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Association Between Use of Bleeding Avoidance
Strategies and Risk of Periprocedural Bleeding
Among Patients Undergoing Percutaneous
Coronary Intervention
Marso et al. JAMA 2010;303:2156-2164
Background
• Percutaneous coronary intervention (PCI) is performed
approximately 1 million times annually in the United States.
• The safety of PCI continues to be excellent with very low rates of
death, myocardial infarction (MI), and need for urgent
revascularization.
• PCI-related bleeding occurs in approximately 2-6% of patients in
national PCI databases; marked institutional variability in rates
exists.
• Bleeding complications are associated with increased length of
stay, hospital costs, and important clinical complications such as
death and MI.
Objective
• To describe the use of 2 bleeding avoidance
strategies—1) vascular closure devices and 2)
bivalirudin—and associated post-PCl bleeding
rates in a nationally representative PCI population.
• Examine clinical usage patterns of these
strategies as a function of bleeding risk.
Marso et al. JAMA 2010;303:2156-2164
Study Patients & Exclusions
• NCDR® CathPCI Registry ®
• Patients undergoing PCI via the femoral artery
• Exclusion criteria:
– >1 PCI procedure during same stay
– Incomplete data on bleeding
– PCI via radial, brachial artery
– Cardiogenic shock
– Missing device data
– Death in cath lab
– Unknown bleeding event data
Marso et al. JAMA 2010;303:2156-2164
Candidate Bleeding Avoidance Strategies
• Bivalirudin
• Vascular closure devices
• Both therapies (bivalirudin + vascular closure)
Marso et al. JAMA 2010;303:2156-2164
Bleeding Risk Strata
• Bleeding risk score calculated for each patient using NCDR
bleeding risk model1
• Clinical elements used to calculate bleeding risk score:
– STEMI/non-STEMI
– Female sex
– Previous CHF
– No previous PCI
– NYHA/CCS Class IV CHF
– PVD
– Age
– Estimated glomerular filtration rate
1 Mehta et al. Circ Cardiovasc Intervent 2009;2:222-229 Marso et al. JAMA 2010;303:2156-2164
Study Outcomes
• In-hospital bleeding according to NCDR data
definition:
– Requiring transfusion and/or
– Prolonged hospital stay and/or
– Decrease in hemoglobin >3 g/dL
Marso et al. JAMA 2010;303:2156-2164
Statistical Analysis
• Patients categorized into 3 groups of bleeding risk based
on NCDR bleeding risk score:
– Low (<1%)
– Intermediate (1-3%)
– High (>3%)
• Propensity score matching with site adjustment using 26
clinical variables for each bleeding avoidance strategy
performed to minimize confounding
• Population was well matched (standard difference plot on
next slide)
Marso et al. JAMA 2010;303:2156-2164
Standardized Difference Before and After
Propensity Matching
STEMI
NYHA Class III/IV
Previous PCI
Hyprcholesterolemia
Hypertension
History of Smoking
Age
BMI
PVD
Previous MI
Previous CABG
Diabetes
Renal Failure
CHF
White Race
Family History of CAD
Gender
Previous CHF
Cerebrovascular Disease
Previous Cardiac Transplant Before Match
Previous Valve Surgery After Match
Chronic Lung Disease
0 10 20 30 40 50
