Sirolimus-Eluting Balloon for the Treatment of Coronary Lesions in Complex ACS Patients: The SELFIE Registry
Background. Sirolimus-coated balloons (SCBs) represent a novel therapeutic option for both in-stent restenosis (ISR) and de novo coronary lesions treatment, especially in small vessels. Our registry sought to evaluate the procedural and clinical outcomes of such devices in a complex acute coronary s...
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| Format: | Article |
| Language: | English |
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Wiley
2020-01-01
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| Series: | Journal of Interventional Cardiology |
| Online Access: | http://dx.doi.org/10.1155/2020/8865223 |
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| author | Gianluca Caiazzo Mario De Michele Luca Golino Vincenzo Manganiello Luciano Fattore |
| author_facet | Gianluca Caiazzo Mario De Michele Luca Golino Vincenzo Manganiello Luciano Fattore |
| author_sort | Gianluca Caiazzo |
| collection | DOAJ |
| description | Background. Sirolimus-coated balloons (SCBs) represent a novel therapeutic option for both in-stent restenosis (ISR) and de novo coronary lesions treatment, especially in small vessels. Our registry sought to evaluate the procedural and clinical outcomes of such devices in a complex acute coronary syndrome (ACS) clinical setting. Methods and Results. We treated 74 consecutive patients with percutaneous coronary intervention (PCI) with at least 1 SCB used for ISR and/or de novo coronary lesion in small vessels at our institution. Sixty-two patients presented with ACS, and their data were included in our analysis. The mean age was 67 ± 10 years, and patients presenting with ST-elevated myocardial infarction (STEMI) were 14 (23%). De novo lesions were 52%, whereas ISR was 48%. Procedural success occurred in 100% of the cases. At the 11 ± 7 months follow-up, major adverse cardiovascular events (MACEs) were 3 (4.8%). Cardiovascular death (CD) occurred in 1 (1.6%) patient and myocardial infarction (MI) in 2 patients (3.2%) as well as ischemia-driven target lesion revascularization (TLR). One probable subacute thrombosis occurred (1.6%) with no major bleedings. In a subgroup analysis, the incidence of MACE did not show significant differences between patients treated for de novo lesions and ISR (HR: 0.239; CI 95%: 0.003–16.761, p=0.509). Conclusions. In the SELFIE prospective registry, SCB showed a good safety and efficacy profile for the treatment of coronary lesions, both ISR and/or de novo in small vessels, in a complex ACS population of patients at the 11 ± 7 months follow-up. |
| format | Article |
| id | doaj-art-9468db20a4bd4f97af1ebd9aefe67a44 |
| institution | Kabale University |
| issn | 0896-4327 1540-8183 |
| language | English |
| publishDate | 2020-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Interventional Cardiology |
| spelling | doaj-art-9468db20a4bd4f97af1ebd9aefe67a442025-02-03T05:58:22ZengWileyJournal of Interventional Cardiology0896-43271540-81832020-01-01202010.1155/2020/88652238865223Sirolimus-Eluting Balloon for the Treatment of Coronary Lesions in Complex ACS Patients: The SELFIE RegistryGianluca Caiazzo0Mario De Michele1Luca Golino2Vincenzo Manganiello3Luciano Fattore4ICCU, San Giuseppe Moscati Hospital, ASL CE, Aversa, ItalyICCU, San Giuseppe Moscati Hospital, ASL CE, Aversa, ItalyICCU, San Giuseppe Moscati Hospital, ASL CE, Aversa, ItalyICCU, San Giuseppe Moscati Hospital, ASL CE, Aversa, ItalyICCU, San Giuseppe Moscati Hospital, ASL CE, Aversa, ItalyBackground. Sirolimus-coated balloons (SCBs) represent a novel therapeutic option for both in-stent restenosis (ISR) and de novo coronary lesions treatment, especially in small vessels. Our registry sought to evaluate the procedural and clinical outcomes of such devices in a complex acute coronary syndrome (ACS) clinical setting. Methods and Results. We treated 74 consecutive patients with percutaneous coronary intervention (PCI) with at least 1 SCB used for ISR and/or de novo coronary lesion in small vessels at our institution. Sixty-two patients presented with ACS, and their data were included in our analysis. The mean age was 67 ± 10 years, and patients presenting with ST-elevated myocardial infarction (STEMI) were 14 (23%). De novo lesions were 52%, whereas ISR was 48%. Procedural success occurred in 100% of the cases. At the 11 ± 7 months follow-up, major adverse cardiovascular events (MACEs) were 3 (4.8%). Cardiovascular death (CD) occurred in 1 (1.6%) patient and myocardial infarction (MI) in 2 patients (3.2%) as well as ischemia-driven target lesion revascularization (TLR). One probable subacute thrombosis occurred (1.6%) with no major bleedings. In a subgroup analysis, the incidence of MACE did not show significant differences between patients treated for de novo lesions and ISR (HR: 0.239; CI 95%: 0.003–16.761, p=0.509). Conclusions. In the SELFIE prospective registry, SCB showed a good safety and efficacy profile for the treatment of coronary lesions, both ISR and/or de novo in small vessels, in a complex ACS population of patients at the 11 ± 7 months follow-up.http://dx.doi.org/10.1155/2020/8865223 |
| spellingShingle | Gianluca Caiazzo Mario De Michele Luca Golino Vincenzo Manganiello Luciano Fattore Sirolimus-Eluting Balloon for the Treatment of Coronary Lesions in Complex ACS Patients: The SELFIE Registry Journal of Interventional Cardiology |
| title | Sirolimus-Eluting Balloon for the Treatment of Coronary Lesions in Complex ACS Patients: The SELFIE Registry |
| title_full | Sirolimus-Eluting Balloon for the Treatment of Coronary Lesions in Complex ACS Patients: The SELFIE Registry |
| title_fullStr | Sirolimus-Eluting Balloon for the Treatment of Coronary Lesions in Complex ACS Patients: The SELFIE Registry |
| title_full_unstemmed | Sirolimus-Eluting Balloon for the Treatment of Coronary Lesions in Complex ACS Patients: The SELFIE Registry |
| title_short | Sirolimus-Eluting Balloon for the Treatment of Coronary Lesions in Complex ACS Patients: The SELFIE Registry |
| title_sort | sirolimus eluting balloon for the treatment of coronary lesions in complex acs patients the selfie registry |
| url | http://dx.doi.org/10.1155/2020/8865223 |
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