Clopidogrel Versus Ticagrelor or Prasugrel After Primary Percutaneous Coronary Intervention According to CYP2C19 Genotype

Background: Guidelines favor ticagrelor or prasugrel over clopidogrel in patients with myocardial infarction. However, the POPular Genetics trial (Patient Outcome After Primary Percutaneous Coronary Intervention [PCI]) showed that in patients with primary PCI, a CYP2C19 genotype–guided strategy was associated with a lower bleeding risk without increasing thrombotic risk, compared with routine ticagrelor/prasugrel treatment. Nevertheless, optimal P2Y 12 inhibitor treatment in specific CYP2C19 genetic subgroups is still a subject of debate. Methods: A prespecified subanalysis of the POPular Genetics trial was performed, using patients in whom CYP2C19 *2, *3, and *17 genotypes was determined. Two different analyses were planned. The first assessed the effect of the CYP2C19 *17 allele in clopidogrel-treated patients. The second compared the effect of clopidogrel in noncarriers of a loss-of-function allele with ticagrelor/prasugrel–treated patients, irrespective of CYP2C19 genotype. Main outcomes were a thrombotic outcome (cardiovascular death, myocardial infarction, stent thrombosis, and stroke) and a bleeding outcome (PLATO [Platelet Inhibition and Patient Outcomes] major and minor bleeding) after 12 months. Results: A total of 2429 patients were used for analyses. In the first analysis, the CYP2C19 *17 polymorphism was not found to have a significant influence on thrombotic (adjusted hazard ratio, 0.95 [95% CI, 0.45–2.02]) or bleeding outcomes (adjusted hazard ratio, 0.74 [95% CI, 0.48–1.18]). In the second analysis, clopidogrel was associated with a lower number of bleeding events compared with ticagrelor/prasugrel (9.9% versus 11.7%, adjusted hazard ratio, 0.74 [95% CI, 0.56–0.96]), without a significant increase in thrombotic events (3.4% versus 2.5%, adjusted hazard ratio, 1.14 [95% CI, 0.68–1.90]). Conclusions: In patients with primary PCI not carrying a CYP2C19 loss-of-function allele, the use of clopidogrel compared with ticagrelor or prasugrel was associated with lower bleeding rates, without an increase in thrombotic events. No effect on clinical outcomes was found for the CYP2C19 *17 polymorphism. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01761786. URL: https://www.trialregister.nl/ ; Unique identifier: NL2872.

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Pretreatment With P2Y12 Inhibitors in Patients With Chronic Coronary Syndrome Undergoing Percutaneous Coronary Intervention: A Report From the Swedish Coronary Angiography and Angioplasty Registry

Circulation Cardiovascular Interventions ◽

10.1161/circinterventions.121.010849 ◽

2021 ◽

Author(s):

Juliane Jurga ◽

Karolina Elizabeth Szummer ◽

Christian Lewinter ◽

Linda Mellbin ◽

Matthias Götberg ◽

...

Keyword(s):

