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Clinical trials Flashcards

1
Q

CLOT 2003

A

Dalteparin vs coumarin for DVT with cancer
GROUP 1: Dalt 200IU/kg x 1 week then coumarin
GROUP 2: Dalt 200 x 1 month then 150 x 5 months

1) Dalt hazard ratio 0.48
2) recurrent VTE 9 vs 17%
3) major bleed same
4) mortality same

CONCLUSION: dalteparin more effective in VTE in cancer

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2
Q

CLEVER 2011

A

Supervised exercise vs stenting for claudication (AIOD)
GROUP 1: optimal medical therapy
GROUP 2: med + exercise
GROUP 3: med + stent

PRIMARY: walking time at 6 months

1) Walking time greatest for exercise, worst for med only
2) QOL best for stent > exercise > med

CONCLUSION: benefit of exercise

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3
Q

ICSS 2015

A

stent vs CEA for symptomatic RCT
GROUP 1: stent 855
GROUP 2: CEA 858

PRIMARY: fatal/disabling stroke any territory

1) intent to treat
2) Fatal/disabling stroke at 5 years 6.4 vs 6.5%
3) Any stroke 15.2% vs 9.4% (favor CEA)

CONCLUSION: long term outcome similar

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4
Q

CAVENT 2012

A

TPA vs AC only for iliofemoral DVT
Norway hospitals
GROUP 1: AC control 108
GROUP 2: tpa CDT 101

PRIMARY: Villalta score at 24 months; patency at 6 months
INTENT TO TREAT

1) Age 18-75
2) first time iliofemoral DVT
3) 55.6% vs 41.4% PTS at 24 mth favour CDT
4) 47.4% vs 65.9% patency at 6 months favour CDT
5) bleeding with CDT: 20% bleed, 3% major

CONCLUSION: consider CDT in low risk bleed

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5
Q

INSTEAD XL 2013

A

Endo in TBAD
GROUP 1: TEVAR 72
GROUP 2: med only 68

PRIMARY: long term 2-5 years outcome
INTENT TO TREAT

1) all cause mortality 11.1 vs 19.3%
2) aorta-specific mortality 6.9 vs 19.3%
3) disease progression 27% vs 46.1%
4) false lumen thrombosis
5) false lumen thrombosis in TEVAR 90.6%

CONCLUSION: TEVAR in stable TBAD with suitable anatomy

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6
Q

STABLE 2012

A

Graft + dissection stent use in complicated TBAD
Single arm COOK device
40 patients

1) acute 60%; subacute 15%; chronic 25%
2) Mortality 30 day 5%
3) Morbidity: 7.5% stroke, 2.5% paraplegia, 5% retrograde dissection, 12.5% renal failure

CONCLUSION: composite TEVAR viable

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7
Q

RELACS 2015

A

Varicose vein endo vs strip 5 years
GROUP 1: EVLA
GROUP 2: high ligation + strip

PRIMARY: clinical, duplex, QOL, satisfaction 5 yaer

1) recurrence of varicose veins 45 vs 54%
2) same site recurrence 18 vs 5% worse in EVLA
3) new site recurrence 31 vs 50% worse in strip
4) raphenofemoral reflux occurrence 28 vs 5% worse in EVLA

CONCLUSION: clinical outcome similar, but same site recurrence worse in EVLA

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8
Q

INPACT SFA 2015 (2018 3 years)

A

DCB in fempop lesion
GROUP 1: DCB (2:1 randomization to total 331)
GROUP 2: POBA

PRIMARY: 24 month patency, CD-TLR, major adverse, QOL, walking

1) patency: 78.9 vs 50.1%
2) CD-TLR: 9.1% vs 28.3%
3) mortality: 8.1% vs 0.9%
4) vessel thrombosis: 1.5 vs 3.8%
5) Functionally same at 2 years: DCB needs less reintervention
6) 3 year: DCB patency 69.5 vs 45.1%
7) 3 year CD-TLR: 15.2 vs 31.1%
8) Functionally still same at 3 years but DCB less reintervention

