Publications by authors named "Robert D McBane"

156 Publications

Early and Late Outcomes of Cardiovascular Surgery in Patients With Ehlers-Danlos Syndrome.

World J Pediatr Congenit Heart Surg 2021 Nov;12(6):773-777

6915Department of Cardiovascular Surgery, Mayo Clinic, Rochester, MN, USA.

Background: Cardiovascular surgical outcomes reports are few for vascular type IV of Ehlers- Danlos Syndrome (vEDS) compared to non-vascular types I-III (nEDS).

Methods: To define cardiovascular surgical outcomes among adult patients (≥18 years) with EDS types, a review of our institution's in-house STS Adult Cardiac Surgery Database-compliant software and electronic medical records from Mayo Clinic (1993-2019) was performed. Outcomes were compared for vEDS patients and nEDS patients. Demographics, baseline characteristics, operative, in-hospital complications and follow-up vital status were analyzed.

Results: Over the study time frame, 48 EDS patients underwent surgery (mean age 52.6 ± 14.6 years; 48% females). Of these, 17 patients had vEDS and 31 patients had nEDS. Six patients (12.5%) underwent prior sternotomy. Urgent or emergent surgery was performed in 10 patients (20.8%). Aortic (vEDS 76.5% vs. nEDS 16.1%) and mitral procedures (vEDS 11.8% vs. nEDS 48.4%) were the two most common cardiovascular surgeries performed (p < .01 and p = .007, respectively). Cardiopulmonary bypass time (CPB) (165 ± 18 vs. 90 ± 13 min; p = .015) and aortic cross clamp times (140 ± 14 vs. 62 ± 10 min; p < .001) were longer for vEDS patients. There was 1 (2.1%) early and 7 (14.6%) late deaths; 6 among vEDS and 2 among nEDS patients. Survival at 5 (80% vs. 93%), 10 (45% vs. 84%) and 15 years (45% vs. 84%) was lower in patients with vEDS (p = .015 for each comparison).

Conclusion: Cardiovascular surgeries are significantly more complex with longer bypass and cross clamp times for type IV vEDS compared to nEDS patients. Reduced overall survival underscores the complexity and fragility of vEDS patients.
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http://dx.doi.org/10.1177/21501351211049253DOI Listing
November 2021

Timing of venous thromboembolism diagnosis in hospitalized and non-hospitalized patients with COVID-19.

Thromb Res 2021 Oct 7;207:150-157. Epub 2021 Oct 7.

Department of Cardiovascular Diseases, Division of Vascular Medicine, Rochester, MN, United States of America; Department of Internal Medicine, Division of Hematology/Oncology, Mayo Clinic, MN, United States of America. Electronic address:

Background: The reported incidence of venous thromboembolism (VTE) in COVID-19 patients varies widely depending on patient populations sampled and has been predominately studied in hospitalized patients. The goal of this study was to assess the evolving burden of COVID-19 and the timing of associated VTE events in a systems-wide cohort.

Methods: COVID-19 PCR positive hospitalized and non-hospitalized patients ≥18 years of age tested between 1/1/2020 through 12/31/2020 were retrospectively analyzed using electronic medical records from multiple states across the Mayo Clinic enterprise. Radiology reports within 90 days before and after confirmed COVID-19 diagnosis were examined for VTE outcomes using validated Natural Language Processing (NLP) algorithms.

Results: A 29-fold increased rate of VTE compared to the pre-COVID-19 period was noted during the first week following the first positive COVID-19 test (RR: 29.39; 95% CI 21.77-40.03). The rate of VTE steadily decreased and returned to baseline by the 6th week. Among 366 VTE events, most occurred during (n = 243, 66.3%) or after (n = 111, 30.3%) initial hospitalization. Only 11 VTE events were identified in patients who did not require hospitalization (3.0% of total VTE events). VTE and mortality increased with advancing age with a pronounced increased each decade in older patients.

Conclusion: We observed a profoundly increased risk of VTE within the first week after positive testing for COVID-19 that returned to baseline levels after 6 weeks. VTE events occurred almost exclusively in patients who were hospitalized, with the majority of VTE events identified within the first days of hospitalization.
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http://dx.doi.org/10.1016/j.thromres.2021.09.021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8495042PMC
October 2021

Evaluation of Changing Vena Cava Filter Use and Inpatient Hospital Mortality from 2016-2019: A Single-Institution Quality Improvement Project.

Mayo Clin Proc Innov Qual Outcomes 2021 Oct 3;5(5):851-858. Epub 2021 Sep 3.

Cardiovascular Diseases, Mayo Clinic, Rochester, MN.

Objective: To evaluate the changing trends of vena cava filter (VCF) insertion and determine whether changes in VCF use affected inpatient mortality.

Patients And Methods: A quality improvement project at Mayo Clinic, Rochester, Minnesota, tracks the type and reason for VCF insertions from January 1, 2016, through December 31, 2019, to facilitate appropriate retrieval. The rate of VCF insertions was compared with inpatient mortality rates, normalized for patient volumes using the number of hospital inpatient discharges.

Results: A total of 698 VCFs were placed in 695 patients: 2016 (n=243), 2017 (n=156), 2018 (n=156), and 2019 (n=120). The rate of VCF insertions (per 1000 inpatient discharges) was 4.02 in 2016, 2.91 in 2017, 2.54 in 2018, and 1.93 in 2019. Mean ± SD age at placement was 62±16.4 years and 59.2% (413/698) were men. Most VCFs were retrievable (85.1%; 594/698) and were placed for treatment (78.4%; 547/698) indications (acute venous thromboembolism within 3 months). The rate of VCF insertions was compared with the inpatient mortality rate (per 100 inpatient discharges) and remained stable (1.83 in 2016, 1.79 in 2017, 1.83 in 2018, and 1.76 in 2019) despite the significant decline in VCF use.

Conclusion: Data from this quality improvement study demonstrate a reduction of more than 50% in the use of VCFs from 2016 through 2019 at a large academic hospital. These changes are difficult to attribute to any single change in clinical use and there was no appreciable increase in the inpatient hospital mortality rate associated with this decrease in VCF filter use.
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http://dx.doi.org/10.1016/j.mayocpiqo.2021.08.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8424125PMC
October 2021

Catheter directed compared to systemically delivered thrombolysis for pulmonary embolism: a systematic review and meta-analysis.

