UC UC SF SF Disclosures EVAR for Rupture: Royalties and - - PowerPoint PPT Presentation

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UC UC SF SF Disclosures EVAR for Rupture: Royalties and - - PowerPoint PPT Presentation

Dec 11, 2022 159 likes •237 views

UC UC SF SF Disclosures EVAR for Rupture: Royalties and research grant Trial Data and Practice support from Cook Medical, Inc. Jade S. Hiramoto, MD, MAS April 14, 2016 VASCULAR SURGERY UC SAN FRANCISCO VASCULAR SURGERY UC

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UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

EVAR for Rupture: Trial Data and Practice

Jade S. Hiramoto, MD, MAS April 14, 2016

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Disclosures

  • Royalties and research grant

support from Cook Medical, Inc.

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Ruptured Abdominal Aortic Aneurysms (RAAA)

  • Despite advances in operative technique and

perioperative management:

  • High death rate
  • High complication rate RAAA
  • Observational and population-based studies

support endovascular aneurysm repair (EVAR)

  • ver open repair (OR) for RAAA
  • Recent meta-analysis of observational studies

and registries

  • EVAR associated with 50% risk reduction in mortality

Van Beek et al; Eur J Vasc Endovasc Surg 2014;47(6):593-602

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Ruptured Abdominal Aortic Aneurysms (RAAA)

  • Some have argued that randomized trial

comparing EVAR and OR

  • Unnecessary
  • Maybe even unethical
  • Given high mortality with OR for RAAA:
  • Expected to see similar improvement in mortality of

EVAR over OR in this high risk patient group

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UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

EVAR vs OR for RAAA:

4 Randomized Trials

  • Nottingham trial – UK
  • Amsterdam Acute Aneurysm Trial (AJAX)
  • Immediate Management of the Patient with

Ruptured Aneurysm: Open Versus Endovascular repair (IMPROVE) – UK

  • Endovasclaire versus Chirugie dans les

Anevrysmes aorto-iliaques Rompus (ECAR) – France

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Nottingham UK Study

  • Patients with RAAA and fit for open repair:
  • Randomized to EVAR or OR
  • Those in EVAR group had pre-op CTA
  • EVAR performed with AUI and cross femoral bypass
  • 9/2002-12/2004: 103 patients w/suspected ruptured

AAA; 32 (31%) recruited to study

  • 30 day mortality: 53% in EVAR and 53% in OR
  • Operative complications: 77% in EVAR and 80% in OR
  • Median hospital stay: 10 days in EVAR and 12 days in OR
  • Median time to operation: 75 minutes in EVAR and 100

minutes in OR

Hinchliffe et al; Eur J Vasc Endovasc Surg 2006;32:506-513

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Nottingham UK Study

  • Pilot study
  • First randomized trial comparing EVAR and OR

for RAAA

  • Demonstrated that it is possible to recruit

patients to a randomized trial

  • CT scanning doesn’t delay treatment

Hinchliffe et al; Eur J Vasc Endovasc Surg 2006;32:506-513

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Amsterdam Acute Aneurysm Trial

  • 4/2004-2/2011: 116 patients (out of 520 RAAA

patients [22%]) suitable for EVAR and OR randomized

  • All patients had preoperative CTA
  • EVAR: AUI with cross femoral bypass graft; +/- aortic
  • cclusion balloon
  • 30 day mortality:
  • 21% in EVAR versus 25% in OR (p=0.66)
  • Death and severe complication rate at 30 days:
  • 42% in EVAR and 47% in OR group (p=0.58)
  • Median hospital stay:
  • 9 days in EVAR vs 13 days in OR (p=0.57)

Reimerink et al; Ann Surg 2013;258:248-256

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UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Amsterdam Acute Aneurysm Trial: Study Limitations

  • High conversion from EVAR to OR
  • 10/57 patients underwent OR, 8 of these crossed over

intraoperatively

  • Another 6 patients needed additional surgery to treat

type I EL

  • These patients were responsible for large percentage
  • f death/complications in EVAR group
  • Analysis performed as intention to treat
  • Underpowered
  • Primary endpoint for EVAR close to initial estimate
  • Outcomes after OR much better than anticipated
  • Outdated devices
  • Only included hemodynamically stable patients

Reimerink et al; Ann Surg 2013;258:248-256

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Amsterdam Acute Aneurysm Trial: Results of Patients Excluded From Randomized Trial

  • No difference in age and sex distribution

compared to randomized patients

  • Most excluded patients treated with OR (n=320)
  • Only 18 patients had EVAR (unfit for OR)
  • 30-day mortality: 30%
  • 17% in EVAR and 34% in OR

Reimerink et al; Ann Surg 2013;258:248-256

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

IMPROVE Study

  • Multicenter trial (29 UK and 1 Canada)
  • Randomized 613 patients with RAAA
  • 316 to “EVAR first strategy”: CTA performed after

randomization

  • 297 to OR
  • If patients were allocated to EVAR but deemed

anatomically unsuitable after CTA, they underwent OR

  • But remained in EVAR group for intention to treat

analysis!

