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1.
Eur Heart J ; 2020 Oct 13.
Artigo em Inglês | MEDLINE | ID: mdl-33049774

RESUMO

AIMS: There are sex differences in presentation, treatment, and outcomes of myocardial infarction (MI) but less is known about these differences in a younger patient population. The objective of this study was to investigate sex differences among individuals who experience their first MI at a young age. METHODS AND RESULTS: Consecutive patients presenting to two large academic medical centres with a Type 1 MI at ≤50 years of age between 2000 and 2016 were included. Cause of death was adjudicated using electronic health records and death certificates. In total, 2097 individuals (404 female, 19%) had an MI (mean age 44 ± 5.1 years, 73% white). Risk factor profiles were similar between men and women, although women were more likely to have diabetes (23.7% vs. 18.9%, P = 0.028). Women were less likely to undergo invasive coronary angiography (93.5% vs. 96.7%, P = 0.003) and coronary revascularization (82.1% vs. 92.6%, P < 0.001). Women were significantly more likely to have MI with non-obstructive coronary disease on angiography (10.2% vs. 4.2%, P < 0.001). They were less likely to be discharged with aspirin (92.2% vs. 95.0%, P = 0.027), beta-blockers (86.6% vs. 90.3%, P = 0.033), angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (53.4% vs. 63.7%, P < 0.001), and statins (82.4% vs. 88.4%, P < 0.001). There was no significant difference in in-hospital mortality; however, women who survived to hospital discharge experienced a higher all-cause mortality rate (adjusted HR = 1.63, P = 0.01; median follow-up 11.2 years) with no significant difference in cardiovascular mortality (adjusted HR = 1.14, P = 0.61). CONCLUSIONS: Women who experienced their first MI under the age of 50 were less likely to undergo coronary revascularization or be treated with guideline-directed medical therapies. Women who survived hospitalization experienced similar cardiovascular mortality with significantly higher all-cause mortality than men. A better understanding of the mechanisms underlying these differences is warranted.

2.
JAMA Intern Med ; 2020 Oct 12.
Artigo em Inglês | MEDLINE | ID: mdl-33044497

RESUMO

Importance: Mortality is a common outcome in trials comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG). Controversy exists regarding whether all-cause mortality or cardiac mortality is preferred as a study end point, because noncardiac mortality should be unrelated to the treatment. Objective: To evaluate the difference in all-cause and cause-specific mortality in randomized clinical trials (RCTs) comparing PCI with CABG for the treatment of patients with coronary artery disease. Data Sources: MEDLINE (1946 to the present), Embase (1974 to the present), and the Cochrane Library (1992 to the present) databases were searched on November 24, 2019. Reference lists of included articles were also searched, and additional studies were included if appropriate. Study Selection: Articles were considered for inclusion if they were in English, were RCTs comparing PCI with drug-eluting or bare-metal stents and CABG for the treatment of coronary artery disease, and reported mortality and/or cause-specific mortality. Trials of PCI involving angioplasty without stenting were excluded. For each included trial, the publication with the longest follow-up duration for each outcome was selected. Data Extraction and Synthesis: For data extraction, all studies were reviewed by 2 independent investigators, and disagreements were resolved by a third investigator in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses guideline. Data were pooled using fixed- and random-effects models. Main Outcomes and Measures: The primary outcomes were all-cause and cause-specific (cardiac vs noncardiac) mortality. Subgroup analyses were performed for PCI trials using drug-eluting vs bare-metal stents and for trials involving patients with left main disease. Results: Twenty-three unique trials were included involving 13 620 unique patients (6829 undergoing PCI and 6791 undergoing CABG; men, 39.9%-99.0% of study populations; mean age range, 60.0-71.0 years). The weighted mean (SD) follow-up was 5.3 (3.6) years. Compared with CABG, PCI was associated with a higher rate of all-cause (incidence rate ratio, 1.17; 95% CI, 1.05-1.29) and cardiac (incidence rate ratio, 1.24; 95% CI, 1.05-1.45) mortality but also noncardiac mortality (incidence rate ratio, 1.19; 95% CI, 1.00-1.41). Conclusions and Relevance: Percutaneous coronary intervention was associated with higher all-cause, cardiac, and noncardiac mortality compared with CABG at 5 years. The significantly higher noncardiac mortality associated with PCI suggests that even noncardiac deaths after PCI may be procedure related and supports the use of all-cause mortality as the end point for myocardial revascularization trials.

