Objectives The purpose of this study was to determine the consistency of the effects of radial artery access in patients with ST-segment elevation myocardial infarction (STEMI) and in those with ...non–ST-segment elevation acute coronary syndrome (NSTEACS). Background The safety associated with radial access may translate into mortality benefit in higher-risk patients, such as those with STEMI. Methods We compared efficacy and bleeding outcomes in patients randomized to radial versus femoral access in RIVAL (RadIal Vs femorAL access for coronary intervention trial) (N = 7,021) separately in those with STEMI (n = 1,958) and NSTEACS (n = 5,063). Interaction tests between access site and acute coronary syndrome type were performed. Results Baseline characteristics were well matched between radial and femoral groups. There were significant interactions for the primary outcome of death/myocardial infarction/stroke/non–coronary artery bypass graft–related major bleeding (p = 0.025), the secondary outcome of death/myocardial infarction/stroke (p = 0.011) and mortality (p = 0.001). In STEMI patients, radial access reduced the primary outcome compared with femoral access (3.1% vs. 5.2%; hazard ratio HR: 0.60; p = 0.026). For NSTEACS, the rates were 3.8% and 3.5%, respectively (p = 0.49). In STEMI patients, death/myocardial infarction/stroke were also reduced with radial access (2.7% vs. 4.6%; HR 0.59; p = 0.031), as was all-cause mortality (1.3% vs. 3.2%; HR: 0.39; p = 0.006), with no difference in NSTEACS patients. Operator radial experience was greater in STEMI versus NSTEACS patients (400 vs. 326 cases/year, p < 0.0001). In primary PCI, mortality was reduced with radial access (1.4% vs. 3.1%; HR: 0.46; p = 0.041). Conclusions In patients with STEMI, radial artery access reduced the primary outcome and mortality. No such benefit was observed in patients with NSTEACS. The radial approach may be preferred in STEMI patients when the operator has considerable radial experience. (A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention (PCI) Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy RIVAL; NCT01014273 )
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objectives The aim of this study was to explore the relationship between baseline resting heart rate and outcomes in patients with chronic heart failure (HF) according to baseline left ventricular ...ejection fraction (LVEF) and cardiac rhythm. Background Elevated resting heart rate is associated with worse outcomes in patients with HF and reduced LVEF. Whether this association is also found in patients with HF and preserved LVEF is uncertain, as is the predictive value of heart rate in patients in atrial fibrillation (AF). Methods Patients enrolled in the CHARM (Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity) Program were divided into groups by tertiles of baseline heart rate. Cox proportional hazard models were used to investigate the association between heart rate and pre-specified outcomes in the overall population as well as in subgroups defined according to LVEF (≤40% vs. >40%) and presence (or absence) of AF at baseline. Results After adjusting for predictors of poor prognosis, patients in the highest heart rate tertile had worse outcomes when compared with those in the lowest heart rate group (e.g., for the composite of cardiovascular death or HF hospital stay hazard ratio: 1.23, 95% confidence interval: 1.11 to 1.36, p < 0.001). The relationship between heart rate and outcomes was similar across LVEF categories and was not influenced by beta-blocker use (p value for interaction >0.10 for both endpoints). However, amongst patients in AF at baseline, heart rate had no predictive value (p value for interaction <0.001). Conclusions Resting heart rate is an important predictor of outcome in patients with stable chronic HF without AF, regardless of LVEF or beta-blocker use.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background A major limitation of primary percutaneous coronary intervention (PPCI) for the treatment of ST-elevation myocardial infarction (STEMI) is impaired microvascular perfusion due to ...embolization and obstruction of microcirculation with thrombus. Manual thrombectomy has the potential to reduce distal embolization and improve microvascular perfusion. Clinical trials have shown mixed results regarding thrombectomy. Objective The objective of this study is to evaluate the efficacy of routine upfront manual aspiration thrombectomy during PPCI compared with percutaneous coronary intervention alone in patients with STEMI. Design This is a multicenter, prospective, open, international, randomized trial with blinded assessment of outcomes. Patients with STEMI undergoing PPCI are randomized to upfront routine manual aspiration thrombectomy with the Export catheter (Medtronic CardioVascular, Santa Rosa, CA) or to percutaneous coronary intervention alone. The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association class IV heart failure up to 180 days. The trial uses an event-driven design and will recruit 10,700 patients. Summary The TOTAL trial will determine the effect of routine manual aspiration thrombectomy during PPCI on clinically important outcomes.