Congenital thrombotic thrombocytopenic purpura (cTTP) results from a deficiency in  ADAMTS13 (A disintegrin and metalloproteinase with thrombospondin motifs 13), a von Willebrand factor (VWF) cleaving protease. This leads to an accumulation of ultra-large VWF multimers in the blood and uncontrolled platelet aggregation and adhesion. Adzynma is a purified recombinant form of the ADAMTS13 protein designed to replace the missing or deficient ADAMTS13 enzyme.

The approval was based on data from a randomized, crossover phase 3 study (ClinicalTrials.gov Identifier: NCT03393975) that evaluated the safety and efficacy of prophylactic ERT with Adzynma in patients with cTTP. Study participants in the prophylaxis cohort (N=46) were randomly assigned to receive 6 months of treatment with either Adzynma or plasma based therapy in the first part of the trial (Period 1), and then crossed over to the other treatment for 6 months in the second part of the trial (Period 2). Thirty-five patients entered the 6-month single arm continuation period (Period 3).

There were no acute TTP events throughout the study among patients who received Adzynma. One acute TTP event occurred in a patient who received plasma-based therapy. Additionally, no subacute TTP events were reported among those who received Adzynma during Periods 1 and 2. Two patients receiving Adzynma had 2 subacute events of which one was treated with 4 supplemental doses. Four patients receiving plasma-based therapy had 5 subacute TTP events in Periods 1 and 2. A total of 7 supplemental doses were given to 3 of these patients.

The study also investigated the efficacy of on-demand ERT based on the proportion of acute TTP events that responded to Adzynma throughout the duration of the study. Patients were randomly assigned to receive on-demand treatment with Adzynma (n=2) or plasma-based therapy (n=3). Findings showed that all 6 acute TTP events resolved after treatment with either Adzynma or plasma based therapy.

“Adzynma provides patients with a treatment option that replaces their deficient ADAMTS13 enzyme and offers a favorable efficacy and safety profile and reduced administration time and volume compared to current plasma-based therapies,” said Spero R. Cataland, MD, professor of internal medicine at the Wexner Medical Center at The Ohio State University, co-director at the US Thrombotic Microangiopathy Alliance and Adzynma clinical trial investigator.

The most common adverse events reported with Adzynma were headache, diarrhea, migraine, abdominal pain, nausea, upper respiratory tract infection, dizziness and vomiting. The prescribing information also includes warnings and precautions related to hypersensitivity and immunogenicity.

Adzynma is administered intravenously once every other week for prophylactic ERT and once daily for on-demand ERT. The product is supplied as a lyophilized powder in single-dose vials containing nominally 500 or 1500 international units and is expected to be available in December 2023.

Dr C was a cardiologist who worked in a mid-sized practice. He was well liked by his patients and had been seeing some of them for many years. One such patient was Ms P, aged 70. Ms P had a variety of cardiac issues, including atrial fibrillation, 2 mechanical heart valves, and a pacemaker. The patient was taking the anticoagulant medication warfarin to reduce her risk of stroke.

Ms P was on a schedule to have monthly blood work done to check her International Normalized Ratio (INR) level. In this way, her warfarin levels were being monitored regularly.    

There came a time when Dr C recommended that Ms P have elective surgery to have the battery in her pacemaker replaced. Ms P agreed, and the cardiologist stopped her warfarin 5 days before the surgery. Prior to the surgery, Ms P’s INR was normal. 

The procedure took place as planned and the battery was replaced without issue. Following the procedure, Dr C had the patient begin taking the blood thinner again, which she did. The following day, however, Ms P returned to the physician’s office with bleeding and a hematoma on the procedure site. Dr C, concerned about the possibility of an infection in the area, prescribed an antibiotic, sulfamethoxazole-trimethoprim, for 5 days. The physician also ordered an INR test for the patient for the following day.

The next day, Ms P went for her bloodwork which revealed an INR of 3.2. Dr C was satisfied with this number and advised the patient to go back for another INR in 1 month, as usual. This was the last conversation Dr C would ever have with his patient. 

