Li Jun, Department of Cardiovascular Medicine, Guang’anmen Hospital, Chinese Academy of Traditional Chinese Medicine
The European Heart Congress 2012 (ESC 2012) was held in Munich, Germany from August 25 to 29, with more than 30,000 scholars from more than 150 countries attending the event. A number of recent trial results were announced at the congress, which became one of the highlights of the meeting.
The FAME 2 trial is a multicenter, randomized, controlled study to evaluate the long-term outcomes of FFR-guided PCI and optimized medication alone for the treatment of 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, respectively, with 74% and 77.8% of single-branch lesions, respectively; 62.4% and 59.6% of proximal or mid-LAD lesions, respectively; and FFR values of 0.68±0.10 and 0.68±0.15, respectively. registry 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 in the PCI+MT group compared with 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). Of 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), whereas 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.