Coronary Artery Disease
Conditions
Brief summary
Despite the routine use of procedural anti-coagulation and anti-platelet therapy for FFR calculation, no study has evaluated the optimal anti-thrombotic regimen in patients undergoing FFR. Therefore, the aim of the Evaluation of Simplified Anti-Thrombotic Therapy for Coronary Fractional Flow Reserve (SMART-FFR) study was to evaluate the safety of using a simplified anti-thrombotic regimen with only upstream dual anti-platelet therapy (DAT) with aspirin and clopidogrel, compared with anticoagulation plus single- or- DAT therapy in patients with intermediate coronary artery stenosis undergoing FFR calculation during elective coronary angiography.
Interventions
PROCEDUREFFR
Fractional flow reserve tracings were calculated using a Volcano pressure wire intra-coronary system after ensuring proper calibration of the aortic pressure transducer and the guidewire, using 6 Fr-guide catheters. Before crossing the stenosis, baseline pressure was measured by the guide catheter and the pressure guidewire were equalized according to the manufacturer's specifications. After advancing the pressure sensor across the stenosis, coronary hyperemia was induced using intravenous adenosine (140μg/kg/min until a steady state was reached for at least 3 minutes). Fractional flow reserve was considered positive if it was less than 0.80.
DRUGAspirin
All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
DRUGClopidogrel
All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure
DRUGBivalirudin
Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure
Sponsors
Odessa Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Healthy volunteers
No
Inclusion criteria
* All patient regardless of sex, or age were eligible for the study if they were scheduled for an elective coronary angiography using a femoral approach, and were agreeable to participate in the study after signing informed consent, and had a coronary stenosis in any major native epicardial coronary artery between 50-70% determined by quantitative angiography that was an adequate target for FFR at the discretion of the operator.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Thrombotic Complications | Hospital Stay and after 30 days post PCI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores | Hospital Stay and after 30 days post PCI | 1. Major: Intracranial bleeding, Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or a ≥15% absolute decrease in haematocrit or Fatal bleeding. 2. Minor: Clinically overt (including imaging), resulting in hemoglobin drop of 3 to \<5 g/dL or ≥10% decrease in haematocrit. No observed blood loss: ≥4 g/dL decrease in the haemoglobin concentration or ≥12% decrease in haematocrit Any overt sign of hemorrhage that meets one of the following criteria and does not meet criteria for a major or minor bleeding event, as defined above Requiring intervention |
| Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure | 48 hours post procedure | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Upstream Aspirin + Clopidrogel Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure | 100 |
| Group 2: Upstream Aspirin and Clopidrogel Plus Bivalirudin Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure
Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure | 100 |
| Group 3: Upstream Aspirin Plus Bivalirudin Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure | 100 |
| Total | 300 |
Baseline characteristics
| Characteristic | Group 1: Upstream Aspirin + Clopidrogel | Group 2: Upstream Aspirin and Clopidrogel Plus Bivalirudin | Group 3: Upstream Aspirin Plus Bivalirudin | Total |
|---|---|---|---|---|
| Age, Continuous | 62 Years STANDARD_DEVIATION 9 | 65 Years STANDARD_DEVIATION 10 | 63 Years STANDARD_DEVIATION 8 | 64 Years STANDARD_DEVIATION 3 |
| Gender Female | 38 Participants | 39 Participants | 35 Participants | 112 Participants |
| Gender Male | 62 Participants | 61 Participants | 65 Participants | 188 Participants |
| Region of Enrollment United States | 100 participants | 100 participants | 100 participants | 300 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 100 | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 | 0 / 100 |
Outcome results
Primary
Thrombotic Complications
Time frame: Hospital Stay and after 30 days post PCI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Thrombotic Complications | 0 Number of Patients |
| Group 2 | Thrombotic Complications | 0 Number of Patients |
| Group 3 | Thrombotic Complications | 0 Number of Patients |
p-value: 1ANOVA
p-value: 1ANOVA
Secondary
Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure
Time frame: 48 hours post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure | 0 participants |
| Group 2 | Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure | 0 participants |
| Group 3 | Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure | 0 participants |
Secondary
TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores
1. Major: Intracranial bleeding, Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or a ≥15% absolute decrease in haematocrit or Fatal bleeding. 2. Minor: Clinically overt (including imaging), resulting in hemoglobin drop of 3 to \<5 g/dL or ≥10% decrease in haematocrit. No observed blood loss: ≥4 g/dL decrease in the haemoglobin concentration or ≥12% decrease in haematocrit Any overt sign of hemorrhage that meets one of the following criteria and does not meet criteria for a major or minor bleeding event, as defined above Requiring intervention
Time frame: Hospital Stay and after 30 days post PCI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores | 1 Patients |
| Group 2 | TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores | 3 Patients |
| Group 3 | TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores | 1 Patients |