The document discusses bleeding as a complication of percutaneous coronary intervention (PCI) and antiplatelet therapy, noting that bleeding is associated with significantly increased mortality and morbidity, and that assessing bleeding risk, optimizing vascular access through the radial approach, and tailoring antiplatelet treatment can help address this problem. Major causes of bleeding include access site complications and prolonged dual antiplatelet therapy beyond 6 months without clear benefits.

1. Rencontres Interventionnelles - Transradial Approach
Prague, Czech Republic,
Thursday 29th & Friday 30th September 2011
BLEEDING
IS IT A REAL PROBLEM?
Philip Urban
La Tour Hospital
Geneva, Switzerland

2. BLEEDING: IS IT A REAL PROBLEM?

3. PCI
&
Bleeding
• The
problem
– Nature
and
8ming
– Prognos8c
impact
• The
solu8ons
– Assess
bleeding
risk
prior
to
PCI
– Op8mize
vascular
access
– An8platelet
treatment
• Drugs
• Dose
• Dura8on

4. Circula8on
2011;123:
2736
• Type 1: not actionable
• Type 2: requiring medical intervention and/or admission and/or
evaluation
• Type 3:
– 3a) Hb drop 3-5 g/dl and/or any blood transfusion
– 3b) Hb drop > 5 g/dl, tamponade, surgery or vasoactive treatment
– 3c) Intracranial or intraocular bleeding with vision impairment
• Type 4: CABG related
– chest tubes > 2 liters/24h, transfusion > 5 units
– intracerebral bleed < 48h
– any reoperation for bleeding
• Type 5: fatal

5. Bleeding in patients admitted for AMI
Spencer FA et al Circulation 2007; 116: 2793
MB = 2.8%
10% of all deaths
Access = 29% of MB
40087 patients, GRACE registry

7. Bleeding
and
DAPT
compliance
Wang
T
et
al,
Circula8on
2008;
118:2139
2498 patients from the PREMIER registry: patients with vs. without bleeding

8. Transfusion in ACS
N=24,111 pts from PURSUIT, PARAGON B, GUSTO IIb
Rao SV, et. al., JAMA 2004

9. Number of stent thrombosis major bleedings
15157 patients treated with SES
Weeks after stent implantation
Urban P et al. J Am Coll Cardiol 2011; 57: 1445

10. PCI
&
Bleeding
• The
problem
– Nature
and
8ming
– Prognos8c
impact
• The
solu8ons
– Assess
bleeding
risk
prior
to
PCI
– Op8mize
vascular
access
– An8platelet
treatment
• Drugs
• Dose
• Dura8on

11. %
15157 patients treated with SES – 1 year follow-up
Urban P et al. J Am Coll Cardiol 2011; 57: 1445

12. PCI
&
Bleeding
• The
problem
– Nature
and
8ming
– Prognos8c
impact
• The
solu8ons
– Assess
bleeding
risk
prior
to
PCI
– Op8mize
vascular
access
– An8platelet
treatment
• Drugs
• Dose
• Dura8on

13. Predictors
of
bleeding
in
ACS
Moscucci
et
al
(GRACE)
EHJ
2003;
24:
1815

14. 15157 patients treated with SES – 1 year follow-up CEC-adjudicated events
N= 1238 3339 1234 427 801 675 291 1596 1062 1776 3179 2278
Urban P et al. J Am Coll Cardiol 2011; 57: 1445

15. CCI= Charlson Comorbidity Index
Urban P et al. J Am Coll Cardiol 2011; 57: 1445 Charlson et al., J Chronic Dis 1987; 40:373-83

16. Hb < 117 g/l Hb > 117/l
(n=801) (n=10067)
Major bleeding 3.8% 0.9% <0.001
Any death 6.0% 1.3% <0.001
15147 patients
Myocardial infarction 5.1% 1.9% <0.001
Clinically driven TLR 4.3% 2.1% <0.001
Definite or probable ST 2.6% 0.8% <0.001
15157 patients treated with SES – 1 year follow-up
Urban P et al. J Am Coll Cardiol 2011; 57: 1445

17. PCI
&
Bleeding
• The
problem
– Nature
and
8ming
– Prognos8c
impact
• The
solu8ons
– Assess
bleeding
risk
prior
to
PCI
– Op8mize
vascular
access
– An8platelet
treatment
• Drugs
• Dose
• Dura8on

18. REPLACE-­‐2
Lincoff
AM
et
al
JAMA
2003;
289:853
6010 patients, 100% femoral access
Rao SV et al, JACC 2010

19. NSTEMI
subsets
(PARAGON,
GUSTO,
PURSUIT,
SYNERGY)
100% femoral access
Rao SV et al, JACC 2010

20. Radial
vs.
Femoral
access
Pooled
analysis
of
23
RCT’s
(n=
7020)
Jolly
et
al
AHJ
2009;157:132

21. Lancet 2011;377:1409
• 7021 ACS patients
• Radial vs.femoral access
• Primary EP @ 30 days:
• Death
• MI
• Stroke
• Non CABG bleed

22. Bleeding in the RIVAL trial
Lancet 2011; 377:1409
Fatal
TF of > 2 units
Hb drop > 5 g/dl
Hemodynamic impact
Need for surgery
Lasting sequellae
Intracebral/ocular
* p<0.0001 - Includes large hematomas and surgically treated pseudo-aneurysms

23. PCI
&
Bleeding
• The
problem
– Nature
and
8ming
– Prognos8c
impact
• The
solu8ons
– Assess
bleeding
risk
prior
to
PCI
– Op8mize
vascular
access
– An8platelet
treatment
• Drugs
• Dose
• Dura8on

24. ACUITY
Stone
G
et
al,
NEJM
2008;358:21
P<0.0001
P=0.03

25. NEJM 2007;357:2001
vendredi,
octobre
7,
2011
25

26. HR for protocol-defined major bleeding = 1.04 (0.95-1.13)

27. PRODIGY - Valgimigli et al. ESC 2011

28. PRODIGY - Valgimigli et al. ESC 2011

29. Conclusions
(I)
• Bleeding
during/ader
PCI
is
associated
with
a
significantly
increased
morbidity
and
mortality
• This
is
par8ally
due
to
the
direct
consequences
of
bleeding
(including
medica8on
adjustments,
transfusions,
etc)
but
is
also
explained
by
the
fact
that
bleeding
is
a
powerful
marker
of
comorbidity
• Early
ader
PCI,
major
bleeding
appears
less
dangerous
than
stent
thrombosis,
and
this
should
be
kept
in
mind
when
adjus8ng
an8thrombo8c
treatment
•
Some
types
of
an8thrombo8c
treatment
can
decrease
both
bleeding
and
mortality
without
loss
of
efficacy
(ACUITY)
• Prolonged
dura8on
of
DAPT
beyond
6
months
may
increase
the
risk
of
bleeding
without
any
gain
in
efficacy
(PRODIGY)

30. Conclusions
(II)
• Access
site
bleeding
accounts
for
30-­‐70%
of
all
significant
bleeding
episodes
in
series
with
100%
femoral
access
• Radial
access
is
associated
with
a
decreased
risk
of
local
vascular
complica8ons
and
bleeding
• Using
a
common
defini8on
for
bleeding
events
(BARC)
will
allow
to
clarify
several
issues
and
compare
different
trials

31. Thank you!

32. EHJ 2011;32:2256
Protocol definition
TIMI Major
TIMI Major @ 30 days
32

33. Title of your presentation…