Endovascular Therapy vs. Open Femoral Endarterectomy Rationale and Design of the Randomized PESTO Trial

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1 Endovascular Therapy vs. Open Femoral Endarterectomy Rationale and Design of the Randomized PESTO Trial Prof. Thomas Zeller, MD Department Angiology Clinic for Cardiology and Angiology II University Heart-Center Freiburg - Bad Krozingen Bad Krozingen, Germany

2 Faculty Disclosure Thomas Zeller, MD For the 12 months preceding this presentation, I disclose the following types of financial relationships: Honoraria received from: Abbott Vascular, Bard Peripheral Vascular, Veryan, Biotronik, Boston Scientific Corp., Cook Medical, Cordis Corp., Gore & Associates, Medtronic, Spectranetics, Straub Medical, TriReme, VIVA Physicians Consulted for: Boston Scientific Corp., Cook Medical, Gore & Associates, Medtronic, Spectranetics, Veryan Research, clinical trial, or drug study funds received from: 480 biomedical, Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, Cordis Corp., Gore & Associates, Medtronic, Spectranetics, Terumo, TriReme, Volcano

3 CFA Standard Treatment Open surgical revascularisation Thrombendartherectomy atheromateous lesions Embolectomy embolic lesions Limitations: Scarred tissue Obesity Morbidity up to 5%: Major hematoma Wound infection Surgical revision Cardon A et al. Endarteriectomy of the femoral tripod: long-term results and analysis of failure factors. Ann Chir 2001;126:

4 CFA Standard Treatment - Complications 1513 patients undergoing elective CFE in the 2007 to 2010 National Surgical Quality Improvement Project database were examined. 30-day mortality rate: 1.5% Postoperative morbidities: cardiac (1.0%) pulmonary (1.9%) renal (0.4%) urinary tract infection (1.7%) thromboembolic (0.5%) neurologic (0.4%) sepsis (2.7%) superficial (6.3%) and deep surgical site complications (2.0%) At least 1 complication: 7.9% Siracuse JJ 1, Gill HL, Schneider DB, Graham AR, Connolly PH, Jones DW, Meltzer AJ. Assessing the perioperative safety of common femoral endarterectomy in the endovascular era. Vasc Endovascular Surg Jan;48(1):27-33.

5 Subgroup Analysis Stented lesions vs. non-stented lesions Stented (n = 133) Nonstented (n = 227) OR 95% CI P Value Failure 2.2% 10.1% 0.20 ( ) Complications 7.5% 5.7% 1.34 ( ) Restenosis 20.0% 31.8% 0.53 ( ) Year TLR 13.1% 23.6% 0.49 ( ) Bonvini et al. JACC 2011

6 Femoro-popliteal Artery - Biomechanics CFA CFA CFA-bifurcation Zone A Zone B Zone C Zone D Bend / Kink Compress / Slight curve Fixed Bend / Kink Modified according to Lansky, A; Angiographic Analysis of Strut Fractures in the SIROCCO Trial. TCT 2004

7 Stent Fractures Distal EIA

8 The Potential New Solution: Drug Coated Balloon angioplasty with or w/o upfront atherectomy / mechanical thrombectomy

9 Subgroup Analysis Atherectomy vs. POBA +/- Stent Atherectomy (N=25) % PTA ±stent (N=335) % RR 95% CI P value Failures Complications Restenosis yr TLR Bonvini et al. JACC 2011

10

11 Atherectomy of the Common Femoral Artery The Bad Krozingen Experience

12 Baseline characteristics N= 286 Mean Age (years): 71 (range 44-93) men 200 (69.9%) CVR Diabetes 101 (35.3%) Hypertension 257 (89.9%) Hyperlipidemia 257 (89.9%) Smoking 194 (67.8%) Coronary heart disease 142 (49.7%) History of stroke 32 (11.2%) COPD 30 (10.5%) Renal failure 82 (28.7%)

13 Atherectomy- and Protection devices N % Silverhawk Turbohawk / Rockhawk / HawkOne Protection device (Spider) Adjunctive Therapy n % Stenting Plain old balloon angioplasty Drug-coated balloon

14 Acute Results Mean Target lesion (TL) stenosis pre intervention (visual) Mean TL stenosis post intervention (visual) Procedural success ( 30% residual TL stenosis) 82.1% 24.2% 255 (89.9%) ABI pre intervention 0.53 ABI post intervention 0.85 (P=0.001)

15 Results at 1 year/2 years N (%) Target lesion revascularization (TLR) at 1 year 13 (4.5) Endovascular 6 (2.1) Surgery 7 (2.3) Target lesion revascularization (TLR) at 2 years 28 (9.8) Endovascular 15 (5.3) Surgery 13 (4.5)

16 PESTO-CFA Study Percutaneous Intervention versus Surgery in the Treatment of Common Femoral Artery Lesions A prospective, multi-centre, randomised study Title: PESTO-CFA Aim: Study design: Patient recruitment: Non inferiority study comparing DCB based endovascular therapy and surgical therapy in the treatment of atherosclerotic CFA disease Prospective, multicenter, randomized, controlled study, 1:1 randomization Follow-up at 6 months, 1, 2 and 5 years 260 patients. Study duration 6.5 years (recruitment time 18 months, follow-up 5 years)

17 PESTO-AFC Study Design DESIGN: Prospective, randomized, multicentre study Aim: Evaluation of acute- and midterm results of atherectomy and DCB compared to TEA in the treatment of CFA disease. Hypothesis: non-inferiority 260 patients to be enrolled in 10 clinical sites in Germany Endovascular - Atherectomy/DCB - Stent (optional) Colloquium consensus Randomization 1:1 Surgery Endarterectomy 6-, 12-, and 24-months FU - ABI-measurement - Treadmill test (optional) - Duplex-ultrasound - Walking-impairment Questionaire

18 PESTO-AFC Main Inclusion Criteria General criteria: - Age 21 years - Written informed consent - Ability to undergo the procedures and follow-up visits - Symptomatic PAOD Fontaine IIa-IV / Rutherford 2-5 Duplex/Angiography/CTA/MRA criteria: - De-novo CFA occlusion or stenosis > 70% diameter reduction including the femoral bifurcation - At least one patent tibial artery - No untreated inflow stenosis > 50%, intervention in the same session possible (true for surgery and endovascular study arm) - Study lesion must be suitable for both treatment modalities (colloquium consensus)

19 PESTO-AFC Primary Endpoints Primary Endpoint (Efficacy) Primary patency rate of target lesion without TLR at 12 months (duplexsonographic patency defined as PSVR < 2.5). Primary Endpoint (Safety) Combined 30-day Endpoint: - Periinterventional/-operative complications including death, MI, major-/minor amputation of target limb. - Access site complications. - Thrombo-embolic events. - Index-procedure related infections.

20 Summary Endovascular Treatment of CFA Disease Surgery is still considered as the gold standard for CFA treatment Limited availability of controlled data Peripheral intervention techniques have reached comparable technical outcomes compared to surgery including Stenting Atherectomy w/o DCB RCT s comparing endovascular treatment with surgery are on the way

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