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# DCBs Putting the Squeeze on DES in Coronary Artery Stenosis
- URL: https://www.themedtechscribe.com/dcbs-putting-the-squeeze-on-des-in-coronary-artery-stenosis/
- Published: 2026-11-02T15:18:10.000Z
- Updated: 2026-11-02T15:29:46.000Z
- Author: Mark McCarty
- Tags: Cardiology

The drug-eluting stent (DES) has dominated the world of device treatment of treatment-naive coronary artery stenosis for two decades, but a study unveiled Nov. 1 may help erode that dominance. One-year data from the TRANSFORM II study suggests that drug-coated balloons (DCBs) may be appropriate for some instances of de novo stenosis, although the data fall short of suggesting the DES is obsolete.

The TRANSFORM II study evaluated the use of a sirolimus-coated balloon as an alternative to a DES using everolimus as the antiproliferative. The study, presented at the 2026 edition of Transcatheter Cardiovascular Therapeutics (TCT), allowed investigators to use any available everolimus-eluting stent for the control arm. It seems likely that patients in the control arm received a DES made by either Abbott Vascular and its Xience series of DES devices, or Boston Scientific and its Promus and Synergy lines of DES units. The balloon in this study is the Magic Touch device by Concept Medical Inc., of Tampa.

The primary endpoint in TRANSFORM II is target-lesion failure, which at 12 months had occurred in 2.1% of patients treated with the Magic Touch and 2.4% of DES patients. Target-lesion failure for the purposes of this study is a composite of cardiac death, revascularization of the lesion due to ischemia, or target-vessel infarct. The results for this endpoint provided a p score of 0.004, demonstrating non-inferiority for the Magic Touch.

A press release from TCT states that the “key secondary endpoint” of net clinical events, also a composite, occurred in 4.1% of the Magic Touch arm and 5.3% of the DES arm. Net clinical events consist of all-cause death, myocardial infarct, ischemic stroke, or major bleeding as described by a scale developed by the Bleeding Academic Research Consortium (BARC).

TCT issued a Nov. 1 press release for this study which states that the hazard ratio for this secondary outcome was 0.77 for the Magic Touch and that the 95% confidence interval was 0.50-1.17\. There is some noise about the standing of this secondary endpoint, given that it has been [previously described](https://www.pcronline.com/News/Press-releases/2022/Much-Awaited-Much-Needed-TRANSFORM-II-Randomized-Controlled-Trial-by-Fondazione-RIC-gets-rolling?ref=themedtechscribe.com) as a co-primary endpoint evaluated for superiority rather than non-inferiority. At any rate, the fact that the confidence interval spanned 1.0 indicates that this co-primary/secondary endpoint did not reach statistical significance.

This study was limited to de novo lesions in vessels with a diameter of 2.0-3.5 millimeters and a length of no greater than 50 millimeters. Previously treated vessels were excluded as were vessels with severe calcification along with lesions occurring in the left main artery. Both arms were populated by roughly 920 enrollees, and 7.6% of the patients initially treated with the study article were converted to bail-out stenting. Patients were enrolled only after a diagnosis of acute or chronic coronary syndrome. The study will follow these patients out to five years, which suggests an opportunity for the differences between the two approaches to shift over time.

The primary clinical investigator, Bernardo Cortese, said in [an interview posted Nov. 1](https://x.com/CMichaelGibson/status/2116972520800710914?ref=themedtechscribe.com) that a similar study had been presented during the 2025 TCT conference, which had also suggested that DCBs were non-inferior to DES for a “pretty much all-comer population.” The reference was likely to studies of the Selution device by Cordis, although 20% of the patients on the Selution device ended up with a stent, a big jump from the 7.6% in TRANSFORM II.

**Stage of randomization may have improved outcomes**

Cortese, director of cardiology at the San Carlo Clinic in Milan, Italy, said “the big difference is that here, we randomized the patient only after successful lesion preparation,” a significant change from the design of the Selution study. Cortese said the investigators were surprised at how low the event rate was in the Magic Touch arm of the study, adding that the non-inferiority margin was met for the as-treated, intent-to-treat and per-protocol populations. “These were absolute \[non-inferiority\] margins” rather than relative margins, he stated, adding that there were a couple of possible reasons for the unexpectedly low adverse event rates.

One of these may have been the exclusion of patients for whom predilation of the target vessel failed, Cortese said. Another factor may be that the study was largely populated by patients whose target vessels were less than 3 millimeters in diameter. Nearly six in 10 of the treated vessels met this threshold, a fact which may have helped suppress any clinical-driven events.

Cortese said the results might alter clinical practice in some nations, but not in the U.S. due to lack of FDA approval. He was wary of predicting a massive uptake in clinical practice in non-U.S. nations in part because only about 5% of the enrollees in TRANSFORM II suffered from severe calcification. The study did not include patients with elevated ST-segment on electrocardiography, commonly assumed to signal injury to the entire thickness of the myocardium and often a harbinger of poor outcomes.

Cortese added that the omission of left main disease is another barrier to more aggressive adoption, which can also be said of complex bifurcation lesions. “It's not the all-comer population” that might encourage clinicians to opt for balloon treatment in lieu of stenting, he said, adding that accumulated data might bring more clinicians off the sidelines.

**The past, present and future of DCBs for CAD**

As the TCT press release points out, the DES has served as the standard treatment for de novo lesions in coronary artery disease (CAD) for quite some time, although drug-coated balloons have made some headway as a treatment for in-stent restenosis (ISR). There was some success for DCBs for ISR in the 2000s, which prompted some manufacturers to investigate their ability to deal with de novo lesions, usually with paclitaxel serving as the antiproliferative.

Interest in this application of DCB waned, however, with the advent of DES devices bearing one of the so-called “limus” series of antiproliferatives. Paclitaxel works as a cytotoxic agent whereas the limus drugs are cytostatic in nature and less likely to incur unwanted damage to nearby tissues. Paclitaxel finds lipids sticky, however, and thus offers more reliable binding to the interior lining of the vessel wall. Concept Medical seeks to overcome the lack of stickiness in sirolimus in part by packaging it into nanospheres that provides the needed persistence.

The market for DCBs in this indication seems likely to heat up, but much of the driver of clinical and patient interest in DCBs in general is the desire to avoid a permanent implant. This interest drove Abbott to develop the Absorb BVS bioresorbable stent, which the company withdrew in 2017 after a significant investment in resources. Abbott has since resurrected the technology behind the Absorb as a treatment for peripheral artery disease.

Boston Scientific is working to expand the indication for its Agent DCB to include treatment of de novo stenosis, a device using paclitaxel and currently approved by FDA for ISR. The Agent DCB Stance study is examining the use of the Agent in de novo lesions while Cordis' Selution device is in trial using sirolimus as the antiproliferative of choice. Other companies pursuing market share in this space include Medtronic (also using paclitaxel), B. Braun and Biotronic. The debate over paclitaxel versus one of the limus drugs seems destined to continue for the foreseeable future, if only because manufacturers have continually engineered novel methods of embedding their choice of antiproliferative into devices such as DESs and DCBs.

Analysts are bullish on DCBs generally, with one source [predicting market growth](https://pmarketresearch.com/hc/drug-eluting-balloon-for-coronary-artery-disease-market/?ref=themedtechscribe.com) from $1.5 billion in 2025 to $1.95 billion in 2032\. De novo lesions accounted for only about 18% of this market in 2025, but that share of the overall market seems poised to grow significantly in the coming years. Concept Medical is not a publicly traded company and thus there is no way to gauge the impact of the TCT presentation on the company's financials.