Clinical Impact of Multi-vessel Infrapopliteal Artery … · Background & Aim Results Conclusion...

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Background & Aim Results Conclusion Clinical Impact of Multi-vessel Infrapopliteal Artery Revascularization Strategy for Patients with Ischemic Ulcerations -Sub-analysis from multicenter RENDEZVOUS Registry- Definition of Pedal Diseases -Kawarada classification- Methods Tatsuya Nakama, MD, Nozomi Watanabe, MD, Takuya Haraguchi, MD, Hiroshi Sakamoto, MD, Daisuke Kamoi, MD, Yoshinori Tsubakimoto, MD, Kenji Ogata, MD, Katsuhiko Satoh, MD, Kazushi Urasawa, MD, Hiroshi Andoh, MD, Hiroshi Fujita, MD and Yoshisato Shibata, MD Multivessel revascularization strategy improve the rate of wound healing in patients with ischemic ulceration (not gangrene), attributed to tibio-pedal diseases. Limitation 1) Study design: sub-analysis form retrospective registry, small sample size 2) Pedal artery condition after EVT is different 3) Patients with patent pedal is not included Disclosure The authors have no financial conflicts of interest to disclose concerning the presentation. Abbreviations: ESRD, end-stage renal disease; HD, hemodialysis; CAD, coronary artery disease; CVD, cerebrovascular disease; LVEF, left ventricular ejection fraction; SVS, Society of Vascular Surgery; WiFi; Wound, Ischemia and Foot Infection; CRP, C-reactive protein; ABI, ankle-brachial index; EVT, endovascular therapy; SPP, skin perfusion pressure. Continuous data are presented as the means ± standard deviation unless noted otherwise; categorical data are given as the counts (percentage). Table 1: Patient & limbs background Overall (n=113) Single vessel ( n = 44) Multi vessel ( n=69) P value ABI before EVT 0.69 ± 0.33 0.68 ± 0.33 0.69 ± 0.33 0.883 ABI after EVT 0.89 ± 0.21 0.85 ± 0.19 0.91 ± 0.22 0.134 SPP (dorsal) before EVT, mmHg 28.6 ± 20.3 29.9 ± 21.2 27.9 ± 20.0 0.649 SPP (plantar) before EVT, mmHg 29.6 ± 17.1 26.8 ± 15.7 31.2 ± 17.9 0.218 SPP (dorsal) after EVT , mmHg 47.8 ± 21.8 48.4 ± 18.8 47.6 ± 23.4 0.866 SPP (plantar) after EVT, mmHg 46.0 ± 20.4 42.7 ± 16.6 47.7 ± 22.0 0.257 Pure infrapopliteal lesion, n (%) 62 (54.9) 23 (52.3) 39 (56.6) 0.658 Runoff vessels before EVT, n 0.86 ± 0.79 0.80 ± 0.85 0.90 ± 0.75 0.513 Runoff vessels after EVT, n 2.01 ± 0.71 1.41 ± 0.54 2.41 ±0.49 <0.0001 No. of recanalized vessels, n 1.73 ± 0.71 0.96 ± 0.21 2.21 ± 0.42 <0.0001 Pedal artery type 2/3 before EVT 69/44 23/21 46/23 0.269 Pedal artery type 1/2/3 after EVT 31/71/11 4/33/7 27/38/4 0.003 Table 2: Hemodynamic & Angiographic findings <Exclusion criteria> With gangrene (n= 144) Failed EVT (n=12) One - year clinical follow - up Primary outcomes; Rate of wound healing 257patients With ischemic wounds Patients with Ischemic ulceration (n= 113) Single -Vessel Revascularization (n= 44) Figure: Primary outcomes Rate of Wound healing at 1-year after primary treatment Time to Wound healing (months) Rate of Wound healing (%) 0 3 6 9 12 Single-vessel strategy 43.3% One straight line strategy is sometimes insufficient for CLI patients. The aim of this study was to evaluate the clinical impact of Multi-vessel revascularization strategy for patients with ischemic ulcerations, attributed to tibiopedal (infrapopliteal +pedal artery) diseases. 0 3 6 9 12 Single-vessel strategy at risk 44 30 27 25 22 % 0.0 31.8 38.6 40.9 43.3 Multi-vessel strategy at risk 69 43 29 26 20 % 0.0 37.7 56.8 61.2 67.3 Standard error did not exceed 10% in both groups Patent Pedal Artery Pedal Artery Diseases (Type 2 & 3) Overall (n = 113) Single vessel ( n = 44) Multi vessel ( n=69) P value <Patients background> Men, n (%) 77 (68.1) 33 (75.0) 44 (63.8) 0.211 Age, years 73.2 ± 11.2 74.6 ± 11.7 72.4 ± 10.8 0.302 Non-ambulatory, n (%) 53 (46.9) 25 (56.8) 28 (40.6) 0.092 Body mass index <18, n(%) 13 (11.5) 8 (18.2) 5 (7.2) 0.076 Hypertension, n (%) 76 (67.3) 27 (61.4) 49 (71.0) 0.286 Dyslipidemia, n (%) 41 (36.3) 15 (34.1) 26 (37.7) 0.699 Diabetes mellitus, n (%) 79 (69.9) 27 (61.4) 52 (75.4) 0.114 Smoking history, n (%) 40 (35.4) 11 (25.0) 29 (42.0) 0.065 ESRD on HD, n (%) 66 (58.4) 26 (59.1) 40 (58.0) 0.906 History of CAD, n (%) 58 (51.3) 23 (52.3) 35 (50.7) 0.872 History of CVD, n (%) 39 (34.5) 14 (31.8) 25 (36.2) 0.630 Albumin level, g/dl 3.5 ± 0.5 3.5 ± 0.5 3.6 ±0.5 0.339 Hemoglobin A1c, % 6.6 ± 1.5 6.2± 1.2 6.8 ± 1.7 0.025 LVEF ,% 62.0 ± 12.0 61.6 ± 11.3 62.2 ± 12.6 0.788 <Target limbs status> Rutherford class 5, n (%) 94 (83.2) 39 (88.6) 55 (79.7) 0.460 University of Texas grade>2, n(%) 28 (24.8) 12 (27.3) 16 (23.2) 0.624 SVS-WIfI CS 1/2/3/4, % 6.2/7.1/55.8/31.0 9.1/6.8/54.5/29.5 4.3/7.2/56.5/31.9 0.789 WIfI composite score 4.5 ± 1.3 4.5 ± 1.3 4.6 ± 1.4 0.637 Multiple ulceration, n (%) 52 (46.0) 31 (44.9) 21 (47.7) 0.771 Wound size, (>5cm 2 ), n (%) 34 (30.1) 11 (25.0) 23 (33.3) 0.346 Wound infection, n (%) 32 (28.3) 12 (27.3) 20 (29.0) 0.844 CRP level, mg/dL 1.63 ± 2.46 2.04 ± 2.75 1.36 ± 2.23 0.173 Surgical procedure, n(%) 36 (31.9) 15 (34.1) 21 (30.4) 0.684 Kawarada O, et al. Catheter Cardiovasc Interv. 2012; 80: 861–871 Nakama T, et al. J Am Coll Cardiol Interv 2017; 10: 79-90 Multi-vessel strategy 67.3% p value = 0.049 Multi-vessel revascularization (n= 69)

