Very long-term efficacy and safety of paclitaxel-eluting balloon after a bare-metal stent for the treatment of ST-elevation myocardial infarction : 8-year results of a randomized clinical trial (PEBSI study)
2023 Cardiovascular Diagnosis and Therapy. All rights reserved..
Background: Drug-eluting stents (DES) are considered the therapy of choice in ST-segment elevation myocardial infarction (STEMI); however, a low persistent rate of revascularizations and stent thrombosis exist over the time. We have previously shown that a paclitaxel (PTX)-drug-coated balloon (DCB) after a bare-metal stent (BMS) implantation (DCB-combined strategy) yields superior angiographic and clinical results compared to BMS in the short term. However, the long-term safety and efficacy of this approach remain uncertain.
Methods: An 8-year clinical follow-up was conducted on patients enrolled in the randomized PEBSI-1 trial (NCT01839890). The original trial included patients who suffered a STEMI, patients were randomly assigned to receive a DCB-combined strategy or BMS only and the primary endpoint was in-stent late luminal loss (LLL) at 9-month follow-up. After the completion of this study, death, myocardial re-infarction, ischemia-driven repeated revascularizations included target lesion revascularization (TLR) and target vessel revascularization (TVR), and stent thrombosis, were assessed by yearly contact by a clinical visit, telephone or by electronic records. These outcomes were adhered to ARC-2 criteria.
Results: The rate of incomplete follow-up was very low, with only 3 out of 111 patients (2.7%) in the DCB-combined strategy group and 1 out of 112 patients (0.9%) in the BMS group. At 8 years there were a lower rate of TVR [3.7% vs. 14.3%; hazard ratio (HR): 0.243; 95% confidence interval (CI): 0.081-0.727; P=0.006], and a trend towards lower TLR (2.8% vs. 8.9%; HR: 0.300; 95% CI: 0.083-1.090; P=0.052) in the DCB-combined strategy group. No statistical difference between the DCB-combined strategy and BMS groups were found for all causes of death, deaths from cardiovascular disease, reinfarctions or stent thrombosis. Notably in the DCB-combined strategy group, no episode of stent thrombosis occurred after the first year. Similarly, there were no cardiovascular deaths, TVR and TLR in the DCB-combined strategy group after 5 years. In contrast, during the period from year 5 to 8, the BMS group experienced an additional cardiovascular death, as well as one case of TVR, one case of TLR, and one case of stent thrombosis.
Conclusions: In STEMI patients, the DCB-combined strategy maintains its safety and clinical efficacy over time. Our rates of TVR, TLR, and very late stent thrombosis (VLST) at very long-term are the lowest ever found in a STEMI trial. Further studies are warranted to assess the potential superiority of this novel strategy as compared with new-generation DES to prevent very late events in these patients.
Trial Registration: ClinicalTrials.gov; identifier: NCT01839890.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
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| Enthalten in: |
Cardiovascular diagnosis and therapy - 13(2023), 5 vom: 31. Okt., Seite 792-804 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
García-Touchard, Arturo [VerfasserIn] |
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| Links: |
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| Themen: |
Bare-metal stent (BMS) |
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| Anmerkungen: |
Date Revised 10.11.2023 published: Print-Electronic ClinicalTrials.gov: NCT01839890 Citation Status PubMed-not-MEDLINE |
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| doi: |
10.21037/cdt-22-623 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM364335831 |
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| 100 | 1 | |a García-Touchard, Arturo |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Very long-term efficacy and safety of paclitaxel-eluting balloon after a bare-metal stent for the treatment of ST-elevation myocardial infarction |b 8-year results of a randomized clinical trial (PEBSI study) |
