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Dolor RJ, Melloni C, Chatterjee R, et al. Treatment Strategies for Women With Coronary Artery Disease [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Aug. (Comparative Effectiveness Reviews, No. 66.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

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Treatment Strategies for Women With Coronary Artery Disease [Internet].

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Appendix HSummary Table for Safety Concerns

Table H-1Summary of RCTs reporting safety concerns (harms)

Study
Author/Year
Related Articles
PopulationComparison# SubjectsHarmsQuality
ARTS I
Vaina et al., 20091

and

van den Brand, et al., 20022
Serruys et al., 19993
Voudris et al., 20064
Anonymous, 19995
UA/NSTEMIPCI vs. CABGTotal: 1,205
Women: 283 (23%)
Major bleeding
PCI (men vs. women):
OR (95% CI) 29.4 (5.3 to 500); p = 0.001

CABG (men vs. women):
OR (95%CI) 1.5 (0.4 to 10.1); p = 0.58
Good
GUSTO II-B
Tamis-Holland et al., 20046
STEMIPCI vs. fibrinolysis (accelerated t-PA)Total: 1,137
Women: 260 (23%)
Intracranial hemorrhage
Women
 PCI: 0
 Optimal medical therapy: 4.1%
Men
 PCI: 0
 Optimal medical therapy: 0.7%
Good
PAMI
Stone et al., 19957
STEMIPCI vs. fibrinolysis (t-PA)Total: 395
Women: 107 (27%)
Nadir HCT (PCI vs. fibrinolysis)
Women: 30 ± 5% vs. 33 ± 5%; p = 0.002
Men: 35 ± 6% vs. 35 ± 6%; p = 0.17

Requirement for blood transfusion (PCI vs. fibrinolysis)
Women: 18% vs. 8.8%; p = 0.16
Men: 9.7% vs. 8.4%; p = 0.71
Good
TACTICS TIMI-18
Cannon et al., 20018

and

Glaser et al., 20029
Cannon et al., 199810
UA/NSTEMIEarly invasive vs. initial conservativeTotal: 2,220
Women: 757 (34%)
Bleeding in women undergoing PTCA was higher compared to men; adjusted OR (95% CI) 3.6 (1.6 to 8.3).

Bleeding related to CABG was similar in women and men (12.6% vs. 15%). Occurrence of stroke at 30 days related to CABG also was similar in women and men (2.1% vs. 1.5%).
Good

Abbreviations: BMS = bare metal stent; CABG = coronary artery bypass graft; CAD = coronary artery disease; CI = confidence interval; DES = drug-eluting stent; HCT = hematocrit; NSTEMI = non-ST elevation myocardial infarction; OR = odds ratio; PCI = percutaneous coronary intervention; PTCA = percutaneous transluminal coronary angioplasty; RCT = randomized controlled trial; t-PA = tissue plasminogen activator; UA = unstable angina

References Cited in Appendix H

1.
Vaina S, Voudris V, Morice MC, et al. Effect of gender differences on early and mid-term clinical outcome after percutaneous or surgical coronary revascularisation in patients with multivessel coronary artery disease: insights from ARTS I and ARTS II. EuroIntervention. 2009;4(4):492–501. [PubMed: 19284072]
2.
van den Brand MJ, Rensing BJ, Morel MA, et al. The effect of completeness of revascularization on event-free survival at one year in the ARTS trial. J Am Coll Cardiol. 2002;39(4):559–64. [PubMed: 11849851]
3.
Serruys PW, Unger F, van Hout BA, et al. The ARTS study (Arterial Revascularization Therapies Study) Semin Interv Cardiol. 1999;4(4):209–19. [PubMed: 10738354]
4.
Voudris V, Ong AT, Serruys PW, et al. Sex differences and their impact on clinical outcome after percutaneous or surgical revascularisation: a report from the Arterial Revascularisation Therapies Study (ARTS) EuroIntervention. 2006;2(2):175–80. [PubMed: 19755257]
5.
The ARTS (Arterial Revascularization Therapies Study): Background, goals and methods. Int J Cardiovasc Intervent. 1999;2(1):41–50. [PubMed: 12623386]
6.
Tamis-Holland JE, Palazzo A, Stebbins AL, et al. Benefits of direct angioplasty for women and men with acute myocardial infarction: results of the Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes Angioplasty (GUSTO II-B) Angioplasty Substudy. Am Heart J. 2004;147(1):133–9. [PubMed: 14691431]
7.
Stone GW, Grines CL, Browne KF, et al. Comparison of in-hospital outcome in men versus women treated by either thrombolytic therapy or primary coronary angioplasty for acute myocardial infarction. Am J Cardiol. 1995;75(15):987–92. [PubMed: 7747700]
8.
Cannon CP, Weintraub WS, Demopoulos LA, et al. Comparison of early invasive and conservative strategies in patients with unstable coronary syndromes treated with the glycoprotein IIb/IIIa inhibitor tirofiban. N Engl J Med. 2001;344(25):1879–87. [PubMed: 11419424]
9.
Glaser R, Herrmann HC, Murphy SA, et al. Benefit of an early invasive management strategy in women with acute coronary syndromes. JAMA. 2002;288(24):3124–9. [PubMed: 12495392]
10.
Cannon CP, Weintraub WS, Demopoulos LA, et al. Invasive versus conservative strategies in unstable angina and non-Q-wave myocardial infarction following treatment with tirofiban: rationale and study design of the international TACTICS-TIMI 18 Trial. Treat Angina with Aggrastat and determine Cost of Therapy with an Invasive or Conservative Strategy. Thrombolysis In Myocardial Infarction. Am J Cardiol. 1998;82(6):731–6. [PubMed: 9761082]
Bookshelf ID: NBK100771

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