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In the TRANSFORM II trial, the Magic Touch sirolimus drug-coated balloon met the prespecified noninferiority standard against an everolimus drug-eluting stent for 12-month target lesion failure in selected de novo coronary lesions. The findings support a stent-free option for some patients, but do not establish that all drug-coated balloons work alike or that the approach suits every lesion.
The TRANSFORM II trial found that a sirolimus drug-coated balloon was noninferior to a drug-eluting stent for preventing target lesion failure at 12 months in selected patients treated for new coronary artery lesions. The result adds evidence for a PCI option that leaves no permanent metal in the treated artery, but applies to lesions that could be successfully prepared and met the trial’s eligibility criteria.
Among 1,842 randomized participants, target lesion failure — a composite of cardiac death, target-vessel heart attack and ischemia-driven repeat treatment of the lesion — occurred in 2.1% of patients assigned the Magic Touch sirolimus balloon and 2.4% assigned an everolimus drug-eluting stent. The hazard ratio was 0.86 (95% CI 0.47-1.59); the balloon met the trial’s prespecified noninferiority criteria (P=0.004), according to results presented by Bernardo Cortese, MD, MSc, at the Transcatheter Cardiovascular Therapeutics meeting.
The trial was open-label and multicenter, enrolling patients in Europe, Asia and Brazil. Patients had native coronary lesions in vessels 2.0 to 3.5 mm in diameter and lesions no longer than 50 mm. After successful vessel preparation, participants were randomized to the balloon or stent. In the balloon group, 7.6% required bailout stenting. The study report said the intention-to-treat findings were consistent with the per-protocol analysis.
Some measures favored the stent on angiographic results: after PCI, residual in-device stenosis was lower with stents, and the proportion with residual stenosis below 30% was 97.9% with stents versus 61.2% with the balloon. Any target-lesion revascularization was reported in 2.5% of the balloon group and 1.1% of the stent group (HR 2.31, 95% CI 1.10-4.85). By contrast, clinically driven revascularization was similar: 0.9% with the balloon and 0.8% with the stent. Net adverse clinical events were not significantly different, at 4.1% and 5.3%, respectively.
A Metal-Free Option for Selected Lesions
Drug-eluting stents are standard treatment for many patients with coronary artery disease, but they leave a permanent metal scaffold in the artery. A drug-coated balloon delivers medication during PCI without leaving that scaffold behind. The trial’s findings suggest that, for patients whose lesions fit the study criteria and can be prepared successfully, the Magic Touch balloon may offer comparable 12-month results on the trial’s primary composite outcome.
The result does not mean the balloon is preferable for every patient. The higher rate of any repeat treatment and the weaker angiographic measurements in the balloon arm are relevant alongside the primary endpoint. Nor does noninferiority show that the treatments are identical; it means the study met a prespecified threshold for ruling out an unacceptable disadvantage on its primary measure. Decisions about use will also be affected by device cost and reimbursement, as well as clinician judgment about lesion features.
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Evidence Beyond Restenosis Treatment
Drug-coated balloons have an established role in treating coronary in-stent restenosis, where tissue growth narrows a previously stented artery. Their use in de novo lesions — arteries being treated for the first time at that site — has been less settled. The source report notes that the negative REC-CAGEFREE I trial raised concerns, while the prior SELUTION De Novo trial found its own balloon noninferior to a drug-eluting stent for target lesion failure.
Those results do not establish a class-wide effect. Cortese cautioned that different drug-coated balloons should not be assumed to perform alike. Magic Touch is designed to release sirolimus and retain it in the arterial wall for an estimated 8 to 12 weeks, according to the report. TRANSFORM II tested this specific device against an everolimus-eluting stent, not every balloon or stent on the market.
“Cath labs will be willing to switch to DCBs if the listing prices are about $6,000, compared with the $300 to $400 for DES.”
— Ajay Kirtane, MD, session co-chair
Patient Selection and Long-Term Results
The findings are limited to the selected lesions studied and the 12-month primary outcome. The report says the results do not apply to lesions that could not be successfully prepared and excluded, among others, severe calcification, highly tortuous vessels, left main or vein-graft lesions, complex bifurcations, recent ST-segment elevation heart attack, previous PCI in the target vessel and ejection fraction below 30%. The trial also included a substantial share of patients with more complex lesions, but that does not remove the eligibility limits.
It remains unclear whether the difference in any target-lesion revascularization will persist with longer follow-up or how clinicians should interpret it alongside similar rates of clinically driven repeat treatment. The source report also does not provide longer-term results, detailed cost-effectiveness findings or evidence that the findings extend to other balloon devices. Cortese’s proposed explanation for the repeat-treatment difference was explicitly speculative, not a proven cause.
Longer Follow-Up and Practical Use
The next questions are whether longer follow-up supports the 12-month findings and which patient and lesion characteristics best identify candidates for balloon treatment rather than stenting. Clinicians and health systems will also have to weigh device pricing, reimbursement and the need for bailout stenting against the potential benefit of leaving no permanent metal behind.
The available report does not specify a further TRANSFORM II publication date or a change to clinical guidance. Until additional data and guidance clarify those issues, the results support consideration of the tested balloon in a selected population, not a general replacement for drug-eluting stents.
Key Questions
What did TRANSFORM II find?
The trial found target lesion failure at 12 months in 2.1% with the Magic Touch sirolimus balloon and 2.4% with an everolimus drug-eluting stent. The balloon met the trial’s prespecified noninferiority criteria for that outcome.
What does stent-free PCI mean here?
A drug-coated balloon delivers medication to the artery during PCI but leaves no permanent metal scaffold. In TRANSFORM II, 7.6% of patients assigned the balloon required bailout stenting.
Does the study show that all drug-coated balloons work as well as stents?
No. The trial tested the Magic Touch sirolimus balloon against an everolimus drug-eluting stent. The presenter cautioned that results should not be assumed to apply to every drug-coated balloon.
Did repeat procedures occur at the same rate?
Clinically driven target-lesion revascularization was similar, at 0.9% with the balloon and 0.8% with the stent. Any target-lesion revascularization was higher with the balloon, 2.5% versus 1.1%; the report said a proposed explanation for that difference was speculative.
Who was not represented by the study findings?
The findings do not cover all coronary lesions. The study excluded, among other groups, patients with severe calcification, highly tortuous vessels, left main or vein-graft lesions, complex bifurcations and lesions that could not be successfully prepared.
Source: medpagetoday.com