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| 500 | |a Date Revised 10.11.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT01839890 | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a 2023 Cardiovascular Diagnosis and Therapy. All rights reserved. | ||
| 520 | |a Background: Drug-eluting stents (DES) are considered the therapy of choice in ST-segment elevation myocardial infarction (STEMI); however, a low persistent rate of revascularizations and stent thrombosis exist over the time. We have previously shown that a paclitaxel (PTX)-drug-coated balloon (DCB) after a bare-metal stent (BMS) implantation (DCB-combined strategy) yields superior angiographic and clinical results compared to BMS in the short term. However, the long-term safety and efficacy of this approach remain uncertain | ||
| 520 | |a Methods: An 8-year clinical follow-up was conducted on patients enrolled in the randomized PEBSI-1 trial (NCT01839890). The original trial included patients who suffered a STEMI, patients were randomly assigned to receive a DCB-combined strategy or BMS only and the primary endpoint was in-stent late luminal loss (LLL) at 9-month follow-up. After the completion of this study, death, myocardial re-infarction, ischemia-driven repeated revascularizations included target lesion revascularization (TLR) and target vessel revascularization (TVR), and stent thrombosis, were assessed by yearly contact by a clinical visit, telephone or by electronic records. These outcomes were adhered to ARC-2 criteria | ||
| 520 | |a Results: The rate of incomplete follow-up was very low, with only 3 out of 111 patients (2.7%) in the DCB-combined strategy group and 1 out of 112 patients (0.9%) in the BMS group. At 8 years there were a lower rate of TVR [3.7% vs. 14.3%; hazard ratio (HR): 0.243; 95% confidence interval (CI): 0.081-0.727; P=0.006], and a trend towards lower TLR (2.8% vs. 8.9%; HR: 0.300; 95% CI: 0.083-1.090; P=0.052) in the DCB-combined strategy group. No statistical difference between the DCB-combined strategy and BMS groups were found for all causes of death, deaths from cardiovascular disease, reinfarctions or stent thrombosis. Notably in the DCB-combined strategy group, no episode of stent thrombosis occurred after the first year. Similarly, there were no cardiovascular deaths, TVR and TLR in the DCB-combined strategy group after 5 years. In contrast, during the period from year 5 to 8, the BMS group experienced an additional cardiovascular death, as well as one case of TVR, one case of TLR, and one case of stent thrombosis | ||
| 520 | |a Conclusions: In STEMI patients, the DCB-combined strategy maintains its safety and clinical efficacy over time. Our rates of TVR, TLR, and very late stent thrombosis (VLST) at very long-term are the lowest ever found in a STEMI trial. Further studies are warranted to assess the potential superiority of this novel strategy as compared with new-generation DES to prevent very late events in these patients | ||
| 520 | |a Trial Registration: ClinicalTrials.gov; identifier: NCT01839890 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Drug-eluting stents (DES) | |
| 650 | 4 | |a bare-metal stent (BMS) | |
| 650 | 4 | |a drug-coated balloons (DCBs) | |
| 650 | 4 | |a myocardial infarction | |
| 700 | 1 | |a Sabaté, Manel |e verfasserin |4 aut | |
| 700 | 1 | |a Gonzalo, Nieves |e verfasserin |4 aut | |
| 700 | 1 | |a Peral, Vicente |e verfasserin |4 aut | |
| 700 | 1 | |a Vaquerizo, Beatriz |e verfasserin |4 aut | |
| 700 | 1 | |a Ruiz-Salmerón, Rafael |e verfasserin |4 aut | |
| 700 | 1 | |a García Del Blanco, Bruno |e verfasserin |4 aut | |
| 700 | 1 | |a Jiménez-Mazuecos, Jesús |e verfasserin |4 aut | |
| 700 | 1 | |a Molina, Eduardo |e verfasserin |4 aut | |
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| 700 | 1 | |a Hernandez-García, José María |e verfasserin |4 aut | |
| 700 | 1 | |a Ruiz-Quevedo, Valeriano |e verfasserin |4 aut | |
| 700 | 1 | |a Urbano, Cristóbal |e verfasserin |4 aut | |
| 700 | 1 | |a Fernández-Portales, Javier |e verfasserin |4 aut | |
| 700 | 1 | |a Rumoroso, José Ramón |e verfasserin |4 aut | |
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