Chronic Thromboembolic Pulmonary Hypertension, CTEPH
Conditions
Keywords
Pulmonary endarterectomy, PEA, Medical therapy
Brief summary
This is a randomised, double-blind, placebo-controlled, multicentre, multinational, prospective study in patients with operable chronic thromboembolic pulmonary hypertension (CTEPH) prior to pulmonary endarterectomy (PEA) with high preoperative pulmonary vascular resistance (PVR). Patients will be randomised in a 1:1 ratio to receive riociguat or matching placebo for 3 months before undergoing PEA. The primary objective of this study is to assess the efficacy of riociguat on preoperative PVR compared to placebo in patients with operable CTEPH.
Interventions
DRUGRiociguat
Riociguat will be initiated at 1 mg tid. The dosage will be increased by 0.5 mg at 2 week intervals based on tolerability as assessed by systolic blood pressure up to a maximum dose of 2.5 mg tid. Downtitration to 0.5 mg tid is foreseen for patients with low optimal tolerability.
DRUGPlacebo
Placebo will be given analogue to riociguat with matching tablets.
PROCEDUREPulmonary endarterectomy
PEA will be performed at the end of medical treatment (Day 90)
Sponsors
International CTEPH Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Is a male or nonpregnant and nonlactating female patient aged from 18 to 80 years, both inclusive * Is diagnosed with operable CTEPH and anticipating symptomatic and/or prognostic benefit from PEA * Has pulmonary vascular resistance (PVR) \>800 dyn·s·cm-5 * Has undergone right heart catheterisation not more than 180 days before randomisation visit * Has been treated with anticoagulants for at least 90 days before randomisation visit * Has ability to swallow oral medication * Has ability and willingness to participate and access the health facility * Is capable of understanding the written informed consent and provides signed and witnessed written informed consent * Female patient must be either surgically sterile, postmenopausal (no menses for the previous 12 months), or must be practicing an effective method of birth control as determined by the investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or male partner with vasectomy or complete abstinence)
Exclusion criteria
* Has unstable disease in need of urgent PEA surgery as determined by the treating physician * Has known hypersensitivity, allergic, or adverse reactions to riociguat or any of the excipients comprising riociguat tablets. * Has known active hepatitis A IgM (HAV-IgM), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV Ab) * Is human immunodeficiency virus positive * Has pulmonary veno-occlusive disease * Has symptomatic hypotension * Has symptomatic carotid disease * Has significant coronary atherosclerotic disease in need of intervention * Has severe left heart disease in need of intervention * Has redo sternotomy * Has received any background therapy for pulmonary arterial hypertension (PAH) in the preceding 30 days before randomisation visit including endothelin receptor antagonists (ERAs), phosphodiesterase 5 (PDE5) inhibitors, or prostanoids * Is receiving nitrates, nitric oxide donors (e.g. amyl nitrite), ERAs, prostanoids, specific PDE5 inhibitors, nonspecific phosphodiesterase inhibitors (e.g. dipyridamole, theophylline) * Is receiving strong cytochrome P450 (CYP) and P-glycoprotein/breast cancer resistance protein inhibitors * Is receiving strong CYP3A inducers * Has creatinine clearance \<15 mL/min or on any form of dialysis * Has severe hepatic impairment classified as Child-Pugh C * Has received an investigational drug within the past 4 weeks before randomisation visit * Is a lactating or pregnant (as demonstrated by a serum pregnancy test) woman, and not willing to take measures for not to become pregnant during the 3 months treatment study period and one month after the last dose of study drug administered * Has smoked or used tobacco in any form, including snuff or chewing within 3 months prior to randomisation visit * Has idiopathic interstitial pneumonitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pulmonary Vascular Resistance (PVR) to Immediately Before Pulmonary Endarterectomy (Pre-PEA) | 90 days | Pulmonary vascular resistance (PVR) will be assessed at baseline and immediately before pulmonary endarterectomy. The change in PVR will be assessed as percentage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Either All-cause Death, PH-related Hospitalization, Need for PAH-targeted Therapy or WHO Functional Class Unchanged or Worse Between Randomization and 6 Months Post Pulmonary Endarterectomy (Composite Endpoint) | 270 days | All deaths occurring post-randomization until the last visit will be included. All PH-related hospitalizations except the in-hospital care during and after pulmonary endarterectomy (PEA) from randomization until 6 months after PEA will be included. The worst value for World Health Organization (WHO) functional class after treatment will be used. |