Less than a month later, Ms P was brought to the emergency department with clear signs of bleeding. Hospital staff worked feverishly to save her. Her INR was 22.8 and she was grossly anemic. Ms P was given blood transfusions in an attempt to replace the blood loss but it was too late. She coded numerous times and died the following day.

After her funeral, her family sought the counsel of a plaintiff’s attorney. They did not understand why Ms P had not been monitored more closely following her procedure. The plaintiff’s attorney had a medical expert look over the records and the expert was critical of Dr C’s treatment of the patient, specifically of his failure to monitor the blood thinner more closely after restarting the medication following Ms P’s pacemaker battery replacement procedure. The attorney agreed to take the case and he filed the papers and served Dr C with notice of the lawsuit. 

Dr C was saddened and upset over the death of his patient, but he did not feel responsible for it, which is what he said after being notified about the lawsuit. Prior to going to the emergency department, her INR had been acceptable, if slightly high, he told his defense attorney. And if she had been in such bad shape before calling an ambulance, why had she not contacted him? 

The case moved forward through the discovery phase and although his attorney had told Dr C that cases are often dismissed or settled early on in the process, the case against him was still proceeding.

HealthDay News — For ambulatory patients on systemic anticancer therapy, anticoagulants do not reduce the risk of arterial thrombotic events (ATEs) and are associated with increased bleeding risk, according to a review published online June 27 in JACC: CardioOncology.

Yan Xu, MD, from the University of Ottawa in Canada, and colleagues examined the efficacy and safety of anticoagulants in ATE prevention among ambulatory cancer patients. The researchers performed a systematic review of studies comparing oral or parenteral anticoagulation with no anticoagulation among patients receiving systemic anticancer therapy with no other indication for anticoagulation. Data were included from 14 randomized trials involving low-molecular-weight heparins, direct oral anticoagulants, and warfarin. ATEs (myocardial infarction, ischemic stroke, intra-abdominal arterial embolism, or peripheral artery occlusion) were captured as coefficacy end points or adverse events.

The researchers observed no association for anticoagulant use with a decrease in ATEs compared with placebo or standard treatment (relative risk [RR], 0.73; 95% CI, 0.50 to 1.04). For major and minor bleeding, the RRs with anticoagulant use were 1.56 (95 percent CI, 1.12 to 2.17) and 2.25 (95% CI, 1.45 to 3.48). The risk of death was not reduced with anticoagulants in 13 trials that reported all-cause mortality (RR, 0.99; 95% CI, 0.95 to 1.02).

“Our data do not support the routine use of anticoagulation for ATE prevention in ambulatory cancer patients,” the authors write.

One author disclosed ties to the pharmaceutical industry.

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HealthDay News — Apixaban has a lower bleeding risk than warfarin or rivaroxaban during initial treatment for patients with venous thromboembolism (VTE), according to a study published online August 28 in the Journal of Internal Medicine.

Katarina Glise Sandblad, from the University of Gothenburg in Sweden, and colleagues compared major bleeding rates by choice of anticoagulation during the initial 6 months of treatment and extended treatment (up to 5 years) for VTE. The analysis included cancer-free patients with a first-time VTE between 2014 and 2020.

The researchers found that during initial treatment, major bleeding rates were 3.86 per 100 patient-years for warfarin, 2.93 for rivaroxaban, and 1.95 for apixaban, yielding adjusted hazard ratios (aHRs) of 0.89 (95% CI, 0.71 to 1.12) for rivaroxaban vs warfarin, 0.55 (95% CI, 0.43 to 0.71) for apixaban vs warfarin, and 0.62 (95% CI, 0.50 to 0.76) for apixaban vs rivaroxaban. Major bleeding rates during extended treatment were 1.55 per 100 patient-years for warfarin, 1.05 for rivaroxaban, and 0.96 for apixaban, with aHRs of 0.72 (95% CI, 0.53 to 0.99) for rivaroxaban versus warfarin, 0.60 (95% CI, 0.44 to 0.82) for apixaban versus warfarin, and 0.85 (95 percent CI, 0.64 to 1.12) for apixaban vs rivaroxaban. During both initial and extended treatment, previous bleeding and increasing age were risk factors for bleeding.

