Quality and Applicability of Included Studies

Rowena J Dolor; Chiara Melloni; Ranee Chatterjee; Nancy M Allen LaPointe; Judson B Williams, Jr; Remy R Coeytaux; Amanda J McBroom; Michael D Musty; Liz Wing; Gregory P Samsa; Manesh R Patel

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This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.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

Table D-1Quality and applicability for RCTs evaluating women with STEMI (KQ 1)

Study Name	Study Author/Year	Comparator	Quality	Limitations to Applicability
CARESS-in-AMI	Di Mario et al., 2008¹	Immediate PCI with fibrinolysis (reteplase) vs. fibrinolysis (reteplase) with rescue PCI	Good	None
DANAMI-2	Andersen et al., 2003²	PCI vs. fibrinolysis (accelerated t-PA)	Good	None
Dobrzycki	Dobrzycki et al., 2007³	Transfer with tirofiban for primary PCI vs. onsite fibrinolysis (streptokinase)	Good	Comparability of care in international settings unclear
GUSTO II-B	Tamis-Holland et al., 2004⁴	PCI vs. fibrinolysis (accelerated t-PA)	Good	Comparability of care in international settings unclear
Minai	Minai et al., 2002⁵	PCI vs. optimal medical therapy (without fibrinolysis)	Fair	Comparability of care in international settings unclear
PAMI	Stone et al., 1995⁶	PCI vs. fibrinolysis (t-PA)	Good	Comparability of care in international settings unclear
SHOCK	Hochman et al., 2001⁷	Early invasive revascularization (PCI or CABG within 6 hours) vs. initial medical stabilization (thrombolysis, IABP)	Good	None

: Abbreviations: CABG = coronary artery bypass grafting; PCI = percutaneous coronary revascularization; STEMI = ST elevation myocardial infarction

Table D-2Quality and applicability for RCTs evaluating women with UA/NSTEMI (KQ 2)

Study Name	Study Author/Year	Comparator	Quality	Limitations to Applicability
FRISC II	Lagerqvist et al., 2001⁸	Early invasive treatment with revascularization vs. initial conservative strategy	Good	Comparability of care in international settings unclear
GUSTO IV-ACS	Ottervanger et al., 2004⁹	Early invasive management vs. initial conservative treatment within 30 days.	Good	Older versions of an intervention no longer in common use Resources available to providers for diagnosis and treatment of condition varied widely Comparability of care in international settings unclear
ICTUS	de Winter et al., 2005¹⁰	Early invasive therapy with revascularization vs. selective invasive strategy	Good	Comparability of care in international settings unclear
RITA-2	Anonymous, 1997¹¹	Early invasive therapy with PCI vs. initial conservative	Fair	Provider type/specialty varied across settings Comparability of care in international settings unclear
RITA-3	Clayton et al., 2004¹²	Early invasive with PCI vs. initial conservative	Good	None
TACTICS TIMI-18	Cannon et al., 2001¹³	Early invasive with PCI vs. initial conservative	Good	None
TIMI III-B	Anonymous, 1994¹⁴	Early invasive with PCI vs. initial conservative	Good	Older versions of an intervention no longer in common use

: Abbreviations: CABG = coronary artery bypass grafting; PCI = percutaneous coronary revascularization

Table D-3Quality and applicability for RCTs evaluating women with stable angina (KQ 3 Strategy 1)

Study Name	Study Author/Year	Comparator	Quality	Limitations to Applicability
Allen	Allen et al., 2004¹⁵	Surgical revascularization vs. optimal medical therapy	Good	Older versions of an intervention no longer in common use Cointerventions that were likely to modify effectiveness of therapy
COURAGE	Boden et al., 2007¹⁶	PCI (or CABG if PCI failed) vs. optimal medical therapy	Good	None
MASS II	Hueb et al., 2010¹⁷	PCI vs. optimal medical therapy CABG vs. optimal medical therapy	Good	Study population not representative of community patients Cointerventions that were likely to modify effectiveness of therapy
OAT	Hochman et al., 2006¹⁸	PCI (or CABG if PCI failed) vs. optimal medical therapy	Good	None
STICH	Velazquez et al., 2011¹⁹	CABG vs. optimal medical therapy	Good	Cointerventions that were likely to modify effectiveness of therapy Comparability of care in international settings unclear

