Drug eluting stent implantation in patients requiring concomitant vitamin K antagonist therapy. One-year outcome of the worldwide e-SELECT registry

Abstract

Background: Outcome of sirolimus-eluting stent (SES) in patients treated with an antivitamin K (VKA) agent before the PCI procedure is unknown. Methods: A total of 7651 patients were selected among 15,147 recipients of SES, included in the worldwide e-SELECT registry, only from those centers which included at least one patient requiring VKA: 296 were pretreated with a VKA agent (VKA group), whereas 7355 patients from the same enrolling medical centers were not (NON-VKA group). The rates of 1) major adverse cardiac events (MACE), including all-cause deaths, myocardial infarction (MI) and target lesion revascularization, 2) stent thrombosis (ST) and 3) major bleeding (MB) in the 2 study groups were compared at 1, 6 and 12 months. Results: The patients in VKA group were on average older as compared to those in NON-VKA group (67.7 ± 9.9 vs.62.9 ± 10.7, P b 0.001). The indications for pre-procedural anticoagulation were atrial fibrillation in 177 (59.8%), presence of a prosthetic valve in 21 (7.1%), embolization of cardiac origin in 17 (5.7%), pulmonary embolism or deep vein thrombosis in 17 (5.7%), and miscellaneous diagnoses in 64 (21.6%) patients. At 1 year, the rates of MACE and MB were higher in the VKA vs. the NON-VKA group (8.3% and 3% vs. 5.3% and 1.2%, P b 0.04and P b 0.002, respectively). The 1-year rates of definite and probable ST were remarkably low in both groups (0.38% vs. 1.1%, p = 0.4). Conclusions: Selected patients anticoagulated with VKA agent may safely undergo SES implantation. Those patients may receive a variety of APT regimen at the cost of a moderate increased risk of MB.