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STENT ANALYSIS. Prasugrel Compared to Clopidogrel in Patients with Acute Coronary Syndromes Undergoing PCI with Stenting: the TRITON - TIMI 38 Stent Analysis .

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STENT ANALYSIS

Prasugrel Compared to Clopidogrel in Patients with Acute Coronary Syndromes Undergoing PCI with Stenting: the TRITON - TIMI 38 Stent Analysis

Stephen D. Wiviott, Elliott M. Antman, Ivan Horvath, Matyas Keltai, Jean-Paul R. Herrman, Frans van de Werf, William Downey, Benjamin M. Scirica, Sabina A. Murphy, Carolyn H. McCabe, Eugene Braunwald.

SCAI – ACCi2 2008Chicago, Illinois

Disclosure Statement: The TRITON-TIMI 38 trial was supported by a research grant to the Brigham and Women’s Hospital from Daiichi Sankyo Co. Ltd and Eli Lilly & Co.


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Main Trial Design

STENT ANALYSIS

ACS (STEMI or UA/NSTEMI) & Planned PCI

N= 13,608

ASA

Double-blind

CLOPIDOGREL

300 mg LD/ 75 mg MD

PRASUGREL

60 mg LD/ 10 mg MD

Duration of therapy: 6-15 months

1o endpoint: CV death, MI, Stroke

2o endpoint: Stent Thrombosis Safety endpoints: TIMI major bleeds, Life-threatening bleeds

Wiviott SD, Antman EM et al AHJ 2006


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Goals of Stent Analysis

STENT ANALYSIS

  • To compare the efficacy and safety of PRASUGREL and CLOPIDOGREL in 12,844 patients with at least one stent as part of the index procedure with respect to:

    • Stent Thrombosis (ARC definitions)

    • Ischemic Events, Bleeding

    • Overall and stratified by stent type received


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Key Efficacy, Safety EP:Stratified by Stent Type

STENT ANALYSIS

CVD/MI/CVA

Non-CABG TIMI Major Bleeding

HR 0.80

(0.69-0.93)

p=0.003

HR 0.82

(0.69-0.97)

p=0.02

CLOPIDOGREL

PRASUGREL

% of Subjects

HR 1.37

(0.95-1.99)

p=0.09

HR 1.19

(0.83-1.72)

p=0.34

N=6461

N=5743


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Definite/Probable ST: Any Stent (N=12844)

STENT ANALYSIS

2.35%

2.5

HR 0.48 [0.36-0.64]

P<0.0001

2

CLOPIDOGREL

52%

1.5

% of Subjects

1.13%

1

PRASUGREL

1 year: 1.06 vs 2.15%

HR 0.48 [0.36-0.65], P<0.0001

0.5

0

0

50

100

150

200

250

300

350

400

450

DAYS


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Definite/Probable ST: Any Stent (N=12844)

STENT ANALYSIS

EARLY ST

LATE ST

HR 0.41 [0.29-0.59]

P<0.0001

HR 0.60 [0.37-0.97]

P=0.03

CLOPIDOGREL

PRASUGREL

1.56%

% of Subjects

59%

0.82%

40%

0.64%

0.49%

DAYS


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Definite/Probable ST: DES Only (N=5743)

STENT ANALYSIS

2.31%

HR 0.36 [0.22-0.58]

P<0.0001

CLOPIDOGREL

64%

% of Subjects

0.84%

PRASUGREL

1 year: 0.74% vs 2.05%

HR 0.35 [0.21-0.58], P<0.0001

DAYS


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Definite/Probable ST: BMS Only (N=6461)

STENT ANALYSIS

2.41%

HR 0.52 [0.35-0.77]

P=0.0009

CLOPIDOGREL

48%

% of Subjects

1.27%

PRASUGREL

1 year: 1.22 vs 2.27%

HR 0.53 [0.36-0.79], P=0.0014

DAYS


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Balance of Efficacy and Safety (Stented Population)

STENT ANALYSIS

Stent Thrombosis

CVD/MI/CVA

w/o ST

Events per 1000 patients treated


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Conclusions/Implications

STENT ANALYSIS

  • Stent Thrombosis is a rare, but devastating complication of PCI associated with a high mortality. Efforts to reduce ST have focused on compliance w/ and duration of ASA/clopidogrel

  • Our data indicate that an agent w/ more rapid, consistent, and greater inhibition of platelet aggregation (prasugrel) results in major reductions in ST regardless of stent type, both early and late, and across a broad array of clinical and procedural characteristics