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In the TRANSFORM II trial, a sirolimus drug-coated balloon met the prespecified standard for noninferiority to an everolimus drug-eluting stent for 12-month target lesion failure in selected native coronary lesions. The balloon avoids leaving a permanent metal implant, but any target-lesion revascularization was more frequent in the balloon group, and the results do not apply to all patients or all drug-coated balloons.
The TRANSFORM II trial found that a sirolimus drug-coated balloon was noninferior to an everolimus drug-eluting stent for 12-month target lesion failure in selected patients undergoing PCI for new, or de novo, native coronary lesions. The result adds evidence for an approach that can treat a narrowed artery without leaving a permanent metal stent, but researchers and clinicians cautioned that it should not be generalized to every lesion or drug-coated balloon.
Among patients assigned to the Magic Touch sirolimus-coated balloon, target lesion failure occurred in 2.1% by 12 months, compared with 2.4% among those who received an everolimus drug-eluting stent. The composite included cardiac death, target-vessel heart attack and ischemia-driven repeat treatment of the target lesion. The reported hazard ratio was 0.86, with a 95% confidence interval of 0.47 to 1.59; the balloon met the trial’s prespecified noninferiority criteria (P=0.004).
TRANSFORM II was an open-label, multicenter trial conducted in Europe, Asia and Brazil. Of 2,699 people screened, 1,842 were randomized after successful lesion preparation. Participants had native coronary lesions in vessels measuring 2.0 to 3.5 millimeters in reference diameter, with lesion lengths no greater than 50 millimeters. The average age was about 63, most participants were men, and roughly 30% were considered at high bleeding risk.
Some findings favored the stent on measures of repeat treatment and artery opening. Any target-lesion revascularization was reported in 2.5% of the balloon group versus 1.1% of the stent group (HR 2.31, 95% CI 1.10-4.85). By contrast, rates of ischemia-driven target-lesion revascularization were similar: 0.9% with the balloon and 0.8% with the stent. The reported post-procedure residual stenosis was also greater with the balloon. Bailout stenting was needed in 7.6% of patients assigned to the balloon.
Where a Stent-Free Approach Fits
The findings could give cardiologists another option for some patients with new coronary lesions. Drug-eluting stents are standard treatment and leave a metal scaffold in the artery; a drug-coated balloon delivers medication to the vessel wall without a permanent implant when the procedure succeeds without bailout stenting. Avoiding an implant may appeal in selected cases, but this trial does not establish that balloons should replace stents as routine care.
The distinction between the trial’s main endpoint and its repeat-procedure findings matters. The primary composite was similar enough to meet the study’s noninferiority test, while any revascularization was more common with the balloon. Because the trial was open-label, treatment decisions could have been affected by clinicians’ knowledge of which device was used. That possibility was raised by the presenting investigator, but was not established as the reason for the difference.
Practical adoption may also depend on price and reimbursement. At the conference, panelists questioned whether centers would use the device widely if its listed price was substantially higher than that of a drug-eluting stent. The trial reports clinical outcomes, not whether the approach is cost-effective in different health systems.
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Evidence Beyond Restenosis Treatment
Drug-coated balloons already have an established role in treating coronary in-stent restenosis, where tissue growth narrows an artery that has previously been treated with a stent. Their use in de novo disease is less settled. The source report notes a negative result from the REC-CAGEFREE I trial, alongside the prior SELUTION De Novo trial, which found its own drug-coated balloon noninferior to a drug-eluting stent for target lesion failure.
The devices are not interchangeable as a class. TRANSFORM II tested the Magic Touch sirolimus balloon, designed to release sirolimus that remains in the arterial wall for eight to 12 weeks. Bernardo Cortese, the presenting investigator, said the results support the device as an alternative in a selected population, while warning against assuming a class-wide effect for all drug-coated balloons.
Trial eligibility also shaped the result. Patients were randomized only after successful lesion preparation. The report says the study excluded several complex or higher-risk groups, including patients with severe calcification, highly tortuous vessels, left-main or vein-graft lesions, complex bifurcations, and ejection fractions below 30%. It also excluded people with a target-vessel PCI history and those with ST-segment elevation heart attack within 48 hours.
“I think we’ll have to wait and see.”
— Ajay Kirtane, MD, session co-chair
Limits and Open Questions
The reported results do not show whether the balloon offers a durable advantage beyond the 12-month follow-up described in the main findings. The source report does not provide longer-term outcomes, nor does it establish whether the higher rate of any target-lesion revascularization reflects a lasting difference between treatments.
It is also unclear how much the findings will change clinical practice. The trial tested one specific sirolimus balloon in a selected group after successful lesion preparation; it does not establish outcomes for other balloons or patients with excluded lesion types. The possible influence of open-label decisions on repeat procedures remains a speculation, not a proven explanation. Comparative costs, reimbursement and broader real-world performance also remain unsettled.
Longer Follow-Up and Patient Selection
Further follow-up and additional evidence will help establish whether the 12-month findings persist and which lesion and patient characteristics best identify candidates for balloon treatment. Clinicians will also need to weigh the potential benefit of avoiding a permanent implant against the observed revascularization figures and the possibility of bailout stenting.
For now, the study supports considering the Magic Touch balloon in a selected population, rather than replacing drug-eluting stents across the board. Decisions about use will also depend on local device pricing, reimbursement and how later evidence compares outcomes across devices and patient groups.
Key Questions
What did TRANSFORM II find?
In selected patients with de novo native coronary lesions, the Magic Touch sirolimus drug-coated balloon met the trial’s prespecified noninferiority criteria versus an everolimus drug-eluting stent for 12-month target lesion failure: 2.1% versus 2.4%.
Does the balloon leave a stent in the artery?
The balloon is intended to deliver medication without leaving a permanent metal implant. In TRANSFORM II, 7.6% of patients assigned to the balloon required bailout stenting.
Did repeat procedures occur at the same rate?
Not on every measure. Ischemia-driven target-lesion revascularization was similar, at 0.9% with the balloon and 0.8% with the stent. Any target-lesion revascularization was higher in the balloon group, at 2.5% versus 1.1%.
Do the results apply to every drug-coated balloon or coronary lesion?
No. The trial tested the Magic Touch sirolimus balloon in patients whose lesions met specific criteria and had successful preparation. The investigator cautioned that results should not be assumed to apply to all drug-coated balloons; several complex or high-risk patient groups were excluded.
Source: medpagetoday.com
