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1.
J Am Coll Cardiol ; 75(6): 608-617, 2020 Feb 18.
Artigo em Inglês | MEDLINE | ID: mdl-32057375

RESUMO

BACKGROUND: Patients with peripheral artery disease (PAD) have a higher risk of major adverse cardiovascular events (MACE) compared with those without PAD. OBJECTIVES: The aim of this post hoc analysis was to evaluate sex-specific differences in MACE and limb events in the EUCLID (Examining Use of Ticagrelor in PAD) trial. METHODS: Cox proportional hazards models were used to compare time-to-event outcomes stratified by sex. Covariates were introduced after adjusted model selection. RESULTS: EUCLID enrolled 13,885 patients with PAD (28% women [n = 3,888]). PAD severity and medical treatment were comparable between sexes, whereas prior lower extremity revascularization was reported less frequently in women (54.8% vs. 57.3%; p = 0.006). Women were older (mean ± SD age: 67.8 ± 8.9 vs. 66.1 ± 8.2 years; p < 0.001) and more likely to have diabetes mellitus (p = 0.004), hypertension, hyperlipidemia, and chronic kidney disease (all p < 0.001). Over a mean follow-up of 30 months, women had a lower risk of MACE (9.5% vs. 11.2%; adjusted hazard ratio: 0.77; 95% confidence interval: 0.68 to 0.88; p < 0.001) and all-cause-mortality (7.6% vs. 9.7%; adjusted hazard ratio: 0.61; 95% confidence interval: 0.53 to 0.71; p < 0.001). In contrast, risk for major adverse limb events (2.6% vs. 3.0%) and hospitalization for acute limb ischemia (1.6% vs. 1.7%) were not different by sex. CONCLUSIONS: Although women with PAD are at lower risk for MACE and all-cause mortality, risk for limb events was similar between sexes over a mean follow-up of 30 months. Understanding sex-specific differences and dissociation between baseline cardiovascular risk and subsequent cardiovascular events requires further investigation. (A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease [EUCLID]; NCT01732822).

3.
J Eval Clin Pract ; 2020 Jan 28.
Artigo em Inglês | MEDLINE | ID: mdl-31994280

RESUMO

RATIONALE, AIMS, AND OBJECTIVES: Clinical studies show equivalent health outcomes from interventional procedures and treatment with medication only for stable angina patients. However, patients may be subject to overuse or access barriers for interventional procedures and may exhibit suboptimal adherence to medications. Our objective is to evaluate whether community-level health literacy is associated with treatment selection and medication adherence patterns. METHOD: The sample included Medicare fee-for-service beneficiaries (20% random sample) with stable angina in 2007-2013. We used an area-level health literacy variable because of the lack of an individual measure in claims. We measured the association between (a) area-based health literacy with treatment selection (medication only, percutaneous coronary intervention [PCI], or coronary artery bypass grafting (CABG) surgery) and (b) area-based health literacy with medication adherence. We controlled for other factors including demographics, co-morbidity burden, dual eligibility, and area deprivation index. RESULTS: We identified 8300 patients of whom 8.7% lived in a low health literacy area. Overall, 56% of patients received medication only, 28% received PCI, and 15% received CABG. Patients in low health literacy areas were less likely to receive CABG (-3.5 percentage points; 95% CI, -6.8 to -0.3) than were patients in high health literacy areas, but the significance was sensitive to specification. Overall, 81.5% and 71.5% of patients were adherent to antianginals and statins, respectively. Living in low health literacy areas was associated with lower adherence to antianginals (-3.3 percentage points; 95% CI, -6.1 to -0.6) but not statins. CONCLUSIONS: Low area-based health literacy was associated with being less likely to receive CABG and lower adherence, but the differences between low and high health literacy areas were small and sensitive to model specification. Individual factors such as dual eligibility status and race/ethnicity had stronger associations with outcomes than had area-based health literacy, suggesting that this area-based measure was inadequate to account for social determinants in this study.

