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Paclitaxel-coated balloon angioplasty superior to balloon angioplasty alone for DES restenosis
Rittger H. J Am Coll Cardiol.2012;doi:10.1016/j.jacc.2012.01.015.
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Paclitaxel-coated balloon angioplasty in patients with drug-eluting stent restenosis was associated with significantly lower late lumen loss, binary restenosis rate and major adverse cardiac events when compared with uncoated balloon angioplasty alone, according to results of the PEPCAD-DES study.
Late lumen loss — the primary endpoint of the study — was significantly lower in lesions treated with paclitaxel-coated balloon angioplasty (0.43 mm) vs. balloon angioplasty alone (1.03 mm; P<.001). Treatment with a drug-coated balloon also reduced late lumen loss in patients with (0.51 mm vs. 1.45 mm; P<.01) and without (0.39 mm vs. 0.91 mm; P<.001) diabetes vs. plain old balloon angioplasty. The restenosis rate was significantly reduced with paclitaxel-coated balloon angioplasty (from 58.1% to 17.2%), as was the composite secondary endpoint of cardiac death, MI attributed to the target vessel or target lesion revascularization (from 50% to 16.7%; P<.001 for both.
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The study included 110 patients with drug-eluting stent restenosis located in a native coronary artery. Patients were randomly assigned to paclitaxel-coated balloon angioplasty (n=72) or balloon angioplasty alone (n=38) from November 2009 to April 2011. Dual antiplatelet therapy was prescribed for 6 months, and angiographic follow-up was scheduled at 6 months.
Researchers found no difference in patient baseline characteristics or procedural results. The angiographic follow-up rate was 91%.
Disclosure: One researcher reports receiving speakers’ fees from B. Braun and Siemens. All other researchers report no relevant financial disclosures.