METHODS: EASTBOURNE is a prospective, international, multicenter, all-comer investigator-driven clinical registry, which is enrolling consecutive patients treated with SCB at 42 European and Asiatic centers. Primary study endpoint is target-lesion revascularization (TLR) at 12 months. Secondary endpoints are procedural success and major adverse cardiac events through 36 months.
RESULTS: Diabetes mellitus was present in 41% of patients. Acute coronary syndrome was present in 45% of patients and de novo lesions were 55%; 83% of the in-stent restenosis (ISR) patients had drug-eluting stents restenosis. Lesion predilatation was performed in 95% of the cases and bailout stenting occurred in 7.5%. So far, 642 patients have a complete 12-month follow-up. TLR occurred in 2.5%, myocardial infarction in 2.3%, total death in 1% and major adverse cardiac events in 5.8% of patients. A prespecified analysis of comparison between ISR and de-novo lesions showed a significantly higher occurrence of TLR in the ISR population (5.4 vs. 0.2%, P = 0.0008).
CONCLUSION: The current interim analysis of 12-month follow-up of the EASTBOURNE registry shows good immediate performance and an adequate and encouraging safety profile through 12 months for this novel SCB.
AIMS: To explore the safety and the feasibility of single antiplatelet therapy in percutaneous coronary intervention with sirolimus-coated balloons.
METHODS: The All-comers Sirolimus-coated Balloon European Registry (EASTBOURNE) is a prospective investigator-driven registry assessing the performance of a novel sirolimus-coated balloon (SCB) in a real-world population. This prespecified post hoc analysis aimed at comparing the outcome in patients prescribed either single antiplatelet therapy (SAPT) or dual antiplatelet therapy (DAPT); choice of antiplatelet agent and duration of the regimen were at operator's discretion in both groups. Primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints were bleeding grade 3-5 according to The Bleeding Academic Research Consortium (BARC) criteria and major adverse cardiovascular events (MACE) at 12 months follow-up.
RESULTS: Among 2123 patients enrolled in the study between September 2016 and November 2020, 113 patients (5.8 %) received SAPT while 1826 patients (94.1 %) received DAPT after SCB. The majority of the patients underwent DCB PCI for de novo lesions (n = 1091, 56.3 %) while 848 patients (47.7 %) had DCB revascularization for in-stent restenosis. No cases of TLR occurred in the SAPT group within one month after the index procedure, and no acute occlusive events were recorded during follow up in patients taking a single antiplatelet agent. Moreover, no differences in terms of TLR were observed between SAPT vs DAPT regimens nor in case of de novo treatment with an overall rate of TLR at 12 months of 7.7 % for SAPT and 5.6 % for DAPT (p = 0.6). The cumulative rate of MACE at 12 months was not different between SAPT and DAPT regimens (n = 12 [11.2 %] vs. n = 162 [8.9 %], p = 0.4), and results were consistent in the de novo and in-stent restenosis groups.
CONCLUSIONS: Our post hoc analysis of the EASTBOURNE registry suggests that the use of single antiplatelet agent after sirolimus-DCB PCI for both de novo or in-stent restenosis lesions is safe and effective and can help to contain the risk of bleeding in a selected population.
CONDENSED ABSTRACT: The manuscript aims to explore the feasibility of a single antiplatelet regimen following angioplasty using drug coated balloon with sirolimus. Among 2123 patients treated with sirolimus coated balloon (SCB), 113 patients (5.8 %) received a single antiplatelet therapy (SAPT) while 1826 patients (94.1 %) received dual antiplatelet therapy DAPT. No cases of target lesion revascularization occurred in the SAPT group within one month after the index procedure, and no acute occlusive events were recorded during follow up in patients taking a single antiplatelet agent. The cumulative rate of major adverse cardiovascular events at 12 months was not different between SAPT and DAPT regimens and results were consistent in the de novo and in-stent restenosis groups.
OBJECTIVES: This study sought to understand the role of a novel SCB for the treatment of coronary artery disease.
METHODS: EASTBOURNE (All-Comers Sirolimus-Coated Balloon European Registry) is a prospective, multicenter, investigator-driven clinical study that enrolled real-world patients treated with SCB. Primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints were procedural success, myocardial infarction (MI), all-cause death, and major adverse clinical events (a composite of death, MI, and TLR). All adverse events were censored and adjudicated by an independent clinical events committee.
RESULTS: A total population of 2,123 patients (2,440 lesions) was enrolled at 38 study centers in Europe and Asia. The average age was 66.6 ± 11.3 years, and diabetic patients were 41.5%. De novo lesions (small vessels) were 56%, in-stent restenosis (ISR) 44%, and bailout stenting occurred in 7.7% of the patients. After 12 months, TLR occurred in 5.9% of the lesions, major adverse clinical events in 9.9%, and spontaneous MI in 2.4% of the patients. The rates of cardiac/all-cause death were 1.5% and 2.5%, respectively. The primary outcome occurred more frequently in the ISR cohort (10.5% vs 2.0%; risk ratio: 1.90; 95% CI: 1.13-3.19). After multivariate Cox regression model, the main determinant for occurrence of the primary endpoint was ISR (OR: 5.5; 95% CI: 3.382-8.881).
CONCLUSIONS: EASTBOURNE, the largest DCB study in the coronary field, shows the safety and efficacy of a novel SCB in a broad population of coronary artery disease including small vessels and ISR patients at mid-term follow-up. (The All-Comers Sirolimus-Coated Balloon European Registry [EASTBOURNE]; NCT03085823).
METHODS: Eighty-nine recognized MBS surgeons from 42 countries participated in the Modified Delphi consensus to vote on 30 statements in two rounds. An agreement/disagreement among ≥ 70.0% of the experts was regarded to indicate a consensus.
RESULTS: Consensus was reached on 29 out of 30 statements. Most experts agreed that before getting privileges to perform MBS, surgeons must hold a general surgery degree and complete or have completed a dedicated fellowship training program. The experts agreed that the learning curves for the various operative procedures are approximately 25-50 operations for the LSG, 50-75 for the OAGB, and 75-100 for the RYGB. 93.1% of experts agreed that MBS surgeons should diligently record patients' data in their National or Global database.
CONCLUSION: MBS surgeons should have a degree in general surgery and have been enrolled in a dedicated fellowship training program with a structured curriculum. The learning curve of MBS procedures is procedure dependent. MBS surgeons must demonstrate proficiency in managing postoperative complications, collaborate within a multidisciplinary team, commit to a minimum 2-year patient follow-up, and actively engage in national and international MBS societies.