4.
Circ Cardiovasc Interv ; 12(12): e007385, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31833412

RESUMO

Atherosclerosis within 2 or more arterial beds has been termed polyvascular disease. Although polyvascular disease has long been associated with heightened cardiovascular risk, much is still unknown regarding its pathophysiology and management. In this past decade, the field of cardiovascular disease has experienced exponential growth in terms of antithrombotic and lipid-lowering therapies aimed at mitigating ischemic events. This review describes the inherent risk associated with polyvascular disease in contemporary observational and clinical trial populations and summarizes novel therapies in this high-risk population.

5.
Am Heart J ; 220: 51-58, 2019 Nov 18.
Artigo em Inglês | MEDLINE | ID: mdl-31783279

RESUMO

BACKGROUND: Rates and predictors of major bleeding in patients with peripheral artery disease (PAD) treated with antiplatelets have not been well studied. This post hoc analysis of EUCLID aimed to determine the incidence of major/minor bleeding, predictors of major bleeding, and risk of major adverse cardiovascular events (MACE) following major bleeding events. METHODS: EUCLID, a multicenter randomized controlled trial of 13,885 patients with symptomatic PAD, compared ticagrelor with clopidogrel for the prevention of MACE. The primary safety end point was Thrombolysis in Myocardial Infarction (TIMI) major bleeding. Baseline characteristics were used to develop a multivariable model to determine factors associated with TIMI major bleeding. The occurrence and timing of MACE relative to a first major bleeding event were determined. RESULTS: TIMI major bleeding occurred in 2.3% of participants overall (0.94 event/100 patient-years). There was no significant difference in major bleeding rates by treatment assignment. Factors associated with TIMI major bleeding included older age, geographic region, Rutherford class, and ß-blocker use. Patients with TIMI major bleeding postrandomization had an increased risk of MACE (hazard ratio [HR] 4.46; 95% CI 3.40-5.84; P < .0001) compared with those without major bleeding; the association was strongest within 30 days after a bleeding event. CONCLUSIONS: In patients with symptomatic PAD, 0.94 major bleeding event/100 patient-years was observed and associated with older age, residing in North America, disease severity, and ß-blocker use. Patients who had a major bleeding event were significantly more likely to experience MACE, especially within the first 30 days, when compared with patients who did not have major bleeding.

6.
Circ Cardiovasc Interv ; 12(12): e008018, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31752517

RESUMO

BACKGROUND: Recent trials have identified anti-diabetes mellitus agents that lower major adverse cardiovascular event (MACE) rates, although some increase rates of lower-extremity amputation (LEA). Patients with peripheral artery disease (PAD) have greater incidence of diabetes mellitus and risk for LEA, prompting this investigation of clinical outcomes in patients with diabetes mellitus and PAD in the EXSCEL trial (Exenatide Study of Cardiovascular Event Lowering). METHODS: EXSCEL evaluated the effects of once-weekly exenatide (a GLP-1 [glucagon-like peptide-1] receptor agonist) versus placebo on the rates of the primary composite MACE end point (cardiovascular death, myocardial infarction, or stroke) among patients with type 2 diabetes mellitus. In this post hoc analysis, we assessed the association of baseline PAD with rates of MACE, LEA, and the effects of exenatide versus placebo in patients with and without PAD. RESULTS: EXSCEL included 2800 patients with PAD (19% of the trial population). These individuals had higher unadjusted and adjusted rates of MACE compared with patients without PAD (13.6% versus 11.4%, respectively) as well as a higher adjusted hazard ratio (adjusted hazard ratio, 1.13 [95% CI, 1.00-1.27]; P=0.047). Patients with PAD had higher all-cause mortality (adjusted hazard ratio 1.38 [95% CI, 1.20-1.60]; P<0.001) and more frequent LEA (adjusted hazard ratio 5.48 [95% CI, 4.16-7.22]; P<0.001). Patients treated with exenatide or placebo had similar rates of MACE and LEA, regardless of PAD status. CONCLUSIONS: EXSCEL participants with PAD had higher rates of all-cause mortality and LEA compared with those without PAD. There were no differences in MACE or LEA rates with exenatide versus placebo. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT01144338.

