Abstract
BackgroundManagement of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) remains a clinical challenge. Currently, riociguat, a soluble guanylate-cyclase stimulator is recommended by international guidelines. More recently, balloon pulmonary angioplasty (BPA) develops as an alternative treatment for inoperable CTEPH.MethodThis study is a single-center randomized controlled trial. Subjects with inoperable CTEPH are randomized into either a BPA combined with riociguat or riociguat monotherapy group (2:1) and observed for 12 months after initiation of treatment. The primary endpoint is the change in pulmonary vascular resistance from baseline to 12 months after initiation of treatment. The secondary endpoints include 6-min walk distance (6MWD), WHO-FC, NT-proBNP, SF-36, and other hemodynamic parameters. Safety endpoints are analyzed too.DiscussionThis study aims to compare the efficacy and safety of BPA combined with riociguat and riociguat monotherapy for inoperable CTEPH.Trial registrationChinese Clinical Trial Registry ChiCTR2000032403. Registered on 27 April 2020.
Highlights
Management of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) remains a clinical challenge
This study aims to compare the efficacy and safety of balloon pulmonary angioplasty (BPA) combined with riociguat and riociguat monotherapy for inoperable CTEPH
A soluble guanylate-cyclase stimulator, has a direct stimulating effect on sGC, which is independent of nitric oxide (NO) level
Summary
Management of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) remains a clinical challenge. Balloon pulmonary angioplasty (BPA) develops as an alternative treatment for inoperable CTEPH. PEA is an established curative treatment and is recommended for patients with operable CTEPH as the first choice by the European Society of Cardiology/European Respiratory Society (ESC/ERS), Cologne Consensus, and Chinese Pulmonary hypertension diagnosis and treatment guidelines (I, C) [3,4,5]. A soluble guanylate-cyclase (sGC) stimulator, has a direct stimulating effect on sGC, which is independent of nitric oxide (NO) level. It increases the sensitivity of sGC to NO [9]. Riociguat gets FDA approval in inoperable or persistent/recurrent CTEPH based on the findings of a multicenter randomized clinical trial (CHEST-1) [11] and its extension study (CHEST-2) [12]
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