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2.
Am Heart J ; 2021 Feb 08.
Artigo em Inglês | MEDLINE | ID: mdl-33571477

RESUMO

BACKGROUND: ROCKET AF demonstrated the efficacy and safety of rivaroxaban compared with warfarin for the prevention of stroke and systemic embolism (SE) in patients with atrial fibrillation (AF). We examined baseline characteristics and outcomes in patients enrolled in Latin America compared with the rest of the world (ROW). METHODS: ROCKET AF enrolled 14,264 patients from 45 countries. Of these, 1878 (13.2%) were from 7 Latin American countries. The clinical characteristics and outcomes (adjusted by baseline characteristics) of these patients were compared with 12,293 patients from the ROW. Treatment outcomes of rivaroxaban compared with warfarin were also stratified by region. RESULTS: The annual rate of stroke/SE was similar in those from Latin American and ROW (p=0.63), but all-cause and vascular death were significantly higher than in ROW (HR 1.40, 95% CI 1.20-1.64; HR 1.38, 95% CI 1.14-1.68; p<0.001). Rates of major or non-major clinically relevant bleeding tended to be lower in Latin America (HR 0.89, 95% CI 0.80-1.0; p=0.05). Rates of stroke/SE were similar with rivaroxaban and warfarin in patients from Latin America and ROW (HR 0.83, 95% CI 0.54-1.29 vs. HR 0.89, 95% CI 0.75-1.07; interaction p=0.77). CONCLUSIONS: Patients with AF in Latin America had similar rates of stroke/SE, higher rates of vascular death, and lower rates of bleeding compared with patients in the ROW. The effect of rivaroxaban compared with warfarin in Latin America was similar to the ROW. Further studies analyzing patient- and country-specific determinants of these regional differences in Latin America are warranted.

3.
J Am Heart Assoc ; 10(4): e018149, 2021 Feb 16.
Artigo em Inglês | MEDLINE | ID: mdl-33554613

RESUMO

BACKGROUND The long-term safety of paclitaxel-coated devices (PCDs; drug-coated balloon or drug-eluting stent) for peripheral endovascular intervention is uncertain. We used data from the Veterans Health Administration to evaluate the association between PCDs, long-term mortality, and cause of death. METHODS AND RESULTS Using the Veterans Administration Corporate Data Warehouse in conjunction with International Classification of Diseases, Tenth Revision (ICD-10) Procedure Coding System, Current Procedural Terminology, and Healthcare Common Procedure Coding System codes, we identified patients with peripheral artery disease treated within the Veterans Administration for femoropopliteal artery revascularization between October 1, 2015, and June 30, 2019. An adjusted Cox regression, using stabilized inverse probability-weighted estimates, was used to evaluate the association between PCDs and long-term survival. Cause of death data were obtained using the National Death Index. In total, 10 505 patients underwent femoropopliteal peripheral endovascular intervention; 2265 (21.6%) with a PCD and 8240 (78.4%) with a non-PCD (percutaneous angioplasty balloon and/or bare metal stent). Survival rates at 2 years (77.4% versus 79.7%) and 3 years (70.7% versus 71.8%) were similar between PCD and non-PCD groups, respectively. The adjusted hazard for all-cause mortality for patients treated with a PCD versus non-PCD was 1.06 (95% CI, 0.95-1.18, P=0.3013). Among patients who died between October 1, 2015, and December 31, 2017, the cause of death according to treatment group, PCD versus non-PCD, was similar. CONCLUSIONS Among patients undergoing femoropopliteal peripheral endovascular intervention within the Veterans Administration Health Administration, there was no increased risk of long-term, all-cause mortality associated with PCD use. Cause-specific mortality rates were similar between treatment groups.

