A three-year SIRONA analysis published in JACC: Cardiovascular Interventions found no difference in changes in patient-reported walking distance between two coated-balloon treatments, despite an exploratory sirolimus advantage in repeat treatment at the original lesion.
The trial assigned 482 patients with femoropopliteal artery disease to sirolimus- or paclitaxel-coated balloon angioplasty at 25 centers in Germany and Austria. Most participants, 96.3%, had intermittent claudication.
Changes in participants’ estimates of pain-free and maximum walking distance did not differ between the groups. Neither did changes in general health-related quality of life. At the three-year telephone visit, researchers asked participants to estimate their walking distances; they did not administer walking tests or use a disease-specific quality-of-life measure.
The JACC analysis also reported an estimated advantage in freedom from repeat treatment at the original lesion: 88.2% for sirolimus, compared with 80.2% for paclitaxel. That measure covers another procedure at the treated site prompted by symptoms and clinical evidence.
The lesion-level finding was not accompanied by a statistically significant difference in clinically driven repeat procedures anywhere in the treated vessel. Estimated freedom from clinically driven target-vessel revascularization was 83.8% with sirolimus and 79.1% with paclitaxel, a difference that was not statistically significant.
Investigators said the lesion-level result needs confirmation. SIRONA was powered to assess its primary endpoints at 12 months, and the three-year comparisons were not adjusted for multiple testing. Clinical follow-up at three years was available for 182 of 238 patients assigned to sirolimus and 194 of 244 assigned to paclitaxel.
Estimated all-cause mortality was 7.4% in each group. The trial lacked the statistical power to compare uncommon safety outcomes.
Concept Medical Inc. funded SIRONA and provided the sirolimus balloons free of charge. The JACC article’s funding disclosure says the company had no role in analyzing the data, interpreting the findings, preparing the manuscript or deciding to submit it. The article also lists author relationships with Concept Medical.
Follow-up through five years is continuing to assess whether the difference in repeat treatment at the original lesion persists.
