Balloon pulmonary angioplasty versus riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (RACE): a multicentre, phase 3, open-label, randomised controlled trial and ancillary follow-up study

Jaïs, Xavier; Brénot, Philippe; Bouvaist, Hélène; Jevnikar, Mitja; Canuet, Matthieu; Chabanne, Céline; Chaouat, Ari; Cottin, Vincent; Groote, P. De; Favrolt, Nicolas; Horeau-Langlard, Delphine; Magro, Pascal; Savale, Laurent; Prévôt, Grégoire; Renard, Sébastien; Sitbon, Olivier; Parent, Florence; Trésorier, Romain; Tromeur, Cécile; Piedvache, Céline; Grimaldi-Bensouda, Lamiae; Fadel, Élie; Montani, David; Humbert, Marc; Simonneau, Gérald

doi:10.1016/s2213-2600(22)00214-4

Cited by 122 publications

(115 citation statements)

References 26 publications

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“…As with all interventional procedures, a significant learning curve has been shown, with reducing complication rates over time [781]; therefore, this procedure should be performed in high-volume CTEPH centres. As the rates of interventional complications can be reduced by medical pre-treatment, patients with a PVR >4 WU should be treated before BPA (Figure 15) [798].…”

Section: Interventional Treatmentmentioning

confidence: 99%

2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension

Humbert

Kovàcs²,

Hoeper³

et al. 2022

Eur Respir J

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Section: Interventional Treatmentmentioning

confidence: 99%

2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension

Humbert

Kovàcs²,

Hoeper³

et al. 2022

Eur Respir J

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1,631

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“…Preoperative PH‐targeted therapy in patients who undergo PTE has been associated with delay in referral time without clear benefit. 25 On the other hand, data from the RACE trial 26 demonstrated that pretreatment with riociguat was associated with a lower BPA complication rate (14% vs. 42% of patients). This observation is in accordance with our treatment strategy at UCSD where patients with severe hemodynamic impairment are first treated with PH‐targeted medical therapy before BPA.…”

Section: Discussionmentioning

confidence: 99%

Patient selection for balloon pulmonary angioplasty: Six‐year results from a high volume PTE surgical center

et al. 2022

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Chronic thromboembolic pulmonary hypertension (CTEPH) is the result of incompletely resolved pulmonary emboli (PE) that lead to chronic right heart failure. The two mechanical treatment options are pulmonary thromboendarterectomy (PTE) and balloon pulmonary angioplasty (BPA). There are no formal criteria for BPA patient selection and treatment decisions vary according to a center's experience with BPA and PTE. We performed a retrospective review of consecutive patients treated with PTE and BPA at UCSD from March 2015 to 2021. Clinical and hemodynamic data were collected. Patients were categorized according to the rationale for BPA. One hundred fifty three patients underwent 643 BPA sessions, and 1104 patients underwent PTE. Patients selected for PTE had worse baseline hemodynamics with mean pulmonary artery pressure 41.1 ± 11.7 versus 34.6 ± 11.2 mmHg, p < 0.001. 59% of patients selected for BPA had surgically inaccessible disease, 21% had residual CTEPH after PTE, 10% had a discordance between disease burden and symptoms/hemodynamics, 7% had comorbidities that prevented PTE and 3% refused PTE surgery. 28% of patients who underwent PTE had exclusively level III or IV disease based on surgical specimen. There were no BPA procedure‐related mortalities and minor pulmonary vascular complication rates during BPA were 9.2%. The most common reason for BPA selection was surgically inaccessible disease followed by residual CTEPH after PTE. Almost one third of patients who underwent PTE had exclusively distal disease by surgical criteria and might have been directed to BPA at a less experienced surgical center.

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“…The severity of lung injury correlates with the level of pre-procedural mPAP [ 68 ]. Pre-treatment with riociguat can be used to minimise the risk of lung injury [ 69 ]. In addition, oxygen therapy decreases mPAP by approximately 10%, regardless of the use of riociguat [ 70 ].…”

Section: Balloon Pulmonary Angioplastymentioning

confidence: 99%

“…Combinations or sequential utilisation of different treatment modalities are under investigation. In particular, the value of pre-treating patients who are scheduled for BPA with medical therapy was recently described by two independent studies from France (RACE) [ 69 ] and Japan (MR BPA) [ 78 ]. Those studies showed good efficacy for both treatment modalities, with stronger immediate haemodynamic benefits for BPA, while the safety of this procedure could be substantially improved if patients were pre-treated with riociguat prior to BPA according to the RACE study.…”

Section: Medical and Multimodal Therapymentioning

confidence: 99%

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Highlights from the International Chronic Thromboembolic Pulmonary Hypertension Congress 2021

et al. 2023

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Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare complication of acute pulmonary embolism. It is caused by persistent obstruction of pulmonary arteries by chronic organised fibrotic clots, despite adequate anticoagulation. The pulmonary hypertension is also caused by concomitant microvasculopathy which may progress without timely treatment. Timely and accurate diagnosis requires the combination of imaging and haemodynamic assessment. Optimal therapy should be individualised to each case and determined by an experienced multidisciplinary CTEPH team with the ability to offer all current treatment modalities. This report summarises current knowledge and presents key messages from the International CTEPH Conference, Bad Nauheim, Germany, 2021. Sessions were dedicated to 1) disease definition; 2) pathophysiology, including the impact of the hypertrophied bronchial circulation, right ventricle (dys)function, genetics and inflammation; 3) diagnosis, early after acute pulmonary embolism, using computed tomography and perfusion techniques, and supporting the selection of appropriate therapies; 4) surgical treatment, pulmonary endarterectomy for proximal and distal disease, and peri-operative management; 5) percutaneous approach or balloon pulmonary angioplasty, techniques and complications; and 6) medical treatment, including anticoagulation and pulmonary hypertension drugs, and in combination with interventional treatments. Chronic thromboembolic pulmonary disease without pulmonary hypertension is also discussed in terms of its diagnostic and therapeutic aspects.

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Balloon pulmonary angioplasty versus riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (RACE): a multicentre, phase 3, open-label, randomised controlled trial and ancillary follow-up study

Cited by 122 publications

References 26 publications

2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension

2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension

Patient selection for balloon pulmonary angioplasty: Six‐year results from a high volume PTE surgical center

Highlights from the International Chronic Thromboembolic Pulmonary Hypertension Congress 2021

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