The ESC Textbook of Cardiovascular Medicine (3 edn)
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This chapter provides the background information and detailed discussion of the data for the following current ESC Guidelines on: 
Diagnosis and Treatment of Peripheral Arterial Diseases - academic.oup.com/eurheartj/article/39/9/763/5033666#117577247
This section was reviewed and edited by The Task Force for the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) Authors/Task Force Members: Helmut Baumgartner (ESC Chairperson) (Germany), Volkmar Falk (EACTS Chairperson) (Germany), Jeroen J. Bax (The Netherlands), Michele De Bonis (Italy), Christian Hamm (Germany), Per Johan Holm (Sweden), Bernard Iung (France), Patrizio Lancellotti (Belgium), Emmanuel Lansac (France), Daniel Rodriguez Muñoz (Spain), Raphael Rosenhek (Austria), Johan Sjögren (Sweden), Pilar Tornos Mas (Spain), Alec Vahanian (France), Thomas Walther (Germany), Olaf Wendler (UK), Stephan Windecker (Switzerland), Jose Luis Zamorano (Spain)
Summary
Rapid changes in therapeutic techniques create the situation in which clinical practice tends to follow technical developments without evidence from RCTs. In addition, RCTs often yield conflicting results because of technical evolution. Moreover, PADs may involve multiple sites, creating a large number of clinical scenarios to investigate.
Rapid changes in therapeutic techniques create the situation in which clinical practice tends to follow technical developments without evidence from randomized clinical trials. In addition, randomized clinical trials often yield conflicting results because of technical evolution. Moreover, peripheral arterial diseases may involve multiple sites, creating a large number of clinical scenarios to investigate. All these contribute to the broad spectrum of gaps in evidence, of which the most relevant are listed in the Table 49.12.1.
Epidemiology |
Data on epidemiology of PADs in Europe are scarce. |
Important challenges are associated with PADs in women. This group has classically been underrepresented in research studies. Therefore, several sex-related challenges regarding diagnosis and management issues should be acknowledged. |
Carotid artery disease |
The benefits of new antiplatelet drugs for the management of asymptomatic carotid artery disease should be assessed by RCTs. |
A multifactorial and standardized score is necessary to stratify the risk of stroke in patients with asymptomatic carotid artery stenosis, to determine the subgroup who may benefit from revascularization, in addition to best medical therapy. |
The efficacy of embolic protection devices during CAS has not been studied in adequately powered RCTs, and the available evidence is conflicting. |
The optimal duration of dual antiplatelet therapy after CAS is not well established. |
The timing of carotid revascularization in the acute phase of stroke after intracerebral thrombolysis/thrombectomy is not yet defined and should be investigated. |
Vertebral artery disease |
Almost no data are available on the comparison between surgical and endovascular revascularization in symptomatic patients. |
Upper extremity artery disease |
Little is known about the natural course in upper extremity artery disease. |
Almost no data are available on the long-term clinical benefit of revascularization (and the optimal mode) of symptomatic subclavian artery stenosis/occlusion. |
Optimal duration for DAPT after subclavian artery stenting is unknown. |
Mesenteric artery disease |
The potential benefits of prophylactic revascularization for asymptomatic mesenteric artery disease involving multiple vessels need investigations. |
In case of symptomatic mesenteric artery disease, no data are available on the potential benefit of covered versus bare stents. |
Optimal duration for DAPT after mesenteric stenting is unknown. |
Renal artery disease |
The role of renal artery stenting for patients with pulmonary flash oedema remains to be demonstrated by RCT. |
Appropriate treatment of in-stent renal artery restenosis is not yet defined. |
Risk stratification would be necessary to clarify whether a subgroup of patients with RAS may benefit from renal revascularization. In case of renal stenting, optimal duration for DAPT is unknown. |
Lower extremity artery disease |
The role of drug-eluting stents and drug-eluting balloons in superficial femoral artery and below-the-popliteal artery interventions has to be established. |
Optimal treatment for popliteal artery stenosis needs to be addressed. |
Clinical studies on self-expanding stents, drug-coated balloons, and drug-eluting stents for below-the-knee interventions in patients with CLTI should include amputation-free survival, wound healing, and quality of life in addition to standard-patency outcomes. |
Optimal duration of DAPT after stenting, as well as the potential benefit of its long-term use in patients with CLTI, should be further investigated. |
The rationale of the angiosome concept to decide on modality of revascularization in patients with CLTI remains to be demonstrated. |
