Another Stent Bests Drug-Coated Balloon for DES Restenosis, Two Studies Suggest

Marlene Busko

July 06, 2015

WASHINGTON, DC — Another stent, rather than a drug-coated balloon, appears to be the most effective approach to treating coronary in-stent restenosis within drug-eluting stents (DES), suggest two studies published in the July 7, 2015 issue of the Journal of the American College of Cardiology, one from Europe and the other from Japan.

In one report[1], based on the RIBS IV trial with >300 patients, treatment with an everolimus-eluting stent provided better 8-month angiographic outcomes and 1-year clinical outcomes than treatment with a paclitaxel-coated balloon. The study, with lead author Dr Fernando Alfonso (Hospital Universitario de La Princesa, Madrid, Spain), had been previously reported at TCT 2014 and covered then by heartwire from Medscape.

A second study[2], from Dr Seiji Habara (Kurashiki Central Hospital, Kurashiki, Japan) and colleagues, showed that 17% of patients with DES restenosis who received paclitaxel-coated balloon angioplasty had late restenosis—that is, restenosis at 18 months. Results were better for bare-metal-stent restenosis.

Thus, "while awaiting new data, the strategy of stenting a stent, even if not perceived as particularly elegant, should be the default approach for most lesions presenting with DES restenosis," Dr Antonio Colombo (EMO-GVM Centro Cuore Columbus, Milan, Italy) and Dr Neil Ruparelia (Imperial College London, UK) conclude in an editorial[3] that accompanies the two studies.

The two studies and editorial convey three main messages, Dr Ron Waksman (Washington Hospital Center, DC) told heartwire . First, he said, DES in-stent restenosis is more challenging to manage than bare-metal-stent in-stent restenosis; second-generation DES are safe, effective, and superior to drug-coated balloons for the treatment of DES in-stent restenosis; and long-term follow-up beyond 1 year reveals attrition in the results with the drug-eluting balloon and questions its utility for routine use for the treatment of DES in-stent restenosis.

"Tempered Appetites" After These Studies

Importantly in this clinical setting, "the US perspective is slightly different" from the European and Japanese perspectives, Waksman explained. In the US, "drug-coated-balloon angioplasty is not available for coronary application, and instead, vascular brachytherapy is used in selected centers, mainly as a second-line therapy for DES failure (usually following an attempt to treat the in-stent restenosis with a second-generation DES) with good results," he said.

Studies such as these two "temper the appetite" for paclitaxel-coated balloon angioplasty in patients with in-stent restenosis, he continued. Paclitaxel is a toxic drug with a narrow therapeutic window, and that, added to that the possible distal embolization of the particulates that carry the drug and the cost of a drug-coated balloon, which currently exceeds the cost of DES (in Europe), "make a second-generation DES more appealing for the treatment of both DES in-stent restenosis and bare-metal stent in-stent restenosis," according to Waksman.

Moreover, potential advantages of drug-coated balloons—such as a shorter duration of dual antiplatelet therapy and no need for another layer of metal in the artery—become less relevant, he continued. The DAPT trial showed that patients with DES in-stent restenosis may benefit from a long duration of dual-antiplatelet therapy to prevent secondary events—and the newer DES are now less than 80 μm thick.

"Put all these together, and the role of [drug-coated balloons] for the treatment of coronary in-stent restenosis is not that rosy," suggesting that these balloons "may become a niche device, limited to patients who cannot take antiplatelet therapy or do not have enough lumen to accommodate another stent," according to Waksman.

Patients presenting with DES in-stent restenosis have already failed the best currently available antirestenosis treatment, Colombo and Ruparelia emphasize. Based on these two current studies, "currently, we can conclude that the use of everolimus-eluting stents for DES in-stent restenosis is safe and effective, but the role of drug-eluting balloons in this context is limited."

RIBS IV: Balloon vs Stent for In-Stent Restenosis

As previously reported by heartwire, the 1-year RIBS-IV results based on 309 patients with in-stent restenosis that were presented at TCT 2014 showed that the everolimus-eluting stent (Xience Prime, Abbott Vascular) was superior to a paclitaxel-coated balloon for the primary end points.

In-segment luminal diameter at 8 months was significantly greater in the everolimus-eluting stent group (2.03 mm vs 1.80 mm; P<0.01). There were also more clinical events in the first year in the drug-eluting-balloon group than in the DES group, largely driven by a greater incidence of target lesion revascularization (19 vs 6), with no differences in definite stent thrombosis, MI, cardiac death, and all-cause mortality.

Late Stenosis With Paclitaxel-Coated Drug-Eluting Balloon

Habara et al looked at angiographic outcomes at 6 months and 18 months in 468 patients at their center who encompassed 550 cases of in-stent restenosis: 114 lesions in bare-metal stents and 436 lesions in drug-eluting stents. The patients were treated with a paclitaxel-coated balloon (SeQuent Please, Braun, Germany).

At an early angiographic follow-up at 6 to 12 months, recurrent restenosis occurred in 13 lesions (13%) in the bare-metal-stent in-stent-restenosis group and in 82 lesions (21.1%) in the DES in-stent-restenosis group.

"The most notable finding, however, was a 'second wave' of late loss in DES in-stent-restenosis lesions when assessed by late angiographic follow-up [at 12 to 24 months]," according to Colombo and Ruparelia. "Late restenosis was significantly greater in the DES in-stent-restenosis group (50 lesions, 16.8%) compared with two lesions (2.5%) in the bare-metal stent in-stent-restenosis group."

That long-term follow-up beyond 1 year revealed attrition in the results with this drug-coated-balloon angioplasty and calls into question the utility of drug-eluting-balloon angioplasty for routine treatment of DES in-stent restenosis, Waksman noted. It also shows that "1-year follow-up is not sufficient to examine these therapies."

Alfonso reports no relevant financial relationships. Disclosures for the coauthors are listed in the article. Habara et al and the editorialists report no relevant financial relationships. Waksman has no relevant financial relationships.

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