Gender Differences in Outcomes Following Percutaneous Coronary Intervention of Patients with Non-ST elevation Acute Coronary Syndrome A Substudy of the Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) trial - PowerPoint PPT Presentation

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Gender Differences in Outcomes Following Percutaneous Coronary Intervention of Patients with Non-ST elevation Acute Coronary Syndrome A Substudy of the Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) trial

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Title: Gender Differences in Outcomes Following Percutaneous Coronary Intervention of Patients with Non-ST elevation Acute Coronary Syndrome A Substudy of the Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) trial


1
Gender Differences in Outcomes Following
Percutaneous Coronary Intervention of Patients
with Non-ST elevation Acute Coronary Syndrome A
Substudy of the Acute Catheterization and Urgent
Intervention Triage strategY (ACUITY) trial
  • Ken Mori1, Alexandra J. Lansky1, Ricardo A.
    Costa1, Angel Cequier2, Charles V. Pollack, Jr.3,
    James Hoekstra4, Michel Bertrand5, Bernard
    Gersh6, Gregg W. Stone1

1Cardiovascular Research Foundation, New York,
NY 2Bellvitge University Hospital, Barcelona,
Spain 3Duke University Medical Center, Durham,
NC 4Wake Forest University School of Medicine,
Winston-Salem, NC 5Hospital Cardiologique,
Lambersart, France 6Mayo Clinic College of
Medicine, Rochester, MN
2
Background
Women are at increased risk for vascular
complications compared to men.
(Leslie Cho, et al,
JACC 200036 381-6) Bivalirudin with
provisional GPIIb/IIIa inhibitor is not inferior
to heparin with planned GPIIb/IIIa inhibitor
during contemporary PCI with regard to
suppression of acute ischemic complications, and
is associated with less bleeding.
(A.Michael Lincoff, et al,
JAMA 2003289 853-863)
3
ACUITY Trial Design
  • Moderate-high risk unstable angina or NSTEMI
    undergoing an invasive strategy (N 13,800)

Moderate- high risk ACS
Aspirin in all Clopidogrel dosing and timing per
local practice
Stratified by pre-angiography thienopyridine use
or administration
ACUITY Design. Stone GW et al. AHJ 200414876475
4
Major entry criteria
  • Moderate-high risk unstable angina or NSTEMI

Inclusion Criteria
Age 18 years Chest pain 10 within 24h At least one of New ST depression or transient ST elevation 1 mm Troponin I, T, or CKMB? Documented CAD All other 4 TIMI risk criteria Age 65 years Aspirin within 7 days 2 angina episodes w/i 24h 3 cardiac risk factors Written informed consent
Exclusion Criteria
No angiography within 72h Acute STEMI or shock Bleeding diathesis or major bleed within 2 weeks Platelet count 100,000/mm3 INR gt1.5 control CrCl 30 ml/min Abcx or 2 prior LMWH doses Prior UFH, LMWH (1 dose), eptifibatide and tirofiban were allowed Allergy to drugs, contrast
ACUITY Design. Stone GW et al. AHJ 200414876475
5
ACUITY Primary Results (ITT)
  • Heparin IIb/IIIa vs. Bivalirudin IIb/IIIa
    vs. Bivalirudin Alone

Heparinunfractionated or enoxaparin
6
Non CABG Major bleeding definitions for ACUITY
  • Intracranial bleeding
  • Intraocular bleeding
  • Access site hemorrhage requiring intervention
  • 5 cm diameter hematoma
  • Reduction in hemoglobin concentration of 4g/dL
    without an overt source of bleeding
  • Reduction in hemoglobin concentration of 3 g/dL
    with an overt source of bleeding
  • Re-operation for bleeding
  • Use of any blood product transfusion

