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Clinical Outcomes of Pedal Artery Angioplastyfor Patients with Ischemic WoundsResult from the Multicenter RENDEZVOUS Registry Tatsuya Nakama1、Nozomi Watanabe¹、Takuya Haraguchi²、Hiroshi Sakamoto³、Daisuke Kamoi⁴、Yoshinori Tsubakimoto⁵、Kenji Ogata¹、Katsuhiko Satoh²、Kazushi Urasawa²、Hiroshi Andoh³、Hiroshi Fujita⁵ and Yoshisato Shibata¹on behalf of the RENDEZVOUS registry investigators¹Miyazaki Medical Association Hospital, Cardiovascular Center, Miyazaki、²Cardiovascular Center, Tokeidai Memorial Hospital, Sapporo、³Department of Cardiology, Kasukabe Chuo General Hospital, Saitama、⁴Department of Cardiology, Nagoya Kyoritsu Hospital, Nagoya、⁵Department of Cardiology, Japanses Red Cross Kyoto Daini Hospital, Kyoto

DisclosureSpeaker name: Tatsuya Nakama MD.I have the following potential conflicts of interest toreport:Consulting: Abbot Vascular, Boston ScientificEmployment in industry: NoneStockholder of a healthcare company: NoneOwner of a healthcare company: NoneOther(s): Honoraria recieved fromAbbot Vascular, Boston Scientific, COOK, Medtronic

Experience of Pedal revascularizationNakama T, et al. EJEVS Extra, ; 27: e7-e9

Pioneer of pedal interventionPalena LM, Manzi M, et al. JEVT ; 19: 805-11Palena LM, Manzi M, et al. CCI ; 83:123-9

Key issue of “aggressive” strategyWhat are the clinical implicationsof pedal artery intervention?

Result of Pedal artery angioplastyNakama et al. Oral presentation, JCS Nakama et al, J Endovasc Ther 23: 83-91

Hypothesis developmentAdjunctive pedal interventionImprove the rate of wound healing

Result from single center studyPAA( )PAA(-)92.9%Time to wound-healingPAA( ): 86.0 18.7 days(IQR: 63 - 155)59.7%PAA(-): 152.0 60.2 days(IQR: 80 - 365)p value 0.05P 0.05Months036912PAA( )at risk%140750379193193PAA(-)at risk%1801229753660660Nakama et al. Oral presentation, JCS Nakama et al, J Endovasc Ther 23: 83-91

Tsubakimoto Y.Japanese Red CrossKyoto Daini HP, KyotoUrasawa K.Tokeidai MemorialHP, SapporoKamoi D.Nagoya Kyoritsu HP,NagoyaMiyazaki MedicalAssociation HP, MiyazakiAndo H.Kasukabe ChuouGenera HP, KasukabeNakama T, et al. J Am Coll Cardiol Intv ; 10: 79-90

Study synopsis Study type・ Retrospective,multi-center Number of patients・257 patients (257 limbs, R5 and 6) Comparison group study・ PAAgroup vs Non-PAA groupNakama T, et al. J Am Coll Cardiol Intv ; 10: 79-90

Outcomes Primary outcome・ Rateof wound (& time to wound healing) Specify the indication of PAA・ Delayedwound healing score(DH-Score)Nakama T, et al. J Am Coll Cardiol Intv ; 10: 79-90

Backgrounds of patientsOverallPAA groupNon-PAAgroupP valueAge, years73.2 11.072.2 11.574.3 10.40.121Male, n (%)175 (68.1)96 (68.6)79 (67.5)0.857Non-ambulatory status, n (%)132 (51.4)64 (45.7)68 (58.1)0.048BMI 18, n (%)40 (15.6)18 (12.9)22 (18.8)0.190Hypertension, n (%)186 (72.4)96 (68.6)90 (76.9)0.136Dyslipidemia, n (%)76 (29.6)44 (31.4)32 (27.4)0.476Diabetes mellitus, n (%)187 (72.8)101 (72.1)86 (73.5)0.807Smoking history, n (%)111 (43.2)67 (47.9)44 (37.6)0.099Regular hemodialysis, n (%)160 (62.3)89 (63.6)71 (60.7)0.634History of IHD, n (%)148 (57.6)88 (62.9)60 (51.3)0.062Previous stroke, n (%)69 (26.8)34 (24.3)35 (29.9)0.311Albumin 3g/dL, n (%)51 (19.8)24 (47.1)27 (23.1)0.23570 % Diabetes60 % Daily hemodialysis50 % NonambulatoryNakama T, et al. J Am Coll Cardiol Intv ; 10: 79-90

