Abstract Background Contemporary use of dual antiplatelet therapy and consistency with guideline recommendations in acute coronary syndrome (ACS) patients undergoing percutaneous coronary ...intervention (PCI) has not been well characterized. Methods The Canadian Observational AntiPlatelet sTudy (COAPT) was a prospective, observational, multicenter, longitudinal study of patients with myocardial infarction (MI) undergoing PCI. Baseline characteristics, treatment patterns, processes of care, factors associated with switching to and from novel adenosine diphosphate receptor inhibitors (ADPris), and in-hospital outcomes are described. Results Among 2179 MI patients undergoing PCI during their index hospitalisation, 1328 (60.9%) had ST elevation. Initial ADPri use included clopidogrel in 1812 (83.2%), prasugrel in 125 (5.7%), and ticagrelor in 242 (11.1%). At discharge, 1597 patients (73.4%) were prescribed clopidogrel, 220 (10.1%) prasugrel and 358 (16.5%) ticagrelor. Switching between ADPri therapies during the index hospitalisation occurred in 15.3%, 22.4%, and 25.2% of patients initially started on clopidogrel, prasugrel, and ticagrelor, respectively. The majority of switches over the 15 month study period occurred during the index admission (16.8% of patients vs. 4.4% switches post-discharge). Major adverse cardiovascular events (MACE) occurred in 7.5% of patients during the index hospitalisation. In-hospital bleeding events occurred in 6.0% of patients and the majority were mild. Conclusions Despite randomized trial evidence and guideline recommendations, only a minority of Canadian MI patients undergoing PCI initially received or were discharged on one of the newer ADPri agents. These findings suggest an opportunity to improve upon the appropriate selection of the ADPris at index hospitalisation and discharge in Canadian MI patients undergoing PCI.
Background Low cardiac output syndrome (LCOS) is associated with increased mortality and occurs in 3–14% of patients undergoing cardiac surgery on cardiopulmonary bypass (CPB). Levosimendan, a novel ...calcium sensitizer and KATP channel activator with inotropic, vasodilatory, and cardioprotective properties, has shown significant promise in reducing the incidence of LCOS and related adverse outcomes in patients undergoing cardiac surgery on CPB. Methods LEVO-CTS is a phase 3 randomized, controlled, multicenter study evaluating the efficacy, safety and cost-effectiveness of levosimendan in reducing morbidity and mortality in high-risk patients with reduced left ventricular ejection fraction (LVEF ≤35%) undergoing cardiac surgery on CPB. Patients will be randomly assigned to receive either intravenous levosimendan (0.2 mcg/kg/min for 1st hour followed by 0.1 mcg/kg for 23 hours) or matching placebo initiated within 8 hours of surgery. The co-primary endpoints are (1) the composite of death or renal replacement therapy through day 30 or perioperative MI, or mechanical assist device use through day 5 (quad endpoint tested at α < 0.01); and (2) the composite of death through postoperative day 30 or mechanical assist device use through day 5 (dual endpoint tested at α < 0.04). Safety endpoints include new atrial fibrillation and death through 90 days. In addition, an economic analysis will address the cost-effectiveness of levosimendan compared with placebo in high-risk patients undergoing cardiac surgery on CPB. Approximately 880 patients will be enrolled at approximately 60 sites in the United States and Canada between July 2014 and September 2016, with results anticipated in January 2017. Conclusion LEVO-CTS, a large randomized multicenter clinical trial, will evaluate the efficacy, safety, and cost-effectiveness of levosimendan in reducing adverse outcomes in high-risk patients undergoing cardiac surgery on CPB. Clinical Trial Registration: ClinicalTrials.gov ( NCT02025621 ).
