Balloon pulmonary angioplasty vs riociguat in patients with inoperable chronic thromboembolic pulmonary hypertension: A systematic review and meta-analysis

Abstract

Backgrounds: No previous meta-analyses have compared the efficacy and safety of BPA with riociguat therapy in inoperable CTEPH patients.

Methods: Relevant published studies were searched in the PubMed, Embase and ClinicalTrial.gov databases.

Results: Twenty-three clinical trials including 1454 patients (631 underwent BPA; 823 underwent riociguat therapy) were analyzed. BPA was associated with a greater improvement in RAP (mean difference (MD) = -3.53 mmHg, 95% CI: [-4.85, -2.21] vs MD = -1.05 mmHg, 95% CI: [-1.82, -0.29]); mPAP (MD = -15.02 mmHg, 95% CI: [-17.32, -12.71] vs MD = -4.19 mmHg, 95% CI: [-5.58, -2.80]); PVR (standard MD = -1.32 woods, 95% CI: [-1.57, -1.08] vs standard MD = -0.65 woods, 95% CI: [-0.79, -0.50]); NYHA functional class (RR = 6.78, 95% CI: [3.14, 14.64] vs RR = 1.49, 95% CI: [1.07, 2.07]); and 6MWD (MD = 71.66 m, 95% CI: [58.34, 84.99] vs MD = 45.25 m, 95% CI: [36.51, 53.99]) than riociguat treatment. However, the increase in CO was greater with riociguat (MD = 0.78 L/min, 95% CI: [0.61, 0.96]) than with BPA (MD = 0.33 L/min, 95% CI: [0.06, 0.59]). No significant difference in cardiac index (CI) was found between BPA (MD = 0.40 L/min/m² , 95% CI: [0.21, 0.58]) and riociguat (MD = 0.40 L/min/m² , 95% CI: [0.26, 0.54]). The most common complications of BPA were pulmonary injury (0.3%-5.6%) and pulmonary edema (0.8%-28.6%). The most common adverse events of riociguat were headache, dizziness, hypotension and nasopharyngitis.

Conclusions: Our meta-analysis indicates that BPA might be associated with greater improvements in exercise tolerance and pulmonary hemodynamics except for cardiac output and cardiac index than riociguat therapy. However, both of them were well tolerated.

Keywords: balloon pulmonary angioplasty; chronic thromboembolic pulmonary hypertension; efficacy; riociguat; safety.