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Aims High-risk cardiac surgery is commonly complicated by low cardiac output syndrome (LCOS), which is associated with high mortality. There are limited data derived from multi-centre studies with adjudicated endpoints describing factors associated with LCOS and its downstream clinical outcomes. Methods and results The Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial evaluated prophylactic levosimendan vs. placebo in patients with a reduced ejection fraction undergoing coronary artery bypass grafting (CABG) and/or valve surgery. We conducted a pre-specified analysis on LCOS, which was characterized by a four-part definition. We constructed a multivariable logistical regression model to evaluate risk factors associated with LCOS and performed Cox proportional hazards modelling to determine the association of LCOS with 90-day mortality. A total of 186 (22%) of 849 patients in the LEVO-CTS trial developed LCOS. The factors most associated with a higher adjusted risk of LCOS were pre-operative ejection fraction [odds ratio (OR) 1.26; 95% confidence interval (CI): 1.08–1.46 per 5% decrease] and age (OR 1.13; 95% CI: 1.04–1.24 per 5-year increase), whereas isolated CABG surgery (OR 0.44, 95% CI: 0.31–0.64) and levosimendan use (OR 0.65; 95% CI: 0.46–0.92) were associated with a lower risk of LCOS. Patients with LCOS had worse outcomes, including renal replacement therapy at 30-day (10 vs. 1%) and 90-day mortality (16 vs. 3%, adjusted hazard ratio of 5.04, 95% CI: 2.66–9.55). Conclusion Low cardiac output syndrome is associated with a high risk of post-operative mortality in high-risk cardiac surgery.

We describe variables and outcomes associated with peri-operative mechanical circulatory support (MCS) utilization among patients enrolled in the Levosimendan in patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial.In the LEVO-CTS trial, MCS utilization (defined as intra-aortic balloon pump, extracorporeal membrane oxygenation, or surgical ventricular assist device) within 5 days of surgery was examined. The association between MCS use and outcomes including 90-day mortality, 30-day renal-replacement therapy, and hospital and critical stay length of stay were determined.Among the 849 patients from 70 centers randomized to levosimendan or placebo, 85 (10.0%) patients were treated with MCS (71 intra-aortic balloon pump, 7 extracorporeal membrane oxygenation, 7 ventricular assist device); with 89.4% started on post-operative day 0. Inter-institutional use ranged from 0% to 100%. Variables independently associated with MCS utilization included combined coronary artery bypass grafting and valve surgery (adjusted odds ratio [OR] 2.73, 95% confidence interval [CI] 1.70-4.37, P.001), history of lung disease (OR 1.70, 95% CI 1.06-2.70, P = .029), and history of heart failure (OR 2.44, 95% CI 1.10-5.45, P = .027). Adjusted 90-day mortality (22.4% vs 4.1%, hazard ratio 6.11, 95% CI 3.95-9.44, P.001) was higher, and median critical care length of stay (8.0 vs 4.0 days, P.001) was longer in patients managed with MCS.In a randomized controlled trial of high-risk cardiac surgical patients in North America, we observed patient, and surgical variables associated with MCS utilization. MCS use was associated with a higher risk of post-operative mortality.

Background: In the VICTORIA trial (Vericiguat Global Study in Patients with Heart Failure with Reduced Ejection Fraction), anemia occurred more often in patients treated with vericiguat (7.6%) than with placebo (5.7%). We explored the association between vericiguat, randomization hemoglobin, development of anemia, and whether the benefit of vericiguat related to baseline hemoglobin. Methods: Anemia was defined as hemoglobin Results: At baseline, 1719 (35.7%) patients had World Health Organization anemia; median hemoglobin was 13.4 g/L (25th, 75th percentile: 12.1, 14.7 g/dL). At 16 weeks from randomization, 1643 patients had World Health Organization anemia (284 new for vericiguat and 219 for placebo), which occurred more often with vericiguat than placebo ( P Conclusions: Anemia was common at randomization and lower hemoglobin was associated with a greater frequency of clinical events. Although vericiguat modestly lowered hemoglobin by 16 weeks, this effect did not further progress nor was it related to the treatment benefit of vericiguat. Registration: URL: https://www.clinicaltrials.gov : Unique identifier: NCT02861534.

ObjectivesRemote ischaemic conditioning (RIC) has been tested as a possible strategy for mitigating reperfusion injury in ST elevation myocardial infarction (STEMI) with primary percutaneous coronary intervention (PPCI). However, surrogate outcomes have shown inconsistent effects with lack of clinical correlation.MethodsWe performed a registry-based randomised study of patients with STEMI allocated to RIC (4 cycles of blood pressure cuff inflation to 200 mm Hg for 5 min of ischaemia followed by 5 min of reperfusion) or standard of care (SOC) during PPCI. We examined the associations of RIC on core laboratory measurements of myocardial perfusion, infarct size (IS), left ventricular (LV) performance and clinical outcomes.ResultsA total of 252 patients were enrolled. The median age was 61 (IQR: 55–70) years and 72.8% were male. Sum ST segment deviation resolution ≥50% was similar between RIC and SOC (65.2% vs 55.7%, p=0.269). In those with 3-day cardiovascular MRI (n=88), no difference in median (25th, 75th percentiles) IS (14.9% (4.5%, 23.1%) vs 16.1% (3.3%, 22.0%), p=0.980), LV dimensions (LV end-diastolic volume index: 78.7 (71.1, 91.2) mL/m2 vs 79.9 (71.2, 88.8) mL/m2, p=0.630; LV end-systolic volume index: 48.8 (35.7, 51.4) mL/m2 vs 37.9 (31.8, 47.5) mL/m2, p=0.551) or ejection fraction (50.0% (41.0%–55.0%) vs 50.0% (43.0%–56.0%), p=0.554) was demonstrated. Similar results were observed with 90-day cardiovascular MRI. At 1 year, the clinical composite of death, congestive heart failure, cardiogenic shock and recurrent myocardial infarction was similar in RIC and SOC (21.7% vs 13.3%, p=0.110).ConclusionsIn a contemporary registry-based randomised study of patients with STEMI undergoing PPCI, adjunctive therapy with RIC did not improve myocardial perfusion, reduce IS or alter LV performance. Consequently, there was no difference in clinical outcomes within 1 year.Trial registration numberNCT03930589.