| Intraoperative Circulatory Arrest Time | intraoperative | Circulatory arrest time will be measured in minutes |
| Number of Patients With Intraoperative Surgery-related Complications (Composite Endpoint) | intraoperative | The occurrence of any of the following complications will be assessed: * Bleeding and/or blood loss \>1 L in 12 hours * Airway bleed with need for extracorporeal membrane oxygenation * Any use of extracorporeal membrane oxygenation for respiratory or hemodynamic support, specified as veno-venous or veno-arterial * Prolonged ventilation \>96 hours * Need for tracheostomy * Need for drainage of pericardial effusion * Neurological complications, ie, stroke, cerebral, subdural bleeding * Reintubation or noninvasive ventilation for reperfusion response * Hemoptysis requiring any intervention * Renal failure requiring dialysis * Wound infections * Pneumonia * Prolonged need for inotropic support (≥ 5 days) |
| Surgical Evaluation of Specimen: Stratification of Patients According to Ease of Dissection Plane | intraoperative | Classed as easier than normal (1); normal (2); more difficult than normal (3) |
| Change From Baseline in Pulmonary Vascular Resistance (PVR) to 6 Months Post Pulmonary Endarterectomy (PEA) | 270 days | Pulmonary vascular resistance (PVR) will be assessed at baseline and 6 months post pulmonary endarterectomy (PEA). The change in PVR will be assessed as percentage. |
| Surgical Evaluation of Specimen: Stratification of Patients According to Appearance of Clot and Vessel Wall | intraoperative | Classed as more solid than usual (1); normal (2); more friable than usual (3) |
| Number of Patients Who Died During the Course of the Study | 270 days | All deaths occurring during the whole course of the study |
| Patients Who Withdraw During the Randomized Treatment Phase | 90 days | Only withdrawals after randomization but before PEA will be included |
| Surgical Evaluation of Specimen: Stratification of Patients According to Completeness of Disease Clearance | intraoperative | Classed as better than expected (1); as expected (2); worse than expected (3) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay for Pulmonary Endarterectomy | intraoperative | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study |
| Length of Intensive Care Unit Stay for Pulmonary Endarterectomy | intraoperative | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study |
| Change in NT-proBNP From Baseline Until the End of Medical Treatment | 90 days | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study |
| WHO Functional Class 6 Months Post Pulmonary Endarterectomy | 270 days | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study |
| Need for PAH-targeted Therapy 6 Months Post-surgery | 270 days | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study |
| WHO Functional Class at the End of Medical Treatment | 90 days | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study |
| Change in NT-proBNP From Baseline Until 6 Months Post-surgery | 270 days | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study |
| Change in Cardiac Index From Baseline Until the End of Medical Treatment | 90 days | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study |
| Change in Cardiac Index From Baseline Until 6 Months Post-surgery | 270 days | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study |
| Change in Mean Right Atrial Pressure From Baseline Until the End of Medical Treatment | 90 days | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study |
| Change in Mean Right Atrial Pressure From Baseline Until 6 Months Post-surgery | 270 days | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study |
| Change in Mean Pulmonary Atrial Pressure From Baseline Until the End of Medical Treatment | 90 days | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study |
| Change in Mean Pulmonary Atrial Pressure From Baseline Until 6 Months Post-surgery | 270 days | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study |
| Change in Pulmonary Artery Wedge Pressure From Baseline Until the End of Medical Treatment | 90 days | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study |
| Change in Pulmonary Artery Wedge Pressure From Baseline Until 6 Months Post-surgery | 270 days | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study |
Countries
France, Germany, United Kingdom, United States
Participant flow
Recruitment details
Eligible patients were recruited at 3 expert centers for CTEPH in France, Germany and the UK between August 2018 and May 2020.
Participants by arm
| Arm | Count |
|---|---|
| Riociguat Patients will receive riociguat for 3 months followed by pulmonary endarterectomy.
Riociguat will be initiated at 1 mg tid. The dosage will be increased by 0.5 mg at 2 week intervals based on tolerability as assessed by systolic blood pressure up to a maximum dose of 2.5 mg tid.
