TY - JOUR
T1 - Treatment of in-stent restenosis with ultrathin-strut versus thin-strut drug-eluting stents or drug-eluting balloons: a multicentre registry
AU - De Filippo, Ovidio
AU - Wańha, Wojciech
AU - Sanavia, Tiziana
AU - Januszek, Rafal
AU - Giacobbe, Federico
AU - Campo, Gianluca
AU - Pinxterhuis, Tineke H
AU - Capodanno, Davide
AU - Tomasiewicz, Brunon
AU - Iannaccone, Mario
AU - Leone, Attilio
AU - Wolny, Rafał
AU - Bruno, Francesco
AU - Patti, Giuseppe Rocco Salvatore
AU - Musumeci, Giuseppe
AU - Liccardo, Gaetano
AU - Verardi, Roberto
AU - Roubin, Sergio Raposeiras
AU - Tarantini, Giuseppe
AU - Kuźma, Łukasz
AU - Perl, Leor
AU - Gagnor, Andrea
AU - Reczuch, Krzysztof
AU - Conrotto, Federico
AU - Tuttolomondo, Domenico
AU - Ploumen, Eline H
AU - Niezgoda, Piotr
AU - Caglioni, Serena
AU - Omedè, Pierluigi
AU - Greco, Antonio
AU - Kubica, Jacek
AU - Gil, Robert J
AU - Piccolo, Raffaele
AU - Kornowski, Ran
AU - Bil, Jacek
AU - Morena, Arianna
AU - Zocca, Paolo
AU - Pennone, Mauro
AU - Gąsior, Mariusz
AU - Jaguszewski, Miłosz
AU - von Birgelen, Clemens
AU - Fariselli, Piero
AU - De Ferrari, Gaetano M
AU - Wojakowski, Wojciech
AU - D'Ascenzo, Fabrizio
PY - 2024
Y1 - 2024
N2 - 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.
AB - 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.
KW - drug-eluting balloon
KW - drug-eluting stent
KW - in-stent restenosis
KW - drug-eluting balloon
KW - drug-eluting stent
KW - in-stent restenosis
UR - https://iris.uniupo.it/handle/11579/200088
U2 - 10.4244/EIJ-D-24-00491
DO - 10.4244/EIJ-D-24-00491
M3 - Article
SN - 1774-024X
VL - 20
JO - EuroIntervention
JF - EuroIntervention
IS - 21
ER -