Expedited Publication
Selection Criteria for Drug-Eluting Versus Bare-Metal Stents and the Impact of Routine Angiographic Follow-Up: 2-Year Insights From the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) Trial

https://doi.org/10.1016/j.jacc.2010.08.608Get rights and content
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Objectives

We sought to identify patients with ST-segment elevation myocardial infarction most likely to benefit from drug-eluting stents (DES), and to evaluate the impact of routine angiographic follow-up on the apparent differences between stent types.

Background

DES might have greatest utility in patients who would benefit most from their antirestenotic properties.

Methods

We randomly assigned 3,006 patients with ST-segment elevation myocardial infarction to paclitaxel-eluting stents (PES) or to bare-metal stents (BMS). Events were assessed at 12 months and 24 months, with a subset undergoing routine angiographic follow-up at 13 months. Using well-known risk factors for restenosis and target lesion revascularization (TLR), risk groups were formed to examine the absolute differences between PES and BMS.

Results

Compared with BMS, PES reduced TLR at 12 months from 7.4% to 4.5% (p = 0.003). Insulin-treated diabetes mellitus (hazard ratio: 3.12), reference vessel diameter ≤3.0 mm (hazard ratio: 2.89), and lesion length ≥30 mm (hazard ratio: 2.49) were independent predictors of 12-month TLR after BMS. In patients with 2 or 3 of these baseline risk factors, PES compared with BMS markedly reduced 12-month TLR (19.8% vs. 8.1%, p = 0.003). In patients with 1 of these risk factors, the 12-month rates of TLR were modestly reduced by PES (7.3% vs. 4.3%, p = 0.02). The 12-month TLR rates were low and similar for both stents in patients with 0 risk factors (3.3% vs. 3.2%, p = 0.93). Routine 13-month angiographic follow-up resulted in a marked increase in TLR procedures (more so with BMS) so that the absolute incremental benefit of PES compared with BMS doubled from 2.9% at 12 months to 6.0% at 24 months, a difference evident in all risk strata.

Conclusions

Patients at high risk for TLR after BMS in ST-segment elevation myocardial infarction for whom DES are of greatest benefit may be identified. Conversely, DES may be of less clinical benefit for patients at lower risk for TLR after BMS. Routine angiographic follow-up increases the perceived clinical benefits of DES, and must be avoided to accurately estimate absolute treatment effects. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966)

Key Words

acute myocardial infarction
angiography
bare-metal stent
drug-eluting stent
outcomes

Abbreviations and Acronyms

BMS
bare-metal stent(s)
DES
drug-eluting stent(s)
PCI
percutaneous coronary intervention
PES
paclitaxel-eluting stent(s)
RVD
reference vessel diameter
STEMI
ST-segment elevation myocardial infarction
TLR
target lesion revascularization

Cited by (0)

Dr. Stone has served on the scientific advisory board for Boston Scientific and Abbott Vascular, and has received honoraria from BMS-Sanofi, AstraZeneca, and The Medicines Company. Dr. Witzenbichler has received lecture honoraria from The Medicines Company and Boston Scientific. Dr. Kirtane has served as a consultant to Abbott Vascular, Boston Scientific, and Medtronic. Dr. Guagliumi has received consulting fees from Boston Scientific, lecture honoraria from The Medicines Company and Medtronic, and grant support from Medtronic, Boston Scientific, and Labcoat. Dr. Brodie is on the Speakers' Bureau for The Medicines Company and Medtronic. Dr. Dudek has received consulting and lecture honoraria from Abbott, Adamed, Biotronik, Balton, Bayer, BBraun, BioMatrix, Boston Scientific, Boehringer Inc., Bristol-Myers Squibb, Cordis, Cook, Eli Lilly, EuroCor, Glaxo, Invatec, Medtronic, The Medicines Company, MSD, Nycomed, Orbus-Neich, Pfizer, Possis, Promed, Sanofi-Aventis, Siemens, Solvay, Terumo, and Tyco. Dr. Möckel has received consulting and lecture honoraria from The Medicines Company. Dr. Lanksy has received research support from Boston Scientificand The Medicines Company. Dr. Mehran reports having received consulting fees from Bristol-Myers Squibb/Sanofi, Medtronic, and The Medicines Company. All other authors have reported that they have no relationships to disclose.