Elective PCI Without On-site Surgery? Crestwood Medical Center Makes the First Move

In the ongoing trend to show the improved outcomes of patients who receive percutaneous coronary intervention versus thrombolytic therapy for the treatment of acute myocardial infarction (MI), Crestwood Medical Center of Huntsville, Alabama has been one of the facilities without on-site surgery (OSS) participating in The Atlantic Cardiovascular Patient Outcomes Research Trial (C-PORT) headed by Thomas Aversano, MD, Associate Professor of Medicine at the Johns Hopkins Medical Institutions. During this primary study, Crestwood’s cath lab demonstrated an average door-to-balloon time of 73 minutes, well below the national average of 105 minutes. Speed to treatment is vital, with data from a June 2005 study in the American Journal of Cardiology showing that treatment occurring more than 90 minutes after onset has up to a 12% one-year mortality rate. During the 2002 Scientific Sessions of the American Heart Association, data was presented with the conclusion that emergency angioplasty in hospitals without surgical backup is safe. With these primary registry results in hand, the C-PORT project has been expanded to include a randomized study of elective percutaneous coronary intervention (PCI). Following completion of a three month, study-required development program, Crestwood Medical Center (CMC) went live with the study pilot on September 1, 2005. In accordance with American College of Cardiology and American Heart Association guidelines for the performance of elective PCI, the state of Alabama has adjusted the State Health Plan and provided a Certificate of Need to allow CMC to participate in the study to collect more data. The objectives of this trial are to compare the outcomes of non-primary PCI at hospitals with and without on-site cardiac surgery. Outcomes that will be compared include mortality, incidence of emergency bypass surgery, myocardial infarction, stroke, clinical and angiographic success rates and the direct cost of care. All patients receiving PCI, whether at Crestwood or a tertiary facility, will have clinical trial follow-ups at 6 weeks, 3 months and 6 months post-procedure. The study will ultimately include approximately 16,000 patients at 30 to 40 hospitals nationwide. Patients are randomized at a 3:1 ratio, so that out of every four eligible patients, three remain at CMC for treatment with the other patient transferring to a facility with on-site surgery (OSS). As of October 14, 2005, Crestwood Medical Center enrolled 11 patients between the four physician investigators involved in the study. With public enthusiasm and support, CMC’s cath lab looks to provide more treatment choices for patients in our community, improve access to and utilization of PCI services and, ultimately, improve the quality of life for our patients.

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