“It is important to keep in mind that patients included in the analysis on extended treatment were free of major bleeding during initial treatment, which could contribute to the low bleeding incidence,” the authors write.

Several authors disclosed ties to the pharmaceutical industry.

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Qingwu Yang, MD, PhD, from Army Medical University in Chongqing, China, and colleagues examined the efficacy and adverse events of adjunctive intravenous low-dose methylprednisolone to endovascular thrombectomy for acute ischemic stroke secondary to LVO in a placebo-controlled trial implemented at 82 hospitals. Eligible patients were randomly assigned to intravenous methylprednisolone at 2mg/kg/day or placebo (839 and 841, respectively) for 3 days.

The researchers found that the median 90-day modified Rankin Scale score was 3 in both groups. The mortality rate was lower in the methylprednisolone group than the placebo group (23.2 vs 28.5%; adjusted risk ratio, 0.84), and the rate of symptomatic intracranial hemorrhage was also lower (8.6 vs 11.7%; adjusted risk ratio, 0.74).

“This study is therefore one of the first, to our knowledge, to provide evidence regarding the potential role of corticosteroid therapy in the setting of endovascular stroke reperfusion,” the authors write.

Several authors disclosed ties to the biopharmaceutical industry.

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Kevin N. Sheth, MD, from the Yale University School of Medicine in New Haven, Connecticut, and colleagues examined whether DTT time is associated with outcome among patients with anticoagulation-associated ICH treated with reversal interventions in a cohort study using data from the American Heart Association Get With The Guidelines-Stroke quality improvement registry. Data were included for 9492 patients with anticoagulation-associated ICH and documented reversal intervention status.

Overall, 7469 patients received reversal therapy, including 85.0% of the 5429 patients taking warfarin and 70.2% of the 2069 taking a non-vitamin K antagonist oral anticoagulant. The researchers found that the median onset-to-treatment time was 232 minutes and median DTT time was 82 minutes among the 5224 patients taking a reversal intervention with documented workflow times. Overall, 27.7% had a DTT time of 60 minutes or less, which was associated with reduced mortality and discharge to hospital, but no difference in functional outcome. White race, higher systolic blood pressure, and lower stroke severity were seen in association with DTT time of 60 minutes or less.

“These findings support intensive efforts to accelerate evaluation and treatment for patients with this devastating form of stroke,” the authors write.

Several authors disclosed ties to biopharmaceutical companies, including AstraZeneca, which partially funded the study.

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HealthDay News — For patients with large ischemic strokes, endovascular therapy is associated with improved outcomes, according to 2 studies published online February 10 in the New England Journal of Medicine to coincide the annual American Stroke Association International Stroke Conference, held from February 8 to 10 in Dallas.

Xiaochuan Huo, MD, PhD, from Beijing Tiantan Hospital, and colleagues conducted a prospective open-label randomized trial involving patients with acute large-vessel occlusion in the anterior circulation. Participants were randomly assigned within 24 hours to undergo endovascular therapy and receive medical management or receive medical management alone (231 and 225, respectively). Due to the efficacy of endovascular therapy, the trial was stopped early after the second interim analysis. The researchers found a shift in the distribution of scores on the modified Rankin scale toward better outcomes in favor of endovascular therapy at 90 days (generalized odds ratio, 1.37).

Amrou Sarraj, MD, from the University Hospitals Cleveland Medical Center-Case Western Reserve University, and colleagues conducted an open-label, randomized trial involving patients with stroke due to occlusion of the internal carotid artery or the first segment of the middle cerebral artery, with large ischemic core volume. Patients were randomly assigned to endovascular thrombectomy plus medical care or medical care alone within 24 hours after onset (178 and 174 patients, respectively). The trial was stopped early for efficacy. The researchers observed a shift in the distribution of modified Rankin scale scores toward better outcomes in favor of thrombectomy (generalized odds ratio, 1.51).

“Together, the trials provide reassuring information from more than a thousand patients with large ischemic strokes in different medical systems that will probably lead to changes in patterns of care delivery,” writes the author of an accompanying editorial.

