PEPCAD-DES Results Support Paclitaxel-Coated Balloon Angioplasty

November 11, 2011—Results from the PEPCAD-DES clinical trial were presented at Cardiovascular Research Foundation's (CRF) annual Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco. The study demonstrated that use of paclitaxel-coated balloon angioplasty to treat patients with restenosis in drug-eluting stents (DES) in native coronary arteries was superior to treatment with uncoated plain old balloon angioplasty (POBA).

The incidence of in-stent restenosis (ISR) in DES remains frequent because of the continuous increase in DES implantations. Treating ISR with an additional stent adds another metal layer within the coronary arteries, abolishing the physiologic vasoreactivity of the vessel. DES significantly reduce the occurrence of restenosis and the subsequent need for repeat vascularization, noted CRF.

As summarized by CRF, paclitaxel-eluting balloon angioplasty has been shown to be superior to POBA for the treatment of ISR in bare-metal stents. Whether it is also effective for ISR in different DES has not been extensively studied thus far. The PEPCAD-DES trial compared the efficacy of a paclitaxel-eluting balloon catheter for treatment of ISR in DES in native coronary arteries versus uncoated POBA to methodologically assess the efficacy of the balloon-mediated drug coating.

This randomized, multicenter, single-blinded trial was conducted at six centers in Germany and included 110 patients with DES ISR in multiple stent types. Patients were divided into two treatment groups: 72 underwent drug-coated balloon (DCB) angioplasty, and 38 underwent POBA (to achieve 90% power). The inclusion criteria were a lesion in a native coronary artery; DES restenosis of
sirolimus-, everolimus-, or paclitaxel-eluting stents; an indication for percutaneous coronary intervention; a reference diameter ranging from 2.5 to 3.5 mm; and lesion length ≤ 22 mm. The exclusion criteria were acute myocardial infarction, chronic total occlusions, lesions in bypass grafts or bifurcations, multiple lesions in the target vessel, left main lesions, ISR in bare-metal stents, and/or contraindications for acetylsalicylic acid or clopidogrel.

The length of the balloon in both treatment groups was chosen to overlap the stenotic segment at least 2 mm at the proximal and distal margin. Dual-antiplatelet therapy was prescribed for 3 months in both treatment groups. All patients were scheduled for control angiography at 6 months. Quantitative coronary analysis was performed in a blinded fashion relative to the treatment groups. The final angiographic follow-up was completed in September 2011.

For the primary endpoint of 6-month late lumen loss, the investigators found that in the POBA group, late lumen loss was 1.03 ± 0.77 mm. In the DCB group, late lumen loss was 0.43 ± 0.61 mm. The rate of target lesion revascularization was 36.8% in the POBA group and 15.3% in the DCB group. The rate of major adverse cardiac events was 50% in the POBA group and 16.7% in the DCB group.

The PEPCAD-DES trial studied the SeQuent Please balloon catheter (B. Braun Interventional Systems Inc., Bethlehem, PA) and was sponsored by Klinikum Coburg in Germany and lead by Principal Investigator Harald Rittger, MD.

Dr. Rittger commented, “Results of this trial showed that for treatment of DES restenosis, a paclitaxel-coated balloon compared with a balloon angioplasty alone showed significantly lower late loss, a significantly lower binary restenosis rate, significantly less major adverse cardiac events, and no definite vessel thrombosis.”