Trial Outcomes & Findings for PRESSUREwire Study (NCT NCT02935088)

Last Updated: 2020-02-07

Results Overview

Major adverse cardiac events (MACE) is defined as a 12-month composite, including all cause death, documented non-fatal myocardial infarction, and unplanned hospitalization leading to urgent revascularization. Fisher Exact test will be performed to evaluate the association between 12-month MACE event and binary FFR variables respectively using the following FFR; Low FFR group (FFR ≤ 0.8) and high FFR group (FFR \> 0.8).

Recruitment status

COMPLETED

Target enrollment

2217 participants

Primary outcome timeframe

12 months

Results posted on

2020-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	FFR-guided PCI Patients Patients presented with either stable coronary artery disease (CAD) or acute coronary syndrome (ACS) who is undergoing Fractional flow reserve (FFR)-guided percutaneous intervention (PCI) procedure
Overall Study STARTED	2217
Overall Study COMPLETED	2115
Overall Study NOT COMPLETED	102

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PRESSUREwire Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FFR-guided PCI Patients n=2217 Participants Patients presented with either stable coronary artery disease (CAD) or acute coronary syndrome (ACS) who are undergoing fractional flow reserve (FFR)-guided Percutaneous intervention (PCI)
Age, Continuous	65.5 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	653 Participants n=5 Participants
Sex: Female, Male Male	1564 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	326 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	46 Participants n=5 Participants
Race (NIH/OMB) White	1681 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	162 Participants n=5 Participants
Region of Enrollment United States	250 participants n=5 Participants
Region of Enrollment Japan	165 participants n=5 Participants
Region of Enrollment Egypt	30 participants n=5 Participants
Region of Enrollment United Kingdom	176 participants n=5 Participants
Region of Enrollment Portugal	29 participants n=5 Participants
Region of Enrollment Spain	43 participants n=5 Participants
Region of Enrollment India	97 participants n=5 Participants
Region of Enrollment Greece	26 participants n=5 Participants
Region of Enrollment Saudi Arabia	56 participants n=5 Participants
Region of Enrollment Canada	57 participants n=5 Participants
Region of Enrollment Austria	39 participants n=5 Participants
Region of Enrollment Netherlands	785 participants n=5 Participants
Region of Enrollment Italy	138 participants n=5 Participants
Region of Enrollment Germany	295 participants n=5 Participants
Region of Enrollment Estonia	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The denominators used in the calculations of adverse event rates will be determined according to the analysis population excluding subjects who are lost to follow-up through given time point without events.

Outcome measures

Outcome measures
Measure	FFR <= 0.80 n=794 Participants Patients who had an FFR \<= 0.80	FFR > 0.8 n=1394 Participants Patients who had an FFR \> 0.80
Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices MACE	50 Participants	51 Participants
Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices Death	19 Participants	30 Participants
Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices Myocardial infarction	20 Participants	23 Participants
Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices Urgent revascularization	23 Participants	17 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: at time of procedure

Population: The number of participants and lesions analyzed were based on the number of participants underwent both FFR and Pd/Pa measurements for this Outcome Measure

Linear correlation will be used for continuous variables to examine agreement between FFR values and resting indices.

Outcome measures

Outcome measures
Measure	FFR <= 0.80 n=2644 Lesion Patients who had an FFR \<= 0.80	FFR > 0.8 Patients who had an FFR \> 0.80
Correlation of Resting Indices With FFR Values	0.55 correlation coefficient	—

OTHER_PRE_SPECIFIED outcome

Timeframe: at time of procedure

Treatment decision was defined as "changed" if there is at least one decision change based on FFR for multiple lesions; if none of the decisions was changed for the multiple lesions, the treatment decision is defined as "unchanged".

Outcome measures

Outcome measures
Measure	FFR <= 0.80 n=2196 Participants Patients who had an FFR \<= 0.80	FFR > 0.8 Patients who had an FFR \> 0.80
Number of Subjects Who Had a Change in Treatment Plan When FFR is Used Compared to the Initial Decision Based on Angiography Alone	763 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Number of subjects with 12-Month Clinical Outcomes (MACE) Major Adverse Cardiac Events of Follow-up subjects in whom the use of FFR did not lead to a change in treatment decision vs subjects in whom the use of FFR led to a change in treatment decision.

