Atherosclerotic Renal Artery Stenosis, Fractional Flow Reserve, Optimal Medical Therapy, Stent Implantation
Conditions
Keywords
Atherosclerotic Renal Artery Stenosis, Fractional Flow Reserve, Optimal Medical Therapy
Brief summary
For patients with atherosclerotic renal artery stenosis, the results of randomized controlled trials published in recent years have failed to demonstrate that renal artery stenting is superior to optimal medical therapy. However, these studies still have limitations. Fractional flow reserve (FFR) has been extensively studied in coronary artery disease, and it has been established that FFR-guided revascularization is superior to both angiography-guided percutaneous coronary intervention and medical therapy alone. Whether FFR can guide interventional treatment in patients with renal artery stenosis and hypertension is currently a hot topic in the field of renal artery stenosis research. Eligible patients meeting the inclusion criteria were enrolled. Pharmacologically induced FFR values were measured as the baseline. Patients with FFR ≥ 0.8 were randomly assigned to either the medical therapy group or the stenting group, while patients with FFR \< 0.8 underwent stent implantation. Changes in eGFR, 24-hour systolic blood pressure, and 24-hour diastolic blood pressure from baseline to 12 months were compared among the groups.
Interventions
DEVICERandomized to stenting
Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to receive either stent implantation.
DEVICEstent implantation
Patients with pharmacologically induced renal FFR \< 0.80 will receive stent implantatio.
DRUGRandomized to optimal medical therapy (OMT)
Patients with pharmacologically induced renal FFR ≥ 0.80 will be randomly assigned to optimal medical therapy.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Patients with FFR ≥ 0.8 were randomly assigned to either the medical therapy group or the stenting group, while patients with FFR \< 0.8 all underwent stenting
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Renal artery diameter stenosis ≥60%; 2. Office systolic blood pressure ≥ 160 mmHg and/or office diastolic blood pressure ≥ 100 mmHg on at least two separate days without antihypertensive medication, or office systolic blood pressure ≥ 140 mmHg and/or office diastolic blood pressure ≥ 90 mmHg while on three antihypertensive drugs at conventional doses; 3. Serum creatinine \< 264 μmol/L (3.0 mg/dL); 4. Affected kidney length ≥ 7.0 cm, with residual glomerular filtration rate (GFR) ≥ 10 mL/min;
Exclusion criteria
1. Unstable clinical condition rendering the patient intolerant to revascularisation therapy; 2. Urinary protein ≥2+; 3. Contrast medium allergy; 4. Renal artery anatomy unsuitable for revascularisation therapy; 5. Reference vessel diameter \<3.5mm or \>8mm. 6. Patients with non-atherosclerotic renal artery stenosis (such as fibromuscular dysplasia or Takayasu arteritis); 7. Reference vessel diameter \< 3.5 mm or \> 8 mm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| eGFR changes | From baseline to 12 months post-procedure | The change in eGFR(Estimated Glomerular Filtration Rate) at 12 months post-procedure compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24h-SBP changes | From baseline to 12 months post-procedure | 24-hour average systolic blood pressure |
| 24h-DBP changes | From baseline to 12 months post-procedure | 24-hour average diastolic blood pressure |
| OBP changes | From baseline to 12 months post-procedure | Change in Office Blood Pressure(OBP) at 12 months post-procedure compared to baseline. |
| medication load changes | From baseline to 12 months post-procedure | Change in antihypertensive medication load at 12 months post-procedure compared to baseline |
| Rate of stent restenosis | From baseline to 12 months post-procedure | Rate of stent restenosis after stent implantation in patients with atherosclerotic renal artery stenosis. |
| perioperative complications | From baseline to 30 days post-procedure | The perioperative complications for atherosclerotic renal artery stenosis includes: renal artery injury, thrombosis, restenosis, infection, aortic dissection. |
| Vascular Complications | From baseline to 12 months post-procedure | Incidence of Vascular complications, including delayed bleeding, pseudoaneurysm, arteriovenous fistula, or femoral artery stenosis/occlusion requiring clinical intervention. |
| renal adverse events | From baseline to 12 months post-procedure | Renal adverse events after surgery in patients with atherosclerotic renal artery stenosis may include acute kidney injury, progressive renal dysfunction, and the need for renal replacement therapy such as dialysis. |
| Rate of Renal Target Organ Damage | From baseline to 12 months post-procedure | sustained eGFR decline, CKD stage progression, new-onset overt proteinuria, kidney atrophy progression, initiation of kidney replacement therapy, or kidney-related hospitalization |
| RBR | From baseline to 12 months post-procedure | risk-benefit ratio |
| all-cause death | From baseline to 12 months post-procedure | Occurrence of death from any cause during the study period |
| cardiovascular death | From baseline to 12 months post-procedure | — |
| Number of Participants with myocardial infarction | From baseline to 12 months post-procedure | — |
| Number of Participants with non-fatal stroke | From baseline to 12 months post-procedure | — |
| Number of Participants with rehospitalization for congestive heart failure | From baseline to 12 months post-procedure | — |
| UACR changes | From baseline to 12 months post-procedure | urinary microalbumin-to-creatinine ratio (UACR) |
Countries
China
Contacts
CONTACTXiongjing Jiang
CONTACTHui Dong
Outcome results
None listed