Table 12.11PCI vs. CABG – Left main coronary artery or 3 vessel disease short term follow-up (1year) for stable angina

Quality assessmentSummary of findings
No of patientsEffectQuality
No of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOther considerationsPCICABGRelative (95% CI)Absolute
Death (all causes) (follow-up 1 years)
Serruys 2009161 (SYNTAX) (d)randomised trialsno serious limitations (a)no serious inconsistencyno serious indirectnessserious (b)none39/891 (4.4%)30/849 (3.5%)RR 1.24 (0.78 to 1.98)8 more per 1000 (from 8 fewer to 35 more)[plus sign in circle][plus sign in circle][plus sign in circle]

MODERATE
cardiac mortality (follow-up 1 years)
Serruys 2009161 (SYNTAX)randomised trialsno serious limitations (a)no serious inconsistencyno serious indirectnessserious (b)none33/891 (3.7%)18/849 (2.1%)RR 1.75 (0.99 to 3.08)16 more per 1000 (from 0 fewer to 44 more)[plus sign in circle][plus sign in circle][plus sign in circle]

MODERATE
Stroke (follow-up 1 years)
Serruys 2009161 (SYNTAX)randomised trialsno serious limitations (a)no serious inconsistencyno serious indirectnessno serious imprecisionnone5/891 (0.6%)19/849 (2.2%)RR 0.25 (0.09 to 0.67)17 fewer per 1000 (from 7 fewer to 20 fewer)[plus sign in circle][plus sign in circle][plus sign in circle][plus sign in circle]

HIGH
MI (follow-up 1 years)
Serruys 2009161 (SYNTAX)randomised trialsno serious limitations (a)no serious inconsistencyno serious indirectnessserious (b)none43/891 (4.8%)28/849 (3.3%)RR 1.46 (0.92 to 2.33)15 more per 1000 (from 3 fewer to 44 more)[plus sign in circle][plus sign in circle][plus sign in circle]

MODERATE
Repeat revascularisation (follow-up 1 years)
Serruys 2009161 (SYNTAX)randomised trialsno serious limitations (a)no serious inconsistencyno serious indirectnessno serious imprecisionnone120/891 (13.5%)50/849 (5.9%)RR 2.29 (1.67 to 3.14)76 more per 1000 (from 39 more to 126 more)[plus sign in circle][plus sign in circle][plus sign in circle][plus sign in circle]

HIGH
Sub group diabetes (Death) (follow-up 1 years)
Banning 2010162 (SYNTAX)randomised trialsno serious limitations (c)no serious inconsistencyno serious indirectnessserious (b)none19/227 (8.4%)13/204 (6.4%)RR 1.31 (0.67 to 2.59)20 more per 1000 (from 21 fewer to 101 more)[plus sign in circle][plus sign in circle][plus sign in circle]

MODERATE
Sub group diabetes (cardiac death) (follow-up 1 years)
Banning 2010162 (SYNTAX)randomised trialsno serious limitations (c)no serious inconsistencyno serious indirectnessserious (b)none16/227 (7%)8/204 (3.9%)RR 1.8 (0.79 to 4.11)31 more per 1000 (from 8 fewer to 122 more)[plus sign in circle][plus sign in circle][plus sign in circle]

MODERATE
Sub group diabetes (stroke) (follow-up 1 years)
Banning 2010162 (SYNTAX)randomised trialsno serious limitations (c)no serious inconsistencyno serious indirectnessserious (b)none2/227 (0.9%)5/204 (2.5%)RR 0.36 (0.07 to 1.83)16 fewer per 1000 (from 23 fewer to 20 more)[plus sign in circle][plus sign in circle][plus sign in circle]

MODERATE
Sub group diabetes (MI) (follow-up 1 years)
Banning 2010162 (SYNTAX)randomised trialsno serious limitations (c)no serious inconsistencyno serious indirectnessserious (b)none11/227 (4.8%)9/204 (4.4%)RR 1.1 (0.46 to 2.6)4 more per 1000 (from 24 fewer to 71 more)[plus sign in circle][plus sign in circle][plus sign in circle]

MODERATE
Sub group diabetes (Repeat revascularisation) (follow-up 1 years)
Banning 2010162 (SYNTAX)randomised trialsno serious limitations (c)no serious inconsistencyno serious indirectnessno serious imprecisionnone46/227 (20.3%)13/204 (6.4%)RR 3.18 (1.77 to 5.71)139 more per 1000 (from 49 more to 300 more)[plus sign in circle][plus sign in circle][plus sign in circle][plus sign in circle]

HIGH
Sub group no diabetes (Death) (follow-up 1 years)
Banning 2010162 (SYNTAX)randomised trialsno serious limitations (c)no serious inconsistencyno serious indirectnessserious (b)none20/664 (3%)17/645 (2.6%)RR 1.14 (0.6 to 2.16)4 more per 1000 (from 11 fewer to 31 more)[plus sign in circle][plus sign in circle][plus sign in circle]