Downtitration to 0.5 mg tid is foreseen for patients with low optimal tolerability.
PEA will be performed at the end of medical treatment (Day 90) | 7 |
| Placebo Patients will receive placebo for 3 months followed by pulmonary endarterectomy.
Placebo will be given analogue to riociguat with matching tablets.
PEA will be performed at the end of medical treatment (Day 90) | 6 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Inability to schedule PEA according to the protocol due to the COVID pandemic | 1 | 1 |
| Overall Study | Study terminated | 3 | 2 |
Baseline characteristics
| Characteristic | Placebo | Riociguat | Total |
|---|---|---|---|
| Age, Continuous | 67 years | 66 years | 66 years |
| Body mass index | 25.4 kg/m^2 STANDARD_DEVIATION 1.7 | 31.2 kg/m^2 STANDARD_DEVIATION 3.9 | 28.8 kg/m^2 STANDARD_DEVIATION 4.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 7 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Mean pulmonary arterial pressure (mPAP) at diagnosis | 53.2 mmHg STANDARD_DEVIATION 4.8 | 50.3 mmHg STANDARD_DEVIATION 8.4 | 51.5 mmHg STANDARD_DEVIATION 7 |
| PVR at diagnosis | 1007.5 dyn*sec/cm^5 STANDARD_DEVIATION 368.2 | 944.0 dyn*sec/cm^5 STANDARD_DEVIATION 92.7 | 973.3 dyn*sec/cm^5 STANDARD_DEVIATION 248.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 6 Participants | 12 Participants |
| Received beta blockers between enrollment and PEA | 0 Participants | 3 Participants | 3 Participants |
| Received new/direct oral anticoagulants between enrollment and PEA | 4 Participants | 6 Participants | 10 Participants |
| Received vitamin K antagonists between enrollment and PEA | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 1 / 7 |
| other Total, other adverse events | 7 / 7 | 5 / 6 |
| serious Total, serious adverse events | 1 / 7 | 2 / 6 |
Outcome results
Primary
Change From Baseline in Pulmonary Vascular Resistance (PVR) to Immediately Before Pulmonary Endarterectomy (Pre-PEA)
Pulmonary vascular resistance (PVR) will be assessed at baseline and immediately before pulmonary endarterectomy. The change in PVR will be assessed as percentage.
Time frame: 90 days
Population: All participants who received at least one dose of randomized study drug and underwent PEA before study termination
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Riociguat | Change From Baseline in Pulmonary Vascular Resistance (PVR) to Immediately Before Pulmonary Endarterectomy (Pre-PEA) | -28.4 percentage of baseline PVR | Standard Deviation 16.2 |
| Placebo | Change From Baseline in Pulmonary Vascular Resistance (PVR) to Immediately Before Pulmonary Endarterectomy (Pre-PEA) | -6.9 percentage of baseline PVR | Standard Deviation 27.9 |
Comparison: The null hypothesis is that there is no difference between the treatment groups in percent change from baseline in PVR immediately before PEA.p-value: 0.1392-sample Wilcoxon rank sum test
Secondary
Change From Baseline in Pulmonary Vascular Resistance (PVR) to 6 Months Post Pulmonary Endarterectomy (PEA)
Pulmonary vascular resistance (PVR) will be assessed at baseline and 6 months post pulmonary endarterectomy (PEA). The change in PVR will be assessed as percentage.
