Tracy Minichiello, MD
Does adding catheter-directed thrombolysis (CDT) to usual care reduce the postthrombotic syndrome (PTS) in patients with acute iliofemoral deep venous thrombosis (DVT)?
Randomized controlled trial (Catheter-directed Venous Thrombolysis [CaVenT] study). ClinicalTrials.gov NCT00251771, EudraCT 2005-114486-42.
Blinded* (outcome assessors).
20 hospitals in Norway.
209 patients 18 to 75 years of age (mean age 52 y, 63% men based on 189 patients) who had objectively verified DVT in the upper half of the thigh, common iliac vein, or combined iliofemoral segment, and symptom duration ≤ 21 days. Exclusion criteria included anticoagulant treatment for more than the past 7 days; contraindications to treatment; indications for thrombolytic treatment (e.g., phlegmasia cerulea dolens); severe anemia or thrombocytopenia; severe renal failure; severe hypertension; history of subarachnoid or intracerebral bleeding; pregnancy or thrombosis ≤ 7 days postpartum; < 14 days after surgery or trauma; life expectancy < 24 months; former ipsilateral proximal DVT; cancer needing chemotherapy; and thrombolytic treatment ≤ 7 days before trial inclusion.
CDT with alteplase plus usual care (n = 101) or usual care alone (low-molecular-weight heparin [LMWH] and warfarin followed by warfarin alone to a target international normalized ratio of 2.0 to 3.0) (n = 108). In the CDT group, LMWH was discontinued for ≥ 8 hours before CDT and reintroduced with warfarin after completion of CDT. Continuous IV infusion of unfractionated heparin was given with CDT (target-activated partial thromboplastin time 1.2 to 1.7 times the upper normal limit). All patients were advised to wear knee-high elastic compression stockings daily for 24 months.
Primary outcomes were iliofemoral patency after 6 months and frequency of PTS (Villalta scale score ≥ 5 or presence of a venous ulcer) at 24 months.
90% at 24 months (intention-to-treat analysis).
The main results are in the Table.
In patients with acute iliofemoral deep venous thrombosis, adding catheter-directed thrombolysis to usual care reduced the postthrombotic syndrome at 24 months.
Catheter-directed thrombolysis (CDT) plus usual care vs usual care in patients with acute deep venous thrombosis†
†Abbreviations defined in Glossary. RRR, RBI, NNT, and CI calculated from event rates in article.
‡Based on 183 patients.
Minichiello T. Catheter-directed thrombolysis reduced the postthrombotic syndrome in acute iliofemoral DVT. Ann Intern Med. 2012;156:JC6–6. doi: 10.7326/0003-4819-156-12-201206190-02006
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Published: Ann Intern Med. 2012;156(12):JC6-6.
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