Clinical trials Flashcards
CLOT 2003
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
CLEVER 2011
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
ICSS 2015
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
CAVENT 2012
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
INSTEAD XL 2013
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
STABLE 2012
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
RELACS 2015
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
INPACT SFA 2015 (2018 3 years)
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
NASCET high grade stenosis 1991
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
ERASE 2015
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
WAVE 2007
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
STAR 2009
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
ASTRAL 2009
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
CORAL 2014
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
STILE 1994
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
TOPAS 1998
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
Rochester 1994
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
CREST 10 year 2016
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
CREST 2010
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
ACT-1 2016
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
CREST by symptomatic status 2011
1321 symptomatic
1181 asymptomatic
Stroke + death:
Symp: 6 vs 3.2%
Asymp: 2.5 vs 1.4%
ACST 2004 (2010 10 year)
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
ADAM 2002
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
BASIL 2005
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
