Key result
The BioFreedom polymer-free drug-coated stent was superior to a bare-metal stent, but a stent thrombosis rate of 2.01% vs 2.20% led to conditional approval requiring a 2,000-patient survey.
Absolute Event Rate: 2.01% vs 2.2%
The BioFreedom stent received conditional regulatory approval in Japan for high bleeding risk patients, requiring a 2,000-patient post-marketing survey due to concerns over stent thrombosis rates.
Conditional approval for high-bleeding-risk patients warrants thrombosis caution; leaves open long-term safety via required 2,000-patient survey.
A prospective randomized clinical trial showed that the BioFreedom stent (Biosensors International), which is a polymer-free and carrier-free drug-coated stent, was significantly superior to a bare-metal stent (BMS) in patients at high bleeding risk who were receiving a 1-month course of dual antiplatelet therapy (DAPT). However, the stent thrombosis rate (2.01% for BioFreedom vs. 2.20% for BMS) was 4-6-fold higher than that of approved drug-eluting stents based on real-world data in Japan. Furthermore, the frequency of stent thrombosis at more than 1 month with the BioFreedom stent was slightly higher than that at less than 1 month. This result suggested that it would not be acceptable to stop DAPT universally at 1 month. Thus, the target patients for the BioFreedom stent are unspecified patients at high bleeding risk needing to continue DAPT for as long as necessary in Japan. Therefore, based on the pre- and post-marketing balance of medical devices regulations, regulatory approval was given for unspecified patients conditionally upon real-world data collection of 2,000 patients with a Use-Results Survey, instead of conducting additional pre-marketing clinical trial(s). The Use-Results Survey System is part of a strategy to expedite patients' access to innovative medical devices and to accelerate the development of medical devices.
No takes yet. Share an insight, caveat, or question.
Konishi et al. (2018) conducted a review in High bleeding risk requiring coronary stenting (n=2,000). BioFreedom stent vs. Bare-metal stent (BMS) was evaluated on Stent thrombosis. The BioFreedom polymer-free drug-coated stent was superior to a bare-metal stent, but a stent thrombosis rate of 2.01% vs 2.20% led to conditional approval requiring a 2,000-patient survey.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: