SPINACH Making Limb Salvage Salad from Spinach alone
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1 SPINACH Making Limb Salvage Salad from Spinach alone Surgical reconstruction versus Peripheral Intervention in patients with critical limb ischemia prospective multicenter registry in Japan Nobuyoshi Azuma, Osamu Iida, Mitsuyoshi Takahara, Akio Kodama, Yoshimitsu Soga, and Hiroto Terashi
2 Japanese-styled Spinach Salad
3 COI disclosure The authors have no financial COI to disclose.
4 Global Aging
5 Pandemic of diabetes
6 Pandemic of diabetes Longer exposure to diabetes may develop macro and microangiopathy.
7 Features of Japanese CLI Demographic differences of patents with CLI Study Namever BASIL trial PREVENT III OLIVE registry CRITSCH registry Country (Year) UK (2005) USA (2005) Japan (2013) Germany (2015) Type of study multicenter multicenter multicenter multicenter RCT RCT registry registry Revascularization Bypass vs EVT Bypass EVT Bypass vs EVT Subject SLI CLI CLI CLI No. Pts Comorbidities hypertention 58% 82% 79% Diabetes 42% 64% 71% 47% CAD 36% 48% 46% 45% CVD 21% 20% 21% 12% ESRD on dialysis 10% 12% 52% 9%
8 Risk factors of atherosclerosis and the location of culprit lesion Diehm N, et al. Eur J Vasc Endovasc Surg 2006:31;59-63 Microangiopathy
9 Revascularization procedures for infrapopliteal arterial lesions Or Distal bypass Balloon Angioplasty
10 Revascularization procedures for infrapopliteal arterial lesions Or There are not enough data guiding how to select open surgery and endovascular treatment properly. Distal bypass Balloon Angioplasty
11 Recommendation for infrapopliteal arterial revascularization ESC (2011)
12 Recommendation for infrapopliteal arterial revascularization ESC (2011) It is still unclear what kind of patients are suitable for distal bypass.
13 SPINACH Registry Azuma N, et al. VASCULAR. 2014; 22:
14 Distribution of the institutions participating the SPINACH Study Co PI : Iida O. Interventional Cardiologist PI : Azuma N. Vascular surgeon Vascular Surgeons Interventional Cardiologists Vascular Surgeons and Interventional Cardiologists
15 Number of Registered Patients X Overall Endovascular treatment Bypass surgery* Non-revascularization Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar * Including hybrid revascularization and some endarterectomy
16 Vascular Surgeons Interventional Cardiologists Plastic Surgeon Diabetologist / Statistician
17 Baseline Characteristics EVT group Surgery group p value (n = 351) (n = 197) Age (years) 74±10 72± Male sex 66% 72% 0.17 Body mass index (kg/m 2 ) 22.0± ± Ambulatory status 0.51 Ambulatory 51% 55% In wheelchair 44% 41% Bed-ridden 5% 4% Current smoking 15% 16% 0.89 Diabetes mellitus 74% 73% 0.84 Dialysis-dependent 55% 51% 0.32 Heart failure (%) 21% 15% 0.10 Contralateral major amputation 5% 3% 0.38 Intention of infrapopliteal revascularization 75% 77% 0.68 Iida O, Azuma N, et al. Circulation Cardiovasc Interv in press
18 Baseline Characteristics EVT group Surgery group p value (n = 351) (n = 197) Age (years) 74±10 72± Male sex 66% 72% 0.17 Body mass index (kg/m 2 ) 22.0± ± Ambulatory status 0.51 Ambulatory 51% 55% In wheelchair 44% 41% Bed-ridden 5% 4% Current smoking 15% 16% 0.89 Diabetes mellitus 74% 73% 0.84 Dialysis-dependent 55% 51% 0.32 Heart failure (%) 21% 15% 0.10 Contralateral major amputation 5% 3% 0.38 Intention of infrapopliteal revascularization 75% 77% 0.68 Iida O, Azuma N, et al. Circulation Cardiovasc Interv in press
