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Bloodstream Infection Rates in Patients with Pulmonary Arterial Hypertension Treated with Epoprostenol for Injection (Veletri®): A Prospect Registry Analysis

Robert Frantz


Murali Chakinala


Robyn Barst


Robert Schilz


Kelly Chin


Anna Hemnes


D. Miller

W. Benton

B. K. Hartline

Harrison Farber


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Conference: 2013 PH Professional Network Symposium

Release Date: 09.28.2013

Presentation Type: Abstracts

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Bloodstream Infection Rates in Patients with Pulmonary ArterialHypertension Treated with Epoprostenol for Injection (Veletri®): A Prospect Registry Analysis


R. Frantz, MD1; M. Chakinala, MD2; R. Barst, MD*3; R. Schilz, DO, PhD4; K. Chin, MD5; A. Hemnes, MD6; D. Miller, MS7; W. Benton,PharmD8; B. Hartline, MD8; H. Farber, MD9

1Mayo Clinic, Rochester, Minn.; 2Washington University School of Medicine, St. Louis, Mo.; 3Columbia University College of Physicians andSurgeons, New York, N.Y.; 4University Hospitals of Cleveland, Cleveland, Ohio; 5UT Southwestern Medical Center, Dallas, Texas; 6VanderbiltUniversity School of Medicine, Nashville, Tenn.; 7ICON Late Phase & Outcomes Research, San Francisco, Calif.; 8Actelion Pharmaceuticals US, Inc.,South San Francisco, Calif.; 9Boston University School of Medicine, Boston, Mass.


PURPOSE: The aim of this study was to determine bloodstream infection (BSI) rates using data from the PROSPECT registry.BACKGROUND: The PROSPECT Registry is a multicenter, observational, US registry evaluating the use of epoprostenol for injection with arginine(Veletri®, Epo-A), offering expanded storage capacity and prolonged room temperature stability in patients with pulmonary arterial hypertension(PAH). PROSPECT includes patients currently receiving, being initiated on, or transitioning from other prostacyclin (PGI2) analog therapy to Epo-A,with follow-up at 1 year from enrollment. Patients with PAH receiving intravenous (IV) therapy are at increased risk of BSIs; however, it is not clearwhether BSI risk with IV PAH therapy is affected by prior PAH therapy.METHOD: BSI rates were determined in the first 300 WHO Grp I Prospect patients enrolled from 45 treatment centers.

FINDINGS: The complete patient cohort had 5 distinct patient groups: 48 who never received a PAH-specific drug (naïve); 74 who never receivedPGI2 or a PGI2 analog (PGI2-naïve); 142 who transitioned from IV epoprostenol (Flolan® or its generic equivalent) (IV-epo-transitioned); 7 who transitioned from IV or subcutaneous (SC) treprostinil (IV/SC-trep-transitioned); and 25 who transitioned from an inhaled PGI2 analog [iloprost ortreprostinil] (inhaled-transitioned). Four patients had insufficient medical history data to be classified as naïve or transitioned. At enrollment, mean± SD age was 50.0 ± 14.6 years, 74.6% were female, 49.3% had idiopathic PAH, 24.2% had connective tissue disease associated with PAH,and PAH duration was 4.9 ± 5.0 years. The follow-up duration was 5.6 ± 4.1 months and 54.0% of patients completed the 6-month assessmentperiod. Twelve BSIs occurred in 10 patients (rate of 0.25 per 1000 patient-days), of which 4 were Gram-negative (1 Enterobacter cloacae; 2 other;1 unknown), 5 Gram-positive (4 Staphylococcus aureus; 1 other), and 3 other/unknown. These BSIs resulted in 11 hospitalizations but no deaths.Naïve, PGI2-naïve, and inhaled-transitioned patients had slightly higher BSI rates than IV-epo-transitioned patients (2 (4.2%) naïve, 5 (6.8%)PGI2-naïve, 4 (2.8%) IV-epo-transitioned, and 2 (8%) inhaled-transitioned patients). Overall, BSI rates associated with Epo-A were similar to thosepreviously documented in patients with PAH receiving parenteral therapy. Gram-negative infections did not predominate.

IMPLICATIONS: Advanced PAH may necessitate initiation or transition to IV Epo-A. The current analysis demonstrated that the BSI ratesassociated with patients on IV Epo-A were similar to those previously reported in PAH patients receiving parenteral therapy. Gram-negativeinfections did not predominate. Naïve, PGI2-naïve, and inhaled-transitioned patients had slightly higher BSI rates than IV Epo-A-transitionedpatients.

 

*The authors are saddened to report the passing of Robyn J. Barst, MD in April 2013. She was an esteemed physician, investigator, and colleague.Her research focused extensively on pulmonary hypertension and she was a distinguished leader in the field of pediatric pulmonary hypertension.Dr. Barst’s contributions to the field are invaluable.


*This study was sponsored by Actelion Pharmaceuticals US, Inc.