Efficacy of Pedal Artery Angioplasty toward Severity of Pedal Artery Disease: a sub-analysis

from RENDEZVOUS registry

Yoshinori Tsubakimoto1, Tatsuya Nakama2, Takuya Haraguchi3, Hiroshi Sakamoto4,Daisuke Kamoi5, Nozomi Watanabe2, Kenji Ogata2, Yoshisato Shibata2, KatsuhikoSatoh3, Kazushi Urasawa3, Nobuhito Kaneko4, Hiroshi Andoh4 and Hiroshi Fujita1

1Department of Cardiology, Japanese Red Cross Kyoto Daini Hospital, Kyoto, JAPAN2Miyazaki Medical Association Hospital, Cardiovascular Center, Miyazaki, JAPAN3Cardiovascular Center, Tokeidai Memorial Hospital, Sapporo, JAPAN4Department of Cardiology, Kasukabe Chuo General Hospital, Saitama, JAPAN5Department of Cardiology, Nagoya Kyoritsu Hospital

Disclosure

Speaker name: Yoshinori TSUBAKIMOTO , M.D., Ph.D.

.................................................................................

I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest✓

Kawarada O et al. Catheterization and Cardiovascular Interventions. 2012

Background

✓ Pedal artery disease impairs the Wound healing and/or Limb salvage rates.

Higashimori A et al. Catheterization and Cardiovascular Interventions. 2016.

Background

Rendezvous registry, Nakama T et al. JACC Intv. 2017.

Non-PAA group

PAA group

Log-rank P=0.003

59.3%

38.1%

✓ Recently, Nakama et al. reported Pedal Artery Angioplasty (PAA) improves WH rates at 1 year for CLI patients with pedal artery disease in “Rendezvous registry”.

✓ However, there are few data whether PAA might improve the wound healing or limb salvage rate depending on the severity of the pedal artery disease.

Severity of pedal artery disease

Kawarada O et al. Catheterization and Cardiovascular Interventions 80:861–871 (2012)

Background

Purpose

✓ To evaluate the clinical efficacy of PAA for patients with CLI depending on the severity of pedal artery disease.

Before PAA After PAA

Methods

Study design: Multicenter, retrospective, observational study (Sub analysis of Rendezvous registry)

Study duration: January 2012 ~ June 2014

Inclusion criteria: ・Rutherford category 5/6・EVT for below the knee lesion ・Comorbid pedal artery disease

Exclusion criteria:・Unrescuable ulcers / gangrene on the target limb・Comorbid Aorto-Iliac lesion

Miyazaki Medical Association Hospital, Miyazaki

Japanese Red Cross Society Kyoto Daini Hospital, Kyoto

Kasukabe Chuou General Hospital, Kasukabe

Nagoya Kyoritsu Hospital, Nagoya

Tokeidai Memorial Hospital, Sapporo

ENDEZVOUS registryRetrospective analysis for the clinical impact of pedal artery revascularization versus non-revascularization strategy for patients with critical limb ischemia

Study Flowchart

Consecutive CLI Patients

with Pedal Arch Disease

257 Limbs (257 patients)

Type 2 Pedal disease

144 Limbs

Type 3 Pedal disease

113 Limbs

PAA

66 Limbs

Non-PAA

78 Limbs

PAA

74 Limbs

Non-PAA

39 Limbs

Analysis

Outcomes12 months after initial treatment

✓Wound healing (WH)

✓ Limb salvage (LS)

✓ Overall survival (OS)

✓ Amputation-free survival (AFS)

✓ Freedom from reintervention (RI)

✓ Freedom from major adverse cardiovascular and limb event (MACLE)

※MACLE: All cause death, Myocardial infarction, Stroke, Major amputation, Target vessel revascularization (TVR)

