TY - JOUR
T1 - Treprostinil Administered to Treat Pulmonary Arterial Hypertension Using a Fully Implantable Programmable Intravascular Delivery System
T2 - Results of the DelIVery for PAH Trial
AU - Bourge, Robert C.
AU - Waxman, Aaron B.
AU - Gomberg-Maitland, Mardi
AU - Shapiro, Shelley M.
AU - Tarver, James H.
AU - Zwicke, Dianne L.
AU - Feldman, Jeremy P.
AU - Chakinala, Murali M.
AU - Frantz, Robert P.
AU - Torres, Fernando
AU - Cerkvenik, Jeffrey
AU - Morris, Marty
AU - Thalin, Melissa
AU - Peterson, Leigh
AU - Rubin, Lewis J.
N1 - Publisher Copyright:
© 2016 The Authors
PY - 2016/7/1
Y1 - 2016/7/1
N2 - Background The use of systemic prostanoids in severe pulmonary arterial hypertension (PAH) is often limited by patient/physician dissatisfaction with the delivery methods. Complications associated with external pump-delivered continuous therapy include IV catheter-related bloodstream infections and subcutaneous infusion site pain. We therefore investigated a fully implantable intravascular delivery system for treprostinil infusion. Methods A multicenter, prospective, single-arm, clinical trial (DelIVery for Pulmonary Arterial Hypertension) was conducted by using an implantable intravascular delivery system. The implanted pumps were refilled percutaneously at least every 12 weeks. The primary end point was the rate of catheter-related complications using the new model 10642 catheter compared with a predefined objective performance criterion of 2.5 per 1,000 patient-days based on the literature. Results Patients (n = 60) with severe PAH (World Health Organization group 1) receiving a stable dose of IV treprostinil for at least 4 weeks received an implant device and were followed up for 12.1 ± 4.4 months. Six catheter-related complications occurred, corresponding to a complication rate of 0.27 per 1,000 patient-days. The 97.5% upper one-sided confidence bound of 0.59 was less than the predefined criterion of 2.5 per 1,000 patient-days (P <.0001). Plasma treprostinil levels at 1 week postimplantation were highly correlated with baseline levels (r = 0.91; P <.0001). The delivery system management time as reported by the patients was 2.5 ± 1.7 hours per week preimplantation, and this time decreased to 0.6 ± 0.8 hour per week at 6 months’ postimplantation (P <.0001). All patients rated overall satisfaction with the implantable system as good, very good, or excellent at 6 weeks and 6 months. There were no catheter-related bloodstream infections or catheter occlusions. Conclusions The implantable intravascular delivery system delivered treprostinil to patients with PAH with a low rate of catheter-related complications and a high rate of patient satisfaction. Trial Registry ClinicalTrials.gov; No.: NCT01321073; URL: www.clinicaltrials.gov
AB - Background The use of systemic prostanoids in severe pulmonary arterial hypertension (PAH) is often limited by patient/physician dissatisfaction with the delivery methods. Complications associated with external pump-delivered continuous therapy include IV catheter-related bloodstream infections and subcutaneous infusion site pain. We therefore investigated a fully implantable intravascular delivery system for treprostinil infusion. Methods A multicenter, prospective, single-arm, clinical trial (DelIVery for Pulmonary Arterial Hypertension) was conducted by using an implantable intravascular delivery system. The implanted pumps were refilled percutaneously at least every 12 weeks. The primary end point was the rate of catheter-related complications using the new model 10642 catheter compared with a predefined objective performance criterion of 2.5 per 1,000 patient-days based on the literature. Results Patients (n = 60) with severe PAH (World Health Organization group 1) receiving a stable dose of IV treprostinil for at least 4 weeks received an implant device and were followed up for 12.1 ± 4.4 months. Six catheter-related complications occurred, corresponding to a complication rate of 0.27 per 1,000 patient-days. The 97.5% upper one-sided confidence bound of 0.59 was less than the predefined criterion of 2.5 per 1,000 patient-days (P <.0001). Plasma treprostinil levels at 1 week postimplantation were highly correlated with baseline levels (r = 0.91; P <.0001). The delivery system management time as reported by the patients was 2.5 ± 1.7 hours per week preimplantation, and this time decreased to 0.6 ± 0.8 hour per week at 6 months’ postimplantation (P <.0001). All patients rated overall satisfaction with the implantable system as good, very good, or excellent at 6 weeks and 6 months. There were no catheter-related bloodstream infections or catheter occlusions. Conclusions The implantable intravascular delivery system delivered treprostinil to patients with PAH with a low rate of catheter-related complications and a high rate of patient satisfaction. Trial Registry ClinicalTrials.gov; No.: NCT01321073; URL: www.clinicaltrials.gov
KW - central venous catheters
KW - drugs
KW - health-related quality of life
KW - pulmonary arterial hypertension
KW - pulmonary hypertension
KW - treprostinil
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U2 - 10.1016/j.chest.2015.11.005
DO - 10.1016/j.chest.2015.11.005
M3 - Article
C2 - 27396777
AN - SCOPUS:84990020922
SN - 0012-3692
VL - 150
SP - 27
EP - 34
JO - Chest
JF - Chest
IS - 1
ER -