3.
Am Heart J ; 2020 Oct 05.
Artigo em Inglês | MEDLINE | ID: mdl-33031789

RESUMO

Dual antiplatelet therapy (DAPT) is key for the prevention of recurrent ischemic events after percutaneous coronary intervention (PCI), however, it increases the risk of bleeding complications. While new generation drug-eluting stents have been shown superior to bare-metal stents after a short DAPT course, the optimal DAPT duration in patients at high bleeding risk (HBR) remains to be determined. TRIAL DESIGN: The XIENCE Short DAPT program consists of three prospective, single-arm studies (XIENCE 90, XIENCE 28 Global and XIENCE 28 USA) investigating 3- or 1-month DAPT durations in HBR patients undergoing PCI with the XIENCE stent. The XIENCE 90 study is being conducted in the US and enrolled 2047 subjects who discontinued DAPT at 3months if they were free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis. The XIENCE 28 program includes the USA study, enrolling 642 patients in US and Canada, and the Global study, enrolling 963 patients in Europe and Asia. In XIENCE 28, patients were to discontinue DAPT at 1month post-PCI if event-free. The primary hypothesis for both XIENCE 90 and XIENCE 28 is that a short DAPT regimen will be non-inferior to a conventional DAPT duration with respect to the composite of all-cause death or MI. Patients enrolled in the prospective multicenter post-market XIENCE V USA study will be used as historical control group in a stratified propensity-adjusted analysis. CONCLUSIONS: The XIENCE Short DAPT Program will provide insights into the safety and efficacy of two abbreviated DAPT regimens of 3- and 1-month duration in a large cohort of HBR patients undergoing PCI with the XIENCE stent.

5.
Artigo em Inglês | MEDLINE | ID: mdl-33038061

RESUMO

OBJECTIVE: To investigate the impact of ischemic and bleeding risk factors on long-term clinical outcomes of patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) with everolimus-eluting stents. BACKGROUND: Second-generation drug-eluting stents have substantially improved outcomes after PCI in the general population; however, DM patients continue to experience high rates of ischemic and bleeding complications. METHODS: DM patients from the pooled XIENCE V registry were divided into high or low bleeding and ischemic risk groups (HBR, LBR, HIR, and LIR) based on established bleeding (age ≥ 75 years; chronic kidney disease; anemia; prior stroke; oral anticoagulation; thrombocytopenia; prior major bleeding) and ischemic (acute coronary syndrome; prior myocardial infarction [MI]; ≥3 stents implanted; ≥3 vessels treated; ≥3 lesions treated; stent length > 60 mm; bifurcation treated with ≥2 stents; chronic total occlusion) risk factors. The primary outcomes were major adverse cardiac events (MACE; cardiac death, MI, or stent thrombosis) and major bleeding at 4-year follow-up. RESULTS: A total of 3,704 DM patients were divided into four groups (21.5% LBR/LIR; 39.0% LBR/HIR; 15.6% HBR/LIR; 23.9% HBR/HIR). Compared with LBR/LIR patients, those at HBR/HIR and HBR/LIR had a significantly higher risk of MACE (HR (95% CI) 2.7 (1.9-3.9) and 2.2 (1.5-3.2), respectively) and major bleeding (2.7 (1.6-4.8) and 2.6 (1.4-4.7), respectively), while LBR/HIR patients did not. CONCLUSIONS: Among DM patients undergoing PCI, presence of bleeding risk factors was associated with a higher risk of both ischemic and bleeding events, whereas commonly used features of ischemic risk did not impact long-term clinical outcomes.

