Two-year outcome after treatment of severely calcified lesions with newer-generation drug-eluting stents in acute coronary syndromes: A patient-level pooled analysis from TWENTE and DUTCH PEERS

Abstract

Background Data on medium-term outcome of patients with acute coronary syndrome (ACS), treated with newer-generation durable polymer drug-eluting stents (DES) in severely calcified coronary lesions, are scarce. We aimed to assess the impact of severe coronary lesion calcification on clinical outcome of patients with ACS, treated with newer-generation DES. Methods The TWENTE and DUTCH PEERS randomized trials comprise 1779 ACS patients, who were categorized into patients with versus without severe target lesion calcification. We performed a patient-level pooled analysis to assess 2-year outcome, including target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction (MI), or target vessel revascularization (TVR). Results Patients with severe target lesion calcification (n = 340, 19.1%) were older (66.8 ± 10.6 years vs. 62.8 ± 11.5 years, p < 0.001) and had more often diabetes (22.1% vs. 16.8%, p = 0.02) and hypercholesterolemia (51.5% vs. 42.9%, p = 0.005) than other patients (n = 1439, 79.9%). In addition they showed a higher TVF rate (12.4% vs.7.0%, p = 0.001), mainly related to a difference in TVR (6.8% vs. 3.3%, p = 0.003). There was a borderline significant between-group difference in cardiac death (3.6% vs. 1.8%, p = 0.05), but not in target vessel MI (3.8% vs.2.6%, p = 0.23) and definite stent thrombosis (0.9% vs. 0.6%, p = 0.71). Multivariate analysis demonstrated that severe lesion calcification was an independent risk factor of TVF (adjusted HR; 1.58, 95% CI: 1.23–2.03; p < 0.001). Conclusions In patients with ACS, treatment of severely calcified lesions with newer-generation DES was associated with an overall higher clinical event risk – related in particular to a higher TVR rate, while the risk of MI was low.