7.
Circ Cardiovasc Interv ; 12(10): e008069, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31581789

RESUMO

BACKGROUND: The relationship between invasive vascular procedures and bleeding in patients with peripheral artery disease has not been well described in the literature. This post hoc analysis from the EUCLID trial (Examining Use of Ticagrelor in Peripheral Artery Disease) aimed to describe the incidence of major and minor postprocedural bleeding and characterize the timing and severity of bleeding events relative to the procedure. METHODS: EUCLID was a multicenter, randomized controlled trial of 13 885 patients with symptomatic peripheral artery disease that tested the efficacy and safety of ticagrelor compared with clopidogrel for the prevention of major adverse cardiovascular events. A total of 2661 patients underwent 3062 coronary revascularization, peripheral revascularization, and amputation during the study. The primary safety end point was Thrombolysis in Myocardial Infarction major or minor bleeding. All bleeding events were formally adjudicated by a clinical end point classification group. RESULTS: Major bleeding events most often occurred ≤7 days following the procedure. The incidence of Thrombolysis in Myocardial Infarction major or minor bleeding ≤7 days following peripheral revascularization (3.3%; 95% CI, 2.5%-4.1%) was similar to rates after coronary revascularization (4.0%; 95% CI, 2.6%-5.4%) and lower extremity amputation (2.3%; 95% CI, 0.8%-3.8%). The severity of bleeding events (as graded by drop in hemoglobin, need for transfusion, bleeding in a critical location, and fatal bleeding) was also similar following peripheral, coronary revascularization, and lower extremity amputation. CONCLUSIONS: The incidence of Thrombolysis in Myocardial Infarction major/minor bleeding following peripheral revascularization is comparable to rates after coronary revascularization and lower extremity amputation, and the majority of bleeding events occur within 7 days following the procedure. The severity of periprocedural bleeding is also similar after procedures, with the most frequently adjudicated reason being a drop in hemoglobin ≥2 g/dL. Future studies should be performed to enhance our understanding of bleeding risk related to revascularization and amputation procedures in peripheral artery disease patients.

8.
Circulation ; 140(23): 1921-1932, 2019 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-31557056

RESUMO

BACKGROUND: The safety and efficacy of antithrombotic regimens may differ between patients with atrial fibrillation who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI. METHODS: Using a 2×2 factorial design, we compared apixaban with vitamin K antagonists and aspirin with placebo in patients with atrial fibrillation who had ACS or were undergoing PCI and were receiving a P2Y12 inhibitor. We explored bleeding, death and hospitalization, as well as death and ischemic events, by antithrombotic strategy in 3 prespecified subgroups: patients with ACS treated medically, patients with ACS treated with PCI, and those undergoing elective PCI. RESULTS: Of 4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI. Apixaban compared with vitamin K antagonist reduced International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding in patients with ACS treated medically (hazard ratio [HR], 0.44 [95% CI, 0.28-0.68]), patients with ACS treated with PCI (HR, 0.68 [95% CI, 0.52-0.89]), and patients undergoing elective PCI (HR, 0.82 [95% CI, 0.64-1.04]; Pinteraction=0.052) and reduced death or hospitalization in the ACS treated medically (HR, 0.71 [95% CI, 0.54-0.92]), ACS treated with PCI (HR, 0.88 [95% CI, 0.74-1.06]), and elective PCI (HR, 0.87 [95% CI, 0.72-1.04]; Pinteraction=0.345) groups. Compared with vitamin K antagonists, apixaban resulted in a similar effect on death and ischemic events in the ACS treated medically, ACS treated with PCI, and elective PCI groups (Pinteraction=0.356). Aspirin had a higher rate of bleeding than did placebo in patients with ACS treated medically (HR, 1.49 [95% CI, 0.98-2.26]), those with ACS treated with PCI (HR, 2.02 [95% CI, 1.53-2.67]), and those undergoing elective PCI (HR, 1.91 [95% CI, 1.48-2.47]; Pinteraction=0.479). For the same comparison, there was no difference in outcomes among the 3 groups for the composite of death or hospitalization (Pinteraction=0.787) and death and ischemic events (Pinteraction=0.710). CONCLUSIONS: An antithrombotic regimen consisting of apixaban and a P2Y12 inhibitor without aspirin provides superior safety and similar efficacy in patients with atrial fibrillation who have ACS, whether managed medically or with PCI, and those undergoing elective PCI compared with regimens that include vitamin K antagonists, aspirin, or both. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02415400.

