A decrease in mechanical complications after ST-elevation myocardial infarction may have contributed to improved survival rates associated with reperfusion by primary percutaneous coronary ...intervention (PCI). Mechanical complications occurred in 52 of 5,745 patients (0.91%) in the largest reported randomized trial in which primary PCI was the reperfusion strategy. The frequencies were 0.52% (30) for cardiac free-wall rupture (tamponade), 0.17% (10) for ventricular septal rupture, and 0.26% (15) for papillary muscle rupture (3 patients had 2 complications). Ninety-day survival rates were 37% (11) for cardiac free-wall rupture, 20% (2) for ventricular septal rupture, and 73.3% (11) for papillary muscle rupture. These mechanical complications occurred at a median of 23.5 hours (interquartile range 5.0 to 76.8) after symptom onset and were associated with 44% (23 of 52) survival through 90 days, which accounted for 11% of the 90-day mortality. Factors associated with mechanical complications were older age, female gender, Q waves, presence of radiologic pulmonary edema, and increased prerandomization troponin levels. In conclusion, rates of mechanical complications are lower with primary PCI than those previously reported after fibrinolytic therapy.
Aim
After an acute coronary syndrome, patients remain at risk of recurrent ischaemic events, despite contemporary treatment, including aspirin and clopidogrel. We evaluated the safety and indicators ...of efficacy of the novel oral direct thrombin inhibitor dabigatran.
Methods and results
In this double-blind, placebo-controlled, dose-escalation trial, 1861 patients (99.2% on dual antiplatelet treatment) in 161 centres were enrolled at mean 7.5 days (SD 3.8) after an ST-elevation (60%) or non-ST-elevation (40%) myocardial infarction and randomized to twice daily treatment with dabigatran 50 mg (n= 369), 75 mg (n= 368), 110 mg (n= 406), 150 mg (n= 347), or placebo (n= 371). Primary outcome was the composite of major or clinically relevant minor bleeding during the 6-month treatment period. There were 96 primary outcome events and, compared with placebo, a dose-dependent increase with dabigatran, hazard ratio (HR) 1.77 (95% confidence intervals 0.70, 4.50) for 50 mg; HR 2.17 (0.88, 5.31) for 75 mg; HR 3.92 (1.72, 8.95) for 110 mg; and HR 4.27 (1.86, 9.81) for 150 mg. Compared with placebo, D-dimer concentrations were reduced in all dabigatran dose groups by an average of 37 and 45% at weeks 1 and 4, respectively (P< 0.001). Fourteen (3.8%) patients died, had a myocardial infarction or stroke in the placebo group compared with 17 (4.6%) in 50 mg, 18 (4.9%) in 75 mg, 12 (3.0%) in 110 mg, and 12 (3.5%) in the 150 mg dabigatran groups.
Conclusions
Dabigatran, in addition to dual antiplatelet therapy, was associated with a dose-dependent increase in bleeding events and significantly reduced coagulation activity in patients with a recent myocardial infarction.
Recommendations for physical activity in patients with stable coronary heart disease (CHD) are based on modest evidence.
The authors analyzed the association between self-reported exercise and ...mortality in patients with stable CHD.
A total of 15,486 patients from 39 countries with stable CHD who participated in the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) study completed questions at baseline on hours spent each week taking mild, moderate, and vigorous exercise. Associations between the volume of habitual exercise in metabolic equivalents of task hours/week and adverse outcomes during a median follow-up of 3.7 years were evaluated.
A graded decrease in mortality occurred with increased habitual exercise that was steeper at lower compared with higher exercise levels. Doubling exercise volume was associated with lower all-cause mortality (unadjusted hazard ratio HR: 0.82; 95% confidence interval CI: 0.79 to 0.85; adjusting for covariates, HR: 0.90; 95% CI: 0.87 to 0.93). These associations were similar for cardiovascular mortality (unadjusted HR: 0.83; 95% CI: 0.80 to 0.87; adjusted HR: 0.92; 95% CI: 0.88 to 0.96), but myocardial infarction and stroke were not associated with exercise volume after adjusting for covariates. The association between decrease in mortality and greater physical activity was stronger in the subgroup of patients at higher risk estimated by the ABC-CHD (Age, Biomarkers, Clinical–Coronary Heart Disease) risk score (p for interaction = 0.0007).
In patients with stable CHD, more physical activity was associated with lower mortality. The largest benefits occurred between sedentary patient groups and between those with the highest mortality risk.
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Atrial fibrillation (AF) is common among patients with impaired renal function. Apixaban, a novel oral anticoagulant with partial renal excretion, was compared with warfarin and reduced the rate ...stroke, death and bleeding in the ARISTOTLE trial. We evaluated these outcomes in relation to renal function.