19 Baseline characteristics Foot lesion severity EVT group (n = 351) Surgery group (n = 197) p value Rutherford classification (%) 0.39 Category 4 12% 15% Category 5 70% 65% Category 6 18% 20% WIfI classification: Wound < W-0 12% 15% W-1 37% 19% W-2 40% 42% W-3 11% 24% WIfI classification: Ischemia I-2 21% 8% < I-3 79% 92% WIfI classification: Foot infection < fi-0 65% 45% fi-1 20% 24% fi-2 15% 26% fi-3 1% 5%
20 Baseline characteristics Foot lesion severity EVT group (n = 351) Surgery group (n = 197) p value Rutherford classification (%) 0.39 Category 4 12% 15% Category 5 70% 65% Category 6 18% 20% WIfI classification: Wound < W-0 12% 15% W-1 37% 19% W-2 40% 42% W-3 11% 24% WIfI classification: Ischemia < I-2 21% 8% I-3 79% 92% WIfI classification: Foot infection < fi-0 65% 45% fi-1 20% 24% fi-2 15% 26% fi-3 1% 5% Iida O, Azuma N, et al. Circulation Cardiovasc Interv in press
21 Baseline characteristics Foot lesion severity EVT group (n = 351) Surgery group (n = 197) p value Rutherford classification (%) 0.39 Category 4 12% 15% Category 5 70% 65% Category 6 18% 20% WIfI classification: Wound < W-0 12% 15% W-1 37% 19% W-2 40% 42% W-3 11% 24% WIfI classification: Ischemia < I-2 21% 8% I-3 79% 92% WIfI classification: Foot infection < fi-0 65% 45% fi-1 20% 24% fi-2 15% 26% fi-3 1% 5% Iida O, Azuma N, et al. Circulation Cardiovasc Interv in press
22 Baseline characteristics Foot lesion severity EVT group (n = 351) Surgery group (n = 197) p value Rutherford classification (%) 0.39 Category 4 12% 15% Category 5 70% 65% Category 6 18% 20% WIfI classification: Wound < W-0 12% 15% W-1 37% 19% W-2 40% 42% W-3 11% 24% WIfI classification: Ischemia < I-2 21% 8% I-3 79% 92% WIfI classification: Foot infection < fi-0 65% 45% fi-1 20% 24% fi-2 15% 26% fi-3 1% 5% Iida O, Azuma N, et al. Circulation Cardiovasc Interv in press
23 Baseline characteristics Foot lesion severity EVT group (n = 351) Surgery group (n = 197) p value Rutherford classification (%) 0.39 Category 4 12% 15% Category 5 70% 65% Category 6 18% 20% WIfI classification: Wound < W-0 12% 15% W-1 37% 19% W-2 40% 42% W-3 11% 24% WIfI classification: Ischemia < I-2 21% 8% I-3 79% 92% WIfI classification: Foot infection < fi-0 65% 45% fi-1 20% 24% fi-2 15% 26% fi-3 1% 5% Iida O, Azuma N, et al. Circulation Cardiovasc Interv in press
24
25 Amputation-free Survival in matched analysis Covariates for propensity score Age, Gender, Ambulatory status, QOL Comorbidities and their management (including DM, renal failure) Contralateral limb status TASC Classification Foot lesion severity UT classification WIfI W grade, I grade, fi grade Plan for infra-popliteal revascularization Iida O, Azuma N, et al. Circulation Cardiovasc Interv. in press
26 Amputation-free Survival in matched analysis Covariates for propensity score Age, Gender, Ambulatory status, QOL Comorbidities and their management (including DM, renal failure) Contralateral limb status This doesn t mean that Sug = EVT in individual patient. TASC Classification Foot lesion severity UT classification WIfI W grade, I grade, fi grade Plan for infra-popliteal revascularization Iida O, Azuma N, et al. Circulation Cardiovasc Interv. in press
27 Factors affecting decision making process of CLI treatment Vascular factors Focal or diffuse lesion Heavy calcification Etiology Quality of vein conduit Foot status Diversity Systemic factors Cardiac risk Renal function Life expectancy Daily activity Walking ability Intellectual activity WIfI grade and stage Social factors Country differences Skill of vascular team
