PRIORITY-CVT
Early Recanalization in Patients With Cerebral Venous Thrombosis Treated With Anticoagulation
Year of Publication: 2020
Authors: Diana Aguiar de Sousa, MD; Lia Lucas Neto, MD, ..., PhD; José M. Ferro
Journal: Stroke
Citation: Stroke. 2020;51:1174-1181.
Link: https://doi.org/10.1161/STROKEAHA.119.028532
PDF: https://www.ahajournals.org/doi/reader/1...EAHA.119.028532
PDF: Clinical Question
In patients with acute cerebral venous thrombosis (CVT) treated with standard anticoagulation, what is the rate of early venous recanalization, and is it associated with the evolution of brain lesions and clinical outcomes?
Bottom Line
In this prospective cohort study of CVT patients, venous recanalization began within 8 days of starting anticoagulation in the majority of patients (74%). Early recanalization was associated with a significantly lower risk of nonhemorrhagic lesion progression and a higher chance of lesion regression. However, early recanalization status was not significantly associated with headache persistence or functional outcome at 90 days.
Major Points
- PRIORITY-CVT was a multicenter, prospective cohort study including 68 patients with newly diagnosed CVT treated with standard anticoagulation.
- At an early follow-up (day 8), 74% of patients had achieved at least partial recanalization of the thrombosed vessels.
- Early recanalization was associated with a significantly lower risk of worsening of nonhemorrhagic lesions (OR, 0.11; P=0.023) and a higher likelihood of lesion improvement (OR, 8.40; P=0.028).
- Reversal of venous infarction (lesions with cytotoxic edema) was observed in 83% of surviving patients, and all of these patients had shown early venous recanalization.
- There was no significant association between early recanalization and the progression of hemorrhagic lesions, persistence of headache, or functional outcome at 90 days.
Design
Study Type: Multicenter, prospective, cohort study.
Randomization:
Blinding: Not applicable (prospective cohort study).
Enrollment Period: May 2014 to April 2018.
Follow-up Duration: 90 days.
Centers: 5
Countries: Portugal, Mexico
Sample Size: 68
Analysis: Prospective cohort analysis with standardized imaging and clinical assessments at baseline, day 8, and day 90.
Inclusion Criteria
- Adult patients (aged ≥18 years) with a new diagnosis of CVT confirmed by imaging.
- Enrollment within 24 hours of starting therapeutic anticoagulation.
Exclusion Criteria
- Medical comorbidities with high risk of short-term death.
- Other intracranial conditions hindering analysis (e.g., brain tumors).
- Contraindication to anticoagulant therapy.
- Patients undergoing any type of endovascular intervention.
- Contraindication to MRI assessment.
Baseline Characteristics
| Characteristic | Control | Active |
|---|---|---|
| Age (mean) | 40 (±14) years | |
| Female (%) | 82% | |
| ... | Not applicable, single-arm cohort study. | |
| Headache at presentation (%) | 94% | |
| Parenchymal lesions at baseline (%) | 44% | |
| Parenchymal hemorrhage at baseline (%) | 29% | |
| Venous infarction at baseline (%) | 19% | |
| Stupor or coma at baseline (%) | 7% |
Arms
| Field | Standard Anticoagulation |
|---|---|
| Intervention | Therapeutic anticoagulation with heparin (low-molecular-weight heparin or unfractioned heparin) started at diagnosis, followed by oral anticoagulation (primarily vitamin K antagonists). |
| Duration | At least 90 days. |
Outcomes
| Outcome | Type | Control | Intervention | HR / OR / RR | P-value |
|---|---|---|---|---|---|
| Early worsening of nonhemorrhagic lesion, defined as enlargement of a baseline lesion or development of a new lesion on MRI at day 8. This analysis compares patients who achieved early recanalization versus those who did not. | Primary | 63% (5/8) [in patients with no early recanalization] | 16% (3/19) [in patients with early recanalization] | 0.11 | 0.023 |
| Early improvement of non-hemorrhagic lesion at day 8 | Secondary | 25% (2/8) [in patients with no early recanalization] | 74% (14/19) [in patients with early recanalization] | OR 8.40 | 0.028 |
| Favorable functional outcome (mRS 0-1) at 90 days | Secondary | 74% [in patients with partial or no recanalization] | 85% [in patients with full recanalization] | OR 2.0 | 0.30 |
| Headache at 90 days | Secondary | 42% [in patients with partial or no recanalization] | 42% [in patients with full recanalization] | No significant difference | |
| Unfavorable functional outcome (mRS > 1) at 90 days | Adverse | 26% [in patients with partial or no recanalization] | 15% [in patients with full recanalization] | OR 2.0 | 0.30 |
Subgroup Analysis
Younger age was significantly associated with achieving early recanalization (OR, 0.62 per 10-year increase; P=0.035).
Criticisms
- The most severe clinical presentations of CVT were likely underrepresented due to the exclusion of medically unstable patients unable to undergo acute MRI.
- Early imaging reassessment at day 8 was not possible in 7% of the included patients.
- There was a lack of information on the time in therapeutic range for patients treated with vitamin K antagonists.
- The 8-day time point for early assessment was arbitrarily defined.
Funding
Fundação AstraZeneca-Faculdade de Medicina Universidade de Lisboa and D. Manuel de Mello grant, Fundação Amélia de Mello.
Based on: PRIORITY-CVT (Stroke, 2020)
Authors: Diana Aguiar de Sousa, MD; Lia Lucas Neto, MD, ..., PhD; José M. Ferro
Citation: Stroke. 2020;51:1174-1181.
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