Myocardial Infarction ◽

Percutaneous Coronary Intervention ◽

Coronary Angiography ◽

Coronary Intervention ◽

Hazard Ratio ◽

Adjusted Hazard Ratio ◽

P2y12 Inhibitors ◽

Catheterization Laboratory ◽

Coronary Syndrome ◽

Percutaneous Coronary

Background: In patients with chronic coronary syndrome undergoing percutaneous coronary intervention, the optimal timing of P2Y12 inhibitors’ administration is uncertain. We compared pretreatment versus treatment in the catheterization laboratory (In-Cathlab) in a real-world population. Methods: In Swedish Coronary Angiography and Angioplasty Registry, all patients with chronic coronary syndrome undergoing coronary angiography and ad hoc percutaneous coronary intervention, between 2006 and 2017 were identified. Pretreatment was defined as P2Y12 inhibitor administration before coronary angiography, outside the catheterization laboratory. Outcomes were net adverse clinical events including death, myocardial infarction, stroke, or bleeding within 30 days of the index procedure and in-hospital bleeding. Results: We included 26 814 patients, 8237 in the In-Cathlab, and 18 577 in the pretreatment group. In-Cathlab treatment compared with pretreatment was associated with lower risk for net adverse clinical event (4.2 versus 5.1%, adjusted hazard ratio 0.79 [0.63–0.99]), bleeding (2.3 versus 2.6%, adjusted hazard ratio, 0.76 [0.57–1.01]). and in-hospital bleeding (1.9 versus 2.1%, adjusted odds ratio, 0.70 [0.51–0.96]). The risk for death, myocardial infarction, or stroke did not significantly differ between the groups. Among the In-Cathlab treated patients, 41% received ticagrelor or prasugrel and 59% clopidogrel. Treatment with ticagrelor or prasugrel was associated with higher risk for net adverse clinical events (5.4% versus 3.4%, adjusted hazard ratio, 1.66 [1.12–2.48]), bleeding (3.4 versus 1.6%, adjusted hazard ratio, 2.14 [1.34–3.42]), and in-hospital bleeding (2.9 versus 1.2%, adjusted odds ratio, 2.24 [1.29–3.90]) but similar risk for death, myocardial infarction, or stroke, compared with clopidogrel. Conclusions: In patients with chronic coronary syndrome undergoing coronary angiography and ad hoc percutaneous coronary intervention, pretreatment with P2Y12 inhibitors, before arrival to the catheterization laboratory, was not associated with improved clinical outcomes but was associated with increased risk for bleeding. Our data support clopidogrel administration in the catheterization laboratory as the standard of care.

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Thrombolytic Therapy in the Current ERA: Myocardial Infarction and Beyond

Current Pharmaceutical Design ◽

10.2174/1381612824666171227211623 ◽

2018 ◽

Vol 24 (4) ◽

pp. 414-426 ◽

Cited By ~ 3

Author(s):

Patrick Proctor ◽

Massoud A. Leesar ◽

Arka Chatterjee

Keyword(s):

Myocardial Infarction ◽

Cardiovascular Disease ◽

Acute Myocardial Infarction ◽

Percutaneous Coronary Intervention ◽

Ischemic Stroke ◽

Thrombolytic Therapy ◽

Coronary Intervention ◽

Evidence Base ◽

Primary Pci ◽

Percutaneous Coronary

Thrombolytic therapy kick-started the era of modern cardiology but in the last few decades it has been largely supplanted by primary percutaneous coronary intervention (PCI) as the go-to treatment for acute myocardial infarction. However, these agents remain important for vast populations without access to primary PCI and acute ischemic stroke. More innovative uses have recently come up for the treatment of a variety of conditions. This article summarizes the history, evidence base and current use of thrombolytics in cardiovascular disease.

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Clinical characteristics and long-term mortality of patients with midrange ejection fraction undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction

European Heart Journal ◽

10.1093/ehjci/ehaa946.0941 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

J Vratonjic ◽

D Milasinovic ◽

M Asanin ◽

V Vukcevic ◽

S Zaharijev ◽

...

Keyword(s):