Background There are limited data on the recent trend in the use of optimal evidence-based medical therapies after acute coronary syndromes (ACSs). We sought to evaluate (1) the temporal changes in ...medical management of patients discharged after an ACS; (2) patient and practice characteristics associated with optimal medical therapy at discharge; and (3) the association between discharge medication use and 1-year outcome. Methods The Canadian ACS I (September 1999-June 2001) and ACS II (October 2002-December 2003) Registries were prospective, multicenter, observational studies of 6853 patients admitted for ACS. We examined the discharge use of medications among 5833 hospital survivors who did not have any contraindications to antiplatelet/anticoagulant, β-blocker, angiotensin-converting enzyme inhibitor, or lipid-modifying therapies. Optimal medical therapy was defined as the use of all indicated medications. Follow-up data at 1 year were collected by telephone interview. We performed hierarchical logistic regression to identify patient characteristics and care patterns associated with optimal medical treatment and to examine its relationship with 1-year mortality. Results There were significant increases in the discharge use of all 4 classes of medications over time; 28.9% and 51.8% of patients in ACS I and ACS II Registries, respectively, were prescribed optimal medical therapy ( P < .001). Advanced age, female sex, prior heart failure, renal dysfunction, and coronary bypass surgery during hospitalization were negative independent predictors of optimal medical therapy. Conversely, enrollment in ACS II Registry, history of dyslipidemia, presence of ST elevation and abnormal cardiac biomarker, previous myocardial infarction, and previous coronary revascularization were independently associated with the use of combination therapy. After adjusting for other validated prognosticators, patients receiving optimal medical therapy had significantly lower 1-year mortality (adjusted odds ratio 0.54, 95% confidence interval 0.36-0.81, P = .003) compared with those given 0 or 1 drug at discharge. Over the 1-year follow-up period, substantial numbers of patients discontinued therapies, whereas others were initiated on treatment. Conclusions Despite the temporal increases in the combined use of evidence-based pharmacologic therapies, which is associated with improved outcome, medical management of ACS remains suboptimal. Quality improvement strategies are needed to enhance the appropriate use of effective therapies, targeting specifically the high-risk but undertreated patients who may derive the greatest therapeutic benefit.
Background Following acute coronary syndrome (ACS), the risk for future cardiovascular events is high and is related to levels of low-density lipoprotein cholesterol (LDL-C) even within the setting ...of intensive statin treatment. Proprotein convertase subtilisin/kexin type 9 (PCSK9) regulates LDL receptor expression and circulating levels of LDL-C. Antibodies to PCSK9 can produce substantial and sustained reductions of LDL-C. The ODYSSEY Outcomes trial tests the hypothesis that treatment with alirocumab, a fully human monoclonal antibody to PCSK9, improves cardiovascular outcomes after ACS. Design This Phase 3 study will randomize approximately 18,000 patients to receive biweekly injections of alirocumab (75-150 mg) or matching placebo beginning 1 to 12 months after an index hospitalization for acute myocardial infarction or unstable angina. Qualifying patients are treated with atorvastatin 40 or 80 mg daily, rosuvastatin 20 or 40 mg daily, or the maximum tolerated and approved dose of one of these agents and fulfill one of the following criteria: LDL-C ≥ 70 mg/dL, non–high-density lipoprotein cholesterol ≥ 100 mg/dL, or apolipoprotein B ≥ 80 mg/dL. The primary efficacy measure is time to first occurrence of coronary heart disease death, acute myocardial infarction, hospitalization for unstable angina, or ischemic stroke. The trial is expected to continue until 1613 primary end point events have occurred with minimum follow-up of at least 2 years, providing 90% power to detect a 15% hazard reduction. Adverse events of special interest include allergic events and injection site reactions. Interim analyses are planned when approximately 50% and 75% of the targeted number of primary end points have occurred. Summary ODYSSEY Outcomes will determine whether the addition of the PCSK9 antibody alirocumab to intensive statin therapy reduces cardiovascular morbidity and mortality after ACS.
Abstract Background Quality indicators in coronary heart disease (CHD) measure the practice gap between optimal care and current clinical practice. However, the potential impact of achieving quality ...indicator benchmarks remains unknown. Methods Using a validated, epidemiologic model of CHD in Ontario, Canada, we estimated the potential impact on mortality of improved utilization on CHD quality indicators from 2005 levels to recommend benchmark utilization of 90%. Eight CHD disease subgroups were evaluated, including inpatients with acute myocardial infarction (AMI), acute coronary syndromes, and heart failure, in addition to ambulatory patients who were post-acute myocardial infarction survivors, or had heart failure, chronic stable angina, hypertension, or hyperlipidemia. The primary outcome was the predicted mortality reduction associated with meeting quality indicator targets for each CHD subgroup-treatment combination. Results In 2005, there were 10,060 CHD deaths in Ontario, representing an age-adjusted CHD mortality of 191 per 100,000 people. By meeting quality indicator utilization benchmarks, mortality could be potentially reduced by approximately 20% (95% confidence interval 17.8-21.1), representing approximately 1960 avoidable deaths. The bulk of this potential benefit was in ambulatory patients with chronic stable angina (36% of reduction) and heart failure (31% of reduction). The biggest drivers were optimizing angiotensin-converting enzyme inhibitor use in chronic stable angina patients (approximately 440 avoidable deaths) and β-blocker use in heart failure (approximately 400 avoidable deaths). Conclusions These findings reinforce the importance of quality indicators and could aid policy makers in prioritizing strategies to meet the goals outlined in the Canadian Heart Health Strategy and Action Plan for reducing cardiovascular mortality.
