Early and aggressive ISR with a polymer- and carrier-free drug-coated stent system.

The LEADERS FREE trial concluded that the polymer free drug-coated BioFreedom™ stent appeared to be both safer and more effective than bare-metal stents (BMS) with an ISR rate comparable to traditional DES without the need for prolonged DAPT. We implanted 45 BioFreedom™ stents in 34 patients over a 4-month period. 4 patients represented early (106-238 days after the implant procedure) with angina symptoms and severe ISR was detected in all patients. The rate of severe and early ISR detected in our patient population of 11.8% is comparable to that of traditional BMS. Further studies are warranted.