Drug-eluting Balloons Show Positive Results in Treating In-stent Restenosis

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Two new reports show continued positive results with paclitaxel-eluting balloons in treating in-stent restenosis (ISR) in patients with coronary and peripheral lesions, according to findings published online October 3, 2012, ahead of print in the Journal of the American College of Cardiology.

In the first study, researchers led by Jochen Wöhrle, MD, of the University of Ulm (Ulm, Germany), looked at 2,095 patients (2,234 lesions) in the SeQuent Please World Wide Registry who received paclitaxel-coated balloons (SeQuent Please, B. Braun, Melsungen, Germany) primarily for coronary in-stent restenosis (72.7%), though over one-quarter (27.3%) were also treated for de novo CAD.

At 9.4-month follow-up, TLR (primary outcome) was 5.2%, with a TVR rate of 6.2%. MACE, meanwhile, was 6.7%, consisting of TLR, cardiac death (1.8%), and MI (0.8%). The thrombosis rate at the target lesion was 0.1%. In the 1,207 patients treated for in-stent restenosis with a documented stent type, paclitaxel-eluting balloons performed better in treating BMS restenosis than DES restenosis with regard to all endpoints except cardiac death (table 1).

Table 1.  Outcomes for Treatment of In-stent Restenosis According to Stent Type at 9.4 Months

Abbreviation: ISR, in-stent restenosis.

In 389 patients with the type of restenosed DES documented, ISR of paclitaxel-eluting stents showed similar results compared with lesions in nonpaclitaxel-eluting stents after treatment with SeQuent Please balloons.

Significant risk factors for the primary outcome (TLR) included DES restenosis (P < 0.001), ACS (P = 0.034), ostial lesions (P = 0.023), and graft lesions (P = 0.004).

In the 491 patients treated for de novo lesions, most (n = 390) received paclitaxel-eluting balloons alone, while some (n = 101) received additional BMS implantation. Rates of MACE, TLR, and TVR were low and did not differ in patients with vs. without additional stenting (table 2).

Table 2. Treatment for De Novo Lesions

“[Paclitaxel-coated balloon] angioplasty in an all-comers, prospective, multicenter registry was safe. . . [confirming] in a large population the low TLR rates seen in randomized clinical trials,” the authors conclude.

They note that the higher TLR rates in patients treated for DES restenosis are probably due to higher late loss after treatment. “This is probably triggered by the use of DES for lesions with a high risk for restenosis, while lesions with a low risk for restenosis are treated with BMS,” they explain.

Results Extend to the Periphery

In the second study, researchers led by Eugenio Stabile, MD, PhD, of Clinica Montevergine (Mercogliano, Italy), looked at 39 consecutive patients with in-stent restenosis of the superficial femoral artery (SFA) following self-expanding nitinol stent implantation. The patients received treatment with uncoated balloon angioplasty followed by post-dilatation with an In.Pact drug-eluting balloon (Medtronic, Minneapolis, MN). The In.Pact balloon is coated with a proprietary formulation of paclitaxel and urea, which serves as a hydrophilic spacer to facilitate separation and release of paclitaxel into the vessel wall.

Technical and procedural success was achieved in all patients. There were no in-hospital MACE or cerebrovascular events. At 1 year, 1 death had occurred due to heart failure. The 12-month primary patency rate (primary endpoint) was 92.1%. There was a 10.5% rate of target limb revascularization and a 1-year secondary patency rate of 100% after duplex assessment showed no recurrent restenosis.

There were no amputations and Rutherford class and ankle brachial index (ABI) both improved from baseline (2.9 to 0.8; P < 0.05 for Rutherford class; 0.77 to 0.98; P < 0.05 for ABI). In addition, treatment of type III in-stent restenosis (20.5% of lesions) was not associated with an increased rate of recurrent restenosis compared with type I (30.8%) or II (48.7%) ISR.

“The data suggest that adjunctive use of [drug-eluting balloons] for the treatment of SFA-ISR represents a potentially safe and effective therapeutic strategy,” the researchers conclude, adding that “the availability of [drug-eluting balloons] can change the paradigm for the treatment of SFA-ISR.”

‘Hop, Skip, and a Jump’

In a telephone interview with TCTMD, Robert S. Schwartz, MD, of the Minneapolis Heart Institute Foundation (Minneapolis, MN), commented, “I think this is huge. It’s a big step for something to successfully treat in-stent restenosis in the coronaries and the SFA, both of those are significant applications. If it works there, it’s a hop, skip, and a jump to understanding if it can work as a primary technology.

“The fact that this is as positive as it was speaks well to future steps down the road,” he continued, “the holy grail being, of course, ‘Can I use a drug-eluting balloon followed by a bare-metal stent and get the benefits of both without the disadvantages compared with drug-eluting stents and the use of dual antiplatelet therapy for 2 years.”

Dr. Schwartz noted that there are some theoretical concerns with drug-eluting balloons such as embolization and systemic travel of the drug and particulate, “but these do not seem to be playing out in the real world. . . and the Europeans don’t seem to be having any troubles.” Drug-eluting balloons are currently not approved for use in the United States by the Food and Drug Administration, although they are available in Europe.

Dr. Schwartz described the SeQuent Please technology as a relatively early-stage device and In.Pact as a “mid-level” one. “They’re all a bit clunky, but they’re still early generation,” he said. “The good news is the early technology is working and the technology is advancing.”

 

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Sources:
1. Wöhrle J, Zadura M, Möbius-Winkler S, et al. SeQuent Please World Wide Registry. Clinical results of SeQuent Please paclitaxel-coated balloon angioplasty in a large-scale, prospective registry study. J Am Coll Cardiol. 2012;Epub ahead of print.

2. Stabile E, Virga V, Salemme L, et al. Drug-eluting balloon for treatment of superficial femoral artery in-stent restenosis. J Am Coll Cardiol. 2012;Epub ahead of print.

 

Disclosures:

• The SeQuent Please World Wide Registry was supported by B. Braun.
• Dr. Wöhrle reports receiving grants and speaker’s honoraria from B. Braun.
• Drs. Stabile and Schwartz report no relevant conflicts of interest.

 

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