Unstable angina: abciximab had no clear effect on long-term mortality.
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Clinical bottom line (level 1b-)
-
Patients with refractory unstable angina who were given abciximab after percutaneous transluminal coronary angioplasty were less likely to be dead at 30 days than those given placebo
(NNT =
22
at 30
days)
, but by 6 months this difference had disappeared.
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The CAPTURE Investigators
:
Lancet
1997;
349:
1429-1435
|
Expires March 2003
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The study
Single-blinded concealed randomised
trial
?with
intention-to-treat
Setting: 69 centres in 12 countries
1266 patients
(aged
mean 61 years,
73%
male)
refractory unstable angina defined as: chest pain at rest with concomitant ECG abnormalities compatible with myocardial ischemia, and one or more episodes of typical chest pain, ECG abnormalities or both, compatible with myocardial ischemia during therapy with iv heparin and glycerol trinitrate, started at least 2 hours previously.
Excluded if
- latest episode of ischaemia not within the 48 hours before enrolment
- recent MI, unless creatine kinase values had returned to below two times the upper limit of normal
- features of persisting ischaemia that would require immediate intervention
- >50% occlusion of the left main coronary artery or a culprit lesion located in a bypass graft
- bleeding risk factors such as surgery, gastrointestinal or genitourinary bleeding during the 6 weeks before enrolment, or a cerebrovascular accident within the previous 2 years
- planned administration of oral anticoagulants, intravenous dextran or a thrombolytic agent before or during percutaneous transluminal coronary angioplasty
- underlying medical conditions such as persistent hypertension despite treatment
- history of haemorrhagic diathesis
- history of autoimmune disease, or a platelet count below 100x10
9
/L
Control Group: (n = 636, 635 analysed):
placebo
Experimental Group: (n = 630, 630 analysed):
abciximab
, 0.25 mg/kg bolus followed by a continuous infusion of 10
µ
g/min.
Heparin was given from before randomisation until at least 1 hour after percutaneous transluminal coronary angioplasty procedure was performed. All patients received aspirin (minimum of 50 mg per day) and intravenous glyceryl trinitrate. Beta-blockers, calcium channel blockers and other cardiovascular drugs were allowed.
99.9% followed for
6
months
Outcome notes:
-
death, myocardial infarction or urgent intervention
: intervention for treatment of recurrent ischaemia
The evidence
| Outcome |
Time to outcome |
CER | EER | RRR (95% CI) | ARR (95% CI) | NNT (95% CI) |
| death, myocardial infarction or urgent intervention
|
30
days |
101 (15.9%) |
71 (11.3%) |
29.0% (6.00% to
47.0%) |
4.64% (0.87% to
8.40%) |
22
(12 to
115)
|
| death, myocardial infarction or urgent intervention
|
6
months |
193 (30.4%) |
193 (30.6%) |
-1.00% (-19.0% to
15.0%) |
-0.24% (-5.32% to
4.83%) |
-415
(NNT = 21 to infinity;
NNH =
19
to infinity)
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Citation
-
The CAPTURE Investigators
,
:
Randomised placebo-controlled trial of abciximab before and during coronary intervention in refractory unstable angina: the CAPTURE study.
Lancet
1997;
349:
1429-1435
Contributor: Clare Wotton and Bob Phillips,
January 2000
Reviewer: Dwight Peretz
Clinical Question.
| Patient |
unstable angina |
| Intervention or Exposure |
abciximab |
| Comparison |
placebo |
| Outcome |
death, infarction or urgent intervention |
|
|