GSR UNMATCHED REAL-WORLD DATA

GSR is the largest RDN data set with more than 3,000 patients enrolled. It has demonstrated the safety and efficacy of RDN in a variety of patients representative of daily clinical practice.

Significant blood pressure (BP) reductions were sustained out to three years in both office and 24-hr ABPM measures:

For patients receiving renal denervation treatment for hypertension, the GSR observational study found that significant blood pressure reductions were sustained out to three years in both office and 24-hr ABPM measures.

GSR SUBGROUP RESULTS

Patients in GSR high-risk subgroups showed similar consistent and meaningful long-term BP-lowering effects between ~10 to 20 mmHg reductions out to three years. Similar sustained reductions were observed in high-risk subgroups.*1

Medtronic Renal Denervation (RDN) graphs covering number of hypertension medications and Office Systolic Blood Pressure (OSBP) of hypertensive pations over a 3 year span.
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Prof. Markus Schlaich discusses safety, efficacy and patient selection insights from the largest study of RDN.

Hypertensive patient and Medtronic clinician who focuses on hypertension (HTN) management and high blood pressure (HBP) treatments.

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The full manuscript of the latest review of GSR data is available from the Journal of the American College of Cardiology.

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OFFICE SYSTOLIC BLOOD PRESSURE CHANGE1

A chart showing that for various high-risk patient subgroups, including resistant HTN, the elderly, diabetic, and ISH patients, office systolic blood pressure decreased by ~17mmHg at three years, similar to overall cohort.

OFFICE SYSTOLIC BLOOD PRESSURE CHANGE

Chart showing that for high-risk patient subgroups, including CKD, atrial fibrillation, obstructive sleep apnea, and current smokers, blood pressure decreased by ~9mmHg (ABPM) at three years.

 

BP decreased ~17mmHg (Office) at three years in various high-risk patients, similar to overall cohort.

BP decreased ~9mmHg (ABPM) at three years in high-risk patients, similar to overall cohort.

 

Safety Results1

Safety Results1

%

All patients
(n=1749)
Age > 65
(n=741)

Age < 65
(n=1008)

DM
(n=675)
ISH
(n=676)
Non-ISH
(n=1028)

AF
(n=236)

No AF
(n=1503)

Death

5.7

9.2

3.1

7.1

6.5

5

8.5

5.3

Cardiovascular death

2.9

4.6

1.7

4.0

4.0

2.2

4.7

2.7

Myocardial infarction

2.5

2.4

2.6

4.0

2.8

2.2

2.5

2.4

Stroke

4.5

5.0

4.2

4.0

4.7

4.4

3.8

4.6

End-stage renal disease (new-onset)

1.8

2.2

1.6

2.8

2.7

1.4

1.3

1.9

Creatinine elevation >50%

1.4

1.5

1.4

2.4

1.5

1.5

0.8

1.5

New renal artery stenosis >70%

0.3

0.3

0.4

0.3

0.3

0.3

0.8

0.3

Hospitalization for HTN Crisis

3.1

3.4

3.0

2.8

2.4

3.7

3.0

3.1

Patient Selection

Who is a candidate for renal denervation?

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A brochure filled with information about RDN
*

Data from GSR are not powered.

Resistant hypertension defined as OSBP >150 mmHg, ≥ anti-hypertensive medications.

Elderly defined as 65 years and older.

§

CKD defined as eGFR <60 ml/min/1.73m2.

1

Mahfoud F, Mancia G, Schmieder R, et. al. Renal Denervation in high-risk patients with hypertension. Journal of the American College of Cardiology. 2020; 75(23): 2879 - 2888.

2

Mahfoud F, Mancia G, Schmieder R, et al. Three-year safety and efficacy in the Global Symplicity Registry: Impact of anti-hypertensive medication burden on blood pressure reduction. Presented at PCR e-Course 2020

3

Mahfoud F, Mancia G, Schmieder R, et al. Three-year safety and efficacy in the Global Symplicity Registry: Subgroup Analysis. Presented at ESH 2019.