Vascular Trials UPDATE

Infra-renal AAA UK Small Aneurysm Trial (Lancet 98) –Method n1090 Surveillance 4-5.5cm V’s Open repair –Result No diff in all cause mortality –5.8% 30 day mortality in surgical arm –2% per year rupture rate in females medical arm

Infra-renal AAA MASS Trial (Lancet 2002) –Method n68,000 Men 65 years one off screen V’s incidental –Results 50% reduction in AAA related mortality (not overall) £8000 per life year saved (over 10 years) –Update National screening programme implemented Current prevalence nearer 2% (5% in study)

Infra-renal AAA -EVAR EVAR 1(Lancet 2004) –Method n1000 Open V’s EVAR –Results 30 day mortality 4.7% V’s 1.7% 4 year FU no diff in all cause mortality but still significant diff in AAA related mortality (7% V’s 4%) Re-intervention rates of 20% at 4 years in EVAR group

Infra-renal AAA -EVAR EVAR 2 (Lancet 2005) –Method n350 unfit for open AAA EVAR V’s BMT –Result No diff in all cause mortality –64% dead at 4 years –20% crossover from BMT to EVAR

Infra-renal AAA -EVAR IMPROVE (VS 2013 early results) –Method n600 ruptured AAA Open V’s EVAR –Results 37% (open) V’s 35% (EVAR [64% suitable]), 30 day mortality. No diff Subgroup –Women better with EVAR –LA better with EVAR –Pre-op hypotension bad –Cost neutral

Carotids - Symptomatic NASCET (NEngJMed ‘91) –Method N1415 symptomatic Mod / Severe $ V’s BMT ECST (Lancet ‘91) –Method N3024 Mild / Mod / Severe $ V’s BMT Results –30% ipsalateral stroke rate over 3 years –CEA confers a ARR of approx 25%

Carotids - Symptomatic Rothwell meta-analysis (Lancet 2003) –Method NASCET, ECST, Veteran Affairs Trial n6092 –Results Trickle flow ARR <4% (no benefit) Direct relationship of time from presenting event / degree of stenosis and benefit of CEA –Women 2-4 week window, men 16 week window with >70% $ (NASCET) –2 week window with 50-70% $ (NASCET)

Carotids - Symptomatic Stenting trials –EVA n527 CAS 8.8% V’s 2.7% procedural stroke risk STOPPED EARLY –SPACE n1100 CAS 4.2% V’s CEA 2.5% (ns) –ICSS n1700 CAS 7.7% V’s 4.1% (p0.002)

Carotids – (A)Symptomatic CREST –Method n2500 Symptomatic and asymptomatic –Results CAS 7.2% V’s CEA 6.8% stroke, MI or death CAS 4.1% V’s 2.3% stroke rate (x2 risk of MI in CEA group)

Carotids - Asymptomatic ACAS (JAMA’95) –Method n1662 Surgery V’s BMT Men and women >60% $ NASCET –Results ARR 6% over 3 years (nnt17) ACST (Lancet 2004) –Method N3120 Surgery V’s BMT Men and women >60% $ NASCET –Result ARR 5.3% over 3 years (nnt 19)

Carotids - anaesthetic GALA –Method n3500 GA V’s LA –Result 4.8% V’s 4.5% MI, stroke, death

Carotids - ongoing ACST 2 –Asymptomatic CEA V’s CAS ECST 2 –CAR score intermediate risk –BMT V’s CEA or CAS SPACE 2 –Asymptomatic –BMT V’s CEA V’s CAS

Venous - Ulcers ESCHAR (Lancet 2004) –Method n500 Compression V’s compression + surgery –Results Reduced ulcer recurrence at 4 years No diff in healing rates EVRA –Endovenous + compression V’s compression alone –Outcomes, cost effectiveness and ulcer healing

PVD BASIL (Lancet 2005) –Method n450 suitable for bypass or endovascular Surgery / angioplasty first, intention to treat 5 year FU –Results No diff in overall amputation free survival After 2 years surgery results in better amputation free survival No improvement seen with angio first then surgery BASIL 2 –Difficulty with ethics

DISSECTION INSTEAD –Method n140 uncomplicated acute thoracic dissection BMT Vs. BMT and stent –Results No diff in overall mortality Reduced aortic mortality at 5years (6.9% Vs. 19.3%

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