PROSPECT Patient Subgroups and Etiologies: Predictors of Outcomes

Purpose 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 (pts) with pulmonary arterial hypertension (PAH). PROSPECT includes pts currently receiving, being initiated on, or transitioning from other prostacyclin (PGI 2 ) analog therapy to Epo-A with follow-up at 1 year from enrollment. Here, we examine predictors of increased mortality. Methods and Materials Data lock was 17 Sept 2012. We conducted univariate and multivariate analyses of candidate predictors with 331 PROSPECT pts who were either “naive” or “transitioned” according to use of synthetic PGI 2 or PGI 2 analog within 30 days prior to Epo-A initiation. Results Mean (± SD) time from diagnosis to study entry for naive (n = 139) and transitioned (n = 192) pts was 35.7 ± 54.9 and 70.5 ± 56.3 mos, respectively. Mean follow-up was 8 and 9 mos for surviving naive and transitioned pts, respectively; 33% of naive and 37% of transitioned pts completed 1 yr of follow-up. Patients had the following characteristics at Epo-A initiation: age (mean ± SD), 50 ± 15 years; female, 77%; functional class (FC) III, 51%, FC IV, 11%; renal insufficiency, 8%; PAH associated with connective tissue disease (CTD-APAH), 26%. Deaths occurred in 14 naive and 24 transitioned pts. Independent predictors of mortality (multivariate HR [95% CI]) were FC IV (3.51 [1.73, 7.09]; P P = 0.002), and male sex (2.58 [1.36, 4.91]; P = 0.004). Notably, the mean time from PAH diagnosis to study entry (56 ± 58 mos) was not a significant predictor of mortality (HR [95% CI] 1.00 [0.99, 1.00]; P = 0.43). Conclusions Renal insufficiency, male sex, and FC IV are significant independent predictors of mortality in PAH pts who are either prostacyclin naive or transitioned to Epo-A. Future analyses from the ongoing PROSPECT registry may provide further insight into this cohort.