: Abbreviations: CABG = coronary artery bypass grafting; PCI = percutaneous coronary revascularization

Table D-4Quality and applicability for RCTs evaluating women with stable/unstable angina (KQ 3 Strategy 2)

Study Name	Study Author/Year	Comparator	Quality	Limitations to Applicability
ARTS I	Vaina et al., 2009²⁰	PCI vs. CABG	Good	None
BARI	Jacobs et al., 1998²¹	PCI vs. CABG	Good	Study population not representative of community patients Older versions of an intervention no longer in common use Cointerventions that were likely to modify effectiveness of therapy
CABRI	Anonymous, 1995²²	PCI vs. CABG	Good	None
CARDia	Kapur et al., 2010²³	PCI vs. CABG	Good	Key characteristics not reported Provider type/specialty varied across settings
EAST	King et al., 2000²⁴	PCI vs. CABG	Good	Study population not representative of community patients Older versions of an intervention no longer in common use Cointerventions that were likely to modify effectiveness of therapy
GABI	Kaehler et al., 2005²⁵	PCI vs. CABG	Good	Cointerventions that were likely to modify effectiveness of therapy
MASS II	Hueb et al., 2010¹⁷	PCI vs. CABG	Good	Study population not representative of community patients Cointerventions that were likely to modify effectiveness of therapy
PRECOMBAT	Park et al., 2011²⁶	PCI vs. CABG	Good	Comparability of care in international settings unclear
SOS	Zhang et al., 2004²⁷	PCI vs. CABG	Fair	Study population not representative of community patients Cointerventions that were likely to modify effectiveness of therapy
SYNTAX	Morice et al., 2010²⁸	PCI vs. CABG	Fair	Data not stratified or adjusted for key predictors Comparability of care in international settings unclear

: Abbreviations: CABG = coronary artery bypass grafting; PCI = percutaneous coronary revascularization

