Late outcomes of IMPROVE - will they be different from EVAR 1? - - PowerPoint PPT Presentation

Janet Powell Imperial College London @IMPROVEtrial

Late outcomes of IMPROVE - will they be different from EVAR 1?

3 questions to be addressed

• Will EVAR for ruptures be associated with worse outcomes compared with
• pen repair in late follow-up?
• Why might they be different?
• Will EVAR continue to be recommended in the management of ruptured AAA?

Differences between EVAR-1 & IMPROVE

EVAR-1 Elective repair Selective recruitment IMPROVE Emergency repair All-comers

Key question addressed Is early & mid-term survival better with EVAR vs open repair Is early & mid-term survival better with a 24/7 emergency EVAR service Patient age 74 years 77 years Sex (% male) 86 78 AAA diameter/morphology 6.2 cm within IFU for EVAR 8.4 cm unselected 5-year survival 74% 41% EVAR-2 (patients unfit for open repair) 34%

Is AJAX a better comparator for EVAR-1? All patients within IFU for EVAR

EVAR-1 Elective repair AJAX Emergency repair

Key question addressed Is early & mid-term survival better with EVAR vs open repair Is early & mid-term survival better with EVAR vs open repair Patient age 74 years 74 years Sex (% male) 86 85 AAA diameter/morphology 6.2 cm within IFU for EVAR 7.6 cm within IFU for EVAR 5-year survival 74% 37%

Defining midterm by time untll <50% survival late outcomes beyond the <50% survival point

 EVAR-1 10 years elective repair in fit patients  EVAR-2 4 years elective repair in those unfit for open repair  IMPROVE or AJAX 4 years ruptured abdominal aortic aneurysm Time to <50% survival

Survival: primary outcome

Mid-term life year gain for EVAR strategy

20 40 60 80 100 243 139 127 110 84 56 23 Open repair 259 161 154 148 108 50 21 Endovascular strategy Number at risk 1 2 3 4 5 6 Years since randomisation Endovascular strategy Open repair

Endovascular strategy Open repair 56% 48% BMJ 2017;359:j4859

3 year mortality OR [95%CI] P= 613 patients 0.73 [0.53 1.00] 0.053 502 rupture repairs 0.62 [0.43, 0.89] 0.009 Live discharges to home 97% vs 77%

Cumulative incidence of re-interventions to 3 years: overall & clinician severity-rated

5 10 15 20 243 125 111 92 Open repair 259 146 132 121 Endovascular strategy Number at risk 1 2 3 Years since randomisation Endovascular strategy Open repair

5 10 15 20 25 30 243 114 96 78 Open repair 259 118 103 92 Endovascular strategy Number at risk 1 2 3 Years since randomisation Endovascular strategy Open repair

time to first re-intervention time to first re-intervention for life-threatening condition Open repair Endovascular strategy

Therefore overall costs remain slightly lower for endovascular strategy

early renal support 32% 48%

Endovascular strategy gains in quality of life: 0.17 QALYs at 3 years

Gain probably increased at 4 years

EQ-5D

So, since costs are slightly lower for endovascular strategy group, this strategy is highly cost-effective

Limited 4y data 0.70 open repair 0.73 EVAR

Incremental net benefit [95% CI] (£ GBP) within 3-years of randomisation, by subgroups, at £30,000 per QALY

Subgroup Incremental cost £ Incremental QALY Increment al net benefit £ p- value Sex Male (N=480)

• 3883

0.084 6401 p= 0.460 Female (N=133) 2817 0.339 7354 Hardman Index Hardman=0 (N=164)

• 3725

0.150 8228 p= 0.253 Hardman=1 (N=254)

• 2198
• 0.015

1747 Hardman≥2 (N=121)

• 1199

0.436 14291 AAA Neck length (mm) Length < 22 (N=234)

• 1215

0.209 8495 p= 0.496 Length ≥ 22 (N=247)

• 3578

0.092 6339 Lowest SBP (mm Hg) SBP < 90 (N=263)

• 4709

0.067 7706 p= 0.446 SBP ≥ 90 (N=305)

• 466

0.193 6249

QALY benefit for EVAR strategy highest in women, shortish necks & most unstable patients

Cost-effectiveness driven by QALY gains

 No indications that QALY gain is attenuated at 4 years  QALY gains for the EVAR strategy tend to be higher in women, those with shorter AAA necks (<22 mm) and the most unstable patients  unselective recruitment design of IMPROVE illuminated these findings and helped show that overall the EVAR strategy was cost- effective for ruptured AAA at 3 years & is likely to remain so Unselective recruitment means generalisability

EVAR strategy has key benefits for patients with rupture at all time points

Getting patients home quickly with no disability Better quality of life, especially in first year Lower rates of amputation & open stoma Better mid-term survival Recommended by NICE

Mid-term* comparison of IMPROVE versus EVAR 1: an EVAR strategy stays good for ruptures

*point until <50% survival Outcome IMPROVE (4y) EVAR-1 (4 or 10y)

Survival EVAR strategy better No difference Quality of life EVAR strategy better No difference QALY s EVAR strategy better No difference Re-interventions No difference EVAR higher Costs EVAR strategy lower EVAR higher Cost-effectiveness EVAR strategy better Open repair better Generalisability Good Limited

The winner EVAR strategy Open repair ???