7
ACUITY Major Bleeding Endpoints
  • Heparin IIb/IIIa vs. Bivalirudin IIb/IIIa
    vs. Bivalirudin Alone

PSup0.38
PSuplt0.001
PSup0.31
PSup0.001
All Major Bleeding (All, including CABG)
Major Bleeding (Non-CABG related)
Heparinunfractionated or enoxaparin
8
Current Analysis
Objective The purpose of this analysis is to
evaluate the outcome of women compared to men
with acute coronary syndrome undergoing PCI in
the ACUITY trial. Methods Comparison of clinical
presentation at baseline, angiographic
characteristics and outcomes at 30 days in men
vs. women with ACS who underwent PCI 13819 ACS
patients (4157 female/ 9662 male) 7789 underwent
PCI (2091 female/5698 male)
9
All patients (including PCI, CABG and medication
patients)
10
Baseline Clinical Characteristics
All patients N13819 FEMALE N4157 MALE N9662 P value
Age, years 65.1 11.8 61.5 11.4 lt0.0001
Diabetes, 32.6 26.2 lt0.0001
Hypertension, 73.8 64.1 lt0.0001
Current Smoker, 24.5 31.1 lt0.0001
Previous MI, 26.2 33.5 lt0.0001
Previous PCI, 36.4 39.9 0.0001
Previous CABG, 13.2 19.9 lt0.0001
Renal insufficiency, 30.0 14.4 lt0.0001
Previous use of Thienopyridine, 62.3 64.6 0.009
CKMB/Troponin elevation, 56.1 60.8 lt0.0001
Defined as creatinine clearance lt 60 mL/min.
11
Angiographic Characteristics
All QCA Patients N6921 FEMALE N2274 MALE N4647 P value
Jeopardy Score 1.92.6 2.62.8 lt0.0001
Ejection Fraction, 66.111.7 63.212.3 lt0.0001
TIMI Flow Grade, lt0.0001
- 0/1 6.2 9.7
- 2 2.8 5.9
- 3 90.9 84.3
Myocardial Blush Grade, lt0.0001
- 0/1 6.2 9.8
- 2 10.2 13.9
- 3 83.6 76.2
12
Angiographic Characteristics
All QCA Patients N6921 FEMALE N2274 MALE N4647 P value
Lesions / pts 3.42.7 4.43.0 lt0.0001
of diseased vessel,
- 0VD 14.7 6.6 lt0.0001
- 1VD 23.4 16.0 lt0.0001
- 2VD 27.7 28.2 0.67
- 3VD 34.1 49.1 lt0.0001
Extent of disease, mm 36.028.2 41.830.8 lt0.0001
Lesion Location,
- LAD 67.6 78.1 lt0.0001
- RCA 59.5 72.7 lt0.0001
- LCX 54.0 69.0 lt0.0001
13
30-day Clinical events in all Patients
()
plt0.0001
15
Female
13.1
Male
10.4
P0.06
plt0.0001
10
7.9
7.6
P0.28
7.0
5.2
4.8
P0.10
5
P0.29
3.4
2.6
2.1
1.6
1.3
0
Ischemic revascularization
Major bleeding
Composite Ischemia
Net Clinical Events
Death
MI
14
PCI patients
15
ACUITY Trial in PCI patients
Unstable angina or non ST-segment elevation MI
(n7789) Prospect, randomized, multi-center trial
ASA clopidogrel (theinopyridine dosing and
timing pre local practice) Angioplasty within 72
hours
Bivalirudin
UFH or Enoxaparin GPI
Bivalirudin GPI
Women N1110, Lesion1447
Men N2554, Lesion3466
30-day endpoints Composite ischemia (Death, MI
and ischemic revascularization) Net clinical
outcomes (Composite ischemia and Major bleeding)
16
PCI Patients Characteristics
FEMALE MALE P value
Age, years 65.9 11.6 61.5 11.3 lt0.0001
Diabetes, 34.5 25.1 lt0.0001
Hypertension, 74.8 62.1 lt0.0001
Current Smoker, 26.9 32.4 lt0.0001
Previous MI, 26.2 32.0 lt0.0001
Previous PCI, 37.7 39.0 0.26
Previous CABG, 13.1 19.1 lt0.0001
Renal insufficiency, 30.9 13.9 lt0.0001
Defined as creatinine clearance lt 60 mL/min.
17
Angiographic Characteristics
PCI QCA Patients N3664 FEMALE N1110 MALE N2554 P value
Lesions / pts 3.92.4 4.52.7 lt0.0001
of diseased vessel,
- 1VD 24.0 16.8 lt0.0001
- 2VD 35.4 33.1 0.17
- 3VD 39.6 49.8 lt0.0001