Baseline glomerular filtration rate (GFR) was estimated using the Cockcroft-Gault and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations as well as cystatin C measurements. According to baseline Cockcroft-Gault, there were 7518 patients (42%) with an estimated GFR (eGFR) of >80 mL/min, 7587 (42%) between >50 and 80 mL/min, and 3017 (15%) with an eGFR of ≤50 mL/min. The rate of cardiovascular events and bleeding was higher at impaired renal function (≤80 mL/min). Apixaban was more effective than warfarin in preventing stroke or systemic embolism and reducing mortality irrespective of renal function. These results were consistent, regardless of methods for GFR estimation. Apixaban was associated with less major bleeding events across all ranges of eGFRs. The relative risk reduction in major bleeding was greater in patients with an eGFR of ≤50 mL/min using Cockcroft-Gault {hazard ratio (HR) 0.50 95% confidence interval (CI) 0.38-0.66, interaction P = 0.005} or CKD-EPI equations HR 0.48 (95% CI 0.37-0.64), interaction P = 0.003.
In patients with AF, renal impairment was associated with increased risk of cardiovascular events and bleeding. When compared with warfarin, apixaban treatment reduced the rate of stroke, death, and major bleeding, regardless of renal function. Patients with impaired renal function seemed to have the greatest reduction in major bleeding with apixaban.
Each guideline is considered current unless and until it is updated, revised, or superseded by a published addendum.\n Munger Content Reviewer University of Utah--Professor of Pharmacy Practice None ...None None None None None E. Magnus Ohman Content Reviewer Duke University--Professor of Medicine, Director of Program for Advanced Coronary Disease AstraZeneca Janssen Pharmaceuticalslow * None None Daiichi-Sankyolow * Eli Lillylow * Janssen Pharmaceuticalslow * None None Eric R. Powers Content Reviewer Medical University of South Carolina--Service Line Medical Director None None None None None None Susan J. Pressler Content Reviewer--ACC/AHA Task Force on Clinical Practice Guidelines Indiana School of Nursing--Professor and Sally Reahard Chair; Center of Enhancing Quality of Life in Chronic Illness--Director None None None None None None Sunil V. Rao Content Reviewer Duke University Medical Center--Associate Professor of Medicine None None None None None None Philippe Gabriel Steg Content Reviewer Université Paris-Diderot--Professor AstraZeneca Bristol-Myers Squibblow * Daiichi-Sankyo Eli Lilly Merck None None AstraZenecalow * None None Tracy Y. Wang Content Reviewer Duke University Medical Center--Associate Professor of Medicine AstraZenecalow * Eli Lilly None None AstraZenecalow * Bristol-Myers Squibblow * Eli Lilly/Daiichi-Sankyo Alliancelow * None None black square This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review and determined to be relevant to this document. Names are listed in alphabetical order within each category of review.According to the ACC/AHA, a person has a relevant relationship IF: a) the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) the person or a member of the person's household has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document.AATS indicates American Association for Thoracic Surgery; ACC, American College of Cardiology; ACEP, American College of Emergency Physicians; AHA, American Heart Association; CSL, Coordinated Science Laboratory; DSMB, data safety monitoring board; PCNA; Preventive Cardiovascular Nurses Association; SCA, Society of Cardiovascular Anesthesiologist; SCAI, Society for Cardiovascular Angiography and Interventions; STS, Society of Thoracic Surgeons; and SVM, Society for Vascular Medicine.
Most patients with atrial fibrillation (AF) and risk factors for stroke require oral anticoagulation (OAC) to decrease the risk of stroke or systemic embolism. This is now best achieved with direct ...oral anticoagulants that decrease the risk of intracranial bleeding compared with vitamin K antagonists. Of note, approximately 5% to 10% of patients undergoing percutaneous coronary intervention have AF, which complicates antithrombotic therapy in daily practice, because the guidelines recommend that these patients also receive dual antiplatelet therapy (DAPT) to reduce the risk of ischemic complications. However, combining OAC with DAPT, a strategy also known as triple antithrombotic therapy, is known to increase the risk of bleeding compared with the use of OAC or DAPT alone. Studies of direct oral anticoagulants are now emerging that show the favorable safety profile of double antithrombotic therapy with OAC and a P2Y
inhibitor in comparison with triple antithrombotic therapy including the use of vitamin K antagonists. The scope of this review is to provide an update on this topic as well as to discuss future directions in the management of antithrombotic therapy after percutaneous coronary intervention in AF patients requiring chronic OAC.
Chronic heart failure (CHF) is an important cause of hospital admission and death. Poor adherence to medication is common in some chronic illnesses and might reduce the population effectiveness of ...proven treatments. Because little is known about adherence in patients with CHF and about the consequences of non-adherence, we assessed the association between adherence and clinical outcome in the CHARM (Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity) programme.