Several authors from the Huo study disclosed financial ties to the biopharmaceutical and medical device industries, including companies that provided study funding. Several authors from the Sarraj study disclosed ties to biopharmaceutical and medical device companies, including Stryker, which funded the study.

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Hooman Kamel, MD, from Weill Cornell Medicine in New York City, and colleagues compared anticoagulation to antiplatelet therapy for secondary stroke prevention in a multicenter trial involving 1015 participants with cryptogenic stroke and evidence of atrial cardiopathy. At the time of randomization, participants had no evidence of atrial fibrillation. Participants were randomly allocated to receive apixaban (5mg or 2.5mg) twice daily or aspirin (81mg) once daily (507 and 508 patients, respectively).

After a planned interim analysis, the trial was stopped for futility after enrollment of 1015 of the target 1100 participants and at a mean follow-up of 1.8 years. The researchers found that recurrent stroke occurred in 40 patients in both groups (annualized rate, 4.4% in both groups). Symptomatic intracranial hemorrhage occurred in zero and seven patients taking apixaban and aspirin, respectively (annualized rate, 1.1% for patients taking aspirin); other major hemorrhages occurred in five patients in both groups (annualized rates, 0.7 and 0.8% for those taking apixaban and aspirin, respectively).

“Oral anticoagulant therapy with apixaban did not significantly reduce the risk of recurrent stroke compared with aspirin,” the authors write.

The BMS-Pfizer Alliance provided the in-kind study drug, and Roche Diagnostics provided ancillary funding for laboratory supplies.

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HealthDay News — Considerable racial differences are seen in the treatment of common poststroke sequelae, according to a study presented at the American Stroke Association International Stroke Conference, held from February 8 to 10 in Dallas.

Kent P. Simmonds, DO, PhD, from the University of Texas Southwestern Medical Center in Dallas, and colleagues used electronic medical record data from 65 large health care organizations to identify a cohort of non-Hispanic White (NHW), Black, and Hispanic hospitalized acute stroke patients. The final cohort included 428,155 patients, including 309,029 NHW; 82,564 Black; and 28,375 Hispanic patients. The NHW-Black comparison included 80,564 propensity-matched pairs and the NHW-Hispanic comparison included 28,375 propensity-matched pairs. Outcomes included medication use for treatment of arousal, spasticity, mood, sleep, bladder incontinence, and seizure, measured at 14, 90, and 365 days.

The researchers found that Black patients were significantly less likely to receive treatment for every condition at nearly every time point compared with NHW patients. The differences were largest for treatment of arousal, spasticity, and mood at 14 days (relative risk, 0.70, 0.73, and 0.83, respectively). For NHW-Hispanic comparisons, differences were similar with slightly smaller magnitudes.

“Stroke may have a devastating impact on an individual’s quality of life, and I think we owe it to our patients to do what we can to improve their level of function and quality of life after a stroke,” Simmonds said in a statement.

One author disclosed ties to the medical device industry.

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HealthDay News — Dual antiplatelet therapy (DAPT) is underused following transient ischemic attack (TIA) and minor acute ischemic stroke (AIS), particularly in women, according to a study presented at the annual American Stroke Association International Stroke Conference, held from February 8 to 10 in Dallas.

Jonathan Solomonow, MD, from the University of Maryland Medical Center in Baltimore, and colleagues examined variations in single vs dual antiplatelet prescribing practices at the time of discharge within the University of Maryland Stroke Clinical Network consisting of nine stroke centers located in rural, suburban, and urban hospitals. The analysis included 2953 adults with a TIA or a minor AIS (admission National Institutes of Health Stroke Scale score <5), who were admitted to the network from 2018 through 2021.

The researchers found that DAPT was prescribed at the time of discharge to 40% of patients overall. However, gender was a significant factor, with men more likely to get prescribed DAPT than women (43 vs 37%). Body mass index (BMI) did not have a lone effect on number of antiplatelets prescribed, but when it was included as a covariate, there was a significant effect seen on the number of antiplatelets prescribed. Higher BMI was associated with a lower likelihood of receiving DAPT. Differences were not significant for age, race, or whether or not the patient was discharged from a tertiary center.

