Trade-off of major bleeding versus myocardial infarction on mortality after percutaneous coronary intervention

BackgroundThe choice of antithrombotic therapy after percutaneous coronary intervention (PCI) is heavily dependent on the relative trade-off between major bleeding (MB) and myocardial infarction (MI). However, the mortality trade-off was mostly described in Western populations and remained unknown in East Asians.MethodThis was a retrospective cohort study from 14 hospitals under the Hospital Authority of Hong Kong between 2004 and 2017. Participants were patients undergoing first-time PCI and survived for the first year. Patients were stratified by the presence of MB and MI during the first year. The primary endpoint was all-cause mortality between 1 and 5 years after PCI. The secondary endpoint was cardiovascular mortality.ResultsA total of 32 180 patients were analysed. After adjustment for baseline characteristics and using patients with neither events as reference, the risks of all-cause mortality were increased in patients with MI only (HR, 1.63; 95% CI 1.45 to 1.84; p<0.001), further increased in those with MB only (HR, 2.11, 95% CI 1.86 to 2.39; p<0.001) and highest in those with both (HR, 2.92; 95% CI 2.39 to 3.56; p<0.001). In both Cox regression and propensity score analyses, MB had a stronger impact on all-cause mortality than MI, but similar impact on cardiovascular mortality.ConclusionsBoth MB and MI within the first year after PCI were associated with increase in all-cause and cardiovascular mortality in Chinese patients, but the impact was stronger with MB.

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Transradial Versus Transfemoral Access for Percutaneous Coronary Intervention in ST-Segment–Elevation Myocardial Infarction

Circulation Cardiovascular Interventions ◽

10.1161/circinterventions.120.009994 ◽

2021 ◽

Vol 14 (3) ◽

Author(s):

Pietro Di Santo ◽

Trevor Simard ◽

George A. Wells ◽

Richard G. Jung ◽

F. Daniel Ramirez ◽

...

Keyword(s):

Myocardial Infarction ◽

Percutaneous Coronary Intervention ◽

Major Bleeding ◽

Coronary Intervention ◽

Access Site ◽

St Segment Elevation ◽

Segment Elevation Myocardial Infarction ◽

St Segment ◽

Percutaneous Coronary ◽

All Cause Mortality

Background: Transradial access (TRA) has emerged as the preferred vascular access site for coronary angiography and percutaneous coronary intervention. This systematic review and meta-analysis was performed to evaluate 30-day all-cause mortality comparing TRA with transfemoral access for percutaneous coronary intervention in patients with ST-segment–elevation myocardial infarction. Methods: We performed a systematic literature search and meta-analysis of randomized controlled studies published from inception until January 7, 2020, in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and Web of Science Core Collection. Preferred Reported Items for Systematic Reviews and Meta-Analyses guidelines were used for abstracting data. The primary outcome was all-cause mortality at 30 days. Secondary outcomes included myocardial infarction, major bleeding, stroke, and access site complications. Results: A total of 14 studies representing 11 707 patients (5802 patients with TRA; 5905 patients with transfemoral access) were included in this systematic review. All-cause mortality (N=8 studies) was significantly reduced in the TRA group with an overall risk ratio (RR) of 0.72 (95% CI, 0.56–0.92) in the pooled analysis. Major bleeding (N=12 studies; RR, 0.60 [95% CI, 0.45–0.80]) and access site complications (N=9 studies; RR, 0.40 [95% CI, 0.30–0.53]) were significantly higher in the transfemoral access group. There was no statistical difference in reinfarction (N=10 studies; RR, 0.96 [95% CI, 0.75–1.25]) or stroke (N=8 studies; RR, 1.47 [95% CI, 0.87–2.50]). Conclusions: TRA is associated with lower 30-day mortality, major bleeding, and access site complications when compared with transfemoral access in ST-segment–elevation myocardial infarction patients who undergo percutaneous coronary intervention. Registration: URL: https://www.crd.york.ac.uk/PROSPERO/ ; Unique identifier: 127955.

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Prognostic Value of Incomplete Revascularization after Percutaneous Coronary Intervention Following Acute Coronary Syndrome: Focus on CKD Patients

Journal of Clinical Medicine ◽

10.3390/jcm8060810 ◽

2019 ◽

Vol 8 (6) ◽

pp. 810 ◽

Cited By ~ 6

Author(s):

Thomas Cardi ◽

Anas Kayali ◽

Antonin Trimaille ◽

Benjamin Marchandot ◽

Jessica Ristorto ◽

...

