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Abstract：
BACKGROUND: The clinical implications of restenosis after drug-coated balloon (DCB) treatment remain unclear. We compared the clinical outcomes between DCB angioplasty for restenosis and de novo femoropopliteal artery lesions. This single-center retrospective study included 571 patients (737 limbs) who underwent either repeat (54 patients, 64 limbs) or de novo DCB (517 patients, 673 limbs) without bailout stenting. After propensity score matching, 49 matched pairs were analyzed. The primary endpoint was the 1-year primary patency, with secondary endpoints including the freedom from target lesion revascularization (TLR), major adverse limb events (MALE), and early restenosis. Predictors of restenosis were identified using multivariable Cox regression analysis.
RESULTS: The repeat-DCB group displayed significantly lower rates of 1-year primary patency and freedom from TLR compared to those of the de novo-DCB group (50.1% vs. 77.4%, p = 0.029 and 54.9% vs. 83.6%, p = 0.0.44, respectively). No significant differences were observed in early restenosis or MALE (10.7% vs. 5.9%, p = 0.455 and 48.3% vs. 73.4%, p = 0.055, respectively). Restenosis after DCB angioplasty was associated with repeat DCB (hazard ratio [HR], 5.13; 95% confidence interval [CI], 1.43-18.4; p = 0.012) and small vessel size of < 4.5 mm (HR, 6.25; 95% CI, 1.17-33.4; p = 0.032). Furthermore, restenosis after repeat DCB angioplasty was associated with the Peripheral Artery Calcification Scoring System (PACSS) grade 4 (HR, 4.20; 95% CI, 1.08-16.3; p = 0.038), small vessel size of < 4.5 mm (HR, 9.44; 95% CI, 1.21-73.7; p = 0.032), and intravascular ultrasound (IVUS) use (HR, 0.05; 95% CI, 0.01-0.44; p = 0.007).
CONCLUSIONS: The 1-year primary patency rate following repeat DCB angioplasty for femoropopliteal lesions was notably lower than that of DCB treatment for de novo lesions. Repeat DCB strategy was associated with an increased risk of patency loss. Regarding repeat restenosis after DCB treatments, PACSS grade 4 calcification and small vessel diameter of < 4.5 mm were associated with an increased risk of restenosis, whereas IVUS use correlated with a decreased risk of restenosis.
RESULTS: The repeat-DCB group displayed significantly lower rates of 1-year primary patency and freedom from TLR compared to those of the de novo-DCB group (50.1% vs. 77.4%, p = 0.029 and 54.9% vs. 83.6%, p = 0.0.44, respectively). No significant differences were observed in early restenosis or MALE (10.7% vs. 5.9%, p = 0.455 and 48.3% vs. 73.4%, p = 0.055, respectively). Restenosis after DCB angioplasty was associated with repeat DCB (hazard ratio [HR], 5.13; 95% confidence interval [CI], 1.43-18.4; p = 0.012) and small vessel size of < 4.5 mm (HR, 6.25; 95% CI, 1.17-33.4; p = 0.032). Furthermore, restenosis after repeat DCB angioplasty was associated with the Peripheral Artery Calcification Scoring System (PACSS) grade 4 (HR, 4.20; 95% CI, 1.08-16.3; p = 0.038), small vessel size of < 4.5 mm (HR, 9.44; 95% CI, 1.21-73.7; p = 0.032), and intravascular ultrasound (IVUS) use (HR, 0.05; 95% CI, 0.01-0.44; p = 0.007).
CONCLUSIONS: The 1-year primary patency rate following repeat DCB angioplasty for femoropopliteal lesions was notably lower than that of DCB treatment for de novo lesions. Repeat DCB strategy was associated with an increased risk of patency loss. Regarding repeat restenosis after DCB treatments, PACSS grade 4 calcification and small vessel diameter of < 4.5 mm were associated with an increased risk of restenosis, whereas IVUS use correlated with a decreased risk of restenosis.
摘要：
背景：药物涂层球囊（DCB）治疗后再狭窄的临床意义仍不清楚。我们比较了DCB血管成形术治疗再狭窄和从头股pop动脉病变的临床结果。这项单中心回顾性研究包括571例患者（737条肢体），这些患者接受了重复治疗（54例患者，64条肢体）或从头DCB（517例患者，673条肢体），无救助支架。在倾向得分匹配后，对49对进行了分析。主要终点是1年的主要通畅，次要终点包括无靶病变血运重建（TLR），主要不良肢体事件（男性），和早期再狭窄。使用多变量Cox回归分析确定再狭窄的预测因子。
结果：与新生DCB组相比，重复DCB组的1年原发性通畅率和无TLR率显着降低（50.1％vs.77.4%,p=0.029和54.9%vs.83.6%,分别为p=0.0.44)。在早期再狭窄或男性中没有观察到显着差异（10.7％vs.5.9%，p=0.455和48.3%与73.4%,分别为p=0.055)。DCB血管成形术后再狭窄与重复DCB相关(风险比[HR],5.13；95%置信区间[CI]，1.43-18.4；p=0.012）和<4.5mm的小血管尺寸（HR，6.25；95%CI，1.17-33.4；p=0.032)。此外，重复DCB血管成形术后的再狭窄与外周动脉钙化评分系统（PACSS）4级（HR，4.20；95%CI，1.08-16.3；p=0.038），小血管尺寸<4.5mm(HR，9.44；95%CI，1.21-73.7；p=0.032），和血管内超声（IVUS）的使用（HR，0.05；95%CI，0.01-0.44；p=0.007）。
结论：股——股———股————————————————————————————————————————————————————————————————————————————————重复DCB策略与通畅性丧失的风险增加相关。关于DCB治疗后的重复再狭窄，PACSS4级钙化和小血管直径<4.5mm与再狭窄风险增加相关。而IVUS使用与再狭窄风险降低相关。
结果：与新生DCB组相比，重复DCB组的1年原发性通畅率和无TLR率显着降低（50.1％vs.77.4%,p=0.029和54.9%vs.83.6%,分别为p=0.0.44)。在早期再狭窄或男性中没有观察到显着差异（10.7％vs.5.9%，p=0.455和48.3%与73.4%,分别为p=0.055)。DCB血管成形术后再狭窄与重复DCB相关(风险比[HR],5.13；95%置信区间[CI]，1.43-18.4；p=0.012）和<4.5mm的小血管尺寸（HR，6.25；95%CI，1.17-33.4；p=0.032)。此外，重复DCB血管成形术后的再狭窄与外周动脉钙化评分系统（PACSS）4级（HR，4.20；95%CI，1.08-16.3；p=0.038），小血管尺寸<4.5mm(HR，9.44；95%CI，1.21-73.7；p=0.032），和血管内超声（IVUS）的使用（HR，0.05；95%CI，0.01-0.44；p=0.007）。
结论：股——股———股————————————————————————————————————————————————————————————————————————————————重复DCB策略与通畅性丧失的风险增加相关。关于DCB治疗后的重复再狭窄，PACSS4级钙化和小血管直径<4.5mm与再狭窄风险增加相关。而IVUS使用与再狭窄风险降低相关。