“All stroke survivors, regardless of sex, should receive optimal proven medications for stroke prevention, including DAPT when medically appropriate,” Solomonow said in a statement. “Identifying systemic inequities is essential to improving patient care across all demographics.”

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HealthDay News — Direct oral anticoagulant (DOAC) treatment is noninferior to low-molecular-weight heparin (LMWH) for preventing recurrent venous thromboembolism (VTE) in cancer patients, according to a study published online June 2 in the Journal of the American Medical Association to coincide with the annual meeting of the American Society of Clinical Oncology, held from June 2 to 6 in Chicago.

Deborah Schrag, MD, from the Memorial Sloan Kettering Cancer Center in New York City, and colleagues assessed the effectiveness of DOACs (335 patients) vs LMWH (336 patients) for preventing recurrent VTE in patients with cancer (any invasive solid tumor, lymphoma, multiple myeloma, or chronic lymphocytic leukemia) over 6 months.

The researchers found that rates of recurrent VTE were 6.1% in the DOAC group vs 8.8% in the LMWH group (difference, −2.7%), consistent with the prespecified noninferiority criterion. None of the six prespecified secondary outcomes were significantly different between the groups. Major bleeding did not meet the noninferiority criterion, as it occurred in 5.2% of the DOAC group vs 5.6% of the LMWH group (difference, −0.4%; 1-sided 95% CI, –100% to 2.5%). Severe adverse events occurred in 33.8% and 35.1% of the groups, respectively. Anemia and death were the most common serious adverse events reported.

“These findings support use of a DOAC to prevent recurrent VTE in patients with cancer,” the authors write.

Several authors disclosed ties to the pharmaceutical industry.

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HealthDay News — Atopic dermatitis (AD) in adulthood is associated with an increased risk for venous thromboembolism (VTE), according to a study published online May 31 in JAMA Dermatology.

Tai-Li Chen, MD, from Taipei Veterans General Hospital in Taiwan, and colleagues examined the risk for incident VTE among patients with AD. The analysis included 284,858 matched participants (142,429 participants with AD newly diagnosed between 2003 and 2017).

The researchers found that 0.7% of participants in the AD group and 0.6% in the non-AD cohort developed VTE, with incidence rates of 1.05 and 0.82 per 1000 person-years, respectively. Compared with adults without AD, adults with AD had a significantly increased risk for incident VTE (hazard ratio, 1.28). Specifically, AD was associated with higher risks for deep vein thrombosis (hazard ratio, 1.26) and pulmonary embolism (hazard ratio, 1.30).

“The results of this cohort study suggest that AD in adulthood is associated with an increased risk of VTE; however, the absolute risk difference of VTE between adults with and without AD appears small,” the authors write. “Nevertheless, cardiovascular examination and imperative management may be considered for adults with AD who present with symptoms suggestive of VTE. Future research is warranted to elucidate the pathophysiology underlying the association between AD and VTE.”

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(HealthDay News) — For 6 cardiovascular diseases (CVDs) examined, coverage of evidence-based medications varies by low-cost generic program (LCGP), drug, and condition, according to a study published online Sept. 5 in the Annals of Internal Medicine.

Ivy T. Ton, PharmD, from the Western University of Health Sciences in Pomona, California, and colleagues examined LCGPs’ coverage of evidence-based CVD medications in a cross-sectional study of 19 publicly available LCGPs in March and April 2023 in the United States. The proportion of LCGPs that offered evidence-based CVD medicines for 6 CVDs was examined according to 4 metrics (breadth, choice, high-quality evidence, and titratability).

The researchers found variation in the availability of CVD medication by program, drug, and CVD condition. Some of the programs had greater breadth and choice of coverage for most CVDs, while many had more focused coverage, and limited offerings were provided by others.

Angiotensin-converting enzyme inhibitors, β-blockers, thiazides, and moderate-intensity statins were offered by nearly all LCGPs, while lower availability was seen for higher-cost or lower-use generics, including antiplatelets and antiarrhythmics. For atrial fibrillation and heart failure, core pharmacotherapy coverage and choices were limited, while for hypertension and hyperlipidemia, they were widely available.

