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ISCVT

Prognosis of Cerebral Vein and Dural Sinus Thrombosis: Results of the International Study on Cerebral Vein and Dural Sinus Thrombosis

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Year of Publication: 2004

Authors: José M. Ferro, Patrícia Canhão, Jan Stam, ..., for the ISCVT Investigators

Journal: Stroke

Citation: Stroke. 2004;35:664-670.

Link: http://www.strokeaha.org

PDF: https://www.ahajournals.org/doi/epub/10....117571.76197.26

Clinical Question

What is the long-term prognosis and what clinical variables predict death or dependence in adult patients with cerebral vein and dural sinus thrombosis?

Bottom Line

CVT prognosis is better than previously reported: at median 16-month follow-up, 79% achieved complete recovery (mRS 0-1) and only 13.4% were dead or dependent. Eight independent predictors of poor outcome identified: age >37 (HR 2.0), male sex (HR 1.6), coma (HR 2.7), mental status disorder (HR 2.0), intracranial hemorrhage (HR 1.9), deep venous thrombosis (HR 2.9), CNS infection (HR 3.3), and cancer (HR 2.9). 30-day case fatality was only 3.4%.

        Major Points
        79% achieved complete recovery (mRS 0-1) at median 16-month follow-up; only 13.4% dead or dependent.
30-day case fatality 3.4% (21/624); total deaths 8.3% (52/624); 44% of late deaths from underlying conditions, not CVT.
8 independent predictors: age >37 (HR 2.0), male sex (HR 1.6), coma/GCS <9 (HR 2.7), mental status disorder (HR 2.0), ICH on admission (HR 1.9), deep venous system thrombosis (HR 2.9), CNS infection (HR 3.3), cancer (HR 2.9).
Isolated intracranial hypertension is favorable: only 7% dead/dependent (HR 0.45; P<0.05).
Seizures in 10.6%, other thrombotic events 4.3%, recurrent CVT 2.2% during follow-up.
Multiple risk factors in 43.6%; thrombophilia 34.1%, oral contraceptives 54.3% of women <50; no risk factor in 12.5%.
83.3% received therapeutic anticoagulation (heparin/LMWH); nonsignificant trend toward benefit (HR 0.73; 95% CI 0.44-1.21).
CVT predominantly affects young women: mean age 39, 74.5% female.
Past CVT not a contraindication to future pregnancy: 61.7% of 34 post-CVT pregnancies uneventful.
Largest prospective CVT cohort: 624 patients, 89 centers, 21 countries, 98.7% follow-up.

      

Design

Study Type: Multinational, multicenter, prospective observational cohort

Randomization:

Blinding: None (observational)

Enrollment Period: May 1998 to May 2001

Follow-up Duration: Median 16 months (mean 18.6±11.1)

Centers: 89

Countries: 21 countries across Europe, Latin America, North America, Asia, Australia

Sample Size: 624

Analysis: Kaplan-Meier + Cox regression (primary); logistic regression backward method (secondary). SPSS 11.0.

Inclusion Criteria

Age ≥15 years.
Symptomatic CVT (cerebral vein and/or dural sinus thrombosis).
Diagnosis confirmed by angiography, CT venography, MRI+MRV, surgery, or autopsy.
Consecutive patients at participating centers.
Commitment to ≥6-month follow-up.

Exclusion Criteria

Age <15 years.
No formal exclusion criteria listed beyond age.

Baseline Characteristics

All Patients (N=624):

Mean age (range): 39.1 (16-86)
Female: 465 (74.5%)
White: 492 (79.2%)
Onset acute (<48h): 232 (37.2%)
Onset subacute: 346 (55.5%)
Headache: 553 (88.8%)
Any seizure: 245 (39.3%)
Any paresis: 232 (37.2%)
Stupor or coma: 87 (13.9%)
Papilledema: 174 (28.3%)
CT/MRI hemorrhage: 245 (39.3%)
CT/MRI infarct: 290 (46.5%)
Superior sagittal sinus: 313 (62.0%)
Lateral sinus L: 279 (44.7%)
Lateral sinus R: 257 (41.2%)
Deep venous system: 68 (10.9%)
Straight sinus: 112 (18.0%)
Oral contraceptives (women <50): 207 (54.3%)
Thrombophilia: 213 (34.1%)
Puerperium (women <50): 53 (13.8%)
Malignancy: 46 (7.4%)
Infection: 77 (12.3%)
No risk factor identified: 78 (12.5%)
>1 risk factor: 272 (43.6%)
Therapeutic anticoagulation: 520 (83.3%)
Antiepileptic drugs: 277 (44.4%)

Arms

Field	Observational cohort
Intervention	Prospective registry. Treatment per local physician: 83.3% therapeutic anticoagulation (64.2% IV heparin, 34.9% SC LMWH), 2.1% local thrombolysis, 1.4% decompressive surgery. Median oral anticoagulation post-discharge: 231 days.
Duration	Median 16 months follow-up

Outcomes

Outcome	Type	Control	Intervention	P-value
Death or dependence (mRS >2) at last follow-up	Primary	—	84/624 (13.4%)	—
Complete recovery (mRS 0-1)	Secondary		493/624 (79.0%)
Death at 30 days	Secondary		21/624 (3.4%)
Death at last follow-up	Secondary		52/624 (8.3%)
Recurrent CVT	Secondary		14/624 (2.2%)
Other thrombotic events	Secondary		27/624 (4.3%)
Seizures during follow-up	Secondary		66/624 (10.6%)
Severe headache	Secondary		88/624 (14.1%)
Severe visual loss	Secondary		4/624 (0.6%)
Complete recovery (mRS 0)	Adverse		356/624 (57.1%)
Minor residual symptoms (mRS 1)	Adverse		137/624 (22.0%)
Mild impairment (mRS 2)	Adverse		47/624 (7.5%)
Moderate impairment (mRS 3)	Adverse		18/624 (2.9%)
Severely handicapped (mRS 4 or 5)	Adverse		14/624 (2.2%)
Death	Adverse		52/624 (8.3%)
Observational study - no systematic AE reporting	Adverse		Multinational prospective observational cohort

Subgroup Analysis

Isolated intracranial hypertension: only 7% dead/dependent (HR 0.45; 95% CI 0.23-0.87). Therapeutic anticoagulation: dead/dependent 12.7% vs 18.3% (HR 0.73; 95% CI 0.44-1.21, NS). Post-CVT pregnancies: 61.7% uneventful (34 women).

