Drug-Eluting Balloon Is Best Option for Restenosis of Limus-Eluting Stents: ISAR DESIRE 3

Reed Miller

October 29, 2012

MIAMI — Angioplasty with a paclitaxel-eluting balloon is a better alternative for in-stent restenosis of limus-eluting stents than either angioplasty with a regular balloon or putting in another drug-eluting stent (DES), according to results of a three-way randomized trial presented here at TCT 2012 [1].

Dr Robert Byrne (Deutsches Herzzentrum, Technische Universität, Munich, Germany) presented results of the Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis Three Treatment Approaches (ISAR DESIRE 3) trial. "Despite over a decade of experience with drug-eluting stents in real-world practice, we still don't know the optimal treatment for restenosis in these devices," he explained. "We know from some smaller studies of drug-eluting balloon therapy that this seems to be a very promising therapy, particularly in patients with bare-metal-stent restenosis. It has the advantage of avoiding additional stent layers, and if we can achieve good results with drug-eluting therapy comparable to that of DES without requiring additional stent layers, that would be a very exciting prospect."

ISAR DESIRE 3 enrolled 402 patients with stenosis >50% in a DES of the limus group and symptoms/signs of ischemia. Exclusion criteria included left main stem disease, acute ST-elevation MI, and cardiogenic shock. The patients were randomized to treatment with the SeQuent Please (B Braun Vascular, Melsungen, Germany) paclitaxel-eluting balloon, "stent-in-stent" treatment with a Taxus paclitaxel-eluting stent (Boston Scientific, Natick, MA), or regular balloon angioplasty. The patients in the study will be followed out to five years.

Angiographic follow-up six to eight months after the procedure showed that for the primary end point, percentage restenosis, the remaining diameter of stenosis was 38% in the restenosed stents treated with the paclitaxel-eluting balloon and 37.4% in the stents treated with a paclitaxel-eluting stent (p for noninferiority=0.007). The stenosis diameter in the stents treated with only regular balloon angioplasty was, on average, 54%. So both the paclitaxel-eluting balloon and paclitaxel-eluting stent were superior to regular balloon angioplasty (p<0.001).

The paclitaxel balloon and paclitaxel stent were noninferior to each other but both superior to regular balloon angioplasty for both secondary end points of binary restenosis and target lesion revascularization. At least 50% restenosis was found in 26.5% of the paclitaxel-eluting-balloon patients, 24% of the paclitaxel-eluting-stent patients (p=0.61), and 56.7% of the regular balloon-angioplasty patients. Target lesion revascularization rates were 22.1% in the paclitaxel-eluting-balloon group, 13.5% in the paclitaxel-eluting-stent group (p=0.09), and 43.5% for the regular balloon-angioplasty group.

A safety analysis found no difference in a composite of death and MI among the three groups, and target lesion thrombosis was low and similar among all three groups, he said.

"We can suggest that, by obviating the need for additional stent implantation, treatment with a drug-eluting balloon should be the default treatment strategy in these patients," Byrne said.

He explained that the study was limited to treatment of in-stent restenosis in everolimus-, sirolimus-, and zotarolimus-eluting stents. "We can't extrapolate these findings to paclitaxel-eluting stents . . . but paclitaxel-eluting stents in de novo lesions now make up a small component of clinical practice, with high-efficacy second-generation limus-eluting stents." And, he added, "I don't think there's strong reason to believe that results with paclitaxel-eluting stents would differ that dramatically."

Commenting on the study, Dr James Hermiller (New York-Presbyterian Hospital, NY) explained that "although less common, in-stent restenosis within DES continues to be a problem, and a lot of these patients have multiple layers of stents as they're treated over the years for this, so this is very important."