J Thromb Thrombolysis 2021 Aug 31. Epub 2021 Aug 31.

Vascular Division, Department of Cardiology, Mayo Clinic, Rochester, MN, 55905, USA.

To compare the efficacy and safety of systemic and catheter directed thrombolysis for patients with pulmonary embolism. Pubmed and Cochrane Central Register of Controlled Trials were systematically searched from inception to May 31st 2020 to identify relevant studies. Outcomes of interest were in-hospital mortality and major bleeding including intracranial hemorrhage. We included 8 observational studies comprising 11,932 patients with PE. Catheter directed thrombolysis was associated with lower in-hospital mortality [RR 0.52; 95% confidence interval (CI) 0.40-0.68]. Although there was no difference in major bleeding by treatment strategy (RR 0.80; 95% CI 0.37-1.76), intracranial hemorrhage was lower in patients receiving catheter directed therapy (RR 0.66; 95% CI, 0.47-0.94).The certainty in these estimates was low. Non-randomized studies suggest that catheter directed delivery of thrombolytic therapy may be associated with lower in-hospital mortality and intracranial hemorrhage rates. These results may help inform management strategies for health care and pulmonary embolism response teams (PERT) involved in the management of high risk patients with massive or submassive pulmonary emboli.
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http://dx.doi.org/10.1007/s11239-021-02556-7DOI Listing
August 2021

Bleeding in Patients With Gastrointestinal Cancer Compared With Nongastrointestinal Cancer Treated With Apixaban, Rivaroxaban, or Enoxaparin for Acute Venous Thromboembolism.

Mayo Clin Proc 2021 Nov 20;96(11):2793-2805. Epub 2021 Aug 20.

Gonda Vascular Center, Thrombophilia Clinic, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN. Electronic address:

Objective: To compare the bleeding risk in patients with gastrointestinal (GI) cancer with that in patients with non-GI cancer treated with anticoagulation for acute cancer-associated venous thromboembolism (Ca-VTE).

Patients And Methods: Consecutive patients with Ca-VTE seen at the Mayo Thrombophilia Clinic between March 1, 2013, and April 20, 2020, were observed prospectively to assess major bleeding and clinically relevant nonmajor bleeding (CRNMB).

Results: In the group of 1392 patients with Ca-VTE, 499 (35.8%) had GI cancer including 272 with luminal GI cancer (lower GI, 208; upper GI, 64), 176 with pancreatic cancer, and 51 with hepatobiliary cancer. The rate of major bleeding and CRNMB in patients with GI cancer was similar to that in 893 (64.2%) patients with non-GI cancer treated with apixaban, rivaroxaban, or enoxaparin. Apixaban had a higher rate of major bleeding in luminal GI cancer compared with the non-GI cancer group (15.59 vs 3.26 per 100 person-years; P=.004) and compared with enoxaparin in patients with luminal GI cancer (15.59 vs 3.17; P=.04). Apixaban had a lower rate of CRNMB compared with rivaroxaban in patients with GI cancer (3.83 vs 9.40 per 100 person-years; P=.03). Patients treated with rivaroxaban in the luminal GI cancer group had a major bleeding rate similar to that of patients with non-GI cancer (2.04 vs 4.91 per 100 person-years; P=.37).

Conclusion: Apixaban has a higher rate of major bleeding in patients with luminal GI cancer compared with patients with non-GI cancer and compared with enoxaparin in patients with luminal GI cancer. Rivaroxaban shows no increased risk of major bleeding in patients with GI cancer or luminal GI cancer compared with patients with non-GI cancer.

Trial Registration: ClinicalTrials.gov identifier: NCT03504007.
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http://dx.doi.org/10.1016/j.mayocp.2021.04.026DOI Listing
November 2021

Macrovascular Thrombotic Events in a Mayo Clinic Enterprise-Wide Sample of Hospitalized COVID-19-Positive Compared With COVID-19-Negative Patients.

Mayo Clin Proc 2021 07 4;96(7):1718-1726. Epub 2021 May 4.

Division of Hematology/Oncology, Mayo Clinic, Rochester, MN; Division of Vascular Medicine, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.

Objective: To determine the difference in the rate of thromboembolic complications between hospitalized coronavirus disease 2019 (COVID-19)-positive compared with COVID-19-negative patients.

Patients And Methods: Adult patients hospitalized from January 1, 2020, through May 8, 2020, who had COVID-19 testing by polymerase chain reaction assay were identified through electronic health records across multiple hospitals in the Mayo Clinic enterprise. Thrombotic outcomes (venous and arterial) were identified from the hospital problem list.

Results: We identified 3790 hospitalized patients with COVID-19 testing across 19 hospitals, 102 of whom had positive test results. The median age was lower in the COVID-positive patients (62 vs 67 years; P=.03). The median duration of hospitalization was longer in COVID-positive patients (8.5 vs 4 days; P<.001) and more required intensive care unit care (56.9% [58 of 102] vs 26.8% [987 of 3688]; P<.001). Comorbidities, including atrial fibrillation/flutter, heart failure, chronic kidney disease, and malignancy, were observed less frequently with COVID-positive admissions. Any venous thromboembolism was identified in 2.9% of COVID-positive patients (3 of 102) and 4.6% of COVID-negative patients (168 of 3688). The frequency of venous and arterial events was not different between the groups. The unadjusted odds ratio (OR) for COVID-positive-patients for any venous thromboembolism was 0.63 (95% CI, 0.19 to 2.02). A multivariable logistic regression model evaluated death within 30 days of hospital discharge; neither COVID positivity (adjusted OR, 1.12; 95% CI, 0.54 to 2.34) nor thromboembolism (adjusted OR, 0.90; 95% CI, 0.60 to 1.32) was associated with death.

Conclusion: Early experience in patients with COVID-19 across multiple academic and regional hospitals representing different US regions demonstrates a lower than previously reported incidence of thrombotic events. This incidence was not higher than a contemporary COVID-negative hospitalized comparator.
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http://dx.doi.org/10.1016/j.mayocp.2021.04.022DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8096191PMC
July 2021

TEMPORARY REMOVAL: Direct Oral Anticoagulants Compared With Dalteparin for Treatment of Cancer-Associated Thrombosis: A Living, Interactive Systematic Review and Network Meta-analysis.