Time frame: 270 days
Population: All participants who received at least one dose of randomized study drug and completed the study prior to study termination
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Riociguat | Change From Baseline in Pulmonary Vascular Resistance (PVR) to 6 Months Post Pulmonary Endarterectomy (PEA) | -68.1 percentage of baseline PVR | Standard Deviation 9.8 |
| Placebo | Change From Baseline in Pulmonary Vascular Resistance (PVR) to 6 Months Post Pulmonary Endarterectomy (PEA) | -83.0 percentage of baseline PVR | Standard Deviation 2.2 |
Secondary
Intraoperative Circulatory Arrest Time
Circulatory arrest time will be measured in minutes
Time frame: intraoperative
Population: All participants who underwent PEA before study termination
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Riociguat | Intraoperative Circulatory Arrest Time | 32 minutes | Standard Deviation 9 |
| Placebo | Intraoperative Circulatory Arrest Time | 40 minutes | Standard Deviation 12 |
Secondary
Number of Patients Who Died During the Course of the Study
All deaths occurring during the whole course of the study
Time frame: 270 days
Population: All participants who underwent PEA before study termination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Riociguat | Number of Patients Who Died During the Course of the Study | 0 Participants |
| Placebo | Number of Patients Who Died During the Course of the Study | 0 Participants |
Secondary
Number of Patients With Either All-cause Death, PH-related Hospitalization, Need for PAH-targeted Therapy or WHO Functional Class Unchanged or Worse Between Randomization and 6 Months Post Pulmonary Endarterectomy (Composite Endpoint)
All deaths occurring post-randomization until the last visit will be included. All PH-related hospitalizations except the in-hospital care during and after pulmonary endarterectomy (PEA) from randomization until 6 months after PEA will be included. The worst value for World Health Organization (WHO) functional class after treatment will be used.
Time frame: 270 days
Population: All participants who underwent PEA before study termination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Riociguat | Number of Patients With Either All-cause Death, PH-related Hospitalization, Need for PAH-targeted Therapy or WHO Functional Class Unchanged or Worse Between Randomization and 6 Months Post Pulmonary Endarterectomy (Composite Endpoint) | 6 Participants |
| Placebo | Number of Patients With Either All-cause Death, PH-related Hospitalization, Need for PAH-targeted Therapy or WHO Functional Class Unchanged or Worse Between Randomization and 6 Months Post Pulmonary Endarterectomy (Composite Endpoint) | 5 Participants |
Secondary
Number of Patients With Intraoperative Surgery-related Complications (Composite Endpoint)
The occurrence of any of the following complications will be assessed: * Bleeding and/or blood loss \>1 L in 12 hours * Airway bleed with need for extracorporeal membrane oxygenation * Any use of extracorporeal membrane oxygenation for respiratory or hemodynamic support, specified as veno-venous or veno-arterial * Prolonged ventilation \>96 hours * Need for tracheostomy * Need for drainage of pericardial effusion * Neurological complications, ie, stroke, cerebral, subdural bleeding * Reintubation or noninvasive ventilation for reperfusion response * Hemoptysis requiring any intervention * Renal failure requiring dialysis * Wound infections * Pneumonia * Prolonged need for inotropic support (≥ 5 days)
Time frame: intraoperative
Population: All participants who underwent PEA before study termination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Riociguat | Number of Patients With Intraoperative Surgery-related Complications (Composite Endpoint) | 0 Participants |
| Placebo | Number of Patients With Intraoperative Surgery-related Complications (Composite Endpoint) | 0 Participants |
Secondary
Patients Who Withdraw During the Randomized Treatment Phase
Only withdrawals after randomization but before PEA will be included
Time frame: 90 days
Population: All participants who received at least one dose of randomized study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Riociguat | Patients Who Withdraw During the Randomized Treatment Phase | 1 Participants |
| Placebo | Patients Who Withdraw During the Randomized Treatment Phase | 1 Participants |
Secondary
Surgical Evaluation of Specimen: Stratification of Patients According to Appearance of Clot and Vessel Wall
Classed as more solid than usual (1); normal (2); more friable than usual (3)
Time frame: intraoperative
Population: All participants who underwent PEA before study termination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Riociguat | Surgical Evaluation of Specimen: Stratification of Patients According to Appearance of Clot and Vessel Wall | More solid than usual | 0 Participants |
| Riociguat | Surgical Evaluation of Specimen: Stratification of Patients According to Appearance of Clot and Vessel Wall | Normal | 4 Participants |
| Riociguat | Surgical Evaluation of Specimen: Stratification of Patients According to Appearance of Clot and Vessel Wall | More friable than usual | 2 Participants |
| Placebo | Surgical Evaluation of Specimen: Stratification of Patients According to Appearance of Clot and Vessel Wall | More solid than usual | 0 Participants |
