Trial Outcomes & Findings for Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes (NCT NCT03081052)

NCT ID: NCT03081052

Last Updated: 2023-02-16

Results Overview

This is defined by the International Society of Heart and Lung Transplantation (ISHLT) as severe hypoxemia with a PaO2-to-FiO2 ratio \< 200 or the presence of venovenous extracorporeal membrane oxygenation (VV ECMO) at a time-point within the first 72 hours after lung transplantation.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 519 participants
• Primary outcome timeframe: Up to 72 hours
• Results posted on: 2023-02-16

Participant Flow

519 participants were randomized, but 87 of those were unable to undergo surgery on protocol. 432 participants started the study (i.e., underwent surgery on protocol).

Participant milestones

Measure	Lung Transplant With iNO iNO: Subject will receive inhaled Nitric Oxide in this intervention	Lung Transplant With iEPO iEPO: Subject will receive inhaled Epoprostrenol in this intervention	Heart Transplant & LVAD Implantation With iNO iNO: Subject will receive inhaled Nitric Oxide in this intervention	Heart Transplant & LVAD Implantation With iEPO iEPO: Subject will receive inhaled Epoprostrenol in this intervention
Overall Study STARTED	98	103	111	120
Overall Study COMPLETED	98	103	111	120
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes

Baseline characteristics by cohort

Measure	Lung Transplant With iNO n=98 Participants iNO: Subject will receive inhaled Nitric Oxide in this intervention	Lung Transplant With iEPO n=103 Participants iEPO: Subject will receive inhaled Epoprostrenol in this intervention	Heart Transplant & LVAD Implantation With iNO n=111 Participants iNO: Subject will receive inhaled Nitric Oxide in this intervention	Heart Transplant & LVAD Implantation With iEPO n=120 Participants iEPO: Subject will receive inhaled Epoprostrenol in this intervention	Total n=432 Participants Total of all reporting groups
Age, Continuous	64 years n=93 Participants	64 years n=4 Participants	59 years n=27 Participants	58 years n=483 Participants	60 years n=36 Participants
Sex: Female, Male Female	39 Participants n=93 Participants	33 Participants n=4 Participants	25 Participants n=27 Participants	35 Participants n=483 Participants	132 Participants n=36 Participants
Sex: Female, Male Male	59 Participants n=93 Participants	70 Participants n=4 Participants	86 Participants n=27 Participants	85 Participants n=483 Participants	300 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	1 Participants n=483 Participants	9 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	92 Participants n=93 Participants	96 Participants n=4 Participants	107 Participants n=27 Participants	116 Participants n=483 Participants	411 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	4 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants	12 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	12 Participants n=93 Participants	9 Participants n=4 Participants	44 Participants n=27 Participants	47 Participants n=483 Participants	112 Participants n=36 Participants
Race (NIH/OMB) White	83 Participants n=93 Participants	91 Participants n=4 Participants	66 Participants n=27 Participants	72 Participants n=483 Participants	312 Participants n=36 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	2 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	4 Participants n=36 Participants

PRIMARY outcome

Timeframe: Up to 72 hours

Population: Only applicable to lung transplant patients on protocol.

This is defined by the International Society of Heart and Lung Transplantation (ISHLT) as severe hypoxemia with a PaO2-to-FiO2 ratio < 200 or the presence of venovenous extracorporeal membrane oxygenation (VV ECMO) at a time-point within the first 72 hours after lung transplantation.

Outcome measures

Measure	Lung Transplant With iNO n=98 Participants iNO: Subject will receive inhaled Nitric Oxide in this intervention	Lung Transplant With iEPO n=103 Participants iEPO: Subject will receive inhaled Epoprostrenol in this intervention	Heart Transplant & LVAD Implantation With iNO iNO: Subjects will receive inhaled Nitric Oxide in this intervention	Heart Transplant & LVAD Implantation With iEPO iEPO: Subjects will receive inhaled Epoprostrenol in this intervention
Number of Participants With Grade 3 Primary Graft Dysfunction (PGD) for Lung Transplant Subjects	39 Participants	46 Participants	—	—

PRIMARY outcome

Timeframe: up to approximately 21 days after LVAD placement, up to approximately 30 days after heart transplantation

Population: Only applicable to heart transplant and LVAD implantation cohort that were treated on protocol.

This is defined by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) score of moderate or severe right-heart failure for LVADS, and by the incidence of an RVAD placement or ECMO for RHF for heart transplants.

