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March 10, 2013

MASS COMM Supports PCI at Hospitals Without On-Site Cardiac Surgery Services

March 11, 2013—Nonemergency angioplasty performed at hospitals without on-site cardiac surgery capability is no less safe and effective than angioplasty performed at hospitals with cardiac surgery services, according to research from the MASS COMM trial, which was presented at the 62nd annual scientific session of the American College of Cardiology (ACC) in San Francisco.

According to the press release issued by the ACC, this study adds to the growing body of evidence supporting favorable outcomes for patients undergoing elective or nonemergency angioplasty at hospitals without cardiac surgery on-site.

The ACC noted that there are several reasons for expansion of nonemergency percutaneous coronary intervention (PCI) to hospitals without cardiac surgery programs. Addressing these reasons in the press release, the study's lead investigator Alice K. Jacobs, MD, commented, “Among them are patient choice and patient and physician convenience afforded by providing the ability to remain in a local and familiar community. In addition, the added volume of PCI procedures at these hospitals could help to provide resources to support active primary PCI programs. However, controversy continues to exist surrounding this expansion of services to treat patients in nonemergency settings, where timely access to angioplasty is less important to cardiovascular outcomes, and the risk to benefit ratio may differ from the emergency setting.”

Dr. Jacobs, who is Professor of Medicine at Boston University School of Medicine, led the team of investigators in this prospective, randomized trial comparing the safety and effectiveness of nonemergency angioplasty at 10 hospitals in Massachusetts without on-site cardiac surgery services and at seven hospitals with on-site cardiac surgery services. A total of 3,691 patients were randomly assigned in a 3:1 ratio to undergo angioplasty: 2,774 at hospitals without on-site cardiac surgery and 917 at hospitals with surgical backup. Of the 3,691 patients, the mean age was 64 years, 32% were women, 32% had diabetes, and 61% presented with acute coronary syndrome.

As summarized in the ACC announcement, the investigators assessed rates of major adverse cardiac events (MACE), including death, heart attack, repeat angioplasty, and stroke at 30 days and 12 months post-PCI. MACE rates at 30 days were 9.5% for sites without on-site cardiac surgery compared to 9.4% for those with surgical services. Outcomes did not differ significantly between the nonsurgical and surgical groups for all-cause mortality, heart attack, repeat angioplasty, or stroke. At the 12-month follow-up, MACE rates were 17.3% for sites without on-site surgery compared to 17.8% for sites with surgical services available, and rates of mortality, heart attack, repeat angioplasty, and stroke did not differ between groups.

A random sample of 376 study subjects was selected to monitor clinical practice patterns between hospitals with and without cardiac surgery on-site. There were no significant differences between the two treatment groups with respect to procedural success rates, completeness of angioplasty, or the proportion of lesions classified as meeting the ACC Foundation/American Heart Association/Society for Cardiovascular Angiography and Interventions PCI guidelines class I or II recommendations for anatomic indications to perform PCI.

“While we did not directly compare all PCI procedures at hospitals with and without cardiac surgery, our results suggest that performance of angioplasty in hospitals without cardiac surgery but with the appropriate experience, established angioplasty programs, and the required hospital and operator volume is an acceptable option for patients presenting to these hospitals for care,” commented Dr. Jacobs in the ACC press release.

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March 11, 2013

Stentys' APPOSITION III Data Demonstrates Low Mortality Rates in STEMI Patients

March 11, 2013

Stentys' APPOSITION III Data Demonstrates Low Mortality Rates in STEMI Patients


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