ESC Guidelines on the diagnosis and treatment of peripheral artery diseases Lower extremity artery disease. Erich Minar Medical University Vienna
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1 ESC Guidelines on the diagnosis and treatment of peripheral artery diseases Lower extremity artery disease Erich Minar Medical University Vienna for the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC)
2 Disclosure Speaker name: Erich Minar I do not have any potential conflict of interest
3 Lower extremity artery disease (LEAD) LEAD has different presentations, categorized according to the Fontaine or Rutherford classifications.
4 Clinical staging of LEAD Fontaine classification Rutherford classification Stage Symptoms Grade Category Symptoms I Asymptomatic 0 0 Asymptomatic I 1 Mild claudication II Intermittent claudication I 2 Moderate claudication I 3 Severe claudication III IV Ischaemic rest pain Ulceration or gangrene II 4 Ischaemic rest pain III 5 Minor tissue loss III 6 Major tissue loss
5 Clinical staging of LEAD Fontaine classification Rutherford classification Stage Symptoms Grade Category Symptoms I Asymptomatic 0 0 Asymptomatic I 1 Mild claudication II Intermittent claudication I 2 Moderate claudication I 3 Severe claudication III IV Ischaemic rest pain Ulceration or gangrene II 4 Ischaemic rest pain CC C L I III 5 Minor tissue loss CLI LI III 6 Major tissue loss
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7 Lower extremity artery disease (LEAD) Asymptomatic patients are also at high risk for cardiovascular events.
8 Mortality and vascular morbidity in older adults with asymptomatic versus symptomatic peripheral artery disease. Diehm C et al. Circulation 2009; 120: Event-free survival by LEAD status at 5 years.
9 LEAD Clinical examination Palpation Auscultation
10 ABI = LEAD -Diagnosis Ankle Brachial - Index Systolic ankle BP Systolic arm BP Definition of LEAD ABI 0,9
11 ABI measurement in patients with LEAD Recommendations Measurement of the ABI is indicated as a first-line non-invasive test for screening and diagnosis of LEAD. In the case of incompressible ankle arteries or ABI >1.40, alternative methods such as the toe-brachial index, Doppler waveform analysis or pulse volume recording should be used. Class Level I I B B
12 Ankle Brachial Index Collaboration. Ankle brachial index combined with Framingham Risk Score to predict cardiovascular events and mortality: a meta-analysis. Fowkes FG et al; JAMA 2008; 300(2):
13 ABI measurement in patients with LEAD Recommendations Class Level Measurement of the ABI is indicated as a first-line noninvasive test for screening and diagnosis of LEAD. In the case of incompressible ankle arteries or ABI >1.40, alternative methods such as the toe-brachial index, Doppler waveform analysis or pulse volume recording should be used. I I B B
14 Diagnostic tests in patients with LEAD Recommendations
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17 Therapeutic strategies in LEAD All patients with LEAD are at increased risk of further CVD events, and general secondary prevention is mandatory to improve prognosis.
18 Therapeutic strategies in LEAD Clinical stage Asymptomatic Claudication CLI Conservative Revascularisation
19 Therapeutic strategies in LEAD The aim of conservative treatment in patients with intermittent claudication is to improve symptoms. Two strategies are currently used: exercise therapy and pharmacotherapy.
20 Recommendations for patients with intermittent claudication Recommendations Class Level Supervised exercise therapy is indicated. I A Non-supervised exercise therapy is indicated when I C supervised exercise therapy is not feasible or available. In patients with intermittent claudication with symptoms IIb A affecting daily life activity, drug therapy may be considered. In the case of intermittent claudication with poor IIa C improvement after conservative therapy, revascularization should be considered. In patients with disabling intermittent claudication that IIa C impacts their activities of daily living, with culprit lesions located at the aorta/iliac arteries, revascularization (endovascular or surgical) should be considered as firstchoice therapeutic option, along with the risk factor management. Stem cell/gene therapy is not indicated. III C
21 Exercise for intermittent claudication. Watson et al; Cochrane Database Syst Rev trials met the inclusion criteria involving a total of 1200 participants with stable leg pain. FU : 2 wk 2yrs. There was some variation in the exercise regimens, all recommended at least 2 sessions weekly of mostly supervised exercise. Exercise programmes were of significant benefit compared with placebo or usual care in improving walking time and distance in selected patients with leg pain from IC.
22 Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication Bendermacher et al; Cochrane Database Syst Rev Supervised exercise therapy showed statistically significant and clinically relevant differences in improvement of maximal treadmill walking distance compared with non-supervised exercise therapy regimens.
