Effect of tailoring anticoagulant treatment duration by applying a recurrence risk prediction model in patients with venous thromboembolism compared to usual care: A randomized controlled trial
Abstract:Background Patients with unprovoked (i.e., without the presence of apparent transient risk factors such as recent surgery) venous thromboembolism (VTE) are at risk of recurrence if anticoagulants are stopped after 3-6 months, yet their risk remains heterogeneous. Thus, prolonging anticoagulant treatment should be considered in high-risk patients, whereas stopping is likely preferred in those with a low predicted risk. The Vienna Prediction Model (VPM) could aid clinicians in estimating this risk, yet its clini… Show more
“…Of the 26 included studies, 12,26–49 14 were RCTs and 12 were prospective cohort studies with a total of 15 603 patients with a first unprovoked or weakly provoked VTE who, after having completed at least 3 months of initial anticoagulant treatment, received extended anticoagulation (Table 1). The duration of initial anticoagulant treatment was exclusively 3 months in 12 studies (Table 1).…”
Background
The long‐term risk for recurrent venous thromboembolism (VTE) during extended anticoagulation for a first unprovoked VTE is uncertain.
Objectives
To determine the incidence of recurrent VTE during extended anticoagulation of up to 5 years in patients with a first unprovoked VTE.
Methods
MEDLINE, EMBASE, and the Cochrane CENTRAL were searched to identify randomized trials and prospective cohort studies reporting recurrent VTE among patients with a first unprovoked VTE who were to receive anticoagulation for a minimum of six additional months after completing ≥3 months of initial treatment. Unpublished data on number of recurrent VTE and person‐years, obtained from authors of included studies, were used to calculate study‐level incidence rate, and random‐effects meta‐analysis was used to pool results.
Results
Twenty‐six studies and 15 603 patients were included in the analysis. During 11 631 person‐years of follow‐up, the incidence of recurrent VTE and fatal pulmonary embolism per 100 person‐years was 1.41 (95% CI, 1.03–1.84) and 0.09 (0.04–0.16), with 5‐year cumulative incidences of 7.1% (3.0%–13.2%) and 1.2% (0.4%–4.6%), respectively. The incidence of recurrent VTE was 1.08 (95% CI, 0.77–1.44) with direct oral anticoagulants and 1.55 (1.01–2.20) with vitamin K antagonists. The case‐fatality rate of recurrent VTE was 4.9% (95% CI, 2.2%–8.7%).
Conclusions
In patients with a first unprovoked VTE, the long‐term risk of recurrent VTE during extended anticoagulation is low but not negligible. Thus, clinicians and patients should be aware of this risk and take appropriate and timely action in case of suspicion of recurrent VTE. Estimates from this study can be used to advise patients on what to expect while receiving extended anticoagulation, and estimate the net clinical benefit of extended treatment to guide long‐term management of unprovoked VTE.
“…Of the 26 included studies, 12,26–49 14 were RCTs and 12 were prospective cohort studies with a total of 15 603 patients with a first unprovoked or weakly provoked VTE who, after having completed at least 3 months of initial anticoagulant treatment, received extended anticoagulation (Table 1). The duration of initial anticoagulant treatment was exclusively 3 months in 12 studies (Table 1).…”
Background
The long‐term risk for recurrent venous thromboembolism (VTE) during extended anticoagulation for a first unprovoked VTE is uncertain.
Objectives
To determine the incidence of recurrent VTE during extended anticoagulation of up to 5 years in patients with a first unprovoked VTE.
Methods
MEDLINE, EMBASE, and the Cochrane CENTRAL were searched to identify randomized trials and prospective cohort studies reporting recurrent VTE among patients with a first unprovoked VTE who were to receive anticoagulation for a minimum of six additional months after completing ≥3 months of initial treatment. Unpublished data on number of recurrent VTE and person‐years, obtained from authors of included studies, were used to calculate study‐level incidence rate, and random‐effects meta‐analysis was used to pool results.
Results
Twenty‐six studies and 15 603 patients were included in the analysis. During 11 631 person‐years of follow‐up, the incidence of recurrent VTE and fatal pulmonary embolism per 100 person‐years was 1.41 (95% CI, 1.03–1.84) and 0.09 (0.04–0.16), with 5‐year cumulative incidences of 7.1% (3.0%–13.2%) and 1.2% (0.4%–4.6%), respectively. The incidence of recurrent VTE was 1.08 (95% CI, 0.77–1.44) with direct oral anticoagulants and 1.55 (1.01–2.20) with vitamin K antagonists. The case‐fatality rate of recurrent VTE was 4.9% (95% CI, 2.2%–8.7%).
Conclusions
In patients with a first unprovoked VTE, the long‐term risk of recurrent VTE during extended anticoagulation is low but not negligible. Thus, clinicians and patients should be aware of this risk and take appropriate and timely action in case of suspicion of recurrent VTE. Estimates from this study can be used to advise patients on what to expect while receiving extended anticoagulation, and estimate the net clinical benefit of extended treatment to guide long‐term management of unprovoked VTE.
“…In doing the assessment, we focused on randomization and masking. Some of the trials [51][52][53] gave the reason why they did not use masking for its difficulty or its nature of the intervention, and some would be not influenced by non-masking [54][55][56] . Masking was also related to study design (i.e.…”
The evidence of the impact of traditional statistical (TS) and artificial intelligence (AI) tool interventions in clinical practice was limited. This study aimed to investigate the clinical impact and quality of randomized controlled trials (RCTs) involving interventions evaluating TS, machine learning (ML), and deep learning (DL) prediction tools. A systematic review on PubMed was conducted to identify RCTs involving TS/ML/DL tool interventions in the past decade. A total of 65 RCTs from 26,082 records were included. A majority of them had model development studies and generally good performance was achieved. The function of TS and ML tools in the RCTs mainly included assistive treatment decisions, assistive diagnosis, and risk stratification, but DL trials were only conducted for assistive diagnosis. Nearly two-fifths of the trial interventions showed no clinical benefit compared to standard care. Though DL and ML interventions achieved higher rates of positive results than TS in the RCTs, in trials with low risk of bias (17/65) the advantage of DL to TS was reduced while the advantage of ML to TS disappeared. The current applications of DL were not yet fully spread performed in medicine. It is predictable that DL will integrate more complex clinical problems than ML and TS tools in the future. Therefore, rigorous studies are required before the clinical application of these tools.
“…Inclusion and exclusion criteria were applied and only relevant research regarding our research question were considered. A total of 31 articles were kept (Figure 1 ) [ 10 - 40 ].…”
Section: Reviewmentioning
confidence: 99%
“…Ultimately, 31 articles were included in this review of which were primarily focused on standard anticoagulation therapies using VKAs, LMWH, warfarin, etc. and another 14 were primarily focused on factor Xa inhibitors, NOACs, or DOACs; six other articles were using mixed therapies or therapies not previously mentioned [ 10 - 40 ].…”
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