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Observational evidence on the effectiveness of endovascular aneurysm repair compared with open surgical repair of unruptured abdominal aortic aneurysms: Abdominal aortic aneurysm: diagnosis and management: Evidence review K2. London: National Institute for Health and Care Excellence (NICE); 2020 Mar. (NICE Guideline, No. 156.)
Observational evidence on the effectiveness of endovascular aneurysm repair compared with open surgical repair of unruptured abdominal aortic aneurysms: Abdominal aortic aneurysm: diagnosis and management: Evidence review K2.
Show detailsF.1. Exclusively or predominantly infrarenal AAA
| No. of studies | Quality assessment | Summary of findings | Quality | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Risk of bias | Indirectness | Inconsistency | Imprecision | No. of patients | Relative effect estimate (95% CI) | Absolute expectation | ||||
| EVAR | OSR | OSR | EVAR (95% CI) | |||||||
| Perioperative mortality – relative effects less than 1 favour EVAR | ||||||||||
| 21a | V seriousb | Not serious | V seriousc | No serious | 219,938 | 166,528 | OR = 0.31 (0.27 to 0.36) | 29 per 1,000d | 20 fewer per 1,000 (18 to 21 fewer) | VERY LOWe |
| Duration of procedure (minutes) – relative effects less than 0 favour EVAR | ||||||||||
| 1f | V seriousb | Not serious | NA | No serious | 157 | 157 | MD = 86.6 shorter (71.9 to 101.3 shorter) | 215 minsg | 128 mins (114 to 143 mins) | VERY LOWe |
| Perioperative complications (all) – relative effects less than 1 favour EVAR | ||||||||||
| 6h | V seriousb | Not serious | Not seriousi | No serious | 124,923 | 85,740 | OR = 0.35 (0.26 to 0.48) | 357 per 1,000j | 194 fewer per 1,000 (147 to 231 fewer) | VERY LOWe |
| Perioperative complications (cardiovascular) – relative effects less than 1 favour EVAR | ||||||||||
| 7k | V seriousb | Not serious | Not seriousi | No serious | 138,692 | 124,481 | OR = 0.35 (0.27 to 0.45) | 88 per 1,000j | 55 fewer per 1,000 (46 to 63 fewer) | VERY LOWe |
| Perioperative complications (respiratory) – relative effects less than 1 favour EVAR | ||||||||||
| 5l | V seriousb | Not serious | Not seriousi | No serious | 134,633 | 120,345 | OR = 0.20 (0.14 to 0.29) | 175 per 1,000j | 134 fewer per 1,000 (117 to 146 fewer) | VERY LOWe |
| Perioperative complications (renal) – relative effects less than 1 favour EVAR | ||||||||||
| 6m | V seriousb | Not serious | Not seriousi | No serious | 134,724 | 120,436 | OR = 0.29 (0.22 to 0.38) | 81 per 1,000j | 55 fewer per 1,000 (47 to 62 fewer) | VERY LOWe |
| Length of critical care stay (days) – relative effects less than 0 favour EVAR | ||||||||||
| 2n | V seriousb | Not serious | Not serious | No serious | 1,446 | 6,131 | MD = 1.61 shorter (1.38 to 1.84 shorter) | 3.4 daysd | 1.8 days (1.5 to 2.0 days) | VERY LOWe |
| Total length of hospital stay (days) – relative effects less than 0 favour EVAR | ||||||||||
| 4o | V seriousb | Not serious | Not seriousi | No serious | 132,337 | 121,319 | MD = 5.67 shorter (5.11 to 6.22 shorter) | 10.5 daysd | 4.8 days (4.3 to 5.4 days) | VERY LOWe |
| Discharge to location other than home – relative effects less than 1 favour EVAR | ||||||||||
| 3p | V seriousb | Not serious | V seriousc | No serious | 131,779 | 120,761 | OR = 0.31 (0.25 to 0.38) | 175 per 1,000q | 113 fewer per 1,000 (100 to 125 fewer) | VERY LOWe |
| Post-perioperative survival – relative effects less than 1 favour EVAR | ||||||||||
| 10r | V seriousb | Not serious | V seriousc | No serious | 55,523 | 54,104 | HR = 1.24 (1.13 to 1.35) | 441 surviving per 1,000 at 10 yearss | 79 fewer per 1,000 (45 to 110 fewer) | VERY LOW |
| Reinterventions (all or unspecified) – relative effects less than 1 favour EVAR | ||||||||||
| 8t | V seriousb | Not serious | V seriousc | No serious | 59,746 | 62,408 | HR = 1.54 (1.21 to 1.96) | 206 per 1,000 at 8 yearsu | 93 more per 1,000 (38 to 158 more) | VERY LOW |
| Reinterventions (vascular) – relative effects less than 1 favour EVAR | ||||||||||
