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BIOFLOW-V: Bioresorbable polymer DES superior to durable polymer DES for 12-month TLF
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An ultra-thin sirolimus-eluting bioresorbable polymer drug-eluting stent was superior to a thin everolimus-eluting durable polymer stent for prevention of target lesion failure at 12 months, according to a late-breaking presentation from the European Society of Cardiology Congress.
The results of the BIOFLOW-V trial showed significantly lower rates of target lesion failure and target vessel-related MI with the ultra-thin sirolimus-eluting bioresorbable polymer stent (Orsiro, Biotronik) vs. the thin everolimus-eluting durable polymer stent (Xience, Abbott Vascular), according to a presentation from David E. Kandzari, MD, director of interventional cardiology and chief scientific officer at Piedmont Heart Institute in Atlanta.
“To our knowledge, this is the first trial that has demonstrated a significant improvement in clinical outcomes and clinically meaningful outcomes compared with the Xience stent that historically has served as a benchmark for standard of comparison in DES trials,” Kandzari told Cardiology Today’s Intervention.
Kandzari and colleagues conducted an international multicenter, prospective, 2:1 randomized trial comparing the two stents.
According to the study, 1,334 patients were enrolled between May 2015 and March 2016 in 13 countries in North America, Europe, Israel, Asia, Australia and New Zealand.
The primary endpoint was 12-month TLF, defined as a composite of CV death, target vessel MI and clinically driven repeat revascularization.
At 12 months, the TLF rate was 6.2% in the bioresorbable polymer stent and 9.6% in the durable polymer stent (P = .04) and the target vessel MI rate was 4.7% in the bioresorbable polymer stent and 8.3% in the durable polymer stent (P = .016), according to the researchers.
Clinically driven target lesion revascularization rates were 2% in the bioresorbable polymer group and 2.4% in the durable polymer stent group (P = .686), while Academic Research Consortium definite/probable stent thrombosis rates were 0.5% for the hybrid stent and 0.7% for the durable polymer stent (P = .694).
A pooled Bayesian analysis of BIOFLOW-V and two prior trials of the bioresorbable polymer stent compared TLF in 2,208 patients who were treated with either the bioresorbable polymer or durable polymer stent. The mean TLF in the pooled analysis at 12 months for the bioresorbable polymer and durable polymer stents were 6.3 and 8.9%, respectively, and resulted in a –2.6% mean difference favoring the Orsiro stent group. According to the study, these results demonstrated a 100% probability of noninferiority and 97% probability of superiority for the Orsiro stent compared with the Xience stent regarding 12-month TLF.
“The results are important first because they reaffirm the outcomes observed by clinicians in other geographies where the stent is presently available or call for a reappraisal in those practices of the benefits of this stent relative to alternative stents,” Kandzari said in the interview. “Second, as a pivotal regulatory trial, we’re hopeful that these results will lead to the approval in the U.S. for this technology as well.” – by Dave Quaile
References:
Kandzari DE, et al. Late-Breaking Science in PCI. Presented at: European Society of Cardiology Congress; Aug. 26-30, 2017; Barcelona, Spain.
Kandzari, DE, et al. Lancet. 2017;doi:10.1016/S0140-6736(17)32249-3.
Disclosures: Kandzari reports receiving consultant fees from Boston Scientific, Medtronic, Micell and St. Jude Medical and research support from Abbott Vascular, Biotronik, Boston Scientific, Medinol, Medtronic and St. Jude Medical. Please see the study for all other authors’ relevant financial disclosures.