28 Amputation-free Survival in matched analysis EVT Surg. EVT=Surg EVT < Surg EVT < Surg EVT=Surg EVT > Surg EVT=Surg EVT > Surg SPINACH Salad Iida O, Azuma N, et al. Circulation Cardiovasc Interv. in press
29 Classification by favorability score for surgical revascularization -Interaction analysis- Circulation Cardiovasc Interv. in press
30 Classification by favorability score for surgical revascularization -Interaction analysis- Circulation Cardiovasc Interv. in press
31 Proposed favorability score for surgical revascularization * P <0.05 Circulation Cardiovasc Interv. in press
32 Proposed favorability score for surgical revascularization * P <0.05 Circulation Cardiovasc Interv. in press
33 Proposed favorability score for surgical revascularization * P <0.05 Circulation Cardiovasc Interv. in press
34 Proposed favorability score for surgical revascularization * P <0.05 Circulation Cardiovasc Interv. in press
35 WIfI staging in SPINACH population WIfI stage 2 / 3 WIfI stage 4 Azuma N et al. Charing cross symposium 2018
36 Limb salvage & Ulcer Healing
37 Freedom from MALE, major amputation, and reintervention P=0.001 Circulation Cardiovasc Interv. in press
38 Limb status Wound healing and Limb status in matched analysis v v v Circulation Cardiovasc Interv. in press
39 Discussion: Roles of SPINACH study Study Name BASIL trial PREVENT III CRITSCH registry SPINACH registry Country (Year) UK (2005) USA (2005) Germany (2015) JAPAN (2017) Type of study multicenter multicenter multicenter multicenter RCT RCT registry registry Revascularization Bypass vs EVT Bypass Bypass vs EVT Bypass vs EVT Subject SLI CLI CLI CLI No. Pts Comorbidities Demographic differences of patents with CLI SPINACH study provides new evidences guiding how to select bypass or EVT for infrapopliteal revascularization in the era of diabetes and global aging. Diabetes 42% 64% 47% 74% CAD 36% 48% 45% 41% ESRD on dialysis 0% 12% 9% 54% Infrapopliteal revascularization 21% 67% 38% 75%
40 Decision Making of Revascularization for CLTI Vascular anatomy (TASC) Foot lesion severity ( WIfI ) Life expectancy (BASIL) Vein availability Expected ADL EVT first Bypass first Primary amputation
41 Accumulation of CLI Evidences CRITISCH registry BEST CLI BASIL 2 / BASIL trial OLIVE registry SPINACH registry
42 Take Home Message The SPINACH registry explores current clinical outcomes of CLI treatment in real world setting in JAPAN, which provides the data recommending how to select adequate revascularization option in respond to patient s general condition and foot lesion severity. In terms of foot lesion severity, WIfI system are very useful to judge the foot lesion conditions, and especially WIfI W grade and fi grade are very important factors to select revascularization procedure.
43 Thank you for your kind attention
44 The reasons why so many dialysis dependent patients undergo revascularization. Data from The Dialysis Outcomes and Practice Patterns Study(DOPPS) Japan Survival Europe USA Goodkin DA, et al. J Am Soc Nephrol 2003
45 The reasons why so many dialysis dependent patients undergo revascularization. Data from The Dialysis Outcomes and Practice Patterns Study(DOPPS) Japan Survival Europe USA Goodkin DA, et al. J Am Soc Nephrol 2003 Robinson BM, et al. Kindney International 2014
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