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Background <p>For patients with chronic thromboembolic pulmonary hypertension (CTEPH), balloon pulmonary angioplasty (BPA) has been associated with superior reductions in mean pulmonary artery pressure (mPAP) and pulmonary vascular resistance (PVR) when compared to riociguat. In patients with pulmonary arterial hypertension (PAH), greater clinical improvements were observed after switching from phosphodiesterase-5 inhibitors (PDE5i) to riociguat. However, the impact of transitioning from PDE5i to riociguat on pulmonary haemodynamics and functional outcomes after BPA remains unclear.</p> Methods <p>This prospective, open-label, single-arm, study enrolled CTEPH patients who remained symptomatic following BPA. After a 24-hour PDE5i washout period, patients were switched to riociguat. At week 26, primary outcomes assessed changes in haemodynamics including PVR and mPAP. Secondary endpoints evaluated cardiac index; functional status including WHO functional class, 6-minute walking distance (6MWD), REVEAL Lite 2 score; biochemical markers such as N-terminal prohormone of brain natriuretic peptide (NT-proBNP); and echocardiographic measurements of right-heart function. Treatment-related adverse events and clinical worsening were monitored throughout the study.</p> Results <p>From July 2024 to January 2025, 16 patients (mean age 62.3 ± 14.6 years; 75% female) were recruited, with 14 completing the 26-week follow-up. At week 26, significant reductions occurred in PVR (-2.16 Wood units; CI -3.64 to -0.69; <i>p</i> = 0.007) and mPAP (-4.79 mmHg; Confidence Interval [CI] -8.05 to -1.52; <i>p</i> = 0.007). Significant improvements were also noted in cardiac index, WHO functional class, 6MWD, REVEAL Lite 2 score and NT-proBNP levels. Echocardiographic measurements of right-heart function did not demonstrate significant improvement. Treatment-related adverse events were observed in 11 patients (68.75%). Clinical worsening occurred in four patients, including two deaths unrelated to treatment and two unplanned hospitalisations due to pulmonary hypertension.</p> Conclusion <p>In CTEPH patients after completion of BPA, replacing PDE5i with riociguat significantly enhanced pulmonary haemodynamics and functional capacity but was accompanied by a considerable risk of treatment-related adverse events.</p> Trial registration <p>ClinicalTrials.gov Identifier NCT06715280 retrospectively registered on 26/11/2024.</p>

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Haemodynamic and clinical impacts of switching phosphodiesterase-5 inhibitors to riociguat in patients with chronic thromboembolic pulmonary hypertension (CTEPH) after balloon pulmonary angioplasty (BPA) – a prospective cohort study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月3日

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  • Timothy Ho Him Kam,
  • Kevin Ka Ho Kam,
  • Michael Ka Lam Wong,
  • Bryan Ping Yen Yan,
  • Guangming Tan

摘要

Background

For patients with chronic thromboembolic pulmonary hypertension (CTEPH), balloon pulmonary angioplasty (BPA) has been associated with superior reductions in mean pulmonary artery pressure (mPAP) and pulmonary vascular resistance (PVR) when compared to riociguat. In patients with pulmonary arterial hypertension (PAH), greater clinical improvements were observed after switching from phosphodiesterase-5 inhibitors (PDE5i) to riociguat. However, the impact of transitioning from PDE5i to riociguat on pulmonary haemodynamics and functional outcomes after BPA remains unclear.

Methods

This prospective, open-label, single-arm, study enrolled CTEPH patients who remained symptomatic following BPA. After a 24-hour PDE5i washout period, patients were switched to riociguat. At week 26, primary outcomes assessed changes in haemodynamics including PVR and mPAP. Secondary endpoints evaluated cardiac index; functional status including WHO functional class, 6-minute walking distance (6MWD), REVEAL Lite 2 score; biochemical markers such as N-terminal prohormone of brain natriuretic peptide (NT-proBNP); and echocardiographic measurements of right-heart function. Treatment-related adverse events and clinical worsening were monitored throughout the study.

Results

From July 2024 to January 2025, 16 patients (mean age 62.3 ± 14.6 years; 75% female) were recruited, with 14 completing the 26-week follow-up. At week 26, significant reductions occurred in PVR (-2.16 Wood units; CI -3.64 to -0.69; p = 0.007) and mPAP (-4.79 mmHg; Confidence Interval [CI] -8.05 to -1.52; p = 0.007). Significant improvements were also noted in cardiac index, WHO functional class, 6MWD, REVEAL Lite 2 score and NT-proBNP levels. Echocardiographic measurements of right-heart function did not demonstrate significant improvement. Treatment-related adverse events were observed in 11 patients (68.75%). Clinical worsening occurred in four patients, including two deaths unrelated to treatment and two unplanned hospitalisations due to pulmonary hypertension.

Conclusion

In CTEPH patients after completion of BPA, replacing PDE5i with riociguat significantly enhanced pulmonary haemodynamics and functional capacity but was accompanied by a considerable risk of treatment-related adverse events.

Trial registration

ClinicalTrials.gov Identifier NCT06715280 retrospectively registered on 26/11/2024.