Mayo Clin Proc 2021 Jun 22. Epub 2021 Jun 22.

Mayo Clinic, Rochester, MN.

The publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/our-business/policies/article-withdrawal.
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http://dx.doi.org/10.1016/j.mayocp.2020.10.041DOI Listing
June 2021

Outcome of anticoagulation in isolated distal deep vein thrombosis compared to proximal deep venous thrombosis.

J Thromb Haemost 2021 09 21;19(9):2206-2215. Epub 2021 Jul 21.

Gonda Vascular Center, Mayo Clinic, Rochester, MN, USA.

Background: Isolated, distal deep vein thrombosis (IDDVT) is thought to have low rates of propagation, embolization, and recurrence compared with proximal DVT (PDVT), but the data are limited.

Objectives: The objective of this study was to assess outcomes among patients with IDDVT compared with PDVT.

Patients/methods: Consecutive patients with ultrasound-confirmed acute DVT (March 1, 2013-August 1, 2020) were identified by reviewing the Mayo Clinic Gonda Vascular Center and VTE Registry databases. Patients were divided into two groups depending on the DVT location (isolated, distal vs. proximal DVT). Outcomes including venous thromboembolism (VTE) recurrence, major bleeding, and death were compared by thrombus location and anticoagulant therapy, warfarin vs. direct oral anticoagulant (DOAC).

Results: Isolated, distal deep vein thrombosis (n = 746) was more often associated with recent surgery, major trauma, or confinement (p < .001), whereas patients with PDVT (n = 1176) were more frequently unprovoked, had a prior history of VTE, or active cancer (p < .001). There was no overall difference in VTE recurrence or major bleeding between groups during follow-up. Patients with IDDVT had a higher death rate at 3 months (p = .001) and when propensity scored for cancer (p = .003). Independent predictors of mortality included warfarin (vs. DOAC) therapy, increasing age, and active cancer. DOAC therapy resulted in lower VTE recurrence, major bleeding, and death rates in both groups.

Conclusion: Outcomes of IDDVT including VTE recurrence and bleeding rates were similar to PDVT despite higher early mortality rates. Outcomes for both groups were positively influenced by the use of DOACs.
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http://dx.doi.org/10.1111/jth.15416DOI Listing
September 2021

Primary pulmonary artery sarcoma versus pulmonary thromboembolism: a multimodal imaging comparison.

J Thromb Thrombolysis 2021 Nov 7;52(4):1129-1132. Epub 2021 May 7.

Gonda Vascular Center, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.

Primary pulmonary artery sarcoma (PPAS) is a rare malignancy that is commonly mistaken for pulmonary embolism due to similarities in clinical presentation and radiographic findings. Distinct radiographic findings to help differentiate between the two diseases are highlighted in the case presented. (1) Several nuances in various imaging modalities have been identified to help distinguish pulmonary artery sarcoma from pulmonary thromboembolic disease. (2) The wall eclipsing sign is considered pathognomonic for pulmonary artery sarcoma. (3) Positron emission tomography/computed tomography may help reduce time between diagnosis and treatment, which may ultimately prolong survival. (4) Providers should be well versed on the subtle differences on imaging to prevent future delays in diagnosis and treatment.
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http://dx.doi.org/10.1007/s11239-021-02464-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8104460PMC
November 2021

Major adverse events associated with inducible cardiac ischemia during treadmill exercise testing for peripheral artery disease.

J Vasc Surg 2021 Oct 19;74(4):1335-1342.e2. Epub 2021 Apr 19.

Gonda Vascular Center, Mayo Clinic, Rochester, Minn; Cardiovascular Department, Mayo Clinic, Rochester, Minn.

Background: The coexistence of coronary artery disease and peripheral artery disease (PAD) is well-established. Whether myocardial ischemia by electrocardiography during treadmill testing to evaluate PAD severity is associated with adverse cardiac and limb events has not been established. The aim of the current study is to assess the risk of major adverse cardiac events (MACE), major adverse limb events (MALE), and all-cause mortality in patients with evidence of myocardial ischemia on ECG compared with those without ischemia in patients undergoing treadmill testing for PAD evaluation.

Methods: Patients undergoing treadmill exercise ankle-brachial index (ABI) evaluation (January 1, 2003, to December 31, 2006) were identified using the Mayo Clinic Gonda Vascular Laboratory database. Patients with ischemia by electrocardiogram (ECG) were age and sex matched to patients without ischemia. Outcomes were compared by ECG category.

Results: Of 4128 patients who underwent treadmill exercise, 170 (4.1%) had inducible myocardial ischemia by ECG. These were matched with 340 patients without ischemia. The positive ECG group had a higher percentage of diabetes mellitus (31.2% vs 21.8%; P = .02), carotid artery disease (22.4% vs 13.2%; P = .009), exercise-induced angina (14.1% vs 2.9%; P < .0001), and dyspnea (60.6% vs 35.6%; P < .0001). While the resting ABI was similar, the postexercise ABI was lower in the positive ECG group (0.5 vs 0.7; P = .04). After a median follow-up of 8 years, MACE were significantly greater in the positive ECG group (62.4% vs 46.5%; P < .001). MALE were significantly less frequent (17.1% vs 23.2%; P = .02), without an increased risk of amputation. In multivariable analysis, inducible ischemia was associated with higher incidence of MACE (hazard ratio, 1.65; 95% confidence interval, 1.25-2.16; P < .001) and lower incidence of MALE (hazard ratio, 0.51; 95% confidence interval, 0.31-0.84; P < .05).

Conclusions: ECG monitoring during vascular treadmill testing identified a subset of patients with more frequent MACE but less MALE.
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http://dx.doi.org/10.1016/j.jvs.2021.03.041DOI Listing
October 2021

Janus Kinase Inhibitors and Risk of Venous Thromboembolism: A Systematic Review and Meta-analysis.

Mayo Clin Proc 2021 07 9;96(7):1861-1873. Epub 2021 Apr 9.

