Key result
In a small case series of 34 patients, the polymer-free drug-coated BioFreedom stent was associated with an 11.8% rate of severe, early in-stent restenosis requiring re-intervention.
Why the study?
Does the polymer- and carrier-free drug-coated stent system have a high rate of early in-stent restenosis?
Observational (n=34)
No
Does the polymer- and carrier-free drug-coated stent system have a high rate of early in-stent restenosis?
In a small case series, the polymer- and carrier-free drug-coated stent system was associated with an 11.8% rate of early and severe in-stent restenosis, challenging previous trial findings that suggested rates comparable to traditional drug-eluting stents.
Warrants caution with polymer-free BioFreedom stents; leaves open whether early ISR exceeds rates in randomized DES trials.
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.
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Loch et al. (2017) conducted an observational in Coronary artery disease (n=34). BioFreedom stent was evaluated on Severe in-stent restenosis requiring re-intervention. In a small case series of 34 patients, the polymer-free drug-coated BioFreedom stent was associated with an 11.8% rate of severe, early in-stent restenosis requiring re-intervention.
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