Myocardial Infarction ◽

Percutaneous Coronary Intervention ◽

Ejection Fraction ◽

Primary Percutaneous Coronary Intervention ◽

Coronary Intervention ◽

Primary Pci ◽

Percutaneous Coronary ◽

St Elevation ◽

Long Term Mortality

Abstract Background Previous studies associated midrange ejection fraction (mrEF) with impaired prognosis in patients with ST-elevation myocardial infarction (STEMI). Purpose Our aim was to assess clinical profile and short- and long-term mortality of patients with mrEF after STEMI treated with primary percutaneous coronary intervention (PCI). Methods This analysis included 8148 patients admitted for primary PCI during 2009–2019, from a high-volume tertiary center, for whom echocardiographic parameters obtained during index hospitalization were available. Midrange EF was defined as 40–49%. Adjusted Cox regression models were used to assess 30-day and 5-year mortality hazard of mrEF, with the reference category being preserved EF (>50%). Results mrEF was present in 29.8% (n=2 427), whereas low ejection fraction (EF<40%) was documented in 24.7% of patients (n=2 016). mrEF was associated with a higher baseline risk as compared with preserved EF patients, but lower when compared with EF<40%, in terms of prior MI (14.5% in mrEF vs. 9.9% in preserved EF vs. 24.2% in low EF, p<0.001), history of diabetes (26.5% vs. 21.2% vs. 30.0%, p<0.001), presence of Killip 2–4 on admission (15.7% vs. 6.9% vs. 26.5%, p<0.001) and median age (61 vs. 59 vs. 64 years, p<0.001). At 30 days, mortality was comparable in mrEF vs. preserved EF group, while it was significantly higher in the low EF group (2.7% vs. 1.6% vs. 9.4%, respectively, p<0.001). At 5 years, mrEF patients had higher crude mortality rate as compared with preserved EF, but lower in comparison with low EF (25.1% vs. 17.0% vs. 48.7%, p<0.001) (Figure). After adjusting for the observed baseline differences mrEF was independently associated with increased mortality at 5 years (HR 1.283, 95% CI: 1.093–1.505, p=0.002), but not at 30 days (HR 1.444, 95% CI: 0.961–2.171, p<0.001). Conclusion Patients with mrEF after primary PCI for STEMI have a distinct baseline clinical risk profile, as compared with patients with reduced (<40%) and preserved (≥50%) EF. Importantly, mrEF did not have a significant impact on short-term mortality following STEMI, but it did independently predict the risk of 5-year mortality. Funding Acknowledgement Type of funding source: None

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Clinical Profile and Outcomes of Patients Undergoing Primary Percutaneous Coronary Intervention in Employee Scheme Insurance Beneficiaries in India

Journal of Evidence Based Medicine and Healthcare ◽

10.18410/jebmh/2020/552 ◽

2020 ◽

Vol 7 (46) ◽

pp. 2685-2689

Author(s):

Lachikarathman Devegowda ◽

Satvic Cholenahally Manjunath ◽

Anindya Sundar Trivedi ◽

Ramesh D ◽

Shanmugam Krishnan ◽

...

Keyword(s):

Myocardial Infarction ◽

Percutaneous Coronary Intervention ◽

Cardiogenic Shock ◽

Primary Percutaneous Coronary Intervention ◽

Coronary Intervention ◽

Clinical Profile ◽

Major Adverse Cardiovascular Events ◽

Primary Pci ◽

Ischemic Time ◽

Percutaneous Coronary

BACKGROUND We wanted to assess the clinical profile and in-hospital outcomes of Primary Percutaneous Coronary Intervention (PPCI) for ST-segment Elevation Myocardial Infarction (STEMI) in India in ESI (Employee Scheme Insurance) beneficiaries. METHODS From January 2017 to July 2018, 122 consecutive acute STEMI patients undergoing PPCI under ESI scheme were included in the study. Patients’ clinical profile, detailed procedural characteristics, time variables along with in-hospital major adverse cardiovascular events (MACE) were also assessed. RESULTS 122 patients underwent primary PCI during the study period. In the study, mean age was 55.23 (27 - 85) years; 94 (77.04 %) were males; 53 (43.44 %) were hypertensives; 38 (31.14 %) were smokers; and 44 (36.06 %) were diabetics. Ten (8.19 %) patients were in cardiogenic shock (CS). Anterior myocardial infarction was present in 70 (57.37 %) patients. The median chest-pain-onset to hospitalarrival-time was 270 (70 - 720), door-to-balloon time was 55 (20 - 180) and total ischemic time was 325 (105 - 780) minutes. In-hospital adverse events occurred in 14 (11.4 %) patients [death 8 (6.55 %), major bleeding 2 (1.63 %), urgent CABG 3 (2.45 %) and stroke 1 (0.81 %)]. Seven patients with cardiogenic shock died. CONCLUSIONS The mean age of our cohort was 55.23 years. In our study, majority of patients were males (77.05 %), hypertension was associated with 43.44 %, and diabetes was associated with 36.06 % of patients. Procedural success was achieved in 95.89 %. The overall in-hospital mortality was 6.55 % and 70 % in the cardiogenic shock subset. KEYWORDS Primary PCI, STEMI, ESI, PCI