CONCLUSION: DCB has better patency, needs less reintervention but same QOL

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9
Q

NASCET high grade stenosis 1991

A

CEA vs med in 70-99% stenosis
GROUP 1: CEA 328
GROUP 2: med only 331

1) any ipsilateral stroke at 2 years 9% vs 26% (ARR 17; NNT 5.8)
2) major ipsilateral stroke 2.5% vs 13.1% (ARR 10.6; NNT 9.6)

CONCLUSION: CEA is beneficial in symptomatic high grade stenosis

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10
Q

ERASE 2015

A

endo vs exercise for PAD IC
GROUP 1: endo selective stent 106
GROUP 2: exercise only 106

PRIMARY: max treadmill 12 months

1) better walking distance in endo
2) pain free walking better in endo
3) better QOL in endo

CONCLUSION: endo treatment in claudication is better at 12 months than exercise alone

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11
Q

WAVE 2007

A

AC and antiplatelet in PAD
GROUP 1: AC (warfarin) + antiplatelet 1080
GROUP 2: antiplatelet alone 1081

PRIMARY: MI, stroke, death

1) endpoint at mean 35 months: 12.2 vs 13.3%
2) bleeding 4 vs 1.2%

CONCLUSION: in PAD, adding AC (warfarin) is not better and can increase bleeding

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12
Q

STAR 2009

A

Renal stent in stenosis and impaired function
GROUP 1: stent 64
GROUP 2: med only 76

Inclusion: GFR < 80; stenosis > 50%

PRIMARY: >20% decrease in GFR

1) GFR drop: 16% vs 22% (not sig)
2) Mortality from stent 3%

CONCLUSION: do not stent

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13
Q

ASTRAL 2009

A

revasc vs med in renal stenosis
GROUP 1: revasc
GROUP 2: med only

inclusion: atherosclerotic renal disease

PRIMARY: renal function at 5 years

1) GFR drop less in revasc
2) No difference in SBP
3) 23 patients with serious complications from procedure

CONCLUSION: revasc has risk and no proven clinical significant benefit

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14
Q

CORAL 2014

A

Stenting vs med therapy in renal artery stenosis
GROUP 1: stenting
GROUP 2: med only

Inclusion: renal artery stenosis AND (HTN with 2+ antiHTN drug or CKD)

PRIMARY: death, MI, stroke, renal replacement

1) no difference in composite endpoint: 35.1 vs 35.8%
2) modest difference in SBP lowering

CONCLUSION: renal artery stenting no sig benefit

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15
Q

STILE 1994

A

Surgery vs thrombolysis for LE ischemia
GROUP 1: surgery
GROUP 2: CDT (tpa, UK)

Inclusion: native or bypass occlusion

PRIMARY: death, ischemia, amputation, morbidity

1) ischemia < 14 days did better with TPA
2) ischemia > 14 days did better with surgery
3) fibrinogen depletion predicted hemorrhagic complications

CONCLUSION: 2 week cut off for TPA vs surgery

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16
Q

TOPAS 1998

A

Surgery vs UK tpa in acute obstruction < 14 days
GROUP 1: surgery
GROUP 2: UK first then surgery/endo

1) amputation free survival 74.8 vs 71.8% at 6 months
2) amputation free survival 69.9 vs 65% at 6 months
3) hemorrhage 5.5 vs 12.5%
4) intracranial hemorrhage 1.6% in UK group
5) UK reduce need for surgery

CONCLUSION: risk of brain hemorrhage but does reduce need for surgery with no difference in outcome

