PCI with ridaforolimus-eluting stent confers similar 2-year outcomes as ZES
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Outcomes at 2 years were similar for patients who underwent PCI with a ridaforolimus-eluting stent compared with a zotarolimus-eluting stent, according to a pooled analysis of two randomized trials published in JACC: Cardiovascular Interventions.
BIONICS and NIREUS trial data
Maayan Konigstein, MD, of the Clinical Trials Center of the Cardiovascular Research Foundation and Tel Aviv-Sourasky Medical Center at Tel Aviv University in Israel, analyzed data from 2,221 patients (mean age, 63 years; 80% men) from the BIONICS and NIREUS trials who underwent PCI.
Patients from the BIONICS trial (n = 1,919) had an estimated reference vessel diameter between 2.5 mm and 4.25 mm with up to two lesions per vessel in a maximum of two major coronary arteries. The NIREUS trial (n = 302) has similar enrollment criteria as the BIONICS trial but had stricter angiographic exclusion criteria such as bypass graft disease and bifurcation lesions with a side branch diameter greater than 2 mm. Patients from both trials were assigned a ridaforolimus eluting stent (RES; EluNIR, Cordis; n = 1,159) or a ZES (Resolute Integrity or Resolute Onyx, Medtronic; n = 1,062). Both groups had similar clinical and angiographic characteristics.
Clinical events were assessed during the hospital stay and at 30 days, 1 year and 2 years after the procedure. Patients in the NIREUS trial also underwent angiographic follow-up at 6 months, and a small cohort of patients from both groups underwent angiographic follow-up at 13 months. Follow-up was conducted for a median of 736 days.
The primary endpoint in the BIONICS trial was target lesion failure at 12 months, which was defined as a composite of target vessel-related MI, cardiac death or clinically driven target lesion revascularization. The NIREUS trial had a primary endpoint of in-stent late lumen loss, defined as the difference between minimal lumen diameter after the procedure and at angiographic follow-up at 6 months.
The primary endpoint of TLF was similar in patients assigned RES vs. ZES at 2 years (7% vs. 7.2%; P = .94). No differences were seen between the RES and ZES groups for rates of target vessel-related MI (3.1% vs. 3.8%, respectively; P = .52) and TLR (4.8% vs. 4.1%, respectively; P = .41). Similarities were also noted for the overall rate of stent thrombosis (0.5% vs. 0.9%, respectively; P = .39).
“Larger trials enrolling patients with even more complex lesions and with longer follow-up will probably be needed to test whether the described advancements in design translate into meaningful differences between contemporary drug-eluting stents,” Konigstein and colleagues wrote. “The trend toward fewer late and very late stent thrombosis events in the RES group supports the long-term safety of this device.”
‘Important and welcome’ data
In a related editorial, Antonio Columbo, MD, director of the cardiac cath lab and interventional cardiology unit at GVM Care and Research at Maria Cecilia Hospital in Cotignola, Italy, and Antonio Mangieri, MD, also of GVM Care and Research, wrote: “Considering all the ... limitations, we need to conclude that the data presented in this formally well-constructed analysis are important and welcome, but not sufficient to give a complete picture regarding the features of EluNIR stent.” – by Darlene Dobkowski
Disclosures: Konigstein and Columbo report no relevant financial disclosures. Mangieri reports he received an institutional grant from Boston Scientific and research fees from Innovative Cardiac Solution. Please see the study for all other authors’ relevant financial disclosures.
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