Diabetes Care for Patients with Peripheral Arterial Disease

The number of diabetics will increase almost 70% in developed countries during the next 20 years: peripheral arterial disease is a common and costly complication. The incidence of cardiovascular disease (mortality and morbidity) due to atherosclerosis, is higher among patients with diabetes than in those without diabetes. Intensive management of diabetes, including glycaemic control, treatment of hypertension and dyslipidemia, as well as nonpharmacological interventions, decreases both micro- and macrovascular complications. Aspirin and clopidogrel have less antiplatelet effect in patients with diabetes. Metformin therapy is considered a risk factor for lactic acidosis if not withdrawn 2 days before angiography, but this risk is extremely low in patients with normal renal function. Peri-operative hyperglycaemia and large fluctuations in plasma glucose increase postoperative mortality and morbidity and careful measures are required to minimise these effects

Response to Dr Herbert Dardik

Farrando Sicilia, Jordi; Lecea, Ignasi de; Fuente Fuente, Carlos; Ribas Seix, Anna; Masana Padrós, Judit; Delgado, José L

PTFE Bypass or Thrupass for Superficial Femoral Artery Occlusion? A Randomised Controlled Trial

AbstractEarly results of a thrupass endograft in the treatment of femoral lesions are promising. Less morbidity and better cost-effectiveness are suggested to be achieved in the treatment of chronic lower limb ischaemia with endovascular treatment compared to surgical treatment.Patients and methodsThis randomised multicentre trial aimed to enroll a group of 60+60 patients for the treatment of 5–25-cm occlusions of superficial femoral artery (SFA) to be followed up for 3 years. Patients were treated either with endoluminal PTFE thrupass (WL Gore & Ass) or with surgical polytetrafluoroethylene (PTFE) bypass to proximal popliteal artery. Primary patency at 3 years was scheduled to be the primary end-point and secondary patency, functional success, costs and quality of life the secondary end-points.ResultsA sample of 100 consecutive SFA occlusions in one of the centres revealed that only 4% of the lesions were amenable for the study. The trial was prematurely terminated due to the results of an interim analysis at the time when 44 patients were recruited: the 1-year primary patency (excluding technical failures) was 48% for thrupass and 95% for bypass (p=0.02). The patency difference in favour of surgical bypass over endovascular thrupass was also sustained after completion of 1-year follow-up, the primary patencies being 46% and 84% at 1 year with grossly equilinear life-table curves thereafter (p=0.18), respectively. The corresponding secondary patencies were 63% and 100% (p=0.05) when excluding technical failures and 58% and 100% (p=0.02) according to intention-to-treat analysis. Secondary outcomes were thus not analysed.ConclusionTreatment of SFA occlusions (TASC IIB and C or Imelda Ia and II) should be done by PTFE bypass rather than by PTFE thrupass, as thrupass is connected with worse early outcome. These results represent only a small category of femoral disease

Chapter VI: Follow-up after Revascularisation

AbstractStructured follow-up after revascularisation for chronic critical limb ischaemia (CLI) aims at sustained treatment success and continued best patient care. Thereby, efforts need to address three fundamental domains: (A) best medical therapy, both to protect the arterial reconstruction locally and to reduce atherosclerotic burden systemically; (B) surveillance of the arterial reconstruction; and (C) timely initiation of repeat interventions. As most CLI patients are elderly and frail, sustained resolution of CLI and preserved ambulatory capacity may decide over independent living and overall prognosis. Despite this importance, previous guidelines have largely ignored follow-up after CLI; arguably because of a striking lack of evidence and because of a widespread assumption that, in the context of CLI, efficacy of initial revascularisation will determine prognosis during the short remaining life expectancy. This chapter of the current CLI guidelines aims to challenge this disposition and to recommend evidentially best clinical practice by critically appraising available evidence in all of the above domains, including antiplatelet and antithrombotic therapy, clinical surveillance, use of duplex ultrasound, and indications for and preferred type of repeat interventions for failing and failed reconstructions. However, as corresponding studies are rarely performed among CLI patients specifically, evidence has to be consulted that derives from expanded patient populations. Therefore, most recommendations are based on extrapolations or subgroup analyses, which leads to an almost systematic degradation of their strength. Endovascular reconstruction and surgical bypass are considered separately, as are specific contexts such as diabetes or renal failure; and critical issues are highlighted throughout to inform future studies

SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial

Contains fulltext : 96315.pdf (publisher's version ) (Open Access)BACKGROUND: Endovascular treatment options for the superficial femoral artery are evolving rapidly. For long lesions, the venous femoropopliteal bypass considered to be superior above the prosthetic bypass. An endoluminal bypass, however, may provide equal patency rates compared to the prosthetic above knee bypass. The introduction of heparin-bonded endografts may further improve patency rates. The SUrgical versus PERcutaneous Bypass (SuperB) study is designed to assess whether a heparin-bonded endoluminal bypass provides equal patency rates compared to the venous bypass and to prove that it is associated with improved quality of life, related to a decreased complication rate, or not. METHODS/DESIGN: Two-hundred-twenty-two patients with peripheral arterial occlusive disease, category 3-6 according to Rutherford, will be randomized in two treatment arms; 1. the surgical femoro-popliteal bypass, venous whenever possible, and 2. the heparin-bonded endoluminal bypass. The power analysis was based on a non-inferiority principle, with an effect size of 90% and 10% margins (alpha 5%, power 80%). Patients will be recruited from 5 teaching hospitals in the Netherlands during a 2-year period. The primary endpoint is primary patency and quality of life evaluated by the RAND-36 questionnaire and the Walking Impairment Questionnaire. Secondary endpoints include secondary patency, freedom-from-TLR and complications. DISCUSSION: The SuperB trial is a multicentre randomized controlled trial designed to show non-inferiority in patency rates of the heparin-bonded endograft compared to the surgical bypass for treatment of long SFA lesions, and to prove a better quality of life using the heparin bonded-endograft compared to surgically treatment, related to a reduction in complications. TRIAL REGISTRATION: Clinicaltrials: NCT01220245