Evidence-Based Optimal Treatment for SFA Disease

Transcription

1 Evidence-Based Optimal Treatment for SFA Disease Endo first Don t burn surgical bridge Don t stent if possible Javairiah Fatima, MD Assistant Professor of Surgery Division of Vascular and Endovascular Surgery University of Florida

2 Disclosures None *Vascular surgeon with modest endovascular skill set

3 Overview Introduction Overview of disease burden and its significance Medical management Open reconstruction vs Endovascular approaches Comparison of outcomes of various modalities

4 Peripheral Arterial Disease (PAD) 20% incidence in patients >75y >8 million of the US population 30-50% of these become symptomatic Up to 30% progress to Critical Limb Ischemia (CLI) 85% in the SFA / Popliteal artery 15% in the tibioperoneal vessels Ouriel K. Peripheral Arterial Disease. The Lancet. 2001; 358:

5 Caveats Multiple, competing, evolving strategies Evidence limited for new therapies Applicability of clinical trials to practice Cost considerations

6 Outcomes in Patients with Intermittent Prevalence Claudication Population >55 yr Worsening Claudication 15% Peripheral Vascular Outcomes Lower Extremity Bypass Surgery 25% Major Amputation <4% Limb Outcomes Intermittent Claudication 5% Weitz JI, et al. Circulation. 1996;94: Other Cardiovascular Morbidity/Total Mortality Nonfatal Cardiovascular Event (MI/Stroke, 5-yr Rate) 20% 5-yr Mortality 30% Cardiovascular Cause 75% Reduce CV Risk

7 Principles and Goals of Treatment Improve functional status & quality of life Limb preservation/salvage, heal wounds Restoring inline-flow from the heart to the ankle Identify and treat systemic atherosclerosis Prevent progression of atherosclerosis.

8 Risk Factors for PAD Conte MS. SVS Practice Guidelines. J Vasc Surg 2015;61:2S.

9 First line of Treatment for Claudication Risk factor modification HTN Hyperlipidemia Diabetes Smoking cessation Obesity Exercise therapy ASA/Statin/BB Pharmacotherapy adjuncts such as Pletal

10 Medical Therapy statin/antiplatelet *5 yr survival after elective vascular procedures in pts discharged on antiplatelets/statins 18% absolute mortality benefit De Martino. J Vasc Surg 2014;59:1615

11 Meta-analysis Medical Therapy *Meta-analysis of 11 RCTs demonstrated cilostazol increased maximal walking distance by 25% Stevens JW. BJS 2012;99:1630.

12 Meta-analysis of Exercise Therapy Increased walking time 4.5 min Walking ability from %, sustained up to 2 years Did not improve ABI, mortality, amputation and peak exercise blood flow *30 RCTs including 1816 participants. Lane R. Cochrane Database Syst Rev 2014.

13 Exercise Therapy - Practical Modest benefit MWD, PFWD Poor patient compliance 30% Not feasible for all patients - 30% No coverage for supervised therapy*** AHA Level 1 recommendation *complementary to revascularization.

14 Indications for Revascularization Revascularization for lifestyle-limiting claudication Reasonable likelihood of success Failed medical/exercise therapy Treatment benefits outweigh the risks Conte MS. SVS Practice Guidelines. J Vasc Surg 2015;61:2S.

15 Revascularization Options Open vs. Endovascular

16 TASC II Guidelines Trans-Atlantic Inter-Society Consensus on management of PAD Developed to provide an international consensus on the diagnosis and treatment of PAD Treatment recommendations based on location and severity of disease Norgren L. J Vasc Surg 2007;45:S5.

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18 TASCII Recommendations TASC A endovascular TASC B endovascular with qualifications TASC C open with qualifications TASC D - open * Moving target - shift of complex lesions to lower groups Jaff MR. Vascular Medicine 2015;20:465.

19 SVS Recommendations FPOD Endo for focal SFA occlusive dz. (non origin) Selective stent for poor angioplasty results Adjunct stent for 5 15 cm lesions Bypass for diffuse disease, small vessels (< 5 mm) or extensive calcification Conte MS. SVS Practice Guidelines. J Vasc Surg 2015;61:2S.