Outcome measures

Measure	Lung Transplant With iNO n=111 Participants iNO: Subject will receive inhaled Nitric Oxide in this intervention	Lung Transplant With iEPO n=120 Participants iEPO: Subject will receive inhaled Epoprostrenol in this intervention	Heart Transplant & LVAD Implantation With iNO iNO: Subjects will receive inhaled Nitric Oxide in this intervention	Heart Transplant & LVAD Implantation With iEPO iEPO: Subjects will receive inhaled Epoprostrenol in this intervention
Number of Participants With Moderate or Severe RV Failure for the LVAD Implantation Subjects and Severe RV Failure for Heart Transplantation Subjects	25 Participants	30 Participants	—	—

SECONDARY outcome

Timeframe: up to approximately 90 days after index surgery

Population: Among patients extubated, if patients transitioned directly from intubation to tracheostomy the duration of mechanical ventilation was censored at the time of tracheostomy placement

Length of time from intubation until patient is extubated

Outcome measures

Measure	Lung Transplant With iNO n=97 Participants iNO: Subject will receive inhaled Nitric Oxide in this intervention	Lung Transplant With iEPO n=100 Participants iEPO: Subject will receive inhaled Epoprostrenol in this intervention	Heart Transplant & LVAD Implantation With iNO n=111 Participants iNO: Subjects will receive inhaled Nitric Oxide in this intervention	Heart Transplant & LVAD Implantation With iEPO n=119 Participants iEPO: Subjects will receive inhaled Epoprostrenol in this intervention
Duration of Postoperative Mechanical Ventilation	17 hours Interval 12.0 to 47.0	18 hours Interval 13.0 to 44.0	26 hours Interval 12.0 to 48.0	24 hours Interval 11.0 to 53.0

SECONDARY outcome

Timeframe: up to approximately 30 days after index surgery

Data reflects a per patient cost in dollars that has been scaled to a unit of measure relative to the cost per hour of drug and multiplied by the duration of iPVD administration. In our study, iNO cost 7 times that of iEPO per hour, hence for each patient this outcome value is the duration of iPVD administration multiplied by 7 if a patient is randomized to iNO or multiplied by 1 if randomized to iEPO.

Outcome measures

Measure	Lung Transplant With iNO n=98 Participants iNO: Subject will receive inhaled Nitric Oxide in this intervention	Lung Transplant With iEPO n=103 Participants iEPO: Subject will receive inhaled Epoprostrenol in this intervention	Heart Transplant & LVAD Implantation With iNO n=111 Participants iNO: Subjects will receive inhaled Nitric Oxide in this intervention	Heart Transplant & LVAD Implantation With iEPO n=120 Participants iEPO: Subjects will receive inhaled Epoprostrenol in this intervention
Per Patient Inhaled Pulmonary Vasodilator (iPVD) Cost	544 relative cost units Standard Deviation 513	70 relative cost units Standard Deviation 70	772 relative cost units Standard Deviation 554	114 relative cost units Standard Deviation 121

SECONDARY outcome

Timeframe: up to approximately 90 days after index surgery

Length of time from ICU admission from surgery until ICU discharge

Outcome measures

Measure	Lung Transplant With iNO n=98 Participants iNO: Subject will receive inhaled Nitric Oxide in this intervention	Lung Transplant With iEPO n=103 Participants iEPO: Subject will receive inhaled Epoprostrenol in this intervention	Heart Transplant & LVAD Implantation With iNO n=111 Participants iNO: Subjects will receive inhaled Nitric Oxide in this intervention	Heart Transplant & LVAD Implantation With iEPO n=120 Participants iEPO: Subjects will receive inhaled Epoprostrenol in this intervention
Length of ICU Stay	4 days Interval 2.0 to 10.0	4 days Interval 2.0 to 10.0	6 days Interval 4.0 to 11.0	6 days Interval 4.0 to 11.0

SECONDARY outcome

Timeframe: up to approximately 1 year after index surgery

Length of time from surgery to hospital discharge

Outcome measures

Measure	Lung Transplant With iNO n=98 Participants iNO: Subject will receive inhaled Nitric Oxide in this intervention	Lung Transplant With iEPO n=103 Participants iEPO: Subject will receive inhaled Epoprostrenol in this intervention	Heart Transplant & LVAD Implantation With iNO n=111 Participants iNO: Subjects will receive inhaled Nitric Oxide in this intervention	Heart Transplant & LVAD Implantation With iEPO n=120 Participants iEPO: Subjects will receive inhaled Epoprostrenol in this intervention
Length of Hospital Stay	23 days Interval 16.0 to 38.0	23 days Interval 15.0 to 38.0	16 days Interval 12.0 to 30.0	17 days Interval 11.0 to 28.0