Keyword(s):

Percutaneous Coronary Intervention ◽

Cardiovascular Mortality ◽

Cardiac Death ◽

Coronary Intervention ◽

Syntax Score ◽

Percutaneous Coronary ◽

All Cause Mortality ◽

Incomplete Revascularization ◽

One Year ◽

The Impact

Background: Residual coronary artery disease (CAD) has been associated with worsened prognosis in patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS). The residual SYNTAX Score (rSS) aims to assess residual CAD after PCI. The association between kidney function and rSS has not been investigated in ACS patients. In this study, we sought to determine whether chronic kidney disease (CKD) patients exhibit more incomplete revascularization following stage revascularization procedures by PCI. We evaluated the impact of incomplete revascularization on the occurrence of major cardiovascular events (MACE) at one-year follow-up. Methods: A total of 831 ACS patients undergoing PCI were divided into 3 subgroups according to their estimated Glomerular Filtration Rate (eGFR): 695 with eGFR ≥ 60 mL/min/1.73 m², 108 with eGFR 60–30 mL/min/1.73 m², 28 with eGFR < 30 mL/min/1.73 m². Initial SYNTAX score (SS) and rSS were calculated for all patients. Incomplete revascularization was defined by rSS > 8. The primary endpoint was the occurrence of MACE (all-cause mortality, myocardial infarction (MI), repeated revascularization except from planned revascularization, stroke and definite or probable recurrent stent thrombosis) one year after the index procedure. Results: Severe CKD patients had significantly higher MACE (12.0% vs. 25.9% vs. 35.7%; p < 0.001), all-cause mortality, cardiovascular mortality and heart failure events. Patients with rSS > 8 had higher MACE, all-cause and cardiovascular mortality. CKD was an independent predictive factor of rSS > 8 (HR: 1.65, 95% CI: 1.01 to 2.71; p = 0.048). Multivariate analysis identified rSS > 8, but not CKD, as an independent predictor of cardiac death and MACE. Conclusion: In ACS, CKD is predictive of incomplete revascularization, which stands out as a strong predictor of adverse cardiovascular outcomes including cardiac death and MACE.

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Primary percutaneous coronary intervention in nonagenarian patients

European Heart Journal ◽

10.1093/ehjci/ehaa946.1744 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

F Angelini ◽

F Fortuni ◽

M Bellettini ◽

M Casula ◽

...

Keyword(s):

Myocardial Infarction ◽

Percutaneous Coronary Intervention ◽

Blood Transfusion ◽

Major Bleeding ◽

Lower Incidence ◽

Meta Analysis ◽

Coronary Intervention ◽

Percutaneous Coronary ◽

All Cause Mortality

Abstract Background Given the continuous increase in life expectancy, elderly patients with ST segment elevation myocardial infarction (STEMI) are becoming a growing proportion of those referred for primary percutaneous coronary intervention (pPCI). However, this population is usually excluded from randomized trials and limited data are available to guide clinical decisions. The aim of this study-level meta-analysis was to describe and analyze the determinants of outcomes in this population. Methods We searched the literature for studies reporting ischemic and hemorrhagic outcomes and/or mortality in nonagenarian patients undergoing pPCI. An analysis of the heterogeneity between studies in outcome reports was performed with I2 test. A univariate meta-regression analysis was conducted to explore the relationship between outcomes of interest and classic cardiovascular risk factors, gender, previous myocardial infarction (MI), MI location, PCI characteristics, hemodynamic instability, vascular access, intra-aortic balloon pump (IABP) and Glycoprotein IIb/IIIa inhibitor (GPI) use. Results Overall, 15 observational studies met our inclusion criteria, with a total of 6787 patients; mean age was 92.4 and 35% were male. The incidence of in-hospital death was 21.3%, 1.4% of our population suffered an in-hospital ischemic stroke and 11.1% faced acute renal failure; in-hospital major bleedings affected 1.7% of the population, but blood-transfusion was needed in 6.9%. Long-term mortality rate was 21.5%. Killip III-IV at admission was related with increased in-hospital mortality (β: 0.2%; p: 0.041), but lower incidence of ARF (β: −0.6%; p: 0.004). Angiographic success was associated with a lower incidence of long-term all-cause mortality (β: −1.7%; p: 0.017) and higher incidence of ARF (β: 1.7%, p<0.001). A higher number of coronary stents implanted was associated with a lower incidence of long-term all-cause mortality (β: −73%; p: 0.01). A higher long-term all-cause mortality was related with male gender (β: 0.9%; p: 0.027) and previous MI (β: 1.5%; p: 0.007). Diabetes was associated with a lower incidence of long-term all-cause mortality (β: −0.8%; p: 0.014) despite a higher incidence of in-hospital blood transfusion (β: 0.5%, p: 0.05), while a history of MI (β: 0.1%; p: 0.049), as well as the use of GPI (β: 0.04) was related with a higher incidence of in-hospital major bleeding. The use of IABP was related with a lower incidence of long-term all-cause death (β: 6.5%; p<0.001) and in-hospital major bleeding (β: −0.4%; p: 0.038). Discussion Our meta-analysis, pooling the largest cohort of nonagenarians undergoing pPCI confirms the feasibility of urgent percutaneous coronary intervention also in this frail population. In particular, although angiographic success increased the incidence of in-hospital ARF, it was associated with a higher long-term survival underling the pivotal role of myocardial reperfusion. Funding Acknowledgement Type of funding source: None

