Sirolimus‐coated balloon versus everolimus‐eluting stent in de novo coronary artery disease: Rationale and design of the TRANSFORM II randomized clinical trial

Abstract

Background: Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is a widely adopted strategy for the treatment of de novo coronary artery disease. DES implantation conveys an inherent risk for short-and long-term complications, including in-stent restenosis and stent thrombosis. Drug-coated balloons are emerging as an alternative approach to fulfill the "leaving nothing behind" principle and avoid long-term DES-related complications.Design: TRANSFORM II is an investigator-initiated, multicenter, noninferiority, randomized clinical trial, testing a sirolimus-coated balloon (SCB) versus the standard of care for native coronary vessels with a 2-3 mm diameter, in terms of 12-month target lesion failure (TLF; primary endpoint) and net adverse cardiovascular events (coprimary endpoint). Patients undergoing PCI will be randomized to be treated with either SCB or new-generation everolimus-eluting stent and will be followed up clinically for up to 60 months. Assuming a TLF rate of 8% at 12 months with DES, a sample size of 1325 patients was chosen to ensure an 80% power to detect a 1.5% lower incidence in the SCB group with a type I error rate of 0.05. The TRANSFORM II trial is registered on clinicaltrials.gov (identification number NCT04893291).Several substudies, including an optical coherence tomography assessment at 9 months (intracoronary imaging substudy), will investigate the study device in different clinical and lesion settings. Conclusions:The randomized TRANSFORM II trial will determine whether a novel SCB is noninferior to a current everolimus-eluting stent when adopted for the treatment of de novo lesions in coronary vessels with a diameter between 2 and 3 mm.

Long term clinical outcome of sirolimus drug coated balloons in large coronary vessels

“…We would like to acknowledge some important limitations for the current study. First, the study lacks of a control group due to the observational design and possible selection biases cannot be excluded and the ongoing TRASFORM II study comparing a sirolimus‐DCB with DES 21 will clarify this point. Moreover, there was no routine angiographic follow up probably reducing the rate of restenosis even though we considered more important clinical outcomes as death and MI that were low despite the elevated risk profile of the patients enrolled.…”

The evolution and revolution of drug coated balloons in coronary angioplasty: An up‐to‐date review of literature data

“…Patients will receive a follow-up until 5 years. 60 1.9 | Evidence for DCB in large vessel de novo lesions…”

“…Study investigators will also analyze the co‐primary endpoint of net‐adverse clinical events, where superiority of DCB is hypothesized. Patients will receive a follow‐up until 5 years 60 …”

Calcific lesions are the last frontier of endovascular therapies

“…And again, we would like to know if the important information provided by this study will automatically translate into the coronary field. Newer approaches with blended therapies of stents and DCB, 4 and newer prospective studies, including the ongoing TRANSFORM II, 5 will, fortunately, give more fuel to the topic and let us understand the best way to treat the last frontier of interventional cardiology.…”