4.
JAMA Netw Open ; 4(1): e2030832, 2021 Jan 04.
Artigo em Inglês | MEDLINE | ID: mdl-33427883

RESUMO

Importance: The proportion of women and underrepresented racial and ethnic groups (UREGs) matriculating into general cardiology fellowships remains low. Objective: To assess a systematic recruitment initiative aimed at ensuring adequate matriculation of women and UREGs in a general cardiology fellowship. Design, Setting, and Participants: This quality improvement study took place at a large, tertiary academic medical center and associated Accreditation Council for Graduate Medical Education Cardiovascular Disease fellowship. Participants included cardiology fellowship and divisional leadership and general cardiology fellow applicants to the Duke Cardiovascular Disease Fellowship Program from 2017 to 2019. Data analysis was performed from December 2019 to May 2020. Exposure: Multipronged initiative that created an environment committed to ensuring equity of opportunity. This included the creation of a fellowship diversity and inclusivity task force that drafted recommendations, which included reorganization of the fellowship recruitment committee, and changes to the applicant screening process, the interview day, applicant ranking process, and postmatch interventions. Main Outcomes and Measures: The percentage of matriculating and overall women and UREGs before and after the interventions were recorded. Results: The fellowship received a mean (SD) of 462 (55) applications annually before the interventions (2006-2016) and 611 (27) applications annually after the interventions (2017-2019). Between the 10-year period before the interventions and the 3-year period during the interventions, there was a significant increase in the annual mean (SD) percentage of women (22.4% [2.9%] vs 26.4% [0.07%]; P < .001) and UREG applicants (10.5% [1.1%] vs 12.5% [1.9%]; P = .01) to the program. Among applicants interviewed, the percentage of women increased from 20.0% to 33.5% (P = .01) and that of and UREGs increased from 14.0% to 20.0% (P = .01). Before the interventions, a mean (SD) of 23.2% (16.2%) women and 9.7% (7.8%) UREGs matriculated as first-year fellows, whereas after the interventions, a mean (SD) of 54.2% (7.2%) women and 33.3% (19.0%) UREGs matriculated as first-year fellows. The proportion of the entire fellowship who were women increased from a 5-year mean (SD) of 27.0% (8.8%) to 54.2% (7.2%) after 3 years of interventions, and that of UREGs increased from 5.6% (4.6%) to 33.3% (19.0%). Overall, the proportion of applicants in the entire population who were either women or from UREGs increased from 27.8% to 66.7%. Conclusions and Relevance: After implementing interventions to promote equity of opportunity in the cardiovascular disease fellowship, the percentage of women and UREGs significantly increased in the fellowship over a 3-year time period. These interventions may be applicable to other cardiovascular disease fellowships seeking to diversify training programs.

5.
Circ Cardiovasc Interv ; 14(2): e009879, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33440999

RESUMO

BACKGROUND: Symptom-to-balloon time (SBT) and door-to-balloon time (DBT) are both considered important metrics in patients undergoing primary percutaneous coronary intervention (pPCI) for ST-segment-elevation myocardial infarction (STEMI). We sought to assess the relationship of SBT and DBT with infarct size and microvascular obstruction (MVO) after pPCI. METHODS: Individual patient data for 3115 ST-segment-elevation myocardial infarction patients undergoing pPCI in 10 randomized trials were pooled. Infarct size (% left ventricular mass) was assessed within 1 month after randomization by technetium-99 m sestamibi single-photon emission computerized tomography (3 studies) or cardiac magnetic resonance imaging (7 studies). MVO was assessed by cardiac magnetic resonance. Patients were stratified by short (≤2 hours), intermediate (2-4 hours), or long (>4 hours) SBTs, and by short (≤45 minutes), intermediate (45-90 minutes), or long (>90 minutes) DBTs. RESULTS: Median [interquartile range] SBT and DBT were 185 [130-269] and 46 [28-83] minutes, respectively. Median [interquartile range] time to infarct size assessment after pPCI was 5 [3-12] days. There was a stepwise increase in infarct size according to SBT category (adjusted difference, 2.0% [95% CI, 0.4-3.5] for intermediate versus short SBT and 4.4% [95% CI, 2.7-6.1] for long versus short SBT) but not according to DBT category (adjusted difference, 0.4% [95% CI, -1.2 to 1.9] for intermediate versus short DBT and -0.1% [95% CI, -1.0 to 3.0] for long versus short SBT). MVO was greater in patients with long versus short SBT (adjusted difference, 0.9% [95% CI, 0.3-1.4]) but was not different between patients with intermediate versus short SBT (adjusted difference, 0.1 [95% CI, -0.4 to 0.6]). There was no difference in MVO according to DBT. Results were similar in multivariable analysis with SBT and DBT included as continuous variables. CONCLUSIONS: Among 3115 patients with ST-segment-elevation myocardial infarction undergoing infarct size assessment after pPCI, SBT was more strongly correlated with infarct size and MVO than DBT.

6.
Curr Cardiol Rep ; 23(3): 13, 2021 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-33483872

RESUMO

PURPOSE OF REVIEW: There is a lack of consistency among the ACC/AHA and ESC Guidelines on the treatment of patients with lower extremity PAD to a targeted LDL-c level. A review of the current guidelines, as well as the evidence that exists for use of various lipid-lower therapies in patients with PAD, is needed to guide clinical practice and to examine the current gaps in evidence that exist. RECENT FINDINGS: There is evidence that statins and PCSK9 inhibitors reduce the risks of major adverse cardiovascular and limb events in patients with PAD. Most statin and non-statin trials have examined the association of LLT use with clinical outcomes, and not the association between the degree of LDL-c lowering and the reduction in risk of clinical outcomes. As such, there is a lack of agreement between the American and European PAD Guidelines over whether to treat patients with PAD to a targeted LDL-c goal. Both statins and PCSK9 inhibitors have been shown to reduce the risk of major cardiovascular and limb events in patients with PAD. Further research is needed to determine if target driven LDL-c lowering is associated with improved outcomes in patients with PAD.

