Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results from a Prospective Multicenter Registry.
Chest. 2015 Apr 9;
Authors: Kuo WT, Banerjee A, Kim PS, DeMarco FJ, Levy JR, Facchini FR, Unver K, Bertini MJ, Sista AK, Hall MJ, Rosenberg JK, DeGregorio MA
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
CLINICAL TRIAL REGISTRATION: NCT01097928, available at http://clinicaltrials.gov/show/NCT01097928.
PMID: 25856269 [PubMed - as supplied by publisher]