Treatment of DES-In-Stent Restenosis with SeQuent Please Paclitaxel Eluting PTCA Catheter - PEPCAD-DES

Oct 23, 2015
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Published:
10/14/2015
Date Updated:
10/23/2015
Original Posted Date:
02/29/2012
References

Description:

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.

Study Design

  • Randomized
  • Blinded
  • Parallel

Patient Populations:

  • 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%

Exclusions:

  • 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

Primary Endpoints:

  • Late lumen loss

Secondary Endpoints:

  • Composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization

Drug/Procedures Used:

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.

Principal Findings:

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).

Interpretation:

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.

References:

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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