Table 7KQ 2: Study characteristics of RCTs evaluating women with UA/NSTEMI

Study
Author/Year
Related Articles
Description of Study# of SubjectsQuality
FRISC II
Lagerqvist et al., 200152

and

Lagerqvist et al., 200658
Wallentin et al., 200059
Anonymous, 199960
Title: Is early invasive treatment of unstable coronary artery disease equally effective for both women and men? FRISC II Study Group Investigators

Comparator: Early invasive treatment with revascularization (PCI, type not specified, for 1- or 2-vessel CAD; CABG for 3-vessel CAD or left main disease) vs. initial conservative strategy

Components of optimal medical therapy: Aspirin 300 to 600 mg (initial), then 75 to 320 mg daily. Beta blockade (unless contraindicated). Organic nitrates and calcium antagonists as needed. Lowering of cholesterol with statins, angiotensin converting-enzyme inhibitors for left-ventricular dysfunction, and aggressive antidiabetic treatment were recommended according to modern treatment guidelines.
Total: 2,457
Women: 749 (30%)
Good
GUSTO IV-ACS
Ottervanger et al., 200453
Title: Association of revascularisation with low mortality in non-ST elevation acute coronary syndrome, a report from GUSTO IV-ACS

Comparator: Early invasive management vs. initial conservative treatment within 30 days. A total of 2265 (30%) patients underwent revascularization: 789 patients CABG, 1450 patients PCI, and 26 both CABG and PCI. Type of PCI was not specified.

Components of optimal medical therapy: Aspirin for 30 days if not contraindicated. IV unfractionated heparin as bolus and infusion for 48 hours or low molecular weight heparin (dalteparin) subcutaneously every 12 hours for 5 to 7 days or until a revascularisation procedure or discharge. Continuation of antithrombin therapy with unfractionated or low molecular weight heparin was left at the discretion of the investigator.
Total: 7,800
Women: 2,896 (37%)
Good
ICTUS
de Winter et al., 200556

and

Damman et al., 201061
Title: Early invasive vs. selectively invasive management for acute coronary syndromes

Comparator: Early invasive therapy with revascularization vs. selective invasive strategy (initial conservative)

Components of optimal medical therapy: Aspirin (300 mg at randomization then 75 mg daily); enoxaparin (1 mg/kg twice daily subcutaneously for 48 hours), Clopidogrel (300 mg immediately, followed by 75 mg daily) in combination with aspirin was recommended after the drug was approved in 2002 for the indication of acute coronary syndromes; intensive lipid-lowering therapy, preferably 80 mg of atorvastatin daily or the equivalent.
Total: 1,200
Women: 320 (27%)
Good
RITA-2
Anonymous, 199754
Title: Coronary angioplasty vs. medical therapy for angina: the second Randomised Intervention Treatment of Angina (RITA-2) trial. RITA-2 trial participants

Comparator: Early invasive therapy with PCI (primarily PTCA, but stent could be used if PTCA failed) vs. initial conservative

Components of optimal medical therapy: Aspirin, unless contraindicated. Antianginal medication for symptom relief. Beta-adrenoceptor blocker with a calcium antagonist and/or long-acting nitrate in maximally tolerated doses. Lipid-lowering drugs prescribed at the discretion of the supervising clinician.
Total: 1,018
Women: 183 (8%)
Fair
RITA-3
Clayton et al., 200422

and

Fox et al., 200262
Title: Do men benefit more than women from an interventional strategy in patients with unstable angina or non-ST elevation myocardial infarction? The impact of gender in the RITA-3 trial

Comparator: Early invasive with PCI (type at discretion of investigator) vs. initial conservative

Components of optimal medical therapy: Aspirin; enoxaparin 1 mg/kg twice daily subcutaneously for 2 to 8 days. Antianginal treatment chosen by the supervising clinician, including a beta-blocker unless contraindicated.
Total: 1,810
Women: 682 (38%)
Good
TACTICS TIMI-18
Cannon et al., 200155

and

Glaser et al., 200251
Cannon et al., 199863
Title: Comparison of early invasive and conservative strategies in patients with unstable coronary syndromes treated with the glycoprotein IIb/IIIa inhibitor tirofiban

Comparator: Early invasive with PCI (type not specified) vs. initial conservative

Components of optimal medical therapy: Aspirin 325 mg daily (unless contraindicated); IV unfractionated heparin (5000 U bolus, then 1000 U/hour for 48 hours); tirofiban (loading dose 0.4 μg/kg per minute for a period of 30 minutes, then 0.1 μg/kg/min for 48 hours or until revascularization, and for at least 12 hours after PCI; beta blockers (82%), nitrates (94%), and lipid-lowering agents (52%).
Total: 2,220
Women: 757 (34%)
Good
TIMI III-B
Anonymous, 199457

and

Anderson et al., 199564
Title: Effects of tissue plasminogen activator and a comparison of early invasive and conservative strategies in unstable angina and non-Q-wave myocardial infarction. Results of the TIMI IIIB Trial

Comparator: Early invasive with PCI (type not specified) vs. initial conservative

Components of optimal medical therapy: Anti-ischemic therapy consisting of a beta-blocker (metoprolol 50 mg p.o. q 12 hours), a calcium antagonist (diltiazem 30 mg p.o. q 6 hours), and a long-acting nitrate (isosorbide dinitrate 10 mg p.o. q 8 hours) or larger doses and supplemented by sublingual nitroglycerin pm. IV heparin. Aspirin 325 mg daily was given on the second day and continued for 1 year.
Total: 1,425
Women: 497 (35%)
Good

CABG = coronary artery bypass graft; PCI = percutaneous coronary intervention; NSTEMI = non-ST elevation myocardial infarction; PTCA: percutaneous transluminal coronary angioplasty; RCT = randomized controlled trial; UA = unstable angina

From: Results

Cover of Treatment Strategies for Women With Coronary Artery Disease
Treatment Strategies for Women With Coronary Artery Disease [Internet].
Comparative Effectiveness Reviews, No. 66.
Dolor RJ, Melloni C, Chatterjee R, et al.

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