Lee Chiu-Yang, Wu Tao-Cheng, Lin Shing-Jong
Division of Cardiovascular Surgery, Department of Surgery, Taipei Veterans General Hospital, Taipei City, Taiwan; Institute of Clinical Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan.
Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; Cardiovascular Research Center, National Yang-Ming University, Taipei, Taiwan.
Clin Ther. 2021 Jan;43(1):195-210.e2. doi: 10.1016/j.clinthera.2020.11.013. Epub 2020 Dec 23.
Critical limb ischemia (CLI) has been identified as being connected to rates of cardiovascular mortality and lower extremity amputation (LEA). This prospective study investigated the effects of percutaneous coronary intervention (PCI), pharmacologic treatment, and predisposing factors on clinical outcomes in patients with and without type 2 diabetes mellitus (DM) along with CLI after endovascular intervention.
249 consecutive patients with CLI (Fontaine stages III-IV) received pharmacologic treatment after successful endovascular intervention. Their primary patency rates of infrapopliteal lesions and cardiovascular and amputation events during a 36-month follow-up period were assessed.
Patients with DM were more likely to be younger (P = 0.026); 50% (n = 63), 42.9% (n = 54), 52.4% (n = 66), and 77% (n = 97) of DM patients had arterial calcification, end-stage renal disease, diabetic neuropathy, and Fontaine stage IV (P < 0.001, P < 0.001, P < 0.001, and P = 0.019, respectively). The primary patency rates were 61%, 48.8%, and 42.3% at 12, 24, and 36 months, in the patients without DM (P = 0.034, P = 0.013, and P = 0.005). Patients with DM had higher risks of 36-month coronary artery disease, cerebrovascular accident, mortality, and LEA (P = 0.005, P = 0.042, P = 0.042, and P < 0.001). Patients with CLI receiving long-term cilostazol treatment had a better primary patency and amputation-free survival, and a lower risk of mortality at 36 months (P < 0.001, P < 0.001, and P = 0.001). Statin use was associated with 36-month amputation-free survival but not with primary patency (P = 0.032 and P = 0.088). Subgroup multivariate Cox analyses showed that primary patency was independently associated with long-term cilostazol treatment, PCI in the first postoperative year, and direct revascularization in the DM group, whereas in the control group, long-term cilostazol treatment was the main independent factor. The risk of amputation was independently associated with a high high-sensitivity chronic reactive protein level, diabetic neuropathy, sole use of an oral hypoglycemic agent, and lack of supervised exercise.
Long-term cilostazol treatment, aggressive management of dyslipidemia, and meticulous assessment and prevention of postoperative unstable coronary artery disease should be considered in CLI patients with and without DM to maximize clinical outcomes. PCI in the first postoperative year may be a predisposing factor for patency failure in patients with CLI, especially those with DM. A large-scale prospective randomized trial should be conducted to confirm these findings (TVGH IRB No. 2013-08-020B).
严重肢体缺血（CLI）已被确定与心血管死亡率和下肢截肢（LEA）率相关。这项前瞻性研究调查了经皮冠状动脉介入治疗（PCI）、药物治疗以及易感因素对接受血管内介入治疗后伴有和不伴有2型糖尿病（DM）的CLI患者临床结局的影响。
249例连续的CLI患者（Fontaine分期III-IV期）在成功进行血管内介入治疗后接受了药物治疗。评估了他们腘动脉以下病变的原发性通畅率以及36个月随访期内的心血管和截肢事件。
DM患者更可能较年轻（P = 0.026）；50%（n = 63）、42.9%（n = 54）、52.4%（n = 66）和77%（n = 97）的DM患者有动脉钙化、终末期肾病、糖尿病神经病变和Fontaine IV期（分别为P < 0.001、P < 0.001、P < 0.001和P = 0.019）。在无DM的患者中，12个月、24个月和36个月时的原发性通畅率分别为61%、48.8%和42.3%（P = 0.034、P = 0.013和P = 0.005）。DM患者发生36个月冠状动脉疾病、脑血管意外、死亡和LEA的风险更高（P = 0.005、P = 0.042、P = 0.042和P < 0.001）。接受长期西洛他唑治疗的CLI患者有更好的原发性通畅率和无截肢生存期，且36个月时死亡风险更低（P < 0.001、P < 0.001和P = 0.001）。使用他汀类药物与无截肢生存期相关，但与原发性通畅率无关（P = 0.032和P = 0.
