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%

End

• ?