The RESOLUTE All Comers trial showed that the Resolute zotarolimus-eluting stent was non-inferior to the Xience V everolimus eluting stent in terms of target lesion failure (revascularisation, myocardial infarction, or cardiac death). However, long-term follow-up data from drug-eluting stent trials are generally scarce. Silber et al. report the 2-year clinical outcomes from the original RESOLUTE trial.
All patients in the study had at least one coronary lesion between 2.25 and 4.0mm in diameter causing more than 50% stenosis. There were no restrictions as to the number of stents implanted, nor the the number of vessels or lesions treated. Safety and efficacy outcomes examined at two years included death, myocardial infarction, revascularisation and stent-related composite outcomes.
1140 patients were assigned to Resolute and 1152 to Xience stents, of which 1121 and 1128, respectively, completed 2-year follow-up. No difference was noted between patient-related outcomes (death, MI, revascularisation, 20.6% vs 20.5%; p=0.958) and stent-related outcomes (11.2% vs 10.7%; p=0.736) in the two patient groups. In additon, only three patients in each group had stent thrombosis after one year (very late stent thrombosis). Therefore despite a low rate of problems with the stents themselves, many patients went on to have further cardiac events.
At 2-year follow-up, no significant safety or efficacy differences existed between Resolute and Xience stents. However, a high rate of recurrent events emphasises the need for effective secondary prevention in patients with established coronary disease.
- Silber S, Windecker SS, Vranckx P et al. Unrestricted randomised use of two new generation drug-eluting coronary stents: 2-year patient-related versus stent-related outcomes from the RESOLUTE All Comers trial. Lancet 2011. DOI: 10.1016/S0140-6736(11)60395-4