title: Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results From a Prospective Multicenter Registry.
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.
  
  
  BACKGROUND
  ClinicalTrials.gov; No.: NCT01097928; URL: www.clinicaltrials.gov.
authors: Division of Vascular and Interventional Radiology, Stanford University Medical Center, Stanford, CA. Electronic address: wkuo@stanford.edu.
authors: William T
authors: WT
authors: Kuo
authors: Division of Vascular and Interventional Radiology, Stanford University Medical Center, Stanford, CA.
authors: Arjun
authors: A
authors: Banerjee
authors: Vascular and Interventional Radiology, Spectrum Medical Group, South Portland, ME.
authors: Paul S
authors: PS
authors: Kim
authors: Critical Care Medicine, Northside Hospital, Cumming, GA.
authors: Frank J
authors: FJ
authors: DeMarco
authors: Vascular and Interventional Radiology, Northside Radiology Associates, Atlanta, GA.
authors: Jason R
authors: JR
authors: Levy
authors: Vascular and Interventional Radiology, Adventist Midwest Health, Hinsdale, IL.
authors: Francis R
authors: FR
authors: Facchini
authors: Division of Vascular and Interventional Radiology, Stanford University Medical Center, Stanford, CA.
authors: Kamil
authors: K
authors: Unver
authors: Vascular and Interventional Radiology, Adventist Midwest Health, Hinsdale, IL.
authors: Matthew J
authors: MJ
authors: Bertini
authors: Division of Interventional Radiology, Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY.
authors: Akhilesh K
authors: AK
authors: Sista
authors: Vascular and Interventional Radiology, Memorial Hospital of South Bend, South Bend, IN.
authors: Michael J
authors: MJ
authors: Hall
authors: Division of Vascular and Interventional Radiology, Stanford University Medical Center, Stanford, CA.
authors: Jarrett K
authors: JK
authors: Rosenberg
authors: Minimally Invasive Techniques Research Group (GITMI), University of Zaragoza, Zaragoza, Spain.
authors: Miguel A
authors: MA
authors: De Gregorio
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002404:Catheterization; D004452:Echocardiography; D017128:Embolectomy; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000000981:diagnostic imaging / Q000628:therapy*; D012042:Registries; D016019:Survival Analysis; D015912:Thrombolytic Therapy / Q000379:methods*; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use; D016896:Treatment Outcome; D014568:Urokinase-Type Plasminogen Activator / Q000627:therapeutic use
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator; D014568:Urokinase-Type Plasminogen Activator