Aorto-iliac & femoral intervention: Japanese evidences

Osamu Iida, MD

Kansai Rosai Hospital

Amagasaki, Hyogo, Japan

Learn From SVS 2015 guideline -Aorto-Iliac lesions-

SVS Lower Extremity Guidelines Writing Group, J Vasc Surg. 2015;61:2S-41S.

Recommendation (Grade 1) Intervention for aortoiliac occlusive disease (AIOD in Pts with IC

Level of evidence

We recommend endovascular interventions as first-line revascularization therapy for most patients with common iliac artery or external iliac artery occlusive disease causing IC.

B

We recommend direct surgical reconstruction (bypass, endarterectomy) in patients with reasonable surgical risk and diffuse AIOD not amenable to an endovascular approach, after 1) one or more failed attempts at EVT, or 2) in patients with combined occlusive and aneurysmal disease.

B

We recommend the use of covered stents for treatment of AIOD in the presence of severe calcification or aneurysmal changes where the risk of rupture may be increased after unprotected dilation.

B

In all patients undergoing revascularization for AIOD, we recommend assessing the CFA. If hemodynamically significant CFA disease is present, we recommend surgical therapy (endarterectomy) as first-line treatment. In patients with iliac artery disease and involvement of the CFA, we recommend hybrid procedures combining femoral endarterectomy with iliac inflow correction.

B

Summary of SVS 2015 AIOD guideline 1) EVT-first 2) Aneurysm and sever calcification 3) CFA disease involvement

Primary patencies were not statistically different among TASCII category. (TASCII A, B, C, D; 77.8%, 78.0%, 73.3%, 80.5% at 5-year, Logrank p=0.55)

TASC D II AI lesions

Soga Y, Iida O, et al. Circ J. 2012;76:2697-704.

Endovascular approach for Leriche syndrome

Aodominal aorta to bilateral common iliac artery 100%⇒0% (10.0*100mm stent )

65 y/r Male, ambulatory status, life limiting claudication DM, ESRD (eGFR 36), CAD (post CABG)

AAA with severe AIOD was treated with EVAR.

Univariate model Unadjusted OR [95% CI]

Multivariate model 2 Adjusted OR [95% CI]

Age ≥ 80 y.o. 2.2 [1.5, 3.3]** 1.9 [1.3, 2.9]**

Male sex 0.8 [0.5, 1.3] ----

BMI < 18.5 kg/m2 1.2 [0.7, 2.0] ----

Diabetes mellitus 1.2 [0.8, 1.7] ----

Hypertension 1.0 [0.6, 1.6] ----

Hyperlipidemia 0.8 [0.5, 1.1] ----

Regular dialysis 1.1 [0.7, 1.7] ----

Cardiovascular disease 1.2 [0.8, 1.7] ----

Critical limb ischemia 2.8 [1.9, 4.2]** 2.3 [1.5, 3.4]**

TASC C or D 2.7 [1.9, 3.9]** 2.4 [1.6, 3.4]**

Femoral lesion 1.6 [1.1, 2.3]* ----

Below-the-knee lesion 1.9 [1.2, 3.1]** ----

Age >80 years, CLI and TASC C/D lesion were positively associated with perioperative complications (POC) after successful aorto-iliac (AI) stenting.

Iida , Soga Y, et al. Eur J Vasc Endovasc Surg. 2014;47:131-8.

-Predictors for future occurrence of POC-

Incidence of Perioperative Complication in REAL-AI: 6.0% (126/2096)

0%

10%

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30%

0(n = 1085)

1(n = 677)

2(n = 207)

3(n = 43)

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Number of risk factors

Risk stratification for POC after AI stenting Risk factors: 1) Age ≥ 80 y.o. 2) CLI, 3) TASC C or D

Iida , Soga Y, et al. Eur J Vasc Endovasc Surg. 2014;47:131-8.

