A new analysis of the SYMPLICITY HTN-3 trial, aimed at
lowering the blood pressure with a procedure called as renal denervation, has
identified factors like variations in the way the procedure was performed and
changes in patients' medications and drug adherence, which may have had a
significant impact on the results, eventually halting the renal denervation
procedure.
Renal denervation is a minimally invasive procedure which
involves deactivating the renal nerves with radiofrequency ablation, a series
of 2 minute blasts of radiofrequency energy, with a catheter inserted via an
artery in the groin to reach the renal arteries. This nerve disruption reduces
the sympathetic nerve drive, and a significant and sustainable reduction in
blood pressure is achieved.
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Results of the SYMPLICITY HTN-3 trial appeared to show that there was no significant difference in patient outcome between renal denervation and a sham procedure among patients with drug resistant hypertension, which resulted in referrals for the procedure drying up completely, making further trials almost impossible.
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High blood pressure or hypertension is defined as a blood pressure of above 140 mm Hg (systolic) and or 90mm Hg (diastolic).
Other confounding factors were changes in medications and patient adherence to their drugs. The protocol for the SYMPLICITY HTN-3 trial specified that from the time of enrollment to the end of the 6-month follow-up period, patients should be maintained on several anti-hypertensive medications at highest possible doses, without any changes unless clinically necessary. During this time, approximately 40 percent patients required medication changes; nearly 70% of which were due to patients experiencing adverse events or side-effects related to the maximally-tolerated dosage of their hypertension medications.
This analysis published in the European Heart Journal, opens the field for new clinical trials to confirm that more ablations delivered in a spiral pattern are able to provide an effective denervation.
Source: Medindia
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