“Medication coverage in LCGPs varies widely for core, evidence-based CVD medications in all CVD conditions investigated, with differences in medication coverage options and strengths by program and condition,” the authors write. “Health care professionals should consider medication availability and LCGP-specific characteristics when recommending their use.”

One author disclosed ties to the pharmaceutical industry and one to the medical device industry.

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Treatment with bempedoic acid, an adenosine triphosphate-citrate lyase inhibitor, reduces the risk of major adverse cardiovascular events (MACE) among statin-intolerant patients compared with placebo, according to phase 3 study data presented at the American College of Cardiology’s Annual Scientific Session & Expo together with the World Congress of Cardiology.

Bempedoic acid is currently marketed under the brand name Nexletol^®, and in combination with ezetimibe, under the brand name Nexlizet^®. Both Nexletol and Nexlizet are indicated as adjuncts to diet and maximally tolerated statin therapy, in patients with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular (CV) disease who require additional lowering of low-density lipoprotein cholesterol (LDL-C).

The randomized, double-blind, placebo-controlled phase 3 CLEAR Outcomes trial (ClinicalTrials.gov Identifier: NCT02993406) included 13,970 adult patients with or at high risk for CV disease with documented statin intolerance (inability to tolerate 2 or more statins, 1 at a low dose) and elevated LDL-C levels (fasting blood LDL-C ≥100 [2.6 mmol/L]).

Patients were randomly assigned 1:1 to receive either bempedoic acid 180mg orally once daily or placebo. The primary endpoint was the time to first occurrence of MACE, defined as CV death, nonfatal myocardial infarction (MI), nonfatal stroke, or coronary revascularization.

Compared with placebo, the incidence of a primary endpoint event was found to be significantly lower with bempedoic acid (11.7% vs 13.3%; hazard ratio [HR], 0.87 [95% CI, 0.79-0.96]; P =.004). Bempedoic acid was also associated with significant reductions in risk for the composite of CV death, nonfatal stroke, or nonfatal MI (8.2 vs 9.5% for placebo; HR, 0.85 [95% CI, 0.76-0.96]; P =.006), fatal or nonfatal MI (3.7% vs 4.8% for placebo; HR, 0.77 [95% CI, 0.66-0.91]; P =.002), and coronary revascularization (6.2% vs 7.6% for placebo; HR, 0.81 [95% CI, 0.72-0.92]; P =.001).

As for safety, the incidences of gout (3.1%) and cholelithiasis (2.2%) were higher with bempedoic acid compared with placebo (2.1% and 1.2%, respectively). Small increases in serum creatinine, uric acid, and liver enzymes were also reported more frequently with bempedoic acid.

“These results are practice changing and exceed our expectations,” said Sheldon Koenig, president and CEO of Esperion. “We expect applicable treatment guidelines to be updated quickly which will then lead to a paradigm shift in patient care. Based upon the strength of the data and the clinical significance they represent, we will be filing with the FDA and EMA by June 2023 and anticipate receipt of expanded CV risk reduction labels in 1H 2024 that will more than double the addressable treatment population for Nexletol and Nexlizet.”

References

1. Landmark CLEAR Outcomes study demonstrates Nexletol^® (bempedoic acid) Tablet is the only LDL-C lowering therapy since statins to reduce hard ischemic events in a broad population of both primary prevention and secondary prevention patients. News release. Esperion. March 4, 2023. Accessed March 6, 2023. https://www.globenewswire.com/news-release/2023/03/04/2620613/0/en/Landmark-CLEAR-Outcomes-Study-Demonstrates-NEXLETOL-bempedoic-acid-Tablet-is-the-Only-LDL-C-Lowering-Therapy-Since-Statins-to-Reduce-Hard-Ischemic-Events-in-a-Broad-Population-of-B.html.
2. Nissen SE, Lincoff AM, Brennan D, et al. Bempedoic acid and cardiovascular outcomes in statin-intolerant patients. N Engl J Med. Esperion. Published online March 4, 2023. doi:10.1056/NEJMoa2215024

HealthDay News — For patients with a first unprovoked venous thromboembolism (VTE), indefinite anticoagulation prevents some recurrent VTE events but induces additional major bleeding events, according to a study published online June 27 in the Annals of Internal Medicine.