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Evaluation of a regional ST-elevation myocardial infarction primary percutaneous coronary intervention program at the Rouge Valley Health System

10.32920/14639403.v1 ◽

2021 ◽

Author(s):

Pria MD Nippak ◽

Jodie Pritchard ◽

Robin Horodyski ◽

Candace J Ikeda-Douglas ◽

Winston W Isaac

Keyword(s):

Myocardial Infarction ◽

Emergency Department ◽

Percutaneous Coronary Intervention ◽

Primary Percutaneous Coronary Intervention ◽

Coronary Intervention ◽

St Elevation Myocardial Infarction ◽

Primary Pci ◽

Percutaneous Coronary ◽

St Elevation ◽

Door To Balloon

Background ST-elevation myocardial infarction (STEMI) remains the second leading cause of death in Canada. Primary percutaneous coronary intervention (PCI) has been recognized as an effective method for treating STEMI. Improved access to primary PCI can be achieved through the implementation of regional PCI centres, which was the impetus for implementing the PCI program in an east Toronto hospital in 2009. As such, the purpose of this study was to measure the efficacy of this program regional expansion. Methods A retrospective review of 101 patients diagnosed with STEMI from May to Sept 2010 was conducted. The average door-to-balloon time for these STEMI patients was calculated and the door-to-balloon times using different methods of arrival were analyzed. Method of arrival was by one of three ways: paramedic initiated referral; patient walk-ins to PCI centre emergency department; or transfer after walk-in to community hospital emergency department. Results The study found that mean door-to balloon time for PCI was 112.5 minutes. When the door-to-balloon times were compared across the three arrival methods, patients who presented by paramedic-initiated referral had significantly shorter door-to-balloon times, (89.5 minutes) relative to those transferred (120.9 minutes) and those who walked into a PCI centre (126.7 minutes) (p = 0.047). Conclusions The findings suggest that the partnership between the hospital and its EMS partners should be continued, and paramedic initiated referral should be expanded across Canada and EMS systems where feasible, as this level of coverage does not currently exist nationwide. Investments in regional centres of excellence and the creation of EMS partnerships are needed to enhance access to primary PCI.

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Evaluation of a regional ST-elevation myocardial infarction primary percutaneous coronary intervention program at the Rouge Valley Health System

10.32920/14639403 ◽

2021 ◽

Author(s):

Pria MD Nippak ◽

Jodie Pritchard ◽

Robin Horodyski ◽

Candace J Ikeda-Douglas ◽

Winston W Isaac

Keyword(s):

Myocardial Infarction ◽

Emergency Department ◽

Percutaneous Coronary Intervention ◽

Primary Percutaneous Coronary Intervention ◽

Coronary Intervention ◽

St Elevation Myocardial Infarction ◽

Primary Pci ◽

Percutaneous Coronary ◽

St Elevation ◽

Door To Balloon

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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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Outcome of inter-hospital transfer versus direct admission for primary percutaneous coronary intervention: An observational study of 25,315 patients with ST-elevation myocardial infarction from the London Heart Attack Group

European Heart Journal Acute Cardiovascular Care ◽

10.1177/2048872619882340 ◽

2020 ◽

Vol 9 (8) ◽

pp. 948-957

Author(s):

Krishnaraj S Rathod ◽

Ajay K Jain ◽

Sam Firoozi ◽

Pitt Lim ◽

Richard Boyle ◽

...

