Treatment of DES-In-Stent Restenosis with SeQuent Please Paclitaxel Eluting PTCA Catheter - PEPCAD-DES
The goal of the trial was to evaluate paclitaxel-coated balloon angioplasty compared with plain balloon angioplasty among patients with drug-eluting stent restenosis of a native artery.
Contribution to the Literature: The PEPCAD-DES trial showed that paclitaxel-coated balloon angioplasty was more effective at treating in-stent restenosis than plain balloon angioplasty.
- Patients with drug-eluting stent (paclitaxel, sirolimus, or everolimus) restenosis with a reference vessel diameter of 2.5-3.5 mm and lesion length <22 mm
Number of enrollees: 110
Duration of follow-up: 6 months, then 36 months
Mean patient age: 70 years
Percentage female: 28%
- Thrombus-containing lesion
- Bifurcation lesion or multiple lesions in the target vessel
- Bypass graft lesion
- Total coronary artery occlusion
- Ostial or left main lesion
- Planned surgery within 6 months
- Contraindication to dual antiplatelet therapy
- Late lumen loss
- Composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization
Patients with drug-eluting stent restenosis of a native artery were randomized to paclitaxel-coated balloon angioplasty (n = 72) versus plain balloon angioplasty (n = 38).
Pre-dilatation with an uncoated balloon according to the size of restenotic stent was mandatory. Study balloon inflation then occurred for 60 seconds.
Overall, 110 patients were randomized. The mean age was 70 years, 28% were women, 36% had diabetes, and mean body mass index was 28 kg/m2. One patient in each group received a bailout stent due to a poor result or edge dissection.
At 6 months, late lumen loss was 0.43 mm in the paclitaxel-coated balloon angioplasty group compared with 1.03 mm in the plain balloon angioplasty group (p < 0.001).
Restenosis: 17.2% versus 58.1% (p < 0.001), and adverse clinical events: 16.7% versus 50.0% (p < 0.001), respectively.
At 36 months, target lesion revascularization was 19.4% in the paclitaxel-coated balloon angioplasty group compared with 36.8% in the plain balloon angioplasty group (p = 0.046).
Among patients with drug-eluting stent restenosis of a native artery, the use of paclitaxel-coated balloon angioplasty appears beneficial. This treatment reduced late lumen loss compared with plain balloon angioplasty, with no late catch-up phenomenon. A previous trial documented the benefit of paclitaxel-coated balloon angioplasty for bare-metal stent restenosis. It is unknown if this treatment modality would be superior to placement of another drug-eluting stent. The marked reduction in restenosis and adverse clinical events is likely overstated from this small trial.
Rittger H, Waliszewski M, Brachmann J, et al. Long-Term Outcomes After Treatment With a Paclitaxel-Coated Balloon Versus Balloon Angioplasty: Insights From the PEPCAD-DES (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter) Study. JACC Cardiovasc Interv 2015;Oct 14:[Epub ahead of print].
Rittger H, Brachmann J, Sinha AM, 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;Feb 29:[Epub ahead of print].
Keywords: Paclitaxel, Follow-Up Studies, Body Mass Index, Coronary Restenosis, Drug-Eluting Stents, Immunosuppressive Agents, Dilatation, Sirolimus, Angioplasty, Balloon, Coronary, Diabetes Mellitus
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