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CLINICAL OUTCOMES OF PATIENTS WITH ACUTE MYOCARDIAL INFARCTION AFTER PERCUTANEOUS CORONARY INTERVENTION AMONG CARDIAC REHABILITATION AND NON CARDIAC REHABILITATION GROUPS-A PROSPECTIVE OBSERVATIONAL STUDY

10.36106/gjra/1900954 ◽

2021 ◽

pp. 25-27

Author(s):

Saroj Mandal ◽

Vignesh. R ◽

Sidnath Singh

Keyword(s):

Myocardial Infarction ◽

Acute Myocardial Infarction ◽

Percutaneous Coronary Intervention ◽

Observational Study ◽

Cardiac Rehabilitation ◽

Prospective Observational Study ◽

Coronary Intervention ◽

Cardiac Mortality ◽

Percutaneous Coronary ◽

All Cause Mortality

OBJECTIVES To determine clinical outcome and to nd out the association between participation of patients with acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI) in cardiac rehabilitation programme. DESIGN A Prospective observational study. STUDY AREA : Department of Cardiology, Institute of Postgraduate Medical Education and Research,Kolkata. PARTICIPANTS: Patients aged ≥18 years who underwent PCI due to AMI. OUTCOME MEASURES The outcomes were subsequent myocardial infarction, revascularisation, all-cause readmission, cardiac readmission, all-cause mortality and cardiac mortality. RESULT: The data of 1107 patients were included and 60.07%% of them participated in CR program. The risks of revascularisation, all cause readmission and cardiac readmission among CR participants were compared. The results of those analysis were consistent and showed that the CR participants had lower allcause mortality ,cardiac mortality,all cause readmission, cardiac admission. However no effect was observed for subsequent myocardial infarction or revascularisation. CONCLUSIONS: It was suggested CR participation may reduce the risk of all-cause mortality ,cardiac mortality, all cause readmission and cardiac admission.

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Abstract 3760: Thiazolidinediones Do Not Reduce 1 Year Event Rates In Diabetic Patients Undergoing Percutaneous Coronary Intervention

Circulation ◽

10.1161/circ.116.suppl_16.ii_855 ◽

2007 ◽

Vol 116 (suppl_16) ◽

Author(s):

Abdul Sheikh ◽

Khan Pohlel ◽

Emir Veledar ◽

Viola Vaccarino ◽

John S Douglas ◽

...

Keyword(s):