Keyword(s):

Myocardial Infarction ◽

Percutaneous Coronary Intervention ◽

Primary Percutaneous Coronary Intervention ◽

Coronary Intervention ◽

Left Ventricular ◽

Primary Pci ◽

Percutaneous Coronary ◽

All Cause Mortality ◽

Hospital Transfer ◽

Direct Admission

Background and aims: In patients with ST-segment elevation myocardial infarction (STEMI), mortality is directly related to time to reperfusion with guidelines recommending patients be delivered directly to centres for primary percutaneous coronary intervention (PCI). The aim of this study was to describe the impact of inter-hospital transfer on reperfusion time and to assess whether or not treatment delays influenced clinical outcomes in comparison with direct admission to a primary PCI centre in a large regional network. Method and results: We undertook an observational cohort study of patients with STEMI treated with primary PCI between 2005 and 2015 in London, UK. Patient details were recorded at the time of the procedure in databases using the British Cardiovascular Intervention Society PCI dataset. The primary end-point was all-cause mortality at a median of 4.1 years (interquartile range: 2.2–5.8 years). Secondary outcomes were in-hospital major adverse cardiac events. Of 25,315 patients, 17,560 (69.4%) were admitted directly to a primary PCI centre and 7755 (31.6%) were transferred from a non-primary PCI centre. Patients in the direct admission group were older and more likely to have left ventricular impairment compared with the inter-hospital transfer group. Median time from call for help to reperfusion in transferred patients was 52 minutes longer compared with patients admitted directly ( p <0.001). However, call to first hospital admission was similar. Kaplan–Meier analysis demonstrated significantly lower mortality rates in patients who were transferred directed to a primary PCI centre compared with patients who were transferred from a non-PCI centre (17.4% direct vs. 18.7% transfer, p=0.017). Furthermore, after propensity matching, direct admission for primary PCI was still a predictor of all-cause mortality (hazard ratio: 0.89, 95% confidence interval: 0.64–0.95). Conclusions: In this large registry of over 25,000 STEMI patients treated by primary PCI survival was better in patients admitted directly to a cardiac centre versus patients transferred for primary PCI, most likely due to longer call to balloon times in patient transferred from other hospitals.

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One-year Results of a Factorial Randomized Trial of Aspirin versus Placebo and Clonidine versus Placebo in Patients Having Noncardiac Surgery

Anesthesiology ◽

10.1097/aln.0000000000003158 ◽

2020 ◽

Vol 132 (4) ◽

pp. 692-701 ◽

Cited By ~ 2

Author(s):

Daniel I. Sessler ◽

David Conen ◽

Kate Leslie ◽

Salim Yusuf ◽

Ekaterina Popova ◽

...

Keyword(s):

Myocardial Infarction ◽

Percutaneous Coronary Intervention ◽

Study Drug ◽

Coronary Intervention ◽

Cardiovascular Complications ◽

Noncardiac Surgery ◽

Hazard Ratio ◽

Nonfatal Myocardial Infarction ◽

Long Term Effects ◽

Percutaneous Coronary

Abstract Background The authors previously reported that perioperative aspirin and/or clonidine does not prevent a composite of death or myocardial infarction 30 days after noncardiac surgery. Moreover, aspirin increased the risk of major bleeding and clonidine caused hypotension and bradycardia. Whether these complications produce harm at 1 yr remains unknown. Methods The authors randomized 10,010 patients with or at risk of atherosclerosis and scheduled for noncardiac surgery in a 1:1:1:1 ratio to clonidine/aspirin, clonidine/aspirin placebo, clonidine placebo/aspirin, or clonidine placebo/aspirin placebo. Patients started taking aspirin or placebo just before surgery; those not previously taking aspirin continued daily for 30 days, and those taking aspirin previously continued for 7 days. Patients were also randomly assigned to receive clonidine or placebo just before surgery, with the study drug continued for 72 h. Results Neither aspirin nor clonidine had a significant effect on the primary 1-yr outcome, a composite of death or nonfatal myocardial infarction, with a 1-yr hazard ratio for aspirin of 1.00 (95% CI, 0.89 to 1.12; P = 0.948; 586 patients [11.8%] vs. 589 patients [11.8%]) and a hazard ratio for clonidine of 1.07 (95% CI, 0.96 to 1.20; P = 0.218; 608 patients [12.1%] vs. 567 patients [11.3%]), with effect on death or nonfatal infarction. Reduction in death and nonfatal myocardial infarction from aspirin in patients who previously had percutaneous coronary intervention at 30 days persisted at 1 yr. Specifically, the hazard ratio was 0.58 (95% CI, 0.35 to 0.95) in those with previous percutaneous coronary intervention and 1.03 (95% CI, 0.91to 1.16) in those without (interaction P = 0.033). There was no significant effect of either drug on death, cardiovascular complications, cancer, or chronic incisional pain at 1 yr (all P > 0.1). Conclusions Neither perioperative aspirin nor clonidine have significant long-term effects after noncardiac surgery. Perioperative aspirin in patients with previous percutaneous coronary intervention showed persistent benefit at 1 yr, a plausible sub-group effect. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

