Experimental and Clinical Endocrinology & Diabetes, Table of Contents Exp Clin Endocrinol Diabetes 2019; 127(S 01): S105-S113DOI: 10.1055/a-1018-9250 German Diabetes Association: Clinical Practice Guidelines © Georg Thieme Verlag KG Stuttgart · New YorkPosition Paper on the Diagnosis and Treatment of Peripheral Arterial Disease (PAD) in People with Diabetes MellitusJoint Statement of the German Diabetes Society (DDG), The German Angiology Society (DGA) and The German Interventional Radiology Society (DeGIR)Authors Author Affiliations Bernd Balletshofer 1 Angiology Centre, Tübingen, Germany Wulf Ito 2 Heart and Vascular Centre Oberallgäu, Kempten, Germany Holger Lawall 3 Joint practice Prof. Dr. C. Diehm/Dr. H. Lawall, Max-Grundig Klinik Bühlerhöhe, Ettlingen, Germany Nasser Malyar 4 Clinic for Cardiology I - Coronary Heart Disease, Heart Failure and Angiology, University Hospital, Münster, Germany Yves Oberländer 5 Clinic for Internal Medicine 1 for Diabetology, Endocrinology, Cardiology and Angiology, Marienhospital, Stuttgart, Germany Peter Reimer 6 Institute for Diagnostic and Interventional Radiology, Municipal Clinic, Karlsruhe, Germany Kilian Rittig 7 Clinic for Internal Medicine IV, Angiology and Diabetology, Klinikum Frankfurt (Oder), Germany Markus Zähringer 8 Clinic for Diagnostic and Interventional Radiology, Marienhospital, Stuttgart, Germany Recommend Article Abstract Full Text References References 1 Lawall H, Huppert P, Rümenapf G. S3-Leitlinie zur Diagnostik, Therapie und Nachsorge der PAVK. AWMF-LL 065/003 2015. 2 Aboyans V, Ricco JB, Bartelink MEL. et al. 2017 ESC Guidelines on the diagnosis and treatmenrt of peripheral arterial disease, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering arterosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriey.. Eur Heart J 2018; 39: 763-816 3 Hinchliffe RJ, Forsythe R, Apelquist J et al. IWGDF Guideline on diagnosis, prognosis and management of peripheral arterial disease in patients with a foot ulcer and diabetes. Diabetes Metab Res Rev. 2019; in press 4 Fowkes GFR, Rudan D, Rudan I. et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: A systematic review and analysis. Lancet 2013; 5 Malyar N, Freisinger E, Meyborg M. et al. Amputations and mortality in in-hospital treated patients with peripheral arterial disease and diabetic foot syndrome. J Diab Compl 2016; 30: 1117-1122 6 Cacoub PP, Bhatt DL, Steg PG. et al. Patients with peripheral arterial disease in the CHARISMA trial.. Eur Heart J 2009; 30: 192-201 7 ASCEND Study Collaborative Group. Effects of Aspirin for Pimary Prevention in Persons with Diabetes Mellitus. N Engl J Med 2018; 8 McNeil JJ, Wolfe R, Woods RL. et al. Effect of aspirin on cardiovascular events and bleeding in the healthy elderly. N Eng J Med 2018; 9 CAPRIE Steering Committee. A randomised, blinded, trial of Clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). Lancet 1996; 348: 1329-1339 10 Hiatt WR, Fowkes FG, Heizer G. EUCLID Trial Steering Committee and Investigatiors et al. Ticagrelor versus clopidogrel in symptomatic peripheral artery disease. N Engl J Med 2017; 376: 32-40 11 Williams B, Mancia G, Spiering W. et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. EUR Heart J 2018; 39: 3021-3104 12 Soga Y, Iida O, Takahara M. et al. Beta-Blocker treatment does not worsen critical limb ischemia in patients receiving endovascular therapy. J Arteroscler Thromb 2015; 22: 481-489 13 Itoga NK, Taefik DS, Lee CK. et al. Association of blood pressure meas- urements with peripheral artery disease events.. Circulation 2018; 138: 1805-1814 14 Anand SS, Bosch J, Eikelboom JW. et al. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: An international, randomised, double-blind, placebo-controlles trial. Lancet 2018; 391: 219-229 15 Hsu CY, Chen YT, Su YW. et al. Statin therapy reduces future risk of lower- limb amputation in patients with diabetes and peripheral artery disease. J Clin Endocrinol Metab 2017; 102: 2373-2381 16 Arya S, Khakharia A, Binney ZO. et al. Association of statin dose with amputation and survival in patients with peripheral artery disease. Circulation 2018; 137: 1435-1446 17 Momsen AH, Jensen MB, Norager CB. et al. Drug therapy for improving walking distance in intermittent claudication: A systematic review and meta-analysis of robust randomised controlled studies.. Eur J Vasc Endo- vasc Surg 2009; 38: 463-474 18 Rajamani K, Colman PG, Li LP. et al. FIELD study investigators Effect of fenofibrate on amputation events in people with type 2 diabetes mellitus (FIELD study): A prespecified analysis of a randomised controlled trial. Lancet 2009; 373: 1780-1788 19 Bonaca MP, Nault P, Giugliano RP. et al. Low density lipoprotein cholesterol lowering with evolocumab and outcomes in patients with peripheral artery disease: Insights from the FOURIER Trial (further cardiovascular outcomes research with PCSK9 inhibition in subjects with elevated risk). Circulation 2018; 137: 338-350 20 Khan SZ, Rivero M, Nader ND. et al. Metformin is associated with improved survival and decreased cardiac events with no impact on patency and limb salvage after revascularization for peripheral arterial disease. Ann Vasc Surg 2019; 55: 63-77 21 Bannister CA, Holden SE, Jenkins-Jones S. et al. Can people with type 2 diabetes live longer than those without? A comparison of mortality in people initiated with metformin or sulphonylurea monotherapy and matched, non-diabetic controls?. Diabetes Obes Metab 2014; 16: 1165-1173 22 Dormandy JA, Charbonnel B, Eckland DJ. et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): A randomised controlled trial.. Lancet 2005; 366: 1279-1289 23 Erdmann E, Dormandy JA, Massi-Benedetti M. et al. The effect of piogli- tazone on recurrent myocardial infarction in 2445 patients with type 2 diabetes and previous myocardial infarction: Results from the PROactive (PROactive 05) Study. J Am Coll Cardiol 2007; 49: 1772-1780 24 Wilcox R, Bousser MG, Betteridge DJ. et al. Effects of pioglitazone in patients with type 2 diabetes with or without previous stroke: Results from PROactive (PROspective pioglitAzone Clinical Trial In macro Vascular Events04). Stroke 2007; 38: 865-873 25 Lincoff AM, Wolski K, Nicholls SJ. et al. Pioglitazone and risk of cardiovas- cular events in patients with type 2 diabetes mellitus: A metaanalysis of randomized trials. JAMA 2007; 298: 1180-1188 26 Kernan WN, Viscoli CM, Furie KL. et al. N Engl J Med 2016; 374: 1321-1331 27 Scirica BM, Braunwald E, Raz I. et al. Heart failure, saxagliptin and dia- betes mellitus: Observations from the saVor – tiMi 53 randomized trial. Circulation 2015; 132: e198 28 White WB, Cannon CP, Heller SR. et al. alogliptin after acute coronary syndrome in patients with type 2 diabetes.. N Engl J Med 2013; 369: 1327-1335 29 Zannad F, Cannon CP, Cushman WC. et al. Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXaMinE: A multicentre, randomised, double-blind trial. Lancet 2015; 385: 2067-2076 30 Green JB, Bethel MA, Armstrong PW. et al. Effect of sitagliptin on cardio- vascular outcomes in type 2 diabetes. N Engl J Med 2015; 373: 232-242 31 Rosenstock J. CAROLINA®: Cardiovascular safety and renal microvascular outcome with linagliptin in patients with T2D at high vascular risk. Oral presentation at the 79th Scientific Sessions of the American Diabetes Association (ADA); 10 June 2019 San Francisco, CA, USA 32 Marso SP, Daniels GH, Brown-Frandsen K. et al. Liraglutide and cardiovascular outcomes in type2 diabetes. N Engl J Med 2016; 375: 311-322 33 Marso SP, Bain SC, Consoli A. SUSTAIN-6 Investigators. et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med 2016; 375: 1834-1844 34 Gerstein HC, Colhoun HM, Dagenais GR. et al. Dulaglutide and cardio- vascular outcomes in type 2 diabetes (REWIND): A double-blind, randomised placebo-controlled trial. Lancet 2019; 394: 121-130 35 Zinman B, Wanner C, Lachin JM. et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 2015; 373: 2117-2128 36 Wanner C, Inzucchi SE, Zinman B. et al. Empagliflozin and progression of kidney disease in type 2 diabetes. N Engl J Med 2016; 375: 323-334 37 Neal B, Perkovic V, Matthews DR.. Canagliflozin and cardiovascular and renal events in type2 diabetes. N Engl J Med 2017; 377: 2099 38 Wiviott SD, Raz I, Bonaca MP. et al. