Predictors of Major Vascular Access Site Complications in Patients with Acute

Coronary Syndromes Undergoing Percutaneous Coronary Intervention:

Insights from the ACUITY Trial

Steven V Manoukian, Reza Fazel, Timothy A. Sanborn, Ramin Ebrahimi, Frederick Feit, Martial Hamon,

Michele D. Voeltz, George D. Dangas, Jeffrey W. Moses, Spencer B. King III, Harvey 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 vascular access site complications were defined as:– access site bleeding requiring invasive intervention, or

– hematoma >5cm. • 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)

Stone GW et al. Am Heart J 2004;148:764–75.

Medicalmanagement

PCIN=7,78956.4%

CABG

Background:

ACUITY PCI:Major Bleeding by Treatment Strategy

6.8%7.5%

3.5%

Non-CABG Major Bleeding (primary endpoint)

30

da

y e

ve

nts

(%

)

Heparin+GPI Bivalirudin+GPI Bivalirudin alone

P<0.0001

Stone GW et al. Lancet 2007;369:907-19.

P<0.0001

Background:

REPLACE-2: Predictors of Major Vascular Complications in PCI

Background: Major vascular complications (MVC) associated with significant morbidity in PCI.

Methods: MVC defined as vascular access site major bleeding or surgical repair.

Results: MVC rate 1.9%, less for BIV vs. H+GPI (1.17% vs. 2.61%, unadjusted OR 0.44, p<0.0001).

Conclusions: Altering treatment strategy with regard to the 3 modifiable factors may reduce MVC in PCI.

Predictors of Major Vascular Complications in PCI (n=5667, 94% of R2)

Variable Odds Ratio 95% CI P-value

Treatment group (H + GPI vs. BIV) 2.38 1.61 - 3.82 <0.0001

Vascular closure device (n= 1400) 1.85 1.18 - 2.90 0.007

Sheath dwell time (in hours) 1.06 1.03 - 1.09 <0.0001

GFR <60 ml/min/1.73 m2 1.70 1.08 - 2.68 0.02

Female gender 2.30 1.53 - 3.46 <0.0001

Fazel R, Voeltz MD, Feit F, Attubato MJ, Rab ST, Samady H, Rao SV, Manoukian SV. ACC 2007.

Stepwise logistic regression. c-statistic 0.71. Test for goodness-of-fit indicated satisfactory fit.

Background and Methods:

Vascular Complications in PCI

• Major vascular assess site complications are associated with significant morbidity in ACS and PCI.

• We determined the baseline and procedural predictors of major vascular complications in patients with ACS undergoing PCI via the femoral approach.

Manoukian SV et al. TCT 2007.

Results:

ACUITY PCI:Management Strategy

Results:

ACUITY PCI:Management Strategy

56.4%

11.1%32.5%CABG (n=1,539)CABG (n=1,539) Medical Rx (n=4,491)Medical Rx (n=4,491)

PCI (n=7,789)PCI (n=7,789)

Femoral access PCIn = 6879

Major vascular complicationn = 179

Manoukian SV et al. TCT 2007.

Results:

ACUITY PCI:Major Vascular Complications by Treatment Strategy

3.3%3.6%

0.9%

Major Vascular Complications

30

da

y e

ve

nts

(%

)

Heparin+GPI Bivalirudin+GPI Bivalirudin alone

P<0.0001

P<0.0001P=ns

Manoukian SV et al. TCT 2007.

Age ≥75 years 1.97 (1.34-2.88) 0.0005

Baseline CrCl <60 mL/min 1.65 (1.13-2.43) 0.01

Female (vs male) 2.20 (1.59-3.03) <0.0001

No Prior PCI 1.75 (1.23-2.48) 0.002

Prior CABG 1.48 (1.00-2.20) 0.05

Randomization to UFH/Enox + GPI (vs. bivalirudin) 4.05 (2.40-6.85) <0.0001

Odds ratio ±95% CI P-valueOR (95% CI)

0 2 4

Results:

ACUITY PCI:Predictors of Major Vascular Complications

Manoukian SV et al. TCT 2007.

Results: The ACUITY Trial PCI Population (n=7789)

Vascular Complications in PCI

• In patients with ACS undergoing PCI via the femoral approach, independent predictors of MVC include: age ≥75 years, creatinine clearance <60 mL/min, female sex, prior PCI, prior CABG, and use of H+GPI (vs. BIV).

• Altering treatment strategy with regard to the modifiable factor (use of H+GPI) may reduce the risk of MVC.

Manoukian SV et al. TCT 2007.