Division of Cardiology Department of Medicine Durham VA Medical Center Durham NC.
Division of Cardiology Duke University School of Medicine Durham NC.
J Am Heart Assoc. 2021 Feb 16;10(4):e018149. doi: 10.1161/JAHA.120.018149. Epub 2021 Feb 6.
BACKGROUND The long-term safety of paclitaxel-coated devices (PCDs; drug-coated balloon or drug-eluting stent) for peripheral endovascular intervention is uncertain. We used data from the Veterans Health Administration to evaluate the association between PCDs, long-term mortality, and cause of death. METHODS AND RESULTS Using the Veterans Administration Corporate Data Warehouse in conjunction with () Procedure Coding System, Current Procedural Terminology, and Healthcare Common Procedure Coding System codes, we identified patients with peripheral artery disease treated within the Veterans Administration for femoropopliteal artery revascularization between October 1, 2015, and June 30, 2019. An adjusted Cox regression, using stabilized inverse probability-weighted estimates, was used to evaluate the association between PCDs and long-term survival. Cause of death data were obtained using the National Death Index. In total, 10 505 patients underwent femoropopliteal peripheral endovascular intervention; 2265 (21.6%) with a PCD and 8240 (78.4%) with a non-PCD (percutaneous angioplasty balloon and/or bare metal stent). Survival rates at 2 years (77.4% versus 79.7%) and 3 years (70.7% versus 71.8%) were similar between PCD and non-PCD groups, respectively. The adjusted hazard for all-cause mortality for patients treated with a PCD versus non-PCD was 1.06 (95% CI, 0.95-1.18, =0.3013). Among patients who died between October 1, 2015, and December 31, 2017, the cause of death according to treatment group, PCD versus non-PCD, was similar. CONCLUSIONS Among patients undergoing femoropopliteal peripheral endovascular intervention within the Veterans Administration Health Administration, there was no increased risk of long-term, all-cause mortality associated with PCD use. Cause-specific mortality rates were similar between treatment groups.
紫杉醇涂层器械(PCD;药物涂层球囊或药物洗脱支架)用于外周血管腔内介入的长期安全性尚不确定。我们使用退伍军人事务部的数据评估了 PCD 与长期死亡率和死因之间的关系。
使用退伍军人事务部公司数据仓库,结合 () 手术编码系统、当前手术术语和医疗保健通用手术编码系统代码,我们确定了 2015 年 10 月 1 日至 2019 年 6 月 30 日期间在退伍军人事务部接受股浅动脉血运重建的外周动脉疾病患者。使用稳定的逆概率加权估计值进行调整后的 Cox 回归,以评估 PCD 与长期生存之间的关系。死因数据通过国家死亡指数获得。共有 10 505 例患者接受股浅外周血管腔内介入治疗;2265 例(21.6%)使用 PCD,8240 例(78.4%)使用非 PCD(经皮血管成形球囊和/或裸金属支架)。2 年(77.4%对 79.7%)和 3 年(70.7%对 71.8%)的生存率在 PCD 组和非 PCD 组之间相似。与非 PCD 相比,PCD 治疗患者的全因死亡率调整后的危险比为 1.06(95%CI,0.95-1.18,=0.3013)。在 2015 年 10 月 1 日至 2017 年 12 月 31 日期间死亡的患者中,按治疗组(PCD 与非 PCD)划分的死因相似。
在退伍军人事务部医疗保健机构接受股浅外周血管腔内介入治疗的患者中,使用 PCD 与长期全因死亡率增加无关。治疗组之间的特定原因死亡率相似。