Faizan Khan, PhD, from the University of Calgary in Canada, and colleagues estimated the benefit-harm tradeoffs of indefinite anticoagulation in patients with a first unprovoked VTE who completed 3 to 6 months of initial anticoagulant treatment.

The researchers found that in a hypothetical cohort of 1000 patients aged 55 years, indefinite anticoagulation prevented 368 recurrent VTE events, including 14 fatal pulmonary emboli in the base-case analysis, but induced 114 major bleeding events, including 30 intracranial hemorrhages and 11 deaths from bleeding. The cost of indefinite anticoagulation was $16,014 (in Canadian dollars) more per person, and did not increase quality-adjusted life years. In the sensitivity analysis, during extended anticoagulation, the model results were most sensitive to the case-fatality rate of major bleeding and the annual risk for major bleeding.

“Continuing versus discontinuing anticoagulation indefinitely in all (that is, unselected) patients with a first unprovoked VTE has little chance of improving life expectancy but might provide a mortality benefit in certain subgroups,” the authors write.

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HealthDay News — A bivalent mRNA COVID-19 vaccine after receipt of an original monovalent COVID-19 vaccine is effective for preventing COVID-19-related thromboembolic events, according to research published in the January 11 issue of the US Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.

Amanda B. Payne, PhD, from the CDC in Atlanta, and colleagues estimated the incremental benefit of receipt of a bivalent mRNA COVID-19 vaccine after receipt of an original monovalent COVID-19 vaccine. Two retrospective cohort studies were conducted among Medicare fee-for-service enrollees during September 4, 2022, to March 4, 2023, to estimate the vaccine effectiveness (VE) of a bivalent mRNA COVID-19 dose for preventing thromboembolic events vs original monovalent COVID-19 doses only.

The researchers found that the effectiveness of a bivalent mRNA COVID-19 vaccine dose vs the original vaccine alone against COVID-19-related thromboembolic events was 47 and 51% among Medicare enrollees aged 65 years and older and among adults aged 18 years and older with end stage renal disease receiving dialysis, respectively. Among Medicare beneficiaries who were immunocompromised, VE was similar: 46 and 45% among adults aged 65 years and older and those aged 18 years and older with end-stage renal disease, respectively.

“To prevent COVID-19-related complications, including thromboembolic events, adults should stay up to date with recommended COVID-19 vaccination,” the authors write.

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HealthDay News — Miscuffing results in inaccurate blood pressure (BP) measurements, according to a study published online August 7 in JAMA Internal Medicine.

Junichi Ishigami, MD, MPH, from the Johns Hopkins Bloomberg School of Public Health in Baltimore, and colleagues examined the effects of using a regular BP cuff vs an appropriately sized BP cuff on automated BP readings in a randomized crossover trial of community-dwelling adults. A total of 195 adults underwent four sets of triplicate BP measurements, using an appropriate, too-small, or too-large BP cuff in random order, followed by a fourth set with an appropriate BP cuff. The difference in mean BP when measured with a regular BP cuff compared to an appropriate BP cuff was assessed as the primary outcome.

The researchers found that use of a regular BP cuff resulted in a statistically significantly lower BP reading among those requiring a small BP cuff (mean systolic BP difference, −3.6 mm Hg). In contrast, use of a regular BP cuff resulted in a statistically significantly higher BP reading among individuals requiring a large or extra-large cuff (mean systolic BP difference, 4.8 and 19.5 mm Hg, respectively). Among those requiring larger BP cuffs, BP differences with overcuffing and undercuffing by 1 and 2 cuff sizes were higher.

“Using a regular BP cuff size for all individuals regardless of arm size resulted in strikingly inaccurate BP readings,” the authors write. “A renewed emphasis on individualized BP cuff selection is warranted, particularly in individuals with larger arm sizes.”

One author disclosed ties to the pharmaceutical industry.

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