Five-year outcomes following a randomized trial of femorofemoral and femoropopliteal bypass grafting with heparin-bonded or standard polytetrafluoroethylene grafts.

BACKGROUND: Cohort studies suggest superior long-term patency of luminal heparin-bonded polytetrafluoroethylene (Hb-PTFE) bypass grafts compared with standard PTFE grafts. The aim of this study was to compare the outcomes of Hb-PTFE grafts with those of standard PTFE grafts 5 years after a randomized trial. METHODS: Patients with intermittent claudication or critical limb ischaemia requiring femorofemoral or femoropopliteal bypass grafting were randomized in a clinical trial of Hb-PTFE versus standard PTFE in 11 Scandinavian centres between 2005 and 2009. Patients were followed up for 5 years with clinical assessment and surveillance Duplex ultrasound imaging. The primary endpoint of this study was primary patency. Secondary endpoints included major amputation and mortality. RESULTS: Overall, 569 patients were enrolled in the randomized trial. Some 552 had follow-up data available for analysis of the primary outcome. Use of Hb-PTFE significantly improved patency by 37 per cent at 2 years, but 5 years after randomization there was no difference in primary patency (adjusted hazard ratio (HR) 0·95, 95 per cent c.i. 0·71 to 1·28; P = 0·748). In patients with critical limb ischaemia the use of Hb-PTFE reduced the 5-year risk of loss of primary patency by 37 per cent (HR 0·63, 0·40 to 0·99; P = 0·049). CONCLUSION: In this study there was no difference in primary graft patency between Hb-PTFE and standard PTFE grafts. Patients receiving Hb-PTFE grafts for critical limb ischaemia were more likely to have a patent graft at 5 years than those with standard PTFE grafts.

The Scandinavian Propaten(®) trial - 1-year patency of PTFE vascular prostheses with heparin-bonded luminal surfaces compared to ordinary pure PTFE vascular prostheses - a randomised clinical controlled multi-centre trial.

OBJECTIVE: To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study. MATERIALS AND METHODS: Eleven Scandinavian centres enrolled 569 patients with chronic functional or critical lower limb ischaemia who were scheduled to undergo femoro-femoral bypass or femoro-poplitaeal bypass. The patients were randomised 1:1 stratified by centre. Patency was assessed by duplex ultrasound scanning. A total of 546 patients (96%) completed the study with adequate follow-up. RESULTS: Perioperative bleeding was, on average, 370 ml with PTFE grafts and 399 ml with Heparin-bonded PTFE grafts (p = 0.32). Overall, primary patency after 1 year was 86.4% for Hb-PTFE grafts and 79.9% for PTFE grafts (OR = 0.627, 95% CI: 0.398; 0.989, p = 0.043). Secondary patency was 88% in Hb-PTFE grafts and 81% in PTFE grafts (OR = 0.569 (0.353; 0.917, p = 0.020)). Subgroup analyses revealed that significant reduction in risk (50%) was observed when Hb-PTFE was used for femoro-poplitaeal bypass (OR = 0.515 (0.281; 0.944, p = 0.030)), and a significant reduction in risk (50%) was observed with Hb-PTFE in cases with critical ischaemia (OR = 0.490 (0.249; 0.962, p = 0.036)). CONCLUSION: The Hb-PTFE graft significantly reduced the overall risk of primary graft failure by 37%. Risk reduction was 50% in femoro-poplitaeal bypass cases and in cases with critical ischaemia.

Risk of early recurrent stroke in symptomatic carotid stenosis after best medical therapy and before endarterectomy.

BACKGROUND: The early recurrence of neurological symptoms (NR) after urgent aggressive best medical therapy (BMT) in symptomatic carotid stenosis is not well documented. AIMS: To investigate the risk of ipsilateral NR after urgent aggressive BMT in patients with symptomatic (50-99%) carotid stenosis up to carotid endarterectomy (CEA), with emphasis on the first 14 days after index-event. METHODS: Prospective population based study, covering a period of 4½ years. NR rate was determined after initiation of urgent aggressive BMT and until CEA and compared to NR up to 90 days prior to index-event. Urgent BMT consisted of loading dose aspirin and clopidogrel thereafter therapy with aspirin and clopidogrel together with a statin. RESULTS: Of 8200 symptomatic patients (ischemic stroke, transient ischemic attack and ocular events), 250 (3%) patients underwent CEA, 47% within 14 days of the index-event and 99% within 14 days of surgical referral. The overall NR from index-event to CEA in symptomatic patients was significantly lower 1.6% (95% CI 0.5-4%) after BMT when compared with NR in the 90 days prior to referral to a stroke clinic 25% (95% CI 20-30%, p < 0.00001). Peri-operative bleeding 5% (95% CI 3-8%) was comparable with other studies. CONCLUSION: Urgent aggressive BMT after index-event is associated with a significant reduction in the risk of early NR in CEA candidates. The early risk of recurrent stroke in patients with symptomatic significant carotid stenosis is dramatically reduced after urgent aggressive BMT in specialised stroke clinics.