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J. Matthew Brennan, MD, MPH Interventional Cardiology Duke University Medical Center

Embolic Protection for Vein Graft PCI Results from the ACC/SCAI NCDR CathPCI Registry. J. Matthew Brennan, MD, MPH Interventional Cardiology Duke University Medical Center. Investigator Team. J. Matthew Brennan, MD, MPH Wesam Al- Hejily , MD David Dai, PhD

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J. Matthew Brennan, MD, MPH Interventional Cardiology Duke University Medical Center

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  1. Embolic Protection for Vein Graft PCI Results from the ACC/SCAI NCDR CathPCI Registry J. Matthew Brennan, MD, MPH Interventional Cardiology Duke University Medical Center

  2. Investigator Team • J. Matthew Brennan, MD, MPH • WesamAl-Hejily, MD • David Dai, PhD • Richard E. Shaw, PhD • Marina Trilesskaya, MD • Sunil V. Rao, MD • EmmanouilS. Brilakis, MD, PhD • Kevin J. Anstrom, PhD • John Messenger, MD • Eric D. Peterson, MD, MPH • Pamela S. Douglas, MD • Michael H. Sketch Jr., MD

  3. Funding Support and Disclaimer This research was supported by the American College of Cardiology Foundation’s National Cardiovascular Data Registry (NCDR). The views expressed in this presentation represent those of the author(s), and do not necessarily represent the official views of the NCDR or its associated professional societies identified at www.ncdr.com.

  4. Disclosures No financial relationships to disclose Personal practice: • ~50% EPD use in SVG PCI cases

  5. Existing EPD Evidence Placebo-controlled (superiority) Active-controlled (non-inferiority)

  6. Study Aims • Evaluate the incidence of inhospital and long-term adverse outcomes in contemporary, ‘real world’ SVG PCI practice; • Evaluate the safety and effectiveness of embolic protection devices (EPD) in contemporary practice; • Evaluate outcomes associated with a ‘balanced practice’ vs. ‘no use’ strategy.

  7. Methods Cohort: NCDR CathPCI, 2005-2009 Seniors (65+) Treatment Comparisons: Embolic Protection Device vs. ‘No EPD’ Treatment Strategy ‘Balanced’ EPD vs. No EPD Use Outcome Assessment: Inhospital – CathPCI To 3 yrs – Medicare-linked Risk-adjustment Methods: Cox Proportional Hazards Propensity Matching

  8. Study Cohort

  9. Inhospital Outcomes p<0.001 p<0.001 p=0.045 p=ns p=0.001 Favors EPD

  10. Long-term Outcomes DEATH PM HR 0.96 (0.91, 1.02) REPEAT REVASC PM HR 1.02 (0.96, 1.08) MYOCARDIAL INFARCTION PM HR 1.00 (0.93, 1.09)

  11. Treatment Preference Outcomes evaluated for patients treated at ‘no use’ vs ‘balanced use’ centers.

  12. In Context Placebo-controlled (superiority) 17% Active-controlled (non-inferiority) Placebo-controlled (superiority) 5.5%

  13. Summary • 30-day MACE following SVG PCI has decreased substantially over the past decade; • Among Seniors treated at CathPCI Centers, there was no evidence that filter-design EPDs improved peri-procedural or long-term outcomes; • Current practice patterns and outcomes support equipoise for a contemporary, placebo-controlled evaluation of EPDs for the treatment of degenerated SVGs.

  14. Limitations • Non-randomized treatment comparisons; • Results derived from patients 65+ years; • Potential for exposure misclassification; • Post-PCI cardiac biomarker assessment is not routine at all PCI centers, particularly in uncomplicated cases.

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