ACC/SCAI – i2 Summit Late Breaking Clinical Trials March 29, 2008

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ACC/SCAI – i2 Summit Late Breaking Clinical Trials March 29, 2008 Percutaneous Coronary Interventions in Facilities without On-Site Cardiac Surgery: A Report from the National Cardiovascular Data Registry (NCDR) ACC/SCAI – i2 Summit Late Breaking Clinical Trials March 29, 2008

Study Population

MI Presentation

Procedural Success and Complications

Observed Outcomes: All PCI Patients

Risk Adjusted Outcomes Odds Ratio (OR): outcomes for patients at On-Site (vs. Off-Site) facilities adjusting for site correlations and potential confounding variables

Conclusions Compared to On-Site PCI centers, Off-Site PCI programs participating in the NCDR: Have smaller bed capacities. Are predominantly located in rural and suburban areas. Have lower annual PCI volume. Treat a higher percentage of patients who present with subsets of MI (STEMI and NSTEMI). Have better reperfusion times in primary PCI.

Conclusions Compared to On-Site PCI centers, Off-Site PCI programs have similar observed: Procedure success Morbidity Emergency surgery rates Mortality in cases that require emergency surgery The risk-adjusted mortality rate in Off-Site facilities was comparable to those PCI centers that have cardiac surgery on-site.

Implications Off-Site PCI centers can provide excellent care to patients – if the program is developed with thoughtfulness and safety. Our results are derived from PCI programs who have demonstrated a strong commitment to quality and attention to key structure, process, and outcomes measurements. Without such a commitment, similar results might not be achievable.

Implications The results of our study should not be extrapolated to encourage the wide-spread proliferation of Off-Site PCI programs. Our study confirms the safety of an Off-Site PCI strategy at centers where rigorous clinical, operator, and institutional criteria are in place and are monitored to assure high quality outcomes.