Safety and Efficacy of Distal Superficial Femoral Artery Puncture for Femoropopliteal Occlusive Lesions

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Safety and Efficacy of Distal Superficial Femoral Artery Puncture for Femoropopliteal Occlusive Lesions ~Result form the Multicenter RIVERside registry~ Tatsuya Nakama, Y Yamamoto, A Matsui, T Doijiri, M Fujihara, N Hayakawa, T Michinao, S Ozaki, Y Tsubakimoto, M Utsunomiya, D Kaomoi, Y Imoto, M Kimura, H Anzai, Y Ohno, M Sugihara, N Fujimura, K Suzuki, N Kaneko, Y Iwata, H Ando, K Urasawa, Y Yokoi and Y Shibata On behalf of REVERside registry investigators

Disclosure Speaker name: Tatsuya Nakama MD.... I have the following potential conflicts of interest to report: Consulting: Boston Scientific Japan, Century Medical Inc. Employment in industry: None Stockholder of a healthcare company: None Owner of a healthcare company: None Other(s): Honoraria recieved from Abbot Vascular, Asahi Intecc., Boston Scientific, COOK, Cordis Cardinal Health, Goodman, KANEKA, Lifeline, Medikit, Medtronic, Orbus Neichi, Terumo,

Backgrounds Retrograde approach is important technique in percutaneous endovascular revascularization for FPA occlusion. Popliteal artery puncture (PAP: URA-pan) is already established as a conventional retrograde approach. Kawarada O. et al. J Endovasc Ther. 2010; 17: 255-258 Distal SFA puncture (DSFAP: OMOTE-pan) has been widely spread as an alternative retrograde access technique. A Schmidt et al. J Endovasc Ther. 2012; 19:23-29 Femoropopliteal artery: FPA, Superficial femoral artery: SFA,

Complications of DSFAP Retrograde access site complications, such as hematoma, re-bleeding, pseudoaneurysm and hemostatic difficulty were sometimes observed during daily clinical practice. Kenji O. et al. LINC2017 Pseudoaneurysm Thrombin injection required Fujihara M. et al. LINC2017 Frequent re-bleeding Covered stent deployment

Multicenter registry was planned Retrospective analysis for the clinical value of retrograde access technique in endovascular therapy for femoropopliteal occlusions

Purpose Distal SFA puncture (OMOTE-pan) To investigate the safety and efficacy of the DSFAP technique in EVT for FP occlusions.

Backgrounds Study type Retrospective, multicenter study (18 site) Study period January 2012 to July 2016 ( 30 months ) Number of patients 609 retrograde procedure for SFA occlusion Study patients Symptomatic PAD patients who underwent EVT for SFA occlusion using retrograde approach

RIVERside registry Retrospective analysis for the clinical value of retrograde access technique in endovascular therapy for femoropopliteal occlusions Tokeidai Memorial Hp. Fukuoka Wajiro Hp. Fukuoka University Hp. Japanese Red Cross Kyoto Daiichi Hp. Japanese Red Cross Kyoto Daini Hp. Kishiwada Tokushukai Hp. Miyazaki Medical Association Hp. Ota Memorial Hp. Yamato Seiwa Hp. Iwaki Kyoritsu General Hp. Kokuho Asahi Chuo Hp. Itabashi Chuo Medical Center Nagoya Kasukabe Chuo General Hp. Kyoritsu Hp. Tokyo Rosai Hp. Chiba University Hp. Tokyo Saiseikai Central Hp.

Methods 609 Patients underwent percutaneous FPA-CTOs recanalization with retrograde approach Trans-collateral approach (n=41) Tibial or peroneal puncture (n=51) Antero-lateral P3 puncture (n= 26) Popliteal puncture (PAP cohort) _ 142 patients Distal SFA puncture (DSFAP cohort) 349 patients Procedural success & complication rate