9.
Circulation ; 140(13): 1115-1124, 2019 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-31545683

RESUMO

Aspirin is the cornerstone of the antithrombotic management of patients with established atherosclerotic cardiovascular disease, but major guidelines provide conflicting recommendations for its use in primary prevention. Findings from recent randomized trials totaling >47 000 patients called into question the net clinical benefits of aspirin in primary prevention for 3 key populations: patients with diabetes mellitus, community-dwelling elderly individuals, and patients without diabetes mellitus who are at intermediate risk for atherosclerotic events. In the context of increasing emphasis on the use of other treatments for primary prevention in patients with moderate-high future risk of developing atherosclerotic cardiovascular disease, the efficacy and safety of aspirin for primary prevention has become uncertain. Key unresolved questions regarding the role of aspirin in primary prevention include the optimal drug formulation, dosing schedule, weight-based dose selection, and interplay between sex and treatment response. In the current era, most patients without established atherosclerotic cardiovascular disease should not be prescribed aspirin. Rather, aggressive management of comorbidities tailored to the expected cardiovascular risk needs to be emphasized. In this context, informed shared decision making between clinicians and patients regarding the use of aspirin for primary prevention of cardiovascular events is a suitable and laudable approach. In this article, we revisit the role of aspirin for the primary prevention of cardiovascular diseases by critically reviewing the key scientific literature, highlight key areas of uncertainties for future research, and propose a decisional framework for clinicians to support prescription of aspirin in primary prevention.

10.
Am Heart J ; 217: 42-51, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31473326

RESUMO

BACKGROUND: With the growing use of drug-coated balloons for the treatment of peripheral artery disease, information regarding the safety and effectiveness of drug-coated balloons in current practice is needed. We examined patient, physician, and procedural characteristics as well as cardiovascular and limb events in patients who underwent peripheral vascular intervention with drug-coated balloons. METHODS: This is a retrospective cohort analysis utilizing Medicare data for 100% of fee-for-service beneficiaries from 2015 to 2016 who had a claim for femoropopliteal intervention. The use of drug-coated balloons was identified via specific transitional pass-through codes. All-cause mortality, all-cause hospitalization, repeat femoropopliteal intervention, and major lower extremity amputation at 1 year were the clinical outcomes of interest. RESULTS: In total, 83,225 patients underwent femoropopliteal intervention, and drug-coated balloons were utilized in 29% of all procedures. Patients treated with drug-coated balloons had a lower cumulative incidence of all-cause hospitalization, all-cause mortality, and major lower extremity amputation, but were more likely to undergo repeat femoropopliteal intervention when compared with patients treated with conventional balloon angioplasty. After adjustment for measured confounders, patients treated with drug-coated balloons had lower rates of hospitalization (HR 0.91 (0.88, 0.93), P < .001), all-cause mortality (HR 0.89 [0.84, 0.94], P < .001), and major amputation (HR 0.93 [0.88, 0.99], P = .017). CONCLUSIONS: Patients who underwent femoropopliteal intervention with drug-coated balloons had lower observed rates of all-cause mortality, all-cause hospitalization, and major amputation at 1 year. Interestingly, there was not a reduction in rates of repeat revascularization, and further work is required to understand this finding. Nevertheless, the use of drug-coated balloons appears to be safe in this large study of contemporary patients in the United States.