7.
Am J Med ; 2020 Sep 30.
Artigo em Inglês | MEDLINE | ID: mdl-33010225

RESUMO

BACKGROUND: New hypertension and heart failure guidelines recommend that systolic blood pressure (SBP) in patients with heart failure with preserved ejection fraction (HFpEF) and hypertension be lowered to <130 mmHg. METHODS: Of the 6778 hospitalized patients with HFpEF and a history of hypertension in the Medicare-linked OPTIMIZE-HF registry, 3111 had a discharge SBP <130 mmHg. Using propensity scores for SBP <130 mmHg, we assembled a matched cohort of 1979 pairs with SBP <130 versus ≥130 mmHg, balanced on 66 baseline characteristics (mean age, 79 years; 69% women; 12% African American). We then assembled a second matched cohort of 1326 pairs with SBP <120 versus ≥130 mmHg. Hazard ratios (HRs) and 95% confidence intervals (CIs) for outcomes associated with SBP <130 and <120 mmHg were separately estimated in the matched cohort using SBP ≥130 mmHg as the reference. RESULTS: HRs (95% CIs) for 30-day, 12-month, and 6-year all-cause mortality associated with SBP <130 mmHg were 1.20 (0.91-1.59; p=0.200), 1.11 (0.99-1.26; p=0.080), and 1.05 (0.98-1.14; p=0.186), respectively. Respective HRs (95% CIs) associated with SBP <120 mmHg were 1.68 (1.21-2.34; p=0.002), 1.28 (1.11-1.48; p=0.001), and 1.11 (1.02-1.22; p=0.022). There was no association with readmission. CONCLUSIONS: Among older patients with HFpEF and hypertension, compared with SBP ≥130 mmHg, the new target SBP <130 mmHg had no association with outcomes, but SBP <120 mmHg was associated with a higher risk of death but not of readmission. Future prospective studies need to evaluate optimal SBP treatment goals in these patients.

8.
Circulation ; 142(14): 1342-1350, 2020 Oct 06.
Artigo em Inglês | MEDLINE | ID: mdl-33017212

RESUMO

BACKGROUND: Equipoise exists between the use of leaflet resection and preservation for surgical repair of mitral regurgitation caused by prolapse. We therefore performed a randomized, controlled trial comparing these 2 techniques, particularly in regard to functional mitral stenosis. METHODS: One hundred four patients with degenerative mitral regurgitation surgically amenable to either leaflet resection or preservation were randomized at 7 specialized cardiac surgical centers. Exclusion criteria included anterior leaflet or commissural prolapse, as well as a mixed cause for mitral valve disease. Using previous data, we determined that a sample size of 88 subjects would provide 90% power to detect a 5-mm Hg difference in mean mitral valve gradient at peak exercise, assuming an SD of 6.7 mm with a 2-sided test with α=5% and 10% patient attrition. The primary end point was the mean mitral gradient at peak exercise 12 months after repair. RESULTS: Patient age, proportion who were female, and Society of Thoracic Surgeons risk score were 63.9±10.4 years, 19%, and 1.4±2.8% for those who were assigned to leaflet resection (n=54), and 66.3±10.8 years, 16%, and 1.9±2.6% for those who underwent leaflet preservation (n=50). There were no perioperative deaths or conversions to replacement. At 12 months, moderate mitral regurgitation was observed in 3 subjects in the leaflet resection group and 2 in the leaflet preservation group. The mean transmitral gradient at 12 months during peak exercise was 9.1±5.2 mm Hg after leaflet resection and 8.3±3.3 mm Hg after leaflet preservation (P=0.43). The participants had similar resting peak (8.3±4.4 mm Hg versus 8.4±2.6 mm Hg; P=0.96) and mean resting (3.2±1.9 mm Hg versus 3.1±1.1 mm Hg; P=0.67) mitral gradients after leaflet resection and leaflet preservation, respectively. The 6-minute walking distance was 451±147 m for those in the leaflet resection versus 481±95 m for the leaflet preservation group (P=0.27). CONCLUSIONS: In this adequately powered randomized trial, repair of mitral prolapse with either leaflet resection or leaflet preservation was associated with similar transmitral gradients at peak exercise at 12 months postoperatively. These data do not support the hypothesis that a strategy of leaflet resection (versus preservation) is associated with a risk of functional mitral stenosis. Registration: URL: https://www.clinicaltrials.gov; Unique identifier NCT02552771.

