Abstract：
OBJECTIVE: There is a lack of consensus regarding the optimal strategy for evaluating the efficiency and safety of dual-pathway inhibition (DPI) in preventing femoropopliteal restenosis in patients undergoing repeated endovascular interventions. Despite several therapeutic interventions available for preventing femoropopliteal restenosis post repeated endovascular interventions, the ideal strategy, particularly evaluating the efficacy and safety of DPI, remains a matter of debate.
METHODS: From January 2015 to September 2021, patients who underwent repeated endovascular interventions for femoropopliteal restenosis were compared with those who underwent DPI or dual antiplatelet therapy (DAPT) after surgery using a propensity score-matched analysis. The primary outcome was clinically driven target lesion revascularization (CD-TLR). The principal safety outcome was a composite of major bleeding and clinically relevant non-major (CRNM) bleeding. To further enhance the rigor, Kaplan-Meier plots, Cox proportional hazards modeling, and sensitivity analyses, as well as subgroup analyses were employed, reducing potential confounders.
RESULTS: A total of 441 patients were included in our study, of whom 294 (66.7%) received DAPT and 147 (33.1%) received DPI, with 114 matched pairs (mean age, 72.21 years; 84.2% male). Cumulative probability of CD-TLR at 36 months in the DPI group (17%) trended lower than that in the DAPT group (32%) (hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.26-0.78; P =.004). The cumulative probability of freedom from CD-TLR at 36 months in the DPI group was 83%. No significant difference was observed in the composite outcome of major or CRNM bleeding between the DPI and DAPT groups (HR, 1.26; 95% CI, 0.34 to 4.69; P = .730). The DPI group was associated with significantly lower rates of CD-TLR in the main subgroup analyses of diabetes (P = .001), previous smoking history (P = .008), longer lesion length (>10 cm) (P = .003), and treatment with debulking strategy (P = .003).
CONCLUSIONS: In our investigation focused on CD-TLR, we found that DPI exhibited a significant reduction in the risk of reintervention compared with other treatment modalities. This underscores the potential of DPI as a viable therapeutic strategy in preventing reinterventions. Moreover, our assessment of safety outcomes revealed that the bleeding risks associated with DPI were on par with DAPT, thereby not compromising patient safety. These findings pave the way for potential broader clinical implications, emphasizing the effectiveness and safety of DPI in the context of reducing reintervention risks.
METHODS: From January 2015 to September 2021, patients who underwent repeated endovascular interventions for femoropopliteal restenosis were compared with those who underwent DPI or dual antiplatelet therapy (DAPT) after surgery using a propensity score-matched analysis. The primary outcome was clinically driven target lesion revascularization (CD-TLR). The principal safety outcome was a composite of major bleeding and clinically relevant non-major (CRNM) bleeding. To further enhance the rigor, Kaplan-Meier plots, Cox proportional hazards modeling, and sensitivity analyses, as well as subgroup analyses were employed, reducing potential confounders.
RESULTS: A total of 441 patients were included in our study, of whom 294 (66.7%) received DAPT and 147 (33.1%) received DPI, with 114 matched pairs (mean age, 72.21 years; 84.2% male). Cumulative probability of CD-TLR at 36 months in the DPI group (17%) trended lower than that in the DAPT group (32%) (hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.26-0.78; P =.004). The cumulative probability of freedom from CD-TLR at 36 months in the DPI group was 83%. No significant difference was observed in the composite outcome of major or CRNM bleeding between the DPI and DAPT groups (HR, 1.26; 95% CI, 0.34 to 4.69; P = .730). The DPI group was associated with significantly lower rates of CD-TLR in the main subgroup analyses of diabetes (P = .001), previous smoking history (P = .008), longer lesion length (>10 cm) (P = .003), and treatment with debulking strategy (P = .003).
CONCLUSIONS: In our investigation focused on CD-TLR, we found that DPI exhibited a significant reduction in the risk of reintervention compared with other treatment modalities. This underscores the potential of DPI as a viable therapeutic strategy in preventing reinterventions. Moreover, our assessment of safety outcomes revealed that the bleeding risks associated with DPI were on par with DAPT, thereby not compromising patient safety. These findings pave the way for potential broader clinical implications, emphasizing the effectiveness and safety of DPI in the context of reducing reintervention risks.
