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Drug-Eluting and Bare Metal Stenting for Acute Myocardial Infarction in Massachusetts

Drug-Eluting and Bare Metal Stenting for Acute Myocardial Infarction in Massachusetts. Laura Mauri, Treacy S. Silbaugh, Robert E. Wolf, Katya Zelevinsky, Ann Lovett, Manu Varma, and Sharon-Lise T. Normand Brigham and Women’s Hospital, Harvard Medical School,

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Drug-Eluting and Bare Metal Stenting for Acute Myocardial Infarction in Massachusetts

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  1. Drug-Eluting and Bare Metal Stenting for Acute Myocardial Infarction in Massachusetts Laura Mauri, Treacy S. Silbaugh, Robert E. Wolf, Katya Zelevinsky, Ann Lovett, Manu Varma, and Sharon-Lise T. Normand Brigham and Women’s Hospital, Harvard Medical School, Harvard School of Public Health all in Boston, Massachusetts March 30, 2008 American College of Cardiology, Chicago

  2. Disclosure Information Drug-Eluting and Bare Metal Stenting for Acute Myocardial Infarction in Massachusetts The following relationships exist related to this presentation: L Mauri Honoraria: Abbott, Boston Scientific, Cordis, Medtronic Modest Level T Silbaugh, R Wolf, K Zelevinsky, A Lovett, and SL Normand: Salary and research funding from Massachusetts Department of Public Health M Varma No disclosures

  3. Drug-Eluting and Bare Metal Stenting for Acute Myocardial Infarction We wish to thank Paul Dreyer, Ph.D. of the Massachusetts Department of Public Health and the members of the Mass-DAC PCI Data Adjudication Committee Kurt Barringhaus, M.D. Clifford J. Berger, M.D. David Cohen, M.D. Angela Corey, R.N. Jean Crossman, R.N. Daniel Fisher, M.D. Joe Garasic, M.D. Jean-Pierre Geagea, M.D. Gregory Giugliano, M.D. Kalon Ho, M.D. Alice Jacobs, M.D. James Kirshenbaum, M.D. Josh Krasnow, M.D. Anthony Marks, M.D. Theo E. Meyer, M.D., Ph.D. Kathy Minahan, R.N. Zoran Nedelijkovic, M.D. Barbara Oxley, R.N. Thomas C. Piemonte, M.D. Kenneth Rosenfield, M.D. Pinak B. Shah, M.D. Samuel J. Shubrooks Jr., M.D. James Waters, M.D. Bonnie Weiner, M.D.

  4. Drug-Eluting and Bare Metal Stenting for Acute Myocardial InfarctionBackground • Acute myocardial infarction represents a large proportion of stenting procedures, and is the clinical syndrome with the greatest documented benefit for PCI • Yet patients with acute myocardial infarction (AMI) have not been included in the major randomized trials comparing drug eluting stents (DES) to bare metal stents (BMS) • And specific studies of AMI have been limited in size and study duration to detect adverse clinical events.

  5. Drug-Eluting and Bare Metal Stenting for Acute Myocardial InfarctionObjectives • To evaluate whether the use of DES is associated with increased rates of death or MI compared with BMS in patients with acute myocardial infarction • To evaluate whether the use of DES is associated with reduction in revascularization compared with BMS in patients with acute myocardial infarction

  6. Drug-Eluting and Bare Metal Stenting for Acute Myocardial InfarctionMethods: • All PCI for NSTEMI or STEMI in Massachusetts non-federal hospitals April 2003 – Sept. 30, 2004 • Clinical and procedural factors collected prospectively using ACC NCDR instrument and reported to Mass-DAC (State Dept of Public Health database) • Mortality from hospital record, MA Registry of Vital Records & Statistics, & Social Security website • Myocardial infarction and revascularization from Mass-DAC PCI and CABG data merged with hospital discharge data • Non-Massachusetts residents excluded

  7. Drug-Eluting and Bare Metal Stenting for Acute Myocardial InfarctionMethods • Patients assigned to DES or BMS groups based on treatment at index procedure • Patients treated with both types were excluded • Propensity score matching • Logistic regression to predict DES treatment by up to 63 patient, procedural, hospital variables • 1:1 caliper matching of DES to BMS patients • Primary outcomes: Matched risk differences for mortality, myocardial infarction and revascularization rates at 2 years • Paired t-test, 2-sided alpha 0.05

  8. Drug-Eluting and Bare Metal Stenting for Acute Myocardial Infarction N=21,019 PCI Patients in Massachusetts April 1, 2003- September 30, 2004 Complete 2 year follow-up 12,565 non-MI PCI patients N=8,454 MI Patients (40%) 575 non-residents excluded 183 administrative files not linkable N=7,696 Patients 480 patients with both stent types excluded N=4,016 DES Only Patients N=3,200 BMS Only Patients 28% PES 72% SES

  9. Drug-Eluting and Bare Metal Stenting for Acute Myocardial InfarctionPatient Characteristics before Match

  10. Drug-Eluting and Bare Metal Stenting for Acute Myocardial InfarctionPatient Characteristics before Match *Although dual antiplatelet therapy (DAP) compliance data are not available, during the time period of entry to the study (4/03- 9/04) consensus recommendations were for 1m DAP for BMS and 3-6m for DES.