Division of Rheumatology, University of Arizona, Tucson; University of Arizona Arthritis Center, University of Arizona, Tucson.

Objective: To assess the risk of venous thromboembolism (VTE) in patients treated with Janus kinase (JAK) inhibitors in clinical trials.

Patients And Methods: We performed a literature search of Ovid MEDLINE and ePub Ahead of Print, In-Process & Other Non-Indexed Citations, and Daily; Ovid EMBASE; Ovid Cochrane Central Register of Controlled Trials; Ovid Cochrane Database of Systematic Reviews; and Scopus, from inception to December 4, 2019, for randomized, placebo-controlled trials with JAK inhibitors as an intervention and reported adverse events. Odds ratio with 95% CI was calculated to estimate the VTE risk using a random effects model. Two independent reviewers screened and extracted data. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach was used to assess certainty in estimated VTE risk.

Results: We included 29 trials (13,910 patients). No statistically significant association was found between use of JAK inhibitors and risk of VTE (odds ratio, 0.91; 95% CI, 0.57 to 1.47; P=.70; I=0; low certainty because of serious imprecision). Results using Bayesian analysis were consistent with those of the primary analysis. Results of stratified and meta-regression analyses suggested no interaction by dose of drug, indication for treatment, or length of follow-up.

Conclusion: We found insufficient evidence to support an increased risk of JAK inhibitor-associated VTE based on currently available data.
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http://dx.doi.org/10.1016/j.mayocp.2020.12.035DOI Listing
July 2021

Calf Vein Thrombosis Outcomes Comparing Anticoagulation and Serial Ultrasound Imaging Management Strategies.

Mayo Clin Proc 2021 05 9;96(5):1184-1192. Epub 2021 Apr 9.

Gonda Vascular Center, Mayo Clinic, Rochester, MN; Cardiovascular Department, Mayo Clinic, Rochester, MN. Electronic address:

Objective: To compare outcomes among patients with calf deep vein thrombosis (DVT) stratified by management strategy because distal or calf DVT is said to have low rates of propagation, embolization, and recurrence and, as such, guideline recommendations include provisions for serial imaging without treatment.

Patients And Methods: Consecutive patients with ultrasound-confirmed acute DVT involving the calf veins (January 1, 2016, to August 1, 2018) were identified by scrutinizing the Gonda Vascular Center Ultrasound database. Patients were segregated into 2 categories depending on management strategy; anticoagulation vs serial surveillance ultrasound without anticoagulation. Outcomes including venous thromboembolism (VTE) recurrence, bleeding, death, and net clinical benefit were compared by treatment strategy.

Results: There were 483 patients with calf DVT identified; 399 were treated with anticoagulation therapy and 84 were managed with surveillance ultrasound. Patients in the surveillance group were older (70.0±13.9 vs 63.0±14.9 years; P<.001) and more likely to have had a recent hospitalization (76.2% [64/84] vs 45.4% [181/399]; P<.001). Common reasons for choosing ultrasound surveillance included guideline prescriptive (58.3% [49/84]), active bleeding (21.4% [18/84]), and recent surgery (17.9% [15/84]). The VTE recurrence composite was lower for patients treated with anticoagulants (7.3% [29/399]) compared with surveillance (14.3% [12/84]; P=.04). The DVT propagation was less frequent in the treated group (2.8% [11/399] vs 8.3% [7/84]; P=.01). There was no difference in bleeding or mortality outcomes by management strategy. Net clinical benefit (VTE recurrence plus major bleeding) favored anticoagulant therapy (9.8% [39/399] vs 20.2% [17/84]; P<.01).

Conclusion: Patients with calf DVT treated with anticoagulants had significantly better outcomes compared with those managed by a strategy of serial ultrasound surveillance without increasing bleeding outcomes.
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http://dx.doi.org/10.1016/j.mayocp.2021.01.024DOI Listing
May 2021

Von Willebrand Factor and ADAMTS13 as Predictors of Adverse Outcomes in Patients With Nonvalvular Atrial Fibrillation.

CJC Open 2021 Mar 13;3(3):318-326. Epub 2020 Nov 13.

Division of Cardiovascular Medicine, Mayo Clinic and Foundation for Education and Research, Rochester, Minnesota, USA.

Background: Von Willebrand factor (VWF) elevation correlates with the left atrial blood stasis in nonvalvular atrial fibrillation (NVAF). However, the long-term impact of elevated VWF in patients with NVAF is not well established.

Methods: To assess the impact of VWF and a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS13) in conjunction with echocardiographic measures of left atrium blood stasis on clinical outcomes, 414 NVAF prospectively recruited (October 4, 2007, to April 27, 2009) patients were followed for 3 years. VWF antigen, VWF activity, ADAMTS13 activity, and echocardiographic findings were assessed at baseline. Thromboembolism (TE) (stroke/transient ischemic attack (TIA)), myocardial infarction, or TE of other locations), major bleeding, clinically relevant nonmajor bleeding, and all-cause mortality were assessed by clinical follow-up, questionnaire, or telephone communication.

Results: Among 374 patients (mean age, 63.4 ± 12.7 years; 25% females) who had complete follow-up data, there were 33 TE in 32 patients (8.6%), 18 deaths (5.1%), and 33 bleeding events (21 major bleeding and 12 clinically relevant nonmajor bleeding) in 25 patients (6.7%). VWF antigen was predictive of TE in the univariate examination (hazard ratio [HR]: 1.007, 95% confidence interval [CI]: 1.002, 1.013,  = 0.011) but not in multivariate analysis. VWF was an independent predictor of all-cause mortality (HR: 1.011, 95% CI: 1.003, 1.020,  = 0.011) and a composite of TE and all-cause mortality (HR: 1.006, 95% CI: 1.001, 1.012,  = 0.039) in multivariate analysis. ADAMTS13 was not predictive of clinical outcomes in multivariate analysis.

Conclusions: Among patients with NVAF, VWF is an independent predictor of poor outcomes including death and a composite of death and TE. As such, VWF measure may help identify high-risk patients and provide further stratification beyond CHADS-VASc assessment.
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http://dx.doi.org/10.1016/j.cjco.2020.10.018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7984998PMC
March 2021

Effect of Corticosteroid Therapy in Patients With Cardiac Sarcoidosis on Frequency of Venous Thromboembolism.

