Abstract 2225: Extended Follow-up for Outcomes of Drug-Eluting Stents in “Real-World” Practice: Is Caution Indicated?
Background: The use of drug-eluting stents (DES) has become widespread in current practice, yet the long-term impact of DES on hard endpoints such as death and myocardial infarction (MI) has not been conclusively determined. Therefore, we studied event rates for DES (including sirolimus [SES] and paclitaxol [PES] DES) compared to bare-metal stents (BMS) in a high volume community-based program.
Methods: A total of 9,043 patients undergoing intracoronary stenting (NBMS = 7,022; NSES = 988; NPES = 1,033) from November 1993 to November 2005 were followed prospectively in the Intermountain Heart Collaborative Study for major adverse cardiac events (MACE) defined as all-cause death, non-fatal MI, target vessel revascularization (TVR) or coronary bypass surgery (CABG). Cox regression models were adjusted for standard cardiovascular risk factors (average length of follow-up: 2.1 = 0.9 years, maximum 3.0 years).
Results: Age averaged 63.7 years and 74% were male. At 6 months, TVR was lower for DES than for BMS (adjusted hazard ratio [HR] = 0.58, p = 0.003). Adjusted 3-year outcomes are provided in the table⇓ below.
Conclusion: Three-year outcomes, in contrast to 6-month outcomes, in patients with DES suggest an increased risk of MACE, especially all-cause death, compared to BMS. While DES demonstrated a lower risk of 6-month TVR, extended follow up showed no difference in TVR or MI. DES patients had a lower risk of CABG. Given the current dominance of DES in clinical practice, this raises alarm that long-term outcomes need more scrutiny.