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Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation

Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation.

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Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation

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  1. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation Eric Eisenstein, DBA; Kevin Anstrom, PhD; David Kong, MD; Linda Shaw, MS; Robert Tuttle, MSPH; Daniel Mark, MD, MPH; Judith Kramer, MD, MS; Robert Harrington, MD; David Matchar, MD; David Kandzari, MD; Eric Peterson, MD, MPH; Kevin Schulman, MD; Robert Califf, MD Published in JAMA January 10, 2007

  2. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation: Background • Instructions for the use of drug-eluting stents (DES) commercially available in the U.S. specify treatment with clopidogrel for at least 3 months (for sirolimus-coated stents) or 6 months (for paclitaxel-coated stents) after implantation • However, studies of late thrombosis events among patients with DES have cast doubt on whether the recommended regimens are sufficient • This study assessed the association between clopidogrel use and long-term rates of death and death or MI following initial percutaneous coronary intervention (PCI) with DES or bare-metal stents (BMS) Eisenstein et al. JAMA. 2007 Jan 10; 297 (2): 159 – 68.

  3. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation: Study Design • Landmark analysis used, and two landmarks were used in this study: • Starting at 6-months following PCI onward • Starting at 12-months following PCI onward • At the 6-month and 12-month landmark times, the patients were divided into four groups for analysis: DES with clopidogrel, DES without clopidogrel, BMS with clopidogrel, and BMS without clopidogrel. • Outcomes for these groups were evaluated up to 24 months after initial PCI procedure. Eisenstein et al. JAMA. 2007 Jan 10; 297 (2): 159 – 68.

  4. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation: Study Design 4,666 patients undergoing PCI with BMS or DES Prospective. Landmark analysis (starting at 6 or 12 mos after PCI). Follow-up at 12, 18, and up to 24-mos. Exclusion Criteria: prior CABG surgery or PCI procedure, significant (>75% stenosis) left main coronary artery disease, interventions other than stent placement during PCI Stent type at Baseline BMS n=3,165 DES n=1,501 6 mos. Landmark Analysis BMS n=2,393 DES n=1,216 Clopidogrel n=416 Clopidogrel n=637 No Clopidogrel n=579 No Clopidogrel n=1,976 24 mos. follow-up • Outcomes analyzed for Death, Nonfatal MI, and Death or MI Eisenstein et al. JAMA. 2007 Jan 10; 297 (2): 159 – 68.

  5. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation: Study Design 4,666 patients undergoing PCI with BMS or DES Prospective. Landmark analysis (starting at 6 or 12 mos after PCI). Follow-up at 12, 18, and up to 24-mos. Exclusion Criteria: prior CABG surgery or PCI procedure, significant (>75% stenosis) left main coronary artery disease, interventions other than stent placement during PCI Stent type at Baseline BMS n=3,165 DES n=1,501 12 mos. Landmark Analysis BMS n=1,990 DES n=528 Clopidogrel n=326 No Clopidogrel n=276 No Clopidogrel n=1,644 Clopidogrel n=252 24 mos. follow-up • Outcomes analyzed for Death, Nonfatal MI, and Death or MI Eisenstein et al. JAMA. 2007 Jan 10; 297 (2): 159 – 68.

  6. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation: Baseline Characteristics for 6 mos. patients Eisenstein et al. JAMA. 2007 Jan 10; 297 (2): 159 – 68.

  7. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation: Baseline Characteristics for 6 mos. patients Eisenstein et al. JAMA. 2007 Jan 10; 297 (2): 159 – 68.

  8. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation: Baseline Characteristics for 12-mos. Patients Eisenstein et al. JAMA. 2007 Jan 10; 297 (2): 159 – 68.

  9. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation: Baseline Characteristics for 12-mos. Patients Eisenstein et al. JAMA. 2007 Jan 10; 297 (2): 159 – 68.

  10. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation: Main Outcome Measures Adjusted rates of Death for Analysis Starting at 6-months • Adjusted outcomes were analyzed at 24 months • Patients in the DES with clop. group had significantly lower rates of death than did patients in the DES without clopidogrel group • Among BMS patients, there were no differences in death • No difference was observed in nonfatal MI Difference=-3.3±3 p=0.03 Difference=-0.7±2.1 p =0.50 Endpoint (%) Eisenstein et al. JAMA. 2007 Jan 10; 297 (2): 159 – 68.

  11. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation: Main Outcome Measures Adjusted rates of Death or MI Starting at 6 mos. • Adjusted outcomes were analyzed at 24 months • Patients in the DES with clop. group had significantly lower rates of death or MI than did patients in the DES without clopidogrel group • Among BMS patients, there were no differences in death or MI Difference=-4.1±3.5 p 0.02 Difference=-0.5±2.7 p=0.70 Endpoint (%) Eisenstein et al. JAMA. 2007 Jan 10; 297 (2): 159 – 68.

  12. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation: Main Outcome Measures • Adjusted outcomes were analyzed at 24 months • Patients in the DES with clop. group had significantly lower rates of death than did patients in the DES without clopidogrel group • Among BMS patients, there were no differences in death Adjusted rates of Death for Analysis Starting at 12-mos. Difference=-3.5±2.4 p=0.004 Difference=0.6±2.1 p=0.57 Endpoint (%) Eisenstein et al. JAMA. 2007 Jan 10; 297 (2): 159 – 68.

  13. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation: Main Outcome Measures • Adjusted outcomes were analyzed at 24 months • Patients in the DES with clop. group had significantly lower rates of death or MI than did patients in the DES without clopidogrel group • Among BMS patients, there were no differences in death or MI Adjusted rates of Death or MI Analysis Starting at 12-mos. Difference=-4.5±2.6 p<0.001 Difference=1.0±2.6 p=0.44 Endpoint (%) Eisenstein et al. JAMA. 2007 Jan 10; 297 (2): 159 – 68.

  14. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation: Limitations • Clopidogrel use was not randomly assigned; thus, the decision to continue the drug beyond the periods recommended by the relevant clinical trials may have been correlated with unmeasured prognostic factors. Eisenstein et al. JAMA. 2007 Jan 10; 297 (2): 159 – 68.

  15. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation: Limitations • Clopidogrel use in this analysis was identified by patient report at 2 discrete points (6- and 12-month follow-up). Therefore, these data are subject to recall bias. • Furthermore, the indications and rationale for long-term clopidogrel regimens and for its discontinuations were not collected. Eisenstein et al. JAMA. 2007 Jan 10; 297 (2): 159 – 68.

  16. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation: Limitations • The 24-month event rates of 0% for death, nonfatal MI, and death or MI for the DES with clopidogrel group in the 12-month landmark analysis may underestimate the true event rates. However, 14 patients receiving DES died or had a nonfatal MI, and none of these 14 patients was in the DES with clopidogrel group. • Extended clopidogrel therapy has its own risks and this analysis does not evaluate the long-term nonfatal implications of its use. Eisenstein et al. JAMA. 2007 Jan 10; 297 (2): 159 – 68.

  17. Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation: Summary • In a large consecutive cohort of contemporary patients receiving PCI, the long-term risk for death and major cardiac events was significantly increased among patients in the DES group who had discontinued clopidogrel therapy at 6 or 12 months. • Extended-duration clopidogrel therapy following DES implantation was associated with a lower incidence of death or MI, a finding that has immediate implications for clinical practice. Eisenstein et al. JAMA. 2007 Jan 10; 297 (2): 159 – 68.

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