20 Determinants of Revascularization Anatomy Comorbidities Functional status Symptom severity Available conduit Outcome/durability Potential for success Prior treatment Expertise Cost Anticipated complications Patient preference Endovascular first standard of care

21 Revascularization Options Endovascular Angioplasty Plain balloon Drug coated balloon Surgical bypass Autogenous Prosthetic Intraluminal stent Bare metal stent Covered stent Drug eluting stent Other therapies

22 FPOD Revascularization - 1º Patency Conte MS. SVS Practice Guidelines. J Vasc Surg 2015;61:2S.

23 Meta-analysis Endo vs Bypass FPOD Meta-analysis of 4 RCTs and 6 observational trials (n= 2817) Endo - 30-day morbidity, technical failure Bypass - primary patency, amp-free survival and overall 1, 2, 3 and 4 yrs Conclusion high level evidence lacking, endo-first for significant comorbidities with bypass for more fit patients. Antoniou GA. J Vasc Surg 2013;57:242.

24 Meta-analysis Conduit for FPOD *Meta-analysis of 13 trials (n= 2313), vein > Dacron > PTFE in AK position at 60 mos. Twine CP. Cochrane Database Syst Rev 2010.

25 Meta-analysis POBA vs BMS SFA *Meta-analysis of 11 RCTs (n = 1387) early patency advantage of stents lost by 24 months. Chowdhury MM. Cochrane Database Syst Rev 2014

26 Drug Coated Balloon IN.PACT Dual mode of action mechanical (balloon angioplasty) pharmacotherapy (local drug delivery to arterial wall)

27 IN.PACT DCBs (FDA approved) Enrolled 331 patients (57 sites) At 12 months Primary patency DCB vs PTA 82% vs 52% (p<0.001) Need for TLR DCB vs PTA 2.4% vs 20.6% (p<0.001)

28 Meta-analysis Drug Coated Balloon *Meta-analysis of 11 trials advantage of DCB for patency, restenosis, and TLR, but no advantage of amp, death, or ABI. Kayssi A. Cochrane Database Syst Rev 2016.

29 VIPER Trial Evaluating new generation Viabahn with heparin bonding and contour edge in treating SFA disease N=119; lesion length 19cm 92% 73%

30 Meta-analysis Covered Stent FPOD *Meta-analysis of 2 RCTs (N = 135) showed patency, ABI, and re-intervention with covered stents. Hajibandeh S J Endovasc Ther 2016;23:442.

31 Zilver PTX 5 year data Matched patient and lesion characteristics (MC, randomized) Zilver PTX vs. Balloon PTA Zilver PTX had 48% reduction in reintervention 41% reduction in restenosis Zilver PTX vs. BMS Zilver PTX had 47% reduction in reintervention 41% reduction in restenosis

32 Meta-analysis Drug-eluting Stent FPOD *Meta-analysis of 4 RCTs and 2 obs trials (N = 544) with improved early patency and freedom from TLR for DES Antoniou GA. J Endovasc Ther 2013;131.

33 Meta-analysis of Endo Treatments *Meta-analysis of 16 RCTs (N = 2532) technical success better with covered stent, but drug-eluting stents, drug-coated balloon with best long term outcome. Katsanos K. J Vasc Surg 2014;59:1123.

34 Meta-analysis of All Treatments SFA nodes participants lines - trials Patency multidimensional scaling Drug eluting S > Bypass > Nitinol S > Covered S > Drug-coated B > Stainless S > Cryoplasty > Balloon A *Network meta-analysis of 33 RCTs (N = 4659) DES promising but bypass still principal intervention Antonopoulos CN. J Vasc Surg :234.

35 My Approach Endo first All SFA, select pop and tibial lesions Rest pain and minimal tissue loss Long segment SFA disease with no vein Surgery first Extensive tissue loss Long occlusion with good conduit (Vein) Young patient with good risk

36 Conclusions The natural history of SFA occlusive disease (intermittent claudication) is benign Initial treatment includes medical management and exercise Revascularization indicated for lifestyle-limiting claudication to improve QoL

37 Conclusions Individualize therapy, reasonable to have endo approach first as long as you don t burn a bridge to bypass Endovascular likely the optimal initial revascularization approach with bypass reserved for more complex lesions in acceptable risk patients

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