Paclitaxel-Eluting Balloon Effective for DES Restenosis

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For patients with restenosis in a sirolimus-eluting stent, a paclitaxel-eluting balloon is more effective at reducing the need for repeat revascularization than conventional balloon angioplasty, according to a small study published in the February 2011 issue of JACC: Cardiovascular Interventions.

Investigators led by Seiji Habara, MD, of Kurashiki Central Hospital (Kurashiki, Japan), randomized 50 patients with restenosis in sirolimus-eluting stents to treatment with a paclitaxel-eluting balloon (SeQuent Please; B. Braun Melsungen AG, Vascular Systems, Berlin, Germany) or conventional balloon angioplasty.

All procedures were successful, and no major complications occurred during hospitalization.

At 6 months, quantitative coronary angiography showed that the primary endpoint of in-segment late lumen loss was lower in the paclitaxel-eluting balloon group than the standard angioplasty group. The drug-coated balloon held the same advantage with regard to recurrent restenosis and TLR (table 1).

Table 1. Six-Month Angiographic Results

 

Paclitaxel-Eluting Balloon Group
(n = 23)

Balloon Angioplasty Group
(n = 24)

P Value

In-Segment
Late Lumen
Loss, mm

0.18 ± 0.45

0.72 ± 0.55

0.001

Recurrent Restenosis

8.7%

62.5%

0.0001

TLR

4.3%

41.7%

0.003

 
The paclitaxel-eluting balloon was particularly effective in nonfocal lesions, which are associated with a higher rate of repeat DES implantation compared with focal lesions, the authors report. The rate of recurrent restenosis in nonfocal lesions was 18.2% in the paclitaxel-eluting balloon group vs. 87.5% in the conventional angioplasty group (P = 0.005), while the rates of TLR were 9.1% and 50.0%, respectively (P = 0.071).

MACE Driven Solely by TLR

No deaths, MIs, or Academic Research Consortium-defined stent thromboses occurred in either arm out to 6 months. Kaplan-Meier rates of cumulative MACE-free survival for that time point were 96% for the paclitaxel-eluting balloon group vs. 60% for the standard balloon angioplasty group (P = 0.005; MACE was composed of all-cause death, MI, and TLR, but the values were entirely due to TLR).

According to the authors, the current results are consistent with previous studies showing superior efficacy of a paclitaxel-coated balloon in BMS restenosis. In fact, based on those findings, the European Society of Cardiology/European Association for Cardio-thoracic Surgery (ESC/EACTS) guidelines awarded the drug-coated balloon a class IIa recommendation for this indication, noted Bruno Scheller, MD, of Saarland University (Hamburg, Germany), in an e-mail communication with TCTMD.

Many of the mechanisms behind DES restenosis are similar to those for BMS restenosis, but certain factors related specifically to drug elution, such as localized hypersensitivity reactions, nonuniform drug deposition, and polymer disruption, contribute to a poorer prognosis for DES restenosis, the investigators say.

Drug-Coated Balloon Holds Advantages Over DES

Although DES have come to be considered the standard treatment for DES restenosis, the authors say, they and Dr. Scheller noted that deploying a drug-coated balloon may be advantageous since the procedure:

  • Avoids introduction of a second layer of metal
  • Allows immediate and homogeneous transfer of drug to the vessel wall without a polymer or other sustained-release mechanism
  • Does not alter the original artery anatomy
  • Can be used multiple times if restenosis recurs
  • Reduces the length of antiplatelet therapy

“The German Drug-Eluting Consensus Group has proposed the so-called [drug-eluting balloon]-only strategy with SeQuent Please as an adjunct for indications where DES show limitations,” Dr. Scheller wrote. “The general principle underlying the recommendations for in-stent restenosis . . . includes predilatation with a conventional balloon. Depending on the result, the operator can decide whether to proceed with a drug-eluting balloon-only strategy in case of an acceptable angiographic result or to use a stent in case of major dissection, significant residual stenosis, or reduced flow.”

As for why the investigators compared the drug-coated balloon to conventional angioplasty, Dr. Scheller observed, “Treatment of DES restenosis by implantation of a second DES has limited efficacy, with repeat restenosis rates between 19% and 32%. Therefore, conventional balloon angioplasty may be an alternative, eg, in the case of focal restenosis. . . . This may have been the rationale for the investigators selecting this study design. However, subsequent randomized clinical trials should compare a drug-coated balloon with a DES.”

Dr. Scheller acknowledged that “limus-eluting stents may reduce the [efficacy] gap between DES and the drug-coated balloon.” Nevertheless, he added, “the basic advantages of drug-coated balloons will be the same.”

Long-term follow-up regarding the efficacy of the drug-eluting balloon is “eagerly awaited,” the authors write. In fact, 6-year data for the earlier PACCOCATH ISR I and II trials (comparing a paclitaxel-eluting balloon and an uncoated balloon) and 3-year follow-up from the PEPCAD II trial (comparing the drug-coated balloon to paclitaxel-eluting stents) will be presented later this year, Dr. Scheller reported.

In addition, the ESC/EACTS guidelines caution that a class effect cannot be assumed for all drug-coated balloons, Dr. Scheller noted, but ongoing trials testing different drug-eluting devices should shed light on that issue.

Study Details

There were no differences in the types of in-stent restenosis or clinical characteristics between the 2 treatment groups except for the inclusion of more men in the conventional angioplasty arm.

Target lesions were required to be less than 26 mm in a vessel 2.5 to 3.5 mm in diameter. Lesions in the left main coronary artery and ostial, bifurcated, or totally occluded lesions were excluded.

All patients received prior aspirin (100 mg/day) and ticlopidine (200 mg/day) or clopidogrel (75 mg/day). Aspirin was prescribed for life and ticlopidine or clopidogrel was recommended for at least 3 months. Predilation was performed for all in-stent restenoses; the recommended inflation time for paclitaxel-eluting balloons was 60 seconds.

 


Source:
Habara S, Mitsudo K, Kadota K, et al. Effectiveness of paclitaxel-eluting balloon catheter in patients with sirolimus-eluting stent restenosis. J Am Coll Cardiol Intv. 2011;4:149-154.

 

 

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Paclitaxel-Eluting Balloon Effective for DES Restenosis

For patients with restenosis in a sirolimus eluting stent, a paclitaxel eluting balloon is more effective at reducing the need for repeat revascularization than conventional balloon angioplasty, according to a small study published in the February 2011 issue of JACC
Disclosures
  • Dr. Habara reports no relevant conflicts of interest.
  • Dr. Scheller reports receiving grant support from B. Braun; speaker honoraria from B. Braun and Invatec; major stock shareholder/equity in InnoRa GmbH; and intellectual property rights as co-inventor of a patent application submitted by Charité University Hospital (Berlin, Germany).

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