PCI significantly improves the prognosis of patients with stable angina

  The FAME 2 trial is a multicenter, randomized, controlled study designed to evaluate the long-term outcomes of FFR-guided PCI and optimized drug therapy alone for stable angina (SA). Patients with SA with at least one lesion and an FFR ≤ 0.80 who were candidates for drug-eluting stent (DES) placement were randomized to the optimized drug therapy alone (MT) and (PCI + MT) groups, while patients with an FFR > 0.80 were enrolled in a registry study (Registry). A total of 1220 patients from 28 medical centers in Europe and the United States were enrolled. The mean number of lesions was 1.52±0.78 and 1.42±0.73 in the randomized trial (PCI+MT) group and 441 in the MT group. 74% and 77.8% of the patients had a single lesion, respectively; 62.4% and 59.6% had proximal or mid-LAD lesions, respectively; and the FFR values were 0.68±0.10 and 0.68±0.15, respectively. registration The study included 322 patients with a mean number of lesions of 1.32±0.59. The primary endpoints were all-cause death, myocardial infarction, and urgent revascularization.  The results showed that the rate of composite endpoint events was significantly lower in the PCI+MT group (HR 0.32, 0.19-0.53; P<0.001) and in the registry group (HR 4.32, 1.75-10.7; P<0.001) than in the MT group, whereas there was no significant difference between the PCI+MT group and the registry group (P=0.61) (see Figure 1). Among the endpoint events, there were no significant differences in all-cause mortality and myocardial infarction rates among the PCI+MT, MT, and registration groups (all P > 0.05); whereas the emergency revascularization rates were significantly higher in the MT group than in the PCI+MT group (HR 0.13, 0.06-0.30; P < 0.001) and the registration group (HR 4.65, 1.72-12.62; P < 0.001), with no significant differences between the PCI+MT and registration groups (P = 0.43) (see Figure 2). Among all patients with urgent revascularization, 51.8% had unstable angina alone, 21.4% had acute myocardial infarction (MI), and 26.8% had unstable angina with ECG showing ischemic changes. The study showed that in patients with stable angina, the long-term outcome of PCI was significantly better than that of drug therapy alone when myocardial ischemia was significant (FFR ≤ 0.8), while good results were obtained with drug therapy alone when myocardial ischemia was not significant (FFR > 0.8).  The results of this study reject the previous conclusion that PCI does not improve the prognosis of patients with stable angina, and will certainly have a positive effect on the choice of treatment strategy and improvement of prognosis in patients with stable angina.