Target limbs statusOverallPAA groupNon-PAAgroupP valueRutherford 6, n (%)57 (22.2)34 (24.3)23 (19.7)0.374University of Texas grade 2, n (%)119 (46.3)71 (50.7)48 (41.0)0.121163 (63.4)96 (68.6)67 (57.3)0.1015.5 1.75.7 1.75.3 1.70.157173 (67.3)98 (70.0)75 (64.1)0.316Forefoot wounds, n (%)190 (73.9)104 (74.3)86 (73.5)0.887Pressure area wounds, n (%)40 (15.6)21 (15.0)19 (16.2)0.78520 % Rutherford class 660 % WiFI Clinical stage 415 % Pressure are woundsWound ClassificationSVS WIfI classificationWIfI Clinical Stage 4 (high risk), n (%)WIfI composite scoreWIfI composite score 5, n (%)Wound locationNakama T, et al. J Am Coll Cardiol Intv ; 10: 79-90

Rate of wound healingP 0.00359.3%211 daysP 0.00338.1%365 daysNakama T, et al. J Am Coll Cardiol Intv ; 10: 79-90

Factors ofWound healingPositiveinfluenceNonambulatoryDepth of woundsDailyhemodialysisHR: 0.43(0.23-0.78)HR: 2.02HR: 2.89HR: 3.24(1.12-3.61) (1.74-6.04) (1.60-5.22)Negative influencePedal angioplastyNakama T, et al. J Am Coll Cardiol Intv ; 10: 79-90

Risk-stratification: DH-scoreDelayed wound healing score (DH-score) was evaluatedNon-ambulatoryDepth of woundDaily hemodialysisDH-score 0DH-score 1 - 2DH-score 3Low-risk populationModerate-risk populationHigh-risk population(n 28)(n 196)(n 33)Nakama T, et al. J Am Coll Cardiol Intv ; 10: 79-90

WHR in low-risk population93.3%62.9%P 0.184Nakama T, et al. J Am Coll Cardiol Intv ; 10: 79-90

WHR in moderate-risk populationP 0.00159.3%33.9%Nakama T, et al. J Am Coll Cardiol Intv ; 10: 79-90

WHR in high-risk populationP 0.47735.7%29.4%Nakama T, et al. J Am Coll Cardiol Intv ; 10: 79-90

Summary of RENDEZVOUS registry PAA showed its positive effect onwound-healing PAA is recommended in themoderate-risk population However, in the high-risk population,PAA could not show its efficacy.Nakama T, et al. J Am Coll Cardiol Intv ; 10: 79-90

Take home message

Let us remember the past

Let us continue the challenges

experiences will become evidences

Let us imagine the future

Trailblazing effort will open theDoor of the future of CLI treatment

Clinical Outcomes of Pedal Artery Angioplastyfor Patients with Ischemic WoundsResult from the Multicenter RENDEZVOUS Registry Tatsuya Nakama1、Nozomi Watanabe¹、Takuya Haraguchi²、Hiroshi Sakamoto³、Daisuke Kamoi⁴、Yoshinori Tsubakimoto⁵、Kenji Ogata¹、Katsuhiko Satoh²、Kazushi Urasawa²、Hiroshi Andoh³、Hiroshi Fujita⁵ and Yoshisato Shibata¹on behalf of the RENDEZVOUS registry investigators¹Miyazaki Medical Association Hospital, Cardiovascular Center, Miyazaki、²Cardiovascular Center, Tokeidai Memorial Hospital, Sapporo、³Department of Cardiology, Kasukabe Chuo General Hospital, Saitama、⁴Department of Cardiology, Nagoya Kyoritsu Hospital, Nagoya、⁵Department of Cardiology, Japanses Red Cross Kyoto Daini Hospital, Kyoto