Division of Vascular Surgery and Endovascular Therapy, University of Alabama at Birmingham, Birmingham, Ala.
Division of Vascular Surgery and Endovascular Therapy, University of Alabama at Birmingham, Birmingham, Ala.
J Vasc Surg. 2020 Apr;71(4):1358-1369. doi: 10.1016/j.jvs.2019.07.063. Epub 2020 Feb 5.
Prior studies have evaluated the effects of statin and antiplatelet agent (APA) medications on patients with peripheral arterial disease. Although the benefits of statin and APA use are well-described, there is a paucity of research into the specific outcomes of patients who are not compliant or those who are unable to take the medication owing to intolerance. Here we examine the outcomes of patients intolerant to statin and APA and compare them with patients who are compliant or noncompliant with these therapies.
Patients treated from 2005 to 2018 in the Vascular Quality Initiative registry were included. Patients with missing data or deaths within 30 days of procedure were removed. Patients were considered noncompliant if they were previously prescribed a medication at discharge but were not taking it at 1-year follow-up or if the patient was reported to be noncompliant in the registry. Medication intolerance was defined if listed as "no, for medical reasons," and mortality data were ascertained using the Social Security Death Index, which is regularly cross-referenced to the Vascular Quality Initiative registry.
We identified 105,628 patients who met our inclusion criteria. Statin intolerance was noted in 2.3% at discharge and 2.1% at the 1-year follow-up, with 0.7% listed as intolerant at all stages. Factors associated with increased risk of intolerance to statins included female gender (P = .001), discharge APA intolerance (P = .004), insurance status (non-U.S. insurance) (P < .001), discharge APA noncompliance (P = .019), and discharge angiotensin converting enzyme inhibitor noncompliance (P = .005). Patients who were compliant with statins showed a 91% survival at 5 years vs 87% survival in noncompliant patients and 87% in intolerant patients at 5 years (P < .001). Patients with statin intolerance have a similar survival curve as noncompliant patients across all registry cohorts. Noncompliance with statins was correlated with noncompliance with APA medications (R = 0.16, P < .001). Factors associated with increased risk of statin noncompliance included preoperative ambulatory status (requiring assistance) (P = .039), female sex (P < .001), peripheral vascular intervention (P < .001) or infrainguinal open bypass procedure surgery (P = .001), discharge status (to nursing home) (P = .006) and insurance (self-pay) (P < .001).
Patients not taking statin and APA medications have a substantially decreased 5-year survival irrespective of the reason for not taking. Importantly, patients noted to be intolerant have a similar survival curve as noncompliant patients across all registry cohorts. Intolerant patients may benefit from attempts to alter statin dose, type (hydrophilic vs lipophilic), or from newer agents such as PCSK9 inhibitors.
先前的研究已经评估了他汀类药物和抗血小板药物（APA）对周围动脉疾病患者的影响。尽管他汀类药物和 APA 药物的使用益处已得到充分描述，但对于不耐受或因不耐受而无法服用药物的患者的具体结果的研究却很少。在这里，我们研究了不耐受他汀类药物和 APA 药物的患者的结局，并将其与依从或不依从这些治疗的患者进行了比较。
纳入了 2005 年至 2018 年血管质量倡议登记处治疗的患者。删除了数据缺失或术后 30 天内死亡的患者。如果患者在出院时被开了处方，但在 1 年随访时未服用药物，或者在登记处报告为不依从，则被认为不依从。如果列为“否，因医疗原因”，则定义为药物不耐受，并使用社会安全死亡指数来确定死亡率数据，该指数定期与血管质量倡议登记处交叉参考。
我们确定了 105628 名符合我们纳入标准的患者。出院时他汀类药物不耐受的发生率为 2.3%，1 年随访时为 2.1%，所有阶段有 0.7%列为不耐受。与他汀类药物不耐受风险增加相关的因素包括女性（P<0.001）、出院时 APA 不耐受（P=0.004）、保险状况（非美国保险）（P<0.001）、出院时 APA 不依从（P=0.019）和出院时血管紧张素转换酶抑制剂不依从（P=0.005）。依从他汀类药物的患者在 5 年时的生存率为 91%，而不依从的患者为 87%，不耐受的患者为 87%（P<0.001）。在所有登记组中，他汀类药物不耐受的患者的生存曲线与不依从的患者相似。他汀类药物不依从与 APA 药物不依从呈正相关（R=0.16，P<0.001）。与他汀类药物不依从风险增加相关的因素包括术前步行状态（需要帮助）（P=0.039）、女性（P<0.001）、外周血管介入治疗（P<0.001）或下肢动静脉旁路手术（P=0.001）、出院状态（疗养院）（P=0.006）和保险（自付）（P<0.001）。
无论不服用的原因是什么，不服用他汀类药物和 APA 药物的患者的 5 年生存率都会显著降低。重要的是，在所有登记组中，被认为不耐受的患者的生存曲线与不依从的患者相似。不耐受的患者可能受益于尝试改变他汀类药物的剂量、类型（亲水性与亲脂性）或使用新型药物，如 PCSK9 抑制剂。