Key Findings of FP Revascularization Based on Current Guideline

-Stenting for FP lesions- ESC 2011: Primary stent implantation should be considered in femoropopliteal TASC B lesions. (IIA, level B)

AHA 2013: Primary stent placement is not recommended in the femoral, popliteal, or tibial arteries. (Level of Evidence: C)

SVS 2015: For intermediate-length lesions in the SFA, we recommend the adjunctive use of self-expanding nitinol stents (with or without paclitaxel) to improve the midterm patency of angioplasty. (Grade 1, level B)

Some practice guidelines advise against primary stenting in

patients with intermittent claudication, whereas others recommend primary stenting in short- or intermediate-length lesions or in the

event of acute PTA failure.

REtrospective multicentre AnaLysis for FemoroPopliteal stenting

Design: Retrospective multicenter Analysis Period: From Jan. 2004 to Dec. 2011 Participant: 13 Japanese cardiovascular centers Enrollment: 2742 pts (3471 limbs)

Kokura Memorial HP

Kansai Rosai HP

Hyogo College of

Medicine HP

Shin Koga HP Matsuyama Red Cross HP

Juntendo Univ.

Nerima HP

Fukuoka Red Cross HP

Kanazawa Medical

Univ. HP

Tokai Univ. HP

YamagataUniv.

School of Medicine

Saiseikai Yokohama-city

Eastern HP

Shinshu University HP

Sendai Kousei HP

Efficacy (durability) of EVT with stenting for FPD

The overall primary patencies were 90.4%, 66.9% and 63.2% at 1, 3 and 5 years,

and the secondary patencies were 90.4%, 87.3% and 86.2% at 1, 3 and 5 years

Soga Y, Iida O, et al. J Vasc Surg. 2011;54:1058-66.

5 years

Primary patency: 63.2%, Secondary patency: 86.2%

Four year follow-up angiography

Stent fracture is risk for adverse event in chronic phase -Pseudo aneurysm and surgical conversion-

Stent fracture is risk for adverse event in chronic phase -Distal embolization with vessel occlusion-

Classification and clinical impact of restenosis after femoropopliteal stenting

Variables Univariate Analysis Multivariate Analysis

HR (95% CI) p Value HR (95% CI) p Value

ISR class III 2.90 (1.83–4.56) < 0.01 2.44 (1.33–4.48) < 0.01

Lesion length 1.004 (1.002–1.007) < 0.01 1.001 (0.998–1.005) 0.50

Reference vessel diameter 0.62 (0.44–0.87) < 0.01 0.63 (0.44–0.89) < 0.01

Early restenosis 1.92 (1.13–3.23) 0.02 1.60 (0.94–2.73) 0.09

Study subjects: 116 patients (133 limbs) Lesion length: 91.4 ± 67.1 mm RVD: 5.4 ± 0.7 mm

Class I Focal ISR group

( ≤ 50 mm in length)

Class II Diffuse ISR group

( > 50 mm in length)

Class III Totally occluded

ISR group

Predictors of Recurrent ISR

Visual estimate on angiography

Class I: 29% Class II: 38% Class III: 33%

Tosaka A, Soga Y, Iida O, et al. J Am Coll Cardiol. 2012;59:16–23.

Classification and clinical impact of restenosis after femoropopliteal stenting

Conclusion: Although balloon angioplasty for the stenotic ISR group is feasible, the freedom from recurrent ISR and occlusion after balloon angioplasty are remarkable low for totally occluded ISR.

Class III Totally occluded

ISR group

Tosaka A, Soga Y, Iida O, et al. J Am Coll Cardiol. 2012;59:16–23.

Cumulative 5-year rate of in-stent occlusion in 2447 limbs after FP stenting with nitinol stents

in-stent occlusion(ISR class III) rate 5.2%@1 year

11.2%@3 years 16.4%@5 years

Class III Totally occluded

ISR group

Dohi T, Iida O, et al. J Vasc Surg 2014;59:1009-15.