Baseline characteristics Overall (n= 491) PAP cohort (n= 142) DSFAP cohort (n= 349) P value General Status Age, years 73.2 ± 8.6 72.9 ± 8.0 73.3 ± 8.9 0.578 Male, n (%) 350 (71.3) 247 (70.8) 103 (72.5) 0.696 Ambulatory status on admission 0.797 Independent gait, n (%) 354 (72.1) 101 (71.1) 253 (72.5) Walk with stick, n (%) 47 (9.6) 12 (8.5) 35 (10.0) Non-ambulatory status, n (%) 90 (18.3) 29 (20.4) 61 (17.5) Wheel chair use, n (%) 71 (14.5) 22 (15.5) 49 (69.0) Bed-ridden, n (%) 19 (3.9) 7 (4.9) 12 (3.4) Limbs status Critical limbs ischemia, n (%) 159 (32.4) 53 (37.3) 106 (30.4) 0.136 With ischemic wounds, n (%) 114 (23.2) 34 (23.9) 80 (22.9) 0.808 ABI before intervention 0.52 ± 0.25 0.52 ± 0.29 0.52 ± 0.23 0.719 ABI after intervention 0.89 ± 0.20 0.89 ± 0.19 0.88 ± 0.21 0.622

Baseline characteristics Overall (n= 491) PAP cohort (n= 142) DSFAP cohort (n= 349) P value Risk factors Hypertension, n (%) 422 (85.9) 118 (83.1) 304 (87.1) 0.247 Dyslipidemia, n (%) 310 (63.1) 88 (62.0) 222 (63.6) 0.733 Diabetes mellitus, n (%) 273 (55.6) 87 (61.3) 186 (53.3) 0.107 Smoking history, n (%) 232 (47.3) 72 (50.7) 160 (45.8) 0.328 Regular hemodialysis, n (%) 99 (20.2) 31 (21.8) 68 (19.5) 0.557 History of ischemic heart disease, n (%) 208 (42.4) 76 (53.5) 132 (37.8) 0.001 History of cerebrovascular disease, n (%) 106 (21.6) 29 (20.4) 77 (22.1) 0.689 Medication Aspirin, n (%) 407 (82.9) 122 (85.9) 285 (81.7) 0.396 Clopidogrel, n (%) 353 (71.9) 105 (73.9) 248 (71.1) 0.570 Cilostazol, n (%) 175 (35.6) 48 (33.8) 127 (36.4) 0.560 DAPT, n (%) 427 (87.0) 124 (87.3) 303 (86.8) 0.665 Anticoagulation therapy, n (%) 63 (12.8) 15 (23.8) 48 (13.8) 0.411 DAPT + anticoagulation therapy, n (%) 52 (10.6) 13 (9.2) 39 (11.2) 0.528

Angiogram characteristics Overall (n= 491) PAP cohort (n= 142) DSFAP cohort (n= 349) P value Angiographic characteristics TASC D, n (%) 397 (80.9) 109 (76.8) 288 (82.5) 0.141 De novo lesion, n (%) 462 (94.1) 134 (94.4) 328 (94.0) 0.870 Lesion length, mm 248 ± 82 235 ± 82 253 ± 81 0.024 Vessel calcification <0.0001 None, n (%) 101 (20.6) 27 (19.0) 74 (21.2) Mild, n (%) 165 (33.6) 26 (18.3) 139 (39.8) Moderate, n (%) 93 (18.9) 33 (23.2) 60 (17.2) Severe, n (%) 132 (26.9) 56 (39.4) 76 (21.8) Moderate to severe calcification, n (%) 225 (45.8) 89 (62.7) 136 (39.0) <0.0001 PACCS score <0.0001 0, n (%) 115 (23.4) 26 (18.3) 89 (25.5) 1, n (%) 109 (22.2) 17 (12.0) 92 (26.4) 2, n (%) 48 (9.8) 20 (14.1) 28 (8.0) 3, n (%) 74 (15.1) 25 (17.6) 49 (14.0) 4, n (%) 145 (29.5) 54 (38.0) 91 (26.1)

