It is not clear how often patients receive aspirin (acetylsalicylic acid) while receiving oral anticoagulation with warfarin sodium without a clear therapeutic indication for aspirin, such as a ...mechanical heart valve replacement, recent percutaneous coronary intervention, or acute coronary syndrome. The clinical outcomes of such patients treated with warfarin and aspirin therapy compared with warfarin monotherapy are not well defined to date.
To evaluate the frequency and outcomes of adding aspirin to warfarin for patients without a clear therapeutic indication for combination therapy.
A registry-based cohort study of adults enrolled at 6 anticoagulation clinics in Michigan (January 1, 2010, to December 31, 2017) who were receiving warfarin therapy for atrial fibrillation or venous thromboembolism without documentation of a recent myocardial infarction or history of valve replacement.
Aspirin use without therapeutic indication.
Rates of any bleeding, major bleeding events, emergency department visits, hospitalizations, and thrombotic events at 1, 2, and 3 years.
Of the study cohort of 6539 patients (3326 men 50.9%; mean SD age, 66.1 15.5 years), 2453 patients (37.5%) without a clear therapeutic indication for aspirin were receiving combination warfarin and aspirin therapy. Data from 2 propensity score-matched cohorts of 1844 patients were analyzed (warfarin and aspirin vs warfarin only). At 1 year, patients receiving combination warfarin and aspirin compared with those receiving warfarin only had higher rates of overall bleeding (cumulative incidence, 26.0%; 95% CI, 23.8%-28.3% vs 20.3%; 95% CI, 18.3%-22.3%; P < .001), major bleeding (5.7%; 95% CI, 4.6%-7.1% vs 3.3%; 95% CI, 2.4%-4.3%; P < .001), emergency department visits for bleeding (13.3%; 95% CI, 11.6%-15.1% vs 9.8%; 95% CI, 8.4%-11.4%; P = .001), and hospitalizations for bleeding (8.1%; 6.8%-9.6% vs 5.2%; 4.1%-6.4%; P = .001). Rates of thrombosis were similar, with a 1-year cumulative incidence of 2.3% (95% CI, 1.6%-3.1%) for those receiving combination warfarin and aspirin therapy compared with 2.7% (95% CI, 2.0%-3.6%) for those receiving warfarin alone (P = .40). Similar findings persisted during 3 years of follow-up as well as in sensitivity analyses.
Compared with warfarin monotherapy, receipt of combination warfarin and aspirin therapy was associated with increased bleeding and similar observed rates of thrombosis. Further research is needed to better stratify which patients may benefit from aspirin while anticoagulated with warfarin for atrial fibrillation or venous thromboembolism; clinicians should be judicious in selecting patients for combination therapy.
We report the use of a novel endovascular approach using chemical neurolysis, via periadventitial injection of dehydrated ethanol (EtOH) to perform renal artery denervation.
A novel, three-needle ...delivery device was introduced into the renal arteries of adult swine using fluoroscopic guidance. EtOH was injected bilaterally with one injection per artery, via the three needles into the adventitial and periadventitial space, using EtOH doses 0.15 ml/artery; n=3, 0.30 ml/artery; n=3, and 0.60 ml/artery; n=3, with saline injection as a sham control (0.4 ml/artery; n=3), and naive subjects (n=7) as a true negative control. The renal parenchymal norepinephrine (NE) concentration at two-week follow-up was the primary efficacy endpoint. The mean renal NE reduction was 54%, 78% and 88% at doses of 0.15 ml, 0.30 ml and 0.60 ml, respectively (p<0.0001 vs. controls). Histological examination revealed marked, and deep, circumferential renal nerve injury at depths of 2-8 mm from the intimal surface. There was no evidence of device-related or EtOH-induced injury to the intimal layers. In some samples at the higher EtOH doses, there was focal loss of smooth muscle cells in the outer media. Angiography at 45 days demonstrated normal appearing renal arteries with no detectable stenoses (n=8).
Circumferential adventitial delivery of very low doses of EtOH may be a promising alternative to energy-based systems to achieve dose-dependent, and predictable renal denervation. Further study is warranted.