There is a need to develop European registries for patients with LEAD in order to provide ‘real-world’ assessment of clinical outcomes and practices. |
There is a need to validate improved classification systems for CLTI that incorporate wound, ischaemia, and foot infection such as the WIfI classification. |
Multisite artery disease |
Whether the screening for other sites of atherosclerosis (e.g. CAD) in patients with PADs may improve their outcome needs further investigation. |
Cardiac conditions in patients with PADs |
The impact of heart failure screening and treatment and its impact on outcome of patients with PADs require further investigations. |
The optimal strategy of antithrombotic treatment in patients with atrial fibrillation and PADs requires specific RCTs. |
Epidemiology |
Data on epidemiology of PADs in Europe are scarce. |
Important challenges are associated with PADs in women. This group has classically been underrepresented in research studies. Therefore, several sex-related challenges regarding diagnosis and management issues should be acknowledged. |
Carotid artery disease |
The benefits of new antiplatelet drugs for the management of asymptomatic carotid artery disease should be assessed by RCTs. |
A multifactorial and standardized score is necessary to stratify the risk of stroke in patients with asymptomatic carotid artery stenosis, to determine the subgroup who may benefit from revascularization, in addition to best medical therapy. |
The efficacy of embolic protection devices during CAS has not been studied in adequately powered RCTs, and the available evidence is conflicting. |
The optimal duration of dual antiplatelet therapy after CAS is not well established. |
The timing of carotid revascularization in the acute phase of stroke after intracerebral thrombolysis/thrombectomy is not yet defined and should be investigated. |
Vertebral artery disease |
Almost no data are available on the comparison between surgical and endovascular revascularization in symptomatic patients. |
Upper extremity artery disease |
Little is known about the natural course in upper extremity artery disease. |
Almost no data are available on the long-term clinical benefit of revascularization (and the optimal mode) of symptomatic subclavian artery stenosis/occlusion. |
Optimal duration for DAPT after subclavian artery stenting is unknown. |
Mesenteric artery disease |
The potential benefits of prophylactic revascularization for asymptomatic mesenteric artery disease involving multiple vessels need investigations. |
In case of symptomatic mesenteric artery disease, no data are available on the potential benefit of covered versus bare stents. |
Optimal duration for DAPT after mesenteric stenting is unknown. |
Renal artery disease |
The role of renal artery stenting for patients with pulmonary flash oedema remains to be demonstrated by RCT. |
Appropriate treatment of in-stent renal artery restenosis is not yet defined. |
Risk stratification would be necessary to clarify whether a subgroup of patients with RAS may benefit from renal revascularization. In case of renal stenting, optimal duration for DAPT is unknown. |
Lower extremity artery disease |
The role of drug-eluting stents and drug-eluting balloons in superficial femoral artery and below-the-popliteal artery interventions has to be established. |
Optimal treatment for popliteal artery stenosis needs to be addressed. |
Clinical studies on self-expanding stents, drug-coated balloons, and drug-eluting stents for below-the-knee interventions in patients with CLTI should include amputation-free survival, wound healing, and quality of life in addition to standard-patency outcomes. |
Optimal duration of DAPT after stenting, as well as the potential benefit of its long-term use in patients with CLTI, should be further investigated. |
The rationale of the angiosome concept to decide on modality of revascularization in patients with CLTI remains to be demonstrated. |
There is a need to develop European registries for patients with LEAD in order to provide ‘real-world’ assessment of clinical outcomes and practices. |
There is a need to validate improved classification systems for CLTI that incorporate wound, ischaemia, and foot infection such as the WIfI classification. |
Multisite artery disease |
Whether the screening for other sites of atherosclerosis (e.g. CAD) in patients with PADs may improve their outcome needs further investigation. |
Cardiac conditions in patients with PADs |
The impact of heart failure screening and treatment and its impact on outcome of patients with PADs require further investigations. |
The optimal strategy of antithrombotic treatment in patients with atrial fibrillation and PADs requires specific RCTs. |
CAD, coronary artery disease; CAS, carotid artery stenting; CLTI, chronic limb-threatening ischaemia; DAPT, dual antiplatelet therapy; LEAD, lower extremity artery disease; PADs, peripheral arterial diseases; RAS, renal artery stenosis; RCT, randomized clinical trial; WIfI, wound, ischaemia, and foot infection.
