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

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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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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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 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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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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Discharge Hemoglobin Association with Long-Term Outcomes of ST-Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention

Cardiovascular Therapeutics ◽

10.1155/2020/8647837 ◽

2020 ◽

Vol 2020 ◽

pp. 1-7

Author(s):

Ming Gao ◽

Xinying Zhang ◽

Ling Qin ◽

Yang Zheng ◽

Zhiguo Zhang ◽

...

Keyword(s):

Myocardial Infarction ◽

Percutaneous Coronary Intervention ◽

Primary Percutaneous Coronary Intervention ◽

Bleeding Event ◽

Coronary Intervention ◽

Minor Bleeding ◽

Percutaneous Coronary ◽

All Cause Mortality ◽

Lower Discharge

Background. Anemia following acute myocardial infarction (AMI) is associated with poor outcomes. While previous studies in patients with AMI have focused on anemia at admission, we hypothesized that hemoglobin (Hb) decline during hospitalization and lower discharge Hb would be associated with greater long-term mortality in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Methods. We analyzed records of 983 STEMI patients who were treated with primary PCI. The primary end point was all-cause mortality at 1 year and 2 years. The relationship between discharge Hb levels, decline in Hb levels, bleeding event classification, and all-cause mortality was determined. Results. Overall, 16.4% of patients had bleeding events, which were classified by the Thrombolysis in Myocardial Infarction (TIMI) score as 7% minimal, 8.6% minor, and 0.9% major. No significant gastrointestinal bleed and cerebral hemorrhage occurred in hospitals among these patients. The incidence rate of the 2-year all-cause mortality increased with severity of the bleeding event score (8.78% for no bleeding vs. 11.59% for minimal bleeding vs. 20.24% for minor bleeding vs. 55.56% for major bleeding, P<0.001). Discharge Hb was significantly associated with 2-year mortality in an unadjusted model (hazard ratio (HR) per 1 g/L decrease in discharge Hb = 1.020, 95% confidence interval (CI): 1.006–1.034, P=0.004) and in a confounder-adjusted model (HR per 1 g/L decrease in discharge Hb = 1.024, 95% CI: 1.011–1.037, P<0.001). The odds ratio (OR) for all-cause mortality at 2 years for participants with Hb below the twentieth percentile was 3.529 (95% CI: 1.976–6.302) and 2.968 (95% CI: 1.614–5.456) after adjustment for age and gender and 2.485 (95% CI: 1.310–4.715) after adjustment for all covariates. Conclusions. In this population of patients hospitalized for STEMI, all-cause mortality increased with lower discharge Hb, and discharge Hb was a significant predictor of mortality risk.

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Prognostic Analysis for Cardiogenic Shock in Patients with Acute Myocardial Infarction Receiving Percutaneous Coronary Intervention

BioMed Research International ◽

10.1155/2017/8530539 ◽

2017 ◽

Vol 2017 ◽

pp. 1-8 ◽

Cited By ~ 3

Author(s):

Mao-Jen Lin ◽

Chun-Yu Chen ◽

Hau-De Lin ◽

Han-Ping Wu

Keyword(s):

Myocardial Infarction ◽

Acute Myocardial Infarction ◽

Percutaneous Coronary Intervention ◽

Cardiogenic Shock ◽

Systolic Pressure ◽

Coronary Intervention ◽

Syntax Score ◽

Long Term Outcome ◽

Percutaneous Coronary ◽

All Cause Mortality

Cardiogenic shock (CS) is uncommon in patients suffering from acute myocardial infarction (AMI). Long-term outcome and adverse predictors for outcomes in AMI patients with CS receiving percutaneous coronary interventions (PCI) are unclear. A total of 482 AMI patients who received PCI were collected, including 53 CS and 429 non-CS. Predictors for AMI patients with CS including recurrent MI, cardiovascular (CV) mortality, all-cause mortality, and repeated-PCI were analyzed. The CS group had a lower central systolic pressure and central diastolic pressure (both P<0.001). AMI patients with hypertension history were less prone to develop CS (P<0.001). Calcium channel blockers and statins were less frequently used by the CS group than the non-CS group (both P<0.05) after discharge. Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score, CV mortality, and all-cause mortality were higher in the CS group than the non-CS group (all P<0.005). For patients with CS, stroke history was a predictor of recurrent MI (P=0.036). CS, age, SYNTAX score, and diabetes were predictors of CV mortality (all P<0.05). CS, age, SYNTAX score, and stroke history were predictors for all-cause mortality (all P<0.05). CS, age, and current smoking were predictors for repeated-PCI (all P<0.05).

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Early stent thrombosis with bivalirudin in patients undergoing percutaneous coronary intervention

Thrombosis and Haemostasis ◽

10.1160/th14-08-0646 ◽

2015 ◽

Vol 113 (05) ◽

pp. 1010-1020 ◽

Cited By ~ 15

Author(s):

Raffaele Piccolo ◽

Chiara De Biase ◽

Carolina D’Anna ◽

Bruno Trimarco ◽

Federico Piscione ◽

...

Keyword(s):

Myocardial Infarction ◽

Percutaneous Coronary Intervention ◽

Stent Thrombosis ◽

Major Bleeding ◽

Meta Analysis ◽

Academic Research ◽

Coronary Intervention ◽

Bleeding Events ◽

Percutaneous Coronary ◽

Research Consortium

SummaryAlthough bivalirudin has been shown to reduce bleeding events in patients undergoing percutaneous coronary intervention, residual concerns remain about a possible higher risk of early (within 30 days) stent thrombosis (ST). Therefore, we performed a meta-analysis of randomised trials reporting ST events with bivalirudin compared to other antithrombotic therapies (heparins ± glycoprotein IIb/IIIa inhibitors). A systematic literature search of electronic resources was performed through May, 2014. The primary endpoint was definite early ST, according to Academic Research Consortium criteria. Secondary endpoints included: all-cause death, myocardial infarction and major bleeding. A total of 11 trials, including 16,415 patients, were accrued. Compared to other regimens, bivalirudin significantly increased the risk of early ST (odds ratio [OR]=1.80; 95 % confidence interval [CI], 1.28 2.52; p=0.0007) and reduced the risk of major bleeding (OR [95 %CI]=0.64 [0.51 0.82], p=0.0003), with a comparable risk of mortality or myocardial infarction. The higher risk of early ST was mainly attributable to acute (OR [95 % CI] =4.33 [2.33 8.05], p < 0.001) than subacute (OR [95 % CI] =0.89 [0.53 1.50], p =0.67) ST events (p for interaction < 0.001). Non-fatal myocardial infarction was the most common presentation (83 %) of early ST events, while death occurred infrequently (about 5 %). In conclusion, in patients undergoing PCI, bivalirudin compared to heparins is associated with a higher risk of early ST, which is mainly related to more frequent acute events. Further studies are required to evaluate alternative strategies to mitigate this risk, without hampering the benefits derived from the reduction in bleeding events with bivalirudin.

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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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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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