AbstractBackground/purposeGeneral Anesthesia (GA) and conscious sedation (CS) are anesthetics for transfemoral transcatheter aortic valve replacement (TF-TAVR). We compared TF-TAVR outcomes using a ...novel anesthetic approach with fascia iliaca block (FIB) plus minimal CS (MCS) versus GA. MethodsThis retrospective propensity-matched study included consecutive TF-TAVR patients from January 2013 to December 2017 and dichotomized into FIB-MCS vs. GA. Data were collected from electronic records, Society of Thoracic Surgery (STS) database, and the Transcatheter Valve Therapies (TVT) Registry. Primary endpoints were operating room (OR) time, intensive care unit (ICU) and hospital length of stay (LOS). Secondary endpoints were 30-day, 1-year mortality, quality of life, 30-day re-hospitalization rate, failure of FIB-MCS, and hospital safety outcomes. ResultsA total of 304 TF-TAVR patients; FIB-MCS ( n = 219) vs. GA ( n = 85). Propensity matched 162 patients; FIB-MCS ( n = 108) vs. GA ( n = 54). FIB-MCS had shorter OR time (197.6 ± 56.3 vs. 248.2 ± 46.3 min, p < 0.001), ICU (67.8 ± 71.7 vs. 84.9 ± 72.1 h, p = 0.004) and hospital LOS (3.2 ± 3.7 vs. 5.9 ± 3.5 d, p < 0.001). FIB-MCS had lower rate of blood transfusion. FIB-MCA vs. GA 30-day and 1-year mortality were similar in the entire (2.3 vs. 2.4%, p = 1.0; and 8.2 vs. 5.9%, p = 0.49) and matched cohorts (0 vs. 3.7%, p = 0.11 and 7.4 vs. 5.6%, p = 0.75). FIB-MCS were less likely to be re-hospitalized Odd Ratio: 0.32, CI:0.13–0.76 and 2% to 3% higher KCCQ-12 score. ConclusionTF-TAVR using FIB-MCS is feasible and safe with shorter OR time, ICU and hospital LOS, lower risk of 30-day re-hospitalization, similar 30-day and 1-year mortality with better quality of life at 1-year follow-up.
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Introduction: Warfarin and aspirin (ASA) are widely used to prevent or treat thromboembolic and atherosclerotic diseases. The most common indications for warfarin use are stroke prevention in ...atrial fibrillation (AF) and for the treatment of venous thromboembolic disease (VTE). When patients are started on warfarin, many are already taking ASA or they are subsequently placed on ASA due to other co-morbidities. There are limited indications for the combination of warfarin plus ASA, including mechanical heart valves, after percutaneous coronary intervention (PCI), or after acute coronary syndromes. Evidence suggests combination warfarin-ASA may offer no benefit, but place patients at increased bleeding risk outside of these indications.
We sought to assess the patient characteristics and outcomes of patients on warfarin for AF or VTE, comparing those who were on concurrent ASA without a strong indication (myocardial infarction MI within 6 months, mechanical heart valve or PCI) to those not on ASA. We hypothesized that combination therapy (warfarin-ASA) would result in increased bleeding rates with similar rates of MI, recurrent VTE, stroke, or death.
Methods: We conducted a retrospective cohort study of adult patients, initiated on warfarin for AF or VTE between January 2009 and June 2017. Patients were recruited through the Michigan Anticoagulation Quality Improvement Initiative, a collaborative of six outpatient anticoagulation clinics throughout the state of Michigan. Patients with less than three months of follow-up, a MI within six months, and/or history of valve replacement were excluded. Patients were analyzed based on their aspirin use at the time of study enrollment. A HAS-BLED score, modified to exclude aspirin use, and a Charlson Co-morbidity Index was calculated for each patient at enrollment.
Analyses were performed using Student's t-tests, Wilcoxon Rank-sum tests, chi-square tests and Fisher's exact tests when appropriate. Survival and Poisson regression analyses were used to evaluate the effect of ASA use on various outcomes.