References Cited in Appendix D

1.: Di Mario C, Dudek D, Piscione F, et al. Immediate angioplasty versus standard therapy with rescue angioplasty after thrombolysis in the Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS-in-AMI): an open, prospective, randomised, multicentre trial. Lancet. 2008;371(9612):559–68. [PubMed: 18280326]
2.: Andersen HR, Nielsen TT, Rasmussen K, et al. A comparison of coronary angioplasty with fibrinolytic therapy in acute myocardial infarction. N Engl J Med. 2003;349(8):733–42. [PubMed: 12930925]
3.: Dobrzycki S, Kralisz P, Nowak K, et al. Transfer with GP IIb/IIIa inhibitor tirofiban for primary percutaneous coronary intervention vs. on-site thrombolysis in patients with ST-elevation myocardial infarction (STEMI): a randomized open-label study for patients admitted to community hospitals. Eur Heart J. 2007;28(20):2438–48. [PubMed: 17884846]
4.: 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]
5.: Minai K, Horie H, Takahashi M, et al. Long-term outcome of primary percutaneous transluminal coronary angioplasty for low-risk acute myocardial infarction in patients older than 80 years: a single-center, open, randomized trial. Am Heart J. 2002;143(3):497–505. [PubMed: 11868057]
6.: 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]
7.: Hochman JS, Sleeper LA, White HD, et al. One-year survival following early revascularization for cardiogenic shock. JAMA. 2001;285(2):190–2. [PubMed: 11176812]
8.: Lagerqvist B, Safstrom K, Stahle E, et al. Is early invasive treatment of unstable coronary artery disease equally effective for both women and men? FRISC II Study Group Investigators. J Am Coll Cardiol. 2001;38(1):41–8. [PubMed: 11451294]
9.: Ottervanger JP, Armstrong P, Barnathan ES, et al. Association of revascularisation with low mortality in non-ST elevation acute coronary syndrome, a report from GUSTO IV-ACS. Eur Heart J. 2004;25(17):1494–501. [PubMed: 15342168]
10.: de Winter RJ, Windhausen F, Cornel JH, et al. Early invasive versus selectively invasive management for acute coronary syndromes. N Engl J Med. 2005;353(11):1095–104. [PubMed: 16162880]
11.: Anonymous. Coronary angioplasty versus medical therapy for angina: the second Randomised Intervention Treatment of Angina (RITA-2) trial. RITA-2 trial participants. Lancet. 1997;350(9076):461–8. [PubMed: 9274581]
12.: Clayton TC, Pocock SJ, Henderson RA, et al. 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. Eur Heart J. 2004;25(18):1641–50. [PubMed: 15351164]
13.: 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]
14.: Anonymous. 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 Thrombolysis in Myocardial Ischemia. Circulation. 1994;89(4):1545–56. [PubMed: 8149520]
15.: Allen KB, Dowling RD, Angell WW, et al. Transmyocardial revascularization: 5-year follow-up of a prospective, randomized multicenter trial. Ann Thorac Surg. 2004;77(4):1228–34. [PubMed: 15063241]
16.: Boden WE, O’Rourke RA, Teo KK, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007;356(15):1503–16. [PubMed: 17387127]
17.: Hueb W, Lopes N, Gersh BJ, et al. Ten-year follow-up survival of the Medicine, Angioplasty, or Surgery Study (MASS II): a randomized controlled clinical trial of 3 therapeutic strategies for multivessel coronary artery disease. Circulation. 2010;122(10):949–57. [PubMed: 20733102]
18.: Hochman JS, Lamas GA, Buller CE, et al. Coronary intervention for persistent occlusion after myocardial infarction. N Engl J Med. 2006;355(23):2395–407. [PMC free article: PMC1995554] [PubMed: 17105759]
19.: Velazquez EJ, Lee KL, Deja MA, et al. Coronary-Artery Bypass Surgery in Patients with Left Ventricular Dysfunction. N Engl J Med. 2011 [PMC free article: PMC3415273] [PubMed: 21463150]
20.: 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]
21.: Jacobs AK, Kelsey SF, Brooks MM, et al. Better outcome for women compared with men undergoing coronary revascularization: a report from the bypass angioplasty revascularization investigation (BARI). Circulation. 1998;98(13):1279–85. [PubMed: 9751675]
22.: Anonymous. First-year results of CABRI (Coronary Angioplasty versus Bypass Revascularisation Investigation). CABRI Trial Participants. Lancet. 1995;346(8984):1179–84. [PubMed: 7475656]
23.: Kapur A, Hall RJ, Malik IS, et al. Randomized comparison of percutaneous coronary intervention with coronary artery bypass grafting in diabetic patients. 1-year results of the CARDia (Coronary Artery Revascularization in Diabetes) trial. J Am Coll Cardiol. 2010;55(5):432–40. [PubMed: 20117456]
24.: King SB 3rd, Kosinski AS, Guyton RA, et al. Eight-year mortality in the Emory Angioplasty versus Surgery Trial (EAST). J Am Coll Cardiol. 2000;35(5):1116–21. [PubMed: 10758949]
25.: Kaehler J, Koester R, Billmann W, et al. 13-year follow-up of the German angioplasty bypass surgery investigation. Eur Heart J. 2005;26(20):2148–53. [PubMed: 15975991]
26.: Park SJ, Kim YH, Park DW, et al. Randomized trial of stents versus bypass surgery for left main coronary artery disease. N Engl J Med. 2011;18:1718–27. [PubMed: 21463149]
27.: Zhang Z, Weintraub WS, Mahoney EM, et al. Relative benefit of coronary artery bypass grafting versus stent-assisted percutaneous coronary intervention for angina pectoris and multivessel coronary disease in women versus men (one-year results from the Stent or Surgery trial). Am J Cardiol. 2004;93(4):404–9. [PubMed: 14969611]
28.: Morice MC, Serruys PW, Kappetein AP, et al. Outcomes in patients with de novo left main disease treated with either percutaneous coronary intervention using paclitaxel-eluting stents or coronary artery bypass graft treatment in the Synergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery (SYNTAX) trial. Circulation. 2010;121(24):2645–53. [PubMed: 20530001]

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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.) Appendix D, Quality and Applicability of Included Studies.
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