Chest
Volume 123, Issue 5, May 2003, Pages 1583-1588
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Clinical Investigations
PULMONARY HYPERTENSION
Effect of Orally Active Prostacyclin Analogue on Survival in Patients With Chronic Thromboembolic Pulmonary Hypertension Without Major Vessel Obstruction

https://doi.org/10.1378/chest.123.5.1583Get rights and content

Objectives:

This study investigated whether treatment with beraprost sodium (BPS), an orally active prostacyclin analog, improves hemodynamics and survival in patients with peripheral-vessel chronic thromboembolic pulmonary hypertension (CTEPH), for which there is no surgical option.

Background:

Oral administration of BPS has been shown to improve the hemodynamics and prognosis in patients with primary pulmonary hypertension; however, whether BPS has beneficial effects in CTEPH remains unknown.

Methods:

Forty-three patients with peripheral-vessel CTEPH were classified into two groups: patients treated with BPS (BPS group, n = 20) and those without BPS (conventional group, n = 23). Baseline demographic and hemodynamic data did not significantly differ between the two groups.

Results:

BPS therapy improved New York Heart Association functional class in 10 patients (50%) and significantly decreased total pulmonary resistance from 18 ± 6 to 15 ± 8 Wood units (p < 0.05) [mean ± SD]. Sixteen patients died of cardiopulmonary causes in the conventional group during a mean follow-up period of 58 ± 45 months. In contrast, only three patients died of cardiopulmonary causes in the BPS group during a mean follow-up period of 44 ± 30 months. The absence of BPS therapy, elevated total pulmonary resistance, heart rate, and age were independently related to the mortality by Cox proportional hazard analysis. The 1-year, 3-year, and 5-year survival rates for the BPS group were 100%, 85%, and 76%, respectively, compared to 87%, 60%, and 46% in the conventional group.

Conclusions:

This preliminary study suggests that oral administration of BPS may improve hemodynamics and survival in patients with peripheral-vessel CTEPH, for which there is no surgical option.

Section snippets

Study Subjects

We studied 43 patients (16 men and 27 women; mean ± SD age, 54 ± 13 years) with peripheral-vessel CTEPH that was not suitable for surgical pulmonary thromboendarterectomy. The diagnosis of CTEPH was made on the basis of the previously reported procedure.14 In brief, patients with clinical symptoms suggesting CTEPH underwent ventilation/perfusion lung scanning to detect pulmonary perfusion defects. The diagnosis was confirmed by pulmonary angiography.15 When characteristic angiographic findings

Results

During a follow-up period of 2 ± 1 month, NYHA functional class significantly improved in 10 patients (50%), worsened in 1 patient (5%), and was unchanged in 9 patients (45%) in the BPS group (Fig 1). However, no significant change in NYHA functional class was observed in the conventional group.

BPS significantly lowered mean pulmonary arterial pressure by 11% (55 ± 15 to 49 ± 16 mm Hg, p < 0.05; Fig 2) and total pulmonary resistance by 18% (18 ± 6 to 15 ± 8 Wood units, p < 0.05) during a

Discussion

In the present study, we demonstrated the following: (1) oral administration of BPS improved NYHA functional class and decreased total pulmonary resistance in patients with peripheral-vessel CTEPH, for which no surgical option exists; (2) the absence of BPS therapy was significantly related to mortality in such patients; and (3) the Kaplan-Meier survival curves demonstrated that the BPS group had a significantly higher survival rate than the conventional group.

IV infusion of epoprostenol

Conclusions

This study suggest that oral administration of BPS may improve NYHA functional class, hemodynamics, and long-term prognosis in patients with peripheral-vessel CTEPH, for which no surgical option exists. Thus, BPS may be a new therapeutic approach to the treatment of inoperable CTEPH.

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This work was supported by a Research Grant for Cardiovascular Disease (12C-2) from the Ministry of Health, Labour and Welfare, the Uehara Memorial Foundation, and a grant from the Japan Cardiovascular Research Foundation.

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