7.
Am Heart J ; 233: 59-67, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33321119

RESUMO

BACKGROUND: The connection between paclitaxel-coated devices (PCD) use during peripheral vascular interventions (PVI) and mortality is debated. We aimed to analyze patterns of PCD use and the safety and effectiveness of PCD use in the superficial femoral and/or popliteal arteries. METHODS: Patients undergoing PVI of femoropopliteal lesions with and without PCD between January 1, 2015 and June 30, 2017 were compared using the American College of Cardiology's National Cardiovascular Data Registry PVI Registry. Outcomes were derived from Centers for Medicare & Medicaid claims data. The primary outcome was all-cause mortality at 6-, 12-, and 24-months following PVI. Inverse probability weighting and frailty models were used to assess the differences between groups. The analysis was IRB-approved. RESULTS: In the overall cohort consisting of 6,302 femoropopliteal PVIs, PCD-PVI patients were more likely to be treated for claudication (63.5% vs 51.3%, P< .001), less likely to have a chronic total occlusion (24.6% vs 34.7%, P < .001), and more likely to be treated in certain geographic and practice settings. In the analytic cohort consisting of 1,666 femoropopliteal PVIs with linked claims outcomes (888 PCD-PVI, 53.3%), unadjusted rates of all outcomes were lower in PCD-PVI patients. After adjustment, there were no significant differences in mortality following PCD-PVI versus non-PCD PVI at 1 year (adjusted RR 0.78, 95% CI 0.60-1.01, P= .055) or 2 years (aRR 0.98, 95% CI 0.77-1.24, P= .844). CONCLUSION: There were significant differences between the patients in whom and settings in which PCD-PVI was versus was not used. PCD-PVI was not associated with an increased risk of 2-year mortality in real-world use.

8.
J Am Heart Assoc ; : e017712, 2020 Dec 08.
Artigo em Inglês | MEDLINE | ID: mdl-33287625

RESUMO

Background Coronary artery disease (CAD) is increasing among young adults. We aimed to describe the cardiovascular risk factors and long-term prognosis of premature CAD. Methods and Results Using the Duke Databank for Cardiovascular Disease, we evaluated 3655 patients admitted between 1995 and 2013 with a first diagnosis of obstructive CAD before the age of 50 years. Major adverse cardiovascular events (MACEs), defined as the composite of death, myocardial infarction, stroke, or revascularization, were ascertained for up to 10 years. Cox proportional hazard regression models were used to assess associations with the rate of first recurrent event, and negative binomial log-linear regression was used for rate of multiple event recurrences. Past or current smoking was the most frequent cardiovascular factor (60.8%), followed by hypertension (52.8%) and family history of CAD (39.8%). Within a 10-year follow-up, 52.9% of patients had at least 1 MACE, 18.6% had at least 2 recurrent MACEs, and 7.9% had at least 3 recurrent MACEs, with death occurring in 20.9% of patients. Across follow-up, 31.7% to 37.2% of patients continued smoking, 81.7% to 89.3% had low-density lipoprotein cholesterol levels beyond the goal of 70 mg/dL, and 16% had new-onset diabetes mellitus. Female sex, diabetes mellitus, chronic kidney disease, multivessel disease, and chronic inflammatory disease were factors associated with recurrent MACEs. Conclusions Premature CAD is an aggressive disease with frequent ischemic recurrences and premature death. Individuals with premature CAD have a high proportion of modifiable cardiovascular risk factors, but failure to control them is frequently observed.

9.
Am Heart J ; 2020 Dec 06.
Artigo em Inglês | MEDLINE | ID: mdl-33296688

RESUMO

BACKGROUND: Non-vitamin K antagonist oral anticoagulants (NOACs) are the preferred class of medications for prevention of stroke and systemic embolism in patients with atrial fibrillation unless contraindications exist. Five large, international, randomized, controlled trials of NOACs versus either warfarin or aspirin have been completed to date. DESIGN: COMBINE AF incorporates de-identified individual patient data from 77,282 patients with atrial fibrillation at risk for stroke randomized to NOAC, warfarin, or aspirin from 5 pivotal randomized controlled trials. All patients randomized in the constituent trials are included. Variables common to ≥3 of the constituent trials are included in the master database. Individual trial data sets from the 4 coordinating centers were combined at the Duke Clinical Research Institute. The final database will be securely shared with the 4 academic coordinating centers. The combined master database will be used to perform statistical analyses aimed at better understanding underlying risk factors and outcomes in patients with atrial fibrillation treated with oral anticoagulants, with a special focus on patient subgroups and uncommon outcomes. The initial analysis from COMBINE AF will be a network meta-analysis investigating the relative efficacy and safety of pooled higher-dose NOACs versus pooled lower-dose NOACs versus warfarin with respect to multiple time-to-event efficacy and safety outcomes. COMBINE AF is registered with PROSPERO (CRD42020178771). CONCLUSIONS: In conclusion, COMBINE AF provides a rich and robust database consisting of individual patient data and will offer opportunities to investigate oral anticoagulants across many patient subgroups. Data sharing and collaboration across academic institutions and investigators will serve as overarching themes.

