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When Are Endovascular and Open Bypass Treatments Preferred for Femoropopliteal Occlusive Disease?

ABSTRACT: Several meta-analyses and multicenter trials have shown that chronic limb ischemia did not occur for up to 5 years in 50%-70% of patients who underwent saphenous vein grafts, with limb salvage and perioperative mortality rates of >80% and 3%, respectively. However, open surgical bypass can have limitations, including postoperative morbidity/wound complications of 10%-20% and prolonged length of hospital stay and outpatient care. Several studies have analyzed clinical outcomes for patients with critical limb ischemia treated with endovascular therapies, but they have been mainly retrospective with significant heterogeneity or were single center. Only few randomized trials have compared surgical vs. endovascular therapy. These included the Bypass vs. Angioplasty in Severe Ischemia of the Leg (BASIL) trial, with no differences found in amputation-free or overall survival rates at 1 year; however, late outcomes favored the surgical group. The Bypass or Angioplasty in Severe Intermittent Claudication (BASIC) trial concluded that the 1-year patency rates were 82% and 43% for bypass and angioplasty, respectively. The BEST Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial is currently enrolling patients. This review analyzed studies comparing open vs. endovascular therapy in patients with femoropopliteal disease. (This is a review article based on the invited lecture of the 45th Annual Meeting of Japanese Society for Vascular Surgery.).

SUBMITTER: AbuRahma AF

PROVIDER: S-EPMC5882358 | biostudies-other | 2018 Mar

REPOSITORIES: biostudies-other

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When Are Endovascular and Open Bypass Treatments Preferred for Femoropopliteal Occlusive Disease?

AbuRahma Ali F AF

Annals of vascular diseases 20180301 1

Several meta-analyses and multicenter trials have shown that chronic limb ischemia did not occur for up to 5 years in 50%-70% of patients who underwent saphenous vein grafts, with limb salvage and perioperative mortality rates of >80% and 3%, respectively. However, open surgical bypass can have limitations, including postoperative morbidity/wound complications of 10%-20% and prolonged length of hospital stay and outpatient care. Several studies have analyzed clinical outcomes for patients with c ...[more]

PMID: 29682105

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Project description:To estimate the clinical and economic impact of drug-eluting endovascular treatment strategies for femoropopliteal artery disease compared with current standard of care.Systematic literature search to pool target lesion revascularisations (TLR). Model-based per-patient cost impact and quasi-cost-effectiveness projection over 24 months based on pooled TLRs and current reimbursement.The UK's National Health Service (NHS).Patients presenting with symptomatic femoropopliteal disease eligible for endovascular treatment.Current National Institute for Health and Care Excellence (NICE) guideline-recommended treatment with percutaneous transluminal balloon angioplasty (PTA) and bailout bare metal stenting (BMS) versus primary BMS placement, or drug-coated balloon (DCB), or drug-eluting stent (DES) treatment.24-month per-patient cost impact to NHS (primary outcome).pooled 24-month TLR rates; numbers needed to treat (NNTs); cost per TLR avoided and estimated incremental cost-effectiveness ratio (ICER) in £ per quality-adjusted life year (QALY).N=28 studies were identified, reporting on 5167 femoropopliteal lesions. Over 24 months, DCB, DES and BMS reduced TLRs of de novo lesions from 36.2% to 17.6%, 19.4% and 26.9%, respectively, at an increased cost of £43, £44 and £112. NNTs to avoid 1 TLR in 24 months were 5.4, 6.0 and 10.8, resulting in cost per TLR avoided of £231, £264 and £1204. DCB was estimated to add 0.011 QALYs, DES 0.010 QALYs and BMS 0.005 QALYs, resulting in estimated ICERs of £3983, £4534 and £20 719 per QALY gained. A subset analysis revealed more favourable clinical and economic outcomes for a 3.5 µg/mm(2) DCB with urea excipient, compared with the rest of DCBs. A modest reduction of 10% in DCB and DES prices made drug-eluting treatments dominant.Widespread adoption of drug-eluting endovascular therapies for femoropopliteal disease would add meaningful clinical benefit at reasonable additional costs to the NHS. Based on currently available data, DCBs offer the highest clinical and economic value.

Project description:ObjectivePatients presenting with occluded aortobifemoral (ABF) bypass grafts are managed with a variety of techniques. Redo ABF (rABF) bypass procedures are infrequently performed because of concerns about procedural complexity and morbidity. The purpose of this analysis was to compare midterm results of rABF bypass with those of primary ABF (pABF) bypass for aortoiliac occlusive disease to determine if there are significant differences in outcomes.MethodsA retrospective review was performed of all patients undergoing ABF bypass for occlusive disease between January 2002 and March 2012. A total of 19 patients underwent rABF bypass and 194 received pABF bypass during that period. Data for an indication- and comorbidity-matched case-control cohort of 19 elective pABF bypass patients were collected for comparison to the rABF bypass group. Primary end points included rate of major complications as well as 30-day and all-cause mortality. Secondary end points were amputation-free survival and freedom from major adverse limb events.ResultsThe rABF bypass patients more frequently underwent prior extra-anatomic or lower extremity bypass operations compared with pABF bypass patients (P = .02); however, no difference was found in the incidence of prior failed endovascular iliac intervention (P = .4). By design, indications for the rABF and pABF bypass groups were the same (claudication, n = 6/6 [31.6%]; P = 1; critical limb ischemia, n = 13/13 [78.4%]; P = 1). Aortic access was more frequently by retroperitoneal exposure in the rABF bypass group (n = 13 vs n = 1; P < .0001), and a significantly higher proportion of the rABF bypass patients required concomitant infrainguinal bypass or intraprocedural adjuncts such as profundaplasty (n = 14 vs n = 5; P = .01). The rABF bypass patients experienced greater blood loss (1097 ± 983 mL vs 580 ± 457 mL; P = .02), received more intraoperative fluids (3400 ± 1422 mL vs 2279 ± 993 mL; P = .01), and had longer overall procedure times (408 ± 102 minutes vs 270 ± 48 minutes; P < .0001). Length of stay (days ± standard deviation) was similar (pABF bypass, 11.2 ± 10.4; rABF bypass, 9.1 ± 4.5; P = .7), and no 30-day or in-hospital deaths occurred in either group. Similar rates of major complications occurred in the two groups (pABF bypass, n = 6 [31.6%]; rABF bypass, n = 4 [21.1%]; observed difference, 9.5%; 95% confidence interval, -17.6% to 36.7%; P = .7). Two-year freedom from major adverse limb events (±standard error mean) was 82% ± 9% vs 78% ± 10% for pABF and rABF bypass patients (log-rank, P = .6). Two-year amputation-free survival was 90 ± 9% vs 89 ± 8% between pABF and rABF bypass patients (P = .5). Two-year survival was 91% ± 9% and 90% ± 9% for pABF and rABF bypass patients (P = .8).ConclusionsPatients undergoing rABF bypass have higher procedural complexity compared with pABF bypass as evidenced by greater operative time, blood loss, and need for adjunctive procedures. However, similar perioperative morbidity, mortality, and midterm survival occurred in comparison to pABF bypass patients. These results support a role for rABF bypass in selected patients.

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When Are Endovascular and Open Bypass Treatments Preferred for Femoropopliteal Occlusive Disease?

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When Are Endovascular and Open Bypass Treatments Preferred for Femoropopliteal Occlusive Disease?

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