HR (95% CI) Unadjusted Adjusted HR (95% CI)

Female 1.91 (1.45-2.53) 1.61 (1.21-2.15)

Age-years 1.00 (0.99-1.02)

Non-ambulatory 1.38 (0.89-2.14)

Diabetes 0.78 (0.59-1.03)

Hemodialysis 0.91 (0.64-1.29)

CLI 1.76 (1.31-2.37) 1.50 (1.11-2.04)

TASC C/D 3.46 (2.50-4.78) 3.30 (2.38-4.56)

Aspirin 0.90 (0.59-1.37) 0.96 (0.63-1.47)

Thienopyridine 0.93 (0.74-1.31) 0.94 (0.70-1.25)

Warfarin 0.82 (0.50-1.36) 0.82 (0.50-1.35)

Ref. vessel diameter 0.78 (0.66-0.93) 0.89 (0.74-1.07)

Stent size used 0.78 (0.66-0.92) 0.85 (0.71-1.02)

-Predictors of in-stent occlusion-

Dohi T, Iida O, et al. J Vasc Surg 2014;59:1009-15.

Cumulative 5-year rate of in-stent occlusion in 2447 limbs after FP stenting with nitinol stents

In-stent occlusion case assessed by angioscopy

In-stent occlusion

Ostium Neointimal

proliferation

Inside Amount of red Soft thrombus

Case: 80-YO, Male Zilver PTX DES for ISR Class II (Pre, Post, 1 Year Angiogram)

Lt-SFA: 90% (ISR) →0% (Zilver PTX 7×120 mm 3 stents)

Pre Post 1 year after EVT

Primary patency@2-year Primary DES: 74.8% PTA with provisional BMS: 57.3% Optimal PTA: 53.4% PTA: 26.5%

Sustained safety and effectiveness of PES for FP lesions; 2-year follow-up

Dake MD, et al. J Am Coll Cardiol 2013;61:2417-2487.

ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy. -Prospective multicenter registry-

Study design Subjects

Prospective, multicenter registry PAD with femoro-popliteal lesion

*ISR lesion was also included

Primary endpoint

Primary patency

Incidence of stent thrombosis

Procedure

Initial: IVUS was mandatory for assessing vessel diameter.

12 months: angiography for assessing restenosis was mandatory.

Iida O, et al. JACC Cardiovasc Interv. 2015;8:1105-12.

Lesion characteristics (n = 831)

Pre-treatment % stenosis 90 ± 15 Chronic total occlusion 378 (45%) Restenosis 198 (24%) In-stent restenosis 124 (15%) Lesion length, cm 17 ± 10 Distal vessel diameter, mm 5.2 ± 1.0 Calcification 541 (65%) No below-the-knee run-off vessel 56 (7%) IVUS-evaluated distal EEM area, mm2 (n = 583) 28 ± 10

Post-treatment % stenosis after stent implantation 4 ± 9 IVUS-evaluated MSA, mm2 (n = 597) 15 ± 4

Lower limb characteristics (n = 797)

Critical limb ischemia 255 (32%) TASC C/D lesions 467 (58%)

Iida O, et al. JACC Cardiovasc Interv. 2015;8:1105-12.

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MALE Restenosis

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One-year incidence of restenosis was estimated to be 37%, while 1-year MALE was observed in 22%, indicating that MALE accounted for 58% in lesions with restenosis.

One-year incidence of restenosis and MALE

Iida O, et al. JACC Cardiovasc Interv. 2015;8:1105-12.

1-year restenosis rate was as low as 15% in cases with none of these risk factors, whereas it reached 51% in those with ≥ 2 risk factors

1) lesion length ≥ 16 cm

2) EEM area ≤ 27 mm2

3) MSA ≤ 12 mm2

0%

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0(n = 146)

1(n = 192)

2-3(n = 231)

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Number of risk factors

MALE RestenosisRisk factors for restenosis

No. of risk factors & restenosis/MALE incidence

Iida O, et al. JACC Cardiovasc Interv. 2015;8:1105-12.