Criticisms

No central imaging review — local interpretation.
No uniform etiological workup — thrombophilia screening recommended but not mandated.
No uniform treatment protocol — physician discretion.
Possible underestimation of severity (most investigators were neurologists, may have missed severe ICU cases).
Limited Africa/Asia representation.
Children (<15) excluded.
Observational design — anticoagulation benefit trend (HR 0.73) not significant.

Funding

PRAXIS grant C/SAU/10248/1998, Fundação para a Ciência e Tecnologia (Portugal).

Based on: ISCVT (Stroke, 2004)

Authors: José M. Ferro, Patrícia Canhão, Jan Stam, ..., for the ISCVT Investigators

Citation: Stroke. 2004;35:664-670.

Content summarized and formatted by NeuroTrials.ai.

ISCVT

(2004)

Objective

To characterize the prognosis, risk factors, and outcomes of cerebral vein and dural sinus thrombosis in a large, international prospective cohort.

Study Summary

• Most patients with CVT recover well, but 13% experience death or dependency. Identified predictors of poor outcome include coma, intracranial hemorrhage, deep venous thrombosis, CNS infection, and malignancy.

Intervention

Prospective observational study. Patients were treated per local practice, including anticoagulation with IV heparin or LMWH in most cases. Follow-up at 6 months and annually up to median of 16 months.

Inclusion Criteria

Patients aged ≥15 years with symptomatic CVT confirmed by imaging, enrolled from 89 centers in 21 countries between 1998–2001, with ≥6 months of follow-up.

Study Design

Arms: Single Arm: Observational Cohort

Patients per Arm: 624

Outcome

• Death or dependency (mRS ≥2) at last follow-up: 13.4%.• Death at follow-up: 8.3%; at 30 days: 3.4%.• Recurrent CVT: 2.2%.• Other thrombotic events: 4.3%.• Seizures: 10.6%; severe headache: 14.1%; severe visual loss: 0.6%.• Predictors of poor outcome: coma (HR 2.65), age >37 (HR 2.00), male sex (HR 1.59), mental status changes (HR 1.95), ICH on imaging (HR 1.88), deep venous thrombosis (HR 2.92), CNS infection (HR 3.34), malignancy (HR 2.90).

Bottom Line

Major Points

79% achieved complete recovery (mRS 0-1) at median 16-month follow-up; only 13.4% dead or dependent.
30-day case fatality 3.4% (21/624); total deaths 8.3% (52/624); 44% of late deaths from underlying conditions, not CVT.
8 independent predictors: age >37 (HR 2.0), male sex (HR 1.6), coma/GCS <9 (HR 2.7), mental status disorder (HR 2.0), ICH on admission (HR 1.9), deep venous system thrombosis (HR 2.9), CNS infection (HR 3.3), cancer (HR 2.9).
Isolated intracranial hypertension is favorable: only 7% dead/dependent (HR 0.45; P<0.05).
Seizures in 10.6%, other thrombotic events 4.3%, recurrent CVT 2.2% during follow-up.
Multiple risk factors in 43.6%; thrombophilia 34.1%, oral contraceptives 54.3% of women <50; no risk factor in 12.5%.
83.3% received therapeutic anticoagulation (heparin/LMWH); nonsignificant trend toward benefit (HR 0.73; 95% CI 0.44-1.21).
CVT predominantly affects young women: mean age 39, 74.5% female.
Past CVT not a contraindication to future pregnancy: 61.7% of 34 post-CVT pregnancies uneventful.
Largest prospective CVT cohort: 624 patients, 89 centers, 21 countries, 98.7% follow-up.

Study Design

Study Type: Multinational, multicenter, prospective observational cohort
Randomization: No
Blinding: None (observational)
Sample Size: 624
Follow-up: Median 16 months (mean 18.6±11.1)
Centers: 89
Countries: 21 countries across Europe, Latin America, North America, Asia, Australia

Primary Outcome

Definition: Death or dependence (mRS >2) at last follow-up

Control	Intervention	HR/OR	P-value
—	84/624 (13.4%)	- (—)	—

Limitations & Criticisms

No central imaging review — local interpretation.
No uniform etiological workup — thrombophilia screening recommended but not mandated.
No uniform treatment protocol — physician discretion.
Possible underestimation of severity (most investigators were neurologists, may have missed severe ICU cases).
Limited Africa/Asia representation.
Children (<15) excluded.
Observational design — anticoagulation benefit trend (HR 0.73) not significant.

Citation

Stroke. 2004;35:664-670.

View Original Publication →

ISCVT

Prognosis of Cerebral Vein and Dural Sinus Thrombosis: Results of the International Study on Cerebral Vein and Dural Sinus Thrombosis

Clinical Question

Bottom Line

Major Points

Design

Inclusion Criteria

Exclusion Criteria

Baseline Characteristics

Arms

Outcomes

Subgroup Analysis

Criticisms

Funding

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