11.
EGEMS (Wash DC) ; 7(1): 42, 2019 Aug 09.
Artigo em Inglês | MEDLINE | ID: mdl-31406699

RESUMO

Background: Stable angina patients have difficulty understanding the tradeoffs between treatment alternatives. In this analysis, we assessed treatment planning conversations for stable angina to determine whether inadequate health literacy acts as a barrier to communication that may partially explain this difficulty. Methods: We conducted a descriptive analysis of patient questionnaire data from the PCI Choice Trial. The main outcomes were the responses to the Decisional Conflict Scale and the proportion of correct responses to knowledge questions about stable angina. We also conducted a qualitative analysis on recordings of patient-clinician discussions about treatment planning. The recordings were coded with the OPTION12 instrument for shared decision-making. Two analysts independently assessed the number and types of patient questions and expressions of preferences. Results: Patient engagement did not differ by health literacy level and was generally low for all patients with respect to OPTION12 scores and the number of questions related to clinical aspects of treatment. Patients with inadequate health literacy had significantly higher decisional conflict. However, the proportion of knowledge questions answered correctly did not differ significantly by health literacy level. Conclusions: Patients with inadequate health literacy had greater decisional conflict but no difference in knowledge compared to patients with adequate health literacy. Inadequate health literacy may act as a barrier to communication, but gaps were found in patient engagement and knowledge for patients of all health literacy levels. The recorded patient-clinician encounters and the health literacy measure were valuable resources for conducting research on care delivery.

13.
Am Heart J ; 216: 74-81, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31419621

RESUMO

Lower extremity peripheral artery disease (PAD) and cerebrovascular disease (CeVD) are prevalent conditions in the United States, and both are associated with significant morbidity (eg, stroke, myocardial infarction, and limb loss) and increased mortality. With a growth in invasive procedures for PAD and CeVD, this demands a more clear responsibility and introduces an opportunity to study how patients are treated and evaluate associated outcomes. The American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry is a prospective, independent collection of data elements from individual patients at participating centers, and it is a natural extension of the already robust NCDR infrastructure. As of September 20, 2018, data have been collected on 45,316 lower extremity PVIs, 12,417 carotid artery stenting procedures, and 11,027 carotid endarterectomy procedures at 208 centers in the United States. The purpose of the present report is to describe the patient and procedural characteristics of the overall cohort and the methods used to design and implement the registry. In collecting these data, ACC and ACC PVI Registry have the opportunity to play a pivotal role in scientific evidence generation, medical device surveillance, and creation of best practices for PVI and carotid artery revascularization.

14.
Am Heart J ; 216: 136-142, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31434031

RESUMO

BACKGROUND: Although the high-risk acute pulmonary embolism (PE) population has been described, little is known about the contemporary inpatient experience and practice patterns of the PE population as a whole. METHODS: All patients with a diagnosis of acute PE from January 1, 2016, to June 30, 2017 within our academic, multihospital health system were retrospectively identified using International Classification of Diseases, 10th Revision, codes, and data were manually abstracted by 2 clinical investigators. Descriptive analyses were performed according to clinical risk stratification categories from the European Society of Cardiology. RESULTS: Of 829 total patients, 372 (44.8%) patients had intermediate or high-risk PE. Mean age was 62.1 years old, and 42.1% of patients had a history of malignancy. One hundred fifty-three (18.5%) patients had an acute PE during a hospitalization for another indication. A total of 6.0% underwent invasive PE therapies, 26.1% required intensive care unit admission, and 9.0% experienced in-hospital death or hospice discharge. In a subgroup description, patients who developed acute PE during a hospitalization for another indication had a higher incidence of incomplete risk stratification and a higher mortality (9.8%) than the primary cohort. Mortality was attributed to PE in 48.4% of cases. CONCLUSIONS: This contemporary description of acute PE managed at a single large, multihospital academic health system highlights substantial health care utilization and high mortality despite the available of advanced therapeutics. Additional work is needed to standardize care for the heterogeneous PE population to ensure appropriate allocation of resources and improved outcomes for all PE patients.