Objectives To describe and evaluate outcomes in STEMI patients sustained on clopidogrel compared to those switched to ticagrelor following fibrinolysis. Background World‐wide, many STEMI patients cannot achieve timely PCI and therefore require fibrinolysis. Although comparable 30‐day and 1‐year safety was shown with clopidogrel or ticagrelor in the TREAT study, there is paucity of long‐term outcomes in pharmacoinvasive treated STEMI. Methods We conducted an observational cohort study evaluating consecutive pharmacoinvasive STEMI patients treated in a network, comparing those switched to ticagrelor to those sustained on clopidogrel. The primary efficacy composite was one‐year all‐cause death, recurrent myocardial infarction, and stroke with major bleeding and intracranial hemorrhage (ICH) as the safety outcomes. Multivariable Cox regression model was used to examine the association between P2Y12 inhibitor and outcomes with inverse probability weighting. Results Of 1426 pharmacoinvasive STEMI patients, 28% (n = 396) were converted to ticagrelor at a mean of 9.9 h after fibrinolysis with comparable GRACE Risk Scores (median; 158 vs 157, p0.352). The primary composite occurred in 3.5% of ticagrelor and 7.0% of clopidogrel treated patients (p0.014). Following adjustment, ticagrelor was associated with a 54% lower composite outcome (adjusted HR 0.46, 95% confidence interval 0.26–0.84). Major bleeding 6.3% vs 6.1% (NS) and ICH 0.0% vs 0.2% (NS) were similar. Conclusions In a prospective STEMI cohort, switching to ticagrelor compared with sustaining clopidogrel following fibrinolysis pharmacoinvasive reperfusion reduced recurrent ischemic events at 1‐year with no differences in major bleeding or ICH. Aligned with randomized data, these findings provide support to switch pharmaco‐invasively treated STEMI patients.

The effect of vericiguat on sequential N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and influence of this relationship on clinical outcomes is unknown.This study assessed the relationship between changes in NT-proBNP and the primary outcome (cardiovascular death or heart failure hospitalization); evaluated the effect of vericiguat on changes in NT-proBNP; and explored the association between the efficacy of vericiguat and changes in NT-proBNP.NT-proBNP was measured at randomization and at 16, 32, 48, and 96 weeks in 4,805 of 5,050 patients. The association between NT-proBNP change at week 16 and the primary outcome was assessed. The relationship between changes in NT-proBNP and the primary outcome according to treatment group was assessed by using joint modeling and mediation analysis.A significant and sustained decline in NT-proBNP levels was seen in both treatment groups. After week 16, NT-proBNP levels decreased more with vericiguat vs placebo (any reduction: odds ratio [OR]: 1.45 [95% CI: 1.28-1.65]; P 0.001; ≥50% reduction: OR: 1.27 [95% CI: 1.10-1.47]; P = 0.001) and were less likely to increase (≥20% increase: OR: 0.68 [95% CI: 0.59-0.78]; P 0.001; ≥50% increase: OR: 0.70 [95% CI: 0.59-0.82]; P 0.001). The treatment effect related to serial NT-proBNP on the primary composite outcome was HR: 0.96 (95% CI: 0.95-0.99) at week 16, which increased to HR: 0.90 (95% CI: 0.85-0.96) at week 48; the average extent of mediation of the composite outcome related to NT-proBNP was 45%.In patients with worsening HFrEF, vericiguat significantly decreased NT-proBNP levels compared with placebo. This change appeared associated with a modest relative improvement in the primary outcome of cardiovascular death or heart failure hospitalization. (Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction [VICTORIA]; NCT02861534).

Aims Whether glycaemic control is associated with cardiovascular outcomes in patients with type 2 diabetes (T2D) is unclear. Consequently, we assessed the relationship between glycated haemoglobin (HbA1c ) and cardiovascular outcomes in a placebo-controlled randomized trial which demonstrated no cardiovascular effect of sitagliptin in patients with T2D and atherosclerotic vascular disease. Methods and results Secondary analysis of 14 656 TECOS participants with time to event analyses using multivariable Cox proportional hazard models. During a median 3.0 (interquartile range 2.3-3.8) year follow-up, 456 (3.1% of 14 656) patients had first hospitalization for heart failure (HF), 1084 (11.5%) died, 1406 (9.6%) died or were hospitalized for HF, and 1689 (11.5%) had a non-HF cardiovascular event (cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, or hospitalization for unstable angina). Associations between baseline or time-varying HbA1c and cardiovascular outcomes were U-shaped, with the lowest risk when HbA1c was around 7%. Each one-unit increase in the time-varying HbA1c above 7% was associated with an adjusted hazard ratio (HR) of 1.21 [95% confidence interval (CI) 1.11-1.33] for first HF hospitalization, 1.11 (1.03-1.21) for all-cause death, 1.18 (1.09-1.26) for death or HF hospitalization, and 1.10 (1.02-1.17) for non-HF cardiovascular events. Each one-unit decrease in the time-varying HbA1c below 7% was associated with an adjusted HR of 1.35 (95% CI 1.12-1.64) for first HF hospitalization, 1.37 (1.16-1.61) for death, 1.42 (1.23-1.64) for death or HF hospitalization, and 1.22 (1.06-1.41) for non-HF cardiovascular events. Conclusion Glycated haemogobin exhibits a U-shaped association with cardiovascular outcomes in patients with T2D and atherosclerotic vascular disease, with nadir around 7%. Clinical trial registration ClinicalTrials.gov Identifier: NCT00790205.

