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How do we interpret the data? PowerPoint PPT Presentation


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Hypothesis: baseline risk status of the patients and proximity to a recent cardiovascular event influence the response to dual anti-platelet therapy. Patients with symptomatic CAD, CVD or PAD and all those with a history of CV events were included in this analysis (n=13,434).

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How do we interpret the data?

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How do we interpret the data

  • Hypothesis: baseline risk status of the patients and proximity to a recent cardiovascular event influence the response to dual anti-platelet therapy.

  • Patients with symptomatic CAD, CVD or PAD and all those with a history of CV events were included in this analysis (n=13,434).


How do we interpret the data

  • How do we interpret the data?

  • Patients with documented vascular events, irrespective of inclusion group

  • Does baseline risk influence the treatment effect?


Primary endpoint mi stroke cv death in patients with previous mi is or pad caprie like cohort

10

Placebo + ASA

8.8 %

Clopidogrel + ASA

7.3 %

8

6

Primary outcome event rate (%)

4

RRR: 17.1 % [95% CI: 4.4%, 28.1%]

p=0.01

2

0

0

6

12

18

24

30

Months since randomization

Primary Endpoint (MI/Stroke/CV Death) in Patients with Previous MI, IS, or PAD“CAPRIE-like Cohort”

N=9,478


How do we interpret the data

Cardiovascular outcomes

according to quartiles of baseline CV risk.

Q4: severe bleeds: 3.1% C vs 3.2% P and ICH 1.0%C vs 1.0%P

moderate bleeds 4.2%C vs 2.6% P, (p=0.02).


How do we interpret the data

  • How do we interpret the data?

  • Patients with documented vascular events, irrespective of inclusion group

  • Does baseline risk influence the treatment effect?

  • The impact of proximity to a CV event


Documented cv disease patients primary outcome mi stroke cv death

Cerebrovascular (n=4320)

Cardiovascular (n=5835)

PAD (n=2838)

12

Placebo +ASA

(9.6%)

12

12

RRR: 13.9%

p=0.130

RRR: 16.0%

p=0.088

RRR: 13.1%

p=0.285

Placebo + ASA

(8.7%)

10

10

10

Placebo + ASA

(7.4%)

8

8

8

6

6

6

Clopidogrel

+ ASA

(8.1%)

Clopidogrel

+ ASA

(7.6%)

Primary outcome event rate (%)

Clopidogrel

+ ASA

(6.5%)

4

4

4

2

2

2

0

0

0

0

6

12

18

24

30

0

6

12

18

24

30

0

6

12

18

24

30

Months since randomization

Months since randomization

Months since randomization

Documented CV Disease Patients: Primary Outcome (MI/Stroke/CV Death)

Median time from qualifying event to randomization:

23.3 months3.5 months23 months

Bhatt DL, Fox KA, Hacke W, et al. N Engl J Med. 2006: 354; 1-12


How do we interpret the data

12

10.8

p= 0.031

10

8.2

8

p= 0.06

Placebo

percent

6

5.6

Clopidogrel

5.3

5

4

3.8

4

3.4

3.4

2.5

2

0

Death/MI/Stroke

Death (all)

CV death

MI

Stroke

Enrolled within 6/12 of event


How do we interpret the data

Proximity to a recent CV event (MI/stroke) was associated with significant benefit with clopidogrel.

For those randomized within 6 months of MI or stroke, the frequency further MI/stroke or death was 8.2% C vs 10.8% P (HR 0.76, 95%CI 0.59-0.98, p=0.034).

In those patients who had a documented prior vascular event or with confirmed PAD (n=9478) the risk of death/MI/stroke was 7.3%C vs 8.8%P (HR 0.83, 95% CI 0.72-0.96, p=0.01).


How do we interpret the data

  • How do we interpret the data?

  • Primary outcome by categories of included patients

  • Patients with included with documented MI or ischemic stroke


How do we interpret the data

Event rate over time for primary outcome in CAD patients with inclusion MI vs coronary inclusion criteria other than MI

CAD patients with qualifying MI (N=3846)

CAD patients without qualifying MI (N=1989)

RRR [95%CI]: 22.6 % [2.2, 38.7]

p = 0.031

RRR [95%CI]: -10.3 % [-58.0, 23.0]

p = 0.593


Event rate over time for primary outcome in cvd patients with qualifying is vs qualifying tia

Event rate over time for primary outcome in CVD patients with qualifying IS vs qualifying TIA

CVD patients with qualifying IS (N=3245)

CVD patients with qualifying TIA (N=1233)

RRR [95%CI]: 22.0 % [2.4, 37.6]

p = 0.029

RRR [95%CI]: -14.7 % [-74.4, 24.6]

p = 0.520


How do we interpret the data

Conclusions:

  • For the overall population the trend for benefit (7% RR)

  • was non-significant

  • Commencing therapy with clopidogrel within 6 months of

  • a stroke or MI suggests evidence of benefit on rates of

  • future death/MI/stroke.

  • Higher risk groups, including those with clear evidence of

  • vascular disease and recent vascular events, suggests

  • the potential for greater benefit


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