U.O.C. UTIC-Cardiologia, P.O. San Giuseppe Moscati - Aversa - ASL Caserta, Aversa, Italy.
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy.
Cardiovasc Diabetol. 2024 Feb 3;23(1):52. doi: 10.1186/s12933-024-02139-9.
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.
To evaluate the impact of diabetes mellitus on the outcomes of patients undergoing PCI with sirolimus-coated balloon (SCB) MagicTouch (Concept Medical, India).
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.
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.
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.
经皮冠状动脉介入治疗（PCI）在糖尿病患者中的疗效仍不理想，目前尚不清楚糖尿病患者是否能从药物涂层球囊的应用中获益。
评估糖尿病对接受西罗莫司涂层球囊（SCB）MagicTouch（Concept Medical，印度）PCI 治疗的患者结局的影响。
我们对前瞻性、多中心、研究者发起的 EASTBOURNE 注册研究进行了亚组分析，评估 MagicTouch SCB 在伴或不伴糖尿病患者中的表现。研究的主要终点是 12 个月随访时的靶病变血运重建（TLR）。次要临床终点为主要不良临床事件（MACE）、死亡、心肌梗死（MI）和 BARC 2-5 型出血。
在 2083 名入组患者中，共有 864 名患者患有糖尿病（41.5%）。糖尿病患者 TLR 的发生率更高（6.5% vs. 4.7%，HR 1.38，95%CI 0.91-2.08）、全因死亡（3.8% vs. 2.6%，HR 1.81，95%CI 0.95-3.46）和 MACE（12.2% vs. 8.9%；HR 1.26，95%CI 0.92-1.74）。糖尿病患者自发性 MI 的发生率显著升高（3.4% vs. 1.5%，HR 2.15，95%CI 1.09-4.25）；出血事件无显著差异。支架内再狭窄（ISR）与新发冠状动脉病变相比，TLR 的总体发生率更高，而与糖尿病状态无关。
在 EASTBOURNE 糖尿病注册研究中，与非糖尿病患者相比，接受 MagicTouch SCB 治疗的糖尿病患者 TLR 发生率无显著增加；此外，在新发病变和 ISR 中，糖尿病状态并不影响研究器械在 TLR 方面的性能。
