Objective: To compare biodegradable-polymer sirolimus-eluting stent (BP-SES) with durable-polymer everolimus-eluting stent (DP-EES) after rotational atherectomy (RA) of severely calcified bifurcation lesions.
Background: New-generation drug-eluting stents (DES) are superior to early-generation DES in all percutaneous coronary intervention (PCI) settings including RA. Among the newer DES generation, the BP-SES (Orsiro, Biotronik) recently proved to be non-inferior to a DP-EES (Xience, Abbott Vascular; Promus, Boston Scientific)) in an all comers’ population.
Methods: In patients who underwent RA for a severely calcified bifurcation lesion at a single center, 111 were treated with BP-SES and 139 with DP-EES. Patients treated with other stent types, presenting with acute myocardial infarction or had a chronic total occlusion were excluded. Incidence of a composite end point of cardiac death, myocardial infarction (MI) or target lesion revascularization (TLR) was retrospectively assessed after three years.
Results: Patients treated with BP-SES were younger (p= 0.003), had a better left ventricular function (p=0.012), less frequently presented with NSTE-ACS (p= 0.033) compared to those treated with DP-EES. Moreover, intravascular imaging was more frequently applied in the BP-SES group (p= <0.001). True bifurcation rates were comparable between the BP-SES and DP-EES groups respectively (16.2 % vs. 10.8%, p= 0.260).
Procedural complications were comparable between the study groups (p= 0.821). Nevertheless, in-hospital MACE rates were lower in the BP-SES group (2.7% vs 9.4 %, OR 0.27; CI 0.08-0.97, p = 0.045), driven by lower rates of periprocedural MI (1.8% vs. 6.5 %, p= 0.073). After three years, the composite endpoint rates in BP-SES and DP-EES groups were 15% and 25%, respectively. In a multivariate regression analysis, both study groups had comparable long term composite outcome (adjusted HR: 0.57, 95%CI: 0.29-1.12, p=0.104). Nevertheless, Age (p=0.046), total stent length (p=0.001) and LVEF < 40% (p=0.001) and presentation with NSTE-ACS (p= 0.030) was associated with the composite endpoint.
Conclusion: BP-SES has might have a potential to improve in-hospital outcomes when used following RA for severely calcified bifurcation lesions. Additionally, BP-SES and DP-EES demonstrated comparable rates of long-term adverse outcomes following this procedure. These results justify the need for further randomized trials to investigate the hypothesis of whether the stent platform may influence bifurcation techniques.
