Effects of Postoperative Percutaneous Coronary Intervention, Pharmacologic Treatment, and Predisposing Factors on Clinical Outcomes in Patients With and Without Type 2 Diabetes Along With Critical Limb Ischemia

Abstract

PurposeCritical 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. Methods249 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. FindingsPatients 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. ImplicationsLong-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).