Myocardial Infarction ◽

Percutaneous Coronary Intervention ◽

Meta Analysis ◽

Composite Endpoint ◽

Coronary Intervention ◽

Similar Rate ◽

Coronary Stenting ◽

Diabetic Patients ◽

Percutaneous Coronary ◽

The Impact

Background: Thiazolidinediones (TZD) have been shown to decrease intimal hyperplasia by intravascular ultrasound after coronary stenting. However, a recent meta-analysis showed increased MI and suggested increased CV deaths with TZD use. We examined the impact of TZD use on the 1-year clinical outcomes of diabetic patients undergoing percutaneous coronary interventions. Methods: From 2000 through 2003, 598 diabetic patients underwent percutaneous coronary intervention at Emory University. Medication profiles were available for all patients who were divided into two groups: those that had a TZD as part of their diabetes regimen and those that did not. We compared the baseline clinical characteristics, angiographic characteristics, and 1 year rate of a composite endpoint of death, myocardial infarction, and revascularization between the two groups. Results: There was no difference between the two groups with regards to age, sex, baseline medical conditions, medication regimens, and overall glycemic control at the time of percutaneous coronary intervention. The lesions in both groups were of similar length, diameter, and characteristics. At 1 year the composite of death, non-fatal myocardial infarction (MI), and revascularization was not statistically different in the diabetics taking TZDs compared to those not taking TZDs (28.5% vs. 23.2%, p=0.15). There were also no differences in the rates of death and non-fatal MI. There was however a statistically significant increase in the rate of revascularization in diabetics taking TZDs compared to those not taking TZDs (25.4% vs. 17.3%, p=0.02). Conclusion: Diabetic patients undergoing coronary stenting who were on TZDs had a statistically significant increased rate of revascularization. However, there was a similar rate of the combined endpoint of death, non-fatal MI, and revascularization in all diabetic patients irrespective of TZD usages.

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Abstract 15728: Machine Learning Helps Predict Short and Intermediate-term Risk for All Cause Mortality in Patients Undergoing Percutaneous Coronary Intervention

Circulation ◽

10.1161/circ.142.suppl_3.15728 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Pradyumna Agasthi ◽

Hasan Ashraf ◽

Chieh-Ju Chao ◽

Panwen Wang ◽

Mohamed Allam ◽

...

Keyword(s):

Machine Learning ◽

Myocardial Infarction ◽

Percutaneous Coronary Intervention ◽

Coronary Intervention ◽

Machine Learning Algorithms ◽

St Elevation Myocardial Infarction ◽

Percutaneous Coronary ◽

All Cause Mortality ◽

St Elevation ◽

Clinical Records

Background: Identifying patients at a high risk of mortality post percutaneous coronary intervention (PCI) is of vital clinical importance. We investigated the utility of machine learning algorithms to predict short and intermediate-term risk of all-cause mortality in patients undergoing PCI. Methods: Patient-level demographics, clinical, electrocardiographic ,echocardiographic and angiographic data from January 2006 to December 2017 were extracted from the Mayo Clinic CathPCI registry and clinical records. For patients with multiple PCI events, data collected at the time of the index PCI was used for analysis. Patients who underwent bailout coronary artery bypass graft surgery (CABG) prior to discharge were excluded. 306 variables were incorporated into random forest machine learning model (RF) to predict all-cause mortality at 6 months and 1 year after PCI. Ten-fold cross-validation repeated five times was used to optimize the hyperparameters and estimate its external performance. The National Cardiovascular Data Registry (NCDR) based logistic regression model was used for comparison. The area under receiver operator characteristic curves (AUC) was calculated to assess the ability of the models to predict all-cause mortality. Results: A total of 17356 unique patients were included for the final analysis after excluding 165 patients who underwent CABG surgery during the index hospitalization. The mean age was 66.9 ± 12.5 years;71% were male. Indications for PCI were ST-elevation myocardial infarction (9.4%), non-ST elevation myocardial infarction (12.9%), unstable angina (17.7%), and stable angina (52.8%) in the cohort. In-hospital, 6-month & 1 year mortality rates were 1.9%,4.2% & 5.8% respectively. The RF model was superior to the NCDR model in predicting inhospital, 6-month, 1 year mortality (p<0.0001) ( Figure 1 ). Conclusion: Machine learning is superior to NCDR model in predicting short and intermediate risk of all-cause mortality post PCI.

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Abstract 15071: Effect of Percutaneous Coronary Intervention on Death and Myocardial Infarction in Patients Withstable Coronary Artery Disease and Inducible Ischemia

Circulation ◽

10.1161/circ.142.suppl_3.15071 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Qais Radaideh ◽

Mohammed Osman ◽

Babikir Kheiri ◽

Ahmad Al-Abdouh ◽

mahmoud Barbarawi ◽

...

