For the treatment of in-stent restenosis, a paclitaxel-coated balloon and DES offer similar angiographic outcomes at 6 to 8 months and clinical outcomes at 1 year, according to retrospective single-center study published online February 19, 2015, ahead of print in EuroIntervention. For restenosis in nonfocal type and bifurcation lesions, however, the balloon may be the better option.

Seiji Habara, MD, of Kurashiki Central Hospital (Kurashiki, Japan), and colleagues looked at 777 lesions in 685 patients with DES restenosis that were treated with the SeQuent Please drug-coated balloon (DCB; n = 306; B. Braun) or one of several DES (n = 471) at their center between 2004 and 2011. Choice of device was at operator discretion.

Within the DES group, devices were:

• Cypher sirolimus-eluting stent (Cordis): 37.6%
• Taxus paclitaxel-eluting stent (Boston Scientific): 34.8%
• Xience V (Abbott Vascular) and Promus (Boston Scientific) everolimus-eluting stents: 27.6%

Angiographic, Clinical Outcomes Similar

At baseline, QCA-determined percent diameter stenosis and minimal lumen diameter (MLD) were similar between the 2 groups. Reference vessel diameter was larger in those who received repeat DES rather than DCB (P = .001), while lesion length was longer in the DCB group (P = .046). Postprocedure MLD and acute gain were shorter and percent diameter stenosis was greater in DCB patients (P < .001 for all).

Angiographic follow-up at 6 to 8 months postprocedure was available for 88.8% of lesions. Recurrent restenosis and per-lesion TLR occurred at similar rates in both the DCB and DES groups, while late lumen loss was lower in the DCB patients (0.34 ± 0.57 mm vs 0.68 ± 0.76 mm; P < .001).

Clinical follow-up at 12 months showed no differences in any outcome between the treatment groups. No DCB-treated lesions resulted in cardiac death, MI, or target lesion thrombosis, and all occurrences of MACE were due to repeat revascularization procedures.

Among 236 propensity-matched pairs, the proportion of propensity-score–matched patients with a postprocedure residual percent stenosis of > 30% was higher in the DCB group, the difference did not remain at angiographic follow-up. Moreover, binary restenosis (primary endpoint), percent diameter stenosis, and TLR were similar between DCB- and DES-treated patients, but MLD and late luminal loss were greater in the DES group (table 1).

Propensity-score matching also confirmed similarity between the treatments for 12-month clinical results.

DCB Better for Complex Lesions

In subgroup analyses of lesions with nonfocal restenosis, DCB offered better results for late lumen loss (P < .0001), binary restenosis (P = .002), and TLR (P = .003) than did DES. Additionally, bifurcation lesions receiving DCB rather than DES had less late lumen loss (P < .0001) and TLR (P = .005), but there was only a trend toward less binary restenosis (26.1% vs 39.9%; P = .13).

Patients with stent-edge restenosis treated with DCB vs DES were roughly twice as likely to have angiography-deduced restenosis (30.4% vs 14.3%) and TLR (26.1% vs 12.2%), but neither association reached significance.

The likelihood developing of binary restenosis, TLR, or late lumen loss was unaffected by whether the DES was first- or second-generation or whether the original stent was paclitaxel eluting or limus eluting.

With DCBs “multiple layers of metal can be avoided within the previously implanted stent, and [they] can be used multiple times for recurrent restenosis even when the previous restenosis was treated by [DCB],” Dr. Habara and colleagues write.

In an email with TCTMD, Bruno Scheller, MD, of the University of Saarland (Homburg, Germany), added that, if required, “a significantly shorter duration of DAPT (4 weeks vs 6 months)” could be another benefit of DCBs.

Optimal Treatment Remains Debatable

“[DCBs] should become standard of care in [in-stent restenosis] treatment,” Dr. Scheller said, explaining that the devices are not currently so in Europe due to a lack of “trust in a stentless approach” and other factors, including lack of training among the current generation of interventional cardiologists in angioplasty and lesion preparation, reimbursement issues, and the unavailability of coronary DCBs worldwide.

“[I]f such a concept works better in complex situations,” Dr. Scheller asked, “why not use it in all cases including focal [in-stent restenosis]?”

However, Robert S. Schwartz, of the Minneapolis Heart Institute Foundation (Minneapolis, MN), told TCTMD in an email that the study offers “interesting” results but cannot completely control for possible bias and differences in lesion characteristics.

Moreover, Dr. Schwartz said, it is “unlikely” to impact practice until US interventionalists have more experience with DCBs and randomized trials are completed. In-stent restenosis treatment, he continued, “will nevertheless be an important use of DCBs to watch.”

Dr. Scheller concluded, “The data from [this study] underline the safety and efficacy of this type of DCB in [in-stent restenosis] treatment.”

Disclosures:

• Drs. Habara and Schwartz report no relevant conflicts of interest.
• Dr. Scheller reports receiving lecture fees/travel support from B. Braun, Medtronic, and Spectranetics; serving as co-inventor on patent applications submitted 2001/2 by Charite Hospital for nonstent-based local drug delivery; and holding shares of InnoRa GmbH.

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