Standardized Difference Marso et al. JAMA 2010;303:2156-2164
Study Population
Marso et al. JAMA 2010;303:2156-2164
Patient Characteristics
Manual Vascular
Total Compression Closure Devices Bivalirudin Both
(N=1,522,935) (N = 529,247) (N=363,583) N = 353,769) (N = 276,336)
Age, mean (SD), y 64.3 (12.1) 63.87 (12.33) 63.34 (12.26) 65.43 (11.86) 64.77 (11.80)
Male, N (%) 1,011,992 (66.5) 350,424 (66.21) 250,753 (68.97) 225,235 (63.67) 185,580 (67.16)
White, N (%) 1,289,673 (84.8) 449,617 (85.05) 301,908 (83.18) 303,317 (85.82) 234,831 (85.11)
Height, mean (SD), cm 171.30 (10.84) 171.22 (10.89) 171.73 (10.77) 170.81 (10.90) 171.50 (10.73)
Weight, mean (SD), kg 87.71 (20.45) 87.25 (20.42) 88.22 (20.28) 87.29 (20.71) 88.47 (20.40)
Body mass index, mean 29.8 (6.3) 29.7 (6.3) 29.8 (6.2) 29.8 (6.4) 30.0 (6.3)
(SD), kg/m2
Obesity , N (%) 643,500 (42.25) 219,470 (41.47) 153,233 (42.15) 150,813 (42.63) 119,984 (43.42)
Current CHF, N (%) 136,489 (8.96) 48,658 (9.19) 30,799 (8.47) 33,173 (9.38) 23,859 (8.63)
NYHA class, N (%)
I 480,785 (31.57) 160,016 (30.24) 125,209 (34.44) 107,678 (30.44) 87,882 (31.81)
II 355,937 (23.37) 107,093 (20.24) 79,475 (21.86) 90,682 (25.64) 78,687 (28.48)
III 415,651 (27.30) 146,439 (27.67) 87,352 (24.03) 107,952 (30.52) 73,908 (26.75)
IV 270,376 (17.76) 115,629 (21.85) 71,508 (19.67) 47,412 (13.40) 35,827 (12.97)
All P<0.001 Marso et al. JAMA 2010;303:2156-2164
Patient Characteristics
Manual Vascular Closure
Total Compression Devices Bivalirudin Both
(N=1,522,935) (N = 529,247) (N=363,583) (N = 353,769) (N = 276,336)
Coronary artery disease risk factors, N (%)
Diabetes 509,455 (33.45) 173,024 (32.69) 113,130 (31.12) 129,335 (36.56) 93,966 (34.00)
Hypertension 1,190,098 (78.15) 405,122 (76.55) 272,906 (75.06) 290,085 (82.00) 221,985 (80.33)
Dyslipidemia 1,167,108 (76.64) 392,248 (74.12) 269,478 (74.12) 283,174 (80.05) 222,208 (80.42)
Smoking , N (%)
Never 600,315 (38.87) 196,423 (37.12) 143,554 (39.49) 138,026 (39.02) 114,318 (41.37)
Past 543,091 (35.17) 178,466 (33.72) 121,980 (33.55) 132,027 (37.32) 102,545 (37.11)
Current 400,845 (25.96) 154,297 (29.16) 97,995 (26.96) 83,681 (23.66) 59,439 (21.51)
Estimated glomerular filtration 73.77 (29.62) 73.60 (29.88) 75.02 (30.48) 72.46 (29.06) 74.09 (28.61)
rate, mean (SD)
Family history of coronary artery 392,815 (25.80) 135,320 (25.57) 100,704 (27.70) 86,660 (24.50) 70,131 (25.38)
disease , N (%)
Coronary artery disease history , N (%)
PCI 576,207 (37.84) 182,518 (34.49) 125,649 (34.56) 151,835 (42.92) 116,205 (42.05)
CABG 291,773 (19.16) 98,038 (18.52) 59,980 (16.50) 79,189 (22.39) 54,566 (19.75)
Myocardial infarction 427,655 (28.08) 144,381 (27.28) 96,191 (26.46) 106,403 (30.08) 80,690 (29.20)
Other cardiovascular disease history , N (%)
CHF 136,483 (8.96) 54,661 (10.33) 32,255 (8.87) 43,082 (12.18) 28,751 (10.40)
All P<0.001 Marso et al. JAMA 2010;303:2156-2164
Patient Characteristics
Vascular
Manual Closure
Total Compression Devices Bivalirudin Both
(N=1,522,935) (N = 529,247) (N=363,583) (N = 353,769) (N = 276,336)
