Critically Appraised Topic
Appraiser: Eric W. Terman
Date: October 21, 1997
Question: What is better for anginal symptoms and prevention of death: Angioplasty or medication?
Clinical Bottom Lines:
1. There was a significantly higher death rate among the angioplasty group, most likely to procedure complications.
2. However angioplasty was better in preventing angina.
3. Unless the patient has active severe ischemia it is probably best to use medication, unless CABG is indicated.
4. When you send someone for PTCA there is a complication risk, such that by agreeing to go for PTCA, they should also be ready to go to CABG if necessary.
Methods/Evidence:
1. Randomized, prospective, trial in patients older than 18.
2. Exclusion criteria included: early myocardial revascularization (for symptomatic or prognostic benefit), pts. with prior revasculariztion, left main disease, hemodynamically significant valve disease.
3. Angioplasty had to occur within 3 months of entering the trial.
4. Prior to randomization an interventional cardiologist determined whether or not there were significant coronary artery lesions.
Level of angina greater than grade 2*
Time: Baseline 3 mos 6 mos 12 mos 24 mos 36 mos PTCA 56% 21% 21% 18% 19% 19% Medical 52% 37.5% 36% 30% 26.5% 19% Difference 6% 16.5% 15% 12% 7.6% 0% * Please note that these values are read off of a graph and the only true numbers are in bold, but calculated by the authors without giving raw data.
Number of anti-anginals
Time since randomization
3 mos
6 mos
1 yr
2yr
3yr
Group
med
PTCA
med
PTCA
med
PTCA
med
PTCA
med
PTCA
% of patients in each group taking x number of meds
none
7%
20%
7%
23%
10%
25%
13%
31%
14%
36%
1
50%
43%
33%
45%
33%
44%
32%
41%
33%
39%
2
38%
26%
40%
24%
41%
22%
40%
20%
38%
19%
3
18%
10%
19%
8%
16%
7%
15%
8%
15%
6%
Comments:
1. This is a large and fairly well constructed trial, with good follow up.
2. The groups were equal in major areas of interest.
3. There was a range in expertise employed in performing the angioplasties.
4. The study was performed before stents were widely used.
5. Clinicians were encouraged to discontinue medications after PTCA, unless there were compelling reasons to keep a person on medication. Did this mean that some patients came off of B-blockers, which we know improve survival.
6. Patients were included even if they did not have significant symptoms.
7. There was a significant decrease in the difference in percentage of patients without angina, it is difficult to know whether this was secondary to cross over of patients going from the medication branch to revascularization or whether this was secondary to plaque re-accumulation in the PTCA group.
8. Patients assigned to a group could be withdrawn depending on the characteristics of the cardiac lesions. This was important so that patients received the most appropriate care.
9. PTCA made the greatest impact in patients with grade 2 or worse angina.
10. Data not present for Kaplan-Meyer tables.
11. They use a combined end point of death and MI, both of which matter, but it is unclear whether there is significance when they stand alone.
Reference:
Pocock S and RITA2 trial participants. Coronary angioplasty versus medical therapy for angina: the second Randomised Intervention Treatment of Angina (RITA-2) trial, Lancet. 1997 350(August 16):461-468.