IMPROVE Trial Investigators; Eur Heart J 2015;36:2061-2069

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

IMPROVE Study: 30-Day Results

  • 30-day mortality:
  • No difference between EVAR and OR groups (35% vs

37%)

  • EVAR under local anesthesia: significantly reduced 30-

day mortality compared to general anesthesia (adjusted OR 0.27, 0.10-0.70)

  • Women benefitted more than men from EVAR strategy

(OR 0.44 [0.22-0.91] vs 1.18 [0.80-1.75])

  • 30-day outcomes:
  • More patients in EVAR group discharged directly to

home (94% vs 77%, p<0.001)

  • Incremental cost saving for EVAR strategy vs OR

IMPROVE Trial Investigators; BMJ 2014;348:f7661 IMPROVE Trial Investigators; BJS 2014;101:216-224

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VASCULAR SURGERY • UC SAN FRANCISCO

IMPROVE Study: 1-Year Results

  • 1-year mortality:
  • 41% for EVAR strategy and 45% for OR (p=0.32)
  • Subgroup analysis: EVAR strategy more effective in

women than in men (OR 0.41; 95% CI:0.16,0.93, p=0.03)

  • Length of stay:
  • 17 days for EVAR strategy and 26 days for OR

(p<0.001)

  • Patients surviving rupture had higher QOL

scores and lower costs in EVAR strategy group

IMPROVE Trial Investigators; Eur Heart J 2015;36:2061-2069

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

IMPROVE:

Study Limitations

  • Treatment allocation before CTA
  • Patients randomized to EVAR strategy (n=316)

but underwent OR still remained in EVAR group

  • 33/316 (10%) had some other diagnosis
  • 174/316 (55%) considered suitable for EVAR
  • EVAR attempted in 154/316 (49%), 4 of which

converted to OR

  • Per protocol 30-day mortality: 25% for EVAR and

38% for OR

  • Flawed “real world” design

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

ECAR Study

  • 1/2008-1/2013, 107 patients in 14 centers
  • Consecutive patients with ruptured AAA (by CT scan)

who were hemodynamically stable (SBP>80 mmHg)

  • Patients had to be clinically and anatomically suitable

for both EVAR and OR

  • No difference in mortality at 30 days and 1 year:
  • 18% in EVAR vs 24% in OR at 30 days (p=0.24)
  • 30% in EVAR and 35% in OR at 1 year (p=0.30)
  • In-hospital death:
  • 23% in EVAR vs 35% in OR (p=0.18)

Desgranges et al; Eur J Vasc Endovasc Surg 2015;50:303-310

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

ECAR Study

  • Time from admission to treatment was longer in

EVAR group (2.9 vs 1.3 hours, p<0.005)

  • Lower pulmonary complications, blood

transfusions, and ICU stay in EVAR group (p<0.05 for each)

  • Lower hospital costs in EVAR group
  • Approximately 2200 euros/patient

Desgranges et al; Eur J Vasc Endovasc Surg 2015;50:303-310

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UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

ECAR: Study Limitations

  • Highly selected group
  • Only 20% of patients were randomized
  • Interventions and outcomes on the other 80% were not

reported

  • Expertise of trial centers
  • Patients waited longer to receive EVAR than OR
  • 73% of patients treated with AUI EVAR configuration

(despite their stability)

  • Underpowered
  • Based power calculation on 40% open repair mortality
  • Intended to enroll 160 patients, but only recruited 107
  • ver 5 years

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

How Do We Interpret The Data From RCT’s for RAAA?

  • Outdated EVAR technology/level of expertise
  • AUI grafts – 100% in AJAX trial and 73% in ECAR
  • No use of adjunctive procedures (parallel grafts, coiling,
  • nyx, etc.)
  • ECAR and AJAX
  • Excluded hemodynamically unstable or technically

difficult patients

  • Did not allow demonstration of advantages of EVAR in

higher-risk patients who would be expected to benefit most from less invasive procedure

  • Meta-analysis of one year trial results in

IMPROVE, ECAR, AJAX

  • Pooled odds ratio favored EVAR: 0.80 (95% CI 0.56-

1.16), p=0.24

UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

How Do We Interpret The Data From RCT’s for RAAA?

  • RCT’s: most rigorous method for determining

cause-effect relationship between

  • Exclusion of many patients can invalidate a good trial
  • High exclusion rates in all four European RCTs (50-80%)
  • Estimated that future randomized trials would require

2500-5000 patients for adequate power

  • Meta-analysis of one-year results of the RCT’s,

together with cost data from IMPROVE trial favor EVAR

  • Most registries and observational studies show

significantly better 30 day mortality for EVAR compared to OR for RAAA

  • Significant biases
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UC SF

VASCULAR SURGERY • UC SAN FRANCISCO

Incorporating The Data From RCT’s for RAAA into Practice

  • EVAR-only policy for RAAA should be discouraged
  • All patients in IMPROVE trial who underwent conversion from

EVAR to OR (based on anatomic misjudgment) died

  • Patients who are poor/complicated anatomic candidates for

EVAR likely best served with expeditious open repair

  • Consider EVAR first in women with RAAA with suitable

anatomy

  • Perform EVAR for RAAA under local anesthesia whenever

possible

  • Centralization of care in centers of expertise and optimization
  • f logistics