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 SAN FRANCISCO UC UC SF SF Ruptured Abdominal Aortic Ruptured Abdominal Aortic Aneurysms (RAAA) Aneurysms (RAAA) • Despite advances in operative technique and perioperative management: • Some have argued that randomized trial - High death rate comparing EVAR and OR - High complication rate RAAA - Unnecessary • Observational and population-based studies - Maybe even unethical support endovascular aneurysm repair (EVAR) over open repair (OR) for RAAA • Given high mortality with OR for RAAA: - Expected to see similar improvement in mortality of • Recent meta-analysis of observational studies EVAR over OR in this high risk patient group and registries - EVAR associated with 50% risk reduction in mortality Van Beek et al; VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO Eur J Vasc Endovasc Surg 2014;47(6):593-602 1
UC UC SF SF EVAR vs OR for RAAA: Nottingham UK Study 4 Randomized Trials • Patients with RAAA and fit for open repair: • Nottingham trial – UK - Randomized to EVAR or OR - Those in EVAR group had pre-op CTA • Amsterdam Acute Aneurysm Trial (AJAX) - EVAR performed with AUI and cross femoral bypass • Immediate Management of the Patient with • 9/2002-12/2004: 103 patients w/suspected ruptured Ruptured Aneurysm: Open Versus AAA; 32 (31%) recruited to study Endovascular repair (IMPROVE) – UK - 30 day mortality: 53% in EVAR and 53% in OR - Operative complications: 77% in EVAR and 80% in OR • Endovasclaire versus Chirugie dans les - Median hospital stay: 10 days in EVAR and 12 days in OR Anevrysmes aorto-iliaques Rompus (ECAR) – - Median time to operation: 75 minutes in EVAR and 100 France minutes in OR Hinchliffe et al; VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO Eur J Vasc Endovasc Surg 2006;32:506-513 UC UC SF SF Nottingham UK Study Amsterdam Acute Aneurysm Trial • 4/2004-2/2011: 116 patients (out of 520 RAAA patients [22%]) suitable for EVAR and OR • Pilot study randomized • First randomized trial comparing EVAR and OR - All patients had preoperative CTA for RAAA - EVAR: AUI with cross femoral bypass graft; +/- aortic • Demonstrated that it is possible to recruit occlusion balloon patients to a randomized trial • 30 day mortality: • CT scanning doesn’t delay treatment - 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) Hinchliffe et al; VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO Reimerink et al; Ann Surg 2013;258:248-256 Eur J Vasc Endovasc Surg 2006;32:506-513 2
UC UC Amsterdam Acute Aneurysm Trial: SF Amsterdam Acute Aneurysm Trial: SF Results of Patients Excluded From Study Limitations Randomized Trial • High conversion from EVAR to OR - 10/57 patients underwent OR, 8 of these crossed over intraoperatively • No difference in age and sex distribution - Another 6 patients needed additional surgery to treat compared to randomized patients type I EL • Most excluded patients treated with OR (n=320) - These patients were responsible for large percentage of death/complications in EVAR group - Only 18 patients had EVAR (unfit for OR) - Analysis performed as intention to treat • 30-day mortality: 30% • Underpowered - 17% in EVAR and 34% in OR - Primary endpoint for EVAR close to initial estimate - Outcomes after OR much better than anticipated • Outdated devices • Only included hemodynamically stable patients VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO Reimerink et al; Ann Surg 2013;258:248-256 Reimerink et al; Ann Surg 2013;258:248-256 UC UC SF SF IMPROVE Study IMPROVE Study: 30-Day Results • 30-day mortality: • Multicenter trial (29 UK and 1 Canada) - No difference between EVAR and OR groups (35% vs • Randomized 613 patients with RAAA 37%) - 316 to “EVAR first strategy”: CTA performed after - EVAR under local anesthesia: significantly reduced 30- randomization day mortality compared to general anesthesia - 297 to OR (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]) • If patients were allocated to EVAR but deemed anatomically unsuitable after CTA, they • 30-day outcomes: underwent OR - More patients in EVAR group discharged directly to - But remained in EVAR group for intention to treat home (94% vs 77%, p<0.001) analysis! - Incremental cost saving for EVAR strategy vs OR IMPROVE Trial Investigators; BMJ 2014;348:f7661 IMPROVE Trial Investigators; VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO Eur Heart J 2015;36:2061-2069 IMPROVE Trial Investigators; BJS 2014;101:216-224 3
UC UC SF SF IMPROVE: IMPROVE Study: 1-Year Results Study Limitations • 1-year mortality: • Treatment allocation before CTA - 41% for EVAR strategy and 45% for OR (p=0.32) - Subgroup analysis: EVAR strategy more effective in • Patients randomized to EVAR strategy (n=316) women than in men (OR 0.41; 95% CI:0.16,0.93, but underwent OR still remained in EVAR group p=0.03) - 33/316 (10%) had some other diagnosis • Length of stay: - 174/316 (55%) considered suitable for EVAR - 17 days for EVAR strategy and 26 days for OR - EVAR attempted in 154/316 (49%), 4 of which (p<0.001) converted to OR • Per protocol 30-day mortality: 25% for EVAR and • Patients surviving rupture had higher QOL 38% for OR scores and lower costs in EVAR strategy group • Flawed “real world” design IMPROVE Trial Investigators; VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO Eur Heart J 2015;36:2061-2069 UC UC SF SF ECAR Study 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) • Time from admission to treatment was longer in - Patients had to be clinically and anatomically suitable EVAR group (2.9 vs 1.3 hours, p<0.005) for both EVAR and OR • Lower pulmonary complications, blood • No difference in mortality at 30 days and 1 year: transfusions, and ICU stay in EVAR group - 18% in EVAR vs 24% in OR at 30 days (p=0.24) (p<0.05 for each) - 30% in EVAR and 35% in OR at 1 year (p=0.30) • Lower hospital costs in EVAR group • In-hospital death: - Approximately 2200 euros/patient - 23% in EVAR vs 35% in OR (p=0.18) Desgranges et al; Desgranges et al; VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO Eur J Vasc Endovasc Surg 2015;50:303-310 Eur J Vasc Endovasc Surg 2015;50:303-310 4
UC UC SF ECAR: Study Limitations SF • 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 over 5 years VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO UC UC SF How Do We Interpret The Data From SF How Do We Interpret The Data From RCT’s for RAAA? RCT’s for RAAA? • Outdated EVAR technology/level of expertise • RCT’s: most rigorous method for determining - AUI grafts – 100% in AJAX trial and 73% in ECAR cause-effect relationship between - No use of adjunctive procedures (parallel grafts, coiling, - Exclusion of many patients can invalidate a good trial onyx, etc.) - High exclusion rates in all four European RCTs (50-80%) • ECAR and AJAX - Estimated that future randomized trials would require - Excluded hemodynamically unstable or technically 2500-5000 patients for adequate power difficult patients • Meta-analysis of one-year results of the RCT’s, - Did not allow demonstration of advantages of EVAR in together with cost data from IMPROVE trial favor higher-risk patients who would be expected to benefit EVAR most from less invasive procedure • Meta-analysis of one year trial results in • Most registries and observational studies show IMPROVE, ECAR, AJAX significantly better 30 day mortality for EVAR compared to OR for RAAA - Pooled odds ratio favored EVAR: 0.80 (95% CI 0.56- 1.16), p=0.24 - Significant biases VASCULAR SURGERY • UC SAN FRANCISCO VASCULAR SURGERY • UC SAN FRANCISCO 5
UC SF 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 of logistics VASCULAR SURGERY • UC SAN FRANCISCO 6
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