PEPCAD-DES at 3 Years: Paclitaxel-Coated Balloon Holds Advantage for DES Restenosis

Treatment with a paclitaxel-coated balloon for restenosis in drug-eluting stents (DES) yields better outcomes persisting to 3 years compared with an uncoated balloon, according to the latest results from the PEPCAD-DES trial presented at TCT 2014.

Harald Rittger, MD, of Universitätsklinikum Erlangen in Germany, and colleagues conducted the prospective, single-blind, multicenter trial that included 110 patients with in-stent restenosis of DES randomized to either a paclitaxel-coated balloon (SeQuent Please, B. Braun) or uncoated balloon.

Baseline characteristics were similar between groups, and lesion length did not significantly differ at 11.2 ± 6.5 mm in the drug-coated balloon (DCB) group and 12.2 ± 8.2 mm in the uncoated balloon group.

For the primary endpoint of in-stent late lumen loss at 6 months, treatment with the DCB was superior to balloon angioplasty alone with an in-stent late loss of 0.43 ± 0.61 mm vs. 1.03 ± 0.77 mm (P<.001). In addition, minimal lumen diameter was larger and percent diameter stenosis lower with the DCB for both the stented and total segment.

At 36 months, rates of target lesion failure (TLR) and MACE (composite of TLR, target vessel MI and cardiac death) were lower in the DCB group (see Table).

One patient in the uncoated balloon group experienced MI, possibly due to stent thrombosis between months 6 and 12. There were no further MIs between months 12 and 36. Additionally, while there were no TLRs between months 6 and 12 in either group, 3 cases occurred between months 12 and 36 in the DCB group.

Rittger told TCT Daily that this is the only study of its kind to allowed more than one stent layer in the restenosed device. Almost half of the patients had more than one stent layer, including one patient with five layers, he noted. “With this complex lesion group at baseline in mind, we can understand the relatively high late lumen loss for the DCB population,” Rittger said.

He added that he was not surprised by the result, even though this was the first trial also to show DCB efficacy with paclitaxel-coated balloons rather than other drugs.

The 36-month results confirm and extend earlier reports from PEPCAD-DES. At 6 months, the TLR rates for the DCB and uncoated balloon groups were 15.3% and 36.8% (P=.005), and MACE rates were 16.7% and 50.0% (P<.001). At 12 months, the TLR rates remained the same, while additional MACE in the uncoated balloon group yielded an even starker divergence between the treatments. Although three more MACE occurred in the DCB group between 12 and 36 months compared with none in the uncoated balloon group, the difference remained significant.

“In my opinion, with the broader evidence for the treatment of in-stent restenosis of BMS and DES, the first choice in any restenosis should be the DCB,” Rittger said. “The only reason not to use a DCB is a prior treatment failure of a DCB in the same lesion.”