Vol. 24 No. 3S (2020): Frontiers of endovascular surgery
ORIGINAL ARTICLES

Anatomically optimized distal renal denervation — sustained blood pressure lowering efficacy during 3 years after the intervention

S. Pekarskiy
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk
Bio
A. Baev
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk
A. Falkovskaya
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk
E. Sitkova
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk
I. Zyubanova
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk
V. Lichikaki
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk
V. Mordovin
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk
S. Popov
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk

Published 2020-11-06

Keywords

  • ambulatory,
  • arterial catheterization,
  • blood pressure monitoring,
  • essential hypertension,
  • peripheral,
  • radiofrequency ablation,
  • renal artery
  • ...More
    Less

How to Cite

Pekarskiy, S., Baev, A., Falkovskaya, A., Sitkova, E., Zyubanova, I., Lichikaki, V., Mordovin, V., & Popov, S. (2020). Anatomically optimized distal renal denervation — sustained blood pressure lowering efficacy during 3 years after the intervention. Patologiya Krovoobrashcheniya I Kardiokhirurgiya, 24(3S), 98–107. https://doi.org/10.21688/1681-3472-2020-3S-98-107

Abstract

Aim. To test the hypothesis that anatomical optimisation of radiofrequency renal denervation (RDN) by redistribution of treatment to segmental branches of the renal artery causes a durable increase in the efficacy of the intervention.
Methods. A double-blind randomised control study in parallel groups with a 3-year follow-up was performed in patients with apparent resistant hypertension (office systolic BP ≥160 or diastolic BP ≥100 mmHg despite stable treatment with ≥3 drugs, including a diuretic). Exclusion criteria were secondary hypertension, mean 24-h systolic BP <135 mmHg, eGFR <30 mL/min/m2 and severe comorbidity increasing procedural risks (investigator’s assessment). Eligible patients were randomised 1:1 into distal RDN or RDN in the main trunk of the renal artery. Treatment assignment was done in the operation room immediately before the procedure. For the duration of the study, the assigned treatment was unknown to patients, physicians and other outcome assessors. Long-term efficacy of the procedure was measured by changes in BP (office and ambulatory), whereas safety was assessed by changes in the 24-h protein excretion, serum creatinine and eGFR 3 years post-procedure.
Results. Of the 55 randomised patients, 39 (71%) completed a 3-year assessment (21 after distal RDN and 18 after RDN in the main trunk of the renal artery). Compared to baseline, the mean 24-h BP remained significantly lowered in the distal RDN group by −16.9 (95% CI −27.3;−6.5)/−8.5 (95% CI −14.2;−2.9) mmHg, p = 0.002/0.004 (systolic/diastolic, respectively). The lowering of the mean 24-h BP was almost twofold less and non-significant in the group of RDN in the main trunk of the renal artery: −8.7 (95% CI −19.6;2.2)/−5.8 (95% CI −11.8;0.1).
Conclusion. Anatomical optimisation of endovascular renal denervation produces a powerful and sustained increase in the efficacy of the intervention.

Received 19 May 2020. Revised 10 July 2020. Accepted 7 September 2020.

Funding: The study did not have sponsorship.

Conflict of interest: Authors declare no conflict of interest.

Clin.Trials.gov Identifier: NCT02667912.

Author contributions
Conception and design: S.E. Pekarskiy
Data collection and analysis: S.E. Pekarskiy, A.E. Baev, A.Yu. Falkovskaya, E.S. Sitkova, I.V. Zyubanova, V.A. Lichikaki, V.F. Mordovin
Statistical analysis: S.E. Pekarskiy
Drafting the article: S.E. Pekarskiy, A.E. Baev
Critical revision of the article: S.V. Popov
Final approval of the version to be published: S.E. Pekarskiy, A.E. Baev, A.Yu. Falkovskaya, E.S. Sitkova, I.V. Zyubanova, V.A. Lichikaki, V.F. Mordovin, S.V. Popov

