Myocardial infarction: angioplasty: stenting: fewer deaths and bleeds occurred with ticlopidine and
aspirin.
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Clinical bottom line (level 1b)
-
Patients who had a recent MI and a successful coronary stent
placement had fewer early clinical events if they had aspirin and ticlopidine
rather than aspirin and warfarin
(NNT =
6
at 30
days)
.
-
Patients also had fewer early non-cardiac events
(NNT =
9
at 30
days)
, fewer bleeds
(NNT =
8
at 30
days)
and fewer had reocclusion of the stented vessels
(NNT =
10
at 30
days)
.
-
After 6 months, fewer patients were dead or had recurrent MI
(NNT =
10
at 6
months)
, though there was no clear difference in the overall cardiac event
rate.
-
There was no clear effect on restenosis rates.
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Schomig et al:
Journal of the American College of
Cardiology
1997;
29:
28-34
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Expires
June 2003
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The study
Unblinded concealed randomised
trial
with
intention-to-treat
Setting: acute hospital, Germany
123 patients
(aged
mean 60 years,
76%
male)
had recent myocardial infarction (<48 hours) and
successful coronary stent placement
Excluded if
- contraindications to the study drugs
- indications for anticoagulant therapy
- cardiogenic shock, mechanical ventilation or both before
angioplasty
Control Group: (n = 62, 62 analysed):
heparin
(adjusted so aPTT 80-100 seconds), followed by
phenprocoumon
. Continued heparin for 5-10 days until stable oral
anticoagulation was achieved (INR 3.5 to 4.5)
Experimental Group: (n = 61, 61 analysed):
ticlopidine
250 mg twice daily for four weeks.
Heparin
infusion was stopped after 12 hours
All patients received aspirin (100 mg twice daily)
and were hospitalised for less than 14 days. Repeat angiography was done at six
months.
100% followed for
6
months
Outcome notes:
-
any clinical event
: death, MI, repeat revascularisation, stroke,
bleed, peripheral vascular event
-
bleeding
: requiring surgery or
transfusion
-
cardiac events
: cardiac death, MI,
revascularisation
The evidence
| Outcome |
Time to outcome |
CER | EER | RRR (95% CI) | ARR (95% CI) | NNT (95% CI) |
| any clinical event
|
30
days |
13 (21.0%) |
2 (3.28%) |
84% (34% to
96%) |
17.7% (6.61% to
28.8%) |
6
(3 to
15)
|
| non-cardiac event
|
30
days |
8 (12.9%) |
1 (1.64%) |
87% (1% to
98%) |
11.3% (2.33% to
20.2%) |
9
(5 to
43)
|
| occlusion of stent vessel
|
30
days |
6 (9.68%) |
0 (0.00%) |
100% (% to
%) |
9.68% (2.32% to
17.0%) |
10
(6 to
43)
|
| bleeding
|
30
days |
8 (12.9%) |
0 (0.00%) |
100% (% to
%) |
12.9% (4.56% to
21.3%) |
8
(5 to
22)
|
| cardiac events
|
6
months |
15 (24.2%) |
11 (18.0%) |
25% (-49% to
63%) |
6.16% (-8.22% to
20.5%) |
16
(NNT = 5 to infinity;
NNH =
12
to infinity)
|
| death or recurrent MI
|
6
months |
6 (9.68%) |
0 (0.00%) |
100% (% to
%) |
9.68% (2.32% to
17.0%) |
10
(6 to
43)
|
| restenosis
|
6
months |
14 (22.6%) |
13 (21.3%) |
6% (-84% to
52%) |
1.27% (-13.4% to
15.9%) |
79
(NNT = 6 to infinity;
NNH =
7
to infinity)
|
- This is a sub study of a larger study comparing ticlopidine
to classical anticoagulation treatment after stent placement during balloon
angioplasty, and has the difficulties of retrospective data analysis.
- Patients had stents inserted due to coronary artery
dissection, complete vessel occlusion, residual diameter stenosis
=
30% after
angioplasty.
Citation
-
Schomig
A,
Neumann
FJ,
Walter
H, et al:
Coronary stent placement in patients with
acute myocardial infarction: comparison of clinical and angiographic outcome
after randomization to antiplatelet or anticoagulant therapy.
Journal of the American College of
Cardiology
1997;
29:
28-34
Search Terms:
unstable angina in Best Evidence
Contributor: Chris Ball and Clare Wotton,
June 2000
Reviewer: Christian Torp-Pedersen
Clinical Question.
| Patient |
recent MI |
| Intervention or Exposure |
ticlopidine |
| Comparison |
phenprocoumon |
| Outcome |
any clinical event |
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