Effectiveness of Paclitaxel-Eluting Balloon Catheter in Patients With Sirolimus-Eluting Stent Restenosis - PEB for SES ISR

Description:

Although in-stent restenosis (ISR) with drug-eluting stents (DES) is significantly reduced, as compared with bare-metal stents, the optimal treatment of DES ISR is unknown. The current trial sought to compare outcomes between the use of paclitaxel-eluting balloons (PEB) versus balloon angioplasty alone (POBA) for the treatment of DES ISR.

Hypothesis:

PEB would be superior to POBA for the treatment of DES ISR.

Study Design

  • Blinded
  • Parallel
  • Randomized
  • Stratified

Patient Populations:

  • Age >18 years
  • Stable angina
  • Evidence of first-time ISR in SES with a restenosis length of <26 mm in a vessel 2.5-3.5 mm in diameter

    Number of enrollees: 50
    Duration of follow-up: 6 months
    Mean patient age: 69.4 years
    Percentage female: 14%

Exclusions:

  • Acute coronary syndrome
  • Severe renal insufficiency (glomerular filtration rate <30 ml/min)
  • Prior stent implantation within 6 months
  • Severe concomitant systemic illness
  • Conditions likely to preclude follow-up angiography
  • Lesions in the left main coronary artery and ostial, bifurcated, or totally occluded lesions

Primary Endpoints:

  • Late lumen loss at 6 months

Secondary Endpoints:

  • Rate of binary restenosis at 6 months
  • Major adverse cardiac events at 6 months

Drug/Procedures Used:

All lesions were predilated. Patients in the PEB arm underwent further dilation with a PEB (SeQuent Please balloon catheter; B. Braun Melsungen AG, Vascular Systems, Berlin, Germany), which was available in 15, 20, 26, and 30 mm lengths and in diameters of 2.5, 3.0, and 3.5 mm, for about 60 seconds.

Concomitant Medications:

All patients received prior treatment of aspirin (100 mg daily) and ticlopidine (200 mg/day), or clopidogrel (75 mg/day). Aspirin treatment was prescribed for life. Ticlopidine/clopidogrel treatment was recommended for at least 3 months. During interventions, heparin was administered to maintain an activated clotting time of more than 250 seconds.

Principal Findings:

A total of 50 patients were randomized, 25 to PEB and 25 to POBA. Baseline characteristics were fairly similar between the two arms, although most patients in the POBA arm were male (96%). About 64% of patients had hypertension; 62% had diabetes mellitus. The left anterior descending artery was the target vessel in about 54% of the patients, with the majority of patients having grade I (focal) or II (diffuse in-stent) pattern of ISR. Post-interventional minimal luminal diameter was similar between the two arms at the end of the procedure.

At 6-month angiographic follow-up, the incidence of angiographic restenosis was significantly lower in the PEB arm, as compared with the POBA arm (8.7% vs. 62.5%, p = 0.0001). Similarly, in-segment late loss was lower in the PEB arm (0.18 vs. 0.45 mm, p = 0.0001). TLR was also lower in the PEB arm (4.3% vs. 41.7%, p = 0.003). No deaths, myocardial infarction, or stent thrombosis occurred during the period of follow-up.

Interpretation:

The results of this small trial indicate that the use of PEB is superior to POBA alone for the treatment of SES ISR. Results are similar to other trials such as PACCOCATH ISR and LOCAL TAX, which have demonstrated that PEB is superior to POBA alone for the treatment of coronary bare-metal stent ISR; the current trial extends these findings for DES ISR.

The PEPCAD II trial had demonstrated superior angiographic outcomes with PEB compared with PES for BMS ISR; a similar study for DES ISR is also warranted. Further trials also need to assess the utility of PEB in situations such as recurrent DES ISR (two layers of stent) and its efficacy compared with brachytherapy for such situations.

References:

Habara S, Mitsudo K, Kadota K, et al. Effectiveness of paclitaxel-eluting balloon catheter in patients with sirolimus-eluting stent restenosis. JACC Cardiovasc Interv 2011;4:149-54.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Prevention, Stable Ischemic Heart Disease, Hypertension, Chronic Angina

Keywords: Paclitaxel, Myocardial Infarction, Follow-Up Studies, Coronary Restenosis, Angina, Stable, Thrombosis, Drug-Eluting Stents, Brachytherapy, Hypertension, Diabetes Mellitus, Stents


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