SECONDARY outcome

Timeframe: up to approximately 14 days

defined by Modified KDIGO-AKI definition:

• Increase in Serum Creatinine (Cr) by ≥0.3mg/dL within 48 hours; or
• Increase in Cr to ≥1.5 times baseline
• Urine output is not included as urine could be under-captured after Foley catheter removal

Outcome measures

Measure	Lung Transplant With iNO n=98 Participants iNO: Subject will receive inhaled Nitric Oxide in this intervention	Lung Transplant With iEPO n=103 Participants iEPO: Subject will receive inhaled Epoprostrenol in this intervention	Heart Transplant & LVAD Implantation With iNO n=111 Participants iNO: Subjects will receive inhaled Nitric Oxide in this intervention	Heart Transplant & LVAD Implantation With iEPO n=120 Participants iEPO: Subjects will receive inhaled Epoprostrenol in this intervention
Number of Participants With Acute Kidney Injury	72 Participants	68 Participants	96 Participants	101 Participants

SECONDARY outcome

Timeframe: up to approximately 1 year after index surgery

Death that occurs during the hospital stay

Outcome measures

Measure	Lung Transplant With iNO n=98 Participants iNO: Subject will receive inhaled Nitric Oxide in this intervention	Lung Transplant With iEPO n=103 Participants iEPO: Subject will receive inhaled Epoprostrenol in this intervention	Heart Transplant & LVAD Implantation With iNO n=111 Participants iNO: Subjects will receive inhaled Nitric Oxide in this intervention	Heart Transplant & LVAD Implantation With iEPO n=120 Participants iEPO: Subjects will receive inhaled Epoprostrenol in this intervention
Number of Participants With In-hospital Mortality	5 Participants	7 Participants	6 Participants	11 Participants

SECONDARY outcome

Timeframe: up to approximately 30 days after index surgery

From the day of surgery to 30 days postoperatively.

Outcome measures

Measure	Lung Transplant With iNO n=98 Participants iNO: Subject will receive inhaled Nitric Oxide in this intervention	Lung Transplant With iEPO n=103 Participants iEPO: Subject will receive inhaled Epoprostrenol in this intervention	Heart Transplant & LVAD Implantation With iNO n=111 Participants iNO: Subjects will receive inhaled Nitric Oxide in this intervention	Heart Transplant & LVAD Implantation With iEPO n=120 Participants iEPO: Subjects will receive inhaled Epoprostrenol in this intervention
Number of Participants With Post-operative Mortality Within 30 Days	2 Participants	1 Participants	4 Participants	7 Participants

SECONDARY outcome

Timeframe: up to approximately 90 days after index surgery

From the day of surgery to 90 days after index surgery

Outcome measures

Measure	Lung Transplant With iNO n=98 Participants iNO: Subject will receive inhaled Nitric Oxide in this intervention	Lung Transplant With iEPO n=103 Participants iEPO: Subject will receive inhaled Epoprostrenol in this intervention	Heart Transplant & LVAD Implantation With iNO n=111 Participants iNO: Subjects will receive inhaled Nitric Oxide in this intervention	Heart Transplant & LVAD Implantation With iEPO n=120 Participants iEPO: Subjects will receive inhaled Epoprostrenol in this intervention
Number of Participants With Post-operative Mortality Within 90 Days	4 Participants	4 Participants	5 Participants	12 Participants

Adverse Events

Lung Transplant With iNO

Serious events: 9 serious events

Other events: 42 other events

Deaths: 9 deaths

Lung Transplant With iEPO

Serious events: 10 serious events

Other events: 41 other events

Deaths: 10 deaths

Heart Transplant & LVAD Implantation With iNO

Serious events: 10 serious events

Other events: 40 other events

Deaths: 10 deaths

Heart Transplant & LVAD Implantation With iEPO

Serious events: 21 serious events

Other events: 48 other events

Deaths: 21 deaths

Serious adverse events

Measure	Lung Transplant With iNO n=98 participants at risk iNO: Subject will receive inhaled Nitric Oxide in this intervention	Lung Transplant With iEPO n=103 participants at risk iEPO: Subject will receive inhaled Epoprostrenol in this intervention	Heart Transplant & LVAD Implantation With iNO n=111 participants at risk iNO: Subject will receive inhaled Nitric Oxide in this intervention	Heart Transplant & LVAD Implantation With iEPO n=120 participants at risk iEPO: Subject will receive inhaled Epoprostrenol in this intervention
General disorders All Cause Mortality	9.2% 9/98 • Number of events 9 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	9.7% 10/103 • Number of events 10 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	9.0% 10/111 • Number of events 10 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	17.5% 21/120 • Number of events 21 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.

