Predictors of death or myocardial infarction, ischaemic-driven revascularisation, and major adverse cardiovascular events following everolimus-eluting or paclitaxel-eluting stent deployment: pooled analysis from the SPIRIT II, III, IV and COMPARE trials

Aims: Although clinical trials have demonstrated superior clinical efficacy and improved safety of the everolimus-eluting stent (EES) compared with paclitaxel-eluting stents (PES) the clinical, angiographic and procedural factors associated with adverse clinical outcomes following drug-eluting stent (DES) deployment have not been carefully analysed. Methods and results: We performed a patient-level pooled database analysis from the SPIRIT II, III, IV and COMPARE prospective randomised (EES versus PES) trials which enrolled 6,789 patients undergoing coronary stenting with follow-up through two years. To determine independent predictors of death, myocardial infarction (MI), ischaemia-driven revascularisation (target lesion [ID-TLR] or target vessel [ID-TVR]), and major adverse cardiovascular events ([MACE]; composite occurrence of cardiovascular death, MI, ID-TLR), we analysed clinical, angiographic and procedural variables using Cox proportional hazard stepwise regression analysis. Treatment with EES (versus PES) was a powerful, independent predictor of relative freedom from MI (HR [95% CI]= 0.54 [0.41, 0.71]; p<0.0001), cardiac death or MI (0.63 [0.49, 0.80]; p=0.0002), ID-TLR (0.59 [0.47, 0.74]; p<0.0001), ID-TVR (0.70 [0.58,0.84]; p=0.0002) and MACE (0.64 [0.54, 0.77]; p<0.0001). Both diabetes and the extent of coronary artery disease as reflected by the number of lesions treated were predictive of cardiac death, ID-TLR, ID-TVR, MI and MACE. Conclusions: This multivariate analysis identified independent predictors of adverse outcomes to two years following DES deployment. Treatment with EES (versus PES) is an independent predictor of freedom from MI, cardiac death or MI, ID-TLR, ID-TVR and MACE.