Cerebrovascular 174,811 60,260 34,638 48,214 31,699
disease (11.48) (11.39) (9.53) (13.63) (11.47)
Peripheral vascular 181,787 65,568 33,064 50,678 29,477
disease (11.74) (12.39) (9.09) (14.33) (10.67)
Previous valve surgery 17,267 (1.13) 5,929 (1.12) 3,672 (1.01) 4,505 (1.27) 3,161 (1.14)
Previous transplant 3,463 (0.23) 1,257 (0.24) 732 (0.20) 899 (0.25) 575 (0.21)
Chronic lung disease 248,918 86,586 52,995 6,5139 44,198
(16.35) (16.36) (14.58) (18.41) (15.99)
Renal failure 83,029 (5.45) 30,004 (5.67) 18,028 (4.96) 21,369 (6.04) 13,628 (4.93)
All data are N (%)
All P<0.001 Marso et al. JAMA 2010;303:2156-2164
Admission Characteristics
Manual Vascular
Total Compression Closure Devices Bivalirudin Both
(N=1,522,935) (N = 529,247) (N=363,583) (N = 353,769) (N = 276,336)
No symptoms 196,190 (12.88) 55,961 (10.57) 42,224 (11.61) 54,346 (15.36) 43,659 (15.80)
Atypical chest pain 113,339 (7.44) 32,570 (6.15) 27,031 (7.44) 27,758 (7.85) 25,980 (9.40)
Stable angina 260,582 (17.11) 73,109 (13.81) 57,179 (15.73) 69,093 (19.53) 61,201 (22.15)
Unstable angina 527,624 (34.65) 168,813 (31.90) 113,413 (31.19) 142,473 (40.27) 102,925 (37.25)
Non-STEMI 238,305 (15.65) 98,866 (18.68) 64,921 (17.86) 43,239 (12.22) 31,279 (11.32)
STEMI 186,810 (12.27) 99,900 (18.88) 58,796 (16.17) 16,843 (4.76) 11,271 (4.08)
PCI type
Elective 758,110 (49.79) 220,576 (41.68) 157,348 (43.28) 212,562 (60.09) 167,624 (60.67)
Urgent 553,524 (36.35) 196,634 (37.16) 140,023 (38.52) 121,995 (34.49) 94,872 (34.34)
Emergency 209,465 (13.76) 110,990 (20.97) 65,758 (18.09) 19,011 (5.37) 13,706 (4.96)
Salvage 1,662 (0.11) 968 (0.18) 422 (0.12) 172 (0.05) 100 (0.04)
All data are N (%)
All P<0.001 Marso et al. JAMA 2010;303:2156-2164
Hospital Characteristics
Manual Vascular Closure
Total Compression Devices Bivalirudin Both
(N=1,522,935) (N = 529,247) (N=363,583) (N = 353,769) (N = 276,336)
Region, N (%)
West 244,853 (16.11) 71,085 (13.47) 73,065 (20.15) 41,801 (11.83) 58,902 (21.36)
Northeast 177,930 (11.71) 56,353 (10.68) 60,120 (16.58) 28,392 (8.04) 33,065 (11.99)
Midwest 505,125 (33.24) 198,609 (37.63) 119,220 (32.88) 104,043 (29.45) 83,253 (30.19)
South 591,568 (38.93) 201,679 (38.22) 110,237 (30.40) 179,071 (50.68) 100,581 (36.47)
Community type, N (%)
Rural 177,441 (15.92) 59,727 (15.44) 54,008 (21.02) 31,542 (11.48) 32,164 (16.38)
Urban 937,476 (84.08) 327,222 (84.56) 202,931 (78.98) 243,165 (88.52) 164,158 (83.62)
Profit type, N (%)
Government 23,838 (1.57) 7,895 (1.49) 4,948 (1.36) 5,988 (1.69) 5,007 (1.81)
Private/community 1,356,756 (89.09) 465,238 (87.91) 319,915 (87.99) 318,550 (90.04) 253,053 (91.57)
University 142,341 (9.35) 56,114 (10.60) 38,720 (10.65) 29,231 (8.26) 18,276 (6.61)
Annual PCI volume, mean (SD) 1095.81 1058.04 981.16 1303.62 1052.94
(795.18) (704.88) (732.27) (782.65) (678.44)
All P<0.001 Marso et al. JAMA 2010;303:2156-2164
High‡ Low*
Bleeding Rates* N=301,056 N=475,152
*Overall bleeding = 30,429 (2%)
Intermediate†
N=746,727
7
6.1
6
*NCDR bleeding risk <1%
†NCDR bleeding risk 1-3%
‡NCDR bleeding risk >3%
5 4.6
Bleeding (%)
M = Manual comp.