9.
Eur Heart J ; 2020 Oct 14.
Artigo em Inglês | MEDLINE | ID: mdl-33051646

RESUMO

AIMS: Lipoprotein(a) concentration is associated with first cardiovascular events in clinical trials. It is unknown if this relationship holds for total (first and subsequent) events. In the ODYSSEY OUTCOMES trial in patients with recent acute coronary syndrome (ACS), the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab reduced lipoprotein(a), low-density lipoprotein cholesterol (LDL-C), and cardiovascular events compared with placebo. This post hoc analysis determined whether baseline levels and alirocumab-induced changes in lipoprotein(a) and LDL-C [corrected for lipoprotein(a) cholesterol] independently predicted total cardiovascular events. METHODS AND RESULTS: Cardiovascular events included cardiovascular death, non-fatal myocardial infarction, stroke, hospitalization for unstable angina or heart failure, ischaemia-driven coronary revascularization, peripheral artery disease events, and venous thromboembolism. Proportional hazards models estimated relationships between baseline lipoprotein(a) and total cardiovascular events in the placebo group, effects of alirocumab treatment on total cardiovascular events by baseline lipoprotein(a), and relationships between lipoprotein(a) reduction with alirocumab and subsequent risk of total cardiovascular events. Baseline lipoprotein(a) predicted total cardiovascular events with placebo, while higher baseline lipoprotein(a) levels were associated with greater reduction in total cardiovascular events with alirocumab (hazard ratio Ptrend = 0.045). Alirocumab-induced reductions in lipoprotein(a) (median -5.0 [-13.6, 0] mg/dL) and corrected LDL-C (median -51.3 [-67.1, -34.0] mg/dL) independently predicted lower risk of total cardiovascular events. Each 5-mg/dL reduction in lipoprotein(a) predicted a 2.5% relative reduction in cardiovascular events. CONCLUSION: Baseline lipoprotein(a) predicted the risk of total cardiovascular events and risk reduction by alirocumab. Lipoprotein(a) lowering contributed independently to cardiovascular event reduction, supporting the concept of lipoprotein(a) as a treatment target after ACS.

10.
Clin Cardiol ; 2020 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-32897582

RESUMO

BACKGROUND: Right heart catheterization-derived hemodynamic parameters have been associated with short-term prognosis. HYPOTHESIS: Hemodynamic parameters will be associated with long-term prognosis. METHODS: Retrospective cohort study from the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program included patients who underwent an index right heart catheterization between 2008 and 2016. Cox proportional hazard models were used to examine the association between stroke volume index and all-cause mortality. RESULTS: For the final cohort of 37 209 patients, mean follow-up was 3.7 ± 2.5 years. All-cause mortality was 42.0% in the low (<35 cc/beat/m2) compared with 33.2% in the normal stroke volume index group (≥35 cc/beat/m2). In adjusted analysis, low stroke volume was significantly associated with higher mortality risk (HR (95% CI) 1.14 (1.10-1.18); P < .001) independent of clinical parameters. The area under the curve (AUC) for continuous measures of stroke volume index at predicting mortality in a Cox proportional hazard model was 0.56 at 3 years. When stroke volume index was combined with 14 clinical covariates, the AUC was 0.70 at 3 years. The addition of stroke volume index to these clinical covariates did not increase the discriminatory ability of the model at 1 year in a clinically meaningful way (integrated discrimination improvement index = 0.0021, 95% CI: 0.0010-0.0034). CONCLUSIONS: The long-term prognostic value of right heart catheterization-derived stroke volume index appears to be marginal. While there was a weak association of low stroke volume index and excess mortality, inclusion of this parameter to a set of clinical covariates did not improve prognostic discrimination.

