External validation or prognostic use of the IMPROVE-DD VTE score to identify hospitalized patients who have COVID-19 and a high risk of thrombosis in the post-discharge period
| Study . | Year . | N . | Type . | Results . | Comments . |
|---|---|---|---|---|---|
| Paz Rios et al10 | 2020 | 184 | Retrospective observational study | Moderate risk for VTE (HR, 5.68; 95% CI, 2.93-11.03; P< .001) and high risk for VTE (HR, 6.22; 95% CI, 3.04-12.71; P< .001) by IMPROVE VTE score had significant association with mortality, 87% sensitivity, and 63% specificity (AUC, 0.752; P< .001). | High risk for VTE by IMPROVE VTE score was associated with thrombotic events (HR, 6.50; 95% CI, 2.72-15.53; P< .001). |
| Spyropoulos et al8 | 2021 | 9407 | Retrospective external validation study | VTE rate was 0.4% for IMPROVE-DD VTE score 0-1 (low risk), 1.3% for score 2-3 (moderate risk), and 5.3% for score ≥4 (high risk). ROC AUC, 0.702. | Of the total population, 45% scored high risk for VTE and 21% scored low risk. IMPROVE-DD discrimination of low risk vs medium risk or high risk showed sensitivity, 0.971; specificity, 0.218; PPV, 0.036; and NPV, 0.996. |
| Goldin et al9 | 2021 | 9407 | Retrospective external validation study | VTE rate was 0.41% for IMPROVE-DD score 0-1 (low risk), 1.21% for score 2-3 (moderate risk), and 5.30% for score ≥4 (high risk). ROC AUC, 0.703. | In all, 45.7% of patients were classified as high risk of VTE, 33.3% moderate risk, and 21.0% low risk. Discrimination of low vs moderate risk or high risk of VTE demonstrated sensitivity, 0.971; specificity, 0.215; PPV, 0.036; and NPV, 0.996. |
| CORE-19 Registry11 | 2021 | 4906 | Prospective registry | IMPROVE-DD VTE model using a cutoff score of ≥4 was an independent predictor of post-discharge thromboembolic outcomes and mortality (OR, 1.51; 95% CI, 1.06-2.14). | Post-discharge anticoagulation was significantly associated with reduction in primary outcomes of major thromboembolism and mortality (OR, 0.54; 95% CI, 0.47-0.81). |
| MICHELLE trial13 | 2021 | 320 | Randomized controlled trial | The primary efficacy outcome occurred in 5 (3%) of 159 patients assigned to rivaroxaban and 15 (9%) of 159 patients assigned to no anticoagulation (relative risk, 0.33; 95% CI, 0.12-0.90; P = .0293). No major bleeding occurred in either study group. | An IMPROVE VTE score of ≥4 or a score of 2-3 with elevated DD (>2 × ULN) was the key enrichment criterium. |
| Study . | Year . | N . | Type . | Results . | Comments . |
|---|---|---|---|---|---|
| Paz Rios et al10 | 2020 | 184 | Retrospective observational study | Moderate risk for VTE (HR, 5.68; 95% CI, 2.93-11.03; P< .001) and high risk for VTE (HR, 6.22; 95% CI, 3.04-12.71; P< .001) by IMPROVE VTE score had significant association with mortality, 87% sensitivity, and 63% specificity (AUC, 0.752; P< .001). | High risk for VTE by IMPROVE VTE score was associated with thrombotic events (HR, 6.50; 95% CI, 2.72-15.53; P< .001). |
| Spyropoulos et al8 | 2021 | 9407 | Retrospective external validation study | VTE rate was 0.4% for IMPROVE-DD VTE score 0-1 (low risk), 1.3% for score 2-3 (moderate risk), and 5.3% for score ≥4 (high risk). ROC AUC, 0.702. | Of the total population, 45% scored high risk for VTE and 21% scored low risk. IMPROVE-DD discrimination of low risk vs medium risk or high risk showed sensitivity, 0.971; specificity, 0.218; PPV, 0.036; and NPV, 0.996. |
| Goldin et al9 | 2021 | 9407 | Retrospective external validation study | VTE rate was 0.41% for IMPROVE-DD score 0-1 (low risk), 1.21% for score 2-3 (moderate risk), and 5.30% for score ≥4 (high risk). ROC AUC, 0.703. | In all, 45.7% of patients were classified as high risk of VTE, 33.3% moderate risk, and 21.0% low risk. Discrimination of low vs moderate risk or high risk of VTE demonstrated sensitivity, 0.971; specificity, 0.215; PPV, 0.036; and NPV, 0.996. |
| CORE-19 Registry11 | 2021 | 4906 | Prospective registry | IMPROVE-DD VTE model using a cutoff score of ≥4 was an independent predictor of post-discharge thromboembolic outcomes and mortality (OR, 1.51; 95% CI, 1.06-2.14). | Post-discharge anticoagulation was significantly associated with reduction in primary outcomes of major thromboembolism and mortality (OR, 0.54; 95% CI, 0.47-0.81). |
| MICHELLE trial13 | 2021 | 320 | Randomized controlled trial | The primary efficacy outcome occurred in 5 (3%) of 159 patients assigned to rivaroxaban and 15 (9%) of 159 patients assigned to no anticoagulation (relative risk, 0.33; 95% CI, 0.12-0.90; P = .0293). No major bleeding occurred in either study group. | An IMPROVE VTE score of ≥4 or a score of 2-3 with elevated DD (>2 × ULN) was the key enrichment criterium. |
AUC, area under the curve; CI, confidence interval; DD, D-dimer; HR, hazard ratio; IMPROVE, International Medical Prevention Registry on Venous Thromboembolism; NPV, negative predictive value; OR, odds ratio; PPV, positive predictive value; ROC, receiver operating characteristic [curve]; ULN, upper limit of normal; VTE, venous thromboembolism.