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Novel stent noninferior to durable polymer stent
An abluminal, groove-filled, biodegradable polymer sirolimus-eluting stent was shown noninferior to a durable polymer stent for in-stent late lumen loss at 9 months for treating patients with single de novo coronary lesions.
The TARGET I study, a prospective, randomized, noninferiority trial, enrolled 458 patients with coronary lesions ≤24 mm in length and a coronary artery ≥2.25 mm to ≤4 mm in diameter. Patients were randomly assigned to a biodegradable polymer sirolimus-eluting stent (SES; Firehawk, MicroPort Medical; n=227) or a durable polymer everolimus-eluting stent (EES; Xience V, Abbott Vascular; n=231).
The 9-month in-stent late lumen loss of the SES was comparable to the EES group (0.13 ± 0.24 mm vs. 0.13 ± 0.18 mm; P for noninferiority <.0001). Rates of cardiac death (SES, 0.4% vs. EES, 0.0%), target vessel MI (SES, 1.3% vs. EES, 1.7%), ischemia-driven target lesion revascularization (both 0.4%) and target lesion failure (both 2.2%) were also similar between the two stents at 12-month follow-up (P for all >.05). No definite or probable stent thrombosis was seen in either group.
“Given the similar and low in-stent [late lumen loss], sufficient inhibition of neointimal proliferation may have been achieved in the Firehawk stent using the groove-filled biodegradable polymer design compared with the Xience V,” the researchers wrote. “Based on this unique technique, the targeted drug release may potentially result in comparable drug release kinetics and uptake of the drug into the arterial wall.”
Disclosure: Gao reports receiving research grants from Abbott Vascular, B. Braun Medical, Boston Scientific and MicroPort.