Abstract 14873: Is There Difference in Clinical Outcomes Following Percutaneous Coronary Intervention (PCI) for Acute Coronary Syndrome (ACS) between Hospitals With and Without Onsite Cardiac Surgery Backup?

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Tomonori Akasaka ◽  
Seiji Hokimoto ◽  
Noriaki Tabata ◽  
Kenji Sakamoto ◽  
Kenichi Tsujita ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Clinical Outcomes ◽  
Primary Endpoint ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards Model ◽  
Bleeding Complications ◽  
Hospital Death ◽  
Coronary Syndrome ◽  
Significant Difference ◽  
The Impact

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.

Abstract 283: Variation In Ticagrelor Utilization And Outcomes In Patients With Acute Coronary Syndrome

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Aya Ozaki ◽  
Cynthia JACKEVICIUS ◽  
Alice Chong ◽  
Maria Koh ◽  
Maneesh Sud ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Proportional Hazards Model ◽  
Temporal Trends ◽  
Cox Proportional Hazards Model ◽  
Secondary Outcome ◽  
Administrative Claims ◽  
Factors Associated ◽  
Coronary Syndrome ◽  
Hospital Variation ◽  
Significant Difference

Background: Ticagrelor is a P2Y12 inhibitor with better cardiovascular outcomes than clopidogrel in clinical trials for acute coronary syndromes. However, the adoption of ticagrelor into clinical practice has been understudied. Therefore, we evaluated: 1) temporal trends in ticagrelor use, 2) factors associated with its use, and 3) hospital variation in its adoption and clinical outcomes. Methods: We conducted a population-based cohort study using administrative claims data in Ontario, Canada between 4/2014 and 3/2018. We identified individuals >65 years of age who were admitted for myocardial infarction (MI) or unstable angina (UA) and filled a prescription for ticagrelor or clopidogrel at or within 7 days of discharge. We categorized hospitals into quartiles based on ticagrelor utilization rates. The primary composite outcome was 1-year death or hospitalization for MI/UA, and 1-year bleeding hospitalization was a secondary outcome. Outcomes were evaluated using a Cox proportional hazards model to compare high vs. low utilization groups. Further, we quantified the between-hospital variability of ticagrelor utilization using multi-level logistic regression analysis, expressed as median odds ratios (MOR). Results: Among 23 962 patients in our cohort, 42.5% were prescribed ticagrelor ≤7 days post-hospital discharge. Ticagrelor utilization increased from 32.6% in 2014 to 51.8% in 2017. Hospitals at the lowest quartile of ticagrelor utilization (<8.8%) had a higher hazard of the primary outcome (adjusted hazard ratio: 1.27 95%CI: 1.11-1.46, p<0.001) compared with high ticagrelor utilization hospitals (>40%). No significant difference in bleeding hospitalization across hospital quartiles was observed. Some factors associated with higher ticagrelor use were cardiologist as most responsible physician during index hospitalization and urban hospital. After adjusting for patient-, prescriber- and hospital-level characteristics, substantial variation remained between hospitals in the likelihood of patients receiving ticagrelor at discharge (MOR: 2.54). Conclusion: Increasing trends of ticagrelor utilization were observed. Ticagrelor utilization rates varied across hospitals, and hospitals with higher ticagrelor adoption were associated with better clinical outcomes.

scholarly journals Does Vancomycin Resistance Increase Mortality? Clinical Outcomes and Predictive Factors for Mortality in Patients with Enterococcus faecium Infections

Antibiotics ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. 105
Author(s):  
Jatapat Hemapanpairoa ◽  
Dhitiwat Changpradub ◽  
Sudaluck Thunyaharn ◽  
Wichai Santimaleeworagun
Keyword(s):  
Risk Factors ◽  
Clinical Outcomes ◽  
Proportional Hazards Model ◽  
Significant Risk ◽  
Vancomycin Resistance ◽  
Cox Proportional Hazards Model ◽  
Factors Associated ◽  
Joint Infections ◽  
Bone And Joint Infections ◽  
The Impact