Extent of disease, mm 36.425.2 40.627.1 lt0.0001
Lesion Location,
- LAD 78.2 81.5 0.0197
- RCA 72.4 77.1 0.0027
- LCX 63.1 73.7 lt0.0001
Jeopardy Score 2.42.3 2.72.3 0.0001
Ejection fraction, 65.212.1 63.212.2 0.0002
18
Target vessel
FEMALE MALE P value
Target Vessel,
- LAD 36.5 33.9 0.08
- RCA 35.9 33.5 0.11
- LCX 27.6 32.6 0.0006
- SVG 5.2 9.0 lt0.0001
- IMA 0.3 0.3 0.92
19
PCI lesion Characteristics
FEMALE MALE P value
TIMI flow,
- 0/1 10.7 13.1 0.0188
- 2 7.7 10.3 0.0051
- 3 81.6 76.6 0.0001
Myocardial blush grade,
- 0/1 13.0 16.6 0.0026
- 2 15.3 15.8 0.68
- 3 71.8 67.6 0.0074
20
PCI lesion Characteristics
FEMALE MALE P value
Lesion Morphology,
Thrombus 13.2 15.6 0.0349
Eccentric 21.8 20.6 0.33
Ulcerated 3.9 5.0 0.09
Aneurysm 0.9 1.5 0.09
Ectasia 4.9 6.2 0.09
Calcium
- Moderate 19.9 21.9 0.13
- Severe 3.5 3.5 0.99
ACC/AHA B2/C, 55.2 60.7 0.0003
21
QCA method
5 mm
5 mm
In-Stent
Proximal Edge
Distal Edge
22
QCA results
FEMALE MALE P value
Pre Procedure
RVD, mm 2.7 0.5 2.8 0.6 lt0.0001
MLD , mm 0.7 0.5 0.7 0.5 0.57
DS 72.9 15.8 73.9 15.8 0.06
Lesion length, mm 14.8 9.4 16.0 10.3 lt0.0001
Post procedure
In-segment
MLD, mm 2.3 0.5 2.3 0.6 lt0.0001
DS 15.1 10.2 15.2 10.7 0.84
Acute gain, mm 1.5 0.6 1.6 0.6 lt0.0001
In-stent
MLD, mm 2.6 0.5 2.7 0.5 lt0.0001
DS 16.6 11.1 17.4 11.8 0.08
Acute gain, mm 1.9 0.5 2.0 0.6 0.0001
23
Post procedural morphology
FEMALE MALE P value
TIMI flow,
- 0/1 1.3 1.4 0.65
- 2 1.0 2.3 0.002
- 3 97.8 96.3 0.008
Myocardial blush grade,
- 0/1 1.8 2.5 0.17
- 2 9.1 11.4 0.028
- 3 89.1 86.1 0.009
Morphology
Thrombus, 0.4 1.0 0.044
No reflow, 0.2 0.1 0.27
Dissection, 0.6 0.6 0.83
Distal embolization, 0.7 0.5 0.47
24
30-day clinical outcomes in PCI patients
plt0.0001
()
Female N2091
17.3
Male N5698
15
plt0.0001
p0.55
11.7
10.5
9.1
10
P0.25
8.7
6.7
6.0
p0.54
4.2
p0.71
5
3.5
3.2
1.0
1.1
0
MI
Net Clinical Outcomes
Death
Ischemic revascularization
Major bleeding
Composite Ischemia
Composite ischemia is defined as death, MI and
ischemic revascularization. Net clinical outcome
is defined as composite ischemia and major
bleeding.
25
Bleeding complications
FEMALE MALE P value
Major bleeding, 10.7 4.2 lt0.0001

Intracranial bleeding, 0.0 0.0 0.80
Access site bleeding, 1.3 0.3 lt0.0001
Hematoma 5cm diameter, 3.8 1.7 lt0.0001
Hb4g/dL fall without overt source , 1.9 0.7 lt0.0001
Hb3g/dL fall with overt source , 4.2 1.6 lt0.0001
Re-operation for bleeding , 0.1 0.1 0.75
Blood product transfusion , 6.0 1.7 lt0.0001

26
Non-CABG Bleeding in Women undergoing PCI
  • Heparin IIb/IIIa vs. Bivalirudin Alone

Plt 0.001
P0.002
Plt0.001
P0.07
27
Conclusions
  • Women with ACS undergoing primary PCI showed
    similar 30-day composite ischemic complications
    compared to men, despite being older, and having
    more co-morbidites.
  • Women had statistically significant increase in
    major bleeding complications compared to men.
  • Bivalirudin alone as compared to Heparin
    IIb/IIIa provided significant bleeding advantage
    in women undergoing PCI.
  • Women with ACS were older, with more diabetes,
    hypertension, chronic renal insufficiency and low
    ejection fraction, but more normal epicardial
    flow (TIMI 3) and fewer lesions per patient
    compared to men.
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