Abstract International registries have reported a wide variation in coronary care unit (CCU) admission rates for patients hospitalized with acute coronary syndromes (ACS) or heart failure (HF). ...Little is known about variation in Canadian inter-provincial utilization and outcomes. Canadian Institute of Health Information data were used to identify hospitalized patients admitted to a CCU between April 1, 2007 and March 31, 2013 with a primary diagnosis of an acute coronary syndrome (ACS) or heart failure (HF). We examined interprovincial differences in CCU admission rates, use of CCU restricted therapies within the first 2 days of admission, and the association between CCU admission rate and risk-adjusted in-hospital mortality at the province level. CCU admission rate among 220,759 patients hospitalized with ACS and HF was 33% and this varied significantly across provinces (interprovincial range IPR 17-50%, p<0.001). A majority (59%, IPR 48-84%, p<0.001) of patients admitted to CCU did not receive critical care restricted therapies within 2 days. In-hospital mortality also varied across provinces (10%, IPR 5-13%, p<0.001). Although statistically significant (p<0.001), the correlation between CCU admission rates and provincial risk adjusted in-hospital mortality was low (r=-0.30). These findings highlight the need for national CCU admission criteria designed to reduce variability and improve health care resource utilization and outcomes.
Abstract Using data collected from 2 national atrial fibrillation (AF) primary care physician chart audits (Facilitating REview and EDucation to OptiMize stroke prevention in Atrial Fibrillation ...FREEDOM AF and CO-ordinated National Network to Engage physicians in the Care and Treatment of patients with Atrial Fibrillation CONNECT AF), we evaluated the frequency of, and factors associated with, the use of cardiovascular (CV) evidence-based therapies in Canadian AF outpatients with at least one CV risk factor or comorbidity. Among the 11,264 patients enrolled, 9,495 (84.3%) patients were eligible for one or more CV evidence-based therapies. The proportions of AF patients receiving all eligible guideline-recommended therapies were: 40.8% of patients with coronary artery disease, 48.9% of patients with diabetes mellitus, 40.2% of patients with heart failure, 96.7% of patients with hypertension, and 55.1% of patients with peripheral arterial disease. Factors that were independently associated with non-receipt of all indicated evidence-based therapies included sinus rhythm rather than AF at baseline and liver disease. In conclusion, although the majority of Canadian AF outpatients have CV risk factors or comorbidities, a substantial portion of these patients did not receive all guideline-recommended therapies. These findings suggest there is an opportunity to improve the quality of care for AF patients in Canada.
Cardiovascular disease is the second-leading cause of death in Canada. However, limited data are available on the prevalence of atherosclerotic cardiovascular disease (ASCVD) in Canada. The study ...objective was to describe the incidence and prevalence of ASCVD in adult patients in Ontario, Canada, and to evaluate temporal trends for subsequent ASCVD events among those with new-onset ASCVD.
This retrospective, observational study identified ASCVD incidence and prevalence data from the Institute for Clinical Evaluative Sciences Data Repository for adults from Ontario. Overall prevalence was established for the period from 2002 to 2018. Incident cases from April 1, 2005 to March 2016 were then identified, and followed up to 2018. Primary outcomes were date and type of index event/procedure, patient characteristics/baseline demographics, and comorbidities. Secondary outcomes assessed were time from first to second ASCVD event, subsequent event(s) and/or mortality, and type of subsequent event(s) relative to the type of index/primary event.
A total of 1,042,621 eligible prevalent ASCVD cases were identified; of these, 743,309 patients (69%) were newly diagnosed with incident ASCVD. The 10-year prevalence rates for all ASCVD subtypes increased over the study period. Overall event incidence rates per 1000 person-years were mostly stable or increased. Among incident cases, 50% experienced subsequent events over the study period.
This observational study demonstrated increasing prevalence and high incidence of new ASCVD diagnoses in adults from Ontario, over the study period. These data, together with the substantial number of subsequent events in ASCVD patients, demonstrate significant clinical burden of this disease in Ontario.
Les maladies cardiovasculaires constituent la deuxième cause de décès au Canada. Toutefois, on dispose de peu de données sur la prévalence de la maladie cardiovasculaire athéroscléreuse (MCVAS) au Canada. L’étude avait pour objectifs de décrire l’incidence et la prévalence de la MCVAS chez les patients adultes en Ontario (Canada) et d’évaluer les tendances temporelles des manifestations subséquentes de MCVAS chez les personnes ayant une MCVAS d’apparition récente.
Cette étude observationnelle rétrospective a permis de colliger les données sur l’incidence et la prévalence de la MCVAS chez les adultes ontariens consignées dans le référentiel de l’Institut des sciences cliniques évaluatives. La prévalence globale a été établie pour la période allant de 2002 à 2018. Les cas incidents survenus du 1er avril 2005 à mars 2016 ont ensuite été recensés et suivis jusqu’en 2018. Les paramètres d’évaluation principaux étaient : date et nature de la manifestation index et de l’intervention; caractéristiques des patients et données démographiques initiales; comorbidités. Les éléments suivants constituaient les paramètres d’évaluation secon-daires : temps écoulé entre la première et la deuxième manifestation de MCVAS, la ou les manifestations subséquentes et/ou le décès; nature de la ou des manifestations subséquentes par rapport à celle de la manifestation index ou primaire.
