Get documents about "Berger
Shared by: xiaopangnv
-
Stats
- views:
- 10
- posted:
- 10/19/2012
- language:
- Unknown
- pages:
- 14
Document Sample
The Guidelines:
How Can They Be Improved?
Peter Berger MD
Interventional Cardiologist
Director, Center for Clinical Studies
Geisinger Clinic
Danville, PA
Recommended Aspirin Dose After
PCI
• The updated 2007 ACC/AHA/SCAI PCI
guidelines recommend:
– 162 - 325 mg for 1 month after BMS, 3
months after sirolimus-eluting stents, 6
months after paclitaxel-eluting stents
– 75 - 162 mg daily thereafter
King III SB, et al. J Am Coll Cardiol. 2008;51:172-209.
Aspirin Dose and Vascular Events in
High-Risk Patients
OR*
Daily Aspirin Dose No. of Trials (%) Odds Ratio
500–1500 mg 34 19
160–325 mg 19 26
75–150 mg 12 32
<75 mg 3 13
Any aspirin 65 23 P = 0.0001
0 0.5 1.0 1.5 2.0
Antiplatelet Better Antiplatelet Worse
Antithrombotic Trialists’ Collaboration. BMJ. 2002;324:71-86.
Reproduced with permission.
Aspirin Dose and Major Bleeding
Post Hoc Analysis Of 192,036
Pts Enrolled In 31 Controlled Trials
7
6
P<0.005
5
Bleeding 4
2.29
Rate
(%) 3
1.56 1.54
*
2
1
0
<100 mg 100-200 mg >200 mg
Aspirin Dose
Serebrauny V, et al. Am J Cardiol. 2005;95:1218-1222.
CURE: Aspirin Dose and Outcome
CV Death, MI, Stroke Major Bleeding
15 13.6 5 4.9
10.5 4 3.7
9.5 9.8 9.8 3.4
10 8.6 3
3 2.8
% 2
1.9
5
1
0 0
≤ 100 mg 101-199 mg ≥ 200 mg ≤ 100 mg 101-199 mg ≥ 200 mg
(N = 5320) (N = 3109) (N = 4110)
ASA/Clopidogrel ASA/Placebo
Peters RJ, et al. Circulation. 2003;108:1682-1687.
CHARISMA
Aspirin Dose and Efficacy
10 N = 15,603
P = 0.14
8 P = 0.07
7.3% 7.6%
CV Death, 6
MI, or
6.7%
Stroke
% 4
2
0
< 100mg 100mg > 100mg
N = 7180 N = 4961 N = 3454
Aspirin Dose
Steinhubl S, et al. Circulation. 2006;114:2490-2497.
CHARISMA: Aspirin Dose and Safety
GUSTO Severe Bleed
5
4
% 3 P = NS
2
1 1.5% 1.8%
1.4%
0
< 100mg 100mg > 100mg
Aspirin Dose
Clopidogrel-treated pts:
100 mg > 100mg P value
CV death/MI/CVA 6.4 8.4 0.010
GUSTO Severe 1.5 2.2 0.056
GUSTO Severe/Moderate 3.5 4.4 0.077
Steinhubl S, et al. Circulation. 2006;114:2490-2497.
ACC/AHA/SCAI 2005 Guideline
Update for PCI
Class IIb: In patients in whom subacute
thrombosis may be catastrophic or lethal
(unprotected left main, bifurcating left
main, or last patent vessel), platelet
aggregation studies may be considered
and the dose of clopidogrel increased to
150 mg per day if less than 50%
inhibition of platelet aggregation is
demonstrated. (Level of Evidence: C)
Level of Evidence C: Only consensus opinion of experts, case studies, or standard-of-care.
Smith S, et al. Circulation. 2006;113:156-175.
Recommended Duration of
Clopidogrel After PCI With a DES
The updated 2007 ACC/AHA/SCAI PCI
guidelines recommend:
• For all post-PCI stented pts receiving a
DES, clopidogrel 75 mg daily should be
given for at least 12 months if pts are
not at high risk of bleeding.
King III SB, et al. J Am Coll Cardiol. 2008;51:172-209.
Cumulative Incidence of Definite ST in
8146 DES Patients During a 4-Year
Follow-Up Period
6
5.7%
Definite and
5 probable ST
4
Cumulative 3.3%
incidence, 3 Definite ST
%
2
1
0
1 2 3 4
Time since PCI in years
Wenaweser P, et al. J Am Coll Cardiol. 2008;52:1134-1140.
Reproduced with permission.
CHARISMA: Documented CV Disease
Population Secondary Efficacy Results
Endpoints Clopidogrel Placebo RR P
+ASA + ASA (95% CI) value
(n=6062) (n=6091)
CV Death, MI, Stroke 420 (6.9) 480 (7.9) 0.88(0.77, 0.998) 0.046
CV Death, MI, Stroke, Hosp 1066 (17.6) 1169 (19.2) 0.91 (0.83, 0.98) 0.02
All-Cause Mortality 278 (4.6) 306 (5.0) 0.91 (0.78, 1.07) 0.27
Cardiovascular Mortality 172 (2.8) 191 (3.1) 0.90 (0.74, 1.11) 0.34
Myocardial Infarction 145 (2.4) 165 (2.7) 0.88 (0.71, 1.10) 0.27
Ischemic Stroke (fatal or not) 145 (2.4) 172 (2.8) 0.85 (0.68, 1.06) 0.14
Stroke (fatal or not) 167 (2.8) 200 (3.3) 0.84 (0.68, 1.03) 0.09
Hospitalization 720 (11.9) 803 (13.2) 0.89 (0.81, 0.99) 0.03
Wang TH, et al. Eur Heart J. 2007; 28:2200-2207.
CHARISMA: Documented CV Disease
Population Safety Results
Safety Outcome - N (%) Clopidogrel Placebo RR P
+ ASA + ASA (95% CI) value
(n=6062) (n=6091)
GUSTO Severe Bleeding 95 (1.6) 84 (1.4) 1.14 0.39
(0.85, 1.52)
Fatal 19 (0.3) 13 (0.2) 1.47 0.28
(0.73, 2.97)
Primary ICH 19 (0.3) 21 (0.3) 0.87 0.65
(0.47, 1.60)
GUSTO Moderate Bleeding 128 (2.1) 79 (1.3) 1.63 <0.001
(1.23, 2.15)
Wang TH, et al. Eur Heart J. 2007; 28:2200-2207.
Summary
• Given these unknowns:
– True duration of risk for DES thrombosis
– Optimal duration of clopidogrel to reduce
that risk
• And that:
– > 12,000 pt CHARISMA subset suggests
benefit > 1 yr of clopidogrel
I would not discontinue clopidogrel in
high risk pts
Summary
• Many areas of uncertainty remain
• The guidelines try to be evidence based
• Controversy remains
