Masahiko Fujihara, MD

Transcription

1 Verify the efficacy of renal artery stenting to define the predictive factors by physiological assessment with pressure wire gradient VERDICT study Masahiko Fujihara, MD Kishiwada Tokushukai Hospital Osaka, Japan

2 Disclosure Speaker name : Mashiko Fujihara I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest

3 BACK GROUND of Renal Artery Stenting STAR, ASTRAL and CORAL trial showed NO benefit in the preservation of renal function, cardiovascular events and reduce blood pressure when compared with optimal medical therapy Bax L et al. STAR trial. Ann Intern Med 2009; 150: , W150 W151. Wheatley K et al. N Engl J Med 2009; 361: Cooper CJ, et al. N Engl J Med 2014; 370:

4 From Latest guideline (ESC 2017) Renal revascularization does not generally improve blood pressure, renal or CV outcomes in patients with atherosclerotic RAD. With the low evidence of a potential benefit for revascularization over medical therapy 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS) European Heart Journal (2017)

5 Post ASTRAL and CORAL era - How do we indicate renal stent? - Significant RAS should be indicated with apparent clinical manifestation of ARAS Negative results of large RCTs posed difficulties in selecting the treatment strategy for ARAS Renal stent may not be effective in all cases, but there are responder for renal revascularization that might give impact on resistant hypertension

6 Define the Predictor Patient Characteristic Character Rapid worsening of renal function BNP> 80 or 50 pg/dl No albuminuria Lesion Characteristic Resistance Index (RI) Pressure Gradient Pd/Pa (Rest) Renal FFR=Pd/Pa (Stress) Procedure Characteristics Embolic Distal Protection (Angiogurard)+abciximab Zeller T, et al. Circulation 4;108(18):2244-9,2003 Muray S, et al. Am J Kidney Dis 39(1):60-6, 2002 Davies MG, et al. J Vasc Surg 51(5):1222-9,2010 Cianci R,et al. Ren Fail 32(10): , 2010 Silva JA, et al. Circulation 25;111(3): Staub D, et al. Eur J Vasc Endovasc Surg 40(5): Santos S, et al. Arq Bras Cardiol 94(4):452-6, 2010 Massound A, et al. J Am Cardiol 53:2263,2009 Fabio Mangiacapra et al, Circulation 3;537-, 2010 Marcin Protasiewicz et al, Am J Cardiol. 112:2013 Mitchell et al : CCI 69: , 2007 Berbard Bruyne et al, JACC 48; , 2006 Christopher J. Cooper et al. (Circulation 117:

7 DESIGN and ENDPOINTS Study Design A prospective, multicenter, single-arm clinical study of patients with significant RAS with hypertension and/or CKD (UMIN ) Treated System the Express SD stent system (Boston Scientific) the Aeris/Certus pressure wire (St Jude Medical) Primary Endpoint Define the prediction factors that reduced blood pressure in the HTN group, and improved renal function in the CKD group Patients / Centers 221 patients/ 32 centers

8 VERDICT Study Scheme 221 patients Enrolled in this study 2 cases were excluded for lack of primary data 7 cases were excluded for protocol violation 212 patients Primary analysis (Basic Characteristics) 193 patients Hypertension group 164 patients CKD group 200 patients Primary analysis (9 months) 183 patients Hypertension group

9 VERDICT Procedural Scheme Clinical Indication Diagnosis of ARAS Significant RAS Renal Artery Stenting Primary Evaluation 9months SBP: 145mmHg (Office) and 135mmHg (24hABPM) with 3 medicine De novo: Duplex: PSV 219cm/s and RAR 3.5 PSV<219cm/s RAR<3.5 Excluded Angiography: %DS>60% physiological assessment: Pressure Gradient 20mmHg (Rest/Stress) <20mmHg Excluded Stent: physiological assessment: (Post) PG Pd/Ps Renal FFR Renal Flow Reserve SBP: (Office/24h) Office/24h DUS: Responder Non Responder

10 Patient Characteristics (N=193) Age (years old) 73.7 Office BP SBP (mmhg) Male (%) 76.6 Office BP DBP (mmhg) 77.7 Diabetes (%) H ABPM SBP (mmhg) CKD (%) H ABPM DBP (mmhg) 76.9 Dyslipidemia (%) Hours Blood Pressure Pattern Obesity(%) BMI> Dipper (%) 42 (25.9) Current Smoking (%) Extreme Dipper (%) 7 (4.3) Heart Failure (%) Non Dipper (%) 67 (41.4) Antihypertensive medicine 2.8±1.3 -Riser (%) 49 (30.2) Ejection Fraction (%) 63.3

11 Treated Lesion Characteristics (N=193) Duplex findings Kidney size (cm) 9.7 PSV (cm/s) RAR 5.07 RI 0.74 Physiological Assessment by pressure wire Rest PG (SYS) mmhg 32.8 Rest Pd/Pa (SYS) 0.79 Stress PG (SYS) mmhg 47.6 Stress Pd/Pa (SYS) =Renal FFR 0.69 Rest PG (MEAN) mmhg 12.0 Stress PG (MEAN) mmhg 18.1 Renal Flow Reserve ( StressPG(Mean)/ RestPG(Mean)) 1.3

12 Clinical Responder Rate in hypertension 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Non Responder 39% Responder 61% OBP Responser Non responder Non Responder 37% Responder 63% 24HABPM Responder; OBP>10 mmhg SBP reduction (Pre SBP 150~180mmHg) OBP>15 mmhg SBP reduction (Pre SBP >180mmHg) 24HABPM> 20mmHg SBP reduction at 9 months

13 The predictive factors of clinical responder Responder (Office BP) Responder ABPM p OR 95%CI p OR 95%CI Age Male Dyslipidemia Diabetes CKD Cr 0.025* CAD 0.002* Heart Failure BNP Calcium channel blocker ARB/ACEi Diuretics 0.002* * The number of AHM Statin

14 The predictive factors of clinical responder Responder (Office BP) Responder ABPM p OR 95%CI p OR 95%CI Baseline Office blood pressure 0.000* Baseline 24HABPM * (DUPLEX) PSV (DUPLEX) RAR (DUPLEX) RI Bilateral treatment Contrast media doze % stenosis Stent diameter Stent diameter IVUS usage Distal protection

15 The predictive factors of clinical responder -physiological assessment- Responder (Office BP) Responder ABPM p OR 95%CI p OR 95%CI Sys PG(Rest) Sys Pd/Pa(Rest) Mean PG(Rest) Mean Pd/Pa (Rest) Sys PG(Stress) Sys Pd/Pa(Stress) Mean PG(Stress) Renal FFR* Renal Flow Reserve* Sys PG(Post Stress) Mean PG (Post Stress) * *1 Renal FFR; Stress Pd/Pa (SYS) *2 Renal Flow reserve StressPG(Mean)/ RestPG(Mean))

16 Conclusion VERDICT study focuses on selecting patients who have hemodynamically proven renal hypo-perfusion with significantly ARAS. The indicated significant renal artery stenosis patients got a better response 60% of hypertension This study gave us some predictive factors for clinical response Otherwise, physiological assessment of ARAS using pressure wire did not predict the clinical response after renal artery stenting, non-similar to the coronary FFR studies.

17 Thank you for your attention JET2018 Osaka, Japan February 23(Fri)-25(Sun) th Anniversary JET 2018