10.
Atherosclerosis ; 315: 10-17, 2020 Nov 06.
Artigo em Inglês | MEDLINE | ID: mdl-33190107

RESUMO

BACKGROUND AND AIMS: Polyvascular disease (PVD) affects approximately 20% of patients with atherosclerosis and is a strong independent risk factor for ischemic outcomes. However, guidelines do not address screening or treatment for PVD, and there have been no PVD-specific trials. We reviewed subgroup analyses of large randomized controlled trials of more intense antithrombotic therapy to determine whether increased intensity of therapy improved ischemic outcomes in patients with PVD. METHODS: MEDLINE, MEDLINE in-Process, EMBASE, and the Cochrane Library were queried for randomized controlled trials larger than 5000 patients evaluating secondary prevention therapies in patients with coronary artery disease or lower extremity peripheral artery disease. RESULTS: Thirteen trials were included ranging in size from 7243 to 27,395 patients. In 9 trials (CHARISMA, TRA 2°P-TIMI 50, PEGASUS-TIMI 54, VOYAGER PAD, TRACER, EUCLID, TRILOGY ACS, PLATO, and COMPASS), patients in the PVD subgroup treated with increased-intensity antithrombotic therapy had similar or greater relative risk reductions for ischemic events in comparison with the general trial cohorts. In four trials (DAPT, THEMIS, APPRAISE-2, and ATLAS ACS 2 TIMI 51), the PVD subgroup had an increased hazard of ischemic events with increased-intensity therapy compared with the general trial cohorts. CONCLUSIONS: More intense antithrombotic therapy in patients with PVD was associated with a similar relative risk reduction for ischemic events compared with patients without PVD. Therefore, patients with PVD benefit from a larger absolute risk reduction because of their higher baseline risk. Future trials in patients with atherosclerotic cardiovascular disease should intentionally include PVD patients to adequately assess treatment options for this under-studied, under-treated population.

11.
Prog Cardiovasc Dis ; 2020 Nov 07.
Artigo em Inglês | MEDLINE | ID: mdl-33171204

RESUMO

Background The role of late gadolinium enhancement (LGE) on cardiac magnetic resonance imaging (c-MRI) for predicting outcomes of patients with hypertrophic cardiomyopathy (HCM) has been debated. Methods We searched PubMed and Embase and various published bibliographies for prospective studies published in English between January 1990 and February 2019. Two investigators screened 2646 abstracts and full-text articles for inclusion and relevant outcomes. We then performed a systematic review and meta-analysis to calculate pooled odds ratios for LGE on c-MRI and a pooled sensitivity and specificity analysis. Results Our systematic review included 8 prospective studies and 3808 patients. LGE positivity was associated with higher odds of the endpoint of sudden cardiac death (SCD;OR 1.69, 95%CI 1.03-2.78), aborted SCD or appropriate implantable cardioverter- defibrillator (ICD) discharge (OR 3.27 [1.75-6.10]), SCD or aborted SCD or appropriate ICD discharge (OR 2.32 [1.56-3.43]), and all-cause mortality (OR 2.10 [CI 1.00-4.41]). The pooled sensitivity and specificity of positive LGE on c-MRI for SCD were 65% and 42%, respectively; for aborted SCD or appropriate ICD discharge, 79% and 39%; for SCD or aborted SCD or appropriate ICD discharge, 74% and 39%; and for all-cause mortality, 78% and 39%. Conclusion In patients with HCM, LGE on c-MRI is a strong predictor of arrhythmic outcomes including SCD, aborted SCD, and appropriate ICD therapy. These data support the routine use of LGE on c-MRI as a marker of SCD risk in this population.