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Antithrombotic Therapy With Ticagrelor in Atrial Fibrillation Subjects After Percutaneous Coronary Intervention

Frontiers in Cardiovascular Medicine ◽

10.3389/fcvm.2021.745549 ◽

2021 ◽

Vol 8 ◽

Author(s):

Wenbin Lu ◽

Yu Wang ◽

Lijuan Chen ◽

Yongjun Li ◽

Rui Zhang ◽

...

Keyword(s):

Myocardial Infarction ◽

Atrial Fibrillation ◽

Percutaneous Coronary Intervention ◽

Cardiovascular Events ◽

Therapy Group ◽

Dual Therapy ◽

Coronary Intervention ◽

Hazard Ratio ◽

Bleeding Events ◽

Percutaneous Coronary

Background: Warfarin, along with aspirin and clopidogrel, has long been recommended for patients with atrial fibrillation (AF) who are undergoing percutaneous coronary intervention with a drug-eluting stent (PCI-DES). However, this triple therapy has been known to increase the risk of bleeding complications. Meanwhile, there is no evidence from prospective trials on the use of ticagrelor in a dual therapy. We here aimed to compare the antiplatelet drug ticagrelor as a dual antithrombotic agent to aspirin and clopidogrel in bleeding events.Methods: In this multicenter, active-controlled, open-label, randomized trial, patients with AF taking warfarin who had undergone PCI-DES were randomly assigned to the ticagrelor therapy group (Dual group) or the clopidogrel plus aspirin therapy group (Triple group). The primary and secondary endpoints were overall bleeding events and major bleeding events, respectively, according to the Thrombolysis in Myocardial Infarction (TIMI) criteria at 6 months. Cardiovascular events [re-PCI, surgical bypass, myocardial infarction (MI), heart failure, rehospitalization due to angina pectoris, stent thrombosis and death due to cardiovascular causes] at 6 months were also recorded.Results: A total of 296 patients from 12 medical centers in China were randomized after PCI-DES to either the Dual therapy group (n = 148) or the Triple group (n = 146) for 6 months. The overall incidence of bleeding events at 6 months was 36.49% in the Dual therapy group and 35.62% in the Triple group [hazard ratio, 0.930; 95% confidence interval (CI), 0.635 to 1.361; P = 0.7088]. The incidence of the secondary endpoint over 6 months was 4.73% in the Dual therapy group and 1.37% in the Triple group (hazard ratio, 0.273; 95% CI, 0.057 to 1.315; P = 0.1056). Cardiovascular event occurrence was also comparable in both groups at 6 months (18.24 vs. 16.44%; hazard ratio, 0.845; 95% CI, 0.488 to 1.465; P = 0.5484).Conclusions: The incidence of total bleeding events in AF patients treated with ticagrelor was comparable to that in patients treated with clopidogrel plus aspirin at 6 month; Meanwhile, the incidence of cardiovascular events were also comparable between the groups.Clinical Trial Registration: MANJUSRI, ClinicalTrials.gov# NCT02206815, 2014, August 1st

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