The prevalence of enterococcal infection, especially E. faecium, is increasing, and the issue of the impact of vancomycin resistance on clinical outcomes is controversial. This study aimed to investigate the clinical outcomes of infection caused by E. faecium and determine the risk factors associated with mortality. This retrospective study was performed at the Phramongkutklao Hospital during the period from 2014 to 2018. One hundred and forty-five patients with E. faecium infections were enrolled. The 30-day and 90-day mortality rates of patients infected with vancomycin resistant (VR)-E. faecium vs. vancomycin susceptible (VS)-E. faecium were 57.7% vs. 38.7% and 69.2% vs. 47.1%, respectively. The median length of hospitalization was significantly longer in patients with VR-E. faecium infection. In logistic regression analysis, VR-E. faecium, Sequential Organ Failure Assessment (SOFA) scores, and bone and joint infections were significant risk factors associated with both 30-day and 90-day mortality. Moreover, Cox proportional hazards model showed that VR-E. faecium infection (HR 1.91; 95%CI 1.09–3.37), SOFA scores of 6–9 points (HR 2.69; 95%CI 1.15–6.29), SOFA scores ≥ 10 points (HR 3.71; 95%CI 1.70–8.13), and bone and joint infections (HR 0.08; 95%CI 0.01–0.62) were significant risk factors for mortality. In conclusion, the present study confirmed the impact of VR-E. faecium infection on mortality and hospitalization duration. Thus, the appropriate antibiotic regimen for VR-E. faecium infection, especially for severely ill patients, is an effective strategy for improving treatment outcomes.

scholarly journals Effect of PCSK9 E670G and R46L Polymorphisms on Major Adverse Cardio-Cerebrovascular Events in Patients with ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

2021 ◽  
Author(s):  
Anwar Santoso ◽  
Yulianto Yulianto ◽  
Hendra Simarmata ◽  
Abhirama Nofandra Putra ◽  
Erlin Listiyaningsih
Keyword(s):  
Myocardial Infarction ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
St Segment Elevation ◽  
Coronary Syndrome ◽  
Segment Elevation Myocardial Infarction ◽  
Cerebrovascular Events ◽  
St Segment ◽  
Significant Difference

AbstractMajor adverse cardio-cerebrovascular events (MACCE) in ST-segment elevation myocardial infarction (STEMI) are still high, although there have been advances in pharmacology and interventional procedures. Proprotein convertase subtilisin/Kexin type 9 (PCSK9) is a serine protease regulating lipid metabolism associated with inflammation in acute coronary syndrome. The MACCE is possibly related to polymorphisms in PCSK9. A prospective cohort observational study was designed to confirm the association between polymorphism of E670G and R46L in the PCSK9 gene with MACCE in STEMI. The Cox proportional hazards model and Spearman correlation were utilized in the study. The Genotyping of PCSK9 and ELISA was assayed.Sixty-five of 423 STEMI patients experienced MACCE in 6 months. The E670G polymorphism in PCSK9 was associated with MACCE (hazard ratio = 45.40; 95% confidence interval: 5.30–390.30; p = 0.00). There was a significant difference of PCSK9 plasma levels in patients with previous statin consumption (310 [220–1,220] pg/mL) versus those free of any statins (280 [190–1,520] pg/mL) (p = 0.001).E670G polymorphism of PCSK9 was associated with MACCE in STEMI within a 6-month follow-up. The plasma PCSK9 level was higher in statin users.

Abstract 13290: GDF-15 at One Month After an Acute Coronary Syndrome is Associated With Increased Risk of Major Bleeding - A PLATO Biomarker Substudy

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Daniel Lindholm ◽  
Emil Hagström ◽  
Stefan K James ◽  
Richard C Becker ◽  
Christopher P Cannon ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Major Bleeding ◽  
Proportional Hazards Model ◽  
Bleeding Risk ◽  
Cox Proportional Hazards Model ◽  
Antiplatelet Treatment ◽  
Additional Information ◽  
Coronary Syndrome ◽  
Increased Risk ◽  
Dual Antiplatelet Treatment

