Aortic Stenosis, Coronary Artery Disease
Conditions
Brief summary
Although concomitant coronary artery disease (CAD) is frequent in patients with severe aortic stenosis (AS), hemodynamic assessment of CAD severity in patients undergoing valve replacement for severe AS is challenging. Myocardial hypertrophic remodeling interferes with coronary blood flow and may influence the values of fractional flow reserve (FFR) and nonhyperemic pressure ratios (NHPRs). The aim of the current study is to investigate the effect of the AS and its treatment on current indices used for evaluation of CAD. The investigators will compare intracoronary hemodynamics before, immediately after, and 6 mo after aortic valve replacement (AVR) when it is expected that microvascular function has improved. Furthermore, the investigators will compare FFR and resting full-cycle ratio (RFR) with myocardial perfusion single-photon emission-computed tomography (SPECT) as indicators of myocardial ischemia in patients with AS and CAD. One-hundred consecutive patients with AS and intermediate CAD will be prospectively included. Patients will undergo pre-AVR SPECT and intracoronary hemodynamic assessment at baseline, immediately after valve replacement \[if transcatheter AVR (TAVR) is chosen\], and 6 mo after AVR. The primary end point is the change in FFR 6 mo after AVR. Secondary end points include the acute change of FFR after TAVR, the diagnostic accuracy of FFR versus RFR compared with SPECT for the assessment of ischemia, changes in microvascular function as assessed by the index of microcirculatory resistance (IMR), and the effect of these changes on FFR. The present study will evaluate intracoronary hemodynamic parameters before, immediately after, and 6 mo after AVR in patients with AS and intermediate coronary stenosis. The understanding of the impact of AVR on the assessment of FFR, NHPR, and microvascular function may help guide the need for revascularization in patients with AS and CAD planned for AVR.
Detailed description
https://journals.physiology.org/doi/full/10.1152/ajpheart.00541.2021?rfr\_dat=cr\_pub++0pubmed&url\_ver=Z39.88-2003&rfr\_id=ori%3Arid%3Acrossref.org
Interventions
None listed
Sponsors
AZ Delta
University Hospital, Antwerp
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Patient undergoing the procedure is older than 18 years, has severe aortic valve stenosis (according to ESC guidelines) and is planned for cardiac catheterization as part of the pre-operative (SAVR) or pre-percutaneous (TAVI) work up. 2\. The patient has an intermediate (50-90%) coronary lesion that requires further evaluation. 3\. The patient undergoing the procedure is male, or if female, has no childbearing potential or is not pregnant.
Exclusion criteria
1. The procedure is an emergency and/or the patient is unstable. 2. Pregnancy or lactation 3. Haemodynamically unstable patients 4. Killip class III-IV heart failure 5. Previous coronary artery by-pass in the artery being assessed 6. Contra-indications for adenosine administration: severe asthma or pre-existing type 2 AV-block 7. No significant coronary artery disease (\<50% stenosis on angiography). 8. Critical coronary artery disease deemed by the Heart Team to require immediate revascularization 9. Patients will be excluded from the SPECT study (secondary objective) if they have a left main coronary stenosis \>50%, triple vessel disease, previous myocardial infarction in the same coronary artery & tandem lesions (separated by \>10mm) requiring independent evaluation in the same coronary artery since these factors interfere with the SPECT analysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FFR 6 Months After SAVR/TAVI. | 6 months | Aortic valve intervention can potentially result in a change in fractional flow reserve (FFR) 6 months after SAVR/TAVI. FFR is the ratio of two intra-coronary measurements (Distal coronary pressure divided by proximal coronary pressure) and can range from 0.0-1.0. A lower FFR means that the lesion is more severe and therefore a higher FFR is considered better. The threshold to speak about hemodynamic significant of a lesion is 0.80. If the lesion has an FFR of ≤ 0.80 means the lesions is significant and treatment is necessary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IMR 6 Months After SAVR/TAVI. | 6 months | Measurement of IMR in patients with AS prior to intervention and 6 months after TAVI/SAVR. IMR is unitless and gives a description of coronary microvascular resistance, it can range from 0-100. Lower values are considered better as they are related with better microvascular function and health. If the IMR \> 25 we say microvascular dysfunction is present and treatment is considered necessary. |
| FFR Versus RFR to Determine Ischemia. | Baseline | Comparison of the diagnostic performance of FFR versus RFR compared with SPECT ischemia. The higher the Area under the curve the better. The range is 0.0-1.0. An area under the curve for a ROC model is considered excellent if \> 0.8. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Patients with AS undergoing TAVI or SAVR | 116 |
| Total | 116 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 110 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 79.48 years STANDARD_DEVIATION 8.18 |
| Race/Ethnicity, Customized White | 116 Participants |
| Region of Enrollment Belgium | 116 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 116 |
| other Total, other adverse events | 0 / 116 |
| serious Total, serious adverse events | 0 / 116 |
Outcome results
Primary
FFR 6 Months After SAVR/TAVI.
Aortic valve intervention can potentially result in a change in fractional flow reserve (FFR) 6 months after SAVR/TAVI. FFR is the ratio of two intra-coronary measurements (Distal coronary pressure divided by proximal coronary pressure) and can range from 0.0-1.0. A lower FFR means that the lesion is more severe and therefore a higher FFR is considered better. The threshold to speak about hemodynamic significant of a lesion is 0.80. If the lesion has an FFR of ≤ 0.80 means the lesions is significant and treatment is necessary.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Entire Study Population | FFR 6 Months After SAVR/TAVI. | -0.0279 ratio | Standard Deviation 0.0368 |
Secondary
FFR Versus RFR to Determine Ischemia.
Comparison of the diagnostic performance of FFR versus RFR compared with SPECT ischemia. The higher the Area under the curve the better. The range is 0.0-1.0. An area under the curve for a ROC model is considered excellent if \> 0.8.
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Entire Study Population | FFR Versus RFR to Determine Ischemia. | 0.8719 probability |
Secondary
IMR 6 Months After SAVR/TAVI.
Measurement of IMR in patients with AS prior to intervention and 6 months after TAVI/SAVR. IMR is unitless and gives a description of coronary microvascular resistance, it can range from 0-100. Lower values are considered better as they are related with better microvascular function and health. If the IMR \> 25 we say microvascular dysfunction is present and treatment is considered necessary.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Entire Study Population | IMR 6 Months After SAVR/TAVI. | -2.8150 Unitless | Standard Deviation 12.16 |