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17
Q

Rochester 1994

A

TPA vs revasc in ALI
GROUP 1: surgery 57
GROUP 2: UK 57

inclusion: <7 days of ALI

PRIMARY: limb salvage, survival

1) TPA success 70%
2) survival 12 months 58 vs 84% favour TPA

CONCLUSION: tpa reduces complications and drives reduction in mortality

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18
Q

CREST 10 year 2016

A

symp + asymp carotid stenosis stent vs CEA
GROUP 1: CAS
GROUP 2: CEA
total 2502 patients

PRIMARY: composite MI, stroke, death

1) primary no difference 11.8 vs 9.9%
2) post-procedural ipsilateral stroke 6.9 vs 5.6%

CONCLUSION: no difference between the two

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19
Q

CREST 2010

A

Symp + asymp for CAS vs CEA
GROUP 1: CAS
GROUP 2: CEA
total 2502 patients

PRIMARY: MI, stroke, death within 4 year

1) primary no difference 7.2 vs 6.8%
2) stroke 6.4 vs 4.7% significant
3) stroke in symptomatic 8 vs 6.4% significant
4) stroke in asymptomatic 4.5 vs 2.7% significant
5) death 0.7 vs 0.3%
6) stroke 4.1 vs 2.3%
7) MI 1.1 vs 2.3%
8) after periprocedural period, stroke rate same

CONCLUSION: no difference in composite; CAS bad for stroke, CEA bad for MI
funded by Abbott

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20
Q

ACT-1 2016

A

CAS with embolic protection vs CEA - asymptomatic
GROUP 1: CAS with embolic protection
GROUP 2: CEA

PRIMARY: death, stroke, MI at 30 days

1) Primary 3.8 vs 3.4%
2) stroke/death 2.9 vs 1.7%

CONCLUSION: stenting non-infeior to endarterectomy and no difference in stroke
funded by Abbott

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21
Q

CREST by symptomatic status 2011

A

1321 symptomatic
1181 asymptomatic

Stroke + death:
Symp: 6 vs 3.2%
Asymp: 2.5 vs 1.4%

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22
Q

ACST 2004 (2010 10 year)

A

Asymptomatic carotid stenosis
GROUP 1: CEA immediately
GROUP 2: med + deferral of CEA 4% got it

PRIMARY: 5 year stroke risk

1) risk of stroke within 30 day of CEA = 3.1%
2) 5 year stroke 3.8 vs 11% (excluding periop)
3) combine 5 year with periop: 6.4 vs 11.8%
4) combine 5 year with periop: disabling only 3.5 vs 6.1%
5) age of benefit: <65 and in 65-74
6) stenosis of benefit: 70, 80, 90%
7) combine 10 years with periop: 13.4 vs 17.9%

CONCLUSION: patients < 75 with carotid >70% stenosis, CEA reduces stroke at 5 year from 12 to 6% (includes the perioperative stroke) and 18 to 13% at 10 years

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23
Q

ADAM 2002

A

repair vs surveillance of small AAA
GROUP 1: immediate repair (569)
GROUP 2: surveillance q 6 months until 5.5 (567)

Inclusion: AAA 4-5.4cm; age 50-79

1) any death - no difference
2) operative mortality 2.7%
3) aneurysm related death 3 vs 2.6% same
4) rupture in surveillance 0.6%/year

CONCLUSION: overall survival outcome not different; does not justify fixing small aneurysms

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24
Q

BASIL 2005

A

Bypass vs angioplasty
GROUP 1: surgery first 228
GROUP 2: angioplasty first 224

PRIMARY: 6 months outcome

1) no difference in amputation free survival
2) no difference in health related QOL
3) cost in 1st year higher in surgery

CONCLUSION: no real difference except for cost in 1 year
bypass after failed angio is worse than bypass primarily
prosthetic bypass worse than angioplasty
women do better with surgery in long term
if more than 2 year life expectancy then should do bypass

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25
Q

CADISS 2015

A

Antiplatelet vs AC for cervical artery dissection
GROUP 1: antiplatelet x 3 months (126)
GROUP 2: anticoagulation x 3 months (124)