Background Obesity is a risk factor for type 2 diabetes (T2D) and cardiovascular disease (CVD). Whether obesity affects outcomes among those with T2D and atherosclerotic CVD (ASCVD) remains uncertain. Our objective was to investigate the relationship between body mass index (BMI) and ASCVD outcomes among TECOS participants with T2D and ASCVD. Methods BMI categories were defined as underweight/normal weight (BMI 2 ), overweight (25-29.9 kg/m 2 ), obese class I (30-34.9 kg/m 2 ), obese class II (35-39.9 kg/m 2 ), and obese class III (≥ 40 kg/m 2 ). Asian-specific BMI categories were applied to Asian participants. Kaplan-Meier survival analysis and Cox proportional hazards models were used to examine associations between baseline BMI and a composite CV outcome (CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina). Results For 14,534 TECOS patients with available BMI, mean age was 65.5 years; 29.3% were female, 32.0% non-White, and 23.1% insulin-treated, with median 3 years' follow-up. At baseline, 11.6% (n = 1686) were underweight/normal weight, 38.1% (n = 5532) overweight, 32.2% (n = 4683) obese class I, 12.4% (n = 1806) obese class II, and 5.7% (n = 827) obese class III. The composite CV outcome occurred in 11.4% (n = 1663) of participants; the outcome risk was lower, compared with under/normal weight, in overweight (HR 0.83, 95% CI 0.71-0.98) and obese class I (HR 0.79, 95% CI 0.67-0.93) individuals. Obesity was not associated with worse glycemic control. Conclusions The majority of TECOS participants with ASCVD and T2D were overweight or obese, yet overweight or obese class I individuals had lower CV risk than those who were under/normal weight. These results suggest the presence of an obesity paradox, but this paradox may reflect an epidemiological artifact rather than a true negative association between normal weight and clinical outcomes.

OBJECTIVE Phenotypic heterogeneity among patients with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD) is ill defined. We used cluster analysis machine-learning algorithms to identify phenotypes among trial participants with T2DM and ASCVD. RESEARCH DESIGN AND METHODS We used data from the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) study (n = 14,671), a cardiovascular outcome safety trial comparing sitagliptin with placebo in patients with T2DM and ASCVD (median follow-up 3.0 years). Cluster analysis using 40 baseline variables was conducted, with associations between clusters and the primary composite outcome (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina) assessed by Cox proportional hazards models. We replicated the results using the Exenatide Study of Cardiovascular Event Lowering (EXSCEL) trial. RESULTS Four distinct phenotypes were identified: cluster I included Caucasian men with a high prevalence of coronary artery disease; cluster II included Asian patients with a low BMI; cluster III included women with noncoronary ASCVD disease; and cluster IV included patients with heart failure and kidney dysfunction. The primary outcome occurred, respectively, in 11.6%, 8.6%, 10.3%, and 16.8% of patients in clusters I to IV. The crude difference in cardiovascular risk for the highest versus lowest risk cluster (cluster IV vs. II) was statistically significant (hazard ratio 2.74 [95% CI 2.29–3.29]). Similar phenotypes and outcomes were identified in EXSCEL. CONCLUSIONS In patients with T2DM and ASCVD, cluster analysis identified four clinically distinct groups. Further cardiovascular phenotyping is warranted to inform patient care and optimize clinical trial designs.

Background In the VICTORIA trial of patients with HFrEF after a worsening HF event, anemia occurred more often in patients treated with vericiguat (7.6%) compared with placebo (5.7%). We explored the association between vericiguat, baseline hemoglobin, and anemia and also whether hemoglobin was related to the benefit of vericiguat in HF. Methods Anemia was defined as a hemoglobin Results Of 4812 patients with baseline hemoglobin data available, 1719 (35.7%) were WHO anemic; median hemoglobin was 13.4 g/dL (IQR 12.1 to 14.7 g/dL). In total, 1643 patients had WHO anemia at 16 weeks (of which 284 were new from baseline for vericiguat and 219 for placebo) and this occurred more often in the vericiguat group than the placebo group (P Conclusions Anemia was present at baseline in over one-third of patients in the VICTORIA trial and was generally mild. Lower hemoglobin was associated with greater frequency of clinical events. Although vericiguat modestly lowered hemoglobin by 16 weeks, this effect did not further progress nor influence the association of benefit of vericiguat. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): Merck & Co., Inc. and Bayer

Introduction: People with type 2 diabetes mellitus (DM) have a large burden of cardiovascular (CV) morbidity and mortality, but the likelihood of these outcomes varies and existing risk calculators do not fully capture risk for individuals. Hypothesis: Circulating metabolites characterizing mitochondrial dysfunction may be novel predictors for CV outcomes. Methods: We performed targeted mass-spectrometry metabolite profiling (45 acylcarnitines, 15 amino acids) on baseline plasma samples from 568 cases (498 with major adverse cardiac events (MACE) and 131 with incident hospitalization for heart failure (hHF)) and 568 matched controls (without events) from the patients assigned to placebo in Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Matching was based on history of HF, coronary artery disease, BMI, hemoglobin A1C, creatinine, low-density lipoprotein cholesterol, fasting status and ejection fraction. Principal components analysis (PCA) was used for dimensionality reduction, and conditional logistic regression to determine association of PCA factors with MACE or hHF and for individual metabolites within significant factors (false discovery rate q Results: Of 12 PCA-derived metabolite factors, three were associated significantly with MACE or hHF; these factors were composed of: 1) short-chain dicarboxylacylcarnitines and long chain acylcarnitines (OR 1.50, q=0.03); 2) medium chain acylcarnitines (OR 1.28, q=0.001); 3) C5:1 and one medium-chain dicarboxylacylcarnitine (OR 1.17, q=0.03). Of these three factors, none were significantly associated with the individual components of MACE. Ten individual metabolites, including short- and medium-chain dicarboxylacylcarnitines and medium- and long-chain acylcarnitines, remained significantly associated with MACE (q Conclusions: Metabolites reporting on dysregulated mitochondrial fatty acid oxidation and endoplasmic reticulum stress are elevated in individuals with DM who progress to MACE and/or hHF. These biomarkers may improve CV risk prediction in DM patients and help highlight emerging risk mechanisms.

Introduction: To date, there are limited data on the potential role of proteomic biomarkers to predict future cardiovascular (CV) events among patients with type 2 diabetes mellitus (DM). Hypothesis: Specific protein biomarkers will be predictive of major adverse CV events (MACE) and incident heart failure hospitalization (HFH) among patients with DM. Methods: Using the Olink aptamer-based platform, we performed proteomic profiling (>700 proteins) on 440 paired cases and matched controls from placebo-assigned participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Cases were defined as having met the primary composite outcome of MACE or incident HFH and matched to controls on baseline prevalent heart failure, coronary artery disease, BMI, hemoglobin A1C, creatinine, low-density lipoprotein cholesterol, fasting status and ejection fraction. Conditional logistic regression was used to determine the association between log-transformed relative protein expression and incident MACE or HFH. False-discovery-rate (FDR) was used to adjust for multiple comparisons. Results: We identified three specific proteins that were significantly associated with prevalent MACE or HFH: METRNL, Notch 3, and ROR1 (OR 2.1, 1.6, 1.7 and q-value 0.01, 0.02, and 0.05 respectively) (Figure 1). METRNL, in particular, performed similarly to the established biomarker NT-proBNP (Figure 1). When MACE and HFH were analyzed separately, METRNL, in particular, remained strongly associated with both outcomes (OR 2.0, p Conclusions: Three novel protein biomarkers, in particular METRNL (a circulating adipokine that regulates insulin-sensitivity), may identify diabetic patients at high risk for subsequent HF and MACE. Additional studies are needed to replicate these findings and uncover the biologic mechanism linking adipokine signaling and heart failure.

