ARTS: A Large, International Trial of Thromboprophylaxis in Intra-abdominal, Gynecologic, and Urologic Surgery

Violette, Philippe D.; Cartwright, Rufus; Devereaux, P.J.; Gross, Peter L.; Kaukonen, Kirsi‐Maija; Sandset, Per Morten; Kilpeläinen, Tuomas P.; Lavikainen, Lauri I; Sallinen, Ville; Horstia, Saana; Guyatt, Gordon; Tikkinen, Kari A.O.

doi:10.1016/j.euf.2021.08.010

Cited by 4 publications

(3 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…We will remedy this deficit by providing the first procedure and patient risk factor specific summaries for these fields. Our results will directly inform clinicians and guideline developers worldwide, resulting in rationalization of current practice and decrease in both under-and overuse of thromboprophylaxis, resulting finally in better patient outcomes and wiser use of limited resources [72].…”

Section: Discussionmentioning

confidence: 85%

Systematic reviews of observational studies of Risk of Thrombosis and Bleeding in General and Gynecologic Surgery (ROTBIGGS): introduction and methodology

et al. 2021

Self Cite

View full text Add to dashboard Cite

Background Venous thromboembolism (VTE) and bleeding are serious and potentially fatal complications of surgical procedures. Pharmacological thromboprophylaxis decreases the risk of VTE but increases the risk of major post-operative bleeding. The decision to use pharmacologic prophylaxis therefore represents a trade-off that critically depends on the incidence of VTE and bleeding in the absence of prophylaxis. These baseline risks vary widely between procedures, but their magnitude is uncertain. Systematic reviews addressing baseline risks are scarce, needed, and require innovations in methodology. Indeed, systematic summaries of these baseline risk estimates exist neither in general nor gynecologic surgery. We will fill this knowledge gap by performing a series of systematic reviews and meta-analyses of the procedure-specific and patient risk factor stratified risk estimates in general and gynecologic surgeries. Methods We will perform comprehensive literature searches for observational studies in general and gynecologic surgery reporting symptomatic VTE or bleeding estimates. Pairs of methodologically trained reviewers will independently assess the studies for eligibility, evaluate the risk of bias by using an instrument developed for this review, and extract data. We will perform meta-analyses and modeling studies to adjust the reported risk estimates for the use of thromboprophylaxis and length of follow up. We will derive the estimates of risk from the median estimates of studies rated at the lowest risk of bias. The primary outcomes are the risk estimates of symptomatic VTE and major bleeding at 4 weeks post-operatively for each procedure stratified by patient risk factors. We will apply the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to rate evidence certainty. Discussion This series of systematic reviews, modeling studies, and meta-analyses will inform clinicians and patients regarding the trade-off between VTE prevention and bleeding in general and gynecologic surgeries. Our work advances the standards in systematic reviews of surgical complications, including assessment of risk of bias, criteria for arriving at the best estimates of risk (including modeling of the timing of events and dealing with suboptimal data reporting), dealing with subgroups at higher and lower risk of bias, and use of the GRADE approach. Systematic review registration PROSPERO CRD42021234119

show abstract

Section: Discussionmentioning

confidence: 85%

Systematic reviews of observational studies of Risk of Thrombosis and Bleeding in General and Gynecologic Surgery (ROTBIGGS): introduction and methodology

et al. 2021

Self Cite

View full text Add to dashboard Cite

show abstract

“…There is the need for trials that adopt high methodological standards (including blinding) and outcome definitions for venous thromboembolism and bleeding that are clinically relevant and objective. The ARTS (Avoiding Risks of Thrombosis and Bleeding in Surgery) trial will compare thromboprophylaxis with a direct oral anticoagulant (apixaban) versus no anticoagulation (placebo) in patients undergoing intra-abdominal, gynaecological, or urological surgery on symptomatic venous thromboembolism and major bleeding 56. ARTS will help fill the gaps that our review identified.…”

Section: Discussionmentioning

confidence: 99%

“…The ARTS (Avoiding Risks of Thrombosis and Bleeding in Surgery) trial will compare thromboprophylaxis with a direct oral anticoagulant (apixaban) versus no anticoagulation (placebo) in patients undergoing intra-abdominal, gynaecological, or urological surgery on symptomatic venous thromboembolism and major bleeding. 56 ARTS will help fill the gaps that our review identified.…”