Am J Cardiol 2021 06 20;149:112-118. Epub 2021 Mar 20.

Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota. Electronic address:

Sarcoidosis is a multisystem inflammatory condition with occasional cardiac involvement (CS), which may be associated with risk of venous thromboembolism (VTE). As data on VTE in CS are sparse and corticosteroid therapy has not been previously examined, we aim to determine the association between CS, corticosteroid treatment for CS, and VTE. Patients referred to our institution with concern for sarcoidosis and underwent a positron emission tomography (PET) scan were retrospectively assessed. Chi-squared and multivariate regression analyses were conducted to determine the association between a diagnosis of sarcoidosis, CS, corticosteroid use, and VTE events. Six hundred and forty nine patients were split into 3 categories: 235 with no sarcoidosis (NS), 91 with extra-cardiac sarcoidosis only (ECS), and 323 with CS (isolated CS and/or CS with extra cardiac sarcoid). Thirty nine CS, 7 ECS, and 9 NS patients developed PE while 44 CS, 3 ECS, and 18 NS patients developed DVT. On multivariate regression, neither CS nor ECS was an independent risk factor for VTE (p >0.05) but corticosteroid use was independently associated with VTE (HR 3.06, p = 0.007 for PE, HR 6.21, p <0.0001 for DVT). On logistic regression analysis, corticosteroid dose was found to be independently associated with both PE (p = 0.001) and DVT (p = 0.007). Optimal threshold for defining VTE risk with corticosteroid therapy was a prednisone-equivalent dose of 17.5 mg. In conclusion, contrary to previous studies, this current study found that neither sarcoidosis nor CS is an independent risk factor for VTE. Rather, corticosteroid therapy was associated with an increased risk of VTE.
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http://dx.doi.org/10.1016/j.amjcard.2021.03.017DOI Listing
June 2021

Usability of a Digital Registry to Promote Secondary Prevention for Peripheral Artery Disease Patients.

Mayo Clin Proc Innov Qual Outcomes 2021 Feb 28;5(1):94-102. Epub 2020 Nov 28.

Department of Cardiovascular Medicine, Mayo Clinic and Mayo Foundation, Rochester, MN.

Objective: To evaluate usability of a quality improvement tool that promotes guideline-based care for patients with peripheral arterial disease (PAD).

Patients And Methods: The study was conducted from July 19, 2018, to August 21, 2019. We compared the usability of a PAD cohort knowledge solution (CKS) with standard management supported by an electronic health record (EHR). Two scenarios were developed for usability evaluation; the first for the PAD-CKS while the second evaluated standard EHR workflow. Providers were asked to provide opinions about the PAD-CKS tool and to generate a System Usability Scale (SUS) score. Metrics analyzed included time required, number of mouse clicks, and number of keystrokes.

Results: Usability evaluations were completed by 11 providers. SUS for the PAD-CKS was excellent at 89.6. Time required to complete 21 tasks in the CKS was 4 minutes compared with 12 minutes for standard EHR workflow (median,  = .002). Completion of CKS tasks required 34 clicks compared with 148 clicks for the EHR (median,  = .002). Keystrokes for CKS task completion was 8 compared with 72 for EHR (median,  = .004). Providers indicated that overall they found the tool easy to use and the PAD mortality risk score useful.

Conclusions: Usability evaluation of the PAD-CKS tool demonstrated time savings, a high SUS score, and a reduction of mouse clicks and keystrokes for task completion compared to standard workflow using the EHR. Provider feedback regarding the strengths and weaknesses also created opportunities for iterative improvement of the PAD-CKS tool.
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http://dx.doi.org/10.1016/j.mayocpiqo.2020.09.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7930799PMC
February 2021

Arterial Thrombosis and Cancer: Implications for Screening and Risk Modification.

Authors:
Robert D McBane

Mayo Clin Proc 2021 03;96(3):526-528

Vascular Division, Department of Cardiology, Gonda Vascular Center, Rochester, MN. Electronic address:

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http://dx.doi.org/10.1016/j.mayocp.2021.01.013DOI Listing
March 2021

Thromboinflammatory Biomarkers in COVID-19: Systematic Review and Meta-analysis of 17,052 Patients.

Mayo Clin Proc Innov Qual Outcomes 2021 Apr 8;5(2):388-402. Epub 2021 Feb 8.

Division of Vascular Medicine, Mayo Clinic, Rochester, MN.

Objective: To evaluate differences in thromboinflammatory biomarkers between patients with severe coronavirus disease 2019 (COVID-19) infection/death and mild infection.

Patients And Methods: MEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, EBSCO, Web of Science, and CINAHL databases were searched for studies comparing thromboinflammatory biomarkers in COVID-19 among patients with severe COVID-19 disease or death (severe/nonsurvivors) and those with nonsevere disease or survivors (nonsevere/survivors) from January 1, 2020, through July 11, 2020. Inclusion criteria were (1) hospitalized patients 18 years or older comparing severe/nonsurvivors vs nonsevere/survivors and (2) biomarkers of inflammation and/or thrombosis. A random-effects model was used to estimate the weighted mean difference (WMD) between the 2 groups of COVID-19 severity.

Results: We included 75 studies with 17,052 patients. The severe/nonsurvivor group was older, had a greater proportion of men, and had a higher prevalence of hypertension, diabetes, cardiac or cerebrovascular disease, chronic kidney disease, malignancy, and chronic obstructive pulmonary disease. Thromboinflammatory biomarkers were significantly higher in patients with severe disease, including D-dimer (WMD, 0.60; 95% CI, 0.49 to 0.71; =83.85%), fibrinogen (WMD, 0.42; 95% CI, 0.18 to 0.67; =61.88%; <.001), C-reactive protein (CRP) (WMD, 35.74; 95% CI, 30.16 to 41.31; =85.27%), high-sensitivity CRP (WMD, 62.68; 95% CI, 45.27 to 80.09; =0%), interleukin 6 (WMD, 22.81; 95% CI, 17.90 to 27.72; =90.42%), and ferritin (WMD, 506.15; 95% CI, 356.24 to 656.06; =52.02%). Moderate to significant heterogeneity was observed for all parameters ( > 25%). Subanalysis based on disease severity, mortality, and geographic region of the studies revealed similar inferences.

