This article is more than 5 years old. Information may no longer be current.
Nanocoated stent yields favorable TVF, restenosis, stent thrombosis outcomes vs. BMS
Click Here to Manage Email Alerts
A nanocoated coronary stent system delivers favorable results in terms of target vessel failure, restenosis and stent thrombosis events vs. traditional bare-metal stents, according to results from the PzF SHIELD study.
In the nonrandomized, multicenter, prospective, single-arm clinical trial of a cobalt-chromium coronary stent coated with a nano-thin layer of Polyzene-F (COBRA PzF, CeloNova BioSciences), Donald E. Cutlip, MD, from Beth Israel Deaconess Medical Center and Harvard Medical School, and colleagues evaluated 296 patients (mean age, 66 years; 30% women; 34% with diabetes) enrolled from 23 centers in the United States and 12 centers outside the country.
Patients eligible for analysis were older than 18 years and had symptomatic ischemic heart disease attributable to one de novo lesion contained within a native coronary artery with reference vessel diameter between 2.5 mm and 4 mm and lesion length ≤ 24 mm.
The first 130 consecutive patients who provided consent were scheduled for protocol-specified angiographic follow-up, which was conducted at 9 months. A subset of this cohort (n = 57) also underwent OCT.
The study’s primary endpoint was TVF, defined as cardiac death, MI, or clinically driven target lesion revascularization, at 270 days. The powered secondary endpoint was angiographic in-stent late lumen loss based on quantitative coronary angiography performed in the 9-month angiographic follow-up subgroup. The researchers reviewed the large volume of accessible information regarding BMS placement outcomes to identify a performance goal based on recent clinical trials including BMS cohorts as the comparator.
The researchers found that, at 30 days, 19 patients (6.4%) experienced TVF events, including 17 MIs, one target vessel revascularization and one cardiac death. No stent thromboses occurred.
At 9 months, 33 patients (11.5%) experienced the primary endpoint of TVF. The upper 1-sided 95% CI was 15.07%, which was well below the 19.62% performance goal. No additional cardiac deaths were observed. Between 30 and 280 days, three MI events occurred; two of these were related to restenosis and subsequent TLR and one was within the setting of aortic stenosis and rapid atrial fibrillation without repeat cardiac catheterization.
Seventeen patients (5.9%) experienced clinically driven TVR, and 13 of these patients (4.6%) experienced clinically driven TLR. Six of these patients underwent TLR after the protocol-required angiographic follow-up, the researchers wrote.
Of the 130 patients in whom routine angiographic follow-up was planned, 115 patients (88%) with 117 lesions completed follow-up. The powered secondary endpoint of late lumen loss was 0.84 ± 0.48 mm. The upper bound of the 1-sided 97.5% CI was 0.92 mm, which was below the performance goal of 1.1 mm. Late lumen loss was < 1 mm in 65% of patients and > 2 mm in only two patients, according to the findings.
“This study showed the COBRA PzF meets a performance goal for an effectiveness endpoint of 9-month TVF with an excellent safety profile, including low risk for MI beyond the periprocedural period and no stent thrombosis,” the researchers wrote. “An ongoing study will compare safety and effectiveness of the COBRA PzF and 2 weeks of [dual antiplatelet therapy] with second-generation [drug-eluting stents] and 6 months of DAPT among patients at high risk for bleeding.” – by Jennifer Byrne
Disclosure: Cutlip reports receiving research support from Boston Scientific, CeloNova BioSciences and Medtronic. Please see the full study for a list of the other researchers’ relevant financial disclosures.
Click Here to Manage Email Alerts