Randomized Comparison of Novel Low-Dose Sirolimus-Eluting Biodegradable Polymer Stent vs Second-Generation DES: TARGET-IV NA Trial.

BACKGROUND

Drug-eluting stents (DESs) with controlled antiproliferative drug release reduce restenosis risk, but durable polymers can delay healing and inhibit reendothelialization. The Firehawk biodegradable polymer sirolimus-eluting stent (BP-SES) has a fully biodegradable sirolimus-containing polymer coating localized to recessed abluminal grooves on the stent surface and delivers roughly one-third the drug dose of other DESs.

OBJECTIVES

We report the primary results of the TARGET-IV NA (Firehawk Rapamycin Target Eluting Coronary Stent North American Trial) randomized controlled trial comparing clinical outcomes with BP-SES vs currently used second-generation DESs.

METHODS

The TARGET-IV NA study was a prospective, multicenter, single-blind, 1:1 randomized noninferiority trial comparing the BP-SES with control in North America and Europe among patients undergoing percutaneous coronary intervention for chronic or acute coronary syndromes. The primary endpoint was target lesion failure (TLF) at 12 months (composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization). The primary analysis (intention-to-treat) tested noninferiority of BP-SES vs control using an absolute margin of 3.85% and 1-sided α of 0.025. Noninferiority-powered secondary endpoints were tested in an optical coherence tomography substudy (endpoint: mean neointimal hyperplasia thickness) and an angiography substudy (endpoint: in-stent late lumen loss).

RESULTS

A total of 1,720 patients (mean age 66 years; 74% male) with 2,159 lesions were randomly allocated to receive either BP-SES (860 patients, 1,057 lesions) or control second-generation DES (860 patients, 1,084 lesions). A total of 61% of patients presented with stable coronary disease, 32% had unstable angina, and 7% had non-ST-segment elevation myocardial infarction (NSTEMI) or recent ST-segment elevation myocardial infarction. The rate of TLF with BP-SES was noninferior to control at 12 months (3.4% vs 3.3%, absolute risk difference 0.13%, upper bound 97.5% CI: 2.03, P

CONCLUSIONS

The biodegradable polymer sirolimus-eluting stent was noninferior to currently used second-generation DES with regard to TLF at 1 year. (Firehawk® Rapamycin Target Eluting Coronary Stent North American Trial; NCT04562532).

Informations de copyright

Copyright © 2024. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures Funding was provided by Microport Medical Ltd (Shanghai, China). Dr Yeh has served as a consultant for Abbott Vascular, Boston Scientific, Medtronic, CathWorks, Elixir Medical, Shockwave, and Zoll; and has received investigator-initiated research grants from Abbott Vascular, Boston Scientific, and Medtronic. Dr Bertrand owns equity in Nanostent Inc; has served as a consultant for Boston Scientific, Microport, and Opsens Medical; and has received investigator-initiated research grant support from Opsens Medical. Dr Mahmud has received research grant support from Boston Scientific, Abbott Vascular, Microport, and Pulnova; and has received consultant fees from Microport, Siemens, and CRF and Pulnova. Dr Redfors has received consultant fees from Pfizer and Boehringer Ingelheim. Dr Popma’s spouse is an employee of Medtronic. Dr van Royen has received research grants from Abbott, Biotronik, Medtronic, and Philips; and has received lecture fees from Abbott, Bayer, and Microport. Dr Choi has received consulting fees from Medtronic. Dr Maehara is a consultant for Boston Scientific, SpectraWave, Amgen, Philips, and Abbott Vascular; and has received lecture fees from Nipro. Dr Leon has received institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and has served as a consultant/advisory board participant for Foldax, Anteris, JenaValve, Medinol, SoloPace, and Bain Capital. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.