DCB in STEMI Match DES Through 5 Years: REVELATION

Five-year follow-up from the small, randomized REVELATION trial indicates that rates of clinical events are similar between STEMI patients initially randomized to a drug-coated balloon (DCB) or drug-eluting stent implantation.

The findings, though not powered for hard outcomes, hint at a potential new niche for drug-coated balloons in the coronaries, although convincing interventionalists to forgo stents in this setting may be difficult, authors of the follow-up study acknowledge.

REVELATION, originally published in 2019, randomized 120 STEMI patients treated at a single center to the paclitaxel-releasing Pantera Lux DCB (Biotronik) or to an Orsiro (Biotronik) or Xience (Abbott) contemporary DES. By 9 months, the DCB group was noninferior to the DES group in terms of fractional flow reserve, with similar rates of late lumen loss in the two study arms.

“The good technical results after 9 months, and the results of clinical outcomes after 2-year follow-up, already were encouraging,” Sander R. Niehe, MD (OLVG Hospital, Amsterdam, the Netherlands), lead author of the new paper, told TCTMD in an email. He added that the 5-year follow-up data are the most extensive to date on DCB versus DES in STEMI.

The 5-year results were published recently as a research letter in JACC: Cardiovascular Interventions.

Evidence Mounts, but Setting Matters

Evidence has continued to roll in for DCB in small coronaries, most notably from the BASKET-SMALL 2 and PICCOLETO II trials, and more are on the way from the ongoing TRANSFORM II and SELUTION trials. For in-stent restenosis (ISR), the AGENT IDE trial’s interim results led to the recent US Food and Drug Administration approval of the Agent DCB (Boston Scientific)—the device is already approved for use in Europe, parts of Asia Pacific, and Latin America for the treatment of ISR and previously untreated small-vessel coronary disease.

Other studies have explored the potential for using DCB in ACS and patients at high bleeding risk, and the Hybrid DEB trial is currently testing a balloon-based strategy for chronic total occlusion PCI. In complex lesions, PICOLETTO III also is on the way.

“We see that there's an increasing enthusiasm for using DCB in different settings, but we have to admit that the use of DCB in [the STEMI] setting still is not common practice,” said Niehe. “Many operators are still not comfortable with leaving a small dissection or [ending up with] a coronary lesion that does not resemble a stent-like result,” and data on the clinical outcomes with DCB alone are still limited, he said, adding that the researchers hope their results can encourage the use of DCB in STEMI. Just last year, a propensity-matched, retrospective study of STEMI patients in the United Kingdom also hinted that DCB could be an alternative to DES in the STEMI space, Niehe and colleagues point out.

Bernardo Cortese, MD (Fondazione Ricerca e Innovazione Cardiovascolare, Milan, Italy), who led PICCOLETTO II and recently presented the ANDROMEDA meta-analysis of DCB at CRT 2024, said that the REVELATION trial, though small and designed as a mechanistic study, is important in that it shows the devices are safe.

Speaking with TCTMD, he recalled the EXAMINATION trial of DES versus BMS in STEMI patients, which showed an advantage for DES at 1 year but no difference between the two devices thereafter. “What physicians, in my opinion, should keep in mind is if you put metal [in], that’s it,” no matter whether the device is a DES or BMS, Cortese commented.

The 5-year data from REVELATION point to DCBs as an alternative, even in STEMI, he said. “This is fascinating for me. [In cardiology] the feeling now is that stents are working well, but in some settings—small vessels, complex lesions, calcific lesions—they are not as perfect as they are perceived, because there is still an [accrual of] events that will never stop.”

Only One Event After 2 Years

Five-year follow-up data from REVELATION were available for 93.3% of the DCB group and 85% of the DES group. MACE rates were 5.4% with DCB (one recurrent MI and two TLRs) and 3.9% with DES (one recurrent MI and one TLR; P = 0.72).  Among these events, only one—a recurrent MI in a DES patient due to a thrombotic occlusion adjacent to index stent—occurred between 2 and 5 years. In the DCB group, one patient who had bailout stenting during the index procedure subsequently underwent multiple target-vessel revascularizations, first to address stent-related problems in other segments then eventually bypass surgery in the target lesion.

But in the entire cohort, only one new event occurred between 2 and 5 years: a recurrent MI in a DES patient.

“These encouraging results suggest a ‘truly leaving nothing behind strategy’ is efficacious in selected patients presenting with STEMI, but more evidence by larger and adequately powered randomized trails is needed to substantiate these findings,” the investigators conclude. They caution, though, that “due to the small sample size and power calculations performed to evaluate the primary endpoint, this study is not powered to detect differences in clinical outcomes.”

Niehe, for his part, also pointed out that REVELATION enrolled a selected group of low-risk patients.

Still, the results for DCB are reassuring in that events related to the target lesion did not accrue. “One could imagine repeat revascularization would be necessary in case of insufficient treatment of the target lesion. Since sufficient lesion preparation was mandatory, we did not expect any late catch-up after DCB treatment,” he explained. “On the contrary, stent-related events are expected to accrue even very late after DES implantation.”

Although Cortese said more trials are necessary to confirm whether there’s an outcomes advantage for DCB in STEMI, he and others are already using the strategy. “Today out of my six PCIs, I did two STEMIs and I used DCB in both of them, with an excellent result,” he said, adding, “We are using it selectively, of course, not in all of the cases.”

Cortese advised that operators, in addition to choosing the right patients for DCB, must also gain relevant experience, first through small vessels and ISR cases and particular subsets like high-bleeding-risk patients. STEMI “is the last frontier” to be mastered, he said. “That stage will arrive with time. You have to be accustomed to this technology.”

The challenge doesn’t lie with the balloons, but with what comes before, said Cortese. “It’s not the DCB. The DCB is the last part of the job. What is very important is, first of all, to address the lesion: do imaging. . . . And after that you have to prepare the lesion. This is a little bit different compared to drug-eluting stents, because you have to be a bit more patient [and] follow some steps.” Using the DCB is the final stage that should only come after understanding and treating the lesion, he added.