CHARM was a double-blind, randomised, controlled clinical trial, comparing the effects of the angiotensin receptor blocker candesartan with placebo in 7599 patients with CHF. Median follow-up was 38 months. The proportion of time patients took more than 80% of their study medication was defined as good adherence and 80% or less as poor adherence. We used a Cox proportional hazards regression model, with adherence as a time-dependent covariate in the model, to examine the association between adherence and mortality in the candesartan and placebo groups.
We excluded 187 patients because of missing information on adherence. In the time-dependent Cox regression model, after adjustment for predictive factors (demographics, physiological and severity-of-illness variables, smoking history, and number of concomitant medications), good adherence was associated with lower all-cause mortality in all patients (hazard ratio HR 0·65, 95% CI 0·57–0·75, p<0·0001). The adjusted HR for good adherence was similar in the candesartan (0·66, 0·55–0·81, p<0·0001) and placebo (0·64, 0·53–0·78, p<0·0001) groups.
Good adherence to medication is associated with a lower risk of death than poor adherence in patients with CHF, irrespective of assigned treatment. This finding suggests that adherence is a marker for adherence to effective treatments other than study medications, or to other adherence behaviours that affect outcome. Understanding these factors could provide an opportunity for new interventions, including those aimed at improving adherence.
Targeted temperature management (TTM) after out-of-hospital cardiac arrest (OHCA) has been a focus of debate in an attempt to improve post-arrest outcomes. Contemporary trials examining the role of ...TTM after cardiac arrest suggest that targeting normothermia should be the standard of care for initially comatose survivors of cardiac arrest. Differences in patient populations have been demonstrated across trials, and important subgroups may be under-represented in clinical trials compared with real-world registries. In this review, we aimed to describe the populations represented in international OHCA registries and to propose a pathway to integrate clinical trial evidence into practice. The patient case mix among registries including survivors to hospital admission was similar to the pivotal trials (shockable rhythm, witnessed arrest), suggesting reasonable external validity. Therefore, for the majority of OHCA, targeted normothermia should be the strategy of choice. There remains conflicting evidence for patients with a nonshockable rhythm, with no clear evidence-based justification for mild hypothermia over targeted normothermia.
Le contrôle ciblé de la température (CCT) après un arrêt cardiaque en milieu extrahospitalier (ACEH) pour tenter d’améliorer le pronostic est un sujet controversé. Les essais contemporains examinant le rôle du CCT après un arrêt cardiaque laissent croire que la normothermie ciblée devrait être le traitement de référence pour les survivants d’un arrêt cardiaque initialement dans un état comateux. Des différences dans les populations de patients ont été observées entre les essais, et des sous-groupes importants pourraient être sous-représentés dans les essais cliniques comparativement aux registres de données du monde réel. Dans cette revue, nous souhaitons décrire les populations représentées dans les registres internationaux d’ACEH et proposer une façon d’intégrer dans la pratique les données probantes issues des essais cliniques. Les types de cas figurant dans les registres y compris des survivants à l’admission à l’hôpital étaient comparables à ceux des essais pivots (rythme défibrillable, arrêt cardiaque devant témoin), ce qui laisse croire à une validité externe raisonnable. Par conséquent, pour la majorité des ACEH, la normothermie ciblée devrait être la stratégie de choix. Des données probantes contradictoires demeurent pour les patients ayant un rythme non défibrillable, et il n’y a pas de données probantes qui permettent de justifier la préférence pour l’hypothermie légère par rapport à la normothermie ciblée.
The risk of stroke in patients with atrial fibrillation (AF) increases with age. In the ARISTOTLE trial, apixaban when compared with warfarin reduced the rate of stroke, death, and bleeding. We ...evaluated these outcomes in relation to patient age.
A total of 18 201 patients with AF and a raised risk of stroke were randomized to warfarin or apixaban 5 mg b.d. with dose reduction to 2.5 mg b.d. or placebo in 831 patients with ≥2 of the following criteria: age ≥80 years, body weight ≤60 kg, or creatinine ≥133 μmol/L. We used Cox models to compare outcomes in relation to patient age during 1.8 years median follow-up. Of the trial population, 30% were <65 years, 39% were 65 to <75, and 31% were ≥75 years. The rates of stroke, all-cause death, and major bleeding were higher in the older age groups (P < 0.001 for all). Apixaban was more effective than warfarin in preventing stroke and reducing mortality across all age groups, and associated with less major bleeding, less total bleeding, and less intracranial haemorrhage regardless of age (P interaction >0.11 for all). Results were also consistent for the 13% of patients ≥80 years. No significant interaction with apixaban dose was found with respect to treatment effect on major outcomes.
The benefits of apixaban vs. warfarin were consistent in patients with AF regardless of age. Owing to the higher risk at older age, the absolute benefits of apixaban were greater in the elderly.
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