Inclusion: carotid or vert dissection within 7 days

1) stroke 2 vs 1%
2) no death
3) one bleed in anticoagulation

CONCLUSION: no difference in either

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26
Q

CLASS 2014

A

Foam vs EVLT vs surgery in varicose veins
GROUP 1: foam
GROUP 2: EVLT
GROUP 3: surgery

1) quality of life worse after foam
2) procedural complication lowest in EVLT
3) clinical success similar
4) main trunk ablation worse with foam

CONCLUSION: EVLT had least complications with similar outcomes

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27
Q

COBEST 2011

A

covered vs bare stent AIOD
GROUP 1: covered stent
GROUP 2: bare stent

PRIMARY: freedom from restenosis and stent occlusion at 1, 6, 12, 18 months

1) hazard ratio for restenosis 0.35 with covered stent
2) occlusion - not stat different
3) difference in restenosis only in TASC C and D, not A, B

CONCLUSION: covered stent for TASC C and D

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28
Q

DREAM 2010

A

6 year result open vs EVAR
GROUP 1: OPEN 178
GROUP 2: EVAR 173

PRIMARY: death, reintervention; good surgical candidates

1) survival 69.9 vs 68.9
2) freedom from reintervention 81.9 vs 70.4%

CONCLUSION: higher rate of reintervention for EVAR with same survival

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29
Q

ECST 1998

A

symptomatic carotid stenosis CEA vs med
GROUP 1: CEA 1811
GROUP 2: control 1213

Inclusion: symptom within 6 months and stenosis

PRIMARY: stroke or death

1) stroke/death: 37 vs 36.5%
2) stroke/death of surgery 7%
3) stroke/death without surgery: worse above 70-80% stenosis
4 ) > 80% stenosis: 14.9% vs 26.5% at 3 years

CONCLUSION: CEA good for symptomatic stenosis > 80%

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30
Q

EVA-3S 4 year 2008

A

CEA vs CAS in symptomatic severe carotid stenosis
GROUP 1: CEA 262
GROUP 2: CAS 265

Inclusion > 60% symptomatic stenosis

Primary: any stroke/death

1) 30d stroke/death any higher in CAS
2) stroke/death 4 year: 6.2 vs 11.1%
3) after periprocedural time, difference is similar

CONCLUSION: need to improve periprocedural risks of CAS

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31
Q

EVAR-1 2010

A

EVAR vs OPEN
GROUP 1: OPEN 626
GROUP 2: EVAR 626

PRIMARY: death, complication, reintervention, cost

1) 30d mortality: 4.3 vs 1.8%
2) any cause mortality long terms - no difference
3) graft related complication higher in EVAR

CONCLUSION: EVAR cost more has more complications and reinterventions without mortality benefit

32
Q

EVAR-2 2005

A

EVAR vs med only
GROUP 1: EVAR 166
GROUP 2: med 172

PRIMARY: all cause mortality

1) 30d operative mortality 9%
2) rupture rate 9/100 person years
3) no difference in all cause mortality
4) no difference in aneurysm-related mortality

CONCLUSION: EVAR did not improve survival and associated with increased cost

33
Q

GALA 2008

A

General vs local anesthesia for CEA
GROUP 1: general 1753
GROUP 2: local 1773

PRIMARY: stroke, MI, death

1) primary outcome: 4.8 vs 4.5% no difference

CONCLUSION: no definitive difference

34
Q

IMPROVE 2014 (2017 3 year)

A

EVAR vs open in rupture
GROUP 1: EVAR 316
GROUP 2: open 297
Intent to treat

PRIMARY: 30d mortality

1) 35.4 vs 37.3%
2) women benefit from EVAR
3) EVAR has higher discharge to home 94 vs 77%
4) cost cheaper in EVAR
5) 3 YEAR: mortality 42 vs 54% better in EVAR
6) 3 YEAR: reintervention same
7) EVAR better QALY, less LOS

CONCLUSION: EVAR did not improve survival at 30 d but yes at 3 year; cost effective for QALY gains

35
Q

OVER 2009

A

EVAR vs OPEN in elective AAA
GROUP 1: EVAR 444
GROUP 2: open 437

1) periop mortality 0.5 vs 7%
2) procedure time shorter in EVAR 2.9 vs 3.7
3) blood loss less 200 vs 1000
4) shorter ICU and LOS
5) benefit of periop mortality sustained to 3 years
6) long term mortality comparable
7) survival benefit of EVAR more pronounced in younger patients!