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Objectives The study sought to evaluate the relationship between procedural volume and outcomes with radial and femoral approach. Background RIVAL (RadIal Vs. femorAL) was a randomized trial of ...radial versus femoral access for coronary angiography/intervention (N = 7,021), which overall did not show a difference in primary outcome of death, myocardial infarction, stroke, or non–coronary artery bypass graft major bleeding. Methods In pre-specified subgroup analyses, the hazard ratios for the primary outcome were compared among centers divided by tertiles and among individual operators. A multivariable Cox proportional hazards model was used to determine the independent effect of center and operator volumes after adjusting for other variables. Results In high-volume radial centers, the primary outcome was reduced with radial versus femoral access (hazard ratio HR: 0.49; 95% confidence interval CI: 0.28 to 0.87) but not in intermediate- (HR: 1.23; 95% CI: 0.88 to 1.72) or low-volume centers (HR: 0.83; 95% CI: 0.52 to 1.31; interaction p = 0.021). High-volume centers enrolled a higher proportion of ST-segment elevation myocardial infarction (STEMI). After adjustment for STEMI, the benefit of radial access persisted at high-volume radial centers. There was no difference in the primary outcome between radial and femoral access by operator volume: high-volume operators (HR: 0.79; 95% CI: 0.48 to 1.28), intermediate (HR: 0.87; 95% CI: 0.60 to 1.27), and low (HR: 1.10; 95% CI: 0.74 to 1.65; interaction p = 0.536). However, in a multivariable model, overall center volume and radial center volume were independently associated with the primary outcome but not femoral center volume (overall percutaneous coronary intervention volume HR: 0.92, 95% CI: 0.88 to 0.96; radial volume HR: 0.88, 95% CI: 0.80 to 0.97; and femoral volume HR: 1.00, 95% CI: 0.94 to 1.07; p = 0.98). Conclusions Procedural volume and expertise are important, particularly for radial percutaneous coronary intervention. (A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention PCI Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy RIVAL; NCT01014273 )
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background Apixaban is superior to aspirin for the prevention of stroke in patients with atrial fibrillation. Apixaban is partially renally excreted and may accumulate in patients with renal ...impairment. Methods We evaluated the efficacy and safety of apixaban 5 mg twice daily (2.5 mg twice daily in selected patients) compared with aspirin 81 to 324 mg daily in 1697 patients with stage III chronic kidney disease (CKD) enrolled in the Apixaban Versus Acetylsalicylic Acid to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or are Unsuitable for Vitamin K Antagonist Treatment (AVERROES) trial. Primary outcome was all stroke and non–central nervous system emboli. Results Compared with patients with estimated glomerular filtration rates (eGFRs) ≥60 mL/min per 1.73 m2 , stage III CKD patients (n = 1697; 30% of the cohort; mean eGFR 49 mL/min per 1.73 m2 ) were older (mean age 75 v 68 years) with more frequent hypertension, diabetes, heart failure, and previous stroke (all P < .01). Stage III CKD was an independent predictor of primary events (hazard ratio HR 1.6; P = .01) and major hemorrhage (HR 2.2; P = .02). Apixaban significantly reduced primary events by 68% (5.6% per year on aspirin v 1.8% per year on apixaban; HR 0.32; 95% confidence interval CI 0.18-0.55; P < .001) for stage III CKD participants and by 43% (2.8% per year on aspirin v 1.6% per year on apixaban; HR 0.57; 95% CI 0.37-0.87; P = .009) for patients with eGFRs ≥60 mL/min per 1.73 m2 ( P for interaction = .10). There was no significant difference in major hemorrhage in stage III CKD patients by treatment: 2.2% per year with aspirin versus 2.5% per year with apixaban (HR 1.2; 95% CI 0.65-2.1). Conclusions Stage III CKD was an independent predictor of stroke in atrial fibrillation patients taking aspirin. Among stage III CKD patients, apixaban significantly reduced stroke relative to aspirin without a significant increase in major hemorrhage.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Antiplatelet therapy with clopidogrel and acetylsalicylic acid (ASA) reduces major cardiovascular events in patients with ST and non–ST-segment-elevation acute coronary syndromes (ACS). ...Recent mechanistic and clinical data suggest that higher loading and maintenance doses of clopidogrel may achieve a more rapid and greater degree of platelet inhibition that translates into improved clinical outcomes, but this is yet to be formally evaluated in an adequately powered randomized trial. Objectives To evaluate the efficacy and safety of (1) a higher loading and initial maintenance dose of clopidogrel compared with the standard-dose regimen and (2) high-dose ASA compared with low-dose ASA in patients with ST or non–ST-segment-elevation ACS managed with an early invasive strategy. Design Multicenter, international, randomized, 2×2 factorial design trial evaluating a clopidogrel high-dose regimen (600 mg loading dose on day 1 followed by 150 mg once daily on days 2 to 7, followed by 75 mg once daily on days 8-30) compared with the standard-dose regimen (300 mg loading dose on day 1, followed by 75 mg once daily on days 2-30) and high-dose ASA (300-325 mg daily) versus low-dose ASA (75-100 mg daily) in patients with ST or non–ST-segment-elevation ACS managed with an early invasive strategy. The clopidogrel dose comparison is double-blind and the ASA dose comparison is open-label. The primary outcome is the composite of death from cardiovascular causes, myocardial (re)infarction or stroke up to day 30. The primary safety outcome is major bleeding. The sample size is 18,000 to 20,000 patients. Conclusions The CURRENT-OASIS 7 trial will help to define optimal dosing regimens for clopidogrel and ASA in patients with ST and non–ST-segment-elevation ACS treated with an early invasive strategy.