Thrombosis Update最新文献

Introduction

Replacement therapy with intravenous (IV) protein C concentrate (Ceprotin®; Baxalta US Inc., a Takeda company, Lexington, MA, USA; Takeda Manufacturing Austria AG, Vienna, Austria) is an approved treatment approach for patients with severe congenital protein C deficiency (SCPCD). Data on the real-world use of protein C concentrate are limited.

Materials and methods

In this non-interventional real-world study, physicians in Europe and the United States (US) with experience using protein C concentrate to treat patients with SCPCD completed an internet-based survey. Information collected included physician clinical practice details, experience treating patients with SCPCD, and opinions on the subcutaneous (SC) administration of protein C concentrate. Physicians responded based on their best recall.

Results

The analysis included 19 physicians (Europe, n = 12; US, n = 7) who had used protein C concentrate to treat 32 patients with SCPCD. Sixteen patients received IV long-term prophylaxis (LTP; treatment duration ≥3 months) and 12 received SC LTP. Five patients received both IV and SC LTP. Eighteen physicians indicated an interest in adding SC administration to the approved administration routes.

Conclusion

This survey shows that LTP with IV protein C concentrate is used in clinical practice by physicians in both Europe and the US for the treatment of patients with SCPCD. Protein C concentrate is also prescribed for SC administration by some physicians in Europe. Although only approved for IV administration, physicians in both Europe and the US indicated an interest in SC administration being an approved administration route for protein C concentrate.

Aims

The identification of venous thromboembolism (VTE) using administrative databases is frequently required for reporting and research. The accuracy of International Classification of Diseases 10th revision (ICD-10) codes for VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE), remains unclear. We examined the accuracy of ICD-10 codes for identifying VTE in adult and pediatric inpatients and outpatients.

Methods

For this systematic review and meta-analysis, we searched MEDLINE, EMBASE, Web of Science, CENTRAL, Epistemonikos and McMaster Superfilters from inception to July 25, 2023 for studies evaluating the sensitivity, specificity, positive predictive value (PPV), and/or negative predictive value (NPV) of ICD-10 codes for VTE in any anatomical location. We assessed risk of bias using QUADAS and certainty of evidence using GRADE. We calculated pooled sensitivity and specificity with 95% confidence intervals (CI) using a random-effects model.

Results

We included 24 studies in the qualitative synthesis and 7 in the meta-analysis. Pooled sensitivity for any VTE based on ICD-10 codes was 72% (95% CI 60–85%, low certainty); pooled specificity was 82% (95% CI 76–88%, low certainty). The PPV for ICD-10 VTE codes ranged from 0% to 100% (median: 80%) while the NPV ranged from 95.4% to 100% (median: 100%). ICD-10 codes for PE had a higher pooled sensitivity (91%) than for DVT (58%).

Conclusion

ICD-10 codes have moderate-to-high sensitivity and specificity for the identification of VTE in electronic databases. The certainty of evidence is low due to inconsistency and risk of bias. Further robust studies validating ICD-10 VTE codes are needed to improve reporting and better understand coding limitations.

Introduction

For patients with mechanical aortic valves, guideline recommended INR targets range from 2.0 to 3.5, depending on thromboembolic risk factors. Supporting data is largely historical and of low quality. We aimed to characterize clinicians’ practices around INR targets for these patients and perceptions of evidence supporting these recommendations.

Methods

A 33-question web-based survey was sent to 75 cardiologists, cardiac surgeons, and thrombosis specialists globally. We inquired about anticoagulation practices for patients with mechanical aortic valves, perceptions of guideline recommendations, and interest in participating in a randomized controlled trial comparing lower and higher INR targets in these patients.

Results

Of 55 respondents (73% response rate), 78% worked in academic hospitals. In patients with mechanical aortic valve and no additional thromboembolic risk factors, 80% targeted an INR of 2.5. Among patients with additional thromboembolic risk factors, 48% targeted an INR of 2.5, while 44% targeted an INR of 3.0. Additionally, 57% of respondents believed that evidence for the guidelines was up to date, and 53% believed that it applied to bi-leaflet valves.

However, 57% of respondents said that the evidence was not high quality. Lastly, 66% of respondents would accept a higher thromboembolic risk to reduce risk of major bleeding; 86% were willing to randomize patients with mechanical aortic valve to a target INR of 2.0 if they had no thromboembolic risk factors.

Conclusion

Clinicians target different INRs for patients with mechanical aortic valves; their perception of the evidence and guidelines varies. Of respondents, 86% would randomize patients to lower INR targets.

Aim

The risk of venous thromboembolism (VTE) and arterial thrombosis events (ATE) and potential corresponding risk factors were assessed in patients with cancer diagnosed with COVID-19.

Methods

Adults with cancer treated in community health systems who were diagnosed with COVID-19 in 2020 were evaluated for absolute risk (risk) of ATE and VTE. Thrombotic events were ascertained in the 90-day window starting with COVID-19 diagnosis (index). ICD codes defined baseline comorbidities, COVID-19, and thrombotic events.

Results

7591 patients were included with median age of 67, 6% with cardiovascular disease (CVD), 4% with prior VTE, and 24% were hospitalized at index. Risk of ATE and VTE were 2.1% (95%CI: 1.8, 2.5) and 3.2% (95%CI: 2.8, 3.6), respectively. Patients with CVD had increased risk [ATE: 20.1% (95%CI: 16.7, 24.1); VTE: 4.9% (95%CI: 3.3, 7.3)] as did patients with prior VTE [ATE: 3.8% (95%CI: 2.2, 6.6; VTE: 20.5% (95%CI: 16.4, 25.3)] and patients hospitalized with ventilator support [(ATE: 5.7% (95%CI: 2.6, 11.8; VTE: 6.6% (95%CI: 3.2, 13.0)]. Incidence rates for ATE and VTE were 0.094 and 0.141 per person-year, respectively.

Conclusions

This study of cancer patients, conducted in a time period prior to vaccine availability, found patients with CVD, prior VTE, and with higher severity of COVID-19 were at increased risk for ATE and VTE. Identifying patients most at risk can help to target interventions.

Objective

The purpose of our study was to examine risk factors for venous thromboembolism (VTE) and VTE associated mortality in elderly acute lymphocytic leukemia (ALL) patients receiving different treatment options.

Methods

We analyzed data from the United States SEER-Medicare database (2007–2015) for patients ≥65 years diagnosed with ALL. Data were stratified by treatment options into three groups as chemotherapy: the use of antimetabolites, anthracyclines, alkylating agents or vinca alkaloids; other treatment: the use of corticosteroids/tyrosine kinase inhibitors without chemotherapy; and no treatment. Logistic regression was used to examine risk factors for VTE and Cox proportional regression was used to evaluate Hazard Ratios (HRs) for the effect of VTE on mortality in ALL patients.

Results

In a cohort of 1088 elderly ALL patients, 17.4 % patients had a diagnosis of VTE. VTE was diagnosed in 27.7 % of 159 patients who received chemotherapy, 16.2 % of 328 patients who received other treatment, and 15.3 % of 601 patients who did not receive any treatment (p < 0.001). Adjusted odds of VTE were 1.59 (95 % CI, 1.02–2.48) in patients who received chemotherapy, and OR_a = 0.88 (95 % CI, 0.60–1.30) in those who received other treatment, compared to those who did not receive any treatment. VTE was not associated with the risk of death in ALL patients (HR_a = 0.85, 95 % CI, 0.70–1.02).

Conclusion

Our study identified VTE risk factors and the effect of VTE on mortality in elderly ALL patients with and without treatment.