Background There are limited data to inform policy mandating primary percutaneous coronary intervention ( PPCI ) volume benchmarks for catheterization laboratories in low‐ and middle‐income countries. Methods and Results This prospective state‐wide registry included ST‐segment–elevation myocardial infarction patients with symptoms of PPCI . From June 2013 to March 2016, we recruited 5560 consecutive patients. We categorized hospitals on the basis of annual PPCI volumes into low, medium, and high volume (PPCI volume and 1‐year mortality. Among 42 recruiting hospitals, there were 24 (57.2%) low‐volume, 8 (19%) medium‐volume, and 10 (23.8%) high‐volume hospitals. The median (25th–75th percentile) TIMI (Thrombolysis in Myocardial Infarction) ST‐segment–elevation myocardial infarction risk score was 3 (2–5). Cardiac arrest before admission occurred in 4.2%, 2.1%, and 2.9% of cases at low‐, medium‐, and high‐volume hospitals, respectively ( P =0.02). Total ischemic time differed significantly among low‐volume (median [25th–75th percentile], 3.5 [2.4–5.5] hours), medium‐volume (median, 3.8 [25th–75th percentile, 2.58–6.05] hours), and high‐volume hospitals (median, 4.16 [25th–75th percentile 2.8–6.3] hours) ( P =0.01). Vascular access was radial in 61.5%, 71.3%, and 63.2% of cases at low‐, medium‐, and high‐volume hospitals, respectively ( P =0.01). The observed 1‐year mortality rate was 6.5%, 3.4%, and 8.6% at low‐, medium‐ and high‐volume hospitals, respectively ( P CI ], 1.80 [1.12–2.90]; high versus medium: hazard ratio [95% CI ], 2.53 [1.78–3.58]) ( P Conclusions Low‐ and middle‐income countries, like India, may have a nonlinear relationship between institutional PPCI volume and outcomes, partly driven by procedural variations and inequalities in access to care.

Background: Recent clinical trial data support a pharmacoinvasive strategy as an alternative to primary percutaneous coronary intervention (pPCI) in ST-segment elevation myocardial infarction. We evaluated whether this is true in a real-world prehospital ST-segment elevation myocardial infarction network using ECG assessment of reperfusion coupled with clinical outcomes within 1 year. Methods: Of the 5583 ST-segment elevation myocardial infarction patients in the Alberta Vital Heart Response Program (Cohort 1 [2006–2011]: n=3593; Cohort 2 [2013–2016]: n=1990), we studied 3287 patients who received a pharmacoinvasive strategy with tenecteplase (April 2013: half-dose tenecteplase was employed in prehospital patients ≥75 years) or pPCI. ECGs were analyzed within a core laboratory; sum ST-segment deviation resolution ≥50% was defined as successful reperfusion. The primary composite was all-cause death, congestive heart failure, cardiogenic shock, and recurrent myocardial infarction within 1 year. Results: The pharmacoinvasive approach was administered in 1805 patients (54.9%), (493 [27.3%] underwent rescue/urgent percutaneous coronary intervention and 1312 [72.7%] had scheduled angiography); pPCI was performed in 1482 patients (45.1%). There was greater ST-segment resolution post-catheterization/percutaneous coronary intervention with a pharmacoinvasive strategy versus pPCI (75.8% versus 64.3%, IP-weighted odds ratio, 1.59; 95% CI, 1.33–1.90; P P =0.033). Major bleeding and intracranial hemorrhage were similar between a pharmacoinvasive strategy and pPCI (7.6% versus 7.5%, P =0.867; 0.6% versus 0.6%; P =0.841, respectively). In the 82 patients ≥75 years with a prehospital pharmacoinvasive strategy, similar ST-segment resolution and rescue rates were observed with full-dose versus half-dose tenecteplase (75.8% versus 88.9%, P =0.259; 31.0% versus 29.2%, P =0.867) with no difference in the primary composite (31.0% versus 25.0%, P =0.585). Conclusions: In this large Canadian ST-segment elevation myocardial infarction registry, a pharmacoinvasive strategy was associated with improved ST-segment resolution and enhanced outcomes within 1 year compared with pPCI. Our findings support the application of a selective pharmacoinvasive reperfusion strategy when delay to pPCI exists.

Aims:The STREAM study randomly assigned ST-elevation myocardial infarction (STEMI) patients to receive a pharmacoinvasive versus primary percutaneous coronary intervention reperfusion strategy. We assessed whether there was an association between outcomes based on randomisation at a community hospital versus a prehospital location.Methods/results:Community hospital patients (358/1866 (19.2%)) were compared to prehospital patients and their outcomes categorised into pharmacoinvasive according to their treatment assignment. Compared to prehospital patients, community hospital patients had more diabetes (17.8% vs. 11.5%, P=0.001), higher Killip Class >1 (9.4% vs. 5.0%, P=0.002) and thrombolysis in myocardial infarction risk scores ⩾5 (18.2% vs. 12.4%, P=0.005). The 30-day primary endpoint (death, shock, congestive heart failure and re-infarction) for community hospital patients was 14.9% versus 13.2% for prehospital patients ( P=0.403). Community hospital pharmacoinvasive patients tended to receive less rescue (35.1% vs. 42.8%, P=0.062); when deployed their rescue was delayed 43 minutes. Community hospital patients undergoing primary percutaneous coronary intervention experienced a delay of 31 minutes versus prehospital patients. Pharmacoinvasive patients receiving scheduled angiography from a community hospital and prehospital patients had comparable times to angiography (17.7 vs. 18.7 hours) and low event rates (6.2% vs. 8.0%). Although the interaction between randomisation location and treatment received on the primary endpoint was not significant ( Pinteraction=0.065) those pharmacoinvasive patients requiring rescue from community hospitals had worse outcomes than prehospital rescue patients (odds ratio 2.28, 95% confidence interval 1.16–4.49).Conclusion:Within STREAM, STEMI patients randomly assigned at community hospitals had a higher baseline risk but similar outcomes compared to those studied prehospital patients irrespective of successful pharmacoinvasive therapy or primary percutaneous coronary intervention. However, worse outcomes in the pharmacoinvasive patients requiring rescue in community hospitals emphasises their need for immediate transfer to a percutaneous coronary intervention-capable hospital.