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Follow-up period (months)

Cumulative incidence of stent thrombosis increased linearly over time during the follow-up, and reached almost 2% at 12 months.

Cumulative incidence of stent thrombosis in cases keeping at least 1 antiplatelet agents during the follow-up period

Iida O, et al. JACC Cardiovasc Interv. 2015;8:1105-12.

The interruption of antiplatelet agents during the follow-up was significantly associated with an increased ST risk.

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No. of antiplatelet agents & stent thrombosis

Iida O, et al. JACC Cardiovasc Interv. 2015;8:1105-12.

Femoropopliteal ISR following DES

-Is there any difference ?-

Distribution of DES-ISR at 12 months

Class I (Focal)

Class II (Diffuse)

Class III (Occlusive)

Iida O, et al. JACC Cardiovasc Interv. 2015;8:1105-1112. Tosaka A, Soga Y, Iida O, et al. J Am Coll Cardiol. 2012;59:16–23.

Armstrong EJ, et al. Catheter Cardiovasc Interv. 2013;82:1168-74.

Class I (Focal)

29%

Class II (Diffuse)

38%

Class III (Occlusive)

33%

Class I (Focal)

38%

Class II (Diffuse)

29%

Class III (Occlusive)

33%

BMS Tosaka A

JACC 2012

BMS Armstrong EJ

CCI 2013

DES-ISR characteristics (vs. no-restenosis case)

Patent (n = 393)

Class I (focal)

(n = 106)

Class II (Diffuse) (n = 52)

Class III (occlusive)

(n = 52) P value

Age (years) 73±8 73±9 73±8 72±10 0.733

Male sex 283 (72%) 76 (72%) 33 (63%) 32 (62%) 0.292

Diabetes mellitus 258 (66%) 81 (76%) 36 (69%) 32 (62%) 0.147

Regular dialysis 96 (24%) 34 (32%) 19 (37%) 11 (21%) 0.111

Smoking 74 (19%) 24 (23%) 13 (25%) 14 (27%) 0.409

Critical limb ischemia 106 (27%) 26 (25%) 13 (25%) 14 (27%) 0.957

de novo Post-PTA restenosis In-stent restenosis

303 (77%) 34 (9%)

56 (14%)

75 (71%) 13 (12%) 18 (17%)

42 (81%) 6 (11%) 4 (8%)

32 (62%) 7 (13%) 13 (25%)

0.138

Calcification 232 (59%) 67 (63%) 37 (71%) 28 (54%) 0.251

Chronic total occlusion

163 (41%) 44 (42%) 28 (54%) 35

(67%)* 0.002

Lesion length (cm) 15±10 17±9 20±10* 19±10* 0.001

EEM area (mm2) 30±10 27±10* 25±8* 22±5* < 0.001

MSA (mm2) 16±4 14±4* 13±4* 13±3* < 0.001

One-year incidence of restenosis and MALE after re-EVT for in-DES restenotic lesion

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100%

Patentat 1 year

Re-EVT forClass I

Re-EVT forClass II

Re-EVT forClass III

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Take-Home Messages

Long-term outcomes after stent implantation for AI-disease are safe and durable in cases with TASC A-D lesions.

The ZEPHYR registry demonstrated real-world 1-year outcomes after Zilver-PTX implantation for FP lesions, including challenging cases. Lesion length, distal EEM area and MSA were independent predictors for restenosis.

Characteristics including CTO and EEM area at DES implantation were significantly associated with restenotic status one year after DES implantation.

One-year prognosis after re-EVT for DES-ISR lesions was suboptimal.

Thank you for your attention !

Aorto-iliac & femoral intervention: Japanese evidences

Osamu Iida, MD

Kansai Rosai Hospital

Amagasaki, Hyogo, Japan