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ACC/i2 2010 Late-breaking clinical trial session, March 16, 2010 PowerPoint PPT Presentation


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Five year clinical follow-up of the PASSION -trial Five Year Follow-up after Primary PCI with a Pa clitaxel-Eluting S tent versus a Bare-Metal Stent in Acute S T-Elevation Myocardial Infarct ion.

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ACC/i2 2010 Late-breaking clinical trial session, March 16, 2010

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Acc i2 2010 late breaking clinical trial session march 16 2010

Five year clinical follow-up of the PASSION-trialFive Year Follow-up after Primary PCI with a Paclitaxel-Eluting Stent versus a Bare-Metal Stent in Acute ST-Elevation Myocardial Infarction

Maarten A. Vink, Maurits T. Dirksen, Maarten J. Suttorp, Jan G.P. Tijssen, GertJan Laarman

on behalf of the PASSION investigators

OLVG Hospital,

Amsterdam, The Netherlands

ACC/i2 2010 Late-breaking clinical trial session, March 16, 2010


Disclosure information

Disclosure information

Maarten A. Vink, M.D.:

Nothing to disclose


Background

Background

DES in primary PCI

  • Several RCTs showed a variable reduction in the need for repeat revascularization of infarct-related artery in favour of DES.

  • No differences in survival rates or recurrent MI

Laarman et al N Engl J Med 2006; Kastrati et al Eur Heart J 2007;

Stone et al N Engl J Med 2009


Background1

Background

DES and stent thrombosis

  • HORIZONS-AMI showed similar rates of stent thrombosis with DES and BMS at one year.

  • However, concern has arisen about the occurrence of (very) late stent thrombosis after implantation of DES.

  • Available data suggest a higher rate of (very) late stent thrombosisafter the use of DES in primary PCI, compared to stenting for stable angina.

Stone et al N Engl J Med 2009; Pfisterer et al J Am Coll Cardiol 2006;

Leibundgut e al Am Heart J 2009;


Background2

Background

DES and stent thrombosis in primary PCI

  • In the absence of long-term outcome of RCTs, this issue remains unresolved.

  • Therefore, guidelines do not uniformly support the use of DES in primary PCI for STEMI.

    • ACC/AHA 2009 IIa B indication

    • ESC 2008 not defined


Passion 5 year clinical follow up

PASSION 5-year clinical follow-up

  • Clinical follow-up at 5 years

  • To elucidate a possible sustained benefit of DES in the occurrence of MACE

  • To address the concern of late and very late stent thrombosis


Passion trial

PASSION-trial

  • Prospective, two-center, randomized, single-blind trial

  • Enrollment March 2003 - December 2004

    • OLVG Hospital, Amsterdam, The Netherlands

    • St. Antonius Hospital, Nieuwegein, The Netherlands

  • 619 consecutive patients with STEMI, eligible for primary PCI with stenting

  • Representative of real world population owing to limited exclusion criteria

  • No routine angiographic follow-up

  • Clinical follow-up at: 6, 12, 24, and 60 months


Limited exclusion criteria

Limited exclusion criteria

  • Cardiogenic shock prior to randomization

  • Mechanical ventilation


Procedure

Procedure

  • Stent diameter and length decided before randomization

  • Randomization to:

    paclitaxel-eluting stent (Taxus/Express2) or

    bare metal stent (Express2 or Liberté)

  • Additional stents according to assigned stent type

  • Thrombus aspiration and direct stenting at the discretion of the operator


Concomitant medication

Concomitant medication

  • GP IIb/IIIa receptor blocker at the discretion of the operator

  • Post-PCI:

    • Clopidogrel 300 mg, followed by 75 mg od for at least 6 months

    • Aspirin 100 to 500 mg, followed by 80-100 mg od indefinitely


Baseline clinical characteristics

Baseline Clinical Characteristics


Baseline angiographic and procedural characteristics

Baseline Angiographic and Procedural Characteristics


Clinical outcome at 1 year

Clinical Outcome at 1 year

Laarman et al N Engl J Med 2006


Long term follow up

Long-term Follow-up

  • Complete follow-up available at 5 years:

    • vital status: 98.5% (9 patients lost to FUP)

    • clinical events: 95.8%


Composite of cardiac death recurrent mi or tlr

Composite of Cardiac death, Recurrent MI, or TLR


Cardiac death

Cardiac death


Recurrent myocardial infarction

Recurrent myocardial infarction


Target lesion revascularization

Target-lesion revascularization


Stent thrombosis

Stent Thrombosis

Incidences were estimated from the Kaplan-Meier curves


Definite stent thrombosis

Definite Stent Thrombosis


Definite or probable stent thrombosis

Definite or Probable Stent Thrombosis


Late and very late stent thrombosis

Late and Very Late Stent Thrombosis

Incidences were estimated from the Kaplan-Meier curves


Conclusions

Conclusions

PASSION 5-year follow-up

PES compared to BMS in primary PCI

  • No significant difference in the occurrence of the composite endpoint of cardiac death, recurrent MI, or TLR

  • No significant differences in the occurrence of individual major adverse cardiac events

  • Comparable incidence of definite or probable stent thrombosis

  • However, the rate of definite stent thrombosis in the PES-group was two-fold as compared to the BMS-group (P = 0.20).


Conclusions1

Conclusions

DES in primary PCI for STEMI

  • 5-year follow-up of the PASSION-trial confirms small risk of (very) late stent thrombosis.

  • The risk of stent thrombosis appears to persist for several years after stent implantation.

  • We have to outweigh the possible advantage of DES in TLR against the potential risk of (very) late stent thrombosis.


Thanks to

Thanks to:

The PASSION Investigators

MT Dirksen, MJ Suttorp, JGP Tijssen, J van Etten,T Slagboom, M Patterson, F Kiemeneij, GJ Laarman

And to all patients and co-workers of the PASSION trial at

OLVG Hospital, Amsterdam

St. Antonius Hospital, Nieuwegein


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