23 Recommendations for patients with intermittent claudication Recommendations Class Level Supervised exercise therapy is indicated. I A Non-supervised exercise therapy is indicated when supervised I C exercise therapy is not feasible or available. In patients with intermittent claudication with symptoms affecting daily life activity, drug therapy may be considered. IIb A In the case of intermittent claudication with poor improvement after conservative therapy, revascularization should be considered. In patients with disabling intermittent claudication that impacts their activities of daily living, with culprit lesions located at the aorta/iliac arteries, revascularization (endovascular or surgical) should be considered as first-choice therapeutic option, along with the risk factor management. Stem cell/gene therapy is not indicated. III C IIa IIa C C
24 Drug Therapy for Improving Walking Distance in Intermittent Claudication: A Systematic Review and Meta-analysis of Robust Randomised Controlled Studies Momsen AH; Eur J Vasc Endovasc Surg 2009; 38: Conclusion Several drugs have shown to improve maximal walking distance, but with limited benefits. Statins seem to be the most efficient drug.
25 Statins and walking distance PFWT 132 ± 9s 121 ± 9s Atorvastatin +63% 80mg / 12 months Placebo +38% Mohler et al. Circulation 2003 =78s p=0.025 n=354 PFWT 225 ± 36s 231 ± 41s Simvastatin +42% 40mg/12 months Placebo - 4% =99s p< n=60 Aronow WS et al. Am J Cardiol 2003 Performance Score Statin User 10.0 Statin Nonuser 9.1 p<0.001 n=392 McDermott MM et al. Circulation 2003
26 Intermittent Claudication: Clinical Effectiveness of Endovascular Revascularization versus Supervised Hospitalbased Exercise Training Randomized Controlled Trial Spronk S et al; Radiology 2009; 250: Conclusion: After 6 and 12 months, patients with intermittent claudication benefited equally from either endovascular revascularization or supervised exercise. Improvement was, however, more immediate after revascularization
27 Recommendations for patients with intermittent claudication Recommendations Class Level Supervised exercise therapy is indicated. I A Non-supervised exercise therapy is indicated when I C supervised exercise therapy is not feasible or available. In patients with intermittent claudication with symptoms IIb A affecting daily life activity, drug therapy may be considered. In the case of intermittent claudication with poor IIa C improvement after conservative therapy, revascularization should be considered. In patients with disabling intermittent claudication that IIa C impacts their activities of daily living, with culprit lesions located at the aorta/iliac arteries, revascularization (endovascular or surgical) should be considered as firstchoice therapeutic option, along with the risk factor management. Stem cell/gene therapy is not indicated. III C
28 59 a, Risk factors: - Smoking - Hyperlipidemia PFWD: 80 m
29 After long-segment stenting
30 Recommendations for patients with intermittent claudication Recommendations Class Level Supervised exercise therapy is indicated. I A Non-supervised exercise therapy is indicated when I C supervised exercise therapy is not feasible or available. In patients with intermittent claudication with symptoms IIb A affecting daily life activity, drug therapy may be considered. In the case of intermittent claudication with poor IIa C improvement after conservative therapy, revascularization should be considered. In patients with disabling intermittent claudication that IIa C impacts their activities of daily living, with culprit lesions located at the aorta/iliac arteries, revascularization (endovascular or surgical) should be considered as first-choice therapeutic option, along with the risk factor management. Stem cell/gene therapy is not indicated. III C
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32 Follow up - Symptoms - CV risk control Endovascular therapy feasible?
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34 Therapeutic strategies in LEAD Clinical stage Asymptomatic Claudication CLI Conservative Revascularisation
35 Recommendations for the management of critical limb ischaemia Recommendations Class Level For limb salvage, revascularization is indicated whenever technically feasible. When technically feasible, endovascular therapy may be considered as the first-line option. If revascularization is impossible, prostanoids may be considered. I IIb IIb A B B
36 Endovascular treatment of lower extremity artery disease Endovascular revascularization for the treatment of patients with LEAD has developed rapidly during the past decade. An increasing number of centres favour an endovascularfirst approach due to reduced morbidity and mortality compared with vascular surgery while preserving the surgical option in case of failure.
37 The selection of the most appropriate revascularization strategy has to be determined on a case-by-case basis in a specialized vascular center. The main issues to be considered are the anatomical suitability, co-morbidities, local availability and expertise, and the patient s preference.
