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Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT) Initial Results From a Prospective Multicenter Registry

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Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT) Initial Results From a Prospective Multicenter Registry CHEST Kuo, W. T., Banerjee, A., Kim, P. S., DeMarco, F. J., Levy, J. R., Facchini, F. R., Unver, K., Bertini, M. J., Sista, A. K., Hall, M. J., Rosenberg, J. K., de Gregorio, M. A. 2015; 148 (3): 667-673

Abstract

Systemic thrombolysis for acute PE carries up to a 20% risk of major bleeding, including a 2-5% risk of hemorrhagic stroke. We evaluated the safety and effectiveness of catheter-directed therapy (CDT) as an alternative treatment for acute PE.One hundred one consecutive patients receiving CDT for acute PE were prospectively enrolled in a multicenter registry. Massive PE (n=28) and submassive PE (n=73) were treated with immediate catheter-directed mechanical or pharmacomechanical thrombectomy and/or catheter-directed thrombolysis via low-dose hourly drug infusion with tPA or urokinase. Clinical success was defined as meeting all criteria: stabilization of hemodynamics, improvement in pulmonary hypertension and/or right heart strain, and survival to hospital discharge. Primary safety outcomes were major procedure-related complications and major bleeding events.There were 53 men and 48 women with average age of 60 years (range, 22-86 years) and mean BMI of 31.03±7.20 kg/m2. The average thrombolytic doses were 28.0±11 mg tPA (n=76) and 2,697,101±936,287 IU for urokinase (n=23). Clinical success was achieved in 24/28 (85.7%)(95% CI, 67.3%-96.0%) patients with massive PE and 71/73 (97.3%)(95% CI, 90.5%-99.7%) with submassive PE. The mean PA pressure improved from 51.17±14.06 mmHg to 37.23±15.81 mmHg (n=92)(P<0.0001). Among patients monitored with follow-up echocardiography, 57/64 (89.1%)(95% CI, 78.8%-95.5%)(p<0.0001) showed improvement in right heart strain. There were no major procedure-related complications, no major hemorrhages, and no hemorrhagic strokes.Catheter-directed therapy improves clinical outcomes in acute PE patients while minimizing the risk of major bleeding. At experienced centers, CDT is a safe and effective treatment for both acute massive and submassive PE.NCT01097928, available at http://clinicaltrials.gov/show/NCT01097928.

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