12.
Circ Cardiovasc Qual Outcomes ; 13(11): e006550, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33176462

RESUMO

BACKGROUND: Peripheral artery disease is common and associated with high mortality. There are limited data detailing causes of death among patients with peripheral artery disease. METHODS: EUCLID (Examining Use of Ticagrelor in Peripheral Artery Disease) was a randomized clinical trial that assigned patients with peripheral artery disease to clopidogrel or ticagrelor. We describe the causes of death in EUCLID using mortality end points adjudicated through a clinical events classification process. The association between baseline factors and cardiovascular death was evaluated by Cox proportional hazards modeling. The competing risk of noncardiovascular death was assessed by the cumulative incidence function for cardiovascular death and the Fine and Gray method to ascertain the association between baseline characteristics and cardiovascular mortality. RESULTS: A total of 1263 out of 13 885 (9.1%) patients died (median follow-up: 30 months). There were 706 patients (55.9%) with a cardiovascular cause of death and 522 (41.3%) with a noncardiovascular cause of death. The most common cause of cardiovascular death was sudden cardiac death (20.1%); while myocardial infarction (5.2%) and ischemic stroke (3.2%) were uncommon. The most common causes of noncardiovascular death were malignancies (17.9%) and infections (11.9%). The factor most associated with a higher risk of cardiovascular death was age per 5 year increase (HR, 1.26 [95% CI, 1.20-1.32]). Female sex was associated with a lower risk of cardiovascular death (HR, 0.68 [95% CI, 0.56-0.82]). To evaluate the effect of noncardiovascular death as a competing risk, we superimposed the cumulative incidence function curve with the Kaplan-Meier curve. These curves closely approximated each other. After accounting for the competing risk of noncardiovascular death, the magnitude and direction of the factors associated with cardiovascular death were minimally changed. CONCLUSIONS: Among patients with symptomatic peripheral artery disease, noncardiovascular causes of death reflected a high proportion (40%) of deaths. Accounting for noncardiovascular deaths as a competing risk, there was not a significant change in the risk estimation for cardiovascular death. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01732822.

13.
Circulation ; 142(23): 2219-2230, 2020 Dec 08.
Artigo em Inglês | MEDLINE | ID: mdl-33138628

RESUMO

BACKGROUND: The VOYAGER PAD trial (Vascular Outcomes Study of ASA Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease) demonstrated superiority of rivaroxaban plus aspirin versus aspirin to reduce major cardiac and ischemic limb events after lower extremity revascularization. Clopidogrel is commonly used as a short-term adjunct to aspirin after endovascular revascularization. Whether clopidogrel modifies the efficacy and safety of rivaroxaban has not been described. METHODS: VOYAGER PAD was a phase 3, international, double-blind, placebo-controlled trial in patients with symptomatic PAD undergoing lower extremity revascularization randomized to rivaroxaban 2.5 mg twice daily plus 100 mg aspirin daily or rivaroxaban placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety end point was TIMI (Thrombolysis in Myocardial Infarction) major bleeding, with International Society on Thrombosis and Haemostasis major bleeding a secondary safety outcome. Clopidogrel use was allowed at the discretion of the investigator for up to 6 months after the qualifying revascularization. RESULTS: Of the randomized patients, 3313 (50.6%) received clopidogrel for a median duration of 29.0 days. Over 3 years, the hazard ratio for the primary outcome of rivaroxaban versus placebo was 0.85 (95% CI, 0.71-1.01) with clopidogrel and 0.86 (95% CI, 0.73-1.01) without clopidogrel without statistical heterogeneity (P for interaction=0.92). Rivaroxaban resulted in an early apparent reduction in acute limb ischemia within 30 days (hazard ratio, 0.45 [95% CI, 0.14-1.46] with clopidogrel; hazard ratio, 0.48 [95% CI, 0.22-1.01] without clopidogrel; P for interaction=0.93). Compared with aspirin, rivaroxaban increased TIMI major bleeding similarly regardless of clopidogrel use (P for interaction=0.71). With clopidogrel use >30 days, rivaroxaban was associated with more International Society on Thrombosis and Haemostasis major bleeding within 365 days (hazard ratio, 3.20 [95% CI, 1.44-7.13]) compared with shorter durations of clopidogrel (P for trend=0.06). CONCLUSIONS: In the VOYAGER PAD trial, rivaroxaban plus aspirin reduced the risk of adverse cardiovascular and limb events with an early benefit for acute limb ischemia regardless of clopidogrel use. The safety of rivaroxaban was consistent regardless of clopidogrel use but with a trend for more International Society on Thrombosis and Haemostasis major bleeding with clopidogrel use >30 days than with a shorter duration. These data support the addition of rivaroxaban to aspirin after lower extremity revascularization regardless of concomitant clopidogrel, with a short course (≤30 days) associated with less bleeding. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02504216.