En tout, 1 042 621 cas de MCVAS prévalents admissibles ont été dénombrés; parmi ceux-ci, il y avait 743 309 (69 %) cas incidents de MCVAS nouvellement diagnostiqués. Les taux de prévalence à 10 ans de tous les sous-types de MCVAS ont augmenté au cours de la période étudiée. Les taux globaux d’incidence des manifestations par 1000 années-personnes étaient généralement stables ou accrus. Cinquante pour cent des cas incidents ont été associés à des manifestations subséquentes au cours de la période étudiée.
Cette étude observationnelle a démontré une prévalence croissante et une incidence élevée de nouveaux diagnostics de MCVAS chez les adultes en Ontario au cours de la période étudiée. Les données à cet égard, ainsi que le grand nombre de manifestations subséquentes de la maladie, démontrent que la MCVAS constitue un fardeau clinique considérable en Ontario.
Factors Associated With Major Bleeding Events Goodman, Shaun G., MD, MSc; Wojdyla, Daniel M., MS; Piccini, Jonathan P., MD ...
Journal of the American College of Cardiology,
03/2014, Letnik:
63, Številka:
9
Journal Article
Recenzirano
Odprti dostop
Objectives This study sought to report additional safety results from the ROCKET AF (Rivaroxaban Once-daily oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of ...Stroke and Embolism Trial in Atrial Fibrillation). Background The ROCKET AF trial demonstrated similar risks of stroke/systemic embolism and major/nonmajor clinically relevant bleeding (principal safety endpoint) with rivaroxaban and warfarin. Methods The risk of the principal safety and component bleeding endpoints with rivaroxaban versus warfarin were compared, and factors associated with major bleeding were examined in a multivariable model. Results The principal safety endpoint was similar in the rivaroxaban and warfarin groups (14.9 vs. 14.5 events/100 patient-years; hazard ratio: 1.03; 95% confidence interval: 0.96 to 1.11). Major bleeding risk increased with age, but there were no differences between treatments in each age category (<65, 65 to 74, ≥75 years; pinteraction = 0.59). Compared with those without (n = 13,455), patients with a major bleed (n = 781) were more likely to be older, current/prior smokers, have prior gastrointestinal (GI) bleeding, mild anemia, and a lower calculated creatinine clearance and less likely to be female or have a prior stroke/transient ischemic attack. Increasing age, baseline diastolic blood pressure (DBP) ≥90 mm Hg, history of chronic obstructive pulmonary disease or GI bleeding, prior acetylsalicylic acid use, and anemia were independently associated with major bleeding risk; female sex and DBP <90 mm Hg were associated with a decreased risk. Conclusions Rivaroxaban and warfarin had similar risk for major/nonmajor clinically relevant bleeding. Age, sex, DBP, prior GI bleeding, prior acetylsalicylic acid use, and anemia were associated with the risk of major bleeding. (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation: NCT00403767 )
Abstract Background Canadian atrial fibrillation (AF) guidelines recommend that all AF patients be risk stratified with respect to stroke and bleeding, and that most should receive antithrombotic ...therapy. Methods As part of the Canadian F acilitating Re view and Ed ucation to O pti m ize Stroke Prevention in A trial F ibrillation (FREEDOM AF) chart audit, data were collected on 4670 patients ≥ 18 years old without significant valvular heart disease from the primary care practices of 474 physicians (February to September, 2011). Results Physicians did not provide an estimate of stroke and bleeding risk in 15% and 25% of patients, respectively. When risks were provided, they were on the basis of a predictive stroke and bleeding risk index in only 50% and 26% of patients, respectively. There were over- and underestimation of stroke and bleeding risk in a large proportion of patients. Antithrombotic therapy included warfarin (90%); 24% of patients had a time in the therapeutic range (TTR) < 50%, 9% between 50% and 60%, 11% between 60% and 70%, and 56% had a TTR ≥ 70%. Conclusions In a large Canadian AF population, primary care physicians did not provide a stroke or bleeding risk in a substantial proportion of their AF patients. When estimates were provided, they were on the basis of a predictive stroke and bleeding risk index in less than half of the patients. Furthermore, there was under- and overestimation of stroke and bleeding risk in a substantial proportion of patients. As many as 1 in 3 patients receiving warfarin have their TTR < 60%. These findings suggest an opportunity to enhance knowledge translation to primary care physicians.
PDF