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2019; 380: 347-357 39 Perkovic V, Jardine MJ, Neal B. et al. CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med 2019; 13 (24) 2295-2306 10.1056/NEJMoa1811744 Epub 2019 Apr 14 40 Holman RR, Coleman RL, Chan JCN. et al. Effects of acarbose on cardio- vascular and diabetes outcomes in patients with coronary heart disease and impaired glucosetolerance (ACE): a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol 2017; 5: 877-886 41 Gerstein HC, Bosch J, Dagenais GR.. et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med 2012; 367: 319-328 42 Greenhalgh RM, Belch JJ, Brown LC. et al. The adjuvant benefit of angio- plasty in patients with mild to moderate intermittent claudication managed by supervised exercise, smoking cessation advice and best medical therapy: Results from two randomised trials for stenotic femoropopliteal and aortoiliac arterial disease. Eur J Vasc Endovasc Surg 2008; 36: 680-688 43 Kersting J, Kamper L, Das M. et al. Leitliniengerechte Therapie der pAVK – aktuelle Studienlage und Ausblick. Fortschr Röntgenstr 2019; 191: 311-322 44 Lawall H, Huppert P, Zemmrich CS. et al. S3-Leitlinie PAVK – Diagnostik, Therapie und Nachsorge der peripher arteriellen Verschlusskrankheit. VASA 2016; 45 (Suppl. 95) 1-100 45 Gerhard-Hermann MD, Gornik HL, Barrett C et al. 2016 AHA/ACC Guideline on the management of patients with lower extremity peripheral artery disease: Executive summary. Vasc Med 2017; 22: NP1–NP43 46 Laird JR, Katzen BT, Scheinert D. et al. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries for patients with claudication: Three-year follow-up from the RESILIENT randomized trial. J Endovasc Ther 2012; 19: 1-9 47 Schlager O, Gschwandtner ME, Willfort-Ehringer A. et al. Drug coated balloons in the superficial femoral artery. J Cardiovasc Surg 2018; 59: 60-69 48 Dake MD, Ansel GM, Jaff MR. et al. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver-PTX randomized trial. Circulation 2016; 133: 1472-1483 49 Katsanos K, Spiliopoulos S, Kitrou P. et al. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: A systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc 2018; 18: 1-13 50 Empfehlung des BfArM Empfehlung für die Verwendung von Paclitaxel- beschichteten Stents (DES) und Ballons (DCB) in der Behandlung der peripheren arteriellen Verschlusskrankheit (pAVK). Referenz Nr. 00092/ 19. Stand 13.06.2019. 51 https://www.fda.gov/medical-devices/letters-health-care-providers/ august-7-2019-update-treatment-peripheral-arterial-disease-paclitaxel- coated-balloons-and-paclitaxel 52 Hinchliffe RJ, Andros G, Apelqvist J.. A systematic review of the effecti- veness of revascularization of the ulcerated foot in patients with diabetes and peripheral arterial disease. Diabetes Metab Res Rev 2012; 28: 179-217 53 Spreen MI, Martens JM, Knippenberg B. et al. Long-term follow-up of the PADI trial: Percutaneous transluminal angioplasty versus drug-eluting stents for infrapopliteal lesions in critical limb ischemia. J Am Heart Assoc 2017; 14: 6 54 Langhoff R, Behne A, Buschmann E.. Promising role of drug-coated balloons in the tibial vessels?. J Cardiovasc Surg 2018; 57: 667-676 55 Manzi M.. Innovations in the management of the diabetic foot. J Cardiovasc Surg 2018; 59: 653-654 56 Walker CM.. Tibiopedal access for crossing of infrainguinal artery occlu- sions: A prospective multicenter observational study.. J Endovasc Ther 2016; 23: 839-846 57 Bundesärztekammer, Kassenärztliche Bundesvereinigung (KBV) Arbeitsgemeinschaft der wissenschaftlichen medizinischen Fachgesellschaften (AWMF). S3-Leitlinie „Nierenerkrankungen bei Diabetes im Erwachsenenalter“. Nationale Versorgungsleitlinie. AWMF-Leitlinien- Register Nr. nvl/001d. 2015; 58 Safian RD.. CO2 angiography: Colorless, odorless but definitely not useless. Catheter Cardiovasc Interv 2017; 90: 449-450 59 Long CA, Zepel L, Greiner MA. et al. Use and 1-year outcomes with conventional and drug-coated balloon angioplasty in patients with lower extremity peripheral artery disease. Am Heart J 2019; 217: 42-51 60 Schneider PA, Laird JR, Doros G. et al. Mortality not correlated with paclitaxel exposure: An independent patient-level meta-analysis of a drug-coated balloon. J Am Coll Cardiol 2019; 73 (20) 2550-2563 61 Dake MD, Ansel GM, Bosiers M. et al. Paclitaxel-coated zilver ptx drug- eluting stent treatment does not result in increased long-term all- cause mortality compared to uncoated devices. Cardiovasc Intervent Radiol 2019;