14.
Eur Heart J Acute Cardiovasc Care ; : 2048872620921601, 2020 Nov 27.
Artigo em Inglês | MEDLINE | ID: mdl-33242980

RESUMO

BACKGROUND: Risk stratification and management of hemodynamically stable pulmonary embolism remains challenging. Professional societies have published stratification schemes, but little is known about the management of patients with intermediate risk pulmonary embolism. We describe the care of these patients at an academic health system. METHODS: Patient encounters from 1 January 2016 to 30 June 2017 were retrospectively identified utilizing a multihospital, electronic health record-based data warehouse. Using the 2019 European Society of Cardiology criteria, differences in hospital resource utilization, defined as intensive care unit admission, use of invasive therapies, and length of stay, were examined in patients with intermediate risk characteristics. RESULTS: A cohort of 322 intermediate risk patients, including 165 intermediate-low and 157 intermediate-high risk patients, was identified. Intermediate-high risk patients more often underwent catheter-directed therapy (14.0% vs. 1.8%; P<0.001) compared to intermediate-low risk patients and had a 50% higher rate of intensive care unit admission (relative risk 1.50; 95% confidence interval 1.06, 2.12; P=0.023). There was no difference in median intensive care unit length of stay (2.7 vs. 2.0 days; P=0.761) or hospital length of stay (5.0 vs. 5.0 days; P=0.775) between intermediate-high risk and intermediate-low risk patients. Patients that underwent invasive therapies had a 3.8-day shorter hospital length of stay (beta -3.75; 95% confidence interval -6.17, -1.32; P=0.002). CONCLUSION: This study presents insights into the hospital resource utilization of patients with intermediate risk pulmonary embolism. The 2019 European Society of Cardiology risk stratification criteria are a clinically relevant scheme that identifies patients more often treated with intensive care unit admission and advanced therapies.

15.
Vasc Endovascular Surg ; : 1538574420968671, 2020 Oct 23.
Artigo em Inglês | MEDLINE | ID: mdl-33094679

RESUMO

PURPOSE: Patients with diabetes mellitus (DM) are known to be at higher risk for peripheral artery disease (PAD), amputations, and major adverse cardiovascular events, though it is unclear whether they are at any higher risk for repeat intervention. LIBERTY 360 offered an opportunity to study a real-world cohort of patients who underwent distal superficial femoral artery endovascular revascularizations. We aimed to describe patients with DM, their outcomes following peripheral vascular intervention, and the effect of DM on outcomes in the LIBERTY 360 cohort. METHODS: LIBERTY 360 is a prospective, multi-center, non-randomized, mono-industry funded observational study of patients undergoing endovascular revascularization. Outcomes included 30-day and 1-year all-cause mortality, major amputation, target vessel/lesion revascularization, and a composite of those events. A multivariable regression model including DM was constructed to examine the effect of DM on outcomes. Multivariable survival estimates were made using Cox proportional hazards models. RESULTS: A total of 1,204 patients were enrolled, of whom 727 had DM (60.4%). Patients with DM had significantly more comorbidities and a third required insulin for DM management. Patients with DM had more severe disease based on Rutherford classification at baseline. After adjusting for comorbidities and disease severity, DM patients had more frequent major amputations at 1 year (5.2% versus 1.2%; HR 2.71, 95%CI 1.05-6.98, p = 0.040). The 1-year rates of all-cause mortality and target vessel/lesion revascularization were not significantly higher for patients with DM. CONCLUSIONS: Diabetes mellitus was associated with increased major amputations at 1 year following endovascular revascularization after accounting for demographics, comorbidities, and PAD-related characteristics. Further research is needed to determine which aspects of PAD and DM are most strongly associated with poor outcomes following lower extremity revascularization.

16.
Am Heart J ; 232: 105-115, 2020 Oct 26.
Artigo em Inglês | MEDLINE | ID: mdl-33121978

RESUMO

Morbidity and mortality associated with COVID-19 has increased exponentially, and patients with cardiovascular (CV) disease are at risk for poor outcomes. Several lines of evidence suggest a potential role for CV therapies in COVID-19 treatment. Characteristics of clinical trials of CV therapies related to COVID-19 registered on ClinicalTrials.gov have not been described. METHODS: ClinicalTrials.gov was queried on August 7, 2020 for COVID-19 related trials. Studies evaluating established CV drugs, other fibrinolytics (defibrotide), and extracorporeal membrane oxygenation were included. Studies evaluating anti-microbial, convalescent plasma, non-colchicine anti-inflammatory, and other therapies were excluded. Trial characteristics were tabulated from study-specific entries. RESULTS: A total of 2,935 studies related to COVID-19 were registered as of August 7, 2020. Of these, 1,645 were interventional studies, and the final analytic cohort consisted of 114 studies evaluating 10 CV therapeutic categories. Antithrombotics (32.5%; n = 37) were most commonly evaluated, followed by pulmonary vasodilators (14.0%; n = 16), renin-angiotensin-aldosterone system-related therapies (12.3%; n = 14), and colchicine (8.8%; n = 10). Trials evaluating multiple CV therapy categories and CV therapies in combination with non-CV therapies encompassed 4.4% (n = 5) and 9.6% (n = 11) of studies, respectively. Most studies were designed for randomized allocation (87.7%; n = 100), enrollment of less than 1000 participants (86.8%; n = 99), single site implementation (55.3%; n = 63), and had a primary outcome of mortality or a composite including mortality (56.1%; n = 64). Most study populations consisted of patients hospitalized with COVID-19 (81.6%; n = 93). At the time of database query, 28.9% (n = 33) of studies were not yet recruiting and the majority were estimated to be completed after December 2020 (67.8%; n = 78). Most lead sponsors were located in North America (43.9%; n = 50) or Europe (36.0%; n = 41). CONCLUSIONS: A minority (7%) of clinical trials related to COVID-19 registered on ClinicalTrials.gov plan to evaluate CV therapies. Of CV therapy studies, most were planned to be single center, enroll less than 1000 inpatients, sponsored by European or North American academic institutions, and estimated to complete after December 2020. Collectively, these findings underscore the need for a network of sites with a platform protocol for rapid evaluation of multiple therapies and generalizability to inform clinical care and health policy for COVID-19 moving forward.

