expected, HF in the setting of ACS is associated with poorer prognosis. Several features may help predict the HF occurrence during hospitalizations, allowing an earlier treatment.


2020 ◽  
Author(s):  
Lorenzo Socias ◽  
Guillem Frontera ◽  
Catalina Rubert ◽  
Joan Torres ◽  
Tomas Ripoll ◽  
...  

Abstract Background. The patients who attend a hospital without a hemodynamic laboratory may have differences in health outcomes, treatment, reperfusion times, the rate of cardiovascular complications, hospital stay, mortality or costs may be affected. The study aimed to analyze the prognostic of patients with STEMI treated in the Emergency Department (ED) and the impact prognostic of the delayed reperfusion time in a Hospital General without hemodynamic laboratory. Methods. After ethics review board approval, this retrospective observational cohort study of patients included acute coronary syndrome with ST elevation of ≤ 24 h in the Illes Balears infarction code registry (CI-IB) between May 2008 and December 2018. The information recorded were age, sex, cardiovascular risk factors, site of AMI, time delays, reperfusion therapy with fibrinolysis and primary angioplasty (PA). Cardiovascular Event (CE) was defined the combined variable: Killip class progression, malignant arrhythmias, Re-infarction, cerebrovascular disease and mortality. Results.605 patients were analyzed. The reperfusion treatment was 83,1% (80,8% with PA). 19% presented some CE. Hospital and monthly mortality was 6.8% and 7.8% respectively. The main differences between patients with and without CE were: age (66 vs 59 years); Chronic obstructive pulmonary disease (COPD); previous infarction; anterior location; Door-To-Needle Time and FPC-PA time. The risk factors of CE were: age, COPD, anterior location, fibrinolysis and patients without reperfusion treatment. In the group with PA, the risk of mortality was higher in COPD (p=0.012), Symptom start –FPC time with (p = 0,084) and FPC-PA time > 90 minutes (p= 0.107). FCM-AP> 90 minutes had a higher mortality (10 vs 4.4%;HR 1,79; IC 95% 1,15-2,78; log-rank:p=0,013)Conclussions. In our cohort, most patients received reperfusion treatment and were performed within the recommended time. In ED, the pacients with a FCM-PA time longer than recommended in the guidelines and COPD had higher CE y mortality.


2015 ◽  
Vol 47 (3) ◽  
pp. 733-741 ◽  
Author(s):  
Adam W. Gaffney ◽  
Jing-qing Hang ◽  
Mi-Sun Lee ◽  
Li Su ◽  
Feng-ying Zhang ◽  
...  

Exposure to air pollution can be particularly high during commuting and may depend on the mode of transportation. We investigated the impact of commuting mode on pulmonary function in Shanghai, China.The Shanghai Putuo Study is a cross-sectional, population-based study. Our primary outcomes were forced expiratory volume in 1 s (FEV1) and forced vital capacity (FVC) % predicted, and the secondary outcome was spirometric airflow obstruction. We tested the association between mode of transportation and these outcomes after adjusting for confounders.The study population consisted of 20 102 subjects. After adjusting for confounders, the change (95% CI) in FEV1 was −2.15% pred (−2.88– −1.42% pred) among pedestrians, −1.32% pred (−2.05– −0.59% pred) among those taking buses without air conditioning, −1.33% pred (−2.05– −0.61% pred) among those taking buses with air conditioning and −2.83% pred (−5.56– −0.10% pred) among those using underground railways, as compared to cyclists (the reference group). The effects of mode on FVC % predicted were in the same direction. Private car use had a significant protective effect on FVC % predicted and the risk of airflow obstruction (defined by Global Initiative for Chronic Obstructive Lung Disease but not by lower limit of normal criteria).Mode of transportation is associated with differences in lung function, which may reflect pollution levels in different transportation microenvironments.


Pharmateca ◽  
2020 ◽  
Vol 14_2020 ◽  
pp. 74-80
Author(s):  
B.G. Iskenderov Iskenderov ◽  
N.V. Berenshtein Berenshtein ◽  
T.V. Lokhina Lokhina ◽  
I.N. Mozhzhukhina Mozhzhukhina ◽  

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Dariusz Dudek ◽  
Petr Widimsky ◽  
Leonardo Bolognese ◽  
Patrick Goldstein ◽  
Christian Hamm ◽  
...  

Objectives: We evaluated the impact of prasugrel pretreatment and timing of coronary artery bypass grafting (CABG) on clinical outcomes of patients with non-ST-segment elevation myocardial infarction (NSTEMI) undergoing CABG based on data from ACCOAST. Methods: We evaluated the impact of troponin, prasugrel pretreatment and CABG timing on clinical outcomes of NSTEMI patients undergoing CABG through 30 days from ACCOAST. Results: CABG patients versus PCI or medically managed patients were more often male, diabetic, had peripheral arterial disease and a higher GRACE score. By randomization assignment, 157 patients received a 30-mg loading-dose of prasugrel before CABG; 157 patients did not. CABG patients were grouped by tertiles of time from randomization to CABG; baseline characteristics in the Table. Patients in the lowest tertile had significantly more events (cardiovascular death, MI, stroke, urgent revascularization or glycoprotein IIb/IIIa bailout) and all TIMI major bleeds than those in the other 2 groups (p<0.045, p<0.002 respectively), but the patients in the higher 2 groups were not significantly different from each other. No difference was detected in all cause death among the 3 groups (p>0.39). A multivariate model evaluated 5 possible predictors of the composite endpoint of all cause death, MI, stroke and TIMI major bleeding. Time from randomization to CABG (HR 0.84 for each 1 hour of delay), left main disease presence (HR 1.76), and region of enrollment (Eastern Europe vs other, HR 3.83) were significant predictors but not prasugrel pretreatment or baseline troponin level ≥3xULN. Conclusions: In this group of high-risk patients presenting with NSTEMI, early surgical revascularization carried an increased risk of bleeding and ischemic complications, without impact on all-cause mortality. No impact of baseline troponin or prasugrel pretreatment (important factors influencing time of CABG) on clinical outcomes was confirmed.


Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Juan J Russo ◽  
Tyler E James ◽  
Nikita Malhotra ◽  
Daniel Goubran ◽  
Fraser D Rubens ◽  
...  

Background: We sought to assess in-hospital clinical outcomes in ACS patients undergoing CABG in relation to the duration of ticagrelor discontinuation prior to surgery. Methods: We identified consecutive ACS patients who underwent CABG after having received ticagrelor. Patients were divided into 3 groups based on the timing of surgery after discontinuation of ticagrelor (<48 hours, 48 hours to <5 days, 5 days or more). We then compared clinical outcomes following CABG in relation to the duration of ticagrelor discontinuation prior to surgery. Clinical variables evaluated included postoperative bleeding, need for surgical reopening or blood transfusions, and length of stay in the intensive care unit (ICU). Results: Of 664 ACS patients undergoing CABG between January 2012 and March 2015, 53 received ticagrelor prior to CABG. Ticagrelor had been discontinued <48 hours prior to CABG in 22 patients (41%); 48 hours to <5 days in 19 (36%); and 5 days or more in 12 (23%). Patients who underwent CABG <48 hours after ticagrelor discontinuation were more likely to require blood transfusions and a prolonged ICU stay (defined as >3 days). In addition, they had numerically higher, but non-statistically significant, rates of postoperative bleeding. Patients who underwent CABG 48 hours to <5 days after ticagrelor discontinuation had similar rates of postoperative bleeding and duration of ICU stay compared to patients who waited at least 5 days. Conclusions: A significant proportion of ACS patients (77%) who require CABG undergo surgery before the guideline recommended ticagrelor discontinuation period of 5 days. Patients who undergo CABG <48 hours after ticagrelor discontinuation are more likely to require postoperative blood transfusions and a prolonged ICU stay. Notably, patients who undergo CABG 48 hours to <5 days after ticagrelor discontinuation have similar postoperative outcomes compared to patients who undergo CABG after 5 days of ticagrelor discontinuation.


2019 ◽  
Vol 6 (4) ◽  
pp. 222-230
Author(s):  
Mariusz Tomaniak ◽  
Ply Chichareon ◽  
Kuniaki Takahashi ◽  
Norihiro Kogame ◽  
Rodrigo Modolo ◽  
...  

Abstract 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.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J Klein ◽  
R Farkash ◽  
F Bayya ◽  
L Taha ◽  
N Abeles ◽  
...  

Abstract Background Referral and participation rates to Cardiac Rehabilitation (CR) after acute coronary syndrome (ASC) are low despite a Class I recommendation in the present guidelines. Our aim was to examine the role of gender on referral, participation and outcomes of CR. Methods Data of ACS patients hospitalized during 2007–2016 in our cardiology department were extracted and compared between referred to CR to those who were not. Multivariable models were used to assess the impact of gender on referral to CR and survival. Results Of the 6175 ACS patients, 1455 (23.6%) were female. Overall referral rate to CR was 66.5%, 51.3% among female and 70.0% in male; p<0.0001. Female were more likely to have characteristics associated with lower referral rate; they were older, had lower rates of STEMI and higher rates of cardiac risk factors. Multivariable model, adjusted for those characteristics revealed that female gender is independently associated with lower referral rate to CR: OR = 0.77 95% CI [0.66–0.89]; p<0.0001. (Table 1) Multivariable COX analysis showed that patients referred to CR had lower mortality hazard – HR = 0.427 95% CI [0.35–0.53]; p<0.0001, with no gender difference – HR=1.04 95% CI [1.04–1.06]; p=0.640. Participation rate within referred patients, program duration as well as number of meetings were similar in female and male p=NS for all. Independent predictors for CR referral OR 95% CI p-value Cath 6.5 5.3–8.0 <0.001 STEMI** 3.9 3.3–4.6 <0.001 NSTEMI** 2.1 1.8–2.4 <0.001 Smoker 1.9 1.6–2.1 <0.001 Age* 0.9 0.9–1.0 <0.001 Hypertension 0.8 0.7–0.9 0.023 Prior MI 0.8 0.7–0.9 0.032 Female gender 0.8 0.7–0.9 0.001 Prior CABG 0.7 0.6–0.9 0.003 CVA 0.7 0.6–0.9 0.010 PVD 0.7 0.52–0.9 0.033 CHF 0.7 0.6–0.9 0.001 *Age: continuous; **UA as reference group. Conclusions Referral of ACS patients to CR significantly lowers mortality rate. Referral rate of women to CR is significantly lower than men. Once referred to CR, no gender difference was found in CR participation rate and program compliance. Acknowledgement/Funding None


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