Positionspapier zur Diagnostik und Therapie der peripheren arteriellen Verschlusskrankheit (pAVK) bei Menschen mit Diabetes mellitus – Gemeinsame Stellungnahme der Deutschen Diabetes Gesellschaft (DDG), der Deutschen Gesellschaft für Angiologie (DGA), der Deutschen Gesellschaft für Interventionelle Radiologie und minimal-invasive Therapie (DeGIR) sowie der Deutschen Gesellschaft für Gefäßchirurgie und Gefäßmedizin (DGG)

Aktualisierungshinweis

Die DDG-Praxisempfehlungen werden regelmäßig zur zweiten Jahreshälfte aktualisiert. Bitte stellen Sie sicher, dass Sie jeweils die neueste Version lesen und zitieren.

Publikationsverlauf

Artikel online veröffentlicht:
21. Oktober 2021

• Literatur

• 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 Measurements 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 Endovasc 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 pioglitazone 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 macroVascular Events04). Stroke 2007; 38: 865-873
• 25 Lincoff AM, Wolski K, Nicholls SJ. et al. Pioglitazone and risk of cardiovascular 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. Pioglitazone after Ischemic Stroke or Transient Ischemic Attack. N Engl J Med 2016; 374: 1321-1331
• 27 Scirica BM, Braunwald E, Raz I. et al. Heart failure, saxagliptin and diabetes 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 cardiovascular 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 79^th 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 cardiovascular 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 . Epub 2019 Apr 14
• 40 Holman RR, Coleman RL, Chan JCN. et al. Effects of acarbose on cardiovascular 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. Investigators OT. et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med 2012; 367: 319-328
• 42 Schaper NC, van Netten JJ, Apelqvist J. et al. Pracitcal Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update). Diabetes Metab Res Rev 2020; 36 (Suppl. 01) e 3266
• 43 Greenhalgh RM, Belch JJ, Brown LC. et al. The adjuvant benefit of angioplasty 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
• 44 Kersting J, Kamper L, Das M. et al. Leitliniengerechte Therapie der pAVK – aktuelle Studienlage und Ausblick. Fortschr Röntgenstr 2019; 191: 311-322
• 45 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
• 46 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
• 47 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
• 48 Schlager O, Gschwandtner ME, Willfort-Ehringer A. et al. Drug coated balloons in the superficial femoral artery. J Cardiovasc Surg 2018; 59: 60-69
• 49 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
• 50 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
• 51 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
• 52 https://www.fda.gov/medical-devices/letters-health-care-providers/august-7-2019-update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel
• 53 Bundesinstitut für Arzneimittel und Medizinprodukte. Sicherheitshinweis: Mit Paclitaxel beschichtete Ballons und Paclitaxel eluierende Stents. 2020 www.bfarm.de 08249-20_kundeninfo_de
• 54 Hinchliffe RJ, Andros G, Apelqvist J. A systematic review of the effectiveness of revascularization of the ulcerated foot in patients with diabetes and peripheral arterial disease. Diabetes Metab Res Rev 2012; 28: 179-217
• 55 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; 6: e004877
• 56 Langhoff R, Behne A, Buschmann E. Promising role of drug-coated balloons in the tibial vessels?. J Cardiovasc Surg 2018; 57: 667-676
• 57 Katsanos K, Spiliopoulos S, Kitrou P. et al. Risk of death and amputation with use of paclitaxel-coated balloons in the infrapopliteal arteries for treatment of critical limb ischemia: a systematic review and meta-analysis of randomized controlled trials. J Vasc Interv Radiol 2020; 31: 202-212
• 58 Medizinischer Dienst des Spitzenverbandes Bund der Krankenkassen (MDS). Drug Eluting Balloons bei pAVK-Nutzenbewertung und Indikationskriterien (22.10.202). Im Internet (Stand: 01.09.2021): https://www.mds-ev.de/fileadmin/dokumente/Publikationen/GKV/Methodik/GA_DEB_pAVK_Update_201022.pdf
• 59 Matsuoka EK, Hasebe T, Ishii R. et al Comparative performance analysis of interventional devices for the treatment of ischemic disease in below‑the-knee lesions: a systematic review and meta‑analysis. Cardiovasc Interv and Therapeutics 2021; Online ahead of print.
• 60 Manzi M. Innovations in the management of the diabetic foot. J Cardiovasc Surg 2018; 59: 653-654
• 61 Walker CM. Tibiopedal access for crossing of infrainguinal artery occlusions: a prospective multicenter observational study. J Endovasc Ther 2016; 23: 839-846
• 62 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.
• 63 Safian RD. CO2 angiography: colorless, odorless but definitely not useless. Catheter Cardiovasc Interv 2017; 90: 449-450
• 64 Conte MS, Bradbury AW, Kolh P. GVG Writing Group. et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg 2019; 69: 3S-125S.e40
• 65 Forsythe R, Apelqvist J, Boyko EJ. et al. Effectiveness of revascularisation of the ulcerated foot in patients with diabetes and peripheral artery disease: A systematic review. Diabetes Metab Res Rev 2020; (Suppl. 01) e3279
• 66 Hicks C, Najafian A, Farber A. et al. Diabetes does not worsen outcomes following infrageniculate bypass or endovascular intervention for patients with critical limb ischemia. J Vasc Surg 2016; 64: 1667-1674.e1
• 67 Hock C, Betz T, Töpel I. et al. A comparison of tibial and peroneal venous and HePTFE bypasses in diabetics with critical limb ischemia. Surgeon 2017; 15: 69-75
• 68 Bonaca MP, Bauersachs RM, Anand SS. et al. Rivaroxaban in Peripheral Artery Disease after Revascularization. N Engl J Med 2020; 382: 1994-2004