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January 1, 2003Pathophysiology of Haemostasis and Thrombosis

Patients with trial-excluding comorbidities had significantly higher rates of fatal pulmonary embolism (OR 3.3, 95% CI 2.5-5.2), major bleeding (OR 3.1, 95% CI 2.3-4.1), and fatal bleeding (OR 4.1, 95% CI 2.1-8.0) at 3 months.

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Why the study?

Do patients with acute VTE and trial-excluding comorbidities have worse clinical outcomes compared to those without such comorbidities?

Population

6,855 consecutively enrolled patients with objectively confirmed, symptomatic acute venous thromboembolism…

Comparison

Presence of at least one co-morbidity that would… vs Patients without trial-excluding co-morbidities.

Design

Cohort

Follow-up

3 months

Authors

MMManuel MonréalCSCarmen SuárezJFJ. A. González Fajardo

Discussion

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Overview

Comorbid VTE patients show higher fatal PE and bleeding rates; leaves open whether trial results generalize to real-world populations.

Key Points

  • To compare three-month clinical outcomes of acute venous thromboembolism therapy between patients with comorbidities that typically exclude them from randomized trials and those without such conditions.
  • Analyzed 6,855 consecutively enrolled patients with objectively confirmed, symptomatic acute venous thromboembolism from the Spanish RIETE registry.
  • Identified patients with trial exclusion criteria, including recent bleeding, renal insufficiency, thrombocytopenia, abnormal prothrombin time, or pregnancy, and followed all cohorts for 3 months.
  • Nearly one-quarter of patients (24%, n=1,635/6,855) met clinical trial exclusion criteria, most frequently renal insufficiency (13.6%) and abnormal prothrombin time (9.1%).
  • Trial-ineligible patients had significantly higher rates of fatal pulmonary embolism (OR: 3.3; 95% CI: 2.5–5.2), minor bleeding (OR: 1.8; 95% CI: 1.3–2.2), major bleeding (OR: 3.1; 95% CI: 2.3–4.1), and fatal bleeding (OR: 4.1; 95% CI: 2.1–8.0) compared to the remaining 5,220 patients.

Structured PICO

Do patients with acute VTE and trial-excluding comorbidities have worse clinical outcomes compared to those without such comorbidities?

P
Population
6,855 consecutively enrolled patients with objectively confirmed, symptomatic acute venous thromboembolism (VTE) from the Spanish RIETE registry.
I
Intervention
Presence of at least one co-morbidity that would typically exclude the patient from clinical trials (recent bleeding, renal insufficiency, thrombocytopenia, abnormal prothrombin time, or pregnancy) (n=1,635).
C
Comparator
Patients without trial-excluding co-morbidities (n=5,220).
O
Outcome
Clinical outcomes during the first 3 months of therapy, including fatal pulmonary embolism, minor bleeding, major bleeding, and fatal bleeding.hard clinical

Real-world patients with acute VTE who have comorbidities typically excluding them from clinical trials experience significantly higher rates of fatal pulmonary embolism and bleeding events.

Cite This Study

Monréal et al. (2003) studied this question.

synapsesocial.com/papers/6a8ba641c716e89f35deee9fhttps://doi.org/10.1159/000083823
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Rationale, Design and Methodology of the Computerized Registry of Patients with Venous Thromboembolism (RIETE)2018 · 228 citations
  2. 2VTE Registry: What Can Be Learned from RIETE?2014 · 28 citations
  3. 3Clinical outcome of patients with major bleeding after venous thromboembolism2008 · 92 citations
  4. 4Clinical outcome of patients with venous thromboembolism and renal insufficiency2007 · 67 citations
  5. 5Venous thromboembolism characteristics and outcomes among RIETE patients tested and untested for inherited thrombophilia2024 · 11 citations