Paclitaxel versus sirolimus based balloon angioplasty for in-stent restenosis: A comparison of the AGENT IDE and SELUTION4ISR Randomized Pivotal Controlled Trials.

BACKGROUND

Drug-coated balloon with paclitaxel was established as a standard of care for the treatment of in-stent restenosis (ISR). The efficacy and safety of sirolimus-eluting balloons compared to paclitaxel-coated is unknown.

OBJECTIVES

The authors performed an interstudy comparison of long-term clinical outcomes of the AGENT IDE and SELUTION4ISR randomized pivotal control trials comparing the efficacy of paclitaxel-coated vs. sirolimus-eluting balloons for the treatment of in-stent restenosis.

METHODS

Data from the pivotal studies of these devices was compared between the paclitaxel-coated vs. sirolimus-eluting arms for their primary endpoint the 1-year target-vessel failure (defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target vessel revascularization).

RESULTS

This analysis included 615 patients, 406 in AGENT and 210 in SELUTION. There were no differences in the one-year TVF rate between the paclitaxel DCB vs. sirolimus DEB arms, 17.9% vs. 16.2%, respectively (log-rank p = 0.3). There was also no difference in the secondary endpoint of the individual components of TVF: CV death (2.9% vs. 2.0%, p = 0.45), TV-MI (7.5% vs. 7.0%, p = 0.38), or TLR (13% vs. 13%, p = 0.64).

CONCLUSIONS

Both devices paclitaxel-coated balloon and sirolimus-eluting balloons have similar performance for the treatment of ISR at one year. Longer follow-up to determine if the results are sustained and similar at longer follow-up are warranted.