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

IF 21.7 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Journal of the American College of Cardiology Pub Date : 2024-10-30 DOI:10.1016/j.jacc.2024.10.074
Robert W. Yeh, Olivier F. Bertrand, Ehtisham Mahmud, Emanuele Barbato, Batla Falah, Melek Ozgu Issever, Björn Redfors, Alexandra Popma, Michael Curtis, Niels van Royen, Jean-Francois Tanguay, Luc Janssens, William N. Newman, Koen Teeuwen, James W. Choi, Maurits T. Dirksen, Akiko Maehara, Martin B. Leon
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Abstract

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, Pnoninferiority < 0.0001). Cardiac death, myocardial infarction, and stent thrombosis rates were similar between groups. Angiographic follow-up was available in 104 patients (97.2% of those enrolled in the angiographic substudy) and 128 (94.1%) lesions. At 13 months, the powered secondary endpoint of mean in-stent late lumen loss was 0.149 ± 0.263 mm for BP-SES and 0.327 ± 0.463 mm for control (least squares mean difference: −0.178; 90% CI: −0.2943 to −0.0632; Pnoninferiority < 0.0001). The optical coherence tomography substudy included 37 patients (42 lesions) with no difference in mean neointimal hyperplasia thickness between groups at 13 months (Pnoninferiority = 0.01).

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)

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新型低剂量西罗莫司洗脱生物可降解聚合物支架与第二代 DES 的随机比较:TARGET-IV NA 试验
背景药物洗脱支架(DES)具有可控的抗增殖药物释放功能,可降低再狭窄风险,但耐久性聚合物会延迟愈合并抑制再内皮化。我们报告了TARGET-IV NA(Firehawk Rapamycin靶向洗脱冠状动脉支架北美试验)随机对照试验的主要结果,该试验比较了BP-SES与目前使用的第二代DES的临床效果。方法TARGET-IV NA 研究是一项前瞻性、多中心、单盲、1:1 随机非劣效性试验,在北美和欧洲接受经皮冠状动脉介入治疗的慢性或急性冠状动脉综合征患者中比较 BP-SES 与对照组。主要终点是 12 个月时的靶病变失败 (TLF)(心源性死亡、靶血管相关心肌梗死或缺血驱动的靶病变血运重建的综合结果)。主要分析(意向治疗)检验了 BP-SES 与对照组的非劣效性,绝对差值为 3.85%,单侧 α 为 0.025。在光学相干断层扫描子研究(终点:平均新血管增生厚度)和血管造影子研究(终点:支架内晚期管腔损失)中对非劣效性次要终点进行了测试。结果 共有1720名患者(平均年龄66岁;74%为男性)的2159个病变被随机分配到BP-SES(860名患者,1057个病变)或对照组第二代DES(860名患者,1084个病变)。61%的患者冠状动脉疾病稳定,32%的患者心绞痛不稳定,7%的患者患有非ST段抬高型心肌梗死(NSTEMI)或近期ST段抬高型心肌梗死。12 个月时,BP-SES 的 TLF 发生率不劣于对照组(3.4% vs 3.3%,绝对风险差异 0.13%,上限 97.5% CI:2.03,Pnoninferiority < 0.0001)。两组的心源性死亡、心肌梗死和支架血栓形成率相似。104名患者(占血管造影子研究入选者的97.2%)和128个病灶(94.1%)接受了血管造影随访。13 个月后,BP-SES 的次要终点平均支架内晚期管腔损失为 0.149 ± 0.263 mm,对照组为 0.327 ± 0.463 mm(最小二乘法平均差:-0.178;90%):-0.178;90% CI:-0.2943 至 -0.0632;Pnoninferiority < 0.0001)。结论可降解聚合物西罗莫司洗脱支架1年后的TLF不劣于目前使用的第二代DES。(Firehawk® Rapamycin靶向洗脱冠状动脉支架北美试验;NCT04562532)。
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来源期刊
CiteScore
42.70
自引率
3.30%
发文量
5097
审稿时长
2-4 weeks
期刊介绍: The Journal of the American College of Cardiology (JACC) publishes peer-reviewed articles highlighting all aspects of cardiovascular disease, including original clinical studies, experimental investigations with clear clinical relevance, state-of-the-art papers and viewpoints. Content Profile: -Original Investigations -JACC State-of-the-Art Reviews -JACC Review Topics of the Week -Guidelines & Clinical Documents -JACC Guideline Comparisons -JACC Scientific Expert Panels -Cardiovascular Medicine & Society -Editorial Comments (accompanying every Original Investigation) -Research Letters -Fellows-in-Training/Early Career Professional Pages -Editor’s Pages from the Editor-in-Chief or other invited thought leaders
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