Very long-term efficacy and safety of paclitaxel-eluting balloon after a bare-metal stent for the treatment of ST-elevation myocardial infarction: 8-year results of a randomized clinical trial (PEBSI study).

IF 2.1 3区 医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS
Cardiovascular diagnosis and therapy Pub Date : 2023-10-31 Epub Date: 2023-10-17 DOI:10.21037/cdt-22-623
Arturo García-Touchard, Manel Sabaté, Nieves Gonzalo, Vicente Peral, Beatriz Vaquerizo, Rafael Ruiz-Salmerón, Bruno García Del Blanco, Jesús Jiménez-Mazuecos, Eduardo Molina, Pedro Martínez-Romero, José María Hernandez-García, Valeriano Ruiz-Quevedo, Cristóbal Urbano, Javier Fernández-Portales, José Ramón Rumoroso, Juan Casanova-Sandoval, Eduardo Pinar, Javier Lopez-Pais, Juan Francisco Oteo, Fernando Alfonso
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引用次数: 0

Abstract

Background: Drug-eluting stents (DES) are considered the therapy of choice in ST-segment elevation myocardial infarction (STEMI); however, a low persistent rate of revascularizations and stent thrombosis exist over the time. We have previously shown that a paclitaxel (PTX)-drug-coated balloon (DCB) after a bare-metal stent (BMS) implantation (DCB-combined strategy) yields superior angiographic and clinical results compared to BMS in the short term. However, the long-term safety and efficacy of this approach remain uncertain.

Methods: An 8-year clinical follow-up was conducted on patients enrolled in the randomized PEBSI-1 trial (NCT01839890). The original trial included patients who suffered a STEMI, patients were randomly assigned to receive a DCB-combined strategy or BMS only and the primary endpoint was in-stent late luminal loss (LLL) at 9-month follow-up. After the completion of this study, death, myocardial re-infarction, ischemia-driven repeated revascularizations included target lesion revascularization (TLR) and target vessel revascularization (TVR), and stent thrombosis, were assessed by yearly contact by a clinical visit, telephone or by electronic records. These outcomes were adhered to ARC-2 criteria.

Results: The rate of incomplete follow-up was very low, with only 3 out of 111 patients (2.7%) in the DCB-combined strategy group and 1 out of 112 patients (0.9%) in the BMS group. At 8 years there were a lower rate of TVR [3.7% vs. 14.3%; hazard ratio (HR): 0.243; 95% confidence interval (CI): 0.081-0.727; P=0.006], and a trend towards lower TLR (2.8% vs. 8.9%; HR: 0.300; 95% CI: 0.083-1.090; P=0.052) in the DCB-combined strategy group. No statistical difference between the DCB-combined strategy and BMS groups were found for all causes of death, deaths from cardiovascular disease, reinfarctions or stent thrombosis. Notably in the DCB-combined strategy group, no episode of stent thrombosis occurred after the first year. Similarly, there were no cardiovascular deaths, TVR and TLR in the DCB-combined strategy group after 5 years. In contrast, during the period from year 5 to 8, the BMS group experienced an additional cardiovascular death, as well as one case of TVR, one case of TLR, and one case of stent thrombosis.

Conclusions: In STEMI patients, the DCB-combined strategy maintains its safety and clinical efficacy over time. Our rates of TVR, TLR, and very late stent thrombosis (VLST) at very long-term are the lowest ever found in a STEMI trial. Further studies are warranted to assess the potential superiority of this novel strategy as compared with new-generation DES to prevent very late events in these patients.

Trial registration: ClinicalTrials.gov; identifier: NCT01839890.

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裸金属支架后紫杉醇洗脱球囊治疗ST段抬高型心肌梗死的长期疗效和安全性:一项随机临床试验的8年结果(PEBSI研究)。
背景:药物洗脱支架(DES)被认为是ST段抬高型心肌梗死(STEMI)的首选治疗方法;然而,随着时间的推移,血运重建和支架血栓形成的持续率较低。我们之前已经表明,与BMS相比,裸金属支架(BMS)植入后的紫杉醇(PTX)-药物涂层球囊(DCB)(DCB联合策略)在短期内产生了更好的血管造影和临床结果。然而,这种方法的长期安全性和有效性仍不确定。方法:对纳入随机PEBSI-1试验(NCT01839890)的患者进行8年的临床随访。最初的试验包括STEMI患者,患者被随机分配接受DCB联合策略或仅接受BMS,主要终点是9个月随访时支架内晚期管腔损失(LLL)。本研究完成后,每年通过临床访视、电话或电子记录对死亡、心肌再梗死、缺血驱动的重复血运重建(包括靶病变血运重建术(TLR)和靶血管血运重建法(TVR))以及支架血栓形成进行评估。这些结果符合ARC-2标准。结果:不完全随访率非常低,DCB联合策略组111例患者中只有3例(2.7%),BMS组112例患者中有1例(0.9%)。在8年时,DCB联合策略组的TVR较低[3.7%对14.3%;危险比(HR):0.243;95%置信区间(CI):0.081-0.727;P=0.006],TLR有降低的趋势(2.8%对8.9%;HR:0.300;95%CI:0.83-1.090;P=0.052)。DCB联合策略和BMS组在所有死亡原因、心血管疾病死亡、再梗死或支架血栓形成方面没有发现统计学差异。值得注意的是,在DCB联合策略组中,第一年后没有发生支架血栓形成。同样,DCB联合策略组5年后没有心血管死亡、TVR和TLR。相反,在第5年至第8年期间,BMS组经历了一例额外的心血管死亡,以及一例TVR、一例TLR和一例支架血栓形成。结论:在STEMI患者中,DCB联合策略随着时间的推移保持其安全性和临床疗效。我们的长期TVR、TLR和晚期支架血栓形成(VLST)的发生率是STEMI试验中发现的最低的。需要进一步的研究来评估与新一代DES相比,这种新策略在预防这些患者的晚期事件方面的潜在优势。试验注册:ClinicalTrials.gov;标识符:NCT01839890。
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来源期刊
Cardiovascular diagnosis and therapy
Cardiovascular diagnosis and therapy Medicine-Cardiology and Cardiovascular Medicine
CiteScore
4.90
自引率
4.20%
发文量
45
期刊介绍: The journal ''Cardiovascular Diagnosis and Therapy'' (Print ISSN: 2223-3652; Online ISSN: 2223-3660) accepts basic and clinical science submissions related to Cardiovascular Medicine and Surgery. The mission of the journal is the rapid exchange of scientific information between clinicians and scientists worldwide. To reach this goal, the journal will focus on novel media, using a web-based, digital format in addition to traditional print-version. This includes on-line submission, review, publication, and distribution. The digital format will also allow submission of extensive supporting visual material, both images and video. The website www.thecdt.org will serve as the central hub and also allow posting of comments and on-line discussion. The web-site of the journal will be linked to a number of international web-sites (e.g. www.dxy.cn), which will significantly expand the distribution of its contents.
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