Aim To examine fracture incidence among participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Research design and methods We used data from 14 671 participants in the TECOS study who were randomized double-blind to sitagliptin (n = 7332) or placebo (n = 7339). Cumulative fracture incidence rates were calculated and their association with study treatment assignment was examined using multivariable Cox proportional hazards regression. Results The baseline mean (standard deviation) participant age was 65.5 (8.0) years, diabetes duration was 11.6 (8.1) years and glycated haemoglobin level was 7.2 (0.5)% [55.2 (5.5) mmol/mol], and 29.3% of participants were women and 32.1% were non-white. During 43 222 person-years’ follow-up, 375 (2.6%; 8.7 per 1000 person-years) had a fracture; 146 were major osteoporotic fractures (hip, n = 34; upper extremity, n = 81; and clinical spine, n = 31). Adjusted analyses showed fracture risk increased independently with older age (P < .001), female sex (P < .001), white race (P < .001), lower diastolic blood pressure (P < .001) and diabetic neuropathy (P = .003). Sitagliptin, compared with placebo, was not associated with a higher fracture risk [189 vs 186 incident fractures: unadjusted hazard ratio (HR) 1.01, 95% confidence interval (CI) 0.82 to 1.23, P = .944; adjusted HR 1.03, P = .745], major osteoporotic fractures (P = .673) or hip fractures (P = .761). Insulin therapy was associated with a higher fracture risk (HR 1.40, 95% CI 1.02-1.91; P = .035), and metformin with a lower risk (HR 0.76, 95% CI 0.59-0.98; P = .035). Conclusion Fractures were common among people with diabetes in the TECOS study, but were not related to sitagliptin therapy. Insulin and metformin treatment were associated with higher and lower fracture risks, respectively.

Contains fulltext : 215191.pdf (Publisher’s version ) (Closed access) BACKGROUND: The effects of beta-blocker therapy in patients with type 2 diabetes (T2D) and established atherosclerotic cardiovascular disease (ASCVD) are unclear. We sought to evaluate associations between beta-blocker use in T2D with ASCVD and cardiovascular (CV) outcomes. METHODS: In patients with T2D and ASCVD enrolled in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), an inverse probability of treatment-weighted Cox proportional hazards model was used to examine the association between baseline beta-blocker therapy (at randomization) and the primary CV composite (defined as CV death, non-fatal myocardial infarction [MI], non-fatal stroke, or hospitalization for unstable angina), including in subgroups with prior MI and heart failure (HF); other outcomes evaluated included individual components of the primary composite, hospitalization for HF, and severe hypoglycemic events. RESULTS: Of the 14,671 patients randomized, 9322 (64%) were on a beta-blocker at baseline; these patients were more likely to have prior MI or HF. Over a median 3.0 (25th, 75th percentile: 2.2, 3.6) years, the risk of the primary CV composite was significantly higher with baseline beta-blocker use versus no beta-blocker use (4.5 vs. 3.4 events/100-patient years, adjusted hazard ratio [HR] 1.17, 95% confidence interval [CI] 1.05-1.29); no significant interaction was noted for patients with versus without prior MI or HF. Baseline beta-blocker use was not associated with risks for severe hypoglycemic events (HR 1.14, 95% CI 0.88-1.48). CONCLUSIONS: In this observational analysis of T2D and ASCVD, baseline beta-blocker use was not associated with risks for severe hypoglycemia yet also was not associated with CV risk reduction over 3 years of follow-up, supporting a randomized examination of chronic beta-blocker therapy in this patient population. (TECOS ClinicalTrials.gov number, NCT00790205).

Objective Uncertainty exists concerning the relative merits of pharmacological versus mechanical coronary reperfusion in patients presenting early with ST-elevation myocardial infarction (STEMI) with extensive myocardium at risk. Accordingly, we investigated whether the extent of baseline ST-segment shift was related to the response of either reperfusion modality in patients with STEMI presenting within 3 h of symptoms. Methods We analysed baseline ECGs from 1859 patients enrolled in the STrategic Reperfusion Early After Myocardial Infarction (STREAM) trial. The sum of ST-segment elevation (∑STE) and ST-segment deviation (∑STD) was categorised into quartiles and associations with the primary endpoint (30-day death/shock/congestive heart failure/re-myocardial infarction) for each reperfusion strategy (early fibrinolysis vs primary percutaneous coronary intervention) were explored. Results Overall, there was a progressive rise in the 30-day primary endpoint according to quartiles of baseline ∑STE (10.3% (0–5 mm), 12.4% (5.5–8.5 mm), 12.1% (9–13.5 mm), 17.6% (>14.0 mm), p=0.008) and ∑STD (9.0% (0–9 mm), 13.5% (9.5–14 mm), 14.7% (14.5–20 mm), 15.3% (>20 mm), p=0.019). Both ∑STE and ∑STD were associated with the primary endpoint (∑STE: p=0.071; ∑STD: p=0.024). However, there was no interaction between quartiles of baseline ∑STE or ∑STD and efficacy of either reperfusion strategy on the 30-day clinical outcomes (∑STE: p (interaction)=0.696; ∑STD: p (interaction)=0.542). Conclusions These data demonstrate an association between ∑STE or ∑STD on the baseline ECG and clinical events at 30 days following reperfusion therapy in STEMI. More importantly, the response to different reperfusion strategies was not influenced by the extent of jeopardised myocardium. Trial registration number NCT00623623; Post-results.

