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SVS Clinical Research Priorities Mesenteric/Renal

SVS Clinical Research Priorities Mesenteric/Renal. Kimberley J. Hansen, MD. ACE inhibitor Rx. Calcium Blockers. PTRA introduced. Cooperative study of renovascular hypertension. Improved surgery. Small, randomized trials. Urgent bilateral nephrectomy for treatment resistant, malignant HTN.

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SVS Clinical Research Priorities Mesenteric/Renal

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  1. SVS Clinical Research PrioritiesMesenteric/Renal Kimberley J. Hansen, MD

  2. ACE inhibitor Rx Calcium Blockers PTRA introduced Cooperative study of renovascular hypertension Improved surgery Small, randomized trials Urgent bilateral nephrectomy for treatment resistant, malignant HTN Med Rx vs PTRA Prospective trials: Med Rx vs Stent Therapy CORAL ASTRAL STAR RAVE Function tests: Blood flow, sodium excretion Renal artery clip hypertension Surgery for renal reconstruction 1930 1940 1950 1970 1990 1980 1960 2000 Nephrectomy for hypertension with a small kidney Early imaging: intravenous pyelography scan Advanced imaging: MRA, CTA ARB Rx Statin therapy Stents

  3. ACE inhibitor Rx Calcium Blockers PTRA introduced Cooperative study of renovascular hypertension Improved surgery Small, randomized trials Urgent bilateral nephrectomy for treatment resistant, malignant HTN Med Rx vs PTRA Prospective trials: Med Rx vs Stent Therapy CORAL ASTRAL STAR RAVE Function tests: Blood flow, sodium excretion Renal artery clip hypertension Surgery for renal reconstruction 1930 1940 1950 1970 1990 1980 1960 2000 Nephrectomy for hypertension with a small kidney Early imaging: intravenous pyelography scan Advanced imaging: MRA, CTA ARB Rx Statin therapy Stents

  4. Prevalence of Renovascular Lesions • CHS Participants > 65 years 6-7% • Patients – Coronary Arteriography 6-18% • Patients – Aortography 16-40% • ‘NEW’ Hypertensives > 60 years 20-30% DBP > 110/mmHg J Vasc Surg 2002;36:443-451, Am Heart J 1998,136:913-918, Cathet Cardiovasc Diagn 1994;32:8-10, J Am Soc Nephrol 1992;2:1608-1616, Am J Med 1990;88:46N-51N, Ann Vasc Surg 1998;12:17-22, J Vasc Surg 1993;18:433-440, Am J Med 2000;109:642-647, J Am Hypertension 1996;10:83-85, Am J Med 1994;96:10-14, Int Angiol 1992;11:195-199

  5. CMS PTRA-S Note. - Procedure totals are from 5% files for analysis of codes 35471, 37205, and both, respectively. Results from the 5% Part B files were multiplied by 20 to yield “extrapolated to 100%” totals. AJR 2004; 183:561-568

  6. PTRA-S per 100,000 Note. - Overall utilization pooled for all regions is listed in the last row (these numbers differ slightly from the average of each region because of slight differences in number of beneficiaries among regions, particularly the low-utilization, sparsely populated “other” region). Average utilization in 2000 ranged from 26 to 87 per 100,000 (excluding “other”). CMS regions are Mid-Atlantic: DE, DC, IN, MD, OH, VA, WV; Southwest: AR, CO, LA, NM, OK, TX; Northeast: CT, ME, MA, NH, NY, RI, VT; Great Lakes: IL, IA, MI, MN, WI; Great Western: AK, ID, KS, MO, MT, NE, ND, OR, SD, UT, WA, WY; Keystone: NJ, PA; Southeast: AL, KY, MS, NC, SC, TN; South: FL, GA Pacific: AZ, CA, HI, NV; Other: Puerto Rico, Virgin Island. CMS = Centers for Medicare and Medicaid Services. aGrowth in annual procedure volume when compairing 2000 with 1996 AJR 2004; 183:561-568

  7. Annual PTRA-S Volume Note. - Physicians identifying their specialty as cardiology or internal medicine are considered cardiologists in this table, those reporting their specialty as interventional radiology or radiology are identified as radiologists, and those reporting their specialty as vascular surgery or general surgery are categorized as surgeons. These specialties accounted for more than 95% of providers submitting claims for renal artery interventional procedures for each year. aGrowth in annual procedure volume when comparing 2000 with 1996 AJR 2004; 183:561-568

