Apixaban for the prevention of venous thromboembolism in high-risk ambulatory cancer patients receiving chemotherapy: Rational and design of the AVERT trial

Kimpton, Miriam; Wells, Philip S.; Carrier, Marc

doi:10.1016/j.thromres.2018.01.018

Cited by 30 publications

(39 citation statements)

References 35 publications

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“…To determine which patients would receive the most benefit from a preventive strategy, recent studies have used a risk‐stratified approach to study the impact of thromboprophylaxis in higher risk VTE patients based on the Khorana score . The Khorana score is a validated clinical score that stratifies patients into low‐ (0), intermediate‐ (1‐2), and high‐risk (3+) categories based on a combination of cancer and patient characteristics before chemotherapy initiation .…”

Section: Introductionmentioning

confidence: 99%

“…8 To determine which patients would receive the most benefit from a preventive strategy, recent studies have used a risk-stratified approach to study the impact of thromboprophylaxis in higher risk VTE patients based on the Khorana score. [9][10][11] The Khorana score is a validated clinical score that stratifies patients into low-(0), intermediate-(1-2), and high-risk (3+) categories based on a combination of cancer and patient characteristics before chemotherapy initiation. 12 In the current study, we report a systematic literature review and meta-analysis of phase III studies of direct oral anticoagulant (DOAC) vs placebo for the prevention of VTE in the adult, ambulatory cancer patients receiving systemic therapy.…”

Section: Introductionmentioning

confidence: 99%

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Direct oral anticoagulant for the prevention of thrombosis in ambulatory patients with cancer: A systematic review and meta‐analysis

Kuderer

García

et al. 2019

Journal of Thrombosis and Haemostasis

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Background It is unclear if direct oral anticoagulant (DOAC) is efficacious and safe for prophylaxis of venous thromboembolism (VTE) in ambulatory patients with cancer. Methods We performed a systematic review using EMBASE, MEDLINE, and CENTRAL. Inclusion criteria included adult ambulatory patients with cancer, prophylactic use of DOAC, and randomized controlled trials. Exclusion criteria included pediatric patients, inpatient or postoperative setting, therapeutic indication of DOAC, or non‐phase III randomized controlled trial. Two authors screened/reviewed articles and abstracted the data. Meta‐analysis was performed using random‐effects model. Efficacy outcome included overall and symptomatic VTE incidence during the first 6 months. Safety outcomes included major bleeding and clinically relevant non‐major bleeding (CRNMB) incidence during the on‐treatment period. Subgroup analysis was performed for intermediate‐ and high‐risk Khorana score. Results A total of 202 records were identified and 28 full‐text articles were assessed. Two studies with 1415 participants were included for meta‐analysis. For DOAC vs placebo, the relative risks for overall and symptomatic VTE incidence by 6 months were 0.56 (0.35‐0.89) and 0.58 (0.29‐1.13), respectively. The relative risks for major bleeding and CRNMB while on‐treatment were 1.96 (0.80‐4.82) and 1.28 (0.74‐2.20), respectively. Patients with high‐risk Khorana score (3+) derived the largest absolute risk reduction of VTE. Conclusions Low‐dose DOAC reduces the rate of overall VTE in higher risk cancer patients starting systemic chemotherapy. It may reduce the rate of symptomatic VTE but increase the likelihood of bleeding.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Direct oral anticoagulant for the prevention of thrombosis in ambulatory patients with cancer: A systematic review and meta‐analysis

Kuderer

García

et al. 2019

Journal of Thrombosis and Haemostasis

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“…16 Moving forward, we believe our findings are particularly relevant in the context of two ongoing trials of thromboprophylaxis-CASSINI and AVERT. 17,18 While both studies are evaluating the benefit of thromboprophylaxis in high-risk patients (defined as KS ≥ 2), the study design of CASSINI introduces a baseline ultrasound prior to randomization whereas AVERT does not. Data from these studies should further clarify the benefit of screening ultrasonography in high-risk cancer patients.…”

Section: Discussionmentioning

confidence: 99%

Implementation of an electronic medical record tool for early detection of deep vein thrombosis in the ambulatory oncology setting

