Treatment of in-stent restenosis with ultrathin-strut versus thin-strut drug-eluting stents or drug-eluting balloons: a multicentre registry

被引:1
|
作者
De Filippo, Ovidio [1 ,2 ]
Wanha, Wojciech [3 ]
Sanavia, Tiziana [4 ]
Januszek, Rafal [5 ]
Giacobbe, Federico [1 ,2 ]
Campo, Gianluca [6 ]
Pinxterhuis, Tineke H. [7 ,8 ]
Capodanno, Davide [9 ]
Tomasiewicz, Brunon [10 ]
Iannaccone, Mario [11 ]
Leone, Attilio [12 ]
Wolny, Rafal [13 ]
Bruno, Francesco [1 ,2 ]
Patti, Giuseppe [14 ]
Musumeci, Giuseppe [15 ]
Liccardo, Gaetano [16 ]
Verardi, Roberto [17 ]
Roubin, Sergio Raposeiras [18 ]
Tarantini, Giuseppe [19 ]
Kuzma, Lukasz [20 ]
Perl, Leor [21 ]
Gagnor, Andrea [22 ]
Reczuch, Krzysztof [23 ]
Conrotto, Federico [1 ]
Tuttolomondo, Domenico [24 ]
Ploumen, Eline H. [7 ,8 ]
Niezgoda, Piotr [25 ]
Caglioni, Serena [6 ]
Omede, Pierluigi [1 ]
Greco, Antonio [9 ]
Kubica, Jacek [25 ]
Gil, Robert J. [26 ]
Piccolo, Raffaele [12 ]
Kornowski, Ran [21 ]
Bil, Jacek [27 ]
Morena, Arianna [1 ,2 ]
Zocca, Paolo [7 ]
Pennone, Mauro [1 ]
Gasior, Mariusz [27 ]
Jaguszewski, Milosz [28 ]
Von Birgelen, Clemens [7 ]
Fariselli, Piero [4 ]
De Ferrari, Gaetano M. [1 ,2 ]
Wojakowski, Wojciech [3 ]
D'Ascenzo, Fabrizio [1 ,2 ]
机构
[1] Citta Salute & Sci Hosp, Cardiovasc & Thorac Dept, Div Cardiol, Turin, Italy
[2] Univ Turin, Dept Med Sci, Turin, Italy
[3] Med Univ Silesia, Dept Cardiol & Struct Heart Dis, Katowice, Poland
[4] Univ Turin, Dept Med Sci, Computat Biomed Unit, Turin, Italy
[5] Jagiellonian Univ Med Coll, Dept Intervent Cardiol, Krakow, Poland
[6] Azienda Osped Univ Ferrara, Cardiol Unit, Ferrara, Italy
[7] Med Spectrum Twente, Thorax Ctr Twente, Dept Cardiol, Enschede, Netherlands
[8] Univ Twente, Fac BMS, Tech Med Ctr, Dept Hlth Technol & Serv Res, Enschede, Netherlands
[9] Univ Catania, Div Cardiol, Azienda Osped Univ Policlin G Rodolico San Marco, Catania, Italy
[10] Wroclaw Univ Hosp, Inst Heart Dis, Wroclaw, Poland
[11] Osped San Giovanni Bosco, Div Cardiol, Turin, Italy
[12] Univ Naples Federico II, Dept Adv Biomed Sci, Naples, Italy
[13] Natl Inst Cardiol, Dept Intervent Cardiol & Angiol, Warsaw, Poland
[14] Univ Piemonte Orientale, Maggiore della Carita Hosp, Dept Translat Med, Novara, Italy
[15] Azienda Osped Ordine Mauriziano Umberto I, Cardiol Dept, Turin, Italy
[16] Humanitas Univ, Dept Biomed Sci, Pieve Emanuele, Italy
[17] Osped Maggiore Carlo Alberto Pizzardi, Div Cardiol, Bologna, Italy
[18] Univ Hosp Alvaro Cunqueiro, Galicia Sur Hlth Res Inst IISGS, Cardiol Dept, Pontevedra, Spain
[19] Univ Padua, Med Sch, Dept Cardiac Thorac Vasc Sci & Publ Hlth, Padua, Italy
[20] Med Univ Bialystok, Dept Invas Cardiol, Bialystok, Poland
[21] Rabin Med Ctr, Dept Otorhinolaryngol, Petah Tiqwa, Israel
[22] Osped Maria Vittoria, Div Cardiol, Turin, Italy
[23] Wroclaw Med Univ, Inst Heart Dis, Wroclaw, Poland
[24] Univ Hosp Parma, Cardiol Unit, Parma, Italy
[25] Nicolaus Copernicus Univ, Dept Cardiol & Internal Med, Coll Med, Bydgoszcz, Poland
[26] Minist Interior & Adm, Dept Invas Cardiol, Ctr Postgrad Med Educ, State Med Inst, Warsaw, Poland
[27] Med Univ Silesia, Dept Radiol & Radiodiagnost, PL-41800 Zabrze, Poland
[28] Med Univ Gdansk, Dept Cardiol 1, Gdansk, Poland
关键词
drug-eluting balloon; drug-eluting stent; in-stent restenosis; DURABLE POLYMER; OUTCOMES; METAANALYSIS; ANGIOPLASTY; TRIAL;
D O I
10.4244/EIJ-D-24-00491
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
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