11.
Artigo em Inglês | MEDLINE | ID: mdl-32969155

RESUMO

BACKGROUND: Transcatheter mitral valve repair (TMVR) is a treatment option for patients with 3+ or greater mitral regurgitation who cannot undergo mitral valve surgery. Outcomes in patients with chronic kidney disease (CKD) and end stage renal disease (ESRD) are unclear. We sought to evaluate the TMVR in-hospital outcomes, readmission rates and its impact on kidney function. METHODS: Data from 2016 National Readmission Database was used to obtain all patients who underwent TMVR. Patients were classified by their CKD status: no CKD, CKD, or ESRD. The primary outcomes were: in-hospital mortality, 30- and 90-day readmission rate, and change in CKD status on readmission. Multivariable logistic regression analysis was used to assess in-hospital, readmission outcomes and kidney function stage. RESULTS: A total of 4,645 patients were assessed (mean age 78.5 ± 10.3 years). In-hospital mortality was higher in patients with CKD (4.0%, odds ratio [OR]:2.01 [95% CI, confidence interval: 1.27-3.18]) and ESRD (6.6%, OR: 6.38 [95% CI: 1.49-27.36]) compared with non-CKD (2.4%). 30-day readmission rate was higher in ESRD versus non-CKD patients (17.8% vs. 10.4%, OR: 2.24 [95% CI: 1.30-3.87]) as was 90-day readmission (41.2% vs. 21% OR: 2.51 [95% CI:1.70-3.72]). Kidney function improved in 25% of patients with CKD stage 3 and in 50% with CKD stage 4-5 at 30-and 90-day readmission. Incidence of AKI, major bleeding, and respiratory failure were higher in CKD group. CONCLUSIONS: Patients with CKD and ESRD have worse outcomes and higher readmission rate after TMVR. In patients who were readmitted after TMVR, renal function improved in some patients, suggesting that TMVR could potentially improve CKD stage.

12.
Nat Rev Cardiol ; 17(11): 673-675, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32873977
13.
Am J Cardiol ; 2020 Sep 28.
Artigo em Inglês | MEDLINE | ID: mdl-32991853

RESUMO

As transcatheter aortic valve implantation (TAVI) continues its rapid growth as a treatment approach for aortic stenosis, costs associated with TAVI, and its burden to healthcare systems will assume greater importance. Patients undergoing TAVI between January 2012 and November 2017 in the Nationwide Readmission Database were identified. Trends in cause-specific readmissions were assessed using Poisson regression. Thirty-day TAVI cost burden (cost of index TAVI hospitalization plus total 30-day readmissions cost) was adjusted to 2017 U.S. dollars and trended over year from 2012 to 2017. Overall, 47,255 TAVI were included and 30-day readmissions declined from 20% to 12% (p <0.0001). Most common causes of readmission (heart failure, infection/sepsis, gastrointestinal causes, and respiratory) declined as well, except arrhythmia/heart block which increased (1.0% to 1.4%, p <0.0001). Cost of TAVI hospitalization ($52,024 to $44,110, p <0.0001) and 30-day cost burden ($54,122 to $45,252, p <0.0001) declined. Whereas costs of an average readmission did not change ($9,734 to $10,068, p = 0.06), cost burden of readmissions (per every TAVI performed) declined ($4,061 to $1,883, p <0.0001), including reductions in each of the top 5 causes except arrhythmia/heart block ($171 to $263, p = 0.04). Index TAVI hospitalizations complicated by acute kidney injury, length of stay ≥5 days, low hospital procedural volume, and skilled nursing facility discharge were associated with increased odds of 30-day readmissions. In conclusion, the costs of index hospitalizations and 30-day cost burden for TAVI in the U.S. significantly declined from 2012 to 2017. However, readmissions due to arrhythmia/heart block and their associated costs increased. Continued strategies to prevent readmissions, especially those for conduction disturbances, are crucial in the efforts to optimize outcomes and costs with the ongoing expansion of TAVI.

14.
Hypertension ; 76(5): 1410-1417, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32981360

RESUMO

Recent randomized sham-controlled trials have demonstrated significant blood pressure reductions following renal denervation (RDN) in patients with hypertension, both in the presence and absence of antihypertensive therapy. These new data encouraged us to revisit previously published insights into potential clinical trial confounding factors that informed the design and conduct of forthcoming trials. Initially identified confounders related to procedural technique, medication variability, and selected patient subgroups have been addressed in contemporary trial design. Regarding procedural method and technology, blood pressure reductions may be improved by ensuring circumferential lesion creation in the distal renal arteries and branch vessels. Safety of the RDN procedure has been demonstrated in multiple independent meta-analyses including thousands of treated patients with low reported rates of renal vessel complications and maintenance of renal function. However, a newer generation of RDN trials has also introduced insights related to medication adherence, patient selection, and the definition of treatment response. Evolving evidence indicates that RDN therapy may be considered in higher risk populations of uncontrolled hypertension regardless of ethnicity and in patients expressing a strong preference for a nondrug therapy option. Despite advances in procedural technique and clinical trial conduct, inconsistent antihypertensive-drug adherence behavior remains perhaps the most critical clinical trial design issue for device-based hypertension therapies. As the balance in clinical equipoise increasingly favors RDN, justification of sham-controlled trial designs will be revisited, and novel study designs may be required to evaluate the safety and efficacy of novel devices and procedures intended to address the escalating prevalence of poorly controlled hypertension.

