There were no statistical differences between groups in the rates of the individual components of the primary endpoint at 12 months: rates of cardiac death were 3.1% versus 1.3% (p=0.113), rates of nonfatal heart attack were 1.6% versus 3.5% (p=0.112), and rates of target vessel revascularisation were 3.4% versus 4.5% (p=0.438) in the balloon versus stent groups, respectively. The rate of major bleeding at 12 months was similar in the balloon (1.1%) and stent (2.4%) groups (p=0.183).
“The potential benefits of a stent-free option to treat small blocked arteries are numerous,” said Professor Jeger. “With no permanent implant left after the procedure, the problem of tissue growth and clot formation within the stent is eliminated. In addition, there may be no need for prolonged treatment with anticlotting medicines, which has been controversial since it increases the risk of bleeding.”
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He concluded: “Drug coated balloon angioplasty has the possibility to become the standard treatment for small blocked arteries. We will continue to monitor patients in the trial for a further two years for major adverse cardiac events, stent thrombosis, and bleeding.”
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