Peripheral arterial disease, acute coronary syndromes, and early invasive management: The TACTICS TIMI 18 trial

Background: Patients with peripheral arterial disease (PAD) represent a high-risk patient subset in the setting of non-ST-segment elevation acute coronary syndromes (NSTE ACS). The efficacy and safety of early invasive management for such patients remains unclear. Hypothesis: Early invasive management would be well tolerated and effective among patients with NSTE ACS and PAD. Methods: Patients from the Treat angina with Aggrastat and determine Cost of Therapy with an Invasive or Conservative Strategy-Thrombolysis In Myocardial Infarction (TACTICS-TTMI) 18 trial were stratified by the presence or absence of PAD and assessed with respect to baseline clinical factors. The outcomes of patients with PAD and NSTE ACS were examined with respect to treatment assignment to either early invasive therapy or conservative treatment of NSTE ACS. Finally, the bleeding and stroke rates of patients with PAD managed invasively were compared with patients with PAD managed conservatively. Results: Of 2,219 patients with NSTE ACS overall, 166 (7.5%) had concomitant PAD. Compared with those patients without PAD, those with PAD were older (75 vs. 62 years, p < 0.001) and were more likely to have high-risk clinical features, including prior histories of bypass surgery (39 vs. 20%, p < 0.001) or diabetes mellitus (38 vs. 27%, p = 0.002), and more ST-segment depression on their 12-lead electrocardiogram (43 vs. 29%, p < 0.001). Among such patients, early invasive management was associated with significant reductions in the risk of myocardial infarction (MI) at 30 days (11.4 vs. 2.3%, p = 0.03). At 180 days, compared with early conservative management, early invasive treatment for patients with PAD and NSTE ACS was associated with similar reductions in MI (12.7 vs. 3.5%, p = 0.04), and was also accompanied by significant reductions in risk of death (10.1 vs. 2.3%, p = 0.05). No excess in bleeding or stroke rates was noted among patients with PAD managed invasively. Conclusions: Among patients with NSTE ACS and a history of PAD, early invasive management is well tolerated and accompanied by significant reductions in morbidity and mortality when compared with a more conservative, ischemia-driven approach.