15.
Circulation ; 2020 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-32886529

RESUMO

Four decades have passed since the first trial suggesting aspirin's efficacy in the secondary prevention of myocardial infarction. Further trials, summarized in the Antithrombotic Trialists' Collaboration, solidified the historical role of aspirin in secondary prevention. Although the benefit of aspirin in the immediate phase following a myocardial infarction remains incontrovertible, a number of emerging lines of evidence - discussed in this narrative review - now raise some uncertainty as to the primacy of aspirin for the lifelong management of all patients with chronic coronary syndrome (CCS). For example, data challenging the previously unquestioned role of aspirin in CCS have come from recent trials where aspirin was discontinued in specific clinical scenarios; including early discontinuation of the aspirin component of dual-antiplatelet therapy following percutaneous coronary intervention and the withholding of aspirin among CCS patients with atrial fibrillation who require anticoagulation. Added to this, recent primary prevention trials have failed to consistently demonstrate net benefit for aspirin in patients treated to optimal contemporary cardiovascular risk-factor targets, indicating that the efficacy of aspirin for secondary prevention of CCS may similarly have changed with the addition of more modern secondary prevention therapies. Therefore, the totality of recent evidence supports further study of the universal need for lifelong aspirin in the modern secondary prevention of all adults with CCS, particularly in stable older patients who are at highest risk for aspirin-induced bleeding.

16.
Curr Opin Cardiol ; 2020 Sep 08.
Artigo em Inglês | MEDLINE | ID: mdl-32925191

RESUMO

PURPOSE OF REVIEW: Following coronary artery bypass grafting (CABG), there remains persistent risk of ischemic events despite secondary prevention strategies, including low-density lipoprotein cholesterol lowering. Although REDUCE-IT recently demonstrated the benefits of icosapent ethyl (IPE) on reducing ischemic events in a broad population of primary and secondary prevention patients, its generalizability to a contemporary CABG population is not known. This article aims to ascertain the proportion of patients with a history of CABG that would be eligible for IPE treatment. RECENT FINDINGS: A review of recent literature highlights the presence of residual ischemic following CABG. Using the Québec Heart Database, a repository of contemporary Canadian cardiac patient information, was searched between 1 January 2006 and 31 December 2016, to ascertain generalizability of IPE. SUMMARY: In a large (N = 12 641), contemporary, Canadian cohort of patients with a history of CABG and currently on statin therapy, 21.9, 33.6 and 26.4% would be eligible for IPE, according to REDUCE-IT, Health Canada, and Food and Drug Administration criteria, respectively. These analyses would support IPE as an adjunct to secondary prevention therapies post-CABG.

17.
Artigo em Inglês | MEDLINE | ID: mdl-32880803

RESUMO

INTRODUCTION: Low-dose rivaroxaban reduced major adverse cardiac and limb events among patients with stable atherosclerotic vascular disease (ASCVD) in the COMPASS trial. The objective of our study was to evaluate the eligibility and budgetary impact of the COMPASS trial in a real-world population. METHODS: The VA administrative and clinical databases were utilized to conduct a cross-sectional study to identify patients eligible for low-dose rivaroxaban receiving care at all 141 facilities between October 1, 2014 and September 30, 2015. Proportion of patients with stable ASCVD eligible for low-dose rivaroxaban and prevalence of multiple risk enrichment criteria among eligible patients. Pharmaceutical budgetary impact using VA pharmacy pricing. Chi-squared and Student's t tests were used to compare patients eligible versus ineligible patients. RESULTS: From an initial cohort of 1,248,214 patients with ASCVD, 488,495 patients (39.1%) met trial eligibility criteria. Eligible patients were older (74.2 vs 64.5 years) with higher proportion of hypertension (84.1% vs 82.1%) and diabetes (46.2% vs 32.9) compared with ineligible patients (p < 0.001 for all comparisons). A median of 38.7% (IQR 4.6%) of total ASCVD patients per facility were rivaroxaban eligible. Estimated annual VA pharmacy budgetary impact would range from $0.47 billion to $1.88 billion for 25% to 100% treatment penetration. Annual facility level pharmaceutical budgetary impact would be a median of $12.3 million (IQR $8.0-$16.3 million) for treatment of all eligible patients. Among eligible patients, age greater than 65 years was the most common risk enrichment factor (86.9%). Prevalence of eligible patients with multiple enrichment factors varied from 34.2% (one factor) to 6.2% (four or more). CONCLUSION: Over one third of patients with stable ASCVD may qualify for low-dose rivaroxaban within the VA. Additional studies are needed to understand eligibility in other populations and a formal cost-effectiveness analysis is warranted.

