Researchers at Johns Hopkins have launched a nationwide study in USA to see if the procedures of angioplasty can be safely performed in smaller hospitals.
The study will enroll of more than 16,000 patients to see if a potentially life-saving angioplasty can be safely performed in smaller, community hospitals, easing access to the therapy for patients. Researchers expect to enroll the first study patients in early fall 2005.
Surgical backup is required for non-emergency angioplasty because, in rare instances, the procedure has led to a tear in a vessel or closing of an artery rather than opening it. The risk that angioplasty patients will need emergency heart bypass surgery is less than 1 to 2 in every 1,000 cases.
In the Hopkins-led study, conducted by the Cardiovascular Patient Outcomes Research Team, or C-PORT, participating patients who require angioplasty will be randomly assigned to have angioplasty at either the community hospital without on-site cardiac surgery where they underwent diagnostic catheterization or at a center with on-site cardiac surgery for angioplasty, which is the usual treatment. The researchers will follow each participant's progress for a period of six months to determine their health status and whether they have any subsequent problems related to their heart. At the end of the study, expected in 2008, the researchers will compare outcomes, or well being, of patients treated in the two groups.
About 40 community hospitals are expected to participate in the study. Special waivers from state authorities are required for participating community hospitals.