Outcome measures

Outcome measures
Measure	FFR <= 0.80 n=760 Participants Patients who had an FFR \<= 0.80	FFR > 0.8 n=1428 Participants Patients who had an FFR \> 0.80
Number of Subjects With 12-Month Clinical Outcomes (MACE) Major Adverse Cardiac Events of Follow-up Subjects in Whom the Use of FFR Did Not Lead to a Change in Treatment Decision vs Subjects in Whom the Use of FFR Led to a Change in Treatment Decision MACE	33 Participants	68 Participants
Number of Subjects With 12-Month Clinical Outcomes (MACE) Major Adverse Cardiac Events of Follow-up Subjects in Whom the Use of FFR Did Not Lead to a Change in Treatment Decision vs Subjects in Whom the Use of FFR Led to a Change in Treatment Decision Death	16 Participants	33 Participants
Number of Subjects With 12-Month Clinical Outcomes (MACE) Major Adverse Cardiac Events of Follow-up Subjects in Whom the Use of FFR Did Not Lead to a Change in Treatment Decision vs Subjects in Whom the Use of FFR Led to a Change in Treatment Decision Myocardial infarction	10 Participants	22 Participants
Number of Subjects With 12-Month Clinical Outcomes (MACE) Major Adverse Cardiac Events of Follow-up Subjects in Whom the Use of FFR Did Not Lead to a Change in Treatment Decision vs Subjects in Whom the Use of FFR Led to a Change in Treatment Decision Urgent revascularization	14 Participants	26 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Number of subjects with 12-month clinical outcomes (MACE) by other PressureWire-derived indices (contrast FFR). Major adverse cardiac events (MACE) is defined as a 12-month composite, including all cause death, documented non-fatal myocardial infarction, and unplanned hospitalization leading to urgent revascularization.

Outcome measures

Outcome measures
Measure	FFR <= 0.80 n=320 Participants Patients who had an FFR \<= 0.80	FFR > 0.8 n=1684 Participants Patients who had an FFR \> 0.80
Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR) MACE	28 Participants	67 Participants
Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR) Death	9 Participants	35 Participants
Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR) Myocardial infarction	13 Participants	20 Participants
Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR) Urgent revascularization	17 Participants	21 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: at time of procedure

Population: The number of participants and lesions analyzed were based on the number of participants underwent both FFR and cFFR measurements for this Outcome Measure

Linear correlation of FFR and contrast FFR (cFFR). Only subjects that had both FFR and cFFR were used in the analysis.

Outcome measures

Outcome measures
Measure	FFR <= 0.80 n=659 Lesion Patients who had an FFR \<= 0.80	FFR > 0.8 Patients who had an FFR \> 0.80
Correlation of Other PressureWire-derived Index, Contrast FFR With FFR Values	0.77 correlation coefficient	—

Adverse Events

FFR-guided PCI Patients

Serious events: 107 serious events

Other events: 114 other events

Deaths: 50 deaths

Serious adverse events

Serious adverse events
Measure	FFR-guided PCI Patients n=2217 participants at risk Patients presented with either stable coronary artery disease (CAD) or acute coronary syndrome (ACS)
Blood and lymphatic system disorders Blood and lymphatic system disorders	0.14% 3/2217 • Number of events 3 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Cardiac disorders Cardiac disorders	3.2% 71/2217 • Number of events 71 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Gastrointestinal disorders Gastrointestinal disorders	0.18% 4/2217 • Number of events 4 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
General disorders General disorders	0.45% 10/2217 • Number of events 10 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Infections and infestations Infections and infestations	0.18% 4/2217 • Number of events 4 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	0.05% 1/2217 • Number of events 1 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.36% 8/2217 • Number of events 8 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Nervous system disorders Nervous system disorders	0.14% 3/2217 • Number of events 3 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Renal and urinary disorders Renal and urinary disorders	0.09% 2/2217 • Number of events 2 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.23% 5/2217 • Number of events 5 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Surgical and medical procedures Acute Aneurysm Abdominalis	0.05% 1/2217 • Number of events 1 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Vascular disorders Vascular disorders	0.27% 6/2217 • Number of events 6 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.

Other adverse events

Other adverse events
Measure	FFR-guided PCI Patients n=2217 participants at risk Patients presented with either stable coronary artery disease (CAD) or acute coronary syndrome (ACS)
Blood and lymphatic system disorders Blood and lymphatic system disorders	0.14% 3/2217 • Number of events 3 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Cardiac disorders Cardiac disorders	3.5% 77/2217 • Number of events 77 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Gastrointestinal disorders Gastrointestinal disorders	0.18% 4/2217 • Number of events 4 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
General disorders General disorders	0.45% 10/2217 • Number of events 10 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Infections and infestations Infections and infestations	0.18% 4/2217 • Number of events 4 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Injury, poisoning and procedural complications Dissection	0.05% 1/2217 • Number of events 1 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.36% 8/2217 • Number of events 8 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Nervous system disorders Nervous system disorders	0.14% 3/2217 • Number of events 3 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Renal and urinary disorders Renal Failure	0.09% 2/2217 • Number of events 2 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.23% 5/2217 • Number of events 5 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Surgical and medical procedures Acute Aneurysm Abdominalis	0.05% 1/2217 • Number of events 1 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
Vascular disorders Vascular disorders	0.32% 7/2217 • Number of events 7 • 12 months Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.

Additional Information

Tarn Teraphongphom, Sr. Clinical Scientist

Abbott Vascular

Phone: 408-9310504

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place