Renal Intervention Douglas E. Drachman, MD, FSCAI Division of Cardiology Vascular Medicine Section December 9, 2014
Disclosure Information Douglas E. Drachman, MD, FACC Abbott Vascular, Inc.: Advisory Board Atrium Medical Corporation: Research Grant Support idev Technologies, Inc.: Research Grant Support Lutonix/BARD: Research Grant Support Off-label use of products will be discussed in this presentation as indicated. Many stents used in the peripherial arterial circulation are indicated for biliary or tracheal application.
10-minute Objectives: Epidemiology and Pathophysiology of RAS Clinical Trials Data: Methodologic Considerations Patient Selection for Renal Artery Stenting Future Directions
Uncontrolled Hypertension is a Scourge 67.5 million HTN in US 33 million uncontrolled (BP >140/>90 ) Inertia, side effects, cost, non-compliance NHANES: 13,375 hypertensive patients Apparent treatment-resistance (>3 medications) 15.9% in phase 1 (1998-2004) 28.0% in phase 2 (2005-2008) Egan, et al. Circulation 2011;124:1046
HTN outcomes: Framingham, AHA A 5mmHg reduction in BP can promote: 14% reduction in stroke 9% reduction in heart disease 7% decrease in death
Renal Artery Stenosis More common than previously thought. General population Hypertensive population HTN & suspected CAD Malignant HTN Malignant HTN & renal insuffiency Incidence 0.1% 4.0% 10-20% 20-30% 30-40% Lesions tend to progress with time. Progressive renal insufficiency ensues. Jean WJ, et al. Cathet Cardiovasc Diagn 1994;32:8-10. Harding MB, et al. J Am Soc Neph 1992;2:1608-1616. Weber-Mzell D,et al. Eur Heart J 2002;23:1684-91.
Renal Artery Revascularization: Why it should control HTN RAAS = the mechanism
Contemporary Trials: Ambiguous Findings DRASTIC (van Jaardsveld et al., NEJM 2000) PTA vs. Med-Rx (n=106) no change in SBP at one year Stenosis > 50% Avg 2 interventions/site over 4 years (selection bias) PTA without stent restenosis in 50% Intention to treat analysis (cross-over) ASTRAL (ASTRAL Investigators, NEJM 2009) Stent vs. Med-Rx (n=806) no change in SCr at one year Enrolled by RADUS (2/5 pts < 70% stenosis, 1/5 <50%) Selection bias: 2 pts/center/year Baseline Cr 2.0, but many with unilateral RAS Enrolled for HTN, but SCr endpoint
N Engl J Med. 2014;370:13-22.
Methods Open-label, randomized, international, multicenter controlled clinical trial All received medical therapy: BP, diabetes, and lipids to goal, with participants provided free: Candesartan ± hydrochlorothiazide (Atacand ) Atorvastatin + Amlodipine (Caduet ) Antiplatelet therapy N Engl J Med. 2014;370:13-22.
Inclusion Criteria Clinical syndrome: Hypertension 2 anti-hypertensive medications, OR Renal dysfunction defined as Stage 3 or greater CKD AND Atherosclerotic renal artery stenosis: Angiographic: 60% and <100%, OR Duplex: systolic velocity of >300 cm/sec, OR Core lab approved MRA, OR Core lab approved CTA N Engl J Med. 2014;370:13-22.
Primary Endpoint Composite of major cardiovascular or renal events: Cardiovascular or renal death Stroke Myocardial infarction Heart failure hospitalization Progressive renal insufficiency Permanent renal replacement therapy N Engl J Med. 2014;370:13-22.
Primary Endpoint N Engl J Med. 2014;370:13-22.
Results: Systolic Blood Pressure P=0.03 Note: BP reduced in med-rx group Were patients truly medically refractory /optimized? N Engl J Med. 2014;370:13-22.
Shortcomings of CORAL: Robust response to med-rx in control group Slow enrollment Patients with severe stenosis not enrolled Average stenosis 67% Equipoise? Is stenosis adequate to determine ischemia? Need for a hemodynamic evaluation? Are hard endpoints the correct ones?
Would you consider randomizing this patient to medical therapy? 78 yo F: - malignant HTN (>230/100mmHg) - 4 meds - Recur pulm edema - Intolerant of meds Renal Stenting it s all about case selection!
74 yo M with CRI ARF + cardiac disturbance syndrome one week after CEA Cr = 4.2, oliguric HD initiated Known RAS
74 yo M with CRI ARF + cardiac disturbance syndrome one week after CEA Cr = 4.2, oliguric HD initiated Known RAS
Selective engagement, attempted wiring ProWater Miracle Bros 3 Whisper IMA guide Sos 3 Sos 1
Anatomic insights from non-contrast CT can save the day: cul-de-sac lumen
Probing until Sos caught on a cleft, then Whisper Sos 1
Transition to HS guide: PTA, stent 6x18mm Herculink Elite Post-dil to 7mmm
Transition to HS guide: PTA, stent 6x18mm Herculink Elite Post-dil to 7mmm
Clinical response after renal stent Urine Output Stent Stent Serum Cr
Data support our ability to select patients
Study Overview Patient-level data from 901 patients (117 centers) 5 prospective multicenter FDA-approved IDE studies of renal artery stenting Associations of BP reduction determined by logistic regression Catheter Cardiovasc Intervent. 2014;83:603-9.
Included studies Study HERCULES Device RX Herculink Elite Number of Subjects 202 SOAR Bridge TM balloon expandable stent 186 RENAISSANCE Express SD Renal Premounted Stent System 100 RESTORE ASPIRE ParaMount XS DoubleStrut balloon expandable stent Palmaz Balloon expandable stent 205 208 Catheter Cardiovasc Intervent. 2014;83:603-9. Selected Inclusion Criteria Uncontrolled BP and suboptimal PTA Uncontrolled BP and failed PTA Uncontrolled BP and suboptimal PTA, renal dysfunction (Cre<3.0 mg/dl), recurrent flash pulmonary edema, or any combination thereof Severe HTN Uncontrolled BP and suboptimal PTA
Blood Pressure Response Blood Pressure (mmhg) p<0.0001 200 164 150 146 Pre Post 100 p<0.0001 79 76 50 0 Systolic BP Catheter Cardiovasc Intervent. 2014;83:603-9. Diastolic BP
ACC/AHA Guidelines: Renal Revasc Hypertension Hemodynamically significant RAS Accelerated HTN Resistant HTN Malignant HTN HTN with unexplained unilateral small kidney HTN with intolerance to medication ØClass II indication, level of evidence = B Pulmonary edema ØClass I indication
SCAI expert consensus document Evaluation of literature Integration to clinical practice Catheter Cardiovasc Intervent. 2014.
Appropriate Use Catheter Cardiovasc Intervent. 2014.
Future Directions Transradial renal intervention PTFE-covered stenting
A recent consult for ARF,CHF, malignant HTN Our clinical dx: renal artery stenosis Our plan: renal intervention Multiple exams documented palpable but diminished distal pulses and femoral bruits To our exam: no palpable leg pulses Monophasic doppler at femorals
We found an I+ CT scan from prior admission
We used radial access
A Patient with Morbid Obesity We used radial access
Future Directions: PTFE-Covered Stents ARTISAN trial Externalization of atheromatous plaque? Reduction of restenosis?
Conclusions: HTN, RAS prevalent Clinical trials data: methodologic shortcomings Patient selection is key Transradial options to reduce vascular complications PTFE-covered stenting may offer promise