dr alex chase
DESCRIPTION
Bleeding Matters and How to Avoid It the radial approach. Dr Alex Chase. R ad I al V s. femor AL access for coronary intervention in patients with acute coronary syndromes study. 2006-2010. anecdotes. Fact 1. Bleeding is Bad. Fact 2 Radial reduces bleeding and transfusion. - PowerPoint PPT PresentationTRANSCRIPT
Dr Alex Chase
Bleeding Matters and How to Avoid It
the radial approach
RadIal Vs. femorAL access for coronary intervention in patients with acute coronary syndromes study
2006-2010
hypothesis generating
unknowns
facts
anecdotes
Bleeding is Bad
Fact 1
Fact 2Radial reduces bleeding and transfusion
•PRCTrials: SYNERGY 9,404 pts Cantor et al CCI 2007;69:73
•Meta-analyses: 1,371 pts Agostoni et al. JACC 2004;44 349
Jolly et al Canadian CC 2008
•real life registries: 593,094 pts Rao et al JACCintv 2008 1
32,822 pts Chase et al Heart 2008
The evidence is conclusive
50-70%6mm 2mm
hypothesis
generating
unknowns
facts
So…..If bleeding is bad& 50-70% access site related…
and radial access reducesbleeding........
Does radial access reduce 30 & 1 year mortality?
39,386 PCI procedures Jan 1999 to Dec 2005 in 32822patients
311 CABG in 10 days
7,972 radial access(20.6%)
30,900 femoral access(79.4%)
transfusion859
(2.8%)
no transfusion
30,041 (97.2%)
43 brachial access37 not
entered
transfusion108
(1.4%)
no transfusion
7,864 (98.6%)
1 year mortality
1,018 (3.4%)
1 year mortality
195(22.7%)
1 year mortality
198(2.5%)
1 year mortality
26(24.1%)
123 repeat procedures same day
30 day mortality
9(8.3%)
30 day mortality
69(0.9%)
30 day mortality
113(13.2%)
30 day mortality
407(1.4%)
38,872 procedures for analysis
M.O.R.T.A.L STUDY(Mortality benefit Of Reduced Transfusion after PCI via the Arm or Leg)
Chase et al Heart 2008
MORTAL: log regression (n=39,386)
• age, sex, BMI, stroke, stable angina, emergency PCI, prior MI, PCI & CABG, diabetes, co-morbidities & creatinine
• reduction in transfusion radial v femoralOR 0.56 95% CI 0.45-0.69, p<0.0001
• increase in 1 year mortality if transfusedOR 3.74 95% CI 3.12-4.47, p<0.0001
OR 0.83 95% CI 0.71-0.98, p<0.001• reduction in 1 year mortality radial v femoral
Chase A, Hilton JD et al, Heart 2008
Oasis 5M
AC
E&
BL
EE
DIN
G
End point Odds ratio (95% CI)
Major bleeding 0.27 (0.16–0.45)
Death, stroke, or MI 0.71 (0.49–1.01)
Death 0.74 (0.42–1.30)
MI 0.76 (0.09–1.75)
Access-site crossover 3.82 (2.83–5.15)
PCI failure 1.31 (0.87–1.96)
Jolly S. Canadian Cardiovascular Congress. October 25-29, 2008; Toronto, ON.
21 study meta-analysis, >5600 ptsradial vs femoral
70%
trend
RIVIERA Study
• 7962 patients, 144 hospitals, 23 countries, 1 year
• prospective study consecutive patients
• 92% elective, 8% primary PCI (not NSTEMI)
• 10.6% via radial, 3.4% any bleeding
Montalescot et al 2007
Registry on IntraVenous anticoagulation In the Elective and primary Real world of Angioplasty
RIVIERA Studyindependent predictors of bleeding
Montalescot et al 2007
bleeding: female, graft PCI, IIbIIIa, UFH & LMWHonly radial access reduced bleeding (OR 0.52 CI 0.31-0.89)
RIVIERA Studyindependent predictors of death & MI
Montalescot et al 2007
•radial, clopidogrel pre-Rx & LMWH reduction in
death or MI
PREVAILProspective REgistry of Vascular Access
in Interventions in Lazio region
Heart 2008
•9 hospitals, 30 days, 1,052 consecutive vascular procedures (40% PCI)•509 radial vs 543 femoral. After Adjustment:
primary:In-hospitalmajor & minor bleedsstrokeentry complicationssecondary:In-hospital death/MI
Am J Cardiol 2009;103:796–800
• specifically designed to prospectively assess impact access site
• multi- centre
• 1,170 consecutive patients after ExCr/FU
• end points: death,MI & bleeding in-hospital & 1 year
• 2003 to 2006
• bleeding diathesis
• recent bleed
• anaemia
• co-morbidity<1 year survival
• arterial disease precluding vascular access
positives exclusion criteria
PRESTO-ACS Vascular Substudy
In Hospital Outcomesradial femoral p
bleeding 0.7% 2.4% 0.05death&MI 2.6% 2.9% 0.79Net Outcome 3.3% 4.6% 0.30
1 Year Outcomesradial femoral p
bleeding 0.7% 2.7% 0.03death&MI 4.9% 8.3% 0.05Net Outcome 5.5% 9.9% 0.02
Am J Cardiol 2009;103:796–800
GpIIbIIIa Use 52% 34% 0.0001
hypothesis generating
unknowns
facts
anecdotes
ObservationalRetrospective
Statistics/voodoo
UnknownsWhat are possible explanations?