Introduction: Levels of Growth Differentiation Factor-15 (GDF-15) are associated with major bleeding events in acute coronary syndromes (ACS), when measured at the time of initial presentation. We hypothesized that an additional measurement of GDF-15 at 1 month after ACS provides additional information regarding risk of major bleeding. Methods: In the PLATO trial, levels of GDF-15 were determined in 4049 ACS patients at both baseline and at 1 month, using an immunoassay (Roche). The primary endpoint was non-CABG related major bleeding. A 1-month landmark analysis was performed, in relation to GDF-15 elevation status at baseline and 1 month, using a cutoff of 1800 ng/L. The relation between GDF-15 at 1 month and the primary endpoint from 1 month onward was evaluated using a Cox proportional hazards model; adjusting for baseline GDF-15, age, anemia (hemoglobin <130 g/L in men, <120 g/L in women), impaired renal function (eGFR <50 mL/min/1.73m2), and history of gastrointestinal bleeding. Results: In the unadjusted analysis, patients with GDF-15 >1800 ng/L at 1 month had increased bleeding rates during follow-up, irrespective of the baseline value. Patients with GDF-15 ≤1800 ng/L at 1 month had lower bleeding risk regardless of initial level (see figure). In the adjusted analysis, GDF-15 >1800 ng/L at 1 month was independently associated with the outcome, hazard ratio 3.39 (95% CI 1.89-6.09). Conclusions: The level of GDF-15 at 1 month after ACS is related to the risk of bleeding during dual antiplatelet treatment. Assessment of GDF-15 level at 1 month provides additional information on the subsequent bleeding risk, regardless of the patient’s index GDF-15 level in the acute phase, and may therefore be helpful for decision-making on continued dual antiplatelet treatment.

P6355The behavior of atrial fibrillation in patients with heart failure hospitalization

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Fukunaga ◽  
K Hirose ◽  
A Isotani ◽  
T Morinaga ◽  
K Ando
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Cardiovascular Disease ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Significant Difference ◽  
The Impact

Abstract Background Relationship between atrial fibrillation (AF) and heart failure (HF) is often compared with proverbial question of which came first, the chicken or the egg. Some patients showing AF at the HF admission result in restoration of sinus rhythm (SR) at discharge. It is not well elucidated that the restoration into SR during hospitalization can render the preventive effect for rehospitalization. Purpose To investigate the impact of restoration into SR during hospitalization for readmission rate of the HF patients showing AF. Methods We enrolled consecutive 640 HF patients hospitalized from January 2015 to December 2015. Patients data were retrospectively investigated from medical record. Patients showing atrial fibrillation on admission but unrecognized ever were defined as “incident AF”; patients with AF diagnosed before admission were defined as “prevalent AF”. Primary endpoint was a composite of death from cardiovascular disease or hospitalization for worsening heart failure. Secondary endpoints were death from cardiovascular disease, unplanned hospitalization related to heart failure, and any hospitalization. Results During mean follow up of 19 months, 139 patients (22%) were categorized as incident AF and 145 patients (23%) were categorized as prevalent AF. Among 239 patients showing AF on admission, 44 patients were discharged in SR (39 patients in incident AF and 5 patients in prevalent AF). Among incident AF patients, the primary composite end point occurred in significantly fewer in those who discharged in SR (19% vs. 42% at 1-year; 23% vs. 53% at 2-year follow-up, p=0.005). To compare the risk factors related to readmission due to HF with the cox proportional-hazards model, AF only during hospitalization [Hazard Ratio (HR)=0.37, p<0.01] and prevalent AF (HR=1.67, p=0.04) was significantly associated. There was no significant difference depending on LVEF. Conclusion Newly diagnosed AF with restoration to SR during hospitalization was a good marker to forecast future prognosis.

Abstract T MP60: Impact of Aortic Arch Atheroma for Stroke Recurrence in Patients With or Without Atrial Fibrillation

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Shigeru Fujimoto ◽  
Masato Osaki ◽  
Masaya Kumamoto ◽  
Makoto Kanazawa ◽  
Naoki Tagawa ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Aortic Arch ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards Model ◽  
Rank Test ◽  
Stroke Recurrence ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
The Impact

