TCT-522 Clinical and angiographic features of a wide population of native coronary artery disease treated with stent or sirolimus-coated balloon. The TRANSFORM II BASIC randomized clinical trial
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Authors
Cortese B.
Ahmed M.
Malik F.T.N.
Paradies V.
Uddin M.J.
Alfonso F.
Costa R.
Sangiorgi G.
Rigattieri S.
Meunier L.
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2025
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Background: Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains the most widely adopted strategy for revascularization in patients with obstructive coronary artery disease (CAD). In recent years, drug-coated balloons (DCB) have emerged as an alternative PCI strategy, with most evidence focused on the treatment of in-stent restenosis. By contrast, data comparing the efficacy of DCB versus DES for the treatment of de novo coronary artery lesions also in large vessels remains limited and inconclusive. Method(s): TRANSFORM II is an investigator-initiated, multicenter, randomized, non-inferiority trial designed to evaluate the efficacy and safety of the Magic Touch sirolimus-coated balloon (SCB, Concept Medical, USA) compared with everolimus-eluting DES. The trial enrolled patients undergoing PCI for de novo coronary lesions in native vessels with a reference diameter between 2.0 and 3.5 mm and was conducted across 53 centers worldwide between November 2021 and June 2025. Primary endpoint of the trial, target-lesion failure, will be completed in May 2026. In this analysis, we compared clinical and angiographic characteristics of patients enrolled during the first versus the last 50th percentile of recruitment at each participating center. Analyses were performed in the overall study population as well as within the SCB and DES treatment arms. Result(s): Of the target population of 1833 patients, 918 were allocated to the DES arm and 915 received treatment with SCB. Thirty- seven percent of patients presented with acute coronary syndrome and 37% had complex target lesions classified as ACC/AHA type B2 or C. The mean lesion length was 21 +/- 9 mm, and the mean reference vessel diameter was 2.80 +/- 0.38 mm. Lesion predilatation was performed in all cases, and approximately 35% of patients underwent multivessel PCI. Bailout stenting occurred in 6.7% of the SCB-treated patients. Patients enrolled in the latter 50th percentile of recruitment had a lower prevalence of dyslipidemia compared to those enrolled in the first half (49% vs. 54%, p = 0.029), and a higher prevalence of complex target lesions (38% vs. 32%, p = 0.008). Additionally, the use of non-compliant balloons for predilatation was more frequent in the latter 50th percentile group (48% vs. 38%, p < 0.001). No other significant differences in baseline clinical or angiographic characteristics were observed between the two groups. When stratified by treatment arm, patients in the SCB group who were enrolled in the latter 50th percentile had a significantly higher prevalence of complex target lesions (35% vs. 26%, p = 0.002) and calcified lesions (38% vs. 31%, p = 0.039). In contrast, within the DES group, no significant angiographic differences were observed between the two enrollment periods. Conclusion(s): The TRANSFORM II trial enrolled 1833 patients, treated with either SCB (n = 915) or DES (n = 918). As enrollment progressed, treated lesions were more complex, especially in the SCB arm. These findings may reflect the progressive confidence in using DCB in more complex lesions in the recent years. Copyright © 2025
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Journal of the American College of Cardiology
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Transcatheter Cardiovascular Therapeutics Abstracts.