Background: Adjudication by an adjudication committee in clinical trials plays an important role in the assessment of outcomes. Controversy exists regarding the utility of adjudication committee versus site-based assessments and their relationship to subsequent clinical events. Methods: This study is a secondary analysis of the Providing Rapid Out of Hospital Acute Cardiovascular Treatment-3 trial, which randomized patients with chest pain or shortness of breath for biomarker testing in the ambulance. The emergency department physician diagnosis at the time of emergency department disposition was compared with an adjudicated diagnosis assigned by an adjudication committee. The level of agreement between emergency department and adjudication committee diagnosis was evaluated using kappa coefficient and compared to clinical outcomes (30-day re-hospitalization, 30-day and 1-year mortality). Results: Of the 477 patients, 49.3% were male with a median age of 70 years; hospital admission rate was 31.2%. The emergency department physicians and the adjudication committee disagreed in 55 cases (11.5%) with a kappa of 0.71 (95% confidence interval: 0.64, 0.78). The 30-day re-hospitalization, 30-day mortality, and 1-year mortality were 22%, 1.9%, and 9.4%, respectively. Although there were similar rates of re-hospitalization irrespective of adjudication, in cases of disagreement compared to agreement between adjudication committee and emergency department diagnosis, there was a higher 30-day (7.3% vs 1.2%, p = 0.002) and 1-year mortality (27.3% vs 7.1%, p Conclusion: Despite substantial agreement between the diagnosis of emergency department physicians and adjudication committee, in the subgroup of patients where there was disagreement, there was significantly worse short-term and long-term mortality.

Background— Using a comprehensive ST-segment–elevation myocardial infarction registry, we evaluated the relationships of baseline Q waves, time from symptom onset, and reperfusion strategy with in-hospital clinical outcomes. Methods and Results— Consecutive ST-segment–elevation myocardial infarction patients from a defined health region were classified by the presence of baseline Q waves and additionally into primary percutaneous coronary intervention, fibrinolysis, or no reperfusion. ECGs were collected at baseline, after reperfusion, and analyzed for the presence of Q waves using Selvester criteria. Among 2290 ST-segment–elevation myocardial infarction patients, 36.9% had Q waves on their baseline ECG. Patients with Q waves were older (median age, 59 versus 57), were more often male (82.0% versus 75.4%), had higher heart rate (80 versus 72), had higher Global Registry of Acute Coronary Events risk score (129 versus 127), and were with longer time to reperfusion (42 minutes longer). They had higher composite end points (16.3% versus 10.0%), consistent across times from symptom onset to presentation (15.4% versus 9.9% ≤3 hours; 18.5% versus 8.9% >3 to ≤6 hours; 15.9% versus 11.3% >6 hours; Q and no Q, respectively). Baseline Q waves, but not time to reperfusion, were associated with an increased odds of the in-hospital composite end point of death, congestive heart failure, cardiogenic shock, and reinfarction (adjusted odds ratio, 1.65; 95% confidence interval, 1.18–2.30; P =0.003). Type of reperfusion did not modify the association of baseline Q waves and in-hospital outcomes ( P interaction=0.918). Conclusions— The presence of baseline Q waves, rather than time to treatment, was significantly associated with adverse in-hospital events in real-world patients, regardless of reperfusion strategy used.

Objectives We evaluated inter-reader agreement of the ST-segment between two electrocardiogram (ECG) core laboratories. Background Accurate measurement of the ST-segment is key to diagnosis and management of acute coronary syndromes (ACS). Clinical trials also rely on adherence to the pre-specified ECG eligibility criteria. Methods 150 patients (100 ST-segment elevation (STE)-ACS, 50 non-STE-ACS) were selected. An experienced ECG reader from each laboratory measured ST-segment deviation on the baseline ECGs (nearest 0.1 mm). Results ∑ ST-segment deviation showed excellent inter-reader agreement (R = 0.965, intraclass correlation coefficient (ICC) 0.949, 95% CI (0.930–0.963)). Similar agreement was observed when ∑ ST-segment elevation (∑ STE) and ∑ ST-segment depression (∑ STD) were assessed separately. Better agreement was evident in STE-ACS cohort (ICC (95% CI): 0.968 (0.953–0.978, 0.969 (0.954–0.979), 0.931 (0.899–0.953)) compared to NSTE-ACS patients (ICC (95% CI): 0.860 (0.768–0.917), 0.816 (0.699–0.890), 0.753 (0.605–0.851) across measurement of ∑ ST-segment deviation, ∑ STE, and ∑ STD. Conclusions We demonstrated excellent agreement on ST-segment measurements between two experienced readers from two ECG core laboratories.

Objective Type 2 diabetes is associated with increased fracture risk, further elevated by treatments such as thiazolidinediones and sodium-glucose co-transporter-2 inhibitors. As data regarding dipeptidyl peptidase-4 inhibitors are mixed, we examined fracture incidence in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Research Design and Methods We used data from 14,671 TECOS patients randomized double-blind to sitagliptin (n=7332) or placebo (n=7339). Cumulative fracture incidence rates were calculated and their association with study treatment assignment examined using multivariable Cox proportional hazards regression. Results Baseline mean (SD) age was 65.5 (8.0) years, diabetes duration 11.6 (8.1) years, HbA1c 7.2% (0.5%) (55.2 mmol/mol [5.5]), with 29.3% of participants women and 32.1% non-White. During 43,222 person-years’ follow-up, 375 (2.6%; 8.7 per 1000 person-years) had a fracture; 146 were major osteoporotic fractures (hip [n=34], upper extremity [n=81], and clinical spine [n=31]). Adjusted analyses showed fracture risk increased independently with older age (p Conclusion Fractures were common among TECOS patients with diabetes, but not related to sitagliptin therapy. Insulin and metformin treatment were associated with increased and decreased fracture risks, respectively.