CONCLUSION: similar long term survival; perioperative advantage sustained for few years

36
Q

PIVOTAL 2010

A

EVAR vs surveillance in small aneurysms
GROUP 1: EVAR 366
GROUP 2: surveillance 362

Inclusion: 4-5 cm AAA

PRIMARY: rupture, aneurysm death, overall mortality 2 years

1) mortality 4.1% in both groups
2) mortality after EVAR 1%
3) rupture or aneurysm related death 0.6% in both groups

CONCLUSION: both are safe alternatives up to 3 years

37
Q

RESCAN 2013

A

Surveillance interval for small AAA - metaanalysis

1) every 0.5 cm increase in diameter, growth increase by 0.59 mm/year and rupture rate double
2) 3cm - 7.4 years surveillance
3) 5cm - 8 months interval

38
Q

SAPPHIRE 2004 (2008 long term)

A

CAS with embolic protection vs CEA in high risk patients
GROUP 1: CAS
GROUP 2: CEA

Inclusion: 50% symptomatic or 80% asymptomatic

PRIMARY: death, stroke, MI

1) primary: 12.2 vs 20.1% favour CAS
2) less revasc needed in CAS

CONCLUSION: non inferior up to 3 year

39
Q

SPACE 2008

A

CAS with embolic protection vs CEA in symptomatic carotid
GROUP 1: CAS 613
GROUP 2: CEA 601

Inclusion: > 70% symptomatic

PRIMARY: 2 year; include recurrent stenosis of 70%

1) ipsilateral stroke at 2 year 9.5 vs 8.8 no difference
2) restenosis 10.7 vs 4.6% worse in stenting

CONCLUSION: no difference in stroke at 2 years but worse restenosis

40
Q

UK small aneurysm 1998

A

OPEN vs surveillance of small aneurysms (4-5.5cm)
GROUP 1: OPEN 563
GROUP 2: surveillance 527

PRIMARY: mortality 5 years

1) no difference in mortality long term 2,4,6 years
2) 30 ay operative mortality 5.8%

CONCLUSION: do not operate on small aneurysms

41
Q

VIASTAR 2013

A

Viabahn vs bare stent
GROUP 1: viabahn 72
GROUP 2: bms 69

PRIMARY: 1, 6, 12 months

1) 12 month primary patency 70.9 vs 55.1%
2) freedom from TLR 84.6 vs 77%
3) ABI 0.94 vs 0.85

CONCLUSION: Viabahn benefit in lesion > 20 cm and perhaps in all lesion

42
Q

VIBRANT 2013

A

Viabahn vs bare stent
GROUP 1: Viabahn 72
GROUP 2: BMS 76

PRIMARY: patency, QOL up to 36 months

1) primary patency 24.2 vs 25.9
2) stent fracture 2.6 vs 50
3) primary assisted patency 69.8 vs 88.8 (worse with viabahn)
4) secondary patency 79.5 vs 89.3
5) no difference in mortality and amputation

CONCLUSION: comparable results

43
Q

Zilver PTX 5 year 2016

A

DES vs POBA
GROUP 1: DES
GROUP 2: POBA then secondary randomization BMS vs DES

Inclusion: 91% claudication

PRIMARY: event free survival, patency for 5 years

1) Freedom from symptoms 79.8 vs 59.3%
2) patency 66.4 vs 43.4%
3) provisional stenting better too