Keyword(s):

Myocardial Infarction ◽

Coronary Artery Disease ◽

Percutaneous Coronary Intervention ◽

Coronary Artery ◽

Stress Testing ◽

Coronary Intervention ◽

Percutaneous Coronary ◽

All Cause Mortality ◽

Artery Disease ◽

Severe Ischemia

Introduction: There has been a continuous debate about the survival benefit of percutaneous coronary intervention (PCI) for the management of patients with stable coronary artery disease (CAD) and moderate to severe ischemia. To address this, we performed a meta-analysis of RCTs comparing PCI plus MT vs. MT alone in stable CAD patients to evaluate endpoints of all-cause mortality, cardiovascular (CV) mortality, and MI in a larger cohort of patients with objective evidence of myocardial ischemia. Methods: An electronic database search was conducted for RCTs that compared PCI on top of MT versus MT alone. A random effects model was used to calculate relative risk (RR) and 95% confidence intervals (CIs). Results: A total of 7 RCTs with 10,043 patients with a mean age of 62.54 ± 1.56 years and a median follow up of 3.9 years were identified. Among patients with (CAD) and moderate to severe ischemia by stress testing, PCI didn’t show any benefit for the primary outcome of all-cause mortality compared to MT(RR = 0.85; 95% CI 0.646-1.12; p= 0.639). There was also no benefit in cardiovascular (CV) death (RR = 0.88 ; 95% CI 0.71-1.09; p =0.18) or myocardial infarction (MI) (RR = 0.271 ; 95% CI 0.782-1.087; P =0.327) in the PCI group as compared to MT. Conclusions: Among patients with (CAD) and evidence of moderate to severe ischemia by stress testing, PCI on top of MT appears to add no mortality benefit as compared to with MT alone.

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Impact of Pre-Existing Depression in Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention; A Nationwide Cohort Study

10.21203/rs.3.rs-121586/v1 ◽

2020 ◽

Author(s):

Jangho Park ◽

Sangwoo Park ◽

Yong-Giun Kim ◽

Soe Hee Ann ◽

Hyun Woo Park ◽

...

Keyword(s):

Coronary Artery Disease ◽

Percutaneous Coronary Intervention ◽

Coronary Artery ◽

Propensity Score ◽

Propensity Score Matching ◽

Coronary Intervention ◽

Percutaneous Coronary ◽

All Cause Mortality ◽

Artery Disease ◽

The Impact

Abstract The impact of pre-existing depression on mortality in individuals with established coronary artery disease (CAD) remains unclear. We evaluate the clinical implications of pre-existing depression in patients who underwent percutaneous coronary intervention (PCI). Based on National Health Insurance claims data in Korea, patients without a known history of CAD who underwent PCI between 2013 and 2017 were enrolled. The study population was divided into patients with angina (n=50,256) or acute myocardial infarction (AMI; n=40,049). The primary endpoint, defined as all-cause death, was compared between the non-depression and depression groups using propensity score matching analysis. After propensity score matching, there were 4,262 and 2,346 matched pairs of patients with angina and AMI, respectively. During the follow-up period, there was no significant difference in the incidence of all-cause death in the angina (hazard ratio [HR] of depression, 1.013; 95% confidence interval [CI]: 0.893-1.151) and AMI (HR, 0.991; 95% CI: 0.865-1.136) groups. However, angina patients less than 65 years of age with depression had higher all-cause mortality (HR, 1.769; 95% CI: 1.240-2.525). In Korean patients undergoing PCI, pre-existing depression is not associated with poorer clinical outcomes. However, in younger patients with angina, depression is associated with higher all-cause mortality.

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P3123Enoxaparin versus unfractionated heparin in ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention

European Heart Journal ◽

10.1093/eurheartj/ehz745.0198 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

L Graca Santos ◽

R Ribeiro Carvalho ◽

F Montenegro ◽

C Ruivo ◽

J Correia ◽

...

Keyword(s):

