Clinical
bottom line:
1. The addition of HBOT to acute MI or unstable angina patients having undergone percutaneous coronary intervention reduces the rate of the clinical restenosis.
Citation/s:
Sharifi M., Fares W.,
Lead author's name and fax: Mohsen Sharifi, mohsen.sharifi@ttuhsc.edu
Three-part Clinical Question:
Among patients with an acute coronary syndrome who have undergone percutaneous
coronary intervention (PCI), does the addition of hyperbaric oxygen therapy (HBOT)
reduce the rate of coronary vessel restenosis?
Search Terms: myocardial infarction AND angina pectoris AND restenosis.
The Study:
Non-blinded randomised controlled trial without intention-to-treat.
The Study Patients: Patients with unstable ACS stabilized on medical
therapy with the resolution of chest pain and normalization of ST-segment
changes.
Control group (N = 37; 37 analysed): Standard PCI in de novo native or
saphenous vein grafts receiving >/=1stent. Received aspirin 325mg/day and
heparin during PCI and 1 month of therapy with clopidogrel 75mg/day. No
additional treatments were given.
Experimental group (N = 33; 24 analysed): As above, plus two HBOT
sessions involving 100% oxygen at 2ATA for 90minutes with a total chamber dwell
time of 120minutes. The first HBOT commenced 2hours before or immediately after
PCI while the second HBOT was given another 18 hours later.
The Evidence:
|
Outcome |
Time
to Outcome |
Control
group |
HBO
group |
Relative
risk reduction |
Absolute
risk reduction |
NNT |
Death
|
8
months |
0.08 |
0 |
100% |
0.08 |
12 |
|
95%
Confidence Intervals: |
45%
to 100% |
-0.01
to 0.17 |
NNT
= 6 to NNF NNH
= 145 to INF |
|||
|
MACE |
8
months |
0.35 |
0.03 |
91% |
0.32 |
3 |
|
95%
Confidence Intervals: |
45%
to 100% |
0.16
to 0.49 |
2
to 6 |
|||
|
MI |
8
months |
0.19 |
0.03 |
84% |
0.16 |
6 |
|
95%
Confidence Intervals: |
11%
to 100% |
0.02
to 0.30 |
3
to 50 |
|||
Comments:
1. 5 patients allocated to HBOT arm were analysed in the control arm, therefore
intention to treat not possible.
2. Follow-up angiography on all patients would have been useful to determine the
rates of coronary vessel reocclusion in the two groups.
3. Effectiveness of HBO may be reduced with modern drug eluting stents.
Appraised
by: Sven Todd.
Email: sventodd@gmail.com
Kill or Update By: 1 June 2007