CONCLUSION: DES shows durable improvements

44
Q

INPACT DEEP 2014

A

DCB vs POBA in infrapopliteal
GROUP 1: DCB
GROUP 2: POBA

PRIMARY: CD-TLR 12 months, late lumen loss

1) 9.2% vs 13.1% for CD-TLR no difference
2) lumen loss no difference
3) major amputation 12 months DCB 8.8 vs 3.6%

45
Q

INSTEAD 2009

A

TEVAR vs med in TBAD
GROUP 1: TEVAR 72
GROUP 2: med only 68

PRIMARY: all cause death 2 years

1) no difference in 2 years of mortality
2) no difference in aortic related death
3) Aortic remodelling 91.3 vs 19.4%

CONCLUSION: no survival benefit at 2 years but better remodelling

46
Q

EUCLID 2016

A

Ticagrelor vs Clopidogrel in symptomatic PAD
GROUP 1: ticagrelor
GROUP 2: clopidogrel

Inclusion ABI < 0.8 and had revasc

Primary: death, MI, stroke

1) Primary 10.8 vs 10.6%
2) Acute ischemia 1.7% in both groups
3) bleeding 1.6% in both groups

CONCLUSION: no difference between the two

47
Q

ATTRACT 2017

A

pharmacomechanical CDT for DVT
GROUP 1: CDT
GROUP 2: AC only

Inclusion: acute proximal DVT

PRIMARY: post thrombotic syndrome up to 24 months

1) no difference in PTS 47 vs 48%
2) bleeding risk 1.7 vs 0.3% significant
3) recurrent DVT 12 vs 8% no difference
4) moderate to severe PTS more common in AC 18 vs 24%
5) Villalta severity score better in CDT
6) QOL no difference

CONCLUSION: CDT did not reduce PTS but increases bleed risk

48
Q

MAJESTIC 3 year 2017

A

Eluvia single arm

PRIMARY: patency, TLR

1) Primary patency 83.5% 2 years
2) freedom from TLR 85.3% 3 years

CONCLUSION: reasonable option

49
Q

EVRA 2018

A

Early endo ablation in venous ulcer
GROUP 1: early endo
GROUP 2: compression only or late endo

PRIMARY: ulcer heal time

1) faster to heal in endo group 56 vs 82 days
2) rate of healing 85.6 vs 76.3%
3) freedom from ulcer 306 vs 278 days

CONCLUSION: endo ablation results in faster healing

50
Q

ESCHAR 2004

A

Compression vs surgery in venous ulcer
GROUP 1: surgery
GROUP 2: compression

PRIMARY: heal rate 24 weeks; recurrence 12 months

1) similar heal rate 65%
2) recurrence 12% vs 28%

CONCLUSION: surgery reduces ulcer recurrence

51
Q

NASCET substudy intracranial stenosis 1998

A

Intracranial atherosclerotic disease (tandem lesion)

1) risk of stroke in tandem lesion higher RR 1.3 for < 50% pICA stenosis to 1.8 for 85-99% stenosis
2) tandem lesions didn’t increase stroke in CEA group
3) NNT in ICA stenosis with tandem lesions vs without:
50-69% 12 vs 26
70-84% 5 vs 7
85-99% 3 vs 6

CONCLUSION: tandem lesion increases risk of stroke and the value of CEA is enhanced

52
Q

VULCAN 2009

A

silver dressing for venous ulcer
GROUP 1: normal dressing
GROUP 2: silver dressing

PRIMARY: ulcer healing 12 weeks

1) no difference in healing or anything

CONCLUSION: no evidence for routine use of silver dressing

53
Q

Dutch SEPS 2006

A

Endoscopic perforating vein surgery
GROUP 1: compression only
GROUP 2: SEPS and compression

1) healing rate not significant
2) recurrence same
3) ulcer-free % higher in surgery