Section: Study Implications For Research and Practicementioning

confidence: 99%

Benefits and harms of direct oral anticoagulation and low molecular weight heparin for thromboprophylaxis in patients undergoing non-cardiac surgery: systematic review and network meta-analysis of randomised trials

Marcucci

Etxeandia‐Ikobaltzeta

Yang

et al. 2022

BMJ

View full text Add to dashboard Cite

Objective To systematically compare the effect of direct oral anticoagulants and low molecular weight heparin for thromboprophylaxis on the benefits and harms to patients undergoing non-cardiac surgery. Design Systematic review and network meta-analysis of randomised controlled trials. Data sources Medline, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL), up to August 2021. Review methods Randomised controlled trials in adults undergoing non-cardiac surgery were selected, comparing low molecular weight heparin (prophylactic (low) or higher dose) with direct oral anticoagulants or with no active treatment. Main outcomes were symptomatic venous thromboembolism, symptomatic pulmonary embolism, and major bleeding. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used for network meta-analyses. Abstracts and full texts were screened independently in duplicate. Data were abstracted on study participants, interventions, and outcomes, and risk of bias was assessed independently in duplicate. Frequentist network meta-analysis with multivariate random effects models provided odds ratios with 95% confidence intervals, and GRADE (grading of recommendations, assessment, development, and evaluation) assessments indicated the certainty of the evidence. Results 68 randomised controlled trials were included (51 orthopaedic, 10 general, four gynaecological, two thoracic, and one urological surgery), involving 45 445 patients. Low dose (odds ratio 0.33, 95% confidence interval 0.16 to 0.67) and high dose (0.19, 0.07 to 0.54) low molecular weight heparin, and direct oral anticoagulants (0.17, 0.07 to 0.41) reduced symptomatic venous thromboembolism compared with no active treatment, with absolute risk differences of 1-100 per 1000 patients, depending on baseline risks (certainty of evidence, moderate to high). None of the active agents reduced symptomatic pulmonary embolism (certainty of evidence, low to moderate). Direct oral anticoagulants and low molecular weight heparin were associated with a 2-3-fold increase in the odds of major bleeding compared with no active treatment (certainty of evidence, moderate to high), with absolute risk differences as high as 50 per 1000 in patients at high risk. Compared with low dose low molecular weight heparin, high dose low molecular weight heparin did not reduce symptomatic venous thromboembolism (0.57, 0.26 to 1.27) but increased major bleeding (1.87, 1.06 to 3.31); direct oral anticoagulants reduced symptomatic venous thromboembolism (0.53, 0.32 to 0.89) and did not increase major bleeding (1.23, 0.89 to 1.69). Conclusions Direct oral anticoagulants and low molecular weight heparin reduced venous thromboembolism compared with no active treatment but probably increased major bleeding to a similar extent. Direct oral anticoagulants probably prevent symptomatic venous thromboembolism to a greater extent than prophylactic low molecular weight heparin. Systematic review registration PROSPERO CRD42018106181.

show abstract

Evidence-based Urology: Introduction to Our Series of Articles

Tikkinen¹,

Guyatt²

2021

European Urology Focus

View full text Add to dashboard Cite

ARTS: A Large, International Trial of Thromboprophylaxis in Intra-abdominal, Gynecologic, and Urologic Surgery

Cited by 4 publications

References 9 publications

Systematic reviews of observational studies of Risk of Thrombosis and Bleeding in General and Gynecologic Surgery (ROTBIGGS): introduction and methodology

Systematic reviews of observational studies of Risk of Thrombosis and Bleeding in General and Gynecologic Surgery (ROTBIGGS): introduction and methodology

Benefits and harms of direct oral anticoagulation and low molecular weight heparin for thromboprophylaxis in patients undergoing non-cardiac surgery: systematic review and network meta-analysis of randomised trials

Evidence-based Urology: Introduction to Our Series of Articles

Contact Info

Product

Resources

About