A sirolimus-coated balloon strategy met the TRANSFORM II trial’s noninferiority test against everolimus-eluting stents at 12 months after patients’ coronary lesions were successfully prepared.
Bernardo Cortese, MD, the trial’s principal investigator and study chair, presented the results Nov. 1 at Transcatheter Cardiovascular Therapeutics (TCT) 2026. Concept Medical announced the findings Nov. 2.
Target lesion failure occurred in 2.1% of patients assigned to the balloon strategy and 2.4% of those assigned to stents. The measure combined cardiac death, target-vessel myocardial infarction and ischemia-driven revascularization of the treated lesion. The hazard ratio was 0.86 (95% confidence interval 0.47 to 1.59), with P=0.004 for noninferiority. The risk difference was -0.40 percentage points, and the one-sided upper bound was 0.78 percentage points, below the prespecified 1.5-point margin.
Concept Medical reported that 1,842 patients took part across 11 countries. The company and the American College of Cardiology (ACC) reported 53 centers or sites; TCTMD reported 52. Participants had new lesions in native coronary arteries, with vessel diameters of 2.0 to 3.5 millimeters and lesion lengths up to 50 millimeters. Nearly half had acute coronary syndrome, more than one-third had diabetes, and about one-third were at high risk of bleeding.
Bailout stenting was used in 7.6% of patients assigned to the balloon strategy. No definite or probable lesion thrombosis was reported in that group, compared with 0.2% in the stent group. Any target lesion revascularization occurred in 2.5% of balloon-assigned patients and 1.1% of stent patients; ischemia-driven revascularization rates were 0.9% and 0.8%, respectively. Net adverse clinical events, including bleeding, were 4.1% with the balloon strategy and 5.3% with stents (hazard ratio 0.77; 95% confidence interval 0.50 to 1.17).
“Drug-coated balloon angioplasty should be seen as a strategy, not a simple device swap,” Cortese said. TCTMD reported that he cited participating centers’ experience with drug-coated balloon procedures as a limit on applying the findings to less experienced hospitals. The outlet also reported that session panelists raised device costs and reimbursement as issues for wider use.
Earlier trials tested different balloon devices and approaches. REC-CAGEFREE I reported three-year device-oriented composite event rates of 8.2% with a paclitaxel-coated balloon strategy and 5.0% with stents. In the separate SELUTION DeNovo trial, a sirolimus-eluting balloon strategy met its one-year noninferiority criterion for target-vessel failure, with rates of 5.3% and 4.4%.
Fondazione RIC lists clinical follow-up for TRANSFORM II as planned for up to five years.