17.
Circ Cardiovasc Interv ; 13(10): e009326, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33040584

RESUMO

BACKGROUND: Patients with peripheral artery disease have a high risk of future cardiovascular disease events and mortality. Little is known about the changes in symptom classification over time in patients with peripheral artery disease and the association of changes in symptom classification with subsequent cardiovascular disease events. METHODS: In this analysis of the EUCLID trial (Examining Use of Ticagrelor in Peripheral Artery Disease), we examined the changes in Rutherford classification (RC) of patients over 12 months. We examined the baseline characteristics of patients by change in symptom classification at 12 months (improved=decreased RC, no change, or worsened=increased RC), and the association between changes in symptom classification (RC) at 12 months and subsequent cardiovascular disease events. RESULTS: Among 12 759 patients, 3240 (25%) were classified as improved by RC at 12 months, 8132 (64%) as no change, and 1387 (11%) as worsened. At 12 months, many patients who were asymptomatic or had mild/moderate claudication at enrollment had no change in symptom classification over 12 months (73.7% and 70.9%). Patients who worsened over 12 months were more likely to have comorbidities (diabetes mellitus and prior myocardial infarction) and more events (myocardial infarction, amputation, and major bleeding) by 12 months postrandomization, all P<0.001. Worsened symptom classification over 12 months was associated with increased risk of all-cause death (adjusted hazard ratio, 1.29 [95% CI, 1.03-1.62]), major amputation (adjusted hazard ratio, 4.12 [95% CI, 2.46-6.88]), and a composite of cardiovascular death, myocardial infarction, or stroke (adjusted hazard ratio, 1.30 [95% CI, 1.05-1.62]), all P<0.05 after 12 months postrandomization. CONCLUSIONS: Patients with comorbidities and prior history of cardiovascular disease events at baseline and within the first 12 months of the trial were more likely to have worsened symptom classification at 12 months. Worsening symptom classification over 12 months was associated subsequently with an increased risk of all-cause death, amputation, and a composite of cardiovascular death, myocardial infarction, or stroke. Graphic Abstract: A graphic abstract is available for this article.

18.
Artigo em Inglês | MEDLINE | ID: mdl-33032976

RESUMO

BACKGROUND: CT coronary angiography (CTA) with Fractional Flow Reserve as determined by CT (FFRCT) is a safe alternative to invasive coronary angiography. A negative FFRCT has been shown to have low cardiac event rates compared to those with a positive FFRCT. However, the clinical utility of FFRCT according to age is not known. METHODS: Patients' in the ADVANCE (Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care) registry, were stratified into those ≥65 or <65 years of age. The impact of FFRCT on clinical decision-making, as assessed by patient age, was determined by evaluating patient management using CTA results alone, followed by site investigators submitting a report on the treatment plan based upon the newly provided FFRCT data. Outcomes at 1-year post CTA were assessed, including major adverse cardiovascular events (myocardial infarction, all-cause mortality or unplanned hospitalization for ACS leading to revascularisation) and total revascularisation. Positive FFRCT was deemed to be ≤ 0.8. RESULTS: FFRCT was calculated in 1849 (40.6%) subjects aged <65 and 2704 (59.4%) ≥ 65 years of age. Subjects ≥65 years were more likely to have anatomic obstructive disease on CTA (≥50% stenosis), compared to those aged <65 (69.7% and 73.2% respectively, p = 0.008). There was a similar graded increase in recommended and actual revascularisation with either CABG or PCI, with declining FFRCT strata for subjects above and below the age of 65. MACE and revascularisation rates were not significantly different for those ≥ or <65, regardless of FFRCT positivity or stenosis severity <50% or ≥50%. With a negative FFRCT result, and anatomical stenosis ≥50%, those ≥ and <65 years of age, had similar rates of MACE (0.2% for both, p = 0.1) and revascularisation (8.7% and 10.4% respectively p = 0.4). Logistic regression analysis, with age as a continuous variable, and adjustment for Diamond Forrester Risk, baseline FFRCT and treatment (CABG, PCI, medical therapy), indicated a statistically significant, but small increase in the odds of a MACE event with increasing age (OR 1.04, 95% CI 1.006-1.08, p = 0.02). Amongst patients with a FFRCT > 0.80, there was no effect of age on the odds of revascularisation. CONCLUSION: The findings of this study point to a low risk of MACE events or need for revascularisation in those aged ≥ or <65 with a FFRCT>0.80, despite the higher incidence of anatomic obstructive CAD in those ≥65 years. The findings show the clinical usefulness and outcomes of FFRCT are largely constant regardless of age.