The secondary prevention effects of beta-blocker therapy (BBT) in type 2 diabetes (T2D) and established atherosclerotic cardiovascular disease (ASCVD) are unclear. Using an inverse probability of treatment-weighted Cox proportional hazards model, we examined the association between baseline BBT and

Ticagrelor (TIC) based dual antiplatelet therapy (DAPT) is standard of care for acute coronary syndromes (ACS) with the exception of fibrinolysis treated ST-segment elevation myocardial infarction (STEMI) patients where clopidogrel (CLOP) is recommended. Although comparable 30-day safety was shown

Coronary plaque rupture mediating acute ST segment elevation myocardial infarction (STEMI) is associated with a systemic inflammatory response. Whether early temporal changes in inflammatory biomarkers are associated with angiographic and electrocardiographic markers of reperfusion and subsequent clinical outcomes is unclear. In the APEX-AMI biomarker substudy, 376 patients with STEMI had inflammatory biomarkers measured at the time of hospital presentation and 24 h later. The primary outcome was the 90-day composite of death, shock, or heart failure. Secondary reperfusion outcomes were (1) worst least residual ST segment elevation (ST-E

Background: Baseline Q waves may provide additional value compared with time from the onset of symptoms in predicting outcomes for patients with ST-segment elevation. We evaluated whether baseline Q waves superseded time from symptom onset as a prognostic marker of one-year mortality in patients with ST-segment elevation acute coronary syndrome. Our study was derived from data from patients undergoing primary percutaneous coronary intervention within 24 hours in the PLATelet inhibition and patient Outcomes trial Methods: Q waves on the baseline electrocardiogram were evaluated by a blinded core laboratory. We assessed the associations between baseline Q waves and time from symptom onset to percutaneous coronary intervention with peak biomarkers, ST-segment resolution on the discharge electrocardiogram, and one-year all-cause and vascular mortality. Results: Of 4341 patients with ST-segment elevation, 46% had baseline Q waves. Compared to those without Q waves, those with baseline Q waves were older, more frequently male, had higher heart rates, more advanced Killip class and had a longer time between the onset of symptoms and percutaneous coronary intervention. They also had higher one-year all-cause mortality than patients without baseline Q waves (baseline Q waves: 4.9%; no baseline Q waves: 2.8%; hazard ratio [HR] 1.78, 95% confidence interval [CI] 1.29–2.45, p p = 0.046) and vascular mortality (adjusted HR 1.58, 95% CI 1.09–2.28, p = 0.02). Interpretation: The presence of baseline Q waves provides useful additional prognostic insight into the clinical outcome of patients with ST-segment elevation. Clinical Trials.gov registration no. NCT00391872

Background Whether prehospital point‐of‐care ( POC ) troponin further accelerates the time to diagnosis in patients with chest pain ( CP ) is unknown. We conducted a randomized trial of POC ‐Troponin testing in the ambulance. Methods and Results Patients with chest pain presenting by ambulance were randomized to usual care ( UC ) or POC ‐Troponin; ST ‐elevation myocardial infarction patients or those with noncardiovascular symptoms were excluded. Pre‐hospital high‐sensitivity troponin was analyzed on a POC device and available to the paramedic and emergency department ( ED ) staff. The final diagnosis was centrally adjudicated. The primary endpoint was time from first medical contact to discharge from ED or admission to hospital. We randomized 601 patients in 19 months; 296 to UC and 305 to POC ‐Troponin. After ambulance arrival, the first troponin was available in 38 minutes in POC ‐Troponin and 139 minutes in UC . In POC ‐Troponin, the troponin was >0.01 ng/mL in 17.4% and >0.03 ng/mL in 9.8%. Patients spent a median of 9.0 hours from first medical contact to final disposition, and 165 (27.4%) were admitted to the hospital. The primary endpoint was shorter in patients randomized to POC ‐Troponin (median 8.8 hours [6.2–10.8] compared to UC (median 9.1 hours [6.7–11.2]; P =0.05). There was no difference in the secondary endpoint of repeat ED visits, hospitalizations, or death in the next 30 days. Conclusions In this broad population of patients with CP , ambulance POC ‐Troponin accelerated the time to final disposition. Enhanced and more cost‐effective early ED discharge of the majority of patients with CP calling 911 is an unrealized opportunity. Clinical Trial Registration URL : https://www.ClinicalTrials.gov/ . Unique identifier: NCT 01634425.

Objectives: The STREAM study randomized STEMI pts Methods: CH pts 358/1866 (19.2%) were compared to PH pts. Results are further categorized according to pts receiving pPCI, PI rescue, PI with scheduled angiography (%’s and medians with 25th-75th percentiles). Results: Overall compared to PH, CH pts had more diabetes (17.8% vs. 11.5%, p=0.001), higher Killip Class >1 (9.4% vs. 5.0%, p=0.002) and TIMI Risk Score ≥5 (18.2% vs. 12.4%, p=0.005). 30-day primary composite endpoint (death, CHF, shock, re-infarction) for CH was 14.9% vs. PH 13.2% (p=0.403). PI pts within CH received less rescue PCI than PH pts (35.1% vs. 42.8%, p=0.062) (table) and it was delayed by approximately 43 min. CH pts undergoing pPCI also had an approximate 31 min delay. After adjusting for TIMI risk score and time from symptom onset, CH pts requiring rescue had worse outcomes compared to PH (OR 2.3, 95% CI, 1.2-4.6); However no difference in outcomes existed between CH and PH pts in those undergoing pPCI (p interaction=0.027). PI pts receiving scheduled cath from CH and PH had comparable times to cath (17.7 vs. 18.7 hours) and low primary composite event rates (6.2% vs 8.0%). Conclusion: Within STREAM CH pts had higher baseline risk but overall similar outcomes to those randomized PH. Despite higher baseline risk, CH pts with successful fibrinolysis and scheduled angiography or those who underwent primary PCI had similar outcomes to PH. The worse outcomes in CH rescue pts emphasizes the need to identify and expeditiously treat those pts needing rescue PCI.

This study combined the kernel smoothing procedure and a nonparametric differential item functioning statistic-Cochran’s Z-to statistically test the difference between the kernel-smoothed item response functions for reference and focal groups. Simulation studies were conducted to investigate the Type I error and power of the proposed kernel-smoothed Cochran’s Z. For the purpose of comparison, the Type I error and power rates with no correction and with regression correction were also include in the simulation. The results of this study suggest the Type I error and power performance of Cochran’s Z improved when kernel smoothing was applied.

