TY - JOUR
T1 - One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in patients needing short dual antiplatelet therapy. Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry)
AU - Godino, Cosmo
AU - Beneduce, Alessandro
AU - Ferrante, Giuseppe
AU - Ielasi, Alfonso
AU - Pivato, Carlo Andrea
AU - Chiarito, Mauro
AU - Cappelletti, Alberto
AU - Perfetti, Giulia
AU - Magni, Valeria
AU - Prati, Eugenio
AU - Falcone, Stefania
AU - Pierri, Adele
AU - De Martini, Stefano
AU - Montorfano, Matteo
AU - Parisi, Rosario
AU - Rutigliano, David
AU - Locuratolo, Nicola
AU - Anzuini, Angelo
AU - Tespili, Maurizio
AU - Margonato, Alberto
AU - Benassi, Alberto
AU - Briguori, Carlo
AU - Fabbiocchi, Franco
AU - Reimers, Bernhard
AU - Bartorelli, Antonio
AU - Colombo, Antonio
PY - 2019/9/1
Y1 - 2019/9/1
N2 - Background: This study aimed to evaluate real-world clinical outcome of patients needing short dual antiplatelet therapy (S-DAPT) following PCI with Ultimaster® thin-strut, biodegradable polymer sirolimus-eluting stent (BP-SES), which was supposed to induce faster stent endothelialization and reduce device thrombogenicity. Methods: In this sub-group analysis of patients enrolled in the ULISSE registry, two groups were identified: 1) patients discharged with S-DAPT (≤3-month) due to high bleeding risk or need for urgent major non-cardiac surgery and 2) patients discharged with recommended DAPT (R-DAPT) duration (≥6-month). The primary ischemic-safety and bleeding-safety endpoints were TLF (composite of cardiac-death, target vessel MI, and clinically driven target lesion revascularization), and BARC major bleedings (≥type-3a) at 1-year follow-up. To account for events occurring before DAPT discontinuation we performed 3-month landmark analysis. Results: 82 patients (5%) were discharged with ≤3-month DAPT (57 ± 27 days), and 1558 patients (94%) were discharged with ≥6-month DAPT (318 ± 75 days). No significant differences between S-DAPT and R-DAPT group were observed in TLF at 1-year (7.9% vs. 4.6%). The rate of BARC major bleeding resulted significantly higher in S-DAPT group (3.9% vs. 0.3%; p = 0.001), with the majority of bleeding events occurring within 3 months. The landmark analysis showed no significant differences in BARC major bleedings between groups (1.4% vs. 0.3%; p = 0.142). Conclusions: As compared to those treated with R-DAPT (≥6-month), patients needing -S-DAPT (≤3-month) after PCI with Ultimaster® BP-SES had similar rates of 1-year TLF and BARC major bleedings following early DAPT discontinuation.
AB - Background: This study aimed to evaluate real-world clinical outcome of patients needing short dual antiplatelet therapy (S-DAPT) following PCI with Ultimaster® thin-strut, biodegradable polymer sirolimus-eluting stent (BP-SES), which was supposed to induce faster stent endothelialization and reduce device thrombogenicity. Methods: In this sub-group analysis of patients enrolled in the ULISSE registry, two groups were identified: 1) patients discharged with S-DAPT (≤3-month) due to high bleeding risk or need for urgent major non-cardiac surgery and 2) patients discharged with recommended DAPT (R-DAPT) duration (≥6-month). The primary ischemic-safety and bleeding-safety endpoints were TLF (composite of cardiac-death, target vessel MI, and clinically driven target lesion revascularization), and BARC major bleedings (≥type-3a) at 1-year follow-up. To account for events occurring before DAPT discontinuation we performed 3-month landmark analysis. Results: 82 patients (5%) were discharged with ≤3-month DAPT (57 ± 27 days), and 1558 patients (94%) were discharged with ≥6-month DAPT (318 ± 75 days). No significant differences between S-DAPT and R-DAPT group were observed in TLF at 1-year (7.9% vs. 4.6%). The rate of BARC major bleeding resulted significantly higher in S-DAPT group (3.9% vs. 0.3%; p = 0.001), with the majority of bleeding events occurring within 3 months. The landmark analysis showed no significant differences in BARC major bleedings between groups (1.4% vs. 0.3%; p = 0.142). Conclusions: As compared to those treated with R-DAPT (≥6-month), patients needing -S-DAPT (≤3-month) after PCI with Ultimaster® BP-SES had similar rates of 1-year TLF and BARC major bleedings following early DAPT discontinuation.
KW - Biodegradable polymer sirolimus-eluting stent
KW - Dual antiplatelet therapy
KW - High bleeding risk
KW - Percutaneous coronary intervention
KW - Stent thrombosis
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U2 - 10.1016/j.ijcard.2019.03.030
DO - 10.1016/j.ijcard.2019.03.030
M3 - Article
C2 - 30917900
AN - SCOPUS:85063144208
VL - 290
SP - 52
EP - 58
JO - International Journal of Cardiology
JF - International Journal of Cardiology
SN - 0167-5273
ER -