HORIZONS-AMI: Bivalirudin, Taxus Improve Outcomes in LAD PCI Patients
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In patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) of the left anterior descending artery (LAD), bivalirudin and paclitaxel-eluting stents each offer superior clinical outcomes, according to subgroup analyses of the HORIZONS-AMI trial published online June 10, 2013, in the American Journal of Cardiology.
The multicenter HORIZONS-AMI (Harmonizing Outcomes with RevascularIZatiON and Stents in AMI) trial randomized 3,602 STEMI patients undergoing primary PCI to receive bivalirudin or heparin plus a glycoprotein IIb/IIIa inhibitor (GPI). Then 3,006 of the patients were randomly assigned in a 3:1 ratio to receive Taxus paclitaxel-eluting stents (n = 2,257; Boston Scientific, Natick, MA) or otherwise identical BMS (n = 749).
For the current subanalyses, Jochen Wöhrle, MD, of the University of Ulm (Ulm, Germany), and colleagues compared outcomes in patients undergoing PCI in the LAD (n = 1,445) vs. other locations (n = 1,884). Patients undergoing LAD PCI had higher rates of risk factors including older age, Killip class II to IV, severely decreased LVEF, and multivessel disease but were less likely to have TIMI 0/1 flow, history of smoking, previous MI or CABG, or to require aspiration catheters.
LAD Outcomes Worse Overall
At 3 years, patients who underwent LAD PCI had twice the risk for cardiac death compared with non-LAD patients (5.4% vs. 2.7%; HR 2.00; 95% CI 1.40-2.86; P = 0.001). This increase resulted in a higher overall risk of MACE (death, reinfarction, stroke, or ischemia-driven TVR) in the LAD PCI group compared with the non-LAD PCI group (24.0% vs. 20.6%; HR 1.20; 95% CI 1.04-1.39; P = 0.013).
Among LAD patients, bivalirudin reduced cardiac death, reinfarction, and major non-CABG-related bleeding events compared with heparin plus GPI use (table 1). Rates of MACE, stroke, ischemic TVR, and stent thrombosis all were similar irrespective of anticoagulant type.
Table 1. Three-Year Outcomes After LAD PCI by Anticoagulant
|
Bivalirudin |
Heparin + GPI |
P Value |
Cardiac Death |
3.8% |
6.8% |
0.01 |
Reinfarction |
5.3% |
9.5% |
0.004 |
Major Bleeding Events |
7.3% |
11.8% |
0.004 |
In addition, treatment with Taxus reduced MACE including TVR compared with BMS (P = 0.003; table 2). No difference between groups was found for death, reinfarction, stroke, or stent thrombosis.
Table 2. Three-Year Outcomes After LAD PCI by Stent Type
Taxus |
BMS |
P Value |
|
MACE |
21.4% |
26.8% |
0.046 |
Ischemic TVR |
13.2% |
19.8% |
0.003 |
The results, though purely hypothesis generating, dovetail with those of other recent studies in their support for bivalirudin in this high-risk population, Dr. Wöhrle and colleagues say, noting that “the observed lesser cardiac mortality in patients treated with bivalirudin is attributed to the fewer bleeding events.”
Moreover, the presence of lesions in the LAD compared with other anatomic locations so clearly elevates risk of cardiac death that this metric alone can be used to guide clinical practice, they advise. “This high-risk population can be easily defined during cardiac catheterization in contrast to risk scores on the basis of multiple variables.”
The clinical implications of the advantage of Taxus over BMS are less obvious, the researchers acknowledge, concluding that “lower stent thrombosis rates in patients with STEMI may be attained with the newer stents, and with further optimization of periprocedural antiplatelet and anticoagulation therapy.”
Note: Study coauthors Gregg W. Stone, MD, of Columbia University Medical Center (New York, NY), and Roxana Mehran, MD, of Mount Sinai Medical Center (New York, NY), are faculty members of the Cardiovascular Research Foundation, which owns and operates TCTMD.
Source:
Wöhrle J, Brodie B, Witzenbichler B, et al. Impact of bivalirudin and paclitaxel-eluting stents on outcomes in patients undergoing primary percutaneous coronary intervention of the left anterior descending artery. Am J Cardiol. 2013;Epub ahead of print.
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Disclosures
- Dr. Wöhrle reports no relevant conflicts of interest.
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