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Chest. 2015 Sep;148(3):667-673. doi: 10.1378/chest.15-0119.

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

Author information

1
Division of Vascular and Interventional Radiology, Stanford University Medical Center, Stanford, CA. Electronic address: wkuo@stanford.edu.
2
Division of Vascular and Interventional Radiology, Stanford University Medical Center, Stanford, CA.
3
Vascular and Interventional Radiology, Spectrum Medical Group, South Portland, ME.
4
Critical Care Medicine, Northside Hospital, Cumming, GA.
5
Vascular and Interventional Radiology, Northside Radiology Associates, Atlanta, GA.
6
Vascular and Interventional Radiology, Adventist Midwest Health, Hinsdale, IL.
7
Division of Interventional Radiology, Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY.
8
Vascular and Interventional Radiology, Memorial Hospital of South Bend, South Bend, IN.
9
Minimally Invasive Techniques Research Group (GITMI), University of Zaragoza, Zaragoza, Spain.

Abstract

BACKGROUND:

Systemic thrombolysis for acute pulmonary embolism (PE) carries up to a 20% risk of major bleeding, including a 2% to 5% risk of hemorrhagic stroke. We evaluated the safety and effectiveness of catheter-directed therapy (CDT) as an alternative treatment of 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 through low-dose hourly drug infusion with tissue plasminogen activator (tPA) or urokinase. Clinical success was defined as meeting all the following criteria: stabilization of hemodynamics; improvement in pulmonary hypertension, right-sided heart strain, or both; and survival to hospital discharge. Primary safety outcomes were major procedure-related complications and major bleeding events.

RESULTS:

Fifty-three men and 48 women (average age, 60 years [range, 22-86 years]; mean BMI, 31.03 ± 7.20 kg/m2) were included in the study. The average thrombolytic doses were 28.0 ± 11 mg tPA (n = 76) and 2,697,101 ± 936,287 International Units for urokinase (n = 23). Clinical success was achieved in 24 of 28 patients with massive PE (85.7%; 95% CI, 67.3%-96.0%) and 71 of 73 patients with submassive PE (97.3%; 95% CI, 90.5%-99.7%). The mean pulmonary artery pressure improved from 51.17 ± 14.06 to 37.23 ± 15.81 mm Hg (n = 92) (P < .0001). Among patients monitored with follow-up echocardiography, 57 of 64 (89.1%; 95% CI, 78.8%-95.5%; P < .0001) showed improvement in right-sided heart strain. There were no major procedure-related complications, major hemorrhages, or hemorrhagic strokes.

CONCLUSIONS:

CDT improves clinical outcomes in patients with acute PE while minimizing the risk of major bleeding. At experienced centers, CDT is a safe and effective treatment of both acute massive and submassive PE.

TRIAL REGISTRY:

ClinicalTrials.gov; No.: NCT01097928; URL: www.clinicaltrials.gov.

PMID:
25856269
DOI:
10.1378/chest.15-0119
[Indexed for MEDLINE]

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