My name is Felix Mahfoud, I'm a cardiologist working
here at the Saarland University Hospital
in Hamburg Saar, Germany.
Well, the Global Symplicity registry is the largest
and longest follow-up population of real world patients
with uncontrolled hypertension
treated with radiofrequency renal denervation.
And the objectives of the registry are to assess
the long-term safety and effectiveness
of the Symplicity renal denervation system.
With renal denervation, we very often see
different clinical benefits that may be measured
by multiple variables such as office and/or
ambulatory blood pressure reductions.
But often, also, we document a change
in antihypertensive medication burden.
The win ratio analysis enables evaluation
of clinical benefits based on multiple variables
and a hierarchical composite endpoint.
And that was the purpose of the study.
We use the Global Symplicity registry,
which is the largest and longest follow-up population
of real-world patients with uncontrolled hypertension.
And in this cohort,
we assessed using a win ratio methodology
the impact of renal denervation on various endpoints
in patients who are elderly,
in patients with diabetes,
and in patients with chronic kidney disease.
Because very often after renal denervation,
the outcomes, the changes, are quite variable.
One patient may show a reduction in office blood pressure,
another patient may show no change in blood pressure
but a decrease in ambulatory blood pressure.
And another, a third patient,
may show no change in blood pressure,
no reduction in ambulatory blood pressure,
but decreases antihypertensive medication burden
throughout follow-up.
All of these are important endpoints,
and the win ratio analysis enables to assess these outcomes
using a hierarchical analysis.
First, we documented significant office
and 24 hour ambulatory blood pressure reductions
that sustained throughout three years
in the Global Symplicity registry
in more than 2,800 patients.
We also documented, using the win ratio analysis,
ranking office 24 hour blood pressure reductions
and medication changes.
Additional insights into the benefits of renal denervation
in high-risk cohorts.
And these cohorts suffered from diabetes
or chronic kidney disease, or were elderly individuals
indeed above 65 years of age.
And what we found were,
that patients were equally likely
to experience a reduction in office,
ambulatory, and/or medication burden
between these high risk subgroups.
And importantly,
a new study, the GSR-DEFINE,
will include patients very shortly
and will extend our knowledge about renal denervation
when used in real world experience.
The results from the win ratio analysis
demonstrate comparable probability
of responding to renal denervation therapy
regardless of age, chronic kidney disease,
or diabetes status.
Indicating similar efficacy based on
ambulatory, office blood pressure and/or medication burden
between these high risk patient cohorts.
The Global Symplicity registry
will now be followed and extended
by the new GSR-DEFINE study
that will expand our knowledge on renal denervation
when used in clinical practise
in over 5,000 real world patients
treated with radiofrequency
catheter-based renal denervation.