15.
Artigo em Inglês | MEDLINE | ID: mdl-31435999

RESUMO

In this review, we report a contemporary appraisal of the available evidence focusing on adjunctive antithrombotic therapy and technical aspects of percutaneous coronary interventions (PCI) in patients with acute myocardial infarction and cardiogenic shock (AMICS). Only few randomized trials have been conducted to evaluate the optimal arterial access choice, antithrombotic therapy, stent type, or the role of aspiration thrombectomy in this population. Observational data suggest that a transradial approach should be preferred for experienced operators, although knowledge and experience of transfemoral access is required to place any mechanical support device. In the absence of high-quality evidence to guide choice of the adjunctive antithrombotic drugs to support PCI in patients with AMICS, knowledge of the altered pharmacokinetics and pharmacodynamics in shock is required to inform decisions. Drug-eluting stents should be favored over bare-metal stents, and routine thrombectomy is not encouraged. Owing to the challenges inherent to the conduct of randomized trials in this acutely ill patient population, concerted multicenter, and international efforts are paramount to orchestrate the development of high-quality evidence to guide clinical practice.

16.
Vasc Med ; 24(5): 422-430, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31339474

RESUMO

In patients with symptomatic peripheral artery disease (PAD), the impact of chronic kidney disease (CKD) on major adverse cardiovascular events has not been fully evaluated. The Examining Use of Ticagrelor In PAD (EUCLID) trial randomized 13,885 patients with PAD to ticagrelor 90 mg twice daily or clopidogrel 75 mg daily. This post hoc analysis compared the incidence of the primary composite endpoint (cardiovascular death, myocardial infarction (MI), or ischemic stroke) in patients with CKD (eGFR < 60 mL/min/1.73 m2) with those without CKD (eGFR ⩾ 60 mL/min/1.73 m2). The primary safety endpoint was thrombolysis in MI (TIMI) major bleeding. A total of 13,483 patients were included; 3332 (25%) had CKD, of whom 237 had stage 4/5 disease. Median follow-up was approximately 30 months. After statistical adjustment, patients with CKD had a higher rate of the primary endpoint compared with those without CKD (6.75 vs 3.72 events/100 patient-years; adjusted hazard ratio (HR) 1.45, 95% CI 1.30-1.63). CKD was not associated with increased risk of hospitalization for acute limb ischemia (ALI) (adjusted HR 0.96, 95% CI 0.69-1.34) or major amputation (adjusted HR 0.92, 95% CI 0.66-1.28). CKD was not associated with a significantly increased risk of major bleeding (adjusted HR 1.21, 95% CI 0.89-1.64), but minor bleeding was significantly increased (adjusted HR 1.51, 95% CI 1.07-2.15). In conclusion, patients with PAD and CKD had higher rates of cardiovascular death, MI, and ischemic stroke, but similar rates of ALI, major amputation, and TIMI major bleeding when compared with patients without CKD. ClinicalTrials.gov Identifier: NCT01732822.