Background & Purpose: In patients with embolic stroke of undetermined source, aortic arch atheroma evaluated using transesophageal echocardiography (TEE) is a possible embolic source. We investigated the impact of embolic sources including aortic arch atheroma for a stroke recurrences and death. Methods: Among the consecutive 1545 acute stroke patients, 542 patients who were admitted within 24 hours after the symptom onset, with ischemic lesions in the cortex or cerebellum on the diffusion-weighted image, NIH stroke scale of 7 or less, and prior modified Rankin scale (mRS) of 0 or 1 were included in the present study. All 542 patients underwent TEE to search for embolic sources. According to the categories of embolic sources, patients were classified into 4 groups: patients with severe aortic arch atheroma of 4mm or more in diameter (group A; n=167), patients with cardiogenic embolic sources such as atrial fibrillation or intracardiac thrombus (group C; n=93), patients with both factors as described above (group B; n=88), and other patients (group O; n=194). We followed them up for average period of 3.2 years, and investigated the frequency of stroke recurrences and death from any cause according to embolic sources. Results: Stroke recurrences were observed in 12.0% patients in group A, 11.8% patients in group C, 18.2% patients in group B, and 6.7% patients in group O respectively (p=0.0371). Stroke recurrences and death from any cause occurred in 14.4%, 15.1%, 21.6% and 6.7% patients respectively (p=0.0041). Kaplan-Meier curve analysis revealed a significant difference in the recurrence-free survival among the four groups (p=0.0076, log-rank test). Stroke recurrence was more frequent in group B than group C patients especially in the early phase from the onset. On COX proportional-hazards model analysis and diabetes mellitus (HR 1.73, p=0.0264) and aortic arch atheroma of 4mm or more (HR 1.86, p=0.0146) were significant predictors for stroke recurrences and death from any cause. Conclusions: Severe aortic arch atheroma can independently be associated with stroke recurrences and death, furthermore, a combination of aortic arch atheroma and cardiogenic embolic sources showed more frequent events than each of them alone.

scholarly journals Mortality Rates do not Differ among Patients Prescribed Various Vitamin d Agents

2015 ◽  
Vol 35 (1) ◽  
pp. 62-69 ◽  
Author(s):  
T. Christopher Bond ◽  
Steve Wilson ◽  
John Moran ◽  
Mahesh Krishnan
Keyword(s):  
Vitamin D ◽  
Peritoneal Dialysis ◽  
Proportional Hazards Model ◽  
Mortality Rates ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Dialysis Patients ◽  
Oral Vitamin ◽  
Significant Difference ◽  
The Impact

BackgroundLimited well-controlled research exists examining the impact of different formulations of oral vitamin D on clinical outcomes in dialysis patients, specifically those on peritoneal dialysis. For this retrospective mortality analysis, we compared mortality rates of patients on 3 of the most commonly prescribed vitamin D agents.MethodsWe examined 2 years (7/1/2008 to 6/30/2010) of oral medication records of peritoneal dialysis patients from a large US dialysis organization. Patients were identified whose physicians prescribed a single form of vitamin D (calcitriol, paricalcitol, or doxercalciferol) for ≥ 90% of all patient-months. We excluded incident patients (< 90 days on dialysis) and patients whose physicians treated < 5 peritoneal dialysis patients at a dialysis facility, and we assessed mortality.ResultsThe analysis inclusion criteria identified 1,707 patients. The subset in this analysis included 12.6% of all prevalent peritoneal dialysis patients and 11.8% of prevalent patient-months. Patients with physicians who predominately prescribed calcitriol had a lower mortality rate: 9.33 (confidence interval (CI) 7.06, 11.60) deaths per 100 patient-years than the doxercalciferol, 12.20 (CI 9.34, 15.06) or paricalcitol, 12.27 (CI 9.27, 15.28) groups. However, these differences were not statistically significant. A Cox proportional hazards model, adjusting for differences in age, vintage, gender, race, body mass index, and comorbidities also showed no significant differences.ConclusionsFor this peritoneal dialysis population, instrumental variable analyses showed no significant difference in mortality in patients taking the most common oral vitamin D formulations (calcitriol, doxercalciferol, paricalcitol).

The impact of chronic hepatitis C virus infection on survival in oropharyngeal cancer patients.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e17556-e17556
Author(s):  
Minas P. Economides ◽  
Erich M. Sturgis ◽  
Moran Amit ◽  
Jeff Hosry ◽  
Parag Mahale ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Proportional Hazards Model ◽  
Univariate Analysis ◽  
Hcv Infection ◽  
Cox Proportional Hazards Model ◽  
Oncologic Outcomes ◽  
Hcv Rna ◽  
Significant Difference ◽  
The Impact