  11. Drug-Eluting and Bare Metal Stenting for Acute Myocardial InfarctionProcedure Indications before Match

  12. Drug-Eluting and Bare Metal Stenting for Acute Myocardial InfarctionProcedural Characteristics before Match

  13. Drug-Eluting and Bare Metal Stenting for Acute Myocardial Infarction N=4,016 patients with DES for MI N=3,200 patients with BMS for MI Propensity score matched pairs 2629 MI 2629 MI 2,453 (61.1%) DES for NSTEMI 1,382 (43.2%) BMS for NSTEMI matched pairs 1,221 NSTEMI 1,221 NSTEMI 1,563 (38.9%) DES for STEMI 1,818 (56.8%) BMS for STEMI matched pairs 1,302 STEMI 1,302 STEMI

  14. Drug-Eluting and Bare Metal Stenting for Acute Myocardial InfarctionPatient Characteristics after Match *%SD = Percent Standardized Difference Values <10% reflect well-matched characteristics

  15. Drug-Eluting and Bare Metal Stenting for Acute Myocardial InfarctionPatient Characteristics after Match *%SD = Percent Standardized Difference Values <10% reflect well-matched characteristics

  16. Drug-Eluting and Bare Metal Stenting for Acute Myocardial InfarctionProcedure Indications after Match

  17. Drug-Eluting and Bare Metal Stenting for Acute Myocardial InfarctionProcedural Characteristics after Match *%SD = Percent Standardized Difference Values <10% reflect well-matched characteristics

  18. MI n=2629 pairs NSTEMI n=1221 pairs STEMI n=1302 pairs Favors DES Favors DES Favors BMS Favors BMS Drug-Eluting & Bare Metal Stenting in Massachusetts Risk Differences in Matched MI Patient Groups at 2 years Risk Difference (95% CI), DES v. BMS Recurrent MI Death -2.7% [-4.5%, 0%] P=0.002 -1.5% [-3.1%, 0.2%] P=0.08 -2.4% [-5.0%, 0.3%] P=0.07 -1.9% [-4.6%, 0.9%] P=0.18 -3.1% [-5.4%, -0.8%] P=0.009 -1.6% [-3.7%, 0.5%] P=0.127

  19. MI n=2629 pairs -3.6% [-5.2%, -2.0%] P<0.001 -5.3% [-7.4%, -3.2%] P<0.001 NSTEMI n=1221 pairs -2.9% [-5.4%, -0.5%] P=0.02 -5.3% [-8.4%, -2.3%] P<0.001 STEMI n=1302 pairs -3.5% [-5.8%, -1.3%] P=0.002 -6.0% [-9.0%, -3.0%] P<0.001 Favors DES Favors DES Favors BMS Favors BMS Drug-Eluting & Bare Metal Stenting in Massachusetts Risk Differences in Matched MI Patient Groups at 2 years Risk Difference (95% CI), DES v. BMS Revascularization TVR

  20. Recurrent MI Death BMS DES Revasc TVR Drug-Eluting & Bare Metal Stenting in Massachusetts 2-Year Outcome in Matched MI Patients No. at Risk 0 30 180 365 730 No. at Risk 0 30 180 365 730 DES 2629 2618 2550 2484 2433 DES 2629 2604 2483 2368 2283 BMS 2629 2614 2512 2431 2373 BMS 2629 2592 2430 2285 2192

  21. Drug-Eluting and Bare Metal Stenting for MI in Massachusetts Sensitivity analyses • Match adjusting for time on market yields consistent conclusions • STEMI group exclusion of programs without surgery on site, or patients with >24h presentation, yields consistent conclusions • No evidence of a 2 day clinical or statistical significant benefit which is supportive of no residual confounding • 2 day mortality DES-BMS D = -0.5% [-1.0,+0.04] • 2 year mortality DES-BMS D = -2.7% [-4.5%, 0%]

  22. Drug-Eluting and Bare Metal Stenting in Massachusetts Conclusions Complete 2 year data are available for 7216 unique DES or BMS procedures for MI in Massachusetts from April 2003- September 2004. Propensity matched analysis of 5258 patients with MI demonstrated: • No increase in rates of death, or myocardial infarction associated with DES as compared to BMS use at 2 years overall and for the subsets of STEMI and NSTEMI • Although our aim was to detect a signal of harm, we observed lower 2y mortality in STEMI patients treated with DES • A lower rate of repeat revascularization in patients treated with DES compared with BMS overall and for both subsets.

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