References

  1. Ettehad D., Emdin C.A., Kiran A., Anderson S.G., Callender T., Emberson J., Chalmers J., Rodgers A., Rahimi K. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. Lancet. 2016;387(10022):957-967. PMID: 26724178. https://doi.org/10.1016/S0140-6736(15)01225-8
  2. Benjamin E.J., Blaha M.J., Chiuve S.E., Cushman M., Das S.R., Deo R., de Ferranti S.D., Floyd J., Fornage M., Gillespie C., Isasi C.R., Jiménez M.C., Jordan L.C., Judd S.E., Lackland D., Lichtman J.H., Lisabeth L., Liu S., Longenecker C.T., Mackey R.H., Matsushita K., Mozaffarian D., Mussolino M.E., Nasir K., Neumar R.W., Palaniappan L., Pandey D.K., Thiagarajan R.R., Reeves M.J., Ritchey M., Rodriguez C.J., Roth G.A., Rosamond W.D., Sasson C., Towfighi A., Tsao C.W., Turner M.B., Virani S.S., Voeks J.H., Willey J.Z., Wilkins J.T., Wu J.H., Alger H.M., Wong S.S., Muntner P., American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update. A Report From the American Heart Association Circulation. Circulation. 2017;135(10):e146-e603. https://doi.org/10.1161/CIR.0000000000000485
  3. Krum H., Schlaich M., Whitbourn R., Sobotka P.A., Sadowski J., Bartus K., Kapelak B., Walton A., Sievert H., Thambar S., Abraham W.T., Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009;373(9671):1275-1281. PMID: 19332353. https://doi.org/10.1016/S0140-6736(09)60566-3
  4. Symplicity HTN-2 Investigators, Esler M.D., Krum H., Sobotka P.A., Schlaich M.P., Schmieder R.E., Böhm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010;376(9756):1903-1909. PMID: 21093036. https://doi.org/10.1016/S0140-6736(10)62039-9
  5. Bhatt D.L., Kandzari D.E., O'Neill W.W., D'Agostino R., Flack J.M., Katzen B.T., Leon M.B., Liu M., Mauri L., Negoita M., Cohen S.A., Oparil S., Rocha-Singh K., Townsend R.R., Bakris G.L., SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014;370(15):1393-1401. PMID: 24678939. https://doi.org/10.1056/NEJMoa1402670
  6. Pekarskiy S., Baev A., Mordovin V., Ripp T., Semke G., Sitkova E., Krylov A., Popov S. Low efficacy of renal denervation as a result of anatomically inadequate operative technique. Eur Heart J. 2014;35(Suppl. 1):851-1187. https://doi.org/10.1093/eurheartj/ehu325
  7. Oldham J.B. Denervation of the kidney. Ann R Coll Surg Engl. 1950;7(3):222-245. PMID: 14771775, PMCID: PMC2238393.
  8. Pekarskiy S.E., Baev A.E., Mordovin V.F., Semke G.V., Ripp T.M., Falkovskaya A.U., Lichikaki V.A., Sitkova E.S., Zubanova I.V., Popov S.V. Denervation of the distal renal arterial branches vs. conventional main renal artery treatment: a randomized controlled trial for treatment of resistant hypertension. J Hypertens. 2017;35(2):369-375. PMID: 28005705. https://doi.org/10.1097/HJH.0000000000001160
  9. Wasserstein R.L., Lazar N.A. The ASA's Statement on p-Values: Context, Process, and Purpose. Am Stat. 2016;70(2):129-133. https://doi.org/10.1080/00031305.2016.1154108
  10. ICH harmonised tripartite guideline. Statistical principles for clinical trials E9. Available from: https://database.ich.org/sites/default/files/E9_Guideline.pdf
  11. Heran B.S., Wong M.M.Y., Heran I.K., Wright J.M. Blood pressure lowering efficacy of angiotensin receptor blockers for primary hypertension. Cochrane Database Syst Rev. 2008;2008(4):CD003822. PMID: 18843650, PMCID: PMC6669255. https://doi.org/10.1002/14651858.CD003822.pub2
  12. Musini V.M., Nazer M., Bassett K., Wright J.M. Blood pressure-lowering efficacy of monotherapy with thiazide diuretics for primary hypertension. Cochrane Database Syst Rev. 2014;(5):CD003824. PMID: 24869750. https://doi.org/10.1002/14651858.CD003824.pub2
  13. Townsend R.R., Mahfoud F., Kandzari D.E., Kario K., Pocock S., Weber M.A., Ewen S., Tsioufis K., Tousoulis D., Sharp A.S.P., Watkinson A.F., Schmieder R.E., Schmid A., Choi J.W., East C., Walton A., Hopper I., Cohen D.L., Wilensky R., Lee D.P., Ma A., Devireddy C.M., Lea J.P., Lurz P.C., Fengler K., Davies J., Chapman N., Cohen S.A., DeBruin V., Fahy M., Jones D.E., Rothman M., Böhm M., SPYRAL HTN-OFF MED trial investigators. 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(10108):2160-2170. PMID: 28859944. https://doi.org/10.1016/S0140-6736(17)32281-X
  14. Kandzari D.E., Bohm M., Mahfoud F., Townsend R.R., Weber M.A., Pocock S., Tsioufis K., Tousoulis D., Choi J.W., East C., Brar S., Cohen S.A., Fahy M., Pilcher G., Kario K., SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018;391(10137):2346-2355. PMID: 29803589. https://doi.org/10.1016/S0140-6736(18)30951-6