e17556 Background: An association between Hepatitis C virus (HCV) infection and oropharyngeal cancers (OPCs) has been reported; however, the clinical significance of this epidemiological finding remains unknown. We therefore analyzed the oncologic outcomes of HCV-infected patients (pts) with OPCs. Methods: In this retrospective cohort study, all pts with OPCs seen at MD Anderson (1/2004-12/2015) were reviewed. HCV infection was defined as detectable HCV RNA in serum. Risk of 5-year (yr) overall survival (OS) and progression-free survival (PFS) was compared between HCV-infected (HCV+) and uninfected (HCV-) pts. OPCs that were positive for p16 by immunohistochemistry were considered HPV-related. Antiviral therapy (AVT) included either interferon (IFN)-based or IFN-free regimens. Multivariate cox proportional hazards model was used to identify independent predictors of mortality. Results: We studied 161 pts. Most of the pts were white (141; 88%), male (132; 82%) and had tumor stage 3 or 4 (147; 92%). The OPC involved tonsils (83; 52%), base of tongue (67; 42%) or soft palate (11; 7%). The median follow-up time after OPC diagnosis was 3 yrs (range: 1-13 yrs). HCV+ (n = 25) and HCV- pts (n = 136) were comparable in regards to smoking and alcohol status. In univariate analysis, HCV+ pts had more OPC progression after 1stline cancer treatment (48% vs 20.6% in HCV-, P = .0009) and were more likely to relapse (26% vs 5% in HCV-, P = .02). In multivariate analysis, HCV was associated with increased all-cause mortality [hazard ratio (HR): 2.15, 95% confidence intervals (CI): 1.08-6.85; P = .02] and risk of OPC progression [HR: 5.42, 95% CI: 2.64-11.14; P = .0008] independent of age and cirrhosis status. In HPV+ OPCs (n = 86), HCV + and HCV- pts did not have significant difference in mortality [HR: 2.03, 95% CI: 0.82-4.98; P = .12]. AVT was administered after OPC diagnosis in 8 of the 25 HCV+ pts (32%), with 6 of them receiving IFN-free AVT. HCV+ pts that received AVT had better 5 yr OS (median of 5.2 vs 2.3 yrs, P = .005) and PFS (median of 3.1 vs 0.7 yrs, P = .007) than the ones who did not. Conclusions: HCV seems to affect the oncologic outcomes of pts with OPCs and treating this infection might be beneficial. HCV screening and treatment should be considered in such pts.

P6439Clinical outcomes of acute coronary syndrome with intact-fibrous cap plaque at the culprit lesions in diabetic and non-diabetic patients

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Niida ◽  
T Yonetsu ◽  
T Lee ◽  
M Nakao ◽  
S Nakagama ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Coronary Syndrome ◽  
Clinical Outcomes ◽  
Diabetic Patients ◽  
Culprit Lesion ◽  
Coronary Syndrome ◽  
Fibrous Cap ◽  
Significant Difference ◽  
The Impact ◽  
Lesion Morphology

Abstract Background Previous studies revealed that the morphological substrates of the culprit lesion assessed by optical coherence tomography (OCT) in acute coronary syndrome (ACS), which includes ruptured plaque (RP) and intact fibrous cap (IFC) plaque, are associated with subsequent clinical outcomes. Nevertheless, the impact of culprit morphology on clinical outcomes has not been evaluated in patients with diabetes mellitus (DM), which is one of the major determinants of clinical prognosis. Purpose We sought to investigate the association of the culprit lesion morphology with clinical outcomes in patients with DM and those without DM. Methods We retrospectively investigated a total of 508 patients with acute myocardial infarction (AMI) experiencing their first episode of ACS in whom OCT-guided, primary percutaneous coronary intervention (PCI) was performed and a culprit lesion was observed by OCT with sufficient image quality. Patients were divided into two groups according to the culprit lesion morphology into patients with RP (RP group) and those without RP (IFC group). The rate of major adverse cardiac events (MACE) including death, myocardial infarction, target or non-target lesion revascularizations were compared between RP and IFC groups in patients with DM (DM) and those without DM (non-DM), separately. Results MACE was captured in 80 patients during the median follow-up of 505 (IQR 274–1300) days. In non-DM, RP group showed significantly worse MACE-free rate than in IFC group (Figure), In DM, there was no significant difference between RP and IFC groups (Figure). Figure 1 Conclusion Culprit lesion morphology assessed by OCT was not associated with clinical outcomes in DM patients unlike non-DM patients. Distinct strategy for secondary prevention may be required for DM patients.

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 ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Primary Endpoint ◽  
Reference Group ◽  
Artery Bypass ◽  
Demographic Characteristics ◽  
Chronic Obstructive ◽  
Cardiovascular Research ◽  
Coronary Syndrome ◽  
P2y12 Antagonists ◽  
The Impact

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.

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