Background

Percutaneous coronary interventions (PCI) of calcified lesions were associated with worse outcomes in the era of bare-metal and first-generation drug-eluting stents (DES). Data on PCI of calcified lesions with newer-generation DES are scarce. Therefore the rationale of this study was to investigate the impact of lesion calcification on clinical outcomes in patients undergoing PCI with a bioresorbable-polymer sirolimus eluting stent (BP-SES) or a durable-polymer everolimus eluting stent (DP-EES).

Methods

Patients (n=2361) from BIOFLOW-II, -IV, and -V trials were categorized into moderate/severe vs. none/mild lesion calcification by a core-laboratory. Endpoints were target lesion failure (TLF: cardiac death, target-vessel myocardial infarction [TV-MI], or target lesion revascularization [TLR]) and probable/definite stent thrombosis (ST) at two years.

Results

Core-laboratory adjudicated lesion calcification was available in 2285 patients. The agreement in calcification assessment between the operator and the core-laboratory was weak (weighted kappa=0.23).

Patients with moderate/severe calcification by core-lab assessment (n= 303; 16%) were older, more often female, more often had hypercholesterolemia, prior coronary revascularization, and more often underwent multivessel treatment. Calcified lesions were more frequently type B2/C, required more pre- and post-dilatations, and showed a higher residual stenosis as compared with none/mild calcification.

TLF (13.5% vs. 8.3%; p=0.004) and ST (2.1% vs. 0.2%; p<0.0001) were higher in patients with moderate/severe vs. none/mild calcification, while TLR was not different between the groups (5.0% vs. 3.8%; p=0.34). On multivariable analysis, calcification did not emerge as an independent predictor of TLF (OR 1.49; 95% CI: 0.95-1.91; p=0.08). Among patients with moderate/severe calcification, TLF rates were similar between BP-SES and DP-EES (12.6% vs. 15.4%, p=0.495). In none/mild calcification, BP-SES showed lower TLF (7.4% vs. 8.9%, p=0.048) and TV-MI (4.0% vs. 6.2%, p=0.047) as compared with DP-EES.

Conclusions

With newer-generation DES, moderate/severe lesion calcification was not associated with more TLF after adjustment for the higher risk of patients with coronary calcification. BP-SES and DP-EES were equally effective and safe in calcified lesions.