18.
Stroke ; 51(10): 2901-2909, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32951537

RESUMO

BACKGROUND AND PURPOSE: Covert brain infarcts are associated with cognitive decline. It is not known whether therapies that prevent symptomatic stroke prevent covert infarcts. COMPASS compared rivaroxaban with and without aspirin with aspirin for the prevention of stroke, myocardial infarction, and vascular death in participants with stable vascular disease and was terminated early because of benefits of rivaroxaban 2.5 mg twice daily plus aspirin over aspirin. We obtained serial magnetic resonance imagings and cognitive tests in a consenting subgroup of COMPASS patients to examine treatment effects on infarcts, cerebral microbleeds, and white matter hyperintensities. METHODS: Baseline and follow-up magnetic resonance imagings were completed in 1445 participants with a mean (SD) interval of 2.0 (0.7) years. Whole-brain T1, T2 fluid-attenuated inversion recovery, T2* sequences were centrally interpreted by blinded, trained readers. Participants had serial measurements of cognition and function. The primary end point was the proportion of participants with incident covert infarcts. Secondary end points were the composite of clinical stroke and covert brain infarcts, cerebral microbleeds, and white matter hyperintensities. RESULTS: At baseline, 493 (34.1%) participants had infarcts. Incident covert infarcts occurred in 55 (3.8%) participants. In the overall trial rivaroxaban plus aspirin reduced ischemic stroke by 49% (0.7% versus 1.4%; hazard ratio [95% CI], 0.51 [0.38-0.68]). In the magnetic resonance imaging substudy the effects of rivaroxaban+aspirin versus aspirin were: covert infarcts: 2.7% versus 3.5% (odds ratio [95% CI], 0.77 [0.37-1.60]); Covert infarcts or ischemic stroke: 2.9% versus 5.3% (odds ratio [95% CI], 0.53 [0.27-1.03]). Incident microbleeds occurred in 6.6% of participants and 65.7% of participants had an increase in white matter hyperintensities volume with no effect of treatment for either end point. There was no effect on cognitive tests. CONCLUSIONS: Covert infarcts were not significantly reduced by treatment with rivaroxaban and aspirin but estimates for the combination of ischemic stroke and covert infarcts were consistent with the effect on ischemic stroke in the overall trial. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01776424.