Myocardial Infarction ◽

Percutaneous Coronary Intervention ◽

Propensity Score ◽

Major Bleeding ◽

Primary Percutaneous Coronary Intervention ◽

Coronary Intervention ◽

Percutaneous Coronary ◽

Group A ◽

St Elevation ◽

Group B

Abstract Background The use of intravenous enoxaparin (LBWH) in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) was upgraded in the latest European Guidelines to a class IIa recommendation. Purpose The authors aim to compare safety and prognostic impact of LMWH versus unfractionated heparin (UFH) use in STEMI patients undergoing primary PCI. Methods Retrospective study of 3875 STEMI patients who underwent pPCI between October 2010 and September 2017 and were included in a national multicenter registry. Group A consisted of patients managed only with LMWH, and Group B patients were treated with UFH regardless of eventual LMWH associated exposure. The groups were compared according to their demographic, clinical and laboratory characteristics. The primary endpoint (PE) results from a composite which included: procedural failure (pPCI failure or bailout use of GPIIb/IIIa inhibitors), in-hospital mortality, re-infarction or major bleeding (according to the registry criteria). The secondary endpoint (SE) included: in-hospital major bleeding, need for red blood cell transfusion, or haemoglobin drop ≥2g/dL. A 1:1 propensity score (PS) analysis was performed according to demographic variables, medical history and previous medication, physical examination, electrocardiogram characteristics and left ventricular function, matching 1558 of the 3875 patients for later comparison between groups. Results Overall, Group A included 1083 (27.9%) and Group B 2792 (72.1%) patients. The mean age was 63±14 years, and 33.5% of the cohort were female. Despite the baseline characteristics heterogeneity between groups, this phenomenon was not observed after PS matching. The PE was more frequent in Group A, without reaching statistical relevance (15.6% vs 13.3%, p=0.07). The SE was superior in Group A (34.4 vs 29.4%, p=0.01). According to the PS matching analysis, there were no differences beetween groups in terms of the PE (13.9% vs 12.0%, p=0.28), while the SE kept more frequent among Group A (34.9% vs 28.5%, p=0.02) [Figure]. Propensity score: group comparison Conclusion In this study based on a national multicentric registry of STEMI patients, the use of LMWH was not associated with better in-hospital prognosis in terms of major cardiovascular events and was related with higher rates of bleeding related events in the scenario of pPCI, compared to UFH. According to these results, further studies are required to support the widespread use of LMWH in this clinical scenario.

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Comparative Methodological Assessment of the Randomized GLOBAL LEADERS Trial Using Total Ischemic and Bleeding Events

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.120.006660 ◽

2020 ◽

Vol 13 (8) ◽

Author(s):

Hironori Hara ◽

David van Klaveren ◽

Kuniaki Takahashi ◽

Norihiro Kogame ◽

Ply Chichareon ◽

...

Keyword(s):

Myocardial Infarction ◽

Percutaneous Coronary Intervention ◽

Coronary Intervention ◽

Hazard Ratio ◽

Event Analysis ◽

Bleeding Events ◽

Percutaneous Coronary ◽

All Cause Mortality ◽

Repeated Events ◽

Analytical Approaches

Background: Time-to-first-event analysis considers only the first event irrespective of its severity. There are several methods to assess trial outcomes beyond time-to-first-event analysis, such as analyzing total events and ranking outcomes. In the GLOBAL LEADERS study, time-to-first-event analysis did not show superiority of ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention to conventional 12-month DAPT followed by aspirin monotherapy in the reduction of the primary composite end point of all-cause mortality or new Q-wave myocardial infarction. This study sought to explore various analytical approaches in assessing total ischemic and bleeding events after percutaneous coronary intervention in the GLOBAL LEADERS study. Methods and Results: Total ischemic and bleeding events were defined as all-cause mortality, any stroke, any myocardial infarction, any revascularization, or Bleeding Academic Research Consortium grade 2 or 3 bleeding. We used various analytical approaches to analyze the benefit of ticagrelor monotherapy over conventional DAPT. For ischemic and bleeding events at 2 years after percutaneous coronary intervention, ticagrelor monotherapy demonstrated a 6% risk reduction, compared with conventional 12-month DAPT in time-to-first-event analysis (hazard ratio, 0.94 [95% CI, 0.88–1.01]; log-rank P =0.10). In win ratio analysis, win ratio was 1.05 (95% CI, 0.97–1.13; P =0.20). Negative binomial regression and Andersen-Gill analyses which include repeated events showed statistically significant advantage for ticagrelor monotherapy (rate ratio, 0.92 [95% CI, 0.85–0.99; P =0.020] and hazard ratio, 0.92 [95% CI, 0.85–0.99; P =0.028], respectively), although in weighted composite end point analysis, the hazard ratio was 0.93 (95% CI, 0.84–1.04; log-rank P =0.22). Conclusions: Statistical analyses considering repeated events or event severity showed that ticagrelor monotherapy consistently reduced ischemic and bleeding events by 5% to 8%, compared with conventional 1-year DAPT. Applying multiple statistical methods could emphasize the multiple facets of a trial and result in accurate and more appropriate analyses. Considering the recurrence of ischemic and bleeding events, ticagrelor monotherapy appeared to be beneficial after percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01813435.

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