ISAR-DESIRE 3: Drug-Coated Balloon Shows Durable Antirestenotic Effect in DES Restenosis
Long-term results from a
randomized trial comparing a paclitaxel-coated balloon (PCB), a
paclitaxel-eluting stent (PES), and balloon angioplasty alone for the treatment
of DES restenosis show that the drug-coated balloon offers sustained efficacy
at 3 years with no safety tradeoffs. The findings were published online May 20,
2015, ahead of print in JACC: Cardiovascular Interventions.
For ISAR-DESIRE 3, Sebastian Kufner, MD, of Deutsches Herzzentrum (Munich, Germany), and colleagues enrolled 402 patients at 3 centers from August 2009 through October 2011. All had developed at least 50% restenosis in a limus-eluting stent (n = 500 vessels). At each center, patients were randomized to receive the SeQuent Please PCB (B. Braun Melsungen AG; Melsungen, Germany; n = 137), Taxus Liberté PES (Boston Scientific; n = 131), or balloon angioplasty (n = 134).
Clinical follow-up was available for 363 patients at a median of 3 years. Risk of TLR (primary efficacy endpoint) was similar between the PCB and the PES groups but lower with PCB compared with balloon angioplasty alone. For the composite of death or MI (primary safety endpoint), the risk of was lower with PCB than PES—driven by a difference in death rates—and similar between PCB and balloon angioplasty alone. Risk of MACE (death, MI, and TLR) was comparable between the PCB and PES groups but lower for PCB than for balloon angioplasty alone (table 1).
There was no interaction between PCB and PES across prespecified subgroups, including age, sex, diabetes, and vessel diameter, for efficacy or safety endpoints.
“The current analysis of 3-year outcome data demonstrates the durable antirestenotic efficacy of PCB as compared with PES or [balloon angioplasty alone],” the study authors write, adding that the data are in line with 3-year results from the PEPCAD-DESrandomized trial, which utilized the same PCB.
“Indeed the low incidence of revascularization with PCB between 1 and 3 years underscores that the significant difference in terms of efficacy between PCB and [balloon angioplasty alone] is achieved during the first year after treatment and suggests that a brief (typically 60-[second]) dilation with a drug-eluting balloon results in long-term sustained suppression of neointimal hyperplasia,” Dr. Kufner and colleagues write.
Durability Established
In an accompanying editorial, Fernando Alfonso, MD, PhD, and Javier Cuesta, MD, both of Hospital Universitario de La Princesa (Madrid, Spain), say the ISAR-DESIRE 3 results confirm “the safety and durable antirestenotic efficacy of this therapeutic modality in patients with DES [in-stent restenosis] with results comparable to those seen with first-generation DES.”
However, they observe that the superiority of everolimus-eluting stents over PCB for treatment of DES restenosis has been demonstrated in several recent trials, including RIBS IV and RIBS V. Ongoing analyses of long-term results from these trials “will help to gain perspective on the role of PCB in the era of new-generation DES,” they write.
“When drug-coated balloon research began, there was skepticism that the paclitaxel-coated balloon would yield long-term, durable results because it was not a controlled drug-delivery system,” added Juan F. Granada, MD, of the CRF Skirball Center for Innovation (Orangeburg, NY), in a telephone interview with TCTMD. “This study and the PEPCAD-DES study confirm that the drug-coated balloon technology is durable over time.”
According to Dr. Granada, the balloons are “very useful” as a means of avoiding a second layer of stents—the so-called “onion skin” phenomenon—as well as avoiding long-term antiplatelet therapy. But he acknowledged that the onion skin issue is based more on intuition and experience than evidence. “We don’t have any hard data that doing that is deleterious, but intuitively in the cath lab, it makes sense both biologically and technically to avoid stents within stents,” he observed.
While 3 years of follow-up is not as much as clinicians or patients would like, Dr. Granada said, it is enough to demonstrate that the balloon technology is long lasting.
Sources:
1. Kufner S, Cassese S,
Valeskini M, et al. Long-term efficacy and safety of paclitaxel-eluting balloon
for the treatment of drug-eluting stent restenosis: 3-year results of a
randomized controlled trial. J Am Coll Cardiol Intv. 2015;Epub ahead of
print.
2. Alfonso F, Cuesta J. Long-term
results of drug-coated balloons for drug-eluting in-stent restenosis: gaining
perspective [editorial]. J Am Coll Cardiol Intv. 2015;Epub ahead of
print.
Disclosures:
- Drs. Kufner, Alfonso, and Cuesta report no relevant conflicts of interest.
- Dr. Granada reports that the CRF Skirball Center for Innovation is a validation center for multiple drug-coated balloon technologies.
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L.A. McKeown is a Senior Medical Journalist for TCTMD, the Section Editor of CV Team Forum, and Senior Medical…
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