Other adverse events

Measure	Lung Transplant With iNO n=98 participants at risk iNO: Subject will receive inhaled Nitric Oxide in this intervention	Lung Transplant With iEPO n=103 participants at risk iEPO: Subject will receive inhaled Epoprostrenol in this intervention	Heart Transplant & LVAD Implantation With iNO n=111 participants at risk iNO: Subject will receive inhaled Nitric Oxide in this intervention	Heart Transplant & LVAD Implantation With iEPO n=120 participants at risk iEPO: Subject will receive inhaled Epoprostrenol in this intervention
Blood and lymphatic system disorders Venous Thromboemolic DVT	27.6% 27/98 • Number of events 27 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	20.4% 21/103 • Number of events 21 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	18.9% 21/111 • Number of events 21 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	23.3% 28/120 • Number of events 28 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.
Blood and lymphatic system disorders Venous Thromboembolic PE	5.1% 5/98 • Number of events 5 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	9.7% 10/103 • Number of events 10 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	3.6% 4/111 • Number of events 4 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	3.3% 4/120 • Number of events 4 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.
Blood and lymphatic system disorders Venous Thromboembolic Other	13.3% 13/98 • Number of events 13 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	9.7% 10/103 • Number of events 10 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	7.2% 8/111 • Number of events 8 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	14.2% 17/120 • Number of events 17 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.
Blood and lymphatic system disorders Arterial Thromboembolic TIA	0.00% 0/98 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	1.9% 2/103 • Number of events 2 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	0.90% 1/111 • Number of events 1 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	0.83% 1/120 • Number of events 1 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.
Blood and lymphatic system disorders Arterial Thromboembolic CVA/Stroke	6.1% 6/98 • Number of events 6 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	1.9% 2/103 • Number of events 2 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	6.3% 7/111 • Number of events 7 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	6.7% 8/120 • Number of events 8 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.
Blood and lymphatic system disorders Arterial Thromboembolic Myocardial Infarction	2.0% 2/98 • Number of events 2 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	3.9% 4/103 • Number of events 4 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	0.90% 1/111 • Number of events 1 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	0.00% 0/120 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.
Blood and lymphatic system disorders Arterial Thromboembolic Mesenteric Ischemia	3.1% 3/98 • Number of events 3 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	1.9% 2/103 • Number of events 2 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	1.8% 2/111 • Number of events 2 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	3.3% 4/120 • Number of events 4 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.
Blood and lymphatic system disorders Arterial Thromboembolic Other	0.00% 0/98 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	1.9% 2/103 • Number of events 2 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	2.7% 3/111 • Number of events 3 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	2.5% 3/120 • Number of events 3 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.
Blood and lymphatic system disorders LVAD Thrombosis	0.00% 0/98 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	0.00% 0/103 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	0.90% 1/111 • Number of events 1 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	0.83% 1/120 • Number of events 1 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.
Cardiac disorders New Onset Atrial Fibrillation	11.2% 11/98 • Number of events 11 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	17.5% 18/103 • Number of events 18 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	9.0% 10/111 • Number of events 10 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	7.5% 9/120 • Number of events 9 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.
Gastrointestinal disorders Upper GI Bleed	2.0% 2/98 • Number of events 2 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	4.9% 5/103 • Number of events 5 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	3.6% 4/111 • Number of events 4 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	5.0% 6/120 • Number of events 6 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.
Gastrointestinal disorders Lower GI Bleed	1.0% 1/98 • Number of events 1 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	3.9% 4/103 • Number of events 4 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	1.8% 2/111 • Number of events 2 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	5.0% 6/120 • Number of events 6 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.
Gastrointestinal disorders Intestinal Perforation	0.00% 0/98 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	2.9% 3/103 • Number of events 3 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	0.90% 1/111 • Number of events 1 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.	1.7% 2/120 • Number of events 2 • Collected from surgery to one year. Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment. Due to the nature of the study design, comparative trial evaluating two standard of care medications, the only SAE reported is mortality at specified intervals.

Additional Information

Kamrouz Ghadimi, M.D., M.H.Sc.

Duke University

Phone: 919-681-6532

Email: kamrouz.ghadimi@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place