Impact of Anemia on One-Year Ischemic Events and Mortality Among Patients with Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention Steven

Impact of Anemiaon One-Year Ischemic Events

and Mortality Among Patients with Acute Coronary Syndromes Undergoing

Percutaneous Coronary Intervention

Steven V. Manoukian, Michele D. Voeltz, George D. Dangas, Frederick Feit, Reza Fazel, Ramin Ebrahimi, Martial Hamon,

A. Michael Lincoff, Jeffrey W. Moses, Spencer B. King III, Harvery D. White, E. Magnus Ohman, Roxana Mehran,

Gregg W. Stone, on behalf of the ACUITY Investigators

Disclosures

• Consultant: BMS, Guerbet, Sanofi-Aventis, Schering-Plough, The Medicines Co.

• Grant Support: Guerbet, The Medicines Co.• Lecture honoraria: Guerbet, The Medicines Co.

Manoukian SV et al. TCT 2007.

Background and Methods:

Study Design and Definitions

• The ACUITY Trial randomized 13,819 patients with moderate and high-risk NSTE-ACS to:– heparin/enoxaparin + GPIIb/IIIa inhibitor,– bivalirudin + GPIIb/IIIa inhibitor, or– bivalirudin alone.

• Major bleeding (non-CABG-related) was defined as:– intracranial, intraocular, or retroperitoneal,– access site with intervention, hematoma >5cm,– hgb drop >3g/dL with source or >4g/dL without source,– reoperation,– transfusion.

Stone GW et al. NEJM 2006;355:2203-16.

Moderate-high risk

ACS

Background and Methods: ACUITY: Study Design

An

gio

gra

ph

y w

ith

in 7

2h

Aspirin in allClopidogrel

dosing and timingper local practice

UFH orEnoxaparin+ GP IIb/IIIa

Bivalirudin+ GP IIb/IIIa

BivalirudinAlone

R*

*Stratified by pre-angiography thienopyridine use or administration

Moderate and high-risk NSTE-ACS

undergoing an invasive strategy (N = 13,819)

Medicalmanagement

PCIN=7,78956.4%

CABG

Stone GW et al. NEJM 2006;355:2203-16.

Background:

ACUITY Overall:Anemic vs. Non-Anemic Population

Short-Term (30-Day) Event Rates

7.2%

3.9%

10.3%8.8%

16.4%

9.9%

Net clinical outcome Composite ischemia Major bleeding (non-CABG)

30 d

ay e

ven

ts (

%)

Non-anemic patients (N=10,839) Anemic patients (N=2200)

P=<0.0001

P=<0.0001P=<0.0001

Dangas GD, Manoukian SV, Nikolsky E et al. ESC 2007.

Background:

ACUITY Overall:Anemic Population by Treatment

9.6% 9.8%

16.5%

9.5%

17.2%

10.1% 10.0%

15.5%

7.0%


30 d

ay e

ven

ts (

%)

UFH/Enox +GPI (n=732) Bivalirudin + GPI (n=739) Bivalirudin alone (n=729)

P=0.74 P=0.59

P=0.71 P=0.77

P=0.81 P=0.052



Background: ACUITY PCI:

Anemic vs. Non-Anemic PopulationShort-Term (30-Day) Event Rates

8.3%

4.9%

12.1% 11.8%

20.0%

11.3%


30 d

ay e

ven

ts (

%)

Non-anemic patients (N=6,238) Anemic patients (N=1,164)

P=<0.0001

P=<0.0001P=0.0007


Background:

ACUITY PCI:Anemic Population by Treatment

11.5% 11.5%

19.2%

14.6%

22.0%

11.4% 11.1%

18.8%

9.0%


30 d

ay e

ven

ts (

%)

UFH/Enox + GPI (n=391) Bivalirudin + GPI (n=396) Bivalirudin alone (n=377)

P=0.33 P=0.90

P=0.95 P=0.87

P=0.19 P=0.26



Background:

REPLACE-2: AnemiaLong-Term (1-Year) Mortality in PCI

Voeltz MD, Patel AD, Feit F, Fazel R, Lincoff AM, Manoukian SV . Am J Cardiol 2007;99:1513-17.