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract Background Several biomarkers have been shown to improve risk stratification in patients with non-ST-segment elevation acute coronary syndrome (NSTEACS); however, they have not been ...integrated into risk prediction tools. Methods C-reactive-protein, N-terminal-pro–brain natriuretic peptide (NT-proBNP), and haemoglobin A1C were measured in 6447 patients with NSTEACS who were enrolled in the Clopidogrel in Unstable Angina to Prevent Recurrent Events trial. A risk score to predict cardiovascular (CV) death, myocardial infarction (MI), or stroke at 1 year was developed by incorporating biomarkers that were independently predictive of events with traditional variables, electrocardiogram, and troponin-T. Model discrimination was evaluated using c-statistic, integrated discrimination improvement, and net reclassification index, and validated using bootstrap methods. Results During 1 year of follow-up, 686 patients experienced a CV event. Each biomarker predicted CV death, MI, or stroke; however, only NT-proBNP and haemoglobin A1C improved model discrimination, increasing the c-statistic (0.66-0.71), integrated discrimination improvement to 3.4%, and net reclassification index to 17.5% ( P < 0.0001 for all measures). A risk score ranging from 0 to 20 points including variables for age, prior MI/stroke, sex, ST-segment deviation, troponin-T, NT-proBNP, and haemoglobin A1C classified individuals into low-, intermediate-, and high-risk groups with rates of CV death, MI, stroke of 3.7%, 9.1%, 17.8%, respectively. The absolute benefit of dual antiplatelet therapy versus aspirin alone was 1.0%, 4.7%, and 3.0% in low-, intermediate-, and high-risk groups, respectively. Conclusions The addition of NT-proBNP and haemoglobin A1C to 5 standard variables creates a 7-variable risk score that improves prediction of CV events at 1 year and aids in risk-based selection of patients with NSTEACS for dual antiplatelet therapy.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
Objectives We evaluated the effect of angiotensin-converting enzyme (ACE) inhibitor ramipril on the incidence of atrial fibrillation (AF) in patients enrolled in the Heart Outcomes Prevention ...Evaluation trial. Background Atrial fibrillation is the most common arrhythmia affecting the general population and is associated with increased morbidity and mortality. Retrospective secondary analyses of some of the large trials of ACE inhibitors have suggested that ACE inhibitors may prevent AF. Methods We evaluated the occurrence of AF by reviewing the electrocardiogram tracings at entry, at 2 years, and at the end of the study, as well as hospitalizations among 8335 high-risk participants from the Heart Outcomes Prevention Evaluation study, ≥55 years, without known heart failure or left ventricular (LV) systolic dysfunction and followed for a median period of 4.5 years. We compared the impact of ramipril and matched placebo on occurrence of AF. The results were compared to similar trials. Results Over the 4.5 years follow-up, the incidence of new AF was low (2.1%, 177/8335), and ramipril did not significantly reduce the rate of new AF compared with placebo (86/4291 2.0% vs 91/4044 2.2%) with an odds ratio of 0.92 (95% confidence interval, 0.68-1.24; P = .57). These results added to the previous ACE inhibitor trials (excluding trials in patients with LV dysfunction) showed no significant reduction in new AF among patients treated with these agents (1088/20,930 5.0% vs 1343/22,878 5.9%; relative risk, 0.92; 95% confidence interval, 0.80-1.05). Conclusion Although the incidence of AF was low, treatment with ramipril in this population without known LV systolic dysfunction did not significantly reduce this dysrrhythmia.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Both a history of diabetes mellitus and elevated inhospital glucose levels predict death after acute myocardial infarction (AMI). However, only diabetes history (and not glucose levels) is ...routinely considered in AMI risk assessment. Methods We conducted a post hoc analysis of 2 randomized controlled trials of AMI with ST-segment elevation to compare the prognostic value of inhospital glucose levels with diabetes history in 30,536 subjects. Average inhospital glucose (mean of glucose levels at admission, 6 hours, and 24 hours), diabetes history, and death at 30 days (occurring in 2,808 subjects) were documented. Results Average glucose predicted 30-day death (OR 1.10 per 1-mmol/L 18-mg/dL increase, 95% CI 1.09-1.11, P < .0001); this was unchanged after adjusting for diabetes history. In contrast, diabetes history alone predicted 30-day death (OR 1.63, 95% CI 1.48-1.78, P < .0001), but not after adjusting for average glucose (OR 0.98, 95% CI 0.88-1.09, P = .72). The C-indices (areas under the receiver operating characteristic curves) for 30-day death were 0.54 for diabetes history alone, 0.64 for average glucose alone, and 0.64 for glucose plus diabetes. Higher glucose levels predicted death in patients with and without diabetes history, but this relationship was more steep in nondiabetic subjects such that their rate of 30-day death (13.2%) matched that of diabetic patients (13.7%) when average glucose was ≥144 mg/dL (8 mmol/L) ( P = .55 after multivariable adjustment). Conclusions Although diabetes history is routinely considered in the risk stratification of AMI patients, inhospital glucose levels are a much stronger predictor of death and should be incorporated in their risk assessment. Patients with AMI with inhospital glucose ≥144 mg/dL have a very high risk of death regardless of diabetes history.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
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