Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Coated Stent for the Treatment of Coronary In-Stent Restenosis

Abstract

Background-Treatment of in-stent restenosis with paclitaxel-coated balloon catheter as compared with plain balloon angioplasty has shown surprisingly low late lumen loss at 6 months and fewer major adverse cardiac events up to 2 years. We compared the efficacy and safety of a paclitaxel-coated balloon with a paclitaxel-eluting stent as the current standard of care. Methods and Results-One hundred thirty-one patients with coronary in-stent restenosis were randomly assigned to treatment by a paclitaxel-coated balloon (3 g/mm 2 ) or a paclitaxel-eluting stent. The main inclusion criteria encompassed diameter stenosis of Ն70% and Յ22 mm in length, with a vessel diameter of 2.5 to 3.5 mm. The primary end point was angiographic in-segment late lumen loss. Quantitative coronary angiography revealed no differences in baseline parameters. At 6 months follow-up, in-segment late lumen loss was 0.38Ϯ0.61 mm in the drug-eluting stent group versus 0.17Ϯ0.42 mm (Pϭ0.03) in the drug-coated balloon group, resulting in a binary restenosis rate of 12 of 59 (20%) versus 4 of 57 (7%; Pϭ0.06). At 12 months, the rate of major adverse cardiac events were 22% and 9%, respectively (Pϭ0.08). This difference was primarily due to the need for target lesion revascularization in 4 patients (6%) in the coated-balloon group, compared with 10 patients (15%) in the stent group (Pϭ0.15). Conclusions-Treatment

Guidelines on myocardial revascularization

“…Using a paclitaxeleluting balloon, three RCTs have targeted in-stent restenosis following BMS implantation: PACCOCATH-I and -II [174,175] and PEPCAD-II [240]. As with DES, one cannot assume a class effect for all drug-eluting balloons.…”

Drug‐coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET‐SMALL 2

“…Specifically, DCB compared to DES show a significant benefit in the treatment of ISR,5, 6, 7, 8, 9, 10, 11, 12 and current guidelines recommend the use of DCB for patients with coronary ISR (class I, level of evidence A) 13. However, there are other potential indications such as coronary small vessel disease and bifurcation lesions 14, 15.…”

Almanac 2011: stable coronary artery disease. The national society journals present selected research that has driven recent advances in clinical cardiology

“…A recent randomised trial in 131 patients with bare metal in-stent restenosis reported 6-month binary restenosis rates of only 7% for the drug-coated balloon compared with 20% for a paclitaxel-eluting stent. 82 However, longer-term data will be needed. A recent registry study reported that SES used for treatment of bare metal in-stent restenosis exhibited sustained efficacy at 4 years with a target lesion revascularisation rate of only 11.1%.…”