Scoring Balloon Combined With Drug-Coated Balloon May Produce Better Outcomes for Patients With Restenosis

SAN FRANCISCO – Use of a scoring balloon (SBC) plus a paclitaxel-coated balloon (PCB) demonstrated angiographical superiority compared with a PCB alone for restenosis treatment, according to results from the ISAR-DESIRE 4 (Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In- Stent Restenosis) clinical trial.

Restenosis after drug-eluting stent (DES) implantation in patients with coronary artery disease (CAD) occurs in 5% to 10% of cases. Drug-coated balloons (DCB) can effectively treat in-stent restenosis, but the ISAR-DESIRE 4 investigators hypothesized that a scoring balloon might deliver the drug into the vessel wall more effectively and produce better long-term outcomes.

The prospective, randomized multicenter clinical trial, led by Robert A. Byrne, MB, BCh, PhD, from Deutsches Herzzentrum in Munich, Germany, enrolled 252 patients (125 in the SBC group; 127 in the PCB-alone group) with DES restenosis between June 2012 and December 2014. Patients needed to exhibit symptoms or signs of ischemia and have a diagnosis of stenosis >50% in a limus-eluting DES to be considered for participation. In addition, approximately 41% of patients had diabetes, 85% to 90% had multivessel disease, and approximately 24% had acute coronary syndrome (ACS).

The primary end point of percent diameter stenosis at follow-up angiography, was  40.4% for the SBC plus PCB group vs 35% for the PCB-alone group (P=.047). Rates of binary restenosis, a secondary end point, were 18.5% for SCB group vs 32% for PCB-alone group; P=.03. Rates of target lesion revascularization (16.8% for SCB group; 22.6% for PCB-alone group; P=.25) and death/myocardial infarction were similar in both groups (3.4% vs 3.3%, P=.99).

Dr Byrne presented the findings at the Transcatheter Cardiovascular Therapeutics (TCT) 2015 meeting in October. Dr Byrne noted that because this stenting technology is not yet available in the United States, “in-stent restenosis will [still] be treated with another stent … [but] when you line up a number of stents, it becomes more and more difficult to treat.”

In previous ISAR-DESIRE trials, researchers examined the efficacy and safety of similar stents and balloons for the treatment of restenosis in different patient populations. In the original ISAR-DESIRE trial, angiographic restenosis occurred in 44.6% of a balloon angioplasty group, 14.3% in a sirolimus-eluting stent (SES) group, and 21.7% in a paclitaxel stent (PES) group. In ISAR-DESIRE 2, patients with SES restenosis responded to treatment either with repeated SES or by switching to PES with a comparable degree of efficacy regardless of diabetic status. In ISAR-DESIRE 3, investigators found that a paclitaxel-eluting balloon could be a useful treatment for patients with restenosis after the implantation of a DES.

With the results of ISAR-DESIRE 4, there is potential to decrease the frequency of angiographic restenosis; however, the 20% rate is still too high. “This might lead to some benefit in outcomes in the long term,” said Dr Byrne. “This is a challenging patient subset…even small, marginal gains are worth pursuing.”

Disclosures: This study was funded by Biotronik (Berlin, Germany). Dr Robert Byrne received lecture fees from B. Braun Melsungen AG, Biotronik, and Boston Scientific.

References

1. Byrne R, Kufner S, Joner M, et al. ISAR-DESIRE 4: A prospective randomized trial of plaque modification with a scoring balloon during drug-coated balloon treatment of coronary in-stent restenosis. Presented at: 27th Annual Transcatheter Cardiovascular Therapeutics Scientific Symposium; October 10-15, 2015; San Francisco, CA. 
2. Byrne RA. Neumann FJ, Mehilli J, et al; for the ISAR-DESIRE 3 Investigators. Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomized, open-label trial. Lancet. 2013;381:461-467.
    
3. Kastrati A, Mehilli J, von Beckerath N, et al. Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. JAMA. 2005;293(2):165-171.
4. Kufner S, Byrne RA, de Waha A, et al. Sirolimus-eluting versus paclitaxel-eluting stents in diabetic and nondiabetic patients within sirolimus-eluting stent restenosis: results from the ISAR-DESIRE 2 trial. Cardiovasc Revasc Med. 2014;15(2):69-75.