Benefits of ultrathin-strut bioresorbable polymer DES remain at 5 years: BIOFLOW-V
An ultrathin-strut bioresorbable polymer sirolimus-eluting stent continued to outperform a durable-polymer drug-eluting stent at 5 years, researchers reported at Cardiovascular Research Technologies.
As Healio previously reported, in the BIOFLOW-V trial of patients undergoing PCI, the bioresorbable polymer DES (Orsiro, Biotronik) was superior to the durable polymer DES (Xience V, Abbott) for the primary outcome of target lesion failure at 1 year and for various outcomes at 1, 2 and 3 years. David E. Kandzari, MD, FACC, FSCAI, director of interventional cardiology at Piedmont Heart Institute in Atlanta and chief scientific officer of Piedmont Healthcare, presented the final 5-year results of the trial at Cardiovascular Research Technologies.
“The final 5-year follow-up data confirms Orsiro’s superior safety profile and low TLF rates,” Kandzari said in a press release. “The ultrathin-strut Orsiro stent significantly reduces the risk for target vessel MI and shows a low rate of stent thrombosis, and specifically a significant reduction in late and very late stent thrombosis. These long-term results confirm that the Orsiro DES sets a new clinical benchmark in PCI treatment options.”
The trial included 1,334 patients with ischemic heart disease, stable or unstable angina or silent ischemia (mean age, 64 years; 26% women).
TLF, defined as CV death, target vessel MI and clinically driven repeat revascularization, significantly favored the ultrathin bioresorbable polymer stent group at 1, 2 and 3 years, whereas at 5 years, the difference was no longer statistically significant but still favored the bioresorbable polymer stent group (13.2% vs. 16.5%; log-rank P = .136), Kandzari said during a presentation.
The bioresorbable polymer stent remained superior to the durable polymer stent in target vessel MI (7.3% vs. 11.5%; P = .021) at 5 years, he said.
There was no difference between the groups in overall or early definite/probable stent thrombosis, but the bioresorbable polymer stent was superior to the durable polymer stent in very late (1 to 5 years) definite/probable stent thrombosis (0.1% vs. 1%; P = .047) and in late/very late (30 days to 5 years) definite/probable stent thrombosis (0.3% vs. 1.6%; P = .021), according to the researchers.
“These findings affirm the durability of longer-term comparative outcomes with ultrathin-strut bioresorbable polymer SES, demonstrating continued differences in late ischemic events,” Kandzari said during the presentation.
Editor's Note: This article was revised on March 14, 2022 to reflect updates to the data.
Reference:
- Biotronik. news.biotronik.com/biotronik-sets-new-clinical-benchmark-with-ultrathin-strut-orsiro-coronary-drug-eluting-stent. Published Feb. 28, 2022. Accessed March 4, 2022.
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Kandzari DE, et al. Late Breaking Trials: Session I. Presented at: Cardiovascular Research Technologies; Feb. 26-March 1, 2022; Washington, D.C.