1 / 25

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

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.

anahid
Download Presentation

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

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. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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 year1. • However, concern has arisen about the occurrence of (very) late stent thrombosis after implantation of DES2. • Available data suggest a higher rate of (very) late stent thrombosisafter the use of DES in primary PCI, compared to stenting for stable angina3. 1Stone et al N Engl J Med 2009; 2Pfisterer et al J Am Coll Cardiol 2006; 3Leibundgut 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. Late and Very Late Stent Thrombosis Incidences were estimated from the Kaplan-Meier curves

  21. Definite Stent Thrombosis

  22. Conclusions PASSION 5-year follow-up PES compared to BMS in primary PCI • The PASSION-trial is the first RCT to report very long-term follow-up. • 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

  23. Conclusions PASSION 5-year follow-up PES compared to BMS in primary PCI • 5-year follow-up of the PASSION-trial confirms small risk of (very) late stent thrombosis. • 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 • 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

More Related