Aortic Valve Stenosis, Coronary Artery Disease
Conditions
Brief summary
The aim of this study is to compare the clinical outcome of patients with severe aortic valve stenosis and associated significant coronary artery disease treated with TAVI and a percutaneous myocardial revascularization dictated according to two different strategies: 1. the Angiographically-guided strategy; 2. the Physiologically-guided strategy.
Detailed description
Nowadays there are no clear recommendations about treatment of coronary in patients with severe aortic valve stenosis eligible for percutaneous valve replacement, and those available rely on a common sense, class C, level of evidence. No randomized trials debride the skein about the best strategy of revascularization in this complex group of patients. In particular, it remains unclear whether it is preferable a preventive treatment or an ischemia-driven revascularization and, in addition, if it is safer and better for patient's health a simultaneous or a staged strategy. The aim of this study is to compare the clinical outcome of patients with severe aortic valve stenosis and associated significant coronary artery disease treated with TAVI and a percutaneous myocardial revascularization dictated according to two different strategies. The Angiographically-guided strategy is that of aiming the most complete degree of revascularization based on angiographic evaluation (stenting all coronary stenosis of major branches \>2.5mm, with a %DS\>50% as evaluated by visual estimation). The Physiologically-guided strategy is that of treating only lesions with FFR ≤0.80, and leaving on optimal medical treatment lesions with FFR \>0.80. The iFR values will be recorded in all patients, and verified in the core laboratory to allow a post-hoc analysis correlating the 0.80 FFR cut-off with different iFR cut-off values, according to recent observations and using the same study end-points. Particular attention will be dedicated to the eventual occurrence of clinical events in patients deferred on the bases of FFR values \>0.80 that show a discrepancy with positive (\<0.89) iFR values to investigate the reliability of the FFR in the Aortic Stenosis setting. Both groups will receive the same TAVI strategy and optimal medical therapy. The study is designed as randomized, prospective, multi.center, open label, experimental trial with medical device. After discharge patients will be contacted at 30 days, 6 - 12 and 24 months after the procedure to assess the general clinical status and at 12 months to assess the occurrence of events included in the primary and secondary endpoints. The duration of study participation is 24 months for enrolment, ad 24 months for final follow-up.
Interventions
DEVICEPhysiologically-guided strategy
The Angiographically-guided strategy is that of aiming the most complete degree of revascularization based on angiographic evaluation (stenting all coronary stenosis of major branches \>2.5mm, with a % coronary stenosis\>50% as evaluated by visual estimation. The Physiologically-guided strategy is that of treating only lesions with FFR ≤0.80, and leaving on optimal medical treatment lesions with FFR \>0.80. The iFR values will be recorded in all patients, and verified in the core laboratory to allow a post-hoc analysis correlating the 0.80 FFR cut-off with different iFR cut-off values, and using the same study end-points. Particular attention will be dedicated to the eventual occurrence of clinical events in patients deferred on the bases of FFR values \>0.80 that show a discrepancy with positive (\<0.89) iFR values to investigate the reliability of the FFR in the aortic stenosis setting. Both groups will receive the same TAVI strategy and optimal medical therapy
Sponsors
Universita di Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years 2. Written informed consent 3. Diagnosis of severe native aortic valve disease with the indication to endovascular valve replacement given by Heart Team 4. Diagnosis of at least one coronary stenosis \>50% at angiography 5. No specific pharmacologic treatment is required to enter the study
Exclusion criteria
1. Age \< 18 years 2. Pregnancy 3. Lack of informed consent 4. Impaired left ventricular function 5. Signs or symptoms of acute (unstable) myocardial ischemia 6. Contraindication to adenosine administration (e.g., asthma, chronic obstructive pulmonary disease, heart rate \<50 beats/min, and systolic blood pressure \<90 mmHg) 7. Reduced survival expectancy due to severe co-morbidities (\<1 year) 8. Impossibility to obtain follow-up information 9. The lack of any of inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of the treatment | 12 months | Composite of all-cause death, myocardial infarction, stroke, major bleeding, need for target vessel revascularization as adjudicated by the Clinical Event Committee |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety endpoint | 30 days | Composite of all cause mortality, all strokes (disabling and not disabling), life threatening bleeding, AKI (stages 2 or 3, including need for dialysis), coronary artery obstruction requiring intervention, major vascular complication, valve related dysfunction requiring repeat procedure |
Countries
Italy
Outcome results
None listed