Balloon pulmonary angioplasty compares favorably with riociguat in CTEPH
When compared with riociguat therapy, balloon pulmonary angioplasty was associated with more improvement in some parameters of hemodynamics and exercise tolerance in patients with inoperable chronic thromboembolic pulmonary hypertension, according to a meta-analysis published in Clinical Cardiology.
For the study, the researchers analyzed 23 clinical trials involving 1,454 patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) — of whom 631 were treated with balloon pulmonary angioplasty and 823 were treated with riociguat (Adempas, Bayer).
Balloon pulmonary angioplasty, as compared with riociguat, was linked to greater improvements in several hemodynamic parameters, including right atrium pressure (mean difference, –3.5 mm Hg vs. –1.1 mm Hg), mean pulmonary artery pressure (mean difference, –15 mm Hg vs. –4.2 mm Hg) and pulmonary vascular pressure (standard mean difference, –1.3 Wood units vs. –0.65 Wood units).
However, riociguat, as compared with balloon pulmonary angioplasty, was associated with a greater increase in cardiac output (mean difference, 0.8 L per minute vs. 0.3 L per minute). Additionally, cardiac index significantly increased in patients who underwent balloon pulmonary angioplasty and riociguat therapy, but there was no significant difference in improvements between the two treatment groups (mean difference, 0.4 L/min/m2 for both).
Measures of exercise tolerance were also more improved with balloon pulmonary angioplasty vs. riociguat, with greater increases seen in New York Heart Association functional class and 6-minute walk distance (mean difference, 71.66 m vs. 45.25 m) in the angioplasty group.
To address heterogeneity among the studies, the researchers calculated pooled estimates using different effects models. For those measures in which severe heterogeneity was found — right atrium pressure, pulmonary vascular pressure and cardiac index — they conducted sensitivity analysis to identify the source of heterogeneity from each contributing study.
The pooled results also showed that balloon pulmonary angioplasty vs. riociguat therapy might be associated with greater improvements in exercise tolerance parameters and pulmonary hemodynamics with the exception of cardiac output and cardiac index, the researchers wrote.
Complication rates associated with each treatment were reported in 17 studies. Results showed that after balloon angioplasty, the most common symptom was hemoptysis. The most common complications after the procedure included pulmonary injury, of which the rate ranged from 0.3% to 5.6% across studies, and pulmonary edema, of which the rate ranged from 0.8% to 28.6% across studies. For riociguat, the most commonly reported adverse events were headache, dizziness, hypotension and nasopharyngitis.
Overall, though, both treatments were generally well tolerated, according to the researchers.
However, they noted that these data should be interpreted with caution, as they are subject to a number of limitations, including the potential for bias and the fact that the meta-analysis only included nonrandomized observational studies. Therefore, further multicenter randomized controlled trials and prospective observational studies are needed to confirm their findings, the researchers wrote. – by Melissa Foster
Disclosures: The authors report no relevant financial disclosures.