BIOFLOW V: SES reduces event rates at 3 years vs. EES
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Patients who underwent coronary revascularization with a bioresorbable polymer sirolimus-eluting stent had significantly lower rates of target vessel MI, late/very late stent thrombosis and clinically driven target lesion revascularization compared with those who underwent the procedure with a durable polymer everolimus-eluting stent, according to 3-year data from the BIOFLOW V trial presented at Cardiovascular Research Technologies.
“These results both advance a new standard of comparison for DES but also direct attention to strut thickness and polymer composition as key features for iterative DES development,” David E. Kandzari, MD, director of interventional cardiology and chief scientific officer at Piedmont Heart Institute in Atlanta, said during the presentation.
Two-year data from the trial were presented in 2018. As Healio previously reported, patients with CAD who underwent PCI with an ultrathin, bioresorbable polymer SES (Orsiro, Biotronik) had reduced risk for target lesion failure and target vessel MI compared with patients assigned a thin, durable polymer EES (Xience, Abbott Vascular).
Three-year follow-up data
Follow-up was conducted during the hospital stay, at 30 days, 6 months and annually through 3 years after the procedure. Annual follow-up is currently planned through 5 years, according to the presentation.
The primary endpoint assessed at 3 years was TLF, defined as a composite of target vessel-related MI, cardiac death or ischemia-driven TLR. Other specified endpoints included MACE, target vessel failure, individual components of the composite endpoints and probable or definite stent thrombosis.
Of the 1,334 patients who were assigned either SES (n = 884) or EES (n = 450), 3-year follow-up data were available for 94.8% of patients for a median follow-up duration of 1,097 days for the primary endpoint.
At 3 years, patients assigned SES had a lower rate of TLF compared with those assigned EES (8.6% vs. 14.4%; P = .003). This represented a moderate increase in the absolute different in event rates vs. 1-year and 2-year events (5.4% at 3 years vs. 3.2% at 1 year and 4% at 2 years). This difference was driven by a lower rate of ischemia-driven TLR (3.4% vs. 6.9%; P = .008) and a difference in target vessel-related MI (5.5% vs. 10.1%; P = .004) in patients assigned SES.
A landmark analysis found that the significant differences in TLR and target vessel MI favored treatment with SES.
Patients assigned SES had a lower rate of definite or probable late or very late stent thrombosis compared with those assigned EES (0.1% vs. 1.2%; P = .018). MI or cardiac death occurred in 7.7% of patients in the SES group and 11.7% of those in the EES group (P = .02).
“Altogether, these findings affirm the durability of late-term comparative outcomes with this specific BP SES,” Kandzari and colleagues wrote in a simultaneous publication of these results in JACC: Cardiovascular Interventions.
“Orsiro’s consistently better long-term outcomes completely alter the dynamic of what had become a highly commoditized DES market,” Ryan Walters, president of Biotronik, said in a press release from the company. “We designed Orsiro with a focus on efficacy even in challenging cases. … Orsiro is proving to be exactly what physicians need for best-in-class performance and what patients deserve.”
Potential implications
In a related editorial in JACC: Cardiovascular Interventions, Bernhard Reimers, MD, director of the clinical and invasive cardiology unit at Humanitas Research Hospital in Rozzano-Milano, Italy, and colleagues wrote: “Definite conclusions regarding the optimal ingredients for the ‘perfect’ stent cannot be drawn yet; the relative importance of Orsiro BP-SES stent design and polymer technology is unknown, as experienced already when Xience DP-EES became available more than a decade ago, before its proven remarkable efficacy and safety profile paved the way to treatment of increasingly complex lesions, such as left main stem.” – by Darlene Dobkowski
References:
Kandzari DE. Late-Breaking Trials: Session I. Presented at: Cardiovascular Research Technologies; Feb. 22-25, 2020; National Harbor, Md.
Kandzari DE, et al. JACC Cardiovasc Interv. 2020;doi:10.1016/j.jcin.2020.02.019.
Reimers B, et al. JACC Cardiovasc Interv. 2020;doi:10.1016/j.jcin.2020.02.020.
Disclosures: The trial was funded by Biotronik AG. Kandzari reports he received institutional research/grant support from Biotronik, Boston Scientific, Medinol, Medtronic, Orbus Neich and Teleflex and personal consultant honoraria from Biotronik, Cardiovascular Systems and Medtronic. Walters is an employee of Biotronik. Reimers reports he received minor speaking honoraria from Boston Scientific. Please see the study and the editorial for all other authors’ relevant financial disclosures.