Success rate of PAA

ALLn=140

Type2n=66

Type3n=74

p value

Success rate % (n) 88.6 (124) 89.4 (59) 87.8 (65) 0.82

Baseline characteristicsType2 pedal artery disease

PAAn=66

Non-PAAn=78

p value

Age (y) 70.7±12.2 72.9±10.4 0.24

Male % (n) 74.2 (49) 71.7 (56) 0.64

DM % (n) 69.6 (46) 78.2 (61) 0.10

HT % (n) 68.1 (45) 74.3 (58) 0.24

HL % (n) 31.8 (21) 26.9 (21) 0.36

Smoking % (n) 16.6 (11) 20.5 (16) 0.40

HD % (n) 72.7 (48) 65.3 (51) 0.18

CAD % (n) 65.1 (43) 53.8 (42) 0.05

Rutherford 5 % (n) 74.2 (49) 78.2 (61) 0.43

pre SPP (dorsal) 30.5±20.4 30.2±18.3 0.91

pre SPP (plantar) 31.8±15.6 30.0±17.3 0.54

post SPP (dorsal) 50.1±23.9 41.8±19.4 0.05

post SPP (plantar) 44.1±22.4 42.6±17.5 0.71

PAAn=74

Non-PAAn=39

p value

Age (y) 73.4±10.6 77.0±9.8 0.08

Male % (n) 63.5 (47) 58.9 (23) 0.50

DM % (n) 74.3 (55) 64.1 (25) 0.10

HT % (n) 68.9 (51) 82.0 (32) 0.03

HL % (n) 31.8 (21) 28.2 (11) 0.65

Smoking % (n) 10.8 (8) 7.6 (3) 0.45

HD % (n) 55.4 (41) 51.2 (20) 0.18

CAD % (n) 60.8 (45) 46.1 (18) 0.03

Rutherford 5 % (n) 77.0 (57) 84.6 (33) 0.17

pre SPP (dorsal) 24.3±16.6 26.2±20.9 0.63

pre SPP (plantar) 24.7±15.9 25.8±15.6 0.76

post SPP (dorsal) 48.4±19.1 42.0±24.1 0.22

post SPP (plantar) 46.5±20.2 44.3±20.4 0.67

Baseline characteristicsType3 pedal artery disease

0

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00 3 6 9 12

Wo

un

d h

ealin

g ra

te (

%)

Time after treatment (months)W

ou

nd

hea

ling

rate

(%

)Time after treatment (months)

Interval (months)

0 3 6 9 12

PAA group(n=66)

% 0 32.4 41.9 48.6 58.8

No at risk 66 43 36 30 25

non-PAA group(n=78)

% 0 24.4 32.1 37.3 39.9

No at risk 78 73 52 46 43

Interval (months)

0 3 6 9 12

PAA group(n=66)

% 0 23.2 42.6 51 59.6

No at risk 74 56 41 35 28

non-PAA group(n=78)

% 0 13.2 32.1 28.9 34.2

No at risk 39 33 27 27 25

Log rank p=0.049 Log rank p=0.021PAA 58.8%

Non- PAA 39.9%

PAA 59.6%

Non-PAA 34.2%

Type 2 pedal disease Type 3 pedal disease

Wound Healing Rate

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Log rank p=0.028

Type 3 PAA 94.7%Type 2 PAA 90.5%Type 2 Non-PAA 86.9%

Type 3 Non-PAA 75.3%

100

80

60

40

20

00 3 6 9 12

Lim

b S

alva

ge r

ate

(%)

Time after treatment (months)

Interval (months)

0 3 6 9 12

No.at risk

type2PAA

66 61 58 54 52

type2non-PAA

78 72 68 62 57

type3PAA

74 62 58 57 55

type3non-PAA

39 33 28 26 24

Limb Salvage rate

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AFS All Cause Mortality

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Free from MACLE

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Free from RI

Log rank p=0.471

PAA 78.7%

Non PAA73.0%

Log rank p=0.786

Log rank p=0.358

Non-PAA 55.1%

PAA 50.0%Log rank p=0.338

Non-PAA 68.8%

PAA 62.4%

Type2 pedal disease

PAA 16.6%

Non-PAA18.5%

0 3 6 9 12

0 3 6 9 12 0 3 6 9 12

0 3 6 9 12Time after treatment (months) Time after treatment (months)

Time after treatment (months) Time after treatment (months)

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AFS All Cause Mortality

Free from MACLE Free from RI

Type3 pedal disease

Log rank p=0.290PAA 74.3%

Non-PAA 64.1%

Log rank p=0.812

Log rank p=0.397

Non-PAA 38.4%

PAA 32.4%

Log rank p=0.789

Non-PAA55.3%

PAA 53.4%

PAA 13.5%

Non-PAA 15.3%

0 3 6 9 12 0 3 6 9 12

0 3 6 9 12 0 3 6 9 12

Time after treatment (months) Time after treatment (months)

Time after treatment (months) Time after treatment (months)

✓ Over all success rate of PAA was 88.6%.

✓ PAA significantly improved WH rate in both type of pedal artery disease.

✓ Limb salvage rate was significantly decreased in the type 3 pedal artery disease without PAA than in other subgroups.

✓ PAA may not affect AFS, mortality, MACLE and RI rates.

Summary

Conclusion

Regardless the severity of the pedal artery disease, PAA might improve the WH rates. Especially in patients with type 3 pedal artery disease, PAA

showed its exceptional efficacy in the setting of limbs salvage.

✚ Japanese Red Cross Kyoto Daini Hospital

Thank You for your attention !!