19.
JAMA Neurol ; 2020 Sep 21.
Artigo em Inglês | MEDLINE | ID: mdl-32955582

RESUMO

Importance: A significant proportion of acute ischemic strokes occur while patients are hospitalized. Limited contemporary data exist on the utilization rates of intravenous thrombolysis or endovascular therapy for in-hospital stroke. Objective: To use a national registry to examine temporal trends in the use of intravenous and endovascular reperfusion therapies for treatment of in-hospital stroke. Design, Setting, and Participants: This retrospective cohort study analyzed data from 267 956 patients who underwent reperfusion therapy for stroke with in-hospital or out-of-hospital onset reported in the Get With the Guidelines-Stroke national registry from January 2008 to September 2018. Exposures: In-hospital onset vs out-of-hospital onset of stroke symptoms. Main Outcomes and Measures: Temporal trends in the use of reperfusion therapy, process measures of quality, and the association between functional outcomes and key patient characteristics, comorbidities, and treatments. Results: Of 67 493 patients with in-hospital stroke onset, this study observed increased rates of vascular risk factors (standardized mean difference >10%) but no significant differences in age or sex in patients undergoing intravenous thrombolysis only (mean [interquartile range {IQR}] age, 72 [80-62] y; 53.2% female) or those undergoing endovascular therapy (mean [IQR] age, 69 [59-79] y; 49.8% female). Of these patients, 10 481 (15.5%) received intravenous thrombolysis and 2494 (3.7%) underwent endovascular therapy. Compared with 2008, in 2018 the proportion of in-hospital stroke among all stroke hospital discharges was higher (3.5% vs 2.7%; P < .001), as was use of intravenous thrombolysis (19.1% vs 9.1%; P < .001) and endovascular therapy (6.4% vs 2.5%; P < .001) in patients with in-hospital stroke, with a significant increase in endovascular therapy in mid-2015 (P < .001). Compared with patients who received intravenous thrombolysis for out-of-hospital stroke onset, those with in-hospital onset were associated with longer median (IQR) times from stroke recognition to cranial imaging (33 [18-60] vs 16 [9-26] minutes; P < .001) and to thrombolysis bolus (81 [52-125] vs 60 [45-84] minutes; P < .001). In adjusted analyses, patients with in-hospital stroke onset who were treated with intravenous thrombolysis were less likely to ambulate independently at discharge (adjusted odds ratio, 0.78; 95% CI, 0.74-0.82; P < .001) and were more likely to die or to be discharged to hospice (adjusted odds ratio, 1.39; 95% CI, 1.29-1.50; P < .001) than patients with out-of-hospital onset who also received intravenous thrombolysis treatment. Comparisons among patients treated with endovascular therapy yielded similar findings. Conclusions and Relevance: In this cohort study, in-hospital stroke onset was increasingly reported and treated with reperfusion therapy. Compared with out-of-hospital stroke onset, in-hospital onset was associated with longer delays to reperfusion and worse functional outcomes, highlighting opportunities to further care for patients with in-hospital stroke onset.

20.
JAMA Cardiol ; 2020 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-32876650

RESUMO

Importance: Medicare Advantage (MA), a private insurance plan option, now covers one-third of all Medicare beneficiaries. Although patients with cardiovascular disease enrolled in MA have been reported to receive higher quality of care in the ambulatory setting than patients enrolled in fee-for-service (FFS) Medicare, it is unclear whether MA is associated with higher quality in patients hospitalized with heart failure, or alternatively, if incentives to reduce utilization under MA plans may be associated with worse care. Objective: To determine whether there are differences in quality of care received and in-hospital outcomes among patients enrolled in MA vs FFS Medicare. Design, Setting, and Participants: Observational, retrospective cohort study of patients hospitalized with heart failure in hospitals participating in the Get With the Guidelines-Heart Failure registry. Exposures: Medicare Advantage enrollment. Main Outcomes and Measures: In-hospital mortality, discharge disposition, length of stay, and 4 heart failure achievement measures. Results: Of 262 626 patients hospitalized with heart failure, 93 549 (35.6%) were enrolled in MA and 169 077 (64.4%) in FFS Medicare. The median (interquartile range) age was 78 (70-85) years for patients enrolled in MA and 78 (69-86) years for patients enrolled in FFS Medicare. Standard mean differences in age, sex, prevalence of comorbidities, or objective measures on admission, including vital signs and laboratory values, were less than 10%. After adjustment, there were no statistically significant differences in receipt of evidence-based ß-blockers when indicated; angiotensin-converting enzyme inhibitor, angiotensin II receptor blockers, or angiotensin receptor-neprilysin inhibitors at discharge; measurement of left ventricular function; and postdischarge appointments by Medicare insurance type. Patients enrolled in MA, however, had higher odds of being discharged directly home (adjusted odds ratio [AOR], 1.16; 95% CI, 1.13-1.19; P < .001) relative to patients enrolled in FFS Medicare and lower odds of being discharged within 4 days (AOR, 0.97; 95% CI, 0.93-1.00; P = .04). There was no significant difference in in-hospital mortality between patients with MA and patients with FFS Medicare (AOR, 0.98; 95% CI, 0.92-1.03; P = .42). Conclusions and Relevance: Among patients hospitalized with heart failure, no observable benefit was noted in quality of care or in-hospital mortality between those enrolled in MA vs FFS Medicare, except lower use of post-acute care facilities. As MA continues to grow, it will be important to ensure that participating private plans provide an added value to the patients they cover to justify the higher administrative costs compared with traditional FFS Medicare.

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