| 3v | V seriousb | Not serious | V seriousc | No serious | 43,190 | 47,875 | HR = 2.90 (1.49 to 5.65) | 37 per 1,000 at 8 yearsu | 67 more per 1,000 (18 to 155 more) | VERY LOWe |
| Reinterventions (non-vascular) – relative effects less than 1 favour EVAR | ||||||||||
| 1w | Seriousx | Not serious | N/A | No serious | 39,966 | 39,966 | HR = 0.38 (0.36 to 0.40) | 177 per 1,000 at 8 yearsu | 106 fewer per 1,000 (102 to 109 fewer) | LOWy |
- a
Chadi et al. (2012), Choke et al. (2012), Hicks et al. (2015), Hua et al. (2005), Huang et al. (2015), Jetty et al. (2010), Johnson et al. (2006), Karthikesalingam et al. (2016) [UK], Karthikesalingam et al. (2016) [USA], Lee et al. (2004), Liang et al. (2018), Lo et al. (2013), Malas et al. (2014), Mark et al. (2013), Quintana et al. (2019), Salata et al. (2019), Schermerhorn et al. (2015) [2001–2004 cohort], Schermerhorn et al. (2015) [2005–2008 cohort], Sugimoto et al. (2017), Symonides et al. (2018), Tarbunou et al. (2019)
- b
Majority of studies at high risk of bias
- c
I2 > 66.7%
- d
Source: UK National Vascular Registry (2017)
- e
Eligible for uprating, owing to large effect size, but cancelled out by multiple other reasons for downgrading
- f
Sugimoto et al. (2017)
- g
Source: EVAR-1 (Brown et al., 2012)
- h
Hua et al. (2005), Huang et al. (2015), Johnson et al. (2006), Locham et al. (2018b), Raval et al. (2012), Schwarze et al. (2009)
- i
High I2, but all estimates agree there is a large effect; hence, no downgrading because statistical inconsistency is not important for decision uncertainty
- j
Source: Schwarze et al. (2009)
- k
Feringa et al. (2007), Huang et al. (2015), Liang et al. (2018), Nguyen et al. (2013), Salata et al. (2019), Schermerhorn et al. (2015), Schwarze et al. (2009)
- l
Huang et al. (2015), Liang et al. (2018), Nguyen et al. (2013), Schermerhorn et al. (2015), Schwarze et al. (2009)
- m
Huang et al. (2015), Liang et al. (2018), Nguyen et al. (2013), Schermerhorn et al. (2015), Schwarze et al. (2009), Zabrocki et al. (2018)
- n
Huang et al. (2015), Jetty et al. (2010)
- o
Huang et al. (2015), Jetty et al. (2010), Schermerhorn et al. (2015), Schwarze et al. (2009)
- p
Jetty et al. (2010), Schermerhorn et al. (2015), Schwarze et al. (2009)
- q
Derived from Karthikesalingam et al. (2016) [UK cohort]
- r
Behrendt et al. (2017), de la Motte et al. (2013), Huang et al. (2015) [2000–2005 cohort], Huang et al. (2015) [2006–2011 cohort], Mark et al. (2013), Salata et al. (2019), Schermerhorn et al. (2015) [2001–2004 cohort], Schermerhorn et al. (2015) [2005–2008 cohort], Sugimoto et al. (2017), Symonides et al. (2018)
- s
Derived from EVAR-1 – 10-year survival conditional on surviving 30 postoperative days
- t
Chang et al. (2015), Huang et al. (2015), Jetty et al. (2010), Liang et al. (2018), Salata et al. (2019), Schermerhorn et al. (2015) [2001–2004 cohort], Schermerhorn et al. (2015) [2005–2008 cohort], Sugimoto et al. (2017)
- u
Source: Schermerhorn et al. (2015)
- v
Jetty et al. (2010), Schermerhorn et al. (2015), Symonides et al. (2018)
- w
Schermerhorn et al. (2015)
- x
Single study at moderate risk of bias
- y
Uprated for large effect size
F.2. Complex AAA
| No. of studies | Quality assessment | Summary of findings | Quality | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Risk of bias | Indirectness | Inconsistency | Imprecision | No. of patients | Relative effect estimate (95% CI) | Absolute expectation (95% CI) | ||||
| EVAR | OSR | OSR | EVAR | |||||||
| Perioperative mortality – relative effects less than 1 favour EVAR0 | ||||||||||
| 6a | V seriousb | Not serious | Seriousc | V seriousd | 980 | 3,383 | OR = 0.90 (0.41 to 1.98) | 4 more per 1,000 (17 fewer to 46 more) | 35 per 1,000e,f | VERY LOW |
| Duration of procedure (minutes) – relative effects less than 0 favour EVAR | ||||||||||
| 2g | V seriousb | Not serious | Not serioush | Not serious | 365 | 365 | MD = 107.7 shorter (23.9 to 191.5 shorter) | 279 minsi | 171 mins (88 to 255 mins) | VERY LOWj |
| Perioperative complications (all) – relative effects less than 1 favour EVAR | ||||||||||