4 3.8
C = Closure only
B = Bival only
2.8 BC = Bival+closure
3
2.3 2.3
2.1
1.9
2 1.6
1.4
0.9 0.9 0.9 0.8
1 0.6
0.4
0
M C B BC M C B BC M C B BC M C B BC P<0.001
all
Overall Low Intermediate High intra-risk group
(<1%) (1-3%) (>3%) comparisons
Estimated Bleeding Reductions—All Patients
(Propensity Adjusted)
Reduction in Bleeding
Events per 1,000 Patients
Treatment Bleeding Odds Ratio NNT Treated
(N) N (%) (95% CI) (95% CI) (95% CI)
Manual compression 508,455 13,597 (2.7) 1 [Reference]
Vascular closure devices 205,606 5,050 (2.5) 0.77 (0.73-0.80) 148 (130-175) 6.7 (5.7-7.7)
Bivalirudin 172,471 3,224 (1.9) 0.67 (0.63-0.70) 118 (107-132) 8.5 (7.6-9.3)
Both 130,378 1,361 (1.0) 0.38 (0.35-0.42) 70 (68-74) 14.2 (13.5-14.8)
Total 1,016,910 23,232 (2.3)
Marso et al. JAMA 2010;303:2156-2164
Estimated Bleeding Reductions (Propensity Adjusted)
Treatment Bleeding Odds Ratio NNT Reduction in Bleeding Events per 1,000
(N) N (%) (95% CI) (95% CI) Patients Treated (95% CI)
Low Risk, <1%
Manual compression 144,594 1,320 (0.9) 1 [Reference]
Vascular closure devices 54,217 532 (1.0) 1.07 (0.93-1.22) NS NS
Bivalirudin 48,378 296 (0.6) 0.65 (0.56-0.77) 315 (247-470) 3.2 (2.1-4.0)
Both 41,999 166 (0.4) 0.42 (0.34-0.51) 188( 167-222) 5.3 (4.5-6.0)
Total 289,188 2,314 (0.8)
Intermediate Risk, 1-3%
Manual compression 252,898 5,722 (2.3) 1 [Reference]
Vascular closure devices 103,095 2,077 (2.0) 0.76 (0.71-0.81) 169 (141-217) 5.9 (4.6-7.1)
Bivalirudin 85,800 1,311 (1.5) 0.69 (0.63-0.74) 153 (131-187) 6.5 (5.3-7.6)
Both 64,003 573 (0.9) 0.39 (0.35-0.44) 80 (75-86) 12.5 (11.6-13.3)
Total 505,796 9,683 (1.9)
High Risk, >3%
Manual compression 110,963 6,555 (5.9) 1 [Reference]
Vascular closure devices 48,294 2,441 (5.1) 0.79 (0.75-0.82) 81 (66-109) 12.3 (9.2-15.3)
Bivalirudin 38,293 1,617 (4.2) 0.67 (0.62-0.73) 56 (49-66) 17.9 (15.1-20.6)
Both 24,376 622 (2.6) 0.42 (0.38-0.47) 33 (31-36) 30.5 (27.9-32.8)
Total 221,926 11,235 (5.1)
Marso et al. JAMA 2010;303:2156-2164
High‡
Bleeding Avoidance Strategy Use by N=301,056
Low*
N=475,152
Pre-PCI Bleeding Risk
Risk-Treatment Paradox Intermediate†
45 N=746,727
40.3
40
35 *NCDR bleeding risk <1%
35 †NCDR bleeding risk 1-3%
30.8 ‡NCDR bleeding risk >3%
30
Bleeding (%)
24.3 23.8 M = Manual comp.
25 23.9 23.3 23.2 22.1 C = Closure only
21 B = Bival only
20 17.8 BC = Bival+closure
14.4
15
10
5
0
M C B BC M C B BC M C B BC P<0.001
for all
Low Intermediate High intra-risk group
(<1%) (1-3%) (>3%) comparisons
Limitations
• Observational, non-randomized study
• Potential unmeasured confounding
• No data on activated clotting time
• Contraindications to use of bleeding avoidance therapies:
– Bivalirudin: in the setting of other anticoagulants, PCI of chronic
total occlusion
– Vascular closure devices: high risk anatomy
• Data insufficient to warrant abandoning use of manual
compression in favor of vascular closure devices:
– Adequately powered randomized trial assessing bleeding
endpoints is needed
Conclusions
• In 1.5 million PCI patients in the NCDR:
– Post-PCI bleeding occurred in 2%
– Use of bivalirudin plus vascular closure devices was
associated with an absolute 3.8% lower rate in PCI
related bleeding in high risk patients
– To prevent 1 bleeding event in high risk patients would
require treating 33 patients with both therapies
– High risk patients were least likely to receive both
strategies (risk-treatment paradox)
Marso et al. JAMA 2010;303:2156-2164
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