Interventional procedure overview of alcohol-mediated perivascular renal sympathetic denervation for resistant hypertension
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Outcome measures
The main outcomes included reduction in BP (ABPM and office BP), use of antihypertensive medications, renal function (such as eGFR and serum creatinine), major or serious adverse events, and device- or procedure-related, nonserious adverse events. The key measures used are detailed in the following paragraphs.
Reduction in BP included ABPM and office BP at follow ups compared with baseline, or between arms. A reduction in mean 24-hour ambulatory systolic BP of at least 5 mmHg relative to baseline was considered a clinically meaningful response to RDN (Mahfoud 2015). A mean decrease in office BP of 10 mmHg for systolic BP compared with baseline was judged to be a clinically meaningful reduction (Persu 2014).
eGFR was used to indicate the overall index of kidney function, with a normal eGFR usually greater than 90 ml/min/1.73m2 and different stages are detailed as follows:
90 or above: possible kidney damage with normal kidney function
60 to 89: kidney damage with mild loss of kidney function
45 to 59: mild to moderate loss of kidney function
30 to 44: moderate to severe loss of kidney function
15 to 29: severe loss of kidney function
less than 15: kidney failure
eGFR could also be shown as a percentage of normal, ranging from 100% (full function) to 0% (no function). It is noted that eGFR declines with age, even in people without kidney disease.
MAEs included all-cause death, end-stage renal disease, significant embolic event resulting in end-organ damage or needing intervention, major vascular complications, major bleeding events, postprocedural renal artery stenosis (>60% diameter stenosis), hypertensive crisis, and symptomatic hypotension needing medication.
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