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Observational Study
. 2015 Feb;147(2):484-494.
doi: 10.1378/chest.14-1004.

Hospitalization and survival in patients using epoprostenol for injection in the PROSPECT observational study

Robert P Frantz  1 , Robert J Schilz  2 , Murali M Chakinala  3 , David B Badesch  4 , Adaani E Frost  5 , Vallerie V McLaughlin  6 , Robyn J Barst  7 , Daniel M Rosenberg  8 , Dave P Miller  9 , Brian K Hartline  10 , Wade W Benton  10 , Harrison W Farber  11
Affiliations
Observational Study

Hospitalization and survival in patients using epoprostenol for injection in the PROSPECT observational study

Robert P Frantz et al. Chest. 2015 Feb.

Abstract

Background: Few studies have prospectively reported outcomes in patients with pulmonary arterial hypertension (PAH) treated with epoprostenol in the modern-day era of oral therapy and combination treatments. The Registry to Prospectively Describe Use of Epoprostenol for Injection (Veletri, prolonged room temperature stable-epoprostenol [RTS-Epo]) in Patients with Pulmonary Arterial Hypertension (PROSPECT) was established to prospectively describe the course of PAH in patients prescribed RTS-Epo.

Methods: PROSPECT is a multicenter, US-based drug registry of primarily group 1 patients with PAH treated with RTS-Epo who were parenteral-naive or parenteral-transitioned at enrollment. Patients were followed until discontinuation of RTS-Epo, withdrawal, loss to follow-up, death, or end of study (maximum 1 year). One-year freedom from hospitalization (FH) and survival estimates were summarized by prostacyclin history (parenteral-naive or parenteral-transitioned), sex, and chronic renal insufficiency (CRI).

Results: A total of 336 patients were included. The overall 1-year FH estimate was 51.0% ± 2.8% and was lower in parenteral-naive patients than parenteral-transitioned patients (42.8% ± 4.3% vs 57.1% ± 3.7%, respectively; P = .002). FH estimates were lower in male patients than female patients (38.3% ± 5.9% vs 54.6% ± 3.2%, respectively; P < .015) and in patients with CRI than patients without CRI (17.0% ± 8.4% vs 53.7% ± 2.9%, respectively; P < .001). The overall 1-year survival estimate was 84.0% ± 2.1%. Survival was poorer in parenteral-naive patients, male patients, and patients with CRI.

Conclusions: Risk of hospitalization and mortality remain high in patients with PAH. In particular, patients who are parenteral-naive at initiation of RTS-Epo therapy, male patients, and patients with CRI require close monitoring and aggressive clinical management.

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Figures

Figure 1 –
Figure 1 –
Rates of on-study hospitalizations* (per 1,000 patient-d) in the PROSPECT cohort by prostacyclin history. *On-study hospitalization defined as those with a date of hospital admission after the date of enrollment into PROSPECT.
Figure 2 –
Figure 2 –
A, B, Freedom from hospitalization at 1 y by prostacyclin history (A) and sex (B).
Figure 3 –
Figure 3 –
A, B, One-y survival by prostacyclin history (A) and sex (B).
See this image and copyright information in PMC

References

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