Bloodstream Infection Rates in Patients With Pulmonary Arterial Hypertension Treated With Epoprostenol for Injection: A PROSPECT Registry Analysis.

SESSION TYPE: Pulmonary Hypertension IPRESENTED ON: Sunday, October 21, 2012 at 10:30 AM - 11:45 AMPURPOSE: Patients with pulmonary arterial hypertension (PAH) receiving IV therapy are at increased risk of bloodstream infections (BSIs). We determined BSI rates in the first 300 patients enrolled in the registry to PROSPECTively evaluate use of epoprostenol for injection (Veletri®, EFI) in PAH patients.METHODS: PROSPECT is an ongoing, multicenter, observational, US registry following patients with PAH for 1 year who are currently receiving, initiating, or transitioning from other PAH prostacyclin analogs to EFI. BSI rates were determined in the first 300 patients enrolled from 45 treatment centers.RESULTS: The complete patient cohort had 5 distinct patient groups: 48 never received a PAH-specific drug (naïve); 74 never received prostacyclin or a prostacyclin analog (prostacyclin-naïve); 142 transitioned from Flolan® or its generic equivalent (IV-epoprostenol-transitioned); 7 transitioned from IV or SC treprostinil (IV/SC-trep-transitioned); 25 transitioned from inhaled prostacyclin analog (iloprost or treprostinil; 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 six-month assessment period. 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. BSIs occurred in naïve (n=2), prostacyclin-naïve (n=5), IV-epoprostenol-transitioned (n=4), and inhaled-transitioned (n=2) patients.CONCLUSIONS: BSI rates associated with patients on EFI were similar to those previously documented in PAH patients receiving parenteral therapy. Gram-negative infections did not predominate. Naïve, prostacyclin-naïve, and inhaled-transitioned patients had slightly higher BSI rates than IV-epoprostenol-transitioned patients.CLINICAL IMPLICATIONS: Advanced PAH may necessitate initiation or transition to EFI. In either scenario, EFI use does not appear to increase the risk of BSI.DISCLOSURE: Robert Frantz: Consultant fee, speaker bureau, advisory committee, etc.: Dr. Frantz has been in consultancy relationships with Actelion, Gilead, and United Therapeutics without personal financial gain , Grant monies (from industry related sources): Dr Frantz has grants or grants pending with Actelion, Gilead, and United TherapeuticsMurali Chakinala: Grant monies (from industry related sources): Dr Chakinala receives research support from Actelion, Gilead, United Therapeutics, Novartis, Bayer, and Lilly, Consultant fee, speaker bureau, advisory committee, etc.: Dr Chakinala is a consultant for and/or receives honoraria from Actelion, Gilead, United Therapeutics, and NovartisRobyn Barst: Consultant fee, speaker bureau, advisory committee, etc.: Dr Barst serves as a consultant for Actelion, Bayer, GSK, GeneraMedix, Gilead, Eli Lilly and Co., MondoBIOTECH, NIH/NHLBI, Novartis, and PfizerRobert Schilz: Consultant fee, speaker bureau, advisory committee, etc.: Dr Schilz serves as consultant and speaker for Actelion, Gilead, United Therapeutics; serves as consultant for Bayer, Grant monies (from industry related sources): Dr Schilz receives research support from Actelion, Bayer, Gilead, Novartis, and United TherapeuticsKelly Chin: Grant monies (from industry related sources): Dr Chin's institution has received research grants from Actelion, Bayer, Gilead, GlaxoSmithKline, Novartis, United Therapeutics, GeNO and the NIH, Consultant fee, speaker bureau, advisory committee, etc.: Dr Chin has served on advisory boards for Actelion, Gilead and BayerAnna Hemnes: Grant monies (from industry related sources): Dr Hemnes has received research funding from NIH, Pfizer, and Actelion, Consultant fee, speaker bureau, advisory committee, etc.: Dr Hemnes has served as a consultant for United Therapeutics, Pfizer, and GileadDave Miller: Other: Dave Miller is employed by ICON Late Phase & Outcomes Research, a company which receives research funding from Actelion and other pharmaceutical companiesWade Benton: Employee: Wade Benton is an employee of Actelion, which funds the PROSPECT registryBrian Hartline: Employee: Brian Hartline is an employee of Actelion,which funds the PROSPECT registryHarrison Farber: Consultant fee, speaker bureau, advisory committee, etc.: Dr Farber has served as a consultant for Gilead, Actelion, United Therapeutics, Novartis, BMS, and Bayer; has been on advisory committees for Gilead, Actelion, and United Therapeutics; and has been a speaker for Actelion and Gilead, Grant monies (from industry related sources): Dr Farber has received research support from Gilead and United TherapeuticsNo Product/Research Disclosure InformationMayo Clinic, Rochester, MN.