| Placebo | Surgical Evaluation of Specimen: Stratification of Patients According to Appearance of Clot and Vessel Wall | Normal | 5 Participants |
| Placebo | Surgical Evaluation of Specimen: Stratification of Patients According to Appearance of Clot and Vessel Wall | More friable than usual | 0 Participants |
Secondary
Surgical Evaluation of Specimen: Stratification of Patients According to Completeness of Disease Clearance
Classed as better than expected (1); as expected (2); worse than expected (3)
Time frame: intraoperative
Population: All participants who underwent PEA before study termination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Riociguat | Surgical Evaluation of Specimen: Stratification of Patients According to Completeness of Disease Clearance | Worse than expected | 0 Participants |
| Riociguat | Surgical Evaluation of Specimen: Stratification of Patients According to Completeness of Disease Clearance | Better than expected | 0 Participants |
| Riociguat | Surgical Evaluation of Specimen: Stratification of Patients According to Completeness of Disease Clearance | As expected | 6 Participants |
| Placebo | Surgical Evaluation of Specimen: Stratification of Patients According to Completeness of Disease Clearance | Worse than expected | 0 Participants |
| Placebo | Surgical Evaluation of Specimen: Stratification of Patients According to Completeness of Disease Clearance | Better than expected | 0 Participants |
| Placebo | Surgical Evaluation of Specimen: Stratification of Patients According to Completeness of Disease Clearance | As expected | 5 Participants |
Secondary
Surgical Evaluation of Specimen: Stratification of Patients According to Ease of Dissection Plane
Classed as easier than normal (1); normal (2); more difficult than normal (3)
Time frame: intraoperative
Population: All participants who underwent PEA
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Riociguat | Surgical Evaluation of Specimen: Stratification of Patients According to Ease of Dissection Plane | Normal | 3 Participants |
| Riociguat | Surgical Evaluation of Specimen: Stratification of Patients According to Ease of Dissection Plane | Easier than normal | 1 Participants |
| Riociguat | Surgical Evaluation of Specimen: Stratification of Patients According to Ease of Dissection Plane | More difficult than normal | 2 Participants |
| Placebo | Surgical Evaluation of Specimen: Stratification of Patients According to Ease of Dissection Plane | Easier than normal | 1 Participants |
| Placebo | Surgical Evaluation of Specimen: Stratification of Patients According to Ease of Dissection Plane | Normal | 4 Participants |
| Placebo | Surgical Evaluation of Specimen: Stratification of Patients According to Ease of Dissection Plane | More difficult than normal | 0 Participants |
Other Pre-specified
Change in Cardiac Index From Baseline Until 6 Months Post-surgery
Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study
Time frame: 270 days
Other Pre-specified
Change in Cardiac Index From Baseline Until the End of Medical Treatment
Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study
Time frame: 90 days
Other Pre-specified
Change in Mean Pulmonary Atrial Pressure From Baseline Until 6 Months Post-surgery
Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study
Time frame: 270 days
Other Pre-specified
Change in Mean Pulmonary Atrial Pressure From Baseline Until the End of Medical Treatment
Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study
Time frame: 90 days
Other Pre-specified
Change in Mean Right Atrial Pressure From Baseline Until 6 Months Post-surgery
Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study
Time frame: 270 days
Other Pre-specified
Change in Mean Right Atrial Pressure From Baseline Until the End of Medical Treatment
Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study
Time frame: 90 days
Other Pre-specified
Change in NT-proBNP From Baseline Until 6 Months Post-surgery
Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study
Time frame: 270 days
Other Pre-specified
Change in NT-proBNP From Baseline Until the End of Medical Treatment
Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study
Time frame: 90 days
Other Pre-specified
Change in Pulmonary Artery Wedge Pressure From Baseline Until 6 Months Post-surgery
Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study
Time frame: 270 days
Other Pre-specified
Change in Pulmonary Artery Wedge Pressure From Baseline Until the End of Medical Treatment
Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study
Time frame: 90 days
Other Pre-specified
Length of Hospital Stay for Pulmonary Endarterectomy
Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study
Time frame: intraoperative
Other Pre-specified
Length of Intensive Care Unit Stay for Pulmonary Endarterectomy
Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study
Time frame: intraoperative
Other Pre-specified
Need for PAH-targeted Therapy 6 Months Post-surgery
Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study
Time frame: 270 days
Other Pre-specified
WHO Functional Class 6 Months Post Pulmonary Endarterectomy
Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study
Time frame: 270 days
Other Pre-specified
WHO Functional Class at the End of Medical Treatment
Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study
Time frame: 90 days