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Therapeutics

Coronary angioplasty led to more nonfatal MIs than medical therapy in patients with coronary artery disease

ACP J Club. 1998 Mar-April; 128:36. doi:10.7326/ACPJC-1998-128-2-036

Related Content in the Archives
Aggressive therapy was ineffective for unstable angina and non-Q-wave MI


Source Citation

RITA-2 Trial Participants. Coronary angioplasty versus medical therapy for angina: the second Randomised Intervention Treatment of Angina (RITA-2) trial. Lancet. 1997 Aug 16; 350:461-8.


Abstract

Objective

To compare the effectiveness of percutaneous transluminal coronary angioplasty (PTCA) with medical therapy in patients with coronary artery disease (CAD) deemed suitable for either treatment.

Design

Randomized controlled trial with a median follow-up of 2.7 years.

Setting

20 centers in the United Kingdom and Ireland.

Patients

1018 patients (median age 58 y, 82% men) with arteriographically proven CAD who were candidates for both medical therapy and PTCA. Exclusion criteria included previous myocardial revascularization, left main stem disease, hemodynamically significant valve disease, unstable angina within 7 days of randomization, and noncardiac disease influencing survival or compliance. Follow-up was 98%.

Intervention

504 patients were assigned to initial PTCA and 514 to medical therapy with ≥ 2 antianginal agents.

Main outcome measures

The primary end point was the combined frequency of death and non-fatal myocardial infarction (MI).

Main results

Intention-to-treat analysis was used. More patients who received PTCA died or had an MI than patients who received medical therapy (P = 0.02); PTCA also led to a greater rate of nonfatal MI alone { P = 0.04}* (Table). No difference existed between the groups for death alone (P = 0.32) (Table). 19% of patients who received PTCA required further PTCAs or coronary bypass graft surgery compared with 23% of patients who received medical therapy. At 3 months, angina and exercise tolerance were more improved in the PTCA group, an effect that attenuated in 1 to 2 years.

Conclusion

Percutaneous transluminal coronary angioplasty led to greater early symptomatic improvement but was associated with a higher risk for nonfatal myocardial infarction in patients with coronary artery disease.

Sources of funding: British Heart Foundation; Medical Research Council; Advanced Cardiovascular Systems Inc. (USA); Intervention Ltd. (UK); Cordis Ltd; Schneider (UK); Nycomed Ltd.

For article reprint: Professor S. Pocock, London School of Hygiene & Tropical Medicine, London WC1E 7HT, England, UK. FAX 44-171-436-5389.

* P value calculated from data in article.


Table. Percutaneous transluminal coronary angioplasty (PTCA) vs medical therapy†

Outcomes at median 2.7 y PTCA EER Medical CER RRI (95% CI) ARI |EER-CER| NNH (CI)
Nonfatal MI and death 6.3% 3.3% 92% (9 to 239) 3.0% 33 (18 to 235)
Nonfatal MI 4.2% 2.0% 114% (4 to 343) 2.2% 46 (22 to 861)
Death 2.2% 1.4% 60% (-35 to 298) 0.8% (CI -0.9 to 2.7) Not significant

†Abbreviations defined in Glossary; RRI, ARI, NNH, and CI calculated from data in article.


Commentary

The patients in the RITA-2 trial had a broad spectrum of CAD, although most were stable with relatively mild disease; 47% had no or mild angina, 48% were receiving ≤ 1 antianginal agent, 60% had single-vessel CAD, and 54% had no segmental wall motion abnormalities. The stable nature of the disease is also reflected by the median time to PTCA of 5 weeks. We do not know how many patients actually had ischemia on stress testing. PTCA was associated with greater symptomatic improvement, but only in patients with more severe angina, and the effect attenuated within 1 year.

The results of this study can now be added to others (1, 2) that show that PTCA is clearly not superior to medical management and may actually increase risk for MI in patients with stable or unstable angina or non-Q-wave MI. Only the recently published Danish trial (3) suggests that for patients who have received thrombolysis and have evidence of ischemia, PTCA leads to better outcomes. Whether the use of stents and new platelet inhibitors will make PTCA a better option remains to be seen. In the meantime, this trial reminds us that "if it ain't broke, don't fix it" and that for patients without severe symptoms, the choice of therapy should be driven by patient preference.

David J. Malenka, MD
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire, USA


References

1. Parisi AF, Folland ED, Hartigan P. A comparison of angioplasty with medical therapy in the treatment of single-vessel coronary artery disease. Veterans Affairs ACME Investigators. N Engl J Med. 1992;326:10-6.

2. Anderson HV, Cannon CP, Stone PH, et al. One-year results of the Thrombolysis in Myocardial Infarction (TIMI) IIIB clinical trial. A randomized comparison of tissue-type plasminogen activator versus placebo and early invasive versus early conservative strategies in unstable angina and non-Q wave myocardial infarction. J Am Coll Cardiol. 1995;26: 1643-50.

3. Madsen JK, Grande P, Saunamaki K, et al. Danish multicenter randomized study of invasive versus conservative treatment in patients with inducible ischemia after thrombolysis in acute myocardial infarction (DANAMI). DANish Trial in Acute Myocardial Infarction. Circulation. 1997;96:748-55.