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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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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

Maarten A. Vink, M.D.:

Nothing to disclose


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


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;


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

  • 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

  • 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

  • Cardiogenic shock prior to randomization

  • Mechanical ventilation


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

  • 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 Angiographic and Procedural Characteristics


Clinical Outcome at 1 year

Laarman et al N Engl J Med 2006


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


Cardiac death


Recurrent myocardial infarction


Target-lesion revascularization


Stent Thrombosis

Incidences were estimated from the Kaplan-Meier curves


Definite Stent Thrombosis


Definite or Probable Stent Thrombosis


Late and Very Late Stent Thrombosis

Incidences were estimated from the Kaplan-Meier curves


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).


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:

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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