Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Korea.
Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
JACC Cardiovasc Interv. 2018 May 28;11(10):969-978. doi: 10.1016/j.jcin.2018.02.002.
The aim of this study was to investigate the impact of optimizing procedure-related factors during drug-eluting balloon (DEB) angioplasty on clinical outcomes of drug-eluting stent in-stent restenosis (ISR).
Although DEB angioplasty is recommended as a reasonable option for ISR, recurrent target lesion failure (TLF) still occurs in many patients after DEB angioplasty.
Consecutive patients with drug-eluting stent ISR treated with DEB (SeQuent Please) were collected from 4 centers in Korea. The primary outcome was 2-year TLF. Procedure-related modifiable independent predictors for TLF and their best cutoff values were determined.
In a total of 256 patients (309 lesions), TLF occurred in 52 patients (20.3%). Modifiable independent predictors of TLF among procedure-related factors were residual diameter stenosis after lesion preparation (residual percentage diameter stenosis [%DS]), DEB-to-stent ratio (BSR), and DEB inflation time (T), whose best cutoff values were 20%, 0.91, and 60 s, respectively. TLF rates were significantly higher in groups with residual %DS ≥20% (34.7% vs. 12.5%; adjusted hazard ratio: 2.15; 95% confidence interval: 1.86 to 2.48; p < 0.001), BSR ≤0.91 (46.4% vs. 21.9%; adjusted hazard ratio: 2.02; 95% confidence interval: 1.75 to 2.34; p < 0.001), and T ≤60 s (26.2% vs. 14.0%; adjusted hazard ratio: 1.82; 95% confidence interval: 1.36 to 2.45; p < 0.001). When classifying ISR lesions by combination of procedure-related factors, TLF occurred in 8.3% in the fully optimized procedure group (residual %DS <20%, BSR >0.91, and T >60 s) and 66.7% in the nonoptimized group (residual %DS ≥20%, BSR ≤0.91, and T ≤60 s) (p < 0.001).
Residual %DS after lesion preparation, BSR, and T were the only modifiable procedure-related factors in DEB angioplasty. Fully optimized DEB angioplasty with optimal lesion preparation, prolonged inflation, and sufficient dilation may play an important role in reducing TLF after DEB angioplasty.
本研究旨在探讨在药物洗脱球囊（DEB）血管成形术中优化与操作相关的因素对药物洗脱支架内再狭窄（ISR）的临床转归的影响。
尽管 DEB 血管成形术被推荐为 ISR 的合理选择，但许多患者在 DEB 血管成形术后仍会出现复发性靶病变失败（TLF）。
从韩国的 4 个中心连续收集接受 DEB（SeQuent Please）治疗的药物洗脱支架 ISR 患者。主要结局是 2 年 TLF。确定与操作相关的可改变的独立 TLF 预测因素及其最佳截断值。
在总共 256 名患者（309 处病变）中，有 52 名患者（20.3%）发生 TLF。与操作相关的因素中，TLF 的可改变独立预测因素为病变准备后的残余直径狭窄率（残余百分比直径狭窄率[％DS]）、DEB-支架比（BSR）和 DEB 充气时间（T），其最佳截断值分别为 20%、0.91 和 60 s。残余％DS≥20%（34.7%比 12.5%；调整后的危险比：2.15；95%置信区间：1.86 至 2.48；p<0.001）、BSR≤0.91（46.4%比 21.9%；调整后的危险比：2.02；95%置信区间：1.75 至 2.34；p<0.001）和 T≤60 s（26.2%比 14.0%；调整后的危险比：1.82；95%置信区间：1.36 至 2.45；p<0.001）的 TLF 发生率明显更高。当根据操作相关因素对 ISR 病变进行分类时，完全优化的操作组（残余％DS<20%，BSR>0.91，T>60 s）中 TLF 的发生率为 8.3%，而非优化组（残余％DS≥20%，BSR≤0.91，T≤60 s）中 TLF 的发生率为 66.7%（p<0.001）。
病变准备后的残余％DS、BSR 和 T 是 DEB 血管成形术中唯一可改变的与操作相关的因素。通过优化病变准备、延长充气时间和充分扩张来进行完全优化的 DEB 血管成形术，可能在降低 DEB 血管成形术后 TLF 方面发挥重要作用。