EVT procedures Overall (n= 491) PAP cohort (n= 142) DSFAP cohort (n= 349) P value Antegrade approach site Crossover, n (%) 302 (61.5) 71 (50.0) 231 (66.2) 0.004 Sheathless technique for retro site, n (%) 366 (74.5) 68 (47.9) 298 (85.4) <0.0001 Guidewire crossing technique <0.0001 Retrograde direct cross (%) 81 (16.5) 38 (26.8) 43 (12.3) Kissing wire, n (%) 32 (6.5) 12 (8.5) 20 (5.7) Wire rendezvous, n (%) 320 (65.2) 66 (46.5) 254 (72.8) CART/ reverse CART, n (%) 51 (10.4) 23 (16.2) 28 (8.0) Retrograde access site hemostasis Tamponade with PTA balloon, n (%) 418 (85.1) 85 (59.9) 333 (95.4) <0.0001 Size of PTA balloon, mm 4.87 ± 0.66 4.69 ± 0.60 4.91 ± 0.67 0.004 Use of compression devices, n (%) 78 (15.9) 49 (34.5) 29 (8.0) <0.0001 Thrombin injection required, n (%) 37 (7.5) 6 (4.2) 31 (8.9) 0.076 Time to complete hemostasis, min 26.6 ± 57.7 71.9 ± 97.0 9.7 ± 6.7 <0.0001

Primary efficacy outcomes Procedural success rate (%) 100 90 80 70 60 50 40 30 20 10 0 P=0.612 98.6% 97.9% 98.9% All cohort POPA cohort DSFAP cohort (Overall) (URA-pan) (OMOTE-Pan) All cohort PAP cohort DSFAP cohort Retro puncture success rate 99.0% 100.0% 98.6%

Primary safety outcomes Incidence of overall complications (%) 12 11 P=0.637 10 9 8 7 9.8% 9.9% 9.7% 6 5 All cohort PAP cohort DSFAP cohort (Overall) (URA-pan) (OMOTE-Pan)

Puncture related complications Puncture 7 relataed complication rate 6 5 4 3 5.7% 6.0% 2 3.3% 4.9% 3.5% 4.0% 1 2.4% 1.4% 2.0% 0 All cohort PAP cohort DSFAP cohort Overall Antegrade Retrograde

Puncture related complications All 7 puncture site P=0.637 6 5 4 3 5.7% 6.0% 2 3.3% 4.9% 3.5% 4.0% 1 2.4% 1.4% 2.0% 0 All cohort PAP cohort DSFAP cohort Overall Antegrade Retrograde

Puncture related complications Antegrade 7 puncture site 6 5 4 P=0.324 3 5.7% 6.0% 2 3.3% 4.9% 3.5% 4.0% 1 2.4% 1.4% 2.0% 0 All cohort PAP cohort DSFAP cohort Overall Antegrade Retrograde

Puncture related complications Retrograde 7 puncture site 6 5 P=0.141 4 3 5.7% 6.0% 2 3.3% 4.9% 3.5% 4.0% 1 2.4% 1.4% 2.0% 0 All cohort PAP cohort DSFAP cohort Overall Antegrade Retrograde

Secondary outcomes Incidence of 30-days adverse event (%) 8 P=0.637 6 4 6.2% 7.6% 5.6% 2 0 All cohort POPA cohort DSFAP cohort (Overall) (URA-pan) (OMOTE-Pan)

Summary of presentation Retrograde puncture success rate PAP: 100% vs. DSFAP: 99% Procedural success rate PAP: 98% vs. DSFAP: 99%

Summary of presentation Overall complication rate PAP: 9.9% vs. DSFAP: 9.7% Puncture related complication rate PAP: 4.9% vs. DSFAP: 6.0% Retrograde site complication rate PAP: 1.5% vs. DSFAP: 4.0% Included 1% blood transfusion

Conclusions Both retrograde access technique, PAP and DSFAP, were feasible and safe technique in percutaneous endovascular revascularization for complex FPA occlusions. Safety and efficacy of DSFAP, which was called OMOTE-pan in Japan, is not inferior compared to conventional PAP, which called URA-pan.

Safety and Efficacy of Distal Superficial Femoral Artery Puncture for Femoropopliteal Occlusive Lesions ~Result form the Multicenter RIVERside registry~ Tatsuya Nakama, Y Yamamoto, A Matsui, T Doijiri, M Fujihara, N Hayakawa, T Michinao, S Ozaki, Y Tsubakimoto, M Utsunomiya, D Kaomoi, Y Imoto, M Kimura, H Anzai, Y Ohno, M Sugihara, N Fujimura, K Suzuki, N Kaneko, Y Iwata, H Ando, K Urasawa, Y Yokoi and Y Shibata On behalf of REVERside registry investigators

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