Abstract 3138: Impact of “Off Label” Utilization of Drug-Eluting Stents on Clinical Outcomes in Patients Undergoing Percutaneous Coronary Intervention
Background: The utilization of drug-eluting stents (DES) in “real world” practice has deviated substantially from Food and Drug Administration (FDA) approved indications. The outcomes of patients undergoing intracoronary DES implantation (versus BMS) for non-FDA approved indications has not been determined.
Methods: The clinical outcomes of 546 patients undergoing DES implantation for ≥1 non-FDA approved (“Off label”) indication after device approval were assessed. This group was then compared to 546 propensity-matched patients receiving BMS prior to DES approval for the same indications. The primary endpoint was major adverse cardiac events [MACE; death-all cause, non-fatal Q-wave MI and target vessel revascularization (TVR)] at 12 months.
Results: Baseline clinical and procedural characteristics were well matched. Patients in the BMS group were more likely to be treated with larger diameter and shorter stents. Though both in-hospital and 30-day all-cause mortality was greater in the DES group, there was no significant difference in cardiac death at both time points. At 30 days all other clinical outcomes were comparable. At 12 months MACE was significantly reduced in the DES group (27.8% vs. 21.4% p=0.014) driven by reductions in repeat revascularization [target lesion revascularization (TLR): 16.4% vs. 7.8% p<0.001, TVR: 20.2% vs.13.1% p<0.003]. There was no significant increase in death and non-fatal Q-wave MI with DES.
Conclusions: The utilization of DES for non-FDA approved indications proved to be efficacious and safe when compared to a propensity-matched BMS cohort. These findings support broadening the current FDA indications for DES use.