  8. Frequency of PTRA-S 2005National Inpatient Sample Estimated Health Cost Expenditure – 75,933 x (5,136 + 723)  444,891,447 Source: National Inpatient Sample (Unpublished)

  9. 2007 MedCAC Voting QuestionsHighly Confident (5) – Not Confident (1) For the treatment of patients with atherosclerotic RAS, how confident are you that the evidence is adequate to draw conclusions about safety and clinical effectiveness of the following renal artery interventions:

  10. 2007 MedCAC Voting QuestionsHighly Confident (5) – Not Confident (1) 2. Based on the evidence presented, how confident are you that the published results apply to :

  11. 2007 MedCAC Voting QuestionsHighly Confident (5) – Not Confident (1) 3. Based on the evidence presented for patients with atherosclerotic RAS, how confident are you that compared to aggressive medical treatment alone there are improved key health outcomes attributable to the following co-interventions:

  12. 2007 MedCAC Voting QuestionsStrongly Agree(1) – Strong Disagree(5) 4. Based on the evidence presented, should Medicare national coverage of any non-medical treatments for atherosclerotic RAS be limited only to patients enrolled in qualified clinical research studies?

  13. PTRA versus Open Repair Prospective Randomized Clinical Trials • Single center, Malmö • Inclusion < 70 years No diabetes Hypertension with unilateral RA stenosis • RVH defined by RVRA’s • GFR estimated by Cr-EDTA clearance • Angiographic follow-up for all • PTRA primary/secondary patency 75%/90% Surgical 96%/97% • PTRA HTN cured/improved 83% Surgical 89% • Non-representative patient cohort Significant difference baseline GFR PTRA crossover to surgery • No Endoluminal stents J Vasc Surg 1993;18:841-850

  14. Early Prospective Randomized Trials From Ives NJ, Wheatley K, Stowe RL, et al: Continuing uncertainty about the value of percutaneous revascularization in atherosclerotic renovascular disease: a meta-analysis of randomized trials. Nephrol Dial Transplant 2003;18:298-304 adapted with permission. *Termination defined as 6 months after randomization or earlier in cases of refractory hypertension (diastolic blood pressure > 1 to 4 mm/Hg despite maximal tolerated antihypertensive regimen. In such cases, blood pressure, treatment score, and SCr were determined prior to renal arteriograph. Nephrol Dial Transplant 2003;18:298-304

  15. STAR Study Prospective Randomized Clinical Trials • STent placement and blood pressure and lipid-lowering for prevention of progression of renal dysfunction caused by Atherosclerotic ostial stenosis of the Renal artery (Netherlands) • Stenting versus angioplasty alone for ostial RAS • Primary ‘Technical’ Success Stent 88% PTRA 57% • Restenosis Rate Stent 14% PTRA 48% • Primary endpoint: <20% Decline EFGR No difference • Secondary endpoints: HTN, heart and vascular events, mortality No difference • ESRD or mortality in 10% patients J Nephrol 2003;16:807-812

  16. Management Of Renovascular DiseaseOngoing Randomized Controlled Trails • Angiopolasty and STent for Renal Artery Lesions (ASTRAL – United Kingdom) • Renal Atherosclerotic ReVascularizationEvaluation (RAVE – Canada) • Nephrology Ischemic ThERapy (NITER – Italy) • Renal Artery Stenting in HemoDynamicAtherosclerotic Renal Artery Stenosis (RADAR) – Europe and South America • Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL – United States, Canada, Australia, and New Zealand

  17. ASTRAL Trial Prospective Randomized Clinical Trials • Angioplasty and STenting For Renal Artery Lesions • Multicenter: 53 UK, 4 Australia • PTRA-S versus Best Medical Management (Statins, Antiplatelet, Antihypertension THX) • 806 Patients (403 in each group); ‘Uncertain Worth’ • Mean follow up: 33.6 months (all 12 months) Mean degree RAS: 76% diameter reduction 60% > 70% stenosis • Primary endpoint: rate of change EGFR • Secondary endpoints: HTN, heart and vascular events, mortality • No difference in 1o or 2o endpoints N Engl J Med 2009;361:1953-1962

