Late loss of early benefit from drug-eluting stents when compared with bare-metal stents and coronary artery bypass surgery: 3 years follow-up of the ERACI III registry.

AIMS

Long-term benefit from coronary revascularization with drug-eluting stents (DES) relative to bare metal stents (BMS) and coronary artery bypass grafting (CABG) has not been established. One year follow-up of the ERACI III registry study showed better outcome with DES. To compare major adverse cardiac and cerebrovascular event (MACCE) rates in patients with multivessel cardiovascular disease (CVD) who received DES with those patients treated with BMS or CABG in the ERACI II trial.

METHODS AND RESULTS

Patients with multivessel CVD who met the ERACI II trial, clinical and angiographic inclusion criteria were treated with DES and enrolled in the ERACI III registry. The primary endpoint was 3-year MACCE. ERACI III-DES patients (n = 225) were compared with the BMS (n = 225) and CABG (n = 225) arms of ERACI II. Patients treated with DES were older, more often smokers, more often high risk by euroSCORE and less frequently had unstable angina. They also had higher incidence of type C lesions and received more stents than the BMS-treated cohort. Three year MACCE was lower in ERACI III-DES (22.7%) than in ERACI II-BMS (29.8%, P = 0.015), mainly reflecting less target vessel revascularization (14.2 vs. 24.4%, P = 0.009). MACCE rates at 3 years were similar in DES and CABG-treated patients (22.7%, P = 1.0), in contrast to results at 1 year (12 vs. 19.6%, P = 0.038). MACCE rates in ERACI III-DES were higher in diabetics (RR 0.81, 0.66-0.99; P = 0.018). Death or non-fatal MI at 3 years trended higher in the DES (10.2%) than BMS cohort (6.2%, P = 0.08) and lower than in CABG patients (15.1%, P = 0.07). Sub-acute late-stent thrombosis (LST) (>30 days) occurred in nine DES patients and no BMS patients (P = 0.008).

CONCLUSION

In patients with multivessel CVD, the initial advantage for PCI with DES over CABG observed at 1 year was not apparent by 3 years. Furthermore, despite continued lower incidence of MACCE, initial advantage over BMS appeared to decrease with time. LST occurred more frequent in DES-treated patients.