Transcript of Clinical Impact of Multi-vessel Infrapopliteal Artery … · Background & Aim Results Conclusion...

Page 1: Clinical Impact of Multi-vessel Infrapopliteal Artery … · Background & Aim Results Conclusion Clinical Impact of Multi-vessel Infrapopliteal Artery Revascularization Strategy for

Background&Aim Results

Conclusion

ClinicalImpactofMulti-vesselInfrapoplitealArteryRevascularizationStrategyforPatientswithIschemicUlcerations -Sub-analysisfrommulticenterRENDEZVOUSRegistry-

DefinitionofPedalDiseases-Kawaradaclassification-

Methods

◉TatsuyaNakama,MD,NozomiWatanabe,MD,TakuyaHaraguchi,MD,HiroshiSakamoto,MD,DaisukeKamoi,MD,YoshinoriTsubakimoto,MD, KenjiOgata,MD,KatsuhikoSatoh,MD,KazushiUrasawa,MD,HiroshiAndoh,MD,HiroshiFujita,MDandYoshisatoShibata,MD

Multivesselrevascularizationstrategyimprovetherateofwoundhealinginpatientswithischemiculceration(notgangrene),attributedtotibio-pedaldiseases.

Limitation1) Studydesign:sub-analysisformretrospectiveregistry,smallsamplesize2) PedalarteryconditionafterEVTisdifferent3) Patientswithpatentpedalisnotincluded

DisclosureTheauthorshavenofinancialconflictsofinteresttodiscloseconcerningthepresentation.

Abbreviations:ESRD,end-stagerenaldisease;HD,hemodialysis;CAD,coronaryarterydisease;CVD,cerebrovasculardisease;LVEF,leftventricularejectionfraction;SVS,SocietyofVascularSurgery;WiFi;Wound,IschemiaandFootInfection;CRP,C-reactiveprotein;ABI,ankle-brachialindex;EVT,endovasculartherapy;SPP,skinperfusionpressure.Continuousdataarepresentedasthemeans±standarddeviationunlessnotedotherwise;categoricaldataaregivenasthecounts(percentage).

