Acute Coronary Syndrome, Coronary Artery Disease
Conditions
Keywords
FFR, Percutaneous coronary intervention
Brief summary
The purpose of this study is to understand routine use of FFR (Fractional Flow Reserve) and alternate indices in clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease, or in patients presenting with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during index and secondary procedures.
Detailed description
The purpose of this study is to understand routine use of FFR and alternate indices in clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease, or in patients presenting with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during index and secondary procedures. The study will also collect data on the routine use of coronary physiologic measurements such as adenosine-induced hyperemia FFR, FFR by contrast-induced hyperemia,
Interventions
DEVICEFractional Flow Reserve
Measurement of physiologic parameters
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is presenting with STEMI, NSTEMI, unstable angina, or stable coronary artery disease * Patient is planned to have FFR performed or underwent a cardiac catheterization where FFR was performed for further PCI (Percutaneous Cardiac Intervention) consideration * Patient signs and dates written informed consent * Patient is eighteen years of age or older at the time of consent
Exclusion criteria
* Patient has extremely tortuous or calcified coronary arteries * Patient with a patent coronary artery bypass graft to the target vessel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices | 12 months | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation of Resting Indices With FFR Values | at time of procedure | Linear correlation will be used for continuous variables to examine agreement between FFR values and resting indices. |
| Number of Subjects Who Had a Change in Treatment Plan When FFR is Used Compared to the Initial Decision Based on Angiography Alone | 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. |
| 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 | 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. |
| Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR) | 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. |
| Correlation of Other PressureWire-derived Index, Contrast FFR With FFR Values | at time of procedure | Linear correlation of FFR and contrast FFR (cFFR). Only subjects that had both FFR and cFFR were used in the analysis. |
Countries
Austria, Canada, Egypt, Estonia, Germany, Greece, India, Italy, Japan, Netherlands, Portugal, Saudi Arabia, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FFR-guided PCI Patients 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) | 2,217 |
| Total | 2,217 |
Baseline characteristics
| Characteristic | FFR-guided PCI Patients |
|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 10.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 326 Participants |
| Race (NIH/OMB) Black or African American | 46 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 162 Participants |
| Race (NIH/OMB) White | 1681 Participants |
| Region of Enrollment Austria | 39 participants |
| Region of Enrollment Canada | 57 participants |
| Region of Enrollment Egypt | 30 participants |
| Region of Enrollment Estonia | 31 participants |
| Region of Enrollment Germany | 295 participants |
| Region of Enrollment Greece | 26 participants |
| Region of Enrollment India | 97 participants |
| Region of Enrollment Italy | 138 participants |
| Region of Enrollment Japan | 165 participants |
| Region of Enrollment Netherlands | 785 participants |
| Region of Enrollment Portugal | 29 participants |
| Region of Enrollment Saudi Arabia | 56 participants |
| Region of Enrollment Spain | 43 participants |
| Region of Enrollment United Kingdom | 176 participants |
| Region of Enrollment United States | 250 participants |
| Sex: Female, Male Female | 653 Participants |
| Sex: Female, Male Male | 1564 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 50 / 2,217 |
| other Total, other adverse events | 114 / 2,217 |
| serious Total, serious adverse events | 107 / 2,217 |
Outcome results
Primary
Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices
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).
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 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 |
| FFR <= 0.80 | Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices | Death | 19 Participants |
| FFR <= 0.80 | Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices | Myocardial infarction | 20 Participants |
| FFR <= 0.80 | Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices | Urgent revascularization | 23 Participants |
| FFR > 0.8 | Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices | Urgent revascularization | 17 Participants |
| FFR > 0.8 | Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices | MACE | 51 Participants |
| FFR > 0.8 | Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices | Myocardial infarction | 23 Participants |
| FFR > 0.8 | Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices | Death | 30 Participants |
Other Pre-specified
Correlation of Other PressureWire-derived Index, Contrast FFR With FFR Values
Linear correlation of FFR and contrast FFR (cFFR). Only subjects that had both FFR and cFFR were used in the analysis.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FFR <= 0.80 | Correlation of Other PressureWire-derived Index, Contrast FFR With FFR Values | 0.77 correlation coefficient |
Other Pre-specified
Correlation of Resting Indices With FFR Values
Linear correlation will be used for continuous variables to examine agreement between FFR values and resting indices.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FFR <= 0.80 | Correlation of Resting Indices With FFR Values | 0.55 correlation coefficient |
Other Pre-specified
Number of Subjects Who Had a Change in Treatment Plan When FFR is Used Compared to the Initial Decision Based on Angiography Alone
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.
Time frame: at time of procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 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
Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR)
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FFR <= 0.80 | Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR) | Myocardial infarction | 13 Participants |
| FFR <= 0.80 | Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR) | MACE | 28 Participants |
| FFR <= 0.80 | Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR) | Urgent revascularization | 17 Participants |
| FFR <= 0.80 | Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR) | Death | 9 Participants |
| FFR > 0.8 | Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR) | Urgent revascularization | 21 Participants |
| FFR > 0.8 | Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR) | MACE | 67 Participants |
| FFR > 0.8 | Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR) | Myocardial infarction | 20 Participants |
| FFR > 0.8 | Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR) | Death | 35 Participants |
Other Pre-specified
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 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 |
| 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 | Death | 16 Participants |
| 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 | Myocardial infarction | 10 Participants |
| 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 | Urgent revascularization | 14 Participants |
| FFR > 0.8 | 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 | 26 Participants |
| FFR > 0.8 | 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 | 68 Participants |
| FFR > 0.8 | 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 | 22 Participants |
| FFR > 0.8 | 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 | 33 Participants |