SPYRAL OFF MED PIVOTAL TRIAL

Renal denervation (RDN) targets the sympathetic nervous system. A pilot study showed proof of principle for reduction of blood pressure in untreated and uncontrolled hypertensive patients.1 The aim of the SPYRAL HTN-OFF MED Pivotal trial was to evaluate powered reduction of blood pressure by RDN.  You can download the complete manuscript of the Pivotal trial results published in The Lancet

Medtronic SPYRAL OFF MED Pivotal trial manuscript covering blood pressure reduction for Renal Denervation (RDN) patient without anti-hypertensive medications.

EXPLORE PIVOTAL TRIAL DATA

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Male patient with a blood pressure cuff.

EFFICACY DATA

The powered efficacy endpoints for the trial were:

  • Change in 24-hour systolic blood pressure at three months
  • Change in office systolic blood pressure at three months

The trial showed clinically significant blood pressure reductions at three months. Specifically, 24-hour systolic ambulatory blood pressure decreased 4.7 mmHg compared to baseline in RDN patients at three months and office systolic blood pressure decreased 9.2 mmHg  compared to baseline in RDN patients at three months.2*

Bar charts comparing 24-hour and office systolic blood pressure (SBP) from the SPYRAL OFF MED Pivotal Trial.

The trial also showed that RDN had superior blood pressure reductions compared to control at three months.2† RDN blood pressure reducing benefits are "always on," protecting all day and night, including during the high-risk early hours.

SPYRAL OFF-MED pivotal trial graph comparing 24-hour systolic blood pressure data with Medtronic RDN baseline data.
SPYRAL OFF-MED pivotal trial graph comparing 24-hour systolic blood pressure data with sham data.

SAFETY DATA

In the trial, there were zero device- or procedure-related major adverse events (MAE) through three months.2 The trial also tracked other MAE:

% (n) 

RDN
(n=165)

Sham
Control
(n=165)

Major Adverse Events

0.6 (1)

0

        Death

0

0

        New onset end stage renal disease

0

0

        Sign. embolic event resulting in end-organ damage

0

0

        Renal artery perforation or dissection requiring intervention

0

0

        Vascular complications

0

0

        Hospitalization for hypertensive crisis/emergency

0.6 (1)

0

New stroke

0

0.6 (1)

Major bleeding (TIMI)

0

0

Serum creatinine elevation >50%

0

0

New myocardial infarction

0

0

TRIAL DESIGN

Diagram covering pathway for high blood pressure (HBP) screening and renal denervation (RDN) treatment as part of the SPYRAL Pivotal HTN-OFF MED Trial.

INCLUSION CRITERIA

  • Patient is either:
    • Not on antihypertensive medications or
    • Permitting discontinuation of drug therapy
  • Office SBP ≥150 and <180 mmHg
  • Office DBP ≥90 mm Hg
  • Systolic 24-hour mean ABPM ≥140 and <170 mmHg

EXCLUSION CRITERIA

  • Ineligible renal artery anatomy (accessory arteries allowed)
  • eGFR < 45 mL/min/1.73m2
  • Type 1 diabetes mellitus or type 2 diabetes mellitus with HbA1C >8.0%
  • Secondary causes of hypertension

Patient Selection

Who is a candidate for renal denervation?

IDENTIFY ELIGIBLE PATIENTS

UNMATCHED REAL-WORLD DATA

The GSR observational study evaluates safety and efficacy in real-world patients.

Review The Data
Decorative charts in shades of Medtronic blue within the OFF MED Pivotal page.

READY TO CONNECT AND HELP LOWER PATIENTS’ BLOOD PRESSURE?

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

WHAT DOES THIS DATA MEAN FOR YOU?

Get a high-level synopsis of each trial.

REVIEW CLINICAL SUMMARIES
*

ANCOVA adjusted; secondary efficacy endpoint.

An analysis of covariance model was used adjusting for baseline blood pressure

1

Townsend R, Mahfoud F, Kandzari DE, et al. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2017;390:2160–2170.

2

Böhm M, Kario K, Kandzari DE, et al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet 2020; Published online March 29, 2020. DOI: 10.1016/S0140-6736(20)30554-7

3

Only for patients discontinuing anti-hypertensive medications.

4

According to scheduling.

5

Drug testing to ensure no medications are present.

6

Optional follow-up at weeks 6 and/or 10 if the patient is not controlled.

7

Only for patients with BP ≥140 mm Hg at 3M.

8

Drug testing to ensure prescribed medications are present (if on drug).

9

6 and 12 month renal imaging.

All rights reserved. Medtronic, Medtronic logo are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. For distribution only in markets where the Symplicity Spyral™ multi-electrode renal denervation catheter and Symplicity G3™ renal denervation RF generator have been approved. Not for distribution in the United States, Japan or France.