Drug-Coated Balloon Flops for De Novo Coronary Lesions

LONDON — Drug-coated balloon (DCB) angioplasty as the initial strategy for de novo coronary artery stenoses didn’t measure up to stenting from the start, the REC-CAGEFREE I randomized trial showed.

DCB with rescue use of drug-eluting stents (DES) nearly doubled the composite 24-month rate of cardiovascular death, target vessel myocardial infarction (MI), and clinically and physiologically indicated target lesion revascularization as compared with randomization to intended stenting (6.4% vs 3.4%, P=0.0008), which failed to meet the non-inferiority criterion.

The difference was driven by target lesion revascularization and by substantially higher risk in non-small vessel disease that required a device diameter of at least 3.0 mm, Ling Tao, MD, PhD, of Xijing hospital in Xi’an, China, reported at the European Society of Cardiology (ESC) meeting. The findings were simultaneously published in The Lancet.

“DES implantation should remain the preferred treatment strategy at the present,” Tao said, adding: “We must acknowledge that DES is so excellent in current days. For 2 years to only have 3.4% of those… it’s difficult to improve currently.”

There’s still room to look for lesion types that might be suitable to treat without leaving a stent behind, she suggested, such as bifurcation lesions or those with fibrosis, and to consider DCB that deliver a more sustained drug dose.

“We will still continue to follow the patients for 10 years to examine the hypothesis of whether late events can be prevented by DCB and also to explore whether the higher rate of revascularization in the DCB group would translate into mortality or MI,” she added.

It’s the first randomized trial powered for outcomes in the context of DCB, noted ESC session study discussant Valeria Paradies, MD, of Maasstad Hospital in Rotterdam, the Netherlands. Still, she concluded, “definitely we need more data.”

The trial included 2,272 adults at 43 sites in China with an indication for percutaneous coronary intervention after successful lesion pre-dilatation due to de novo, non-complex coronary artery disease regardless of target vessel diameter. They were randomly assigned to open-label treatment with either a strategy of paclitaxel-coated balloon angioplasty with the Swide balloon coated with a mixture of paclitaxel and iopromide (followed by optional rescue stenting, if unsatisfactory) or intended deployment of a second-generation thin-strut sirolimus-eluting Firebird 2 stent. Neither device is FDA approved.

The study population was entirely of Chinese ethnicity and predominantly male (69.3%), with a median age of 62. Bailout stenting was used for 9.4% of the DCB group.

No acute vessel closures occurred in the DCB group during the procedure; one (0.1%) occurred in the DES group. Periprocedural MI rates were similar between groups, at 0.9% and 0.8%, respectively.

Paradies cautioned that neither the interventional or control devices have been tested in randomized trials or in registries in Europe.

“We know that we do have good results in term of late lumen enlargement for paclitaxel-eluting balloons as compared to sirolimus-eluting balloon,” she said. “But we cannot really assume a class effect for these devices considering the extreme variability in terms of dose concentration but also carrier of the drug.”

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