摘要：
背景：对于评估双路抑制（DPI）预防反复血管内介入治疗患者股pop再狭窄的有效性和安全性的最佳策略，目前尚无共识。尽管有几种治疗性干预措施可用于预防反复血管内干预后的股pop再狭窄，理想的战略，特别是评估双途径抑制（DPI）的有效性和安全性，仍然是一个辩论的问题。
方法：从2015年1月至2021年9月，使用倾向评分匹配分析，将反复接受股吧骨再狭窄血管内介入治疗的患者与术后接受DPI或双重抗血小板治疗（DAPT）的患者进行比较。主要结果是临床驱动的靶病变血运重建（CD-TLR）。主要安全性结果是大出血和临床相关非大出血（CRNM）的复合。为了进一步提高严谨性，卡普兰·迈耶地块，Cox比例风险建模，并采用了敏感性和亚组分析，减少潜在的混杂因素。
结果：本研究共纳入441例患者，其中294人(66.7%)获得DAPT，147人(33.1%)获得DPI，其中114对配对(平均年龄，72.21年,84.2%男性)。DPI组36个月时CD-TLR的累积概率(17%)明显低于DAPT组(32%)(危险比[HR],0.45；95%置信区间[CI]，0.26至0.78；p=0.004）。DPI组36个月时无CD-TLR的累积概率为83%。DPI和DAPT组之间的主要或CRNM出血的复合结局没有显着差异（HR，1.26；95%CI，0.34至4.69；p=0.730)。在糖尿病的主要亚组分析中，DPI组的CD-TLR发生率显著降低（p=0.001）。既往吸烟史（p=0.008），较长的病变长度（>10cm）（p=0.003），并采用减积策略治疗(p=0.003)。
结论：在我们针对CD-TLR的调查中，我们发现,与其他治疗方式相比,DPI的再干预风险显著降低.这强调了DPI作为预防再干预的可行治疗策略的潜力。此外，我们对安全性结果的评估显示，与DPI相关的出血风险与DAPT相当，从而不损害患者安全。这些发现为潜在的更广泛的临床意义铺平了道路，在降低再干预风险的背景下，强调DPI的有效性和安全性。
方法：从2015年1月至2021年9月，使用倾向评分匹配分析，将反复接受股吧骨再狭窄血管内介入治疗的患者与术后接受DPI或双重抗血小板治疗（DAPT）的患者进行比较。主要结果是临床驱动的靶病变血运重建（CD-TLR）。主要安全性结果是大出血和临床相关非大出血（CRNM）的复合。为了进一步提高严谨性，卡普兰·迈耶地块，Cox比例风险建模，并采用了敏感性和亚组分析，减少潜在的混杂因素。
结果：本研究共纳入441例患者，其中294人(66.7%)获得DAPT，147人(33.1%)获得DPI，其中114对配对(平均年龄，72.21年,84.2%男性)。DPI组36个月时CD-TLR的累积概率(17%)明显低于DAPT组(32%)(危险比[HR],0.45；95%置信区间[CI]，0.26至0.78；p=0.004）。DPI组36个月时无CD-TLR的累积概率为83%。DPI和DAPT组之间的主要或CRNM出血的复合结局没有显着差异（HR，1.26；95%CI，0.34至4.69；p=0.730)。在糖尿病的主要亚组分析中，DPI组的CD-TLR发生率显著降低（p=0.001）。既往吸烟史（p=0.008），较长的病变长度（>10cm）（p=0.003），并采用减积策略治疗(p=0.003)。
结论：在我们针对CD-TLR的调查中，我们发现,与其他治疗方式相比,DPI的再干预风险显著降低.这强调了DPI作为预防再干预的可行治疗策略的潜力。此外，我们对安全性结果的评估显示，与DPI相关的出血风险与DAPT相当，从而不损害患者安全。这些发现为潜在的更广泛的临床意义铺平了道路，在降低再干预风险的背景下，强调DPI的有效性和安全性。
