采用超薄支架与薄支架药物洗脱支架或药物洗脱球囊治疗支架内再狭窄：一项多中心注册研究。
Treatment of in-stent restenosis with ultrathin-strut versus thin-strut drug-eluting stents or drug-eluting balloons: a multicentre registry.
机构信息
Division of Cardiology, Cardiovascular and Thoracic Department, "Citta della Salute e della Scienza" Hospital, Turin, Italy.
Department of Medical Sciences, University of Turin, Turin, Italy.
出版信息
EuroIntervention. 2024 Nov 4;20(21):e1340-e1354. doi: 10.4244/EIJ-D-24-00491.
BACKGROUND
Limited data exist on ultrathin-strut drug-eluting stent (ultrathin DES) performance in DES in-stent restenosis (ISR).
AIMS
We aimed to assess the efficacy and safety of ultrathin DES compared to thin-strut DES and drug-eluting balloons (DEB) for DES-ISR.
METHODS
Patients from the DEB Dragon (ClinicalTrials.gov: NCT04415216) and ULTRA registries (ClinicalTrials.gov: NCT05205148) were divided into ultrathin DES, thin-strut DES, or DEB groups for DES-ISR treatment. Both propensity score matching (PSM) and inverse probability weighting (IPW) were considered to adjust the distribution of patients in each class. Cox regression was applied to the following main endpoints: device-oriented composite endpoints (DOCE; including cardiac death, target lesion revascularisation [TLR] and target vessel myocardial infarction), TLR and target vessel revascularisation (TVR).
RESULTS
A total of 269, 541, and 557 patients received an ultrathin DES, thin-strut DES, and DEB, respectively. After 3 years of follow-up, in the IPW-adjusted overall cohort, ultrathin DES were associated with a significantly reduced risk of DOCE compared to DEBs (hazard ratio [HR] 0.353, 95% confidence interval [CI]: 0.194-0.642; p<0.001), as well as thin-strut DES (HR 0.645, 95% CI: 0.457-0.911; p=0.013). Compared to DEBs, ultrathin DES also reduced the risks of both TLR (HR 0.184, 95% CI: 0.081-0.417; p<0.001) and TVR (HR 0.188, 95% CI: 0.093-0.379; p<0.001), while thin-strut DES did not (TLR: HR 0.686, 95% CI: 0.407-1.157; p=0.157; TVR: HR 0.706, 95% CI: 0.453-1.101; p=0.124). For diffuse ISR patients, ultrathin DES reduced the risk of DOCE (HR 0.364, 95% CI: 0.188-0.705; p=0.003), as did thin-strut DES (HR 0.602, 95% CI: 0.367-0.987; p=0.044), while a reduction of TLR (HR 0.220, 95% CI: 0.091-0.531; p<0.001) and TVR (HR 0.241, 95% CI: 0.113-0.513; p<0.001) was achieved only by ultrathin DES.
CONCLUSIONS
Ultrathin DES were associated with reduced DOCE, TLR and TVR risks in diffuse ISR compared to DEBs.
背景
在药物洗脱支架内再狭窄（DES-ISR）中，超亲脂性药物洗脱支架（ultrathin DES）的性能数据有限。
目的
我们旨在评估与薄壁 DES 和药物洗脱球囊（DEB）相比，超薄 DES 治疗 DES-ISR 的疗效和安全性。
方法
来自 DEB Dragon（ClinicalTrials.gov：NCT04415216）和 ULTRA 登记处（ClinicalTrials.gov：NCT05205148）的患者被分为超薄 DES、薄壁 DES 和 DEB 组，分别接受 DES-ISR 治疗。均考虑使用倾向评分匹配（PSM）和逆概率加权（IPW）来调整每个类别中患者的分布。应用 Cox 回归分析以下主要终点：器械导向的复合终点（DOCE；包括心源性死亡、靶病变血运重建[TLR]和靶血管心肌梗死）、TLR 和靶血管血运重建（TVR）。
结果
共纳入 269、541 和 557 例患者分别接受超薄 DES、薄壁 DES 和 DEB 治疗。在 3 年随访后，在 IPW 调整后的整体队列中，与 DEB 相比，超薄 DES 与 DOCE 风险显著降低（风险比[HR]0.353，95%置信区间[CI]：0.194-0.642；p<0.001），也低于薄壁 DES（HR 0.645，95% CI：0.457-0.911；p=0.013）。与 DEB 相比，超薄 DES 还降低了 TLR（HR 0.184，95% CI：0.081-0.417；p<0.001）和 TVR（HR 0.188，95% CI：0.093-0.379；p<0.001）的风险，而薄壁 DES 则没有（TLR：HR 0.686，95% CI：0.407-1.157；p=0.157；TVR：HR 0.706，95% CI：0.453-1.101；p=0.124）。对于弥漫性 ISR 患者，与 DEB 相比，超薄 DES 降低了 DOCE（HR 0.364，95% CI：0.188-0.705；p=0.003）和薄壁 DES（HR 0.602，95% CI：0.367-0.987；p=0.044）的风险，而降低 TLR（HR 0.220，95% CI：0.091-0.531；p<0.001）和 TVR（HR 0.241，95% CI：0.113-0.513；p<0.001）的风险仅通过超薄 DES 实现。
结论
与 DEB 相比，在弥漫性 ISR 中，超薄 DES 与降低 DOCE、TLR 和 TVR 风险相关。
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