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

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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  1. 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

  2. Disclosure information Maarten A. Vink, M.D.: Nothing to disclose

  3. 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

  4. 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;

  5. 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

  6. 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

  7. 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

  8. Limited exclusion criteria • Cardiogenic shock prior to randomization • Mechanical ventilation

  9. 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

  10. 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

  11. Baseline Clinical Characteristics

  12. Baseline Angiographic and Procedural Characteristics

  13. Clinical Outcome at 1 year Laarman et al N Engl J Med 2006

  14. Long-term Follow-up • Complete follow-up available at 5 years: • vital status: 98.5% (9 patients lost to FUP) • clinical events: 95.8%

  15. Composite of Cardiac death, Recurrent MI, or TLR

  16. Cardiac death

  17. Recurrent myocardial infarction

  18. Target-lesion revascularization

  19. Stent Thrombosis Incidences were estimated from the Kaplan-Meier curves

  20. Definite Stent Thrombosis

  21. Definite or Probable Stent Thrombosis

  22. Late and Very Late Stent Thrombosis Incidences were estimated from the Kaplan-Meier curves

  23. 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).

  24. 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.

  25. 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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