Conclusion: Thromboinflammatory biomarkers (D-dimer, fibrinogen, CRP, high-sensitivity CRP, ferritin, and interleukin 6) and marker of end-organ damage (high-sensitivity troponin I) are associated with increased severity and mortality in COVID-19 infection.
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http://dx.doi.org/10.1016/j.mayocpiqo.2021.01.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7869679PMC
April 2021

Arterial Thrombosis and Coronavirus Disease 2019.

Authors:
Robert D McBane

Mayo Clin Proc 2021 02 23;96(2):274-276. Epub 2020 Dec 23.

Vascular Division, Department of Cardiology, Gonda Vascular Center, Mayo Clinic, Rochester, MN. Electronic address:

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http://dx.doi.org/10.1016/j.mayocp.2020.12.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7758023PMC
February 2021

Pulmonary venous thrombosis in a patient with COVID-19 infection.

J Thromb Thrombolysis 2021 May 30;51(4):985-988. Epub 2021 Jan 30.

Vascular Division, Department of Cardiology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.

Objectives: Infection with the SARS-COV2 virus (COVID-19) may be complicated by thrombotic diathesis. This complication often involves the pulmonary microcirculation. While macrovascular thrombotic complications of the lung may include pulmonary artery embolism, pulmonary artery thrombus in situ has also been hypothesized. Pulmonary vein thrombosis has not been described in this context.

Methods/results: Herein, we provide a case of an otherwise healthy male who developed an ischemic stroke with left internal carotid thrombus. Further imaging revealed pulmonary emboli with propagation through the pulmonary veins into the left atrium. This left atrial thrombus provides a source of atypical "paradoxic arterial embolism".

Conclusions: Thrombotic outcomes in the setting of severe COVID 19 pneumonia may include macrovascular venous thromboembolism, microvascular pulmonary vascular thrombosis and arterial thromboembolism. Pulmonary vein, herein described, provides further mechanistic pathway for potential arterial embolic phenomenon.
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http://dx.doi.org/10.1007/s11239-021-02388-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7846916PMC
May 2021

A Review of Pathophysiology, Clinical Features, and Management Options of COVID-19 Associated Coagulopathy.

Shock 2021 06;55(6):700-716

Division of Trauma, Critical Care, and General Surgery, Department of Surgery, Mayo Clinic, Rochester, Minnesota.

Abstract: There is increasing evidence that novel coronavirus disease 2019 (COVID-19) leads to a significant coagulopathy, a phenomenon termed "COVID-19 associated coagulopathy." COVID-19 has been associated with increased rates of both venous and arterial thromboembolic events, a source of significant morbidity and mortality in this disease. Further evidence suggests a link between the inflammatory response and coagulopathy associated with COVID-19. This presents a unique set of challenges for diagnosis, prevention, and treatment of thrombotic complications. In this review, we summarize and discuss the current literature on laboratory coagulation disruptions associated with COVID-19 and the clinical effects of thromboembolic events including pulmonary embolism, deep vein thrombosis, peripheral arterial thrombosis, and acute ischemic stroke in COVID-19. Endothelial injury and augmented innate immune response are implicated in the development of diffuse macro- and microvascular thrombosis in COVID-19. The pathophysiology of COVID-19 associated coagulopathy is an important determinant of appropriate treatment and monitoring of these complications. We highlight the importance of diagnosis and management of dysregulated coagulation in COVID-19 to improve outcomes in COVID-19 patients with thromboembolic complications.
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http://dx.doi.org/10.1097/SHK.0000000000001680DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8122038PMC
June 2021

Anticoagulation in COVID-19: A Systematic Review, Meta-analysis, and Rapid Guidance From Mayo Clinic.

Mayo Clin Proc 2020 11 31;95(11):2467-2486. Epub 2020 Aug 31.

Evidence-based Practice Center and Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN. Electronic address:

A higher risk of thrombosis has been described as a prominent feature of coronavirus disease 2019 (COVID-19). This systematic review synthesizes current data on thrombosis risk, prognostic implications, and anticoagulation effects in COVID-19. We included 37 studies from 4070 unique citations. Meta-analysis was performed when feasible. Coagulopathy and thrombotic events were frequent among patients with COVID-19 and further increased in those with more severe forms of the disease. We also present guidance on the prevention and management of thrombosis from a multidisciplinary panel of specialists from Mayo Clinic. The current certainty of evidence is generally very low and continues to evolve.
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http://dx.doi.org/10.1016/j.mayocp.2020.08.030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458092PMC
November 2020

Thromboembolism and the Pandemic.

Authors:
Robert D McBane

J Am Coll Cardiol 2020 11;76(18):2073-2075

Department of Cardiovascular Medicine, Gonda Vascular Center, Mayo Clinic, Rochester, Minnesota. Electronic address:

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http://dx.doi.org/10.1016/j.jacc.2020.09.543DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7588177PMC
November 2020

In-home Compared With In-Clinic Warfarin Therapy Monitoring in Mechanical Heart Valves: A Population-Based Study.

Mayo Clin Proc Innov Qual Outcomes 2020 Oct 15;4(5):511-520. Epub 2020 Aug 15.

Division of Vascular Medicine, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN.

Objective: To evaluate differences in time in therapeutic range (TTR), major bleeding, thromboembolism, and survival comparing in-home and in-clinic international normalized ratio monitoring for patients with mechanical heart valves receiving warfarin anticoagulation.

Patients And Methods: An observational population-based study of 383 patients (mean ± SD age, 61.5±14.1 years; 38.6% female) with mechanical heart valves (aortic, 77.8%; mitral, 31.1%; tricuspid, 1%; pulmonic 0.2%; and multiple, 9.7%) was performed from January 1, 2012, through December 31, 2017. The target international normalized ratio was 2.5 for 199 patients (52.0%) and 3.0 for 184 (48.0). Of these patients, 37.9% (n=145) were managed by in-home monitoring (cases) and 62.1% (n=238) were monitored in the clinic (controls).

