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A paclitaxel-coated balloon is better than an uncoated balloon for opening a restenosed drug-eluting stent, a small randomized trial showed.
Late lumen loss at the target lesion was significantly lower at 6 months with paclitaxel-coated balloon angioplasty (0.43 versus 1.03 mm, P<0.001), according to Harald Rittger, MD, of the Universitätsklinikum Erlangen in Germany, and colleagues.
And, although the trial was not powered for clinical outcomes, using the paclitaxel-coated balloon reduced the rate of cardiac death, myocardial infarction (MI) attributed to the target vessel, or target lesion revascularization (16.7% versus 50%, P<0.001), the researchers reported in the April 10 issue of the Journal of the American College of Cardiology.
Action Points
- This study found that a paclitaxel-coated balloon is better than an uncoated balloon for opening a restenosed drug-eluting stent.
- The researchers found that using the paclitaxel-coated balloon reduced the rate of cardiac death, myocardial infarction (MI) attributed to the target vessel, or target lesion revascularization, although the trial was not powered for clinical outcomes.
"Although use of a drug-eluting stent for drug-eluting stent restenosis is a common treatment strategy, the use of a paclitaxel-coated balloon should be considered as an effective treatment strategy ... after successful balloon pre-dilation," they wrote.
Drug-coated balloon angioplasty has been associated with good results for treatment of bare-metal stent restenosis, although it has not been studied for restenosis of drug-eluting stents.
The PEPCAD-DES study was a single-blind, multicenter, randomized trial that included 110 patients with drug-eluting stent restenoses in a native coronary artery. The patients had sirolimus-eluting Cypher or Yukon stents, everolimus-eluting Xience stents, or paclitaxel-eluting Taxus stents.
The patients were randomized in a 2:1 ratio to angioplasty with a paclitaxel-coated SeQuent Please balloon or an uncoated balloon. Pre-dilation with an uncoated balloon was required.
All of the patients received dual antiplatelet therapy with aspirin and clopidogrel (Plavix) for 6 months.
The length and size of the restenosed stents were not different in the two groups. Procedural success of balloon angioplasty was 100% in both groups.
The reduction in late lumen loss at 6 months with the paclitaxel-coated balloon was significant for the target lesion, overall, and the distal segments. The findings were similar in patients regardless of diabetes status and the type of drug-eluting stent.
The 6-month restenosis rate at the target lesion was significantly lower in the paclitaxel-coated balloon group (17.2% versus 58.1%, P<0.001).
Most of the clinical events were target vessel revascularizations, which were significantly less frequent with the paclitaxel-coated balloon compared with an uncoated balloon (15.3% versus 36.8%, P=0.01).
There was only one MI attributed to the target vessel and it was in the uncoated balloon group. Five patients -- one in the paclitaxel-coated balloon group and four in the uncoated balloon group -- died from cardiac causes.
There were no cases of definite vessel thrombosis in either group.
The authors acknowledged that the study was limited by the small sample size, the inability to blind the operators to treatment assignment, the lack of a comparison with a drug-eluting stent for treatment of restenosis, and the lack of an intravascular ultrasound to evaluate stent underexpansion or neointimal proliferation.
From the American Heart Association:
Disclosures
Rittger has received speaker honoraria from B. Braun and Siemens. One of the study authors is a full-time employee of B. Braun.
Primary Source
Journal of the American College of Cardiology
Rittger H, et al "A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study" J Am Coll Cardiol 2012; 59: 1377-1382.