Results: A total of 6,572 patients met the inclusion criteria, with a mean duration of follow-up of 21.2 months; 38% were on warfarin-ASA compared to 62% on warfarin monotherapy. Patients on warfarin-ASA were older (mean 70.2±12.7 vs. 63.7±16.5, p<0.001), more often male (56.7% vs. 47.3%, p<0.001), and were more likely anticoagulated for AF (66.3% vs. 42.3%, p<0.001). Warfarin-ASA patients were more likely to have cardiovascular risk factors (diabetes mellitus, tobacco use, or hypertension), a history of stroke, heart failure, or a history of coronary artery disease (CAD). Patients on warfarin-ASA had a higher HAS-BLED score (mean 2.4±1.2 vs. 1.8±1.2, p<0.001), and Charlson Co-morbidity Index (mean 4.8±2.0 vs. 3.6±2.1, p<0.001).
Patients treated with warfarin-ASA vs. warfarin alone experienced less DVTs (0.7/100 patient years pt-yr vs. 1.3/100-pt-yr, p=0.002) and PE (0.1/100-pt-yr vs. 0.4/100-pt-yr, p=0.002), but had a higher rate of ischemic/embolic strokes (0.7/100-pt-yr vs. 0.4/100-pt-yr, p=0.02). Emergency department visits and hospitalizations for thromboembolic events were similar. Patients treated with warfarin-ASA vs. warfarin alone had a higher 1-year probability of having a major bleeding event (6.1% vs. 3.2%, p<0.001) or non-major bleeding event (22.9% vs. 18.7%, p=0.004). Warfarin-ASA treated patients had a higher rate of hospitalizations for bleeding (8.4/100-pt-yr vs. 5.7/100-pt-yr, p<0.001), blood transfusions (5.2/100-pt-yr vs. 4.1/100-pt-yr, p=0.009) and all-cause mortality relative to warfarin alone (4.1/100-pt-yr vs. 3.1/100-pt-yr, p=0.005). Kaplan-Meier curves for any clotting event, all bleeding events, major bleeding events, and death are shown (figure 1). A sensitivity analysis was performed that further excluded any history of MI, CAD, PCI, peripheral arterial disease, or coronary artery bypass grafting, and showed similar results.
Conclusion: Over one-third of patients in an unselected practice-based setting are treated with warfarin-ASA for AF and/or VTE without a clear indication. Compared to warfarin monotherapy, this was associated with minimally increased protection against VTE but with a significant increase in bleeding and perhaps mortality. Further research is needed to better stratify who should receive aspirin while on warfarin.
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Sood:Bayer: Research Funding. Kline-Rogers:Janssen: Consultancy; ACP: Consultancy; AC Forum: Membership on an entity's Board of Directors or advisory committees. Almany:Trice Orthopedics: Consultancy; Micardia: Consultancy; Ablative Solutions: Equity Ownership; Kona: Consultancy; Biostar Ventures: Equity Ownership; Boston Scientific Watchman: Research Funding; Abbott Absorb Trial: Research Funding. Kaatz:Daiichi Sankyo: Consultancy, Honoraria; CSL Behring: Honoraria; Boehringer Ingelheim: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Bristol Myers Squibb: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Portola: Consultancy. Froehlich:Merck: Consultancy; Fibromuscular Disease Society of America: Research Funding; Blue Cross/Blue Shield of Michigan: Research Funding; Boehringer Ingelheim: Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy; Novartis: Consultancy; Pfizer: Membership on an entity's Board of Directors or advisory committees. Barnes:Pfizer: Research Funding; Bristol Myers Squibb: Research Funding; Blue Cross/Blue Shield of Michigan: Research Funding; Aralez: Consultancy.
Introduction: The regulatory approval and growing clinical acceptance of the direct oral anticoagulants (DOACs: apixaban, dabigatran, edoxaban, and rivaroxaban) has challenged warfarin as the ...mainstay of anticoagulation for the management of venous thromboembolic disease (VTE: deep vein thrombosis and pulmonary embolism) and atrial fibrillation/flutter (Afib). As clinicians and patients choose from the expanded menu of oral anticoagulant options, it is unknown how socioeconomic variables like income, race, gender, health insurance, or marital status may influence which anticoagulant a patient utilizes.
We sought to explore if patients who stayed on warfarin differed from those who changed to a DOAC, with regard to the aforementioned socioeconomic variables. Furthermore, we desired to assess how the clinical variable of INR management, as reflected by the percent of time in therapeutic range (TTR), compared between these two groups.