CONCLUSION: patients with medial or recurrent ulcer should get SEPS

54
Q

EC IC 1985

A

joining superficial temporal to middle cerebral

1) stroke and death 0.6 vs 2.5%
2) no benefit no significant differences

CONCLUSION: not worth

55
Q

AJAX 2013

A

EVAR vs OPEN for ruptured AAA
GROUP 1: EVAR
GROUP 2: OPEN

PRIMARY: death and complication 30 days

1) primary 42 vs 47%
2) mortality 21 vs 25%

CONCLUSION: no difference between the two

56
Q

IMPERIAL 2018

A

Eluvia vs zilver PTX
GROUP 1: ELUVIA
GROUP 2: ZILVER PTX

PRIMARY: primary patency

1) similar efficacy primary 86.8 vs 81.5%

CONCLUSION: non inferior

57
Q

NASCET 1998

A

CEA vs BMT
GROUP 1: CEA
GROUP 2: BMT

Inclusion: stroke/tia within 180 days with < 69% stenosis

PRIMARY: any stroke ipsilateral

1) < 50% stenosis, no significant difference 14.9 vs 18.7%
2) 50-69%: 15.7 vs 22.2%
3) > 70% stenosis; benefit up to 8 years

CONCLUSION: no benefit in < 50%

58
Q

ACAS 1995

A

asymptomatic carotid stenosis CEA VS BMT
GROUP 1: CEA
GROUP 2: BMT

Inclusion > 60% stenosis

PRIMARY: TIA, stroke, death

1) 5 year risk of stroke 5.1% vs 11.0%

CONCLUSION: people with > 60% and good candidate can have surgery if < 3% perioperative morbidity

59
Q

CAPRIE 1996

A

ASA vs plavix in CV outcome
GROUP 1: ASA 325 mg
GROUP 2: PLAVIX 75 mg

PRIMARY: stroke, MI, death

1) 5.82 vs 5.32 % annual risk - significant

CONCLUSION: plavix more effective than ASA without significant bleed risk

60
Q

UK AAA women screen 2002

A

9342 women screened 65-80 years old
Prevalence of AAA 1.3% vs 7.6% in men
Rupture no difference between screened or not screened

CONCLUSION: no point to screen women

61
Q

DANISH AAA screen 2002

A

Screening men is cost-effective and reduces hospital AAA mortality

65-73 years old men

62
Q

MASS screen 2002

A

screening of 65-74 yo men

benefit of screening for AAA in men

63
Q

CAESAR 2010

A

Surveillance vs EVAR for small aneurysms 4.1-5.4
GROUP 1: EVAR 182
GROUP 2: surveillance 178

PRIMARY: all cause mortality

1) no difference in mortality
2) aneurysm related mortality same
3) loss of EVAR feasibility at 3 years is 16.4%
4) 60% require repair at 3 years of surveillance

CONCLUSION: no advantage in mortality but many end up needing surgery and lose ENDO capability

64
Q

DREAM 2004

A

EVAR vs OPEN for AAA elective
GROUP 1: EVAR
GROUP 2: OPEN

PRIMARY: 30 day mortality

1) 1.2% vs 4.6% mortality
2) mortality + complication: 9.8 vs. 4.7%

CONCLUSION: endo better n short term

65
Q

ECAR 2015

A

EVAR vs OPEN in rupture
GROUP 1: EVAR 56
GROUP 2: OPEN 51

PRIMARY: 30 day mortality

1) Delay to treatment: 2.9 vs 1.3 hours
2) mortality no difference at 30d or 1 yr
3) less resp support, less transfusion, less ICU

CONCLUSION: EVAR has same mortality but less complication and less hospital resources

66
Q

ACE 2011

A

EVAR vs OPEN in low-mod risk elective AAA
GROUP 1: EVAR 150
GROUP 2: OPEN 149

1) no difference in mortality 3 years
2) in hospital mortality no difference
3) EVAR has higher reintervention 16 vs 2.4%
4) EVAR has higher aneurysm related mortality 4 vs 0.7%