MODERATE
Sub group no diabetes (no cardiac death) (follow-up 1 years)
Banning 2010162 (SYNTAX)randomised trialsno serious limitations (c)no serious inconsistencyno serious indirectnessserious (b)none17/664 (2.6%)10/645 (1.6%)RR 1.65 (0.76 to 3.58)10 more per 1000 (from 4 fewer to 40 more)[plus sign in circle][plus sign in circle][plus sign in circle]

MODERATE
Sub group no diabetes (stroke) (follow-up 1 years)
Banning 2010162 (SYNTAX)randomised trialsno serious limitations (c)no serious inconsistencyno serious indirectnessno serious imprecisionnone3/664 (0.5%)14/645 (2.2%)RR 0.21 (0.06 to 0.72)17 fewer per 1000 (from 6 fewer to 20 fewer)[plus sign in circle][plus sign in circle][plus sign in circle][plus sign in circle]

HIGH
Sub group no diabetes (MI) (follow-up 1 years)
Banning 2010162 (SYNTAX)randomised trialsno serious limitations (c)no serious inconsistencyno serious indirectnessserious (b)none32/664 (4.8%)19/645 (2.9%)RR 1.64 (0.94 to 2.86)19 more per 1000 (from 2 fewer to 55 more)[plus sign in circle][plus sign in circle][plus sign in circle]

MODERATE
Sub group no diabetes (Repeat revasc) (follow-up 1 years)
Banning 2010162 (SYNTAX)randomised trialsno serious limitations (c)no serious inconsistencyno serious indirectnessno serious imprecisionnone74/664 (11.1%)37/645 (5.7%)RR 1.94 (1.33 to 2.84)54 more per 1000 (from 19 more to 106 more)[plus sign in circle][plus sign in circle][plus sign in circle][plus sign in circle]

HIGH
a

Serruys 2009[153] (SYNTAX): Randomised, allocation concealment reported, baseline comparisons made, nos. lost to follow-up reported ((5.4% in CABG and 1.3% in PCI group), Intention to treat analysis reported. Blind outcome assessment (adjudicated by an independent Clinical Events Committee). Patients aware of the intervention allocated.

b

95% CI around the pooled estimate of effect includes both: 1) no effect and 2) appreciable benefit or appreciable harm.

c

Banning 2010[154] (SYNTAX): Randomised, ITT used, one year MACCE was evaluated in 849 (94.6%) CABG patients (645 non diabetic and 204 medically treated diabetes) and 891 (98.7%) PES patients (664 non diabetic and 227 with medically treated diabetes). Allocation concealment reported. Baseline comparisons made. This is a sub group analysis of the SYNTAX trial.

d

Authors note:

  • Most cases of stent thrombosis occurred within 30 days after the procedure, and the 12 month rate of stent thrombosis in the PCI group was similar to the rate of symptomatic graft occlusion in the CABG group. Stent thrombosis often has more serious consequences for patients (rate of death, approximately 30%, rate of MI approximately 60%) than does graft occlusion, which often results only in angina leading to revascularisation.
  • The use of antiplatelet medication was high among patients in the PCI group (with 71.1% receiving a thienopyridine at 12 months). The authors report that the low rate of stroke among patients with PCI may have resulted from the use of highly effective dual antiplatelet therapy which prevents thrombo embolic events.
  • More patients in the CABG group than in PCI declined to participate after proving consent; this imbalance was due to the greater invasiveness of CABG.

Serruys 2009[153] (SYNTAX): Randomised, allocation concealment reported, baseline comparisons made, nos. lost to follow-up reported ((5.4% in CABG and 1.3% in PCI group), Intention to treat analysis reported. Blind outcome assessment (adjudicated by an independent Clinical Events Committee). Patients aware of the intervention allocated.

95% CI around the pooled estimate of effect includes both: 1) no effect and 2) appreciable benefit or appreciable harm.

Banning 2010[154] (SYNTAX): Randomised, ITT used, one year MACCE was evaluated in 849 (94.6%) CABG patients (645 non diabetic and 204 medically treated diabetes) and 891 (98.7%) PES patients (664 non diabetic and 227 with medically treated diabetes). Allocation concealment reported. Baseline comparisons made. This is a sub group analysis of the SYNTAX trial.

Authors note:

  • Most cases of stent thrombosis occurred within 30 days after the procedure, and the 12 month rate of stent thrombosis in the PCI group was similar to the rate of symptomatic graft occlusion in the CABG group. Stent thrombosis often has more serious consequences for patients (rate of death, approximately 30%, rate of MI approximately 60%) than does graft occlusion, which often results only in angina leading to revascularisation.
  • The use of antiplatelet medication was high among patients in the PCI group (with 71.1% receiving a thienopyridine at 12 months). The authors report that the low rate of stroke among patients with PCI may have resulted from the use of highly effective dual antiplatelet therapy which prevents thrombo embolic events.
  • More patients in the CABG group than in PCI declined to participate after proving consent; this imbalance was due to the greater invasiveness of CABG.

From: 12, Revascularisation

Cover of Stable Angina
Stable Angina: Methods, Evidence & Guidance [Internet].
NICE Clinical Guidelines, No. 126.
National Clinical Guidelines Centre (UK).
Copyright © 2011, National Clinical Guidelines Centre.

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