Methods: The Michigan Anticoagulation Quality Improvement Initiative (MAQI2) is a multi-center collaborative registry of 6 active anticoagulation clinics across Michigan. Patients newly initiating warfarin for Afib or VTE between October 2009 and July 2016 were included. Enrollees who remained on warfarin in follow-up ("non-switchers") were compared to those that transitioned to a DOAC ("switchers") on the basis of demographics, TTR by linear interpolation, race, marital status, and insurance. Patients in each group were further analyzed in quartiles based on the median household income of their zip code of residence, derived from the 2014 U.S. Census Bureau's American Community Survey. Analyses were performed using Student's t-tests and Wilcoxon Rank-sum tests for continuous variables, and chi-square and Fisher's exact tests for categorical variables.
Results: 8,480 patients met the inclusion criteria, 54.4% with Afib, 45.6% with VTE, and 1.1% with both; out of this group, 675 (8%) switched from warfarin to a DOAC. There were no significant differences between switchers and non-switchers for age (mean 68.1±13.6 and 67.4±15.7, p=0.23), gender (53.9% vs. 51.5% male, p=0.23), percent TTR on warfarin (55.1% vs. 56.9%, p=0.056), or percent with commercial health insurance (33.9% vs. 34.4%, p=0.78) or uninsured (0.3% vs. 0.9%, p=0.17).
Patients were more likely to switch to DOAC therapy if they had Afib vs. VTE (10.9% vs. 4.5%, p<0.001). When comparing switchers to non-switchers, switchers were more often white race (88.8% vs. 81.5%, p<0.001), married/living with a partner (68.9% vs. 59.7%, p<0.001), and had Government Health Insurance (58.9% vs. 54.6%, p=0.032). As compared to non-switchers, switchers were less often African American (7% vs. 15.3%, p<0.001), and less often had insurance through a Health Maintenance Organization (HMO) (6.9% vs. 10.2%, p=0.008). Non-switchers more often resided in a zip code with a lower median household income compared to switchers (p<0.001).
Conclusion: While DOACs are often considered in patients who have difficulty maintaining a therapeutic INR, TTR was not predictive of changing from warfarin to a DOAC in this population. However, we found that SES factors, such as race, insurance status and income are associated with a patient's likelihood for switching to DOAC therapy vs. remaining on warfarin therapy. Further investigation into the reason for, and clinical impact of, these observed disparities in the care of our patients is needed.
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Sood:Bayer: Research Funding. Kline-Rogers:Janssen: Consultancy; ACP: Consultancy; AC Forum: Membership on an entity's Board of Directors or advisory committees. Almany:Abbott: Research Funding; Kona: Consultancy; Trice Orthopedics: Consultancy; MiCardia: Consultancy; Biostar Ventures: Equity Ownership; Ablative Solutions: Equity Ownership; Boston Scientific: Research Funding. Kaatz:Pfizer: Consultancy; Bristol-Myers Squibb: Consultancy; Daiichi Sankyo: Consultancy; Janssen: Consultancy; Boehringer Ingelheim: Consultancy; Boehringer Ingelheim: Honoraria; Janssen: Honoraria; Bristol Myer Squibb: Honoraria; Pfizer: Honoraria; CSL Behring: Honoraria. Froehlich:Boehringer-Ingelheim: Membership on an entity's Board of Directors or advisory committees; Fibromuscular Disease Society of America: Research Funding; Blue Cross/Blue Shield of Michigan: Research Funding; Novartis: Consultancy; Janssen: Consultancy; Merck: Consultancy; Pfizer: Membership on an entity's Board of Directors or advisory committees. Barnes:Portolal: Consultancy; Blue Cross Blue Shield of Michigan: Research Funding; Bristol-Myers Squibb: Research Funding; Pfizer: Research Funding.
The diagnosis of an acute coronary syndrome associated with heparin‐induced thrombocytopenia is an increasingly recognized complication of heparin exposure. We describe a case of an acute myocardial ...infarction 2 weeks after elective aortobifemoral bypass surgery, subsequent subacute coronary artery stent thrombosis, and the treatment strategies available.
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