Madanchi Mehdi, Attinger-Toller Adrian, Gjergjizi Varis, Majcen Irena, Cioffi Giacomo M, Epper Angelika, Gnan Eleonora, Koch Tanja, Zhi Yuan, Cuculi Florim, Bossard Matthias
Cardiology Division, Heart Center, Luzerner Kantonsspital, Lucerne, Switzerland.
Department of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland.
Front Cardiovasc Med. 2024 Feb 13;11:1316580. doi: 10.3389/fcvm.2024.1316580. eCollection 2024.
There is mounting data supporting the use of drug-coated balloons (DCB) not only for treatment of in-stent restenosis (ISR), but also in native coronary artery disease. So far, paclitaxel-coated balloons represented the mainstay DCBs. The SeQuent® crystalline sirolimus-coated balloon (SCB) (B.Braun Medical Inc, Germany) represents a novel DCB, which allows a sustained release of the limus-drug. We evaluated its performance in an all-comer cohort, including complex coronary lesions.
Consecutive patients treated with the SeQuent® SCB were analyzed from the prospective SIROOP registry (NCT04988685). We assessed clinical outcomes, including major adverse cardiovascular events (MACE), target lesion revascularization (TLR), target vessel myocardial infarction (TV-MI) and cardiovascular death. Angiograms and outcomes were independently adjudicated.
From March 2021 to March 2023, we enrolled 126 patients and lesions, of which 100 (79%) treated using a "DCB-only" strategy and 26 (21%) with a hybrid approach (DES + DCB). The mean age was 68 ± 10 years, 48 (38%) patients had an acute coronary syndrome. Regarding lesion characteristics, ISR was treated in 27 (21%), 11 (9%) underwent CTO-PCI and 59 (47%) of the vessels were moderate to severe calcified. Procedural success rate was 100%. At a median follow-up time of 12.7 (IQR 12; 14.2) months, MACE occurred in 5 patients (4.3%). No acute vessel closure was observed.
Our data indicates promising outcomes following treatment with this novel crystalline SCB in an all-comer cohort with complex coronary lesions. These results require further investigation with randomized trials.
越来越多的数据支持药物涂层球囊（DCB）不仅可用于治疗支架内再狭窄（ISR），还可用于治疗原发性冠状动脉疾病。到目前为止，紫杉醇涂层球囊是主要的DCB。SeQuent® 结晶西罗莫司涂层球囊（SCB）（德国贝朗医疗公司）是一种新型DCB，可实现雷帕霉素类药物的持续释放。我们在一个包括复杂冠状动脉病变的所有患者队列中评估了其性能。
从前瞻性SIROOP注册研究（NCT04988685）中分析连续接受SeQuent® SCB治疗的患者。我们评估了临床结局，包括主要不良心血管事件（MACE）、靶病变血运重建（TLR）、靶血管心肌梗死（TV-MI）和心血管死亡。血管造影和结局由独立人员判定。
2021年3月至2023年3月，我们纳入了126例患者和病变，其中100例（79%）采用“单纯DCB”策略治疗，26例（21%）采用联合方法（DES+DCB）治疗。平均年龄为68±10岁，48例（38%）患者患有急性冠状动脉综合征。关于病变特征，27例（21%）治疗ISR，11例（9%）接受CTO-PCI，59例（47%）血管为中度至重度钙化。手术成功率为100%。在中位随访时间12.7（IQR 12；14.2）个月时，5例患者（4.3%）发生MACE。未观察到急性血管闭塞。
我们的数据表明，在一个患有复杂冠状动脉病变的所有患者队列中，使用这种新型结晶SCB治疗后预后良好。这些结果需要通过随机试验进一步研究。
