Objective
This presentation is the property of its rightful owner.
Sponsored Links
1 / 14

Objective PowerPoint PPT Presentation


  • 99 Views
  • Uploaded on
  • Presentation posted in: General

Objective. To determine whether nonresponsiveness to clopidogrel as revealed by high in vitro residual platelet reactivity after a 600 mg loading of the drug is predictive of drug-eluting stent thrombosis and cardiac mortality at long-term follow-up. Background.

Download Presentation

Objective

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Objective

Objective

To determine whether nonresponsiveness to clopidogrel as revealed by high in vitro residual platelet reactivity after a 600 mg loading of the drug is predictive of drug-eluting stent thrombosis and cardiac mortality at long-term follow-up


Background

Background

The RECLOSE trial showed that nonresponsiveness to clopidogrel is predictive of drug-eluting stent (DES) thrombosis and cardiac mortality at 6 months. No data exist about the predictive value of long-term adverse events in patients with DES and clopidogrel loading non-responsiveness


Methods 1

Methods (1)

  • Consecutive pts receiving DES implantation and for whom platelet reactivity after clopidogrel loading was prospectively assessed.

  • All pts were compliant to 6-month dual antiplatelet treatment.

  • Blood samples for platelet reactivity assessment was obtained 12 to 18 hours from clopidogrel loading (600 mg). For patients receiving in the cath lab both the loading dose of clopidogrel and a IIb/IIIa inhibitor, blood samples were obtained after 6 days while patients were on 75 mg maintenance dose of clopidogrel.


Objective

Methods (2)

Platelet-rich plasma was stimulated with 10 M ADP and aggregation was assessed using LTA. Patients with platelet aggregation by 10 µmol ADP ≥ 90th percentile of controls (70%) were defined as nonresponders.


Primary end point stent thrombosis arc definitions

Primary end-point: stentthrombosis (ARC definitions)

  • Definite Stent Thrombosis

    • Angiographicorpathologicconfirmation

      AND at least ONE additional criteria:

      • Acuteischemicsymptoms

      • Ischemic ECG changes

      • Elevatedcardiacbiomarkers

  • Probable Stent Thrombosis

    • Anyunexplaineddeathwithin 30 daysof stent implantation

    • Anymyocardialinfarctionin the territory of the implanted stent without angiographic confirmation of stent thrombosis

  • Possible Stent Thrombosis

    • Anyunexplaineddeathbeyond 30 days

Secondary end-point: compositeofcardiacmortalityandstentthrombosis


Baseline clinical characteristics according to responsiveness to clopidogrel

Baseline Clinical Characteristics According to Responsiveness to Clopidogrel

  • OverallResp.Nonresp.p value

  • (n=804)(n=699)(n=105)

  • Age69 ± 1168 ± 1171 ± 100.021

  • Sex (male)602 (75)528 (76)74 (70)0.265

  • Smokers179 (22)164 (24)15 (14)0.034

  • Hypertension501 (62)434 (62)67 (64)0.748

  • Diabetes mellitus169 (21)131 (19)38 (36)<0.001

  • Hypercolesterol.405 (50)347 (50)58 (55)0.291

  • Prior MI206 (26)173 (25)33 (31)0.146

  • Stable angina 275 (34)242 (35)33 (31)0.520

  • Unstable angina312 (39)258 (37)54 (51)0.004

  • AMI217 (27)199 (28)18 (17)0.015

  • Renal failure 87 (11)73 (10)14 (14)0.374

  • LVEF %47±1247±1244±140.008


Baseline procedural characteristics according to responsiveness to clopidogrel

Baseline Procedural Characteristics According to Responsiveness to Clopidogrel

  • OverallResp.Nonresp.p value

  • n=804n=699n=105

  • Multivessel disease457 (57)386 (55)71 (68)0.017

  • Multivessel PCI327 (41)273 (39)54 (51)0.016

    • Lesion treated 13691171198

  • Thrombotic lesion177 (13)166 (24)11 (10)<.001

  • Bifurcation lesion371 (27)318 (27)53 (27)0.909

  • Chronic total occl. 106 (8)86 (7)20 (10)0.180

  • Lesion length > 20 mm359 (26)294 (25)65 (33)0.022

  • Total stent length (mm) 38 ± 2937 ± 2944 ± 320.015

  • Cypher stent447 (56)391 (56)56 (53)0.617

  • Taxus stent303 (38)264 (38)39 (37)0.902

  • Both stent types54 (7)44 (6)10 (10)0.218

  • Glycoprotein IIb/IIIa 349 (43)311 (44)38 (36)0.110


Cox multivariate analysis predictors of stent thrombosis at six months

Cox Multivariate Analysis:Predictors of Stent Thrombosis at Six Months

  • HR(95%CI)P VALUE

  • Nonresponsiveness to clopidogrel3.08 (1.32-7.16)0.009

  • Acute myocardial infarction 2.41 (1.04-5.63)0.041

    • Total stent length (mm) 1.01 (1.00-1.02)0.010

  • LVEF per 1% increase0.95 (0.92-0.98)0.001


Long term follow up n 803

Long-term follow-up (n=803)


Objective

LONG-TERM SURVIVAL FOR PRIMARY END-POINT

100

97 ± 1

95

Log rank p <.001

89 ± 3

Event-free survival %

(definite or probable stent thrombosis)

90

Responders

Nonresponders

85

n=803 pts; median time follow-up 639 days - IQ 555-756

80

0

60

120

180

240

300

360

420

480

540

600

660

720

Time (days)


Incidence of cardiac mortality

Incidenceofcardiacmortality

nonresponders

responders

11,4 %

3,8 %

2,7 %

1 %

Cardiac mortality

(after six months)

Cardiac mortality

(overall)


Timing of primary end point stent thrombosis

Timing ofprimaryend-point (stentthrombosis)

Events, n


Incidence of stent thrombosis

Incidenceofstentthrombosis

nonresponders

responders

11,4 %

2,6 %

2,8 %

0,3 %

Stent thrombosis

(after six months)

Stent thrombosis

(overall)


Objective

Conclusions

High residual platelet reactivity after 600 mg loading dose of clopidogrel, as revealed by a single assessment with LTA, is a strong predictor of cardiac death and DES thrombosis.


  • Login