Results: During median follow-up of 3.1 years, mean ± SD TTR was similar between in-home (66.6%±19.2%) and in-clinic (67.2%±19.8%) monitoring (=.76). There were no differences between the in-home and in-clinic groups regarding survival to major bleeding (5.7% per person-year vs 6.7% per person-year; =.66) or thrombotic complications (2.3% vs 1.8%; =.56). In-home monitoring was associated with reduced all-cause mortality (hazard ratio, 0.40; 95% CI, 0.19 to 0.83; =.01) on univariate analysis; however, this was no longer apparent when controlling for age and baseline left ventricular ejection fraction.

Conclusion: In this real-world population-based study of patients with mechanical heart valves, in-home monitoring was equivalent to in-clinic monitoring regarding TTR and important clinical outcomes.
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http://dx.doi.org/10.1016/j.mayocpiqo.2020.05.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7560573PMC
October 2020

Calf muscle pump function as a predictor of all-cause mortality.

Vasc Med 2020 12 25;25(6):519-526. Epub 2020 Sep 25.

Gonda Vascular Center, Mayo Clinic, Rochester, MN, USA.

Calf muscle pump (CMP) promotes venous return from the lower extremity and contributes to preload and cardiac output. Impaired CMP function may reflect a measure of frailty or cumulative disease burden or may impede cardiac function. The study objective was to test the hypothesis that impaired CMP negatively impacts survival. Consecutive adult patients who underwent venous strain gauge plethysmography at the Mayo Clinic Gonda Vascular Laboratory (January 1, 1998 - December 31, 2011) were assessed for overall survival. Patients with venous incompetence, venous obstruction or unilateral calf pump dysfunction were excluded. Risk of mortality was assessed with Cox proportional hazard ratios and after adjusting for Charlson Comorbidity Index variables. Over the study period, 2728 patients were included in the analysis. Compared to patients with normal CMP, those with impaired CMP were older ( < 0.001), predominantly female ( = 0.01) and had higher mean Charlson scores ( < 0.001). Patients with impaired CMP had a higher mortality rate at 5 (8.9% vs 2.4%), 10 (17.5% vs 5.9%), and 15 years (22.8% vs 8.3%) compared to those with normal CMP ( < 0.001 for each comparison). Of patients with heart failure, those with impaired CMP had worse survival at each 5-year increment compared to those with normal CMP ( < 0.05 at each increment). In conclusion, impaired CMP appears to be an independent predictor of poor outcomes after adjusting for variables within the Charlson Comorbidity Index. The association between impaired CMP, heart failure, and mortality may represent a negative impact on circulatory function or a surrogate measure of frailty.
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http://dx.doi.org/10.1177/1358863X20953212DOI Listing
December 2020

Calf Vein Thrombosis Comparison of Outcomes for Axial and Muscular Venous Thrombosis.

Thromb Haemost 2021 Feb 22;121(2):216-223. Epub 2020 Aug 22.

Gonda Vascular Center, Mayo Clinic, Rochester, Minnesota, United States.

Background:  The objective of this study was to characterize clinical features and outcomes among patients with calf deep vein thrombosis (DVT) limited to the muscular veins compared with axial veins.

Methods:  Consecutive patients with ultrasound confirmed acute DVT involving the calf veins (January 1, 2016-August 1, 2018) were identified from the Gonda Vascular Center ultrasound database. Patients were divided into axial or muscular groups based on thrombus location. Demographics, management, and outcomes were compared.

Results:  Over the study period, there were 647 patients with calf DVT equally distributed between axial ( = 321) and muscular ( = 326) locations. Within these groups, peroneal and soleal veins were most commonly involved. Nearly all cases were provoked (97%). Synchronous pulmonary embolism (PE) were more common for axial (30.8%) compared to muscular groups (20.2%;  = 0.001); nearly one-third had no pulmonary symptoms. Anticoagulation for a median of 3 months was initiated for 85.5% of both groups. Venous thromboembolism (VTE) recurrence was more common in the axial group (15.9% vs. 7.1%,  = 0.0015) including more frequent DVT propagation (9.4% vs. 3.1%;  = 0.0017) and PE (3.4% vs. 0.6%;  = 0.0168). Major bleeding, clinically relevant nonmajor bleeding, and mortality rates did not differ between groups. Withholding anticoagulation led to more frequent thrombus propagation in the axial group (3.4% vs. 0.9%;  = 0.029).

Conclusion:  Several important features distinguish muscular from axial DVT. Axial DVT are more likely to have an associated PE and are more likely to experience recurrent VTE, particularly if anticoagulation is withheld.
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http://dx.doi.org/10.1055/s-0040-1715646DOI Listing
February 2021

Effectiveness and safety of apixaban and rivaroxaban for acute venous thromboembolism therapy in patients with extremes in bodyweight.

Eur J Haematol 2020 Oct 27;105(4):484-494. Epub 2020 Jul 27.

Gonda Vascular Center, Thrombophilia Clinic, Division of Vascular Medicine, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.

Objectives: To investigate the association of extremes in bodyweight (EBW) and outcomes in patients with acute venous thromboembolism (VTE). Recurrent VTE, major bleeding, and clinically relevant non-major bleeding were compared between patients with bodyweight <60 kg, 60-120 kg, and >120 kg.

Methods: Consecutive patients enrolled in the Mayo Clinic VTE Registry (03/28/2013-8/31/2019) with acute VTE were followed prospectively. Patient status was assessed in person, by mailing a written questionnaire, or by a scripted phone interview.

Results: Among 2577 patients with weight ranging from 27.0 kg to 263.2 kg, 2123 (82%) had a bodyweight between 60 and 120 kg, 223 (8.7%) had bodyweight < 60 kg, and 230 (8.9%) had bodyweight >120 kg. Patients with bodyweight <60 kg treated with DOACs had higher 3- and 6-month incidence of major bleeding compared to the bodyweight 60-120kg group (4.4% vs 1.1%, P = .03, and 4.4% vs 1.4%, P = .05, respectively). Patients with bodyweight >120 kg and cancer on rivaroxaban had higher VTE recurrence compared to bodyweight 60-120kg group (P = .01).

