Study Compares Biosensors' BioFreedom DES and Alvimedica's Cre8 DES in Italian Registries
February 25, 2019—A study published by Mauro Chiarito, MD, et al in Circulation: Cardiovascular Interventions demonstrated that the polymer-free BioFreedom biolimus-eluting stent (BES; Biosensors International Group, Ltd.) and the polymer-free Cre8 amphilimus-eluting stent (AES; Alvimedica Medical Technologies) have favorable and comparable safety and efficacy profiles in all-comer patients undergoing percutaneous coronary intervention (PCI). Further evaluation in large-scale, randomized trials are necessary to confirm these findings, advised the investigators.
As summarized in Circulation: Cardiovascular Interventions, the BioFreedom BES and the Cre8 AES were investigated in two recent multicenter registries: RUDI-Free and ASTUTE. These studies included a total of 2,320 all-comer patients undergoing PCI at 22 Italian centers.
Using propensity score matching, the investigators compared safety and efficacy outcomes among 1,280 patients (640 matched pairs) treated with BioFreedom BES or Cre8 AES. The primary endpoint was target lesion failure—a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization.
At 1 year, the investigators found that target lesion failure occurred in 4% of BES-treated patients and 4.2% of AES-treated patients (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.57–1.7).
Other findings were comparable in patients treated with BioFreedom BES versus Cre8 AES:
- Risks of cardiac death (2% vs 2.1%; HR, 1.03; 95% CI, 0.47–2.26)
- Target vessel myocardial infarction (0.8% vs 0.3%; HR, 1.89; 95% CI, 0.5–6.8)
- Target lesion revascularization (1.5% vs 2.2%; HR, 0.74; 95% CI, 0.34–1.62)
- Definite/probable stent thrombosis (0.9% vs 0.8%; HR, 1.17; 95% CI, 0.36–3.81)
An observed differential treatment effect by diabetes mellitus status indicated a benefit of AES in patients with diabetes mellitus (P interaction = .003), reported the investigators in Circulation: Cardiovascular Interventions.