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Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons - PACCOCATH ISR – Presented at AHA 2006
Description:
The goal of the trial was to evaluate the efficacy and safety of a paclitaxel-eluting balloon catheter compared with a non-eluting balloon catheter among patients with coronary in-stent restenosis.
Study Design
Study Design:
Patients Enrolled: 52
Mean Follow Up: 12-month follow-up
Mean Patient Age: Mean age 64 years
Female: 29
Patient Populations:
Single, in-stent restenosis in a coronary artery with a diameter stenosis of ≥70%, <25 mm length, and vessel diameter of 2.5-3.5 mm; stable or unstable angina or a positive functional study
Exclusions:
Acute MI within prior previous 72 hours; chronic renal insufficiency with a serum creatinine >2.0 mg/dl; known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, or paclitaxel; sensitivity to contrast medium that could not be controlled with premedication; concomitant medical illnesses that required cytostatic or radiation therapy, that might cause the patient to be noncompliant with the protocol, or that were associated with a life expectancy of <2 years; stented segment ≥30 mm; vessel diameter <2.5 mm; stenosis of <70%; clinically significant calcification or thrombus of the target lesion.
Primary Endpoints:
Angiographic late lumen loss at 6 months
Secondary Endpoints:
Binary restenosis rate and MACE
Drug/Procedures Used:
Patients were randomized in a double-blind manner to repeat percutaneous transluminal coronary angioplasty with either a paclitaxel-eluting balloon catheter (3 µg paclitaxel/mm2; n = 26) or a non-eluting balloon catheter (n = 26) of the same type to maintain blinding. Balloon inflation time was to be 60 seconds in both groups. The balloon delivers the total dose immediately rather than through a slow elution process.
Patients underwent repeat angiography at 6 months. Angiograms were assessed by a core laboratory blinded to randomization. Patients were enrolled at multiple German centers.
Principal Findings:
In the paclitaxel-eluting group, 96% of the drug was released with balloon deployment. TIMI grade 3 flow was present in 100% of the non-eluting group and 96.3% of the eluting group. There was no difference in post-procedural minimum lumen diameter (2.46 mm for bare balloon vs. 2.49 mm for eluting balloon, p = 0.83). Repeat angiography at 6 months was performed in 88% of the bare balloon group and 85% of the paclitaxel-eluting balloon group.
The primary endpoint of in-segment late lumen loss was smaller in the paclitaxel-eluting balloon group (0.03 ± 0.48 mm vs. 0.74 ± 0.86 mm, p = 0.002), while the minimum lumen diameter at 6 months was larger (2.22 mm vs. 1.57 mm, p = 0.005). Binary restenosis occurred less frequently in the paclitaxel-eluting balloon group (5% vs. 43%, p = 0.002).
At 12 months, there were no cases of target lesion revascularization in the paclitaxel-eluting balloon group compared with 23% of the bare balloon group (p = 0.02). Among the other components of the major adverse cardiac event (MACE) endpoint, there was one death in the paclitaxel-eluting balloon group, one myocardial infarction in the paclitaxel-eluting balloon group, and two in the bare balloon group, and one stroke in the paclitaxel-eluting balloon group.
Interpretation:
Among patients with coronary in-stent restenosis, treatment with a paclitaxel-eluting balloon catheter was associated with lower late lumen loss at 6-month angiography compared with a bare balloon catheter. Multiple studies have shown the benefit of drug-eluting stents in preventing restenosis in de novo lesions. However, only one randomized trial, ISAR-DESIRE, has been conducted in patients with pre-existing restenosis. While ISAR-DESIRE did demonstrate a reduction in restenosis compared with bare-metal stents, a stent-in-stent approach for treating in-stent restenosis may not be optimal or feasible in all patients.
The present study, while small, is the first reported randomized trial of a paclitaxel-eluting balloon catheter used for treatment of in-stent restenosis. A small study of similar size that used the same protocol by the same investigators showed similar results. Larger trials are warranted. Additionally, it is unknown if similar results would be observed using this strategy with de novo lesions rather than in-stent restenosis.
References:
Scheller B, Hehrlein C, Bocksch W, et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med 2006;355:2113-24.
Presented by Dr. Bruno Scheller at the American Heart Association Annual Scientific Sessions, Chicago, IL, November 2006.
Presented by Dr. Bruno Scheller at the EuroPCR meeting, Paris, France, May 2005.
Keywords: Paclitaxel, Myocardial Infarction, Stroke, Coronary Restenosis, Metals, Drug-Eluting Stents, Constriction, Pathologic, Angioplasty, Balloon, Coronary
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