Kunapareddy

Switzer

Jain

et al. 2019

Research and Practice in Thrombosis and Haemostasis

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Background Venous thromboembolism ( VTE ) is a major cause of morbidity, mortality, and hospitalization in cancer patients. Objectives To evaluate the feasibility of an electronic alert to identify and screen at‐risk individuals and gather rates of early detection of deep vein thrombosis ( DVT ). Patients/Methods An alert was built into the electronic medical record based on a validated risk tool (Khorana Score [ KS ]) and outcomes evaluated in an initial silent phase. The alert functioned in real time to warn physicians of high‐risk patients ( KS ≥ 3) and suggested lower extremity screening ultrasonography in a subsequent active phase. Results Of 194 consecutive patients identified as high risk in the silent phase, 14 (7.2%) developed subsequent DVT or pulmonary embolism ( PE ) over 90‐day follow‐up, with a median of 27 days. Mean 90‐day emergency room ( ER ) visits, all‐cause admissions, and length of stay (days) for patients with DVT were 1.2, 1.6, and 9.1 compared to 0.89, 0.93, and 5.1 for all patients, respectively. In the active phase, 197 consecutive alerts met inclusion criteria, and 40 patients (20.3%) received a screening ultrasound. Five (12.5%) had a DVT and were started on therapeutic anticoagulation. Of patients with alerts who had screening deferred, 13 (8.3%) were later diagnosed with DVT (median 50.5 days) and 7 (4.5%) with PE . Conclusion An automated alert may have value in early detection of DVT in high‐risk cancer patients leading to earlier intervention, and could potentially prevent VTE ‐related morbidity.

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“…Our data suggest that ACPC patients undergoing pancreatic cancer surgery have higher VTE risk in the postoperative period and extended thromboprophylaxis should be considered in these patients. Novel thromboprophylaxis strategies in patients with cancer and high VTE risk are currently being explored in two ongoing trials . The effectiveness of direct oral anticoagulants is being studied in these trials and the results may offer a new approach to prevent thrombosis in patients with cancer.…”

Section: Discussionmentioning

confidence: 99%

Postoperative venous thromboembolism and mortality in patients with pancreatic surgery

Majmudar

Quintero

Fuentes

et al. 2019

Journal of Surgical Oncology

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Background and Objectives Pancreatic cancer is strongly associated with thrombosis. We investigated early postoperative venous thromboembolism (PVTE) mortality among patients with pancreatic surgery and compared outcomes in adenocarcinoma pancreatic cancer (ACPC) to non‐adenocarcinoma pancreatic neoplasm (NACPN). Methods We analyzed a prospectively collected database of patients who underwent pancreatic cancer or neoplasm‐related surgery. As NACPN is underrepresented in other studies, we selected NACPN patients and a random sample of ACPC patients. PVTE was defined as VTE occurring within 3 months of surgical intervention. Statistical analysis was performed using Cox proportional hazards regression. Results A total of 441 pancreatic surgery patients were included, with 331 ACPC and 110 NACPN. Median follow‐up was 449 days during which 90 (20.4%) patients developed VTE. PVTE occurred in 53 (12.0%) patients, including 41 (12.4%) ACPC patients and 12 (10.9%) NACPN patients. Those with PVTE had 60% higher mortality rate. A multivariable analysis found that PVTE is an independent predictor of increased mortality (HR Adj, 1.6; 95% CI, 1.1‐2.2; P < .01). The mortality impact was not consistent between ACPC (HR, 3.2; 95% CI, 1.3‐7.9) and NACPN groups (HR, 1.3; 95% CI, 0.9‐1.8). Conclusions Postoperative venous thromboembolism is an independent predictor of increased mortality in pancreatic surgery, specifically in adenocarcinoma pancreatic cancer surgery.

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Apixaban for the prevention of venous thromboembolism in high-risk ambulatory cancer patients receiving chemotherapy: Rational and design of the AVERT trial

Cited by 30 publications

References 35 publications

Direct oral anticoagulant for the prevention of thrombosis in ambulatory patients with cancer: A systematic review and meta‐analysis

Direct oral anticoagulant for the prevention of thrombosis in ambulatory patients with cancer: A systematic review and meta‐analysis

Implementation of an electronic medical record tool for early detection of deep vein thrombosis in the ambulatory oncology setting

Postoperative venous thromboembolism and mortality in patients with pancreatic surgery

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