No causalityBleeding is a marker of high risk and poor outcomeOutcome is NOT because of the bleedPoor ‘pedigree’ or protoplasmRadial vs femoral result from chance, confounding (poor risk adjustment)
Femoral bleeds kill patientsBleed to deathBleeding causes ischaemic events
Our management of bleeding causes ischaemic events
Antiplatelet cessationTransfusion with old blood
Yes bleeding can cause death/ischaemic events but it’s GI or intracranial, not access bleeds –these are just a nuisance
Our management of ischaemia differs because of bleeding riskMore adjunct IIbIIIa in radials
hypothesis generating
unknowns
facts
anecdotes
ObservationalRetrospective
Statistics/voodoo
What Is The Evidence Linking Access Bleeds to Adverse Cardiac
Events?
Access site haematoma requiring transfusion predicts mortality
Data from the National Heart, Lung, and Blood Institute Dynamic RegistryN=6,656Overall 120 (1.8%) patients had access site haematoma requiring transfusionOver 50% of the PCIs were elective
Yatskar et al. CCI 2007;69: 961
Retrospective Analysis Of the Bivalirudin Trials: Type Of
Bleeding• TIMI major/minor 30-day bleeding dataset from the
REPLACE-2, ACUITY and HORIZONS-AMI trials in 17,393 femoral PCI patients.
• TIMI major/minor bleeding 5.3% (1.6%/3.7%)• 38.2% of which were only-access site bleeds. • After multivariable adjustment, TIMI bleeding increased risk
of 1-year mortality (HR 3.17 (95%CI 2.51–4.00), p<0.0001).• mortality risk non-access site TIMI bleed
HR 3.94 (95%CI 3.07–5.15), p<0.0001• adjusted mortality risk access site-only TIMI bleed
HR 1.82 (95%CI 1.17–2.83), p=0.008 • adjusted mortality risk non-access site bleed was 2 fold
that of an access site bleed HR 2.27 (95%CI 1.42-3.64), p=0.0007
Verheugt, Steg et alPersonal communication
RE
PL
AC
E2
TIMI minor
TIMI major
NonTIMI
AC
UIT
YH
OR
IZO
NS
Bival Trials
Mehran et alESC 2009
17,002 pts
M.O.R.T.A.L STUDY Chart Review(Mortality benefit Of Reduced Transfusion after PCI via the Arm or Leg)
• 38,952 patients 952 transfusions (2.5%)
• Impact of source of bleeding
121831
% %
SD Robinson 2010 CCS
alive dead
†: p<0.05
M.O.R.T.A.L Study Chart Review
•higher transfusion volumes predicted increased risk of death (OR 1.25 [1.16-1.34], p=0.008)
•patients dying within 30 days more often received blood stored for at least 28 days (65.3 vs 52.9%, p=0.02)
• After adjustment for baseline risk, RBC storageage >28 days (odds ratio 2.46 [95% CI 1.44 –4.21], p=0.001)
•Transfusion of other blood products than RBCs After adjustment for baseline risk, transfusion of platelets (OR 2.27 [95% C.I. 1.17-4.44]) and plasma/cryoprecipitate (OR 4.95 [2.67-9.19]) predicted an increased risk of death at 30 days
SD Robinson 2010 CCSUndoes your anticoag
Robinson 2010 CCS
M.O.R.T.A.L Study Chart Review
transfused alive
non transfuseddead 30 days
transfused dead 30 days
PREVAIL- Internet Only AppendicesProspective REgistry of Vascular Access in Interventions in
Lazio region
Heart 2008
•9 hospitals, 30 days, 1,052 consecutive pts•509 radial vs 543 femoral. After Adjustment:
primary:In-hospitalmajor & minor bleedsstrokeentry complicationssecondary:In-hospital death/MI
bleeds- femoral access site• 1 death directly from femoral access bleed• 2 other major bleeds requiring transfusion• 4 pseudoaneurysms, 2 x AV fistula• 1 x stroke• 15 minor bleeds 1-10cm haematoma without transfusion
bleeds radial access• 1 spontaneous RP haematoma (prosthetic valve) – death• no major access bleeds• zero transfusions• 6 minor bleeds 0-5cm haematoma without transfusion
9 hospitals, 30 days, 1,052 consecutive pts509 radial vs 543 femoral
PREVAILBreakdown - Complex Composite
End Point Per Treatment
Heart 2008
Massive haematoma
NSTEMIdeath
PREVAIL Ischemic Endpoint- Adjunct
Therapy Hypothesis
stable ACS
ischemic endpoint
(death & MI)
IIbIIIa use radial 15% vs femoral 8%, p=0.002
Heart 2008
Vascular Closure Devices Birmingham 2004-2005
1214 PCI (1077 fem:137 radial)
15 vascular complications 1.2%transfusion 0.64% femoral PCI n=7, 1077 Routledge, Ludman et al
? impactspeculative calculation
• difference transfusion rate 2.8 -1.4%=1.4%
• if save 3 patients transfusions / 200 PCI
• need to prevent 7.4 transfusions to save 1 life @ 1 year
• ? 1’avoided death’ / 500 cases
• ? diagnostic angiograms1.5 x106
74,000
Chase et al Heart 2008
Bleeding Matters and How to Avoid It
the radial approach• Increased patient comfort
• Early ambulation
• Reduced hospital stay
• Reduced vascular complications
• Reduced Nursing requirements
• Reduced cost
hypothesis generating
unknowns
facts