The purpose of this study is to describe how the attribute hierarchy method (AHM) can be used to evaluate differential group performance at the cognitive attribute level. The AHM is a psychometric method for classifying examinees’ test item responses into a set of attribute-mastery patterns associated with different components in a cognitive model of task performance. Attribute probabilities, computed using a neural network, can be estimated on each attribute for each examinee thereby providing specific information about the examinee’s attribute-mastery level. These probabilities can also be compared across groups. We describe a four-step procedure for estimating and interpreting group differences using the AHM. We also provide an example using student response data from a sample of algebra items on the SAT to illustrate our pattern recognition approach for studying group differences. Assessment engineering (AE) is emerging as a new research area in educational and psychological measurement (Luecht, 2006a, 2006b). AE is an innovative approach to measurement, where engineering-like principles are used to direct the design and the analysis of assessments as well as the scoring and the reporting of the results. With this approach, an assessment begins with specific, empirically derived cognitive models (e.g., Leighton & Gierl, 2007). Next, assessment task templates are created using established frameworks derived from the cognitive model to produce test items. Finally, psychometric methods are applied to the examinee response data, typically in a confirmatory mode, to produce scores that are interpretable (Luecht, Gierl, Tan, & Huff, 2006). AE differs from more traditional approaches to test design and analysis in three fundamental ways. First, cognitive models guide task design and item development, rather than content-based test specifications. While the categories in content blueprints can be included in the task templates, the assessment principles used to develop items are based on cognitive principles and, thus, provide more specific information for measuring problem-solving skills. Second, task templates are created to control and manipulate both the content and cognitive attributes of the items. Item writers are required to use the templates during development, thereby producing items that adhere to strict quality controls and that meet high psychometric standards. Third, psychometric models are employed in a confirmatory, versus exploratory, manner to assess the model-data fit relative to the intended underlying structure of the constructs or traits the test is designed to measure. The outcomes from these model-data fit analyses also provide developers with guidelines for

Background A pharmacoinvasive ( PI ) strategy for early presenting ST ‐segment elevation myocardial infarction nominally reduced 30‐day cardiogenic shock and congestive heart failure compared with primary percutaneous coronary intervention ( PPCI ). We evaluated whether infarct size ( IS ) was related to this finding. Methods and Results Using the peak cardiac biomarker in patients randomized to PI versus PPCI within the Strategic Reperfusion Early After Myocardial Infarction ( STREAM ) trial, IS was divided into 3 groups: small (≤2 times the upper limit normal [ ULN ]), medium (>2 to ≤5 times the upper limit normal) and large (>5 times the upper limit normal). The association between IS and 30‐day shock and congestive heart failure was subsequently examined. Data on 1701 of 1892 (89.9%) patients randomized to PI (n=853, 50.1%) versus PPCI (n=848, 49.9%) within STREAM were evaluated. A higher proportion of PPCI patients had a large IS ( PI versus PPCI : small, 49.8% versus 50.2%; medium, 56.9% versus 43.1%; large, 48.4% versus 51.6%; P =0.035), despite comparable intergroup ischemic times for each reperfusion strategy. As IS increased, a parallel increment in shock and congestive heart failure occurred in both treatment arms, except for the small IS group. The difference in shock and congestive heart failure in the small IS group (4.4% versus 11.6%, P =0.026) in favor of PI likely relates to higher rates of aborted myocardial infarction with the PI strategy (72.7% versus 54.3%, P =0.005). After adjustment, a trend favoring PI persisted in this subgroup (relative risk 0.40, 95% CI 0.15 to 1.06, P =0.064); no difference in treatment‐related outcomes was evident in the other 2 groups. Conclusion A PI strategy appears to alter the pattern of IS after ST ‐segment elevation myocardial infarction, resulting in more medium and fewer large infarcts compared with PPCI . Despite a comparable number of small infarcts, PI patients in this group had more aborted myocardial infarctions and less 30‐day shock and congestive heart failure. Clinical Trial Registration URL : http://ClinicalTrials.gov . Unique identifier: NCT 00623623.

Summary Background & aims Concerns have been raised about the impact of dietary sodium restriction on the overall dietary intake and nutritional status in patients with heart failure (HF). The objective of this study was to evaluate the association between a significant reduction in sodium intake and dietary changes and nutritional status in patients with chronic HF. Methods This is a secondary analysis of 38 patients enrolled in a pilot study of dietary sodium reduction. Patients were classified into two groups according to a level of sodium reduction achieved (≥25% [n = 21 patients] and Results Patients had a median age of 65 years, 51% were male, median body mass index was 30.7 kg/m2 and median ejection fraction was 39%. Over 6 months, the group with ≥25% sodium reduction exhibited a greater increase in folate intake [median change 50 mcg/day (25th–75th percentiles: −101, 167) vs. −31 mcg/day (25th–75th percentiles: −221, 51), p = 0.04 between groups] and a larger reduction in calcium intake [median change −262 (25th–75th percentiles: −585, −9) vs. 91 (25th–75th percentiles: −114, 210), p = 0.01 between groups], and were more likely to meet the parameters of the DASH diet compared to the Conclusions Dietary sodium reduction may be achieved without compromising overall dietary intake and nutritional status in patients with HF when an individualized and comprehensive dietary approached is used. Clinical Trial Identifier : Clinicaltrials.gov identifier: NCT01480401 .

Background The prognostic value of time from symptom onset to reperfusion may be enhanced by the identification of Q waves on the presenting electrocardiogram (ECG) in patients with ST-segment elevation myocardial infarction (STEMI). We evaluated whether the relative prognostic utility of these 2 metrics was altered by sex. Methods Q waves in the distribution of the ST-segment elevation on the baseline ECG were evaluated by a blinded core laboratory in 2838 STEMI patients (2163 men and 675 women) from the PLATelet inhibition and patient Outcomes (PLATO) trial who underwent percutaneous coronary intervention (PCI) within 12 hours of symptom onset. Results Women were older (median 63 vs 57 years), more likely to be diabetic (24.1% vs 15.5%), hypertensive (69.2% vs 50.9%), and a higher Killip class > I (8.6% vs 5.9%), as compared with men. Whereas the Q waves frequency rose progressively over time to ECG in men, this relationship was attenuated in women ( P = .057). Q waves on the baseline ECG were associated with a higher excess hazard of 1-year vascular death in men (hazard ratio [HR] 2.03; 95% confidence interval [CI], 1.13-3.72), and a similar trend existed in women (HR 1.97; 95% CI, 0.86-4.51). Women with baseline Q waves tended to have higher risk of 1-year vascular death than men as continuous time from symptom onset to PCI increased ( P [interaction] = .182). Conclusions These differences in the evolution of baseline Q waves and relationship between time from symptom onset and vascular death in women and men deserve recognition in future studies of STEMI.