19.
Circ Cardiovasc Qual Outcomes ; 13(9): e006512, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32862697

RESUMO

BACKGROUND: Current guidelines recommend aggressive management of hypertension. Recent evidence suggested potential harm with low blood pressure targets in patients with peripheral artery disease. We investigated the association of a history of hypertension and office systolic blood pressure (SBP) with major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs). METHODS AND RESULTS: The EUCLID trial (Examining the Use of Ticagrelor in Peripheral Artery Disease) included 13 885 participants with symptomatic peripheral artery disease; median follow-up was 30 months. Cox proportional hazards regression was used to calculate hazard ratios (HRs) for any MACE, MALE, and MALE including lower extremity revascularization. A clinical history of arterial hypertension was present in 10 857 (78%) participants, and these participants were older and more likely to be female when compared with the 3026 (22%) patients without hypertension. In patients with a history of hypertension, the adjusted hazard ratio for MACE was 0.94, 95% CI, 0.82-1.08; P=0.39, and the adjusted hazard ratio for MALE was 1.08, 95% CI, 0.96-1.23; P=0.21. During follow-up, average SBP was 135 mm Hg (125-145). Every 10 mmHg increase in SBP>125 mmHg was associated with an increased risk of MACE (HR, 1.10 [95% CI, 1.06-1.14]; P<0.001), a marginally increased risk of MALE (HR, 1.07 [95% CI, 1.00-1.15]; P=0.062), and an increased risk of MALE/lower extremity revascularization (HR, 1.08 [95% CI, 1.04-1.11]; P<0.001). Every decrease in 10 mmHg SBP ≤125 mmHg was associated with an increased risk of MACE (HR, 1.19 [95% CI, 1.09-1.31]; P<0.001) but not MALE or MALE/lower extremity revascularization (HR, 1.02 [95% CI, 0.84-1.23], P=0.824; HR, 1.04 [95% CI, 0.95-1.13], P=0.392, respectively). CONCLUSIONS: History of hypertension was not associated with higher hazard for MACE or MALE in patients with peripheral artery disease. In contrast, there was a higher hazard of MACE in patients with out-of-target low and high SBP. High but not low SBP was associated with an increased risk of ischemic limb events. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01732822.

20.
J Am Heart Assoc ; 9(18): e016620, 2020 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-32896194

RESUMO

Background Although guidelines recommend the use of coronary computed tomographic angiography (CTA) in patients with stable pain syndromes, the clinical benefits of the use of coronary CTA in a broad spectrum of patients is unknown. We evaluated the contemporary practice pattern and diagnostic yield of coronary CTA and their impact on the subsequent diagnostic-therapeutic cascade and clinical outcomes. Methods and Results We identified 39 906 patients without known coronary artery disease (CAD) who underwent coronary CTA between January 2007 and December 2013. The patients' demographic characteristics, risk factors, symptoms, results of coronary CTA, the appropriateness of downstream diagnostic and therapeutic interventions, and long-term outcomes (death or myocardial infarction) were evaluated. The number of coronary CTAs had increased over time, especially in asymptomatic patients. Coronary CTA revealed that 6108 patients (15.3%) had obstructive CAD (23.7% of symptomatic and 9.3% of asymptomatic patients). Subsequent cardiac catheterization was performed in 19.2% of symptomatic patients (appropriate, 80.6%) and in 3.9% of asymptomatic patients (appropriate, 7.9%). The 5-year rate of death or myocardial infarction was significantly higher in patients with obstructive CAD on CTA than those without (7.2% versus 3.0%; P<0.001; adjusted hazard ratio [95% CI], 1.34 [1.17-1.54]). However, obstructive CAD on CTA had limited added value over conventional risk factors for predicting death or myocardial infarction. Conclusions Although the use of coronary CTA had substantially increased, CTA had a low diagnostic yield for obstructive CAD, especially in asymptomatic patients. The use of CTA in asymptomatic patients seemed to have led to inappropriate subsequent diagnostic or therapeutic interventions without clinical benefit.

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