4.3%

1.5%

Background:

REPLACE-2: AnemiaIndependent Predictor of 1-Year Mortality in PCI

Voeltz MD, Patel AD, Feit F, Fazel R, Lincoff AM, Manoukian SV . Am J Cardiol 2007;99:1513-17.

Background and Methods:

Anemia in ACS Patients Undergoing PCI

• Baseline anemia is associated with an increased risk of short-term (30-day) ischemic complications and mortality in ACS and PCI.

• Anemia was defined using WHO criteria:– hgb <13 g/dL men,– hgb <12 g/dL women.

• We assessed the impact of anemia on rates of long-term (1-year) ischemic events and mortality in patients with ACS undergoing PCI in the ACUITY trial.


Results:

ACUITY PCI: AnemiaPopulation Characteristics

Non-Anemic (N=6238, 84.3%)

Anemic(N=1164, 15.7%)

P value

Age (median [range], yrs) 62 (21, 92) 69 (34, 95) <0.0001

Male 74.6 67.1 <0.0001

Weight (median [IQR], kg) 84 (74.9, 96.0) 82 (71, 95) <0.001

Diabetes 24.3 43.3 <0.0001

Hypertension 62.8 79.4 <0.0001

Hyperlipidemia 53.9 66.3 <0.0001

Current smoker 33.6 16.8 <0.0001

Prior MI 29.4 35.0 0.0001

Prior PCI 36.2 51.7 <0.0001

Prior CABG 16.2 25.0 <0.0001

Hemoglobin (mean) 14.5 11.7 <0.0001

Renal insufficiency* 15.4 34.7 <0.0001

CKMB/Troponin 66.0 59.4 <0.0001

* creatinine clearance <60 mL/minManoukian SV et al. TCT 2007.

Results:

ACUITY PCI:Anemic vs. Non-Anemic Population

Long-Term (1-Year) Ischemic Event Rates

17.5%

24.4%

Composite ischemia

1 Y

ear

even

ts (

%)


P=<0.0001


Results:

ACUITY PCI:Anemic vs. Non-Anemic Population

Long-Term (1-Year) Mortality

2.5%

6.4%

Mortality

1-ye

ar m

ort

alit

y (%

)


P=<0.0001


Results:

ACUITY PCI:Anemic Population by Treatment

Long-Term (1-Year) Event Rates

0.1 1 10

HR ±95% CI

Composite Ischemia 1.04 (0.77-1.39)

HR (95% CI)

Bivalirudin Better UFH/Enox+ IIb/IIIa Better

Mortality 0.99 (0.56-1.76)


Results:

ACUITY PCI:Independent Predictors of 1-Year Mortality

HR ±95% CI HR (95% CI)

0.1 1 10

Age (≥75 years) 2.67 (1.95-3.66)

Anemia 1.58 (1.18-2.13)

Baseline CrCl <60 mL/min 1.62 (1.17-2.24)

Prior CVA 1.43 (1.07-1.90)

CKMB/Troponin+ 2.14 (1.56-2.93)

ECG changes 1.54 (1.18-2.01)

History of CAD 1.95 (1.45-2.62)

Diabetes 1.79 (1.39-2.31)


Conclusions:

Anemia and Long-term (1-Year) Outcomes in Patients with ACS Undergoing PCI

• Anemia is not uncommon in patients with:– ACS (16.9%), and in patients with– ACS undergoing PCI (15.7%).

• Anemia is associated with a significant increase in rates of long-term (1-year) ischemic events.

• Anemia is associated with an over 2-fold increase in rates of long-term (1-year) mortality and is an independent predictor of long-term (1-year) mortality in patients with ACS undergoing PCI.


Documents

Impact of Anemia on One-Year Ischemic Events and Mortality Among Patients with Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention Steven