Assuntos
Clopidogrel/administração & dosagem , Taxa de Filtração Glomerular , Isquemia/tratamento farmacológico , Rim/fisiopatologia , Doença Arterial Periférica/tratamento farmacológico , Inibidores da Agregação de Plaquetas/administração & dosagem , Insuficiência Renal Crônica/fisiopatologia , Ticagrelor/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Amputação , Isquemia Encefálica/mortalidade , Isquemia Encefálica/prevenção & controle , Clopidogrel/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Hemorragia/mortalidade , Humanos , Incidência , Isquemia/diagnóstico , Isquemia/mortalidade , Isquemia/fisiopatologia , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/prevenção & controle , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Inibidores da Agregação de Plaquetas/efeitos adversos , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/mortalidade , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/mortalidade , Acidente Vascular Cerebral/prevenção & controle , Ticagrelor/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
18.
Circulation ; 140(7): 556-565, 2019 Aug 13.
Artigo em Inglês | MEDLINE | ID: mdl-31238713

RESUMO

BACKGROUND: Acute limb ischemia (ALI) is an important clinical event and an emerging cardiovascular clinical trial outcome. Risk factors for and outcomes after ALI have not been fully evaluated. METHODS: EUCLID (Examining Use of Ticagrelor in Peripheral Artery Disease) randomized patients with peripheral artery disease to ticagrelor versus clopidogrel. Enrollment criteria included an ankle-brachial index ≤0.80 or previous lower extremity revascularization. Patients were grouped according to the primary outcome, postrandomization ALI hospitalization. Baseline factors associated with ALI were identified using Cox proportional hazards modeling. Models with ALI hospitalization as a time-dependent covariate were developed for secondary outcomes of major adverse cardiovascular events (myocardial infarction, cardiovascular death, ischemic stroke), all-cause mortality, and major amputation. RESULTS: Among 13 885 patients, 1.7% (n=232) had 293 ALI hospitalizations (0.8 per 100 patient-years). Patients with versus without ALI were younger and more often had previous peripheral revascularization and lower baseline ankle-brachial index. Treatment during ALI hospitalization included endovascular revascularization (39.2%, n=115), surgical bypass (24.6%, n=72), and major amputation (13.0%, n=38). After multivariable adjustment, any previous peripheral revascularization (Hazard Ratio [HR] 4.7, 95% CI 3.3-6.8, P<0.01), baseline atrial fibrillation (HR 1.8, 95% CI 1.1-3.2, P=0.03), and baseline ankle-brachial index ≤0.60 (HR 1.3 per 0.10 decrease, 95% CI 1.1-1.5, P<0.01) were associated with higher ALI risk. Older age (HR 0.8 per 10-year increase, 95% CI 0.7-1.0, P=0.02) and baseline statin use (HR 0.7, 95% CI 0.5-0.9, P<0.01) were associated with lower risk for ALI. There was no relationship between randomized treatment to ticagrelor or clopidogrel and ALI. Among patients with previous revascularization, surgical versus endovascular procedures performed more than 6 months prior were associated with ALI (adjusted HR 2.63, 95% CI 1.75-3.96). In the overall population, ALI hospitalization was associated with subsequent MACE (adjusted HR 1.4, 95% CI 1.0-2.1, P=0.04), all-cause mortality (adjusted HR 3.3, 95% CI 2.4-4.6, P<0.01), and major amputation (adjusted HR 34.2, 95% CI 9.7-20.8, P<0.01). CONCLUSIONS: Previous peripheral revascularization, baseline atrial fibrillation, and lower ankle-brachial index identify peripheral artery disease patients at heightened risk for ALI, an event associated with subsequent cardiovascular and limb-related morbidity and mortality. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01732822.

