What is the risk of Pulmonary Embolism (PE) in patients with confirmed Deep Vein Thrombosis (DVT)?

From the Guidelines

Yes, there is data on the risk of pulmonary embolism (PE) in patients with confirmed deep vein thrombosis (DVT), with an estimated annualized risk of recurrent PE of 3.3 per 100 patient-years for patients with unprovoked VTE, as reported in the American Society of Hematology 2020 guidelines 1. The risk of PE in patients with DVT is a significant concern, as it can lead to severe morbidity and mortality.

• The annualized risk of recurrent PE is estimated to be 3.3 per 100 patient-years for patients with unprovoked VTE, while the risk of recurrent DVT is estimated to be 4.1 per 100 patient-years 1.
• The risk of PE is higher for proximal DVT compared to distal DVT, with proximal clots carrying a greater risk of PE 1.
• Prompt anticoagulation therapy for DVT significantly reduces the risk of PE development, highlighting the importance of early diagnosis and treatment of DVT to prevent this potentially life-threatening complication 1.
• The American Society of Hematology 2020 guidelines provide evidence-based recommendations for the management of VTE, including the treatment of DVT and PE, and emphasize the importance of individualized treatment approaches to minimize the risk of recurrent VTE and anticoagulant-related bleeding 1.
• Key factors to consider when assessing the risk of PE in patients with DVT include the location and extent of the DVT, the presence of provoking risk factors, and the patient's overall clinical condition 1.

From the FDA Drug Label

The major efficacy outcome in the MAGELLAN trial was a composite endpoint that included asymptomatic proximal deep venous thrombosis (DVT) in lower extremity, symptomatic proximal or distal DVT in the lower extremity, symptomatic non-fatal pulmonary embolism (PE), and death related to venous thromboembolism (VTE) Events from Day 1 to Day 35, mITT analysis setXARELTO 10 mg N=2967 n (%) Enoxaparin 40 mg/placebo N=3057 n (%) RR (95% CI) Primary Composite Endpoint at Day 35131 (4.4%)175 (5.7%)0.77 (0.62,0.96) Symptomatic non-fatal PE10 (0.3)14 (0.5)

The incidence of pulmonary embolism (PE) in patients with confirmed DVT is not directly reported in the study. However, the study does report the incidence of symptomatic non-fatal PE in the overall population, which was 0.3% in the XARELTO 10 mg group and 0.5% in the enoxaparin 40 mg/placebo group 2.

• Key points:
  • The study does not provide direct data on the risk of PE in patients with confirmed DVT.
  • The incidence of symptomatic non-fatal PE in the overall population was reported.
  • The study compared the efficacy of XARELTO 10 mg to enoxaparin 40 mg/placebo in preventing VTE in hospitalized acutely ill medical patients.

From the Research

Risk of Pulmonary Embolism in Patients with Confirmed DVT

• The risk of pulmonary embolism (PE) in patients with confirmed deep vein thrombosis (DVT) is a significant concern, as DVT and PE are two manifestations of venous thromboembolism (VTE) 3.
• Studies have shown that patients with DVT are at a short-term risk of symptomatic or even life-threatening PE, and a long-term risk of post-thrombotic syndrome 4.
• A retrospective analysis of patients undergoing catheter-directed therapy for PE found that 76.6% of patients had concomitant DVT, and 65.0% had proximal DVT 5.
• Another study found that the factors associated with symptomatic PE in DVT patients include proximal DVT, prior PE, obesity, chronic lung disease, and omission of prophylaxis 6.

Incidence of PE in DVT Patients

• The incidence of PE in DVT patients varies depending on the study, but it is estimated that around 10-30% of DVT patients will develop PE 6.
• A study of 5,451 consecutive patients with ultrasound-confirmed DVT found that 639 (11.7%) had symptomatic PE 6.
• Another study found that the rate of DVT and proximal DVT in PE patients receiving catheter-directed therapy were 76.6% and 65.0%, respectively 5.

Predictors of PE in DVT Patients

• The predictors of PE in DVT patients include proximal DVT, prior PE, obesity, chronic lung disease, and omission of prophylaxis 6.
• A study found that previous DVT was the only significant factor associated with the presence of concomitant DVT in PE patients undergoing catheter-directed therapy 5.
• Another study found that age, gender, and body mass index (BMI) were similar in DVT plus PE patients and DVT patients, but chronic lung disease, a personal history of PE, and a family history of DVT or PE were more frequent in DVT plus PE patients 6.