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Medtronic

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Clinical Articles, Lead Article

ACC Scientific Sessions update on renal nerve denervation

The American College of Cardiology (ACC) recently held its 61st Annual Scientific Sessions, presenting data for both renal denervation and Resolute Integrity™ zotarolimus-eluting stent (ZES). Professor Martin T Rothman, Vice President of Medical Affairs for Coronary and Renal Denervation Business at Medtronic, gave his perspective on the presentations.

Outcomes in the Symplicity HTN-1 trial out to 3 years

The long-term follow-up results of this study on sympathetic renal denervation  (RDN) were presented, with data from 153 patients enrolled from June of 2007, and 3 year follow-up results. Results showed:

  • A maintained blood pressure (BP) reduction of (-33/-19 mmHg) at 3 years
  • No late procedure-related safety events out to 3 years
  • For patients who have completed 3 year follow up, 100% have been classified as responders (>10 mmHg reduction), while at 6 months 71% of patients were classified as responders

Outcomes in Symplicity HTN-2 at 1 year

Previously, the Symplicity HTN-2 study showed in the primary endpoint a superior BP reduction at 6 months for the RDN group (-32/-12 mmHg) when compared to the control group (+1/0 mmHg). Extended follow up has shown sustained reduction for the RDN group to 12 months as well as a significant reduction from baseline for the control cross-over group:

  • BP reduction of RDN patients (-28/-10 mmHg) sustained to 12 months
  • BP reduction of control cross-over patients (-24/-8 mmHg) at 6 months (this is similar to the long-term average reduction -28/-10 mmHg and very slightly less than the -32/-12 mmHg from the RDN arm at 6 months)

Symplicity health economics

The results of an important health economics model for treatment with the renal denervation system were also presented:

  • RDN is a clinically and economically effective treatment for patients with treatment resistant hypertension.
  • A robust statistical Markov model demonstrates greater cost-effectiveness of RDN among patients with lower starting blood pressure.
  • Incremental cost-effectiveness ratios (ICERs) increase with higher baseline systolic blood pressure (SBP), but remain an order of magnitude below the commonly accepted threshold of $50k/QALY.
  • In the lower range of the study treatment population (SBP 160-170 mmHg), RDN is cost-saving.
  • This model was designed to predict event rate and relative risk of cardiovascular events (stroke, myocardial infarction (MI), coronary heart disease, heart failure, end stage renal disease, cardiovascular and all-cause mortality) in patients treated with RDN and standard-of-care versus those treated with standard-of-care alone.

Overall, these data are extremely encouraging for renal denervation therapy showing a consistent and sustained treatment effect of renal denervation therapy and mark the beginning of a revolution in blood pressure management.

Low event rates out to 2 years in RESOLUTE US

The RESOLUTE US (R-US) trial is a multi-centre, prospective trial designed to evaluate the clinical effectiveness of the Resolute stent ( zotarolimus-eluting coronary stent system) in a US patient population with lesions suitable for stenting in up to two vessels. Although the eligibility criteria were not as broad as the RESOLUTE All Comers trial (acute coronary syndrome and ST segment elevation MI were excluded in R-US), the inclusion of 34.4% diabetes mellitus patients still makes this a very interesting patient population.

Dr Laura Mauri presented the 2 years outcomes: the incidence of target lesion failure (TLF) was 7.3%, comprised of low rates of cardiac death (1.5%), target vessel MI (1.9%) and target lesion revascularisation (TLR) of only 4.3%. Furthermore, there was only one stent thrombosis event (ST, ARC definite/probable) between years 1-2, resulting in an extraordinary low ST rate of just 0.2% at 2 years.

RESOLUTE pooled shows a consistent treatment benefit in over 1,500 diabetic patients

The 2 year outcomes of over 1,500 diabetic patients in the RESOLUTE Pooled global clinical trial program were also presented by Dr Alan Yeung. The main results are:

  • At 2 years, the incidence of TLF in all diabetic patients was 11.1% and ST only 1.2%
  • Out to 2 years, the outcomes for the noninsulin-dependent diabetic (NIDDM) patients were similar to the outcomes of non-diabetic (Non-DM) patients:
  • TLR was 4.3% in Non-DM and 4.7% in NIDDM
  • Cardiac death and target vessel MI was 4.9% in Non-DM and 5.2% in NIDDM
  • ST was 0.8% in Non-DM and 0.9% in NIDDM

Professor Rothman concluded: “While recognising the limitations of post-hoc pooled analyses, I am impressed by the strong performance of the Resolute stent throughout the pooled program and in this large diabetic cohort in particular. Furthermore, the consistent treatment effect in the noninsulin-dependent diabetic population with results comparable to non-diabetics continues out to 2 years. This provides reassuring and strong evidence for the safety and effectiveness of the Resolute Integrity stent in the diabetic population, which is currently the only drug eluting stent approved by the US Food and Drug Administration for this indication”.

Published on: May 24, 2012

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