Department of Medicine Yale School of Medicine New Haven CT USA.
Vascular Medicine Outcomes Program (VAMOS), Section of Cardiovascular Medicine, Department of Medicine Yale School of Medicine New Haven CT USA.
J Am Heart Assoc. 2023 Apr 4;12(7):e028622. doi: 10.1161/JAHA.122.028622. Epub 2023 Mar 28.
Background Patients with severe-stage chronic kidney disease (CKD) were excluded from femoropopliteal disease trials evaluating drug-coated balloons (DCBs) and drug-eluting stents (DESs) versus plain balloon angioplasty (POBA) and bare metal stents (BMSs). We examined the interaction between CKD status and device type for the association with 24-month all-cause mortality and major amputation risk. Methods and Results We studied patients undergoing femoropopliteal interventions (September 2016-December 2018) from Medicare-linked VQI (Vascular Quality Initiative) registry data. We compared outcomes for: (1) early-stage CKD (stages 1-3) receiving DCB/DES, (2) early-stage CKD receiving POBA/BMS, (3) severe-stage (4 and 5) CKD receiving DCB/DES, and (4) severe-stage CKD receiving POBA/BMS. We studied 8799 patients (early-stage CKD: 94%; severe-stage: 6%). DCB/DES use was 57% versus 51% in patients with early-stage versus severe-stage CKD. Twenty-four-month mortality risk for patients with early-stage CKD receiving DCB/DES (reference) was 21% versus 28% (hazard ratio [HR], 1.47 [95% CI, 1.31-1.65]) for those receiving POBA/BMS; patients with severe-stage CKD: those receiving DCB/DES had a 49% (HR, 2.61 [95% CI, 2.06-3.31]) mortality risk versus 52% (HR, 3.64 [95% CI, 2.91-4.55]) for those receiving POBA/BMS (interaction <0.001). Adjusted analyses attenuated these results. For severe-stage CKD, DCB/DES versus POBA/BMS mortality risk was not significant at 24 months (post hoc comparison =0.06) but was higher for the POBA/BMS group at 18 months (post hoc <0.05). Patients with early-stage CKD receiving DCB/DES had the lowest 24-month amputation risk (6%), followed by 11% for early-stage CKD-POBA/BMS, 15% for severe-stage CKD-DCB/DES, and 16% for severe-stage CKD-POBA/BMS (interaction <0.001). DCB/DES versus POBA/BMS amputation rates in patients with severe-stage CKD did not differ (post hoc =0.820). Conclusions DCB/DES versus POBA/BMS use in patients with severe-stage CKD was associated with lower mortality and no difference in amputation outcomes.
背景 患有严重阶段慢性肾脏病（CKD）的患者被排除在评估药物涂层球囊（DCB）和药物洗脱支架（DES）与单纯球囊血管成形术（POBA）和裸金属支架（BMS）治疗股腘动脉疾病的试验之外。我们研究了 CKD 状态与器械类型之间的相互作用与 24 个月全因死亡率和主要截肢风险的关系。
方法 我们研究了 Medicare 相关 VQI（血管质量倡议）登记数据中接受股腘动脉介入治疗的患者（2016 年 9 月至 2018 年 12 月）。我们比较了以下结果：（1）接受 DCB/DES 的早期 CKD（1-3 期）患者，（2）接受 POBA/BMS 的早期 CKD 患者，（3）接受 DCB/DES 的严重 CKD（4 期和 5 期）患者，（4）接受 POBA/BMS 的严重 CKD 患者。我们研究了 8799 名患者（早期 CKD：94%；严重 CKD：6%）。早期 CKD 患者中 DCB/DES 的使用率为 57%，而严重 CKD 患者中为 51%。早期 CKD 接受 DCB/DES 治疗的患者（参考）的 24 个月死亡率风险为 21%，而接受 POBA/BMS 治疗的患者为 28%（风险比[HR]，1.47 [95%CI，1.31-1.65]）；严重 CKD 患者：接受 DCB/DES 治疗的患者的死亡率风险为 49%（HR，2.61 [95%CI，2.06-3.31]），而接受 POBA/BMS 治疗的患者为 52%（HR，3.64 [95%CI，2.91-4.55]）（交互作用<0.001）。调整后的分析结果减弱了这些结果。对于严重 CKD，DCB/DES 与 POBA/BMS 的 24 个月死亡率风险无显著差异（事后比较=0.06），但 POBA/BMS 组在 18 个月时的死亡率更高（事后比较<0.05）。接受 DCB/DES 治疗的早期 CKD 患者的 24 个月截肢风险最低（6%），其次是早期 CKD-POBA/BMS 组（11%），严重 CKD-DCB/DES 组（15%）和严重 CKD-POBA/BMS 组（交互作用<0.001）。严重 CKD 患者中 DCB/DES 与 POBA/BMS 的截肢率没有差异（事后比较=0.820）。
结论 在严重 CKD 患者中，与 POBA/BMS 相比，使用 DCB/DES 与较低的死亡率相关，且在截肢结局方面无差异。
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