CONCLUSION: open repair is safe and durable

67
Q

RADAR 2017

A

BMT vs renal stent in hemodynamically relevant stenosis
GROUP 1: BMT
GROUP 2: stent

PRIMARY: GFR at 12 months

1) no difference in GFR
2) clinical event rate no difference
3) 3 year no difference

CONCLUSION: no benefit

68
Q

PRESERVE 2018

A

angiography with Sodium bicarb and acetylcysteine

PRIMARY: death, dialysis, increase Cr

1) no diference in sodium bicarb or acetylcysteine

CONCLUSION: no point

69
Q

ADSORB 2014

A

TEVAR of uncomplicated TBAD
GROUP 1: BMT
GROUP 2: TEVAR

PRIMARY: false lumen patency, aortic dilatation, aortic rupture 1 year

1) Incomplete thrombosis 97 vs 43%
2) false lumen decrease size in TEVAR only
3) true lumen increase in size in TEVAR only
4) total lumen diameter decrease in TEVAR only

CONCLUSION: GORE TAG good for remodelling

70
Q

PREVENT III 2006

A

edifoligide in preventing vein graft failure
GROUP 1: Edifoligide
GROUP 2: placebo

PRIMARY: 1 year patency

1) no difference in primary patency, limb salvage
2) secondary graft patency better 83 vs 78% at 1 year

CONCLUSION: didn’t work

71
Q

Dutch BOA 2000

A

Oral AC vs ASA after bypass surgery
GROUP 1: AC (warfarin)
GROUP 2: ASA

PRIMARY: graft occlusion

1) AC better in vein grafts
2) ASA better in non-venous grafts
3) AC had worse bleeding

CONCLUSION: AC better for venous bypass occlusions

72
Q

MANAGE 2018

A

Dabigatran for MINS
GROUP 1: dabigatran 877
GROUP 2: control 877

PRIMARY: major vascular complication, MI, stroke, mortality, thrombosis, amputation, VTE, bleed

1) primary outcome 11% vs 15% better in dabigatran
2) bleed 3% vs 4%

CONCLUSION: dabigatran after MINS can help lower risk without significant bleed

73
Q

MINS 2018

A

MINS incidence 19.1%
all cause mortality 12.5% vs 1.5% without MINS

74% of patients have MINS but no MI

CONCLUSION: need to measure troponin to identify MINS

74
Q

POISE-2 2018

A

ASA vs placebo in non-cardiac surgery
GROUP 1: ASA
GROUP 2: control

PRIMARY: death + MI at 30 days

1) 13.7% vs 9% worse in ASA not significant

CONCLUSION: perioperative withdrawal of chronic ASA did not increase cardiovascular or vascular occlusive complications

75
Q

COMPASS 2017

A

ASA vs rivaroxaban on CV prevention
GROUP 1: rivaroxaban + ASA
GROUP 2: ASA only
GROUP 3: rivaroxaban only

PRIMARY: death, stroke, MI

1) primary 4.1 vs 5.4 better for rivaroxaban
2) bleeding 3.1 vs 1.9% worse for rivaroxaban
3) no difference in major or fatal bleed
4) mortality 3.4 vs 4.1% better for rivaroxaban

CONCLUSION: combined therapy better but more bleed

76
Q

VOYAGER 2020

A

rivaroxaban vs ASA in PAD revasc
GROUP 1: rivaroxaban + ASA
GROUP 2: ASA only

PRIMARY: ALI, MALE, MI, stroke, death, major bleed

1) primary 17.3 vs 19.9% significantly better for rivaroxaban
2) TIMI bleed 1.87 vs 1.43% worse for rivaroxaban
3) ISTH bleed 5.94 vs 4.06% worse for rivaroxaban

CONCLUSION: rivaroxaban has benefit in primary outcome with some higher bleed

Vascular supplements (3 decks)

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