  18. CORAL Trial Prospective Randomized Clinical Trials • Cardiovascular Outcomes in Renal Atherosclerotic Lesions • Multicenter: Enrolled 1050 patients (U.S., Canada, Australia, New Zealand) • PTRA-S versus Best Medical Management • Primary endpoint: composite CV mortality, MI, CHF, CVA, Doubling SCr, ESRD • Secondary endpoints: all cause mortality, EGFR, restenosis, microvascular function, BP control • Renal artery stenoses measured PRIOR to randomization at angiography • Translesional pressure gradients before and after randomization • Distal embolic protection encouraged (complete balloon occlusion) • Recruitment/randomization closed 2010 • Publication/presentation 1/2014 (C. Cooper) Am Heart J 2006;152:59-66

  19. Atherosclerotic Renovascular DiseaseMultivariate Analysis – Death or Dialysis J Vasc Surg 2002;35:236-245

  20. Management of Renovascular Disease (# Pts) Improved Unchanged Worsened Cured Improved Failed (%) Rees CR (1991) 14 36% 36% 29% 11% 5% 36% 39% Kuhn FP (1991) n/r n/r n/r n/r 22% 34% 44% 17% Joffre F (1992) 4 50% 50% 0% 27% 64% 9% 18% Hennequin LM (1994) 6 20% 40% 40% 7% 93% 0% 27% MacLeod M (1995) 16 25% 0% 40% 60% 17% van de Ven PJG (1995) n/r 33% 58% 8% 0% 73% 27% 13% Dorros G (1995) 29 28% 28% 45% 6% 46% 48% 25% Henry M (1996) 10 20% 18% 57% 24% 9% Iannone LA (1996) 29 36% 46% 18% 4% 35% 61% 14% Harden PN (1997) 32 35% 35% 29% n/r n/r n/r 13% Blum U (1997) 20 0% 100% 0% 16% 62% 22% 17% Boisclair C (1997) 17 41% 35% 24% 6% 61% 33% 0% Rundback JH (1998) 45 18% 53% 30% n/r n/r n/r 26% Fiala LA (1998) 9 0% 100% 0% 47% 65% Dorros G (1998) 63 1% 42% 57% n/r Tuttle KR (1998) 74 16% 75% 9% 2% 46% 52% 14% Gross CM (1998) 12 55% 27% 18% 0% 69% 31% 13% Henry M (1999) 48 29% 67% 2% 19% 61% 20% 11% Rodriguez-Lopez JA (1999) 32 13% 55% 32% 26% van de Ven PJ (1999) 29 17% 55% 28% 15% 43% 42% 14% Baumgartner I (2000) n/r 33% 42% 25% 57% 28% Giroux (2000) 21 24% 47% n/r Lederman (2001) 111 8% 78% 14% 30% 21% Bush (2001) 50 23% 51% 26% PTRA-S and Ischemic Nephropathy Reference/Date Renal Dysfunction Function response (%) HTN Response (%) Restenosis 75% 80% 53% No change in mean SCr No change in mean SCr 43% 76% 53% 70% n/r n/r n/r n/r Zeller (2004) 239 34% 39% 27% 46% 54% n/r Totals= 1017 22% 56% 22% 10% 51% 39% 19% n/r: Not Reported SCr: Serum Creatinine

  21. Chronic Mesenteric IschemiaPTVA+S vs. Open Repair J Vasc Surg 2007;45:1162-11711 J Endovasc Ther 2010;17:540-5492 Ann Vasc Surg 2009;23:700-7123

  22. Acute Mesenteric IschemiaPercutaneous vs. Open Repair J Vasc Surg 2011;53:698-705

  23. Atherosclerotic Renovascular DiseaseSummary •Severe Hypertension Key Clinical Characteristic Favoring Presence of Renovascular Disease •Improved Renal Function Key Postoperative Result Favoring of Dialysis-free Survival •Associations With Improved Renal Function •Severe Associated Hypertension •Bilateral Renovascular Disease With Bilateral Reconstruction •Rapidly Deteriorating Renal Function • Test(s) Physiologic Significance/Response

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