HORIZONS-AMI Substudy: Women at Higher Risk for Bleeding After STEMI

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Women with ST-segment elevation myocardial infarction (STEMI) are at increased risk of long-term bleeding—but not major adverse cardiovascular events (MACE)—compared with men, according to a substudy of the HORIZONS-AMI trial published online September 2, 2014, ahead of print in Catheterization and Cardiovascular Interventions. However, female sex is associated with comorbidities that impart an increased risk of long-term ischemic events.

Methods
In the multicenter HORIZONS-AMI (Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction) trial, 3,602 STEMI patients undergoing primary PCI were first randomized to anticoagulation with unfractionated heparin plus a GPI or bivalirudin monotherapy. After angiography, 3,006 patients with lesions eligible for stenting were randomized 3:1 to a paclitaxel-eluting stent (PES; Taxus Express) or a BMS (Express; both Boston Scientific; Natick, MA).
Researchers led by Roxana Mehran, MD, of Mount Sinai Medical Center (New York, NY), conducted a substudy to examine differences in long-term bleeding and ischemic outcomes between men (n = 2,760) and women (n = 842).

At 30 days, women had higher rates of MACE, non-CABG-related major bleeding, death, and TVR compared with men, but the differences for death and TVR did not remain significant at 3 years. Additionally, the composite endpoint of death or reinfarction was higher in women at 30 days but not at 3 years (table 1).

Table 1. Clinical Outcomes

 

Women

(n = 842)

Men

(n = 2,760)

P Value

MACE

    30 Days

    3 Years

 

7.4%

24.0%

 

4.9%

21.2%

 

.01

.046

Major Bleeding

    30 Days

    3 Years

 

11.3%

13.8%

 

6.0%

7.2%

 

< .0001

< .0001

Death

    30 Days

    3 Years

 

3.8%

8.2%

 

2.2%

6.4%

 

.01

.06

Reinfarction

    30 Days

    3 Years

 

2.1%

7.1%

 

1.8%

7.2%

 

.63

.91

Ischemic TVR

    30 Days

    3 Years

 

3.4%

14.5%

 

2.0%

12.8%

 

.02

.14

Definite/Probable Stent Thrombosis

    30 Days

    3 Years

 

3.1%

5.3%

 

2.2%

5.0%

 

.18

.71

Death or Reinfarction

    30 Days

    3 Years

 

5.4%

13.7%

 

3.8%

12.7%

 

.04

.36

 

In a landmark analysis, women had a nearly doubled risk of major bleeding compared with men at both 30 days (HR 1.94; 95% CI 1.51-2.50) and from 30 days to 3 years (HR 1.88; 95% CI 1.13-3.14).

Women had a longer symptom-to-balloon time compared with men (237.5 vs 218 minutes; P = .007) and were more likely to be treated with medical management alone (6.9% vs 4.7%; P = .01).

Also, women on average were older and more likely to have a history of hypertension, hyperlipidemia, and congestive heart failure; had lower body weight; and had a higher prevalence of Killip class > 1 heart failure, anemia, and creatinine clearance < 60 mL/min at presentation. Men were more likely to be smokers and to have a history of MI and prior coronary revascularization.

After adjustment for baseline differences, female sex remained a predictor of major bleeding at 3 years (adjusted HR 1.81; 95% CI 1.41-2.33) but not of MACE or death.

The benefits of randomization to bivalirudin rather than heparin plus GPI and to PES rather than BMS were similar regardless of sex.

Comorbidities Explain Differences

“The consensus, based on our findings as well as the majority of the available literature, would be that women with STEMI are at higher risk of increased mortality and MACE in the short- and long-term due, at least in part, to their more adverse baseline risk profile as compared to their male counterparts,” Dr. Mehran and colleagues write. “Temporal improvements in PCI and STEMI management may also account for some of the discrepant results in the literature.”

Given that symptom-to-balloon time was longer in women, the researchers also note that further reductions in this interval will “[require] community-based strategies… including patient education, public health awareness programs, and efforts to address specific barriers to health care in disenfranchised populations.”

Note: Dr. Mehran and several study co-authors are faculty members of the Cardiovascular Research Foundation, which owns and operates TCTMD.

 


Source:
Yu J, Mehran R, Grinfeld L, et al. Sex-based differences in bleeding and long-term adverse events after percutaneous coronary intervention for acute myocardial infarction: three-year results from the HORIZONS-AMI trial. Catheter Cardiovasc Interv. 2014;Epub ahead of print.

 

Disclosure:
Dr. Mehran reports receiving institutional grant support from Bristol-Myers Squibb/Sanofi, Eli Lilly and Company/Daiichi Sankyo, Regado Biosciences, STENTYS, and The Medicines Company.

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