19.
JACC Cardiovasc Interv ; 12(12): 1140-1149, 2019 Jun 24.
Artigo em Inglês | MEDLINE | ID: mdl-31221303

RESUMO

OBJECTIVES: This study sought to assess periprocedural bleeding complications in lower-extremity peripheral vascular interventions (PVIs). BACKGROUND: Few studies have examined the incidence, predictors, or outcomes of periprocedural bleeding after lower-extremity PVI. METHODS: The study examined patients undergoing PVI at 76 hospitals in the National Cardiovascular Data Registry PVI registry from 2014 to 2016. Post-PVI major bleeding was defined as any overt bleeding with a hemoglobin (Hb) drop of ≥3 g/dl, any Hb decline of ≥4 g/dl, or blood transfusion in patients with pre-procedure Hb >8 g/dl within 72 h of their procedure. Hierarchical multivariable logistic regression was used to identify factors independently associated with post-PVI bleeding. The study also examined adjusted in-hospital mortality among patients with or without major bleeding complications. RESULTS: Among 18,289 PVI procedures, major bleeding occurred in 744 (4.10%). Patient characteristics independently associated with bleeding included age, female sex, heart failure, pre-procedural hemoglobin <12 g/dl, nonelective PVI, and critical limb ischemia on presentation. Procedural characteristics associated with bleeding included nonfemoral vascular access, use of thrombolytic therapy, PVI of the aortoiliac segment, and multilesion interventions, whereas use of closure devices was associated with less bleeding. All-cause in-hospital mortality was higher in patients who experienced bleeding than in those who did not (6.60% vs. 0.30%; p < 0.001; adjusted hazard ratio: 10.9; 95% confidence interval: 6.9 to 17.0). CONCLUSIONS: Major bleeding occurred in 4.10% of lower-extremity PVI procedures and was associated with several patient and procedural characteristics, as well as in-hospital mortality. These insights can be incorporated into strategies to reduce periprocedural bleeding after PVI.

20.
Clin Trials ; 16(4): 419-430, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31081367

RESUMO

BACKGROUND/AIMS: Health plan administrative claims data present a cost-effective complement to traditional trial-specific ascertainment of clinical events typically conducted through patient report or a single health system electronic health record. We aim to demonstrate the value of health plan claims data in improving the capture of endpoints in longitudinal pragmatic clinical trials. METHODS: This retrospective cohort study paralleled the design of the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) trial designed to compare the effectiveness of two doses of aspirin. We applied the ADAPTABLE identification query in claims data from Anthem, an American health insurance company, and identified health plan members who met the ADAPTABLE trial criteria. Among the ADAPTABLE eligible members, we selected overlapping members with PCORnet Clinical Data Research Networks in the 2 years prior to the index date (1 April 2014). PCORnet Clinical Data Research Networks consist of network partners (or healthcare systems) that store their electronic health record data in the same format to support multi-institutional research. ADAPTABLE outcome events-cardiovascular hospitalizations including admissions for myocardial infarction, stroke, or cardiac procedures; hospitalizations for major bleeding; and in-hospital deaths-were evaluated for a 2-year follow-up period. Events were classified as within or outside PCORnet Clinical Data Research Networks using facility identifiers affiliated with each hospital stay. Patient characteristics were examined with descriptive statistics, and incidence rates were reported for available Clinical Data Research Networks and claims data. RESULTS: Among 884,311 ADAPTABLE eligible health plan members, 11,101 patients overlapped with PCORnet Clinical Data Research Networks. Average age was 70 years, 71% were male, and average follow-up was 20.7 months. Patients had 1521 cardiovascular hospitalizations (571 (37.5%) occurred outside PCORnet Clinical Data Research Networks), 710 for major bleeding (296 (41.7%) outside PCORnet Clinical Data Research Networks), and 196 in-hospital deaths (67 (34.2%) outside PCORnet Clinical Data Research Networks). Incidence rates (events per1000 patient-months) differed between available network partners and claims data: cardiovascular hospitalizations, 4.1 (95% confidence interval: 3.9, 4.4) versus 6.6 (95% confidence interval: 6.3, 7.0), major bleeding, 1.8 (95% confidence interval: 1.6, 2.0) versus 3.1 (95% confidence interval: 2.9, 3.3), and in-hospital death, 0.56 (95% confidence interval: 0.47, 0.67) versus 0.85 (95% confidence interval: 0.74, 0.98), respectively. CONCLUSION: This study demonstrated the value of supplementing longitudinal site-based clinical studies with administrative claims data. Our results suggest that claims data together with network partner electronic health record data constitute an effective vehicle to capture patient outcomes since >30% of patients have non-fatal and fatal events outside of enrolling sites.

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