38 TASC A and D lesions: Endovascular therapy is the treatment of choice for type A lesions and surgery is the treatment of choice for type D lesions [C]. TASC B and C lesions: Endovascular treatment is the preferred treatment for type B lesions and surgery is the preferred treatment for good-risk patients with type C lesions. TASC II; 2007
39 Revascularization in patients with aorto-iliac lesions Recommendations Class Level 1 When revascularization is indicated, an endovascular-first strategy is recommended in all aortoiliac TASC A C lesions. A primary endovascular approach may be considered in aortoiliac TASC D lesions in patients with severe comorbidities, if done by an experienced team. Primary stent implantation rather than provisional stenting may be considered for aortoiliac lesions. I IIb IIb C C C TASC = TransAtlantic Inter-Society Consensus
40 Revascularization in patients with aorto-iliac lesions Recommendations Class Level 1 When revascularization is indicated, an endovascular-first strategy is recommended in all aortoiliac TASC A C lesions. A primary endovascular approach may be considered in aortoiliac TASC D lesions in patients with severe comorbidities, if done by an experienced team. Primary stent implantation rather than provisional stenting may be considered for aortoiliac lesions. I IIb IIb C C C TASC = TransAtlantic Inter-Society Consensus
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42 Revascularization in patients with aorto-iliac lesions Recommendations Class Level 1 When revascularization is indicated, an endovascular-first strategy is recommended in all aortoiliac TASC A C lesions. A primary endovascular approach may be considered in aortoiliac TASC D lesions in patients with severe comorbidities, if done by an experienced team. Primary stent implantation rather than provisional stenting may be considered for aortoiliac lesions. I IIb IIb C C C TASC = TransAtlantic Inter-Society Consensus
43 Iliac Arteries PTA plus selective Stent vs. primary Stent Klein et al; Dutch Iliac Stent Trial, Radiology 2006; 238:
44 Revascularization in patients with femoropopliteal lesions Recommendations Class Level When revascularization is indicated, an endovascular-first strategy is recommended in all femoropopliteal TASC A C lesions. Primary stent implantation should be considered in femoropopliteal TASC B lesions. A primary endovascular approach may also be considered in TASC D lesions in patients with severe comorbidities and the availability of an experienced interventionist. TASC = TransAtlantic Inter-Society Consensus I IIa IIb C A C
45 Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial Lancet 2005; 366:
46 Revascularization in patients with femoropopliteal lesions Recommendations Class Level When revascularization is indicated, an endovascular-first strategy is recommended in all femoropopliteal TASC A C lesions. Primary stent implantation should be considered in femoropopliteal TASC B lesions. A primary endovascular approach may also be considered in TASC D lesions in patients with severe comorbidities and the availability of an experienced interventionist. TASC = TransAtlantic Inter-Society Consensus I IIa IIb C A C
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48 Recommendations for revascularization in patients with infrapopliteal lesions Recommendations Class Level When revascularization in the infrapopliteal segment is indicated, endovascular-first strategy should be considered. For infrapopliteal lesions, angioplasty is the preferred technique, and stent implantation should be considered only in the case of insufficient PTA. IIa IIa C C PTA = percutaneous transluminal angioplasty
49 BTK interventions in patients with CLI typical discrepancy between morphologic patency and limb salvage Pooled data from metaanalysis of infrapopliteal PTA (30 articles) Romiti et al, J Vasc Surg 2008;47:975-81
50 Recommendations for revascularization in patients with infrapopliteal lesions Recommendations Class Level When revascularization in the infrapopliteal segment is indicated, endovascular-first strategy should be considered. For infrapopliteal lesions, angioplasty is the preferred technique, and stent implantation should be considered only in the case of insufficient PTA. IIa IIa C C PTA = percutaneous transluminal angioplasty
51 Occlusion of all lower leg arteries in a patient with CLI
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54 Antithrombotic therapy after infrainguinal bypass Dutch Bypass Oral Anticoagulants or Aspirin (BOA) Study Group (Lancet 2000) Randomized study: OAC vs. Aspirin after infrainguinal bypass - n=2690 patients; OAC: INR 3-4,5; Aspirin 80 mg/day Inclusion <5 days postop; Follow-up: x 21 Mo Occlusion Subgroup analysis Venous bypass Graft OAC (n=1310) ASS (n=1311) RR(95% CI) 23.5% 7.2% 17.8% 24.6% 10 % 15.1% 0.95 ( ) 0.69 ( ) 1.96 ( ) Bleedings 8.1% 4.2% 1.96 ( )
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