| 4k | V seriousb | Not serious | V seriousl | V seriousd | 448 | 614 | OR = 0.64 (0.23 to 1.76) | 96 more per 1,000 (96 fewer to 347 more) | 270 per 1,000f,m | VERY LOW |
| Perioperative complications (cardiovascular) – relative effects less than 1 favour EVAR | ||||||||||
| 4k | V seriousb | Not serious | Not serious | Not serious | 448 | 614 | OR = 0.34 (0.21 to 0.55) | 138 more per 1,000 (64 to 233 more) | 92 per 1,000f,f,m | VERY LOWj |
| Perioperative complications (respiratory) – relative effects less than 1 favour EVAR | ||||||||||
| 4k | V seriousb | Not serious | Seriousc | V seriousd | 448 | 614 | OR = 0.50 (0.17 to 1.47) | 47 more per 1,000 (16 fewer to 192 more) | 52 per 1,000f,f,m | VERY LOW |
| Perioperative complications (renal) – relative effects less than 1 favour EVAR | ||||||||||
| 4k | V seriousb | Not serious | V seriousl | V seriousd | 448 | 614 | OR = 0.54 (0.21 to 1.40) | 32 more per 1,000 (11 fewer to 126 more) | 40 per 1,000f,f,m | VERY LOW |
| Length of critical care stay (days) – relative effects less than 0 favour EVAR | ||||||||||
| 2g | V seriousb | Not serious | V seriousc | V seriousd | 365 | 365 | MD = 1.32 shorter (3.9 shorter to 1.3 longer) | 3.1 days (0.5 to 5.7 days) | 1.8 dayse,f | VERY LOW |
| Total length of hospital stay (days) – relative effects less than 0 favour EVAR | ||||||||||
| 1n | V seriousb | Not serious | N/A | Not serious | 263 | 263 | MD = 5.65 shorter (5.2 to 6.1 shorter) | 14.5 days (14.0 to 14.9 days) | 8.8 dayse,f | VERY LOWj |
| Discharge to location other than home – relative effects less than 1 favour EVAR | ||||||||||
| 1n | V seriousb | Not serious | N/A | Not serious | 263 | 263 | OR = 0.23 (0.14 to 0.39) | 125 per 1,000o | 93 fewer per 1,000 (72 to 105 fewer) | VERY LOWj |
| Post-perioperative survival – relative effects less than 1 favour EVAR | ||||||||||
| 2p | V seriousb | Not serious | N/A | Not serious | 143 | 204 | HR = 1.94 (1.15 to 3.27) | 441 per 1,000 surviving at 10 yearsq | 237 fewer per 1,000 (51 to 372 fewer) | VERY LOW |
| Reinterventions (all or unspecified) – relative effects less than 1 favour EVAR | ||||||||||
| 1r | V seriousb | Not serious | N/A | Seriouss | 102 | 102 | HR = 3.02 (0.96 to 9.51) | 206 per 1,000 at 8 yearst | 296 more per 1,000 (7 fewer to 682 more) | VERY LOW |
- a
Fiorucci et al. (2019), Michel et al. (2015), Orr et al. (2017), Raux et al. (2014), Tinelli et al. (2018), Tsilimparis et al. (2013)
- b
Majority of studies at high risk of bias
- c
33.3% < I2 < 66.7%
- d
95% confidence interval encompasses meaningful benefit for either EVAR or OSR
- e
Source: National Vascular Registry (2017)
- f
EVAR preferred as baseline option as more reliable data available
- g
Orr et al. (2017), Tinelli et al. (2018)
- h
High I2, but all estimates agree there is a large effect; hence, statistical inconsistency is not important for decision uncertainty
- i
Weighted average of OSR arms in included studies
- j
Eligible for uprating, owing to large effect size, but cancelled out by reasons for downgrading
- k
Fiorucci et al. (2019), Orr et al. (2017), Raux et al. (2014), Tinelli et al. (2018)
- l
I2 > 66.7%
- f,m
Source: Roy et al. (2017)
- n
Orr et al. (2017)
- o
Derived from Karthikesalingam et al. (2016) [UK cohort] (in absence of long-term data specific to complex AAA)
- p
Fiorucci et al. (2019), Tinelli et al. (2018)
- q
Source: EVAR-1 - 10-year survival conditional on surviving 30 postoperative days (in absence of long-term data specific to complex AAA)
- r
Tinelli et al. (2018)
- s
95% confidence interval encompasses meaningful harm for EVAR and no difference
- t
Source: Schermerhorn et al. (2015) (in absence of long-term data specific to complex AAA)
- GRADE tables - Observational evidence on the effectiveness of endovascular aneur...GRADE tables - Observational evidence on the effectiveness of endovascular aneurysm repair compared with open surgical repair of unruptured abdominal aortic aneurysms
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