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Reference - CLOTS 3 trial Lancet 2013 Aug 10;382(9891):516, (level 2 [mid-level] evidence)
Patients who are hospitalized and immobile following an acute stroke are at increased risk for deep vein thrombosis (DVT), and most guidelines recommend antithrombotic drugs for DVT prophylaxis in these patients. Mechanical prophylaxis with intermittent pneumatic compression (IPC) is commonly used for surgical patients but its efficacy in patients with stroke (and in medical patients in general) has not been well established. The CLOTS 3 trial evaluated IPC for prevention of DVT in 2,876 patients with acute stroke.
Patients (median age 76 years) with acute stroke within 3 days who were unable to walk to the toilet without help were randomized to IPC for ≥ 30 days vs. no IPC and were followed for 6 months. IPC was applied continuously, except during washing, physical therapy, and during compression duplex ultrasound. Treatment was discontinued early if the patient became independently mobile, was discharged from hospital, declined to continue IPC, or had adverse events. Patients in each group could receive heparin for prophylaxis or treatment at the discretion of treating clinicians. 24% in each group were receiving warfarin or heparin at recruitment or had received thrombolysis (alteplase) for treatment of acute stroke. The primary outcome was any proximal DVT (symptomatic or asymptomatic detected on ultrasound) within 30 days.
Median duration of IPC use was 9 days (only 31% used the device every day). The primary outcome occurred in 8.5% with IPC vs. 12.1% without IPC (p < 0.05, NNT 28). Symptomatic proximal or calf DVTs occurred in 4.6% vs. 6.3% (p = 0.045, NNT 59). The beneficial effects of IPC on DVT rates were similar in subgroup analyses of patients who did or did not receive heparin, warfarin, or alteplase. Rates of prophylactic and therapeutic heparin use after randomization were similar between the IPC and no IPC groups. IPC was also associated with a reduced rate of any DVT at 6 months (16.7% vs. 25.1%, p = 0.001, NNT 12), and with nonsignificant reductions in mortality at 30 days (10.8% vs. 13.1%, p = 0.057) and at 6 months (22.3% vs. 25.1%, p = 0.059). Skin breakdown was more common in the IPC group. There was no significant difference in the rate of falls.
For more information, see the Anticoagulation therapy for acute stroke and Deep vein thrombosis (DVT) prophylaxis for medical patients topic in DynaMed.