Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.
Eulji University Hospital, College of Medicine, Seoul, Republic of Korea.
Angiology. 2021 Nov;72(10):986-993. doi: 10.1177/00033197211015534. Epub 2021 May 13.
We evaluated the angiographic parameter and clinical outcomes of drug-coated balloon (DCB) to assess the optimal angiographic criteria in de novo small vessel disease (SVD). Patients (n = 424, mean age: 64.4 ± 11.2 years, men: 69.8%) at 20 sites in Korea were prospectively enrolled. The primary end point was late luminal loss (LLL) at 9-month follow-up angiography. Secondary end points included restenosis rates, target lesion failure (TLF), and DCB-related thrombosis during the 12-month follow-up period. We included 403 patients for analysis excluding 21 patients who required bailout stenting. Baseline mean reference vessel .diameter was 2.52 ± 0.39 mm and mean minimal luminal diameter (MLD) was 0.71 ± 0.40 mm. The mean MLD was 1.54 ± 0.37 mm after DCB. Late luminal loss was -0.01 ± 0.43 mm and restenosis was noted in 26 patients (12.2%). Minimal luminal diameter >1.6 mm and %DS <45% after DCB was associated maintenance of MLD without LLL at 9-months. Multivariate analysis demonstrated that %DS at baseline and post-MLD was associated with the restenosis. During 12-month follow-up, TLF was 2.6% including 1 cardiac death, 1 myocardial infarction, and 10 ischemia-driven target lesion revascularizations. Drug-coated balloon showed a low restenosis and lower LLL despite high in-segment DS. Post-MLD and % DS may be helpful to get optimal results in de novo SVD after DCB.
我们评估了药物涂层球囊(DCB)的血管造影参数和临床结果,以评估新出现的小血管疾病(SVD)的最佳血管造影标准。在韩国的 20 个地点前瞻性纳入了 424 名患者(平均年龄:64.4±11.2 岁,男性:69.8%)。主要终点是 9 个月随访血管造影时的晚期管腔丢失(LLL)。次要终点包括再狭窄率、靶病变失败(TLF)和 12 个月随访期间与 DCB 相关的血栓形成。我们排除了 21 名需要紧急支架置入的患者,共纳入了 403 名患者进行分析。基线平均参考血管直径为 2.52±0.39mm,最小管腔直径(MLD)为 0.71±0.40mm。DCB 后平均 MLD 为 1.54±0.37mm。晚期管腔丢失为-0.01±0.43mm,26 名患者(12.2%)出现再狭窄。DCB 后 MLD>1.6mm 和%DS<45%与 9 个月时 MLD 无 LLL 维持相关。多变量分析表明,基线和 post-MLD 的%DS 与再狭窄相关。在 12 个月的随访期间,TLF 为 2.6%,包括 1 例心脏死亡、1 例心肌梗死和 10 例缺血驱动的靶病变血运重建。尽管节段内 DS 较高,但 DCB 后药物涂层球囊显示出较低的再狭窄和较低的 LLL。post-MLD 和%DS 可能有助于在新出现的 SVD 后获得 DCB 的最佳结果。