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Sirolimus-coated balloon in all-comer population of coronary artery disease patients: the EASTBOURNE DIABETES prospective registry.
Caiazzo, Gianluca; Oliva, Angelo; Testa, Luca; Heang, Tay M; Lee, Chuey Y; Milazzo, Diego; Stefanini, Giulio; Pesenti, Nicola; Mangieri, Antonio; Colombo, Antonio; Cortese, Bernardo.
Afiliação
  • Caiazzo G; U.O.C. UTIC-Cardiologia, P.O. San Giuseppe Moscati - Aversa - ASL Caserta, Aversa, Italy.
  • Oliva A; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy.
  • Testa L; Humanitas Research Hospital IRCCS, Rozzano - Milan, Italy.
  • Heang TM; IRCCS Policlinico San Donato, Milano, Italy.
  • Lee CY; Pantai Hospital Ayer Keroh, Melaka, Malaysia.
  • Milazzo D; Sultanah Aminah Hospital Johor Bahru, Johor bahru, Malaysia.
  • Stefanini G; ASP S. Giovanni di Dio, Agrigento, Italy.
  • Pesenti N; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy.
  • Mangieri A; Humanitas Research Hospital IRCCS, Rozzano - Milan, Italy.
  • Colombo A; Department of Statistics and Quantitative Methods, Division of Biostatistics, Epidemiology, and Public Health, University of Milano-Bicocca, Milano, Italy.
  • Cortese B; We 4 Clinical Research, Milano, Italy.
Cardiovasc Diabetol ; 23(1): 52, 2024 02 03.
Article em En | MEDLINE | ID: mdl-38310281
ABSTRACT

BACKGROUND:

The outcomes of percutaneous coronary intervention (PCI) in diabetic patients are still suboptimal, and it is unclear if diabetic patients might derive a benefit from the use of drug-coated balloons.

AIMS:

To evaluate the impact of diabetes mellitus on the outcomes of patients undergoing PCI with sirolimus-coated balloon (SCB) MagicTouch (Concept Medical, India).

METHODS:

We conducted a subgroup analysis of the prospective, multicenter, investigator-initiated EASTBOURNE registry, evaluating the performance of MagicTouch SCB in patients with and without diabetes. The study primary endpoint was target lesion revascularization (TLR) at 12-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, myocardial infarction (MI), and BARC 2-5 bleedings.

RESULTS:

Among 2,083 enrolled patients, a total of 864 suffered from diabetes (41.5%). Patients with diabetes had a numerically higher occurrence of TLR (6.5% vs. 4.7% HR 1.38, 95%CI 0.91-2.08), all-cause death (3.8% vs. 2.6%, HR 1.81, 95%CI 0.95-3.46), and MACE (12.2% vs. 8.9%; HR 1.26 95%CI 0.92-1.74). The incidence of spontaneous MI was significantly higher among diabetic patients (3.4% vs. 1.5%, HR 2.15 95%CI 1.09-4.25); bleeding events did not significantly differ. The overall incidence of TLR was higher among in-stent restenosis (ISR) as compared to de-novo coronary lesions, irrespectively from diabetes status.

CONCLUSIONS:

In the EASTBOURNE DIABETES registry, diabetic patients treated with the MagicTouch SCB did not have a significant increase in TLR when compared to non-diabetic patients; moreover, diabetic status did not affect the study device performance in terms of TLR, in both de-novo lesions and ISR.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Doença da Artéria Coronariana / Reestenose Coronária / Diabetes Mellitus / Intervenção Coronária Percutânea / Infarto do Miocárdio Tipo de estudo: Clinical_trials / Diagnostic_studies / Etiology_studies / Risk_factors_studies Limite: Humans Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Doença da Artéria Coronariana / Reestenose Coronária / Diabetes Mellitus / Intervenção Coronária Percutânea / Infarto do Miocárdio Tipo de estudo: Clinical_trials / Diagnostic_studies / Etiology_studies / Risk_factors_studies Limite: Humans Idioma: En Ano de publicação: 2024 Tipo de documento: Article