Conclusions: Treatment of acute VTE is associated with a higher incidence of bleeding in patients with bodyweight <60 kg. A higher VTE recurrence rate occurred only in cancer patients with bodyweight >120 kg on rivaroxaban.
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http://dx.doi.org/10.1111/ejh.13471DOI Listing
October 2020

Adverse Events and Mortality in Anticoagulated Patients with Different Categories of Pulmonary Embolism.

Mayo Clin Proc Innov Qual Outcomes 2020 Jun 5;4(3):249-258. Epub 2020 Jun 5.

Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.

Objective: To determine whether the pulmonary embolism (PE) categories of massive, submassive, PE with no right ventricle dysfunction (NRVD), and subsegmental only (SSO) adequately predict clinical outcome.

Methods: Patients treated for acute PE (March 1, 2013, through July 31, 2019) were followed forward prospectively to compare venous thromboembolism (VTE) recurrence, all-cause mortality, major bleeding, and clinically relevant nonmajor bleeding (CRNMB) across 4 PE categories.

Results: Of 2703 patients with VTE, 1188 (44%) had PE, of which 1021 (85.9%) completed at least 3 months of therapy or had clinical outcomes precluding further treatment (27 with massive, 217 submassive, 557 NRVD, and 220 SSO PE). One patient with massive, 8 with submassive, 23 with NRVD, and 5 with SSO PE had recurrent VTE (3.90, 5.33, 5.36, and 3.66 per 100 person-years, respectively; =.84). There were 3 deaths in massive, 27 in submassive, 140 in NRVD, and 34 in SSO PE groups (11.59, 17.37, 31.74, and 24.74 per 100 person-years, respectively; =.02); when adjusted for cancer, the relationship was no longer significant (=.27). One patient with massive, 5 with submassive, 22 with NRVD, and 5 with SSO PE had major bleeding (3.90, 3.31, 5.24, and 3.75 per 100 person-years, respectively; =.66). Similar cumulative rates for CRNMB were observed (=.87). Three-month rates of VTE recurrence, death, major bleeding, and CRNMB did not differ by PE category.

Conclusion: In the setting of anticoagulation therapy with maximal standardization and evidence-based practice, there is no evidence of a difference between PE categories and outcomes.

Trial Registration: clinicaltrials.gov Identifier: NCT03504007.
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http://dx.doi.org/10.1016/j.mayocpiqo.2020.02.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7283932PMC
June 2020

End-Stage Renal Disease, Nonvalvular Atrial Fibrillation, and the Warfarin Dilemma.

Authors:
Robert D McBane

Mayo Clin Proc 2020 06;95(6):1099-1101

Division of Vascular Cardiology, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN. Electronic address:

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http://dx.doi.org/10.1016/j.mayocp.2020.04.023DOI Listing
June 2020

DOACs Versus VKAs in Older Adults Treated for Acute Venous Thromboembolism: Systematic Review and Meta-Analysis.

J Am Geriatr Soc 2020 09 22;68(9):2021-2026. Epub 2020 May 22.

Division of Vascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.

Background/objectves: Four direct-acting oral anticoagulants (DOACs) are currently approved by the Food and Drug Administration for the treatment of venous thromboembolism (VTE). Limited efficacy and safety data are available for their use in older adults (aged ≥75 years).

Methods: Medline, Cochrane Central Register of Controlled Trials, Embase, EBSCO, Web of Science, and CINAHL databases were searched for trials comparing DOACs with vitamin K antagonists (VKAs) for the treatment of VTE in older adults from inception through January 1, 2020. Meta-analysis was performed to assess the combined endpoint of recurrent VTE and related deaths and bleeding events (composite of major and clinically relevant nonmajor bleeding). The Mantel-Haenszel relative risk (RR) random effects model was used to pool results across studies.

Results: Six randomized controlled trials at low risk of bias met criteria for inclusion with a total of 3,665 patients aged 75 years and older with follow-up of 24 weeks or longer. Data for bleeding events were not available for dabigatran. Overall, DOACs had an improved efficacy over VKAs (RR = .56; 95% confidence interval [CI] = .38-.82). There was no statistically significant difference in the safety outcomes (RR = .77; 95% CI = .56-1.05). No significant heterogeneity was observed for efficacy outcome, and only moderate heterogeneity was observed for safety outcome.

Conclusion: In older adults with VTE, DOACs appear to improve rates of recurrent VTE and VTE-related deaths compared with VKAs with similar bleeding outcomes.
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http://dx.doi.org/10.1111/jgs.16549DOI Listing
September 2020

Direct oral anticoagulants for cancer-associated venous thromboembolism: a systematic review and meta-analysis.

Blood 2020 09;136(12):1433-1441

Department of Vascular Medicine, Amsterdam Cardiovascular Science, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.

Direct oral anticoagulants (DOACs) are an emerging treatment option for patients with cancer and acute venous thromboembolism (VTE), but studies have reported inconsistent results. This systematic review and meta-analysis compared the efficacy and safety of DOACs and low-molecular-weight heparins (LMWHs) in these patients. MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and conference proceedings were searched to identify relevant randomized controlled trials. Additional data were obtained from the original authors to homogenize definitions for all study outcomes. The primary efficacy and safety outcomes were recurrent VTE and major bleeding, respectively. Other outcomes included the composite of recurrent VTE and major bleeding, clinically relevant nonmajor bleeding (CRNMB), and all-cause mortality. Summary relative risks (RRs) were calculated in a random effects meta-analysis. In the primary analysis comprising 2607 patients, the risk of recurrent VTE was nonsignificantly lower with DOACs than with LMWHs (RR, 0.68; 95% CI, 0.39-1.17). Conversely, the risks of major bleeding (RR, 1.36; 95% CI, 0.55-3.35) and CRNMB (RR, 1.63; 95% CI, 0.73-3.64) were nonsignificantly higher. The risk of the composite of recurrent VTE or major bleeding was nonsignificantly lower with DOACs than with LMWHs (RR, 0.86; 95% CI, 0.60-1.23). Mortality was comparable in both groups (RR, 0.96; 95% CI, 0.68-1.36). Findings were consistent during the on-treatment period and in those with incidental VTE. In conclusion, DOACs are an effective treatment option for patients with cancer and acute VTE, although caution is needed in patients at high risk of bleeding.
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http://dx.doi.org/10.1182/blood.2020005819DOI Listing
September 2020
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