Table1:Patient&limbsbackground

Overall(n=113)

Singlevessel(n=44)

Multivessel(n=69)

Pvalue

ABIbeforeEVT 0.69± 0.33 0.68± 0.33 0.69± 0.33 0.883

ABIafterEVT 0.89± 0.21 0.85± 0.19 0.91± 0.22 0.134

SPP(dorsal)beforeEVT,mmHg 28.6± 20.3 29.9± 21.2 27.9± 20.0 0.649

SPP(plantar)beforeEVT,mmHg 29.6± 17.1 26.8± 15.7 31.2± 17.9 0.218

SPP(dorsal)afterEVT,mmHg 47.8± 21.8 48.4± 18.8 47.6± 23.4 0.866

SPP(plantar)afterEVT,mmHg 46.0± 20.4 42.7± 16.6 47.7± 22.0 0.257

Pureinfrapopliteallesion,n(%) 62(54.9) 23 (52.3) 39(56.6) 0.658

RunoffvesselsbeforeEVT,n 0.86± 0.79 0.80± 0.85 0.90± 0.75 0.513

RunoffvesselsafterEVT, n 2.01± 0.71 1.41± 0.54 2.41±0.49 <0.0001No. ofrecanalizedvessels,n 1.73± 0.71 0.96± 0.21 2.21± 0.42 <0.0001Pedalarterytype2/3beforeEVT 69/44 23/21 46/23 0.269

Pedalarterytype1/2/3afterEVT 31/71/11 4/33/7 27/38/4 0.003

Table2:Hemodynamic&Angiographicfindings<Exclusioncriteria>・Withgangrene (n=144)・FailedEVT(n=12)

One-yearclinicalfollow-up

Primaryoutcomes;Rateofwoundhealing

257patientsWithischemicwounds

PatientswithIschemiculceration(n=113)

Single-VesselRevascularization

(n=44)

Figure:PrimaryoutcomesRateofWoundhealingat1-yearafterprimarytreatment

TimetoWoundhealing(months)

RateofW

ound

healin

g(%

)

0 3 6 9 12

Single-vesselstrategy

43.3%

OnestraightlinestrategyissometimesinsufficientforCLIpatients.Theaimofthisstudywastoevaluatetheclinicalimpactof

Multi-vesselrevascularizationstrategyforpatientswithischemiculcerations,attributedtotibiopedal(infrapopliteal+pedalartery)diseases.

0 3 6 9 12Single-vesselstrategy

at risk 44 30 27 25 22% 0.0 31.8 38.6 40.9 43.3

Multi-vesselstrategy

atrisk 69 43 29 26 20% 0.0 37.7 56.8 61.2 67.3

Standarderrordidnotexceed10%inbothgroups

PatentPedalArtery PedalArteryDiseases(Type2&3)

Overall(n=113)

Singlevessel(n=44)

Multivessel(n=69)

Pvalue

<Patients background>Men,n(%) 77(68.1) 33(75.0) 44(63.8) 0.211Age,years 73.2± 11.2 74.6± 11.7 72.4± 10.8 0.302Non-ambulatory, n(%) 53(46.9) 25(56.8) 28(40.6) 0.092Bodymassindex<18,n(%) 13(11.5) 8(18.2) 5(7.2) 0.076Hypertension,n(%) 76(67.3) 27 (61.4) 49(71.0) 0.286Dyslipidemia,n(%) 41(36.3) 15(34.1) 26(37.7) 0.699Diabetesmellitus,n(%) 79(69.9) 27(61.4) 52(75.4) 0.114Smokinghistory, n(%) 40(35.4) 11 (25.0) 29(42.0) 0.065ESRDonHD,n(%) 66(58.4) 26(59.1) 40(58.0) 0.906HistoryofCAD,n(%) 58(51.3) 23(52.3) 35(50.7) 0.872HistoryofCVD,n(%) 39(34.5) 14(31.8) 25(36.2) 0.630Albuminlevel, g/dl 3.5± 0.5 3.5± 0.5 3.6±0.5 0.339HemoglobinA1c,% 6.6± 1.5 6.2± 1.2 6.8± 1.7 0.025LVEF, % 62.0± 12.0 61.6± 11.3 62.2± 12.6 0.788<Targetlimbsstatus>Rutherfordclass5,n(%) 94(83.2) 39(88.6) 55(79.7) 0.460UniversityofTexas grade>2,n(%) 28(24.8) 12(27.3) 16(23.2) 0.624SVS-WIfICS1/2/3/4, % 6.2/7.1/55.8/31.0 9.1/6.8/54.5/29.5 4.3/7.2/56.5/31.9 0.789WIfIcompositescore 4.5± 1.3 4.5± 1.3 4.6± 1.4 0.637Multipleulceration,n(%) 52(46.0) 31(44.9) 21(47.7) 0.771Woundsize,(>5cm2),n(%) 34(30.1) 11(25.0) 23(33.3) 0.346Woundinfection,n(%) 32(28.3) 12(27.3) 20(29.0) 0.844CRPlevel, mg/dL 1.63± 2.46 2.04± 2.75 1.36± 2.23 0.173Surgicalprocedure,n(%) 36(31.9) 15(34.1) 21(30.4) 0.684

KawaradaO,etal.CatheterCardiovascInterv.2012;80:861–871

NakamaT,etal.JAmCollCardiolInterv2017;10:79-90

Multi-vesselstrategy

67.3%pvalue=0.049

Multi-vesselrevascularization

(n=69)