Effect of PCI on Long-Term Survival in Patients with Stable Ischemic Heart Disease
Steven P Sedlis1, Pamela M Hartigan, Koon K Teo
1From the New York Veterans Affairs (VA) Healthcare Network, New York (S.P.S., J.D.L.), and Upstate New York VA Healthcare Network and Albany Medical College, Albany (W.E.B.) - all in New York; VA Connecticut Healthcare System, West Haven (P.M.H.) and Hartford Hospital, Hartford (M.D.) - both in Connecticut; McMaster University Medical Center, Hamilton, ON (K.K.T.), Vancouver Hospital and Health Sciences Center, Vancouver, BC (G.B.J.M.), and London Health Sciences Centre, London, ON (W.K.) - all in Canada; Stanford University Medical Center, Stanford, CA (D.J.M.); Mid-America Heart Institute, University of Missouri, Kansas City, Kansas City (J.A.S.); Saint Louis University School of Medicine, St. Louis (B.R.C.); Cedars-Sinai Medical Center, Los Angeles (D.B.); and Christiana Care Health System, Newark, DE (W.S.W.).
Insights
Percutaneous coronary intervention (PCI) did not improve long-term survival for stable ischemic heart disease patients compared to optimal medical therapy alone. Extended follow-up to 15 years confirmed no significant survival benefit from adding PCI.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Percutaneous coronary intervention (PCI) is used to relieve angina in stable ischemic heart disease (SIHD).
- Previous clinical trials showed PCI did not improve survival in SIHD patients.
- A study compared optimal medical therapy alone versus optimal medical therapy plus PCI in 2287 SIHD patients.
Purpose of the Study:
- To report the long-term survival rates of patients with stable ischemic heart disease.
- To determine if an initial strategy of PCI plus optimal medical therapy improves survival compared to optimal medical therapy alone.
- To extend the follow-up period of a previous clinical trial to up to 15 years.
Main Methods:
- Survival data was tracked for patients using Social Security numbers via the VA national Corporate Data Warehouse and National Death Index.
- Kaplan-Meier method was used to calculate survival rates.
- Cox proportional-hazards model adjusted for baseline characteristics.
Main Results:
- Extended survival information was available for 1211 patients (53% of the original population).
- The median follow-up was 11.9 years for patients at sites permitting survival tracking.
- A total of 561 deaths occurred: 284 in the PCI group (25%) and 277 in the medical-therapy group (24%), with an adjusted hazard ratio of 1.03 (P=0.76).
Conclusions:
- No significant difference in survival was found between the PCI group and the medical-therapy group after up to 15 years of follow-up.
- An initial strategy of PCI plus optimal medical therapy did not improve survival compared to optimal medical therapy alone in patients with stable ischemic heart disease.
- The findings reinforce that optimal medical therapy is the primary treatment for stable ischemic heart disease.
Background:
Percutaneous coronary intervention (PCI) relieves angina in patients with stable ischemic heart disease, but clinical trials have not shown that it improves survival. Between June 1999 and January 2004, we randomly assigned 2287 patients with stable ischemic heart disease to an initial management strategy of optimal medical therapy alone (medical-therapy group) or optimal medical therapy plus PCI (PCI group) and did not find a significant difference in the rate of survival during a median follow-up of 4.6 years. We now report the rate of survival among the patients who were followed for up to 15 years.
Methods:
We obtained permission from the patients at the Department of Veterans Affairs (VA) sites and some non-VA sites in the United States to use their Social Security numbers to track their survival after the original trial period ended. We searched the VA national Corporate Data Warehouse and the National Death Index for survival information and the dates of death from any cause. We calculated survival according to the Kaplan-Meier method and used a Cox proportional-hazards model to adjust for significant between-group differences in baseline characteristics.
Results:
Extended survival information was available for 1211 patients (53% of the original population). The median duration of follow-up for all patients was 6.2 years (range, 0 to 15); the median duration of follow-up for patients at the sites that permitted survival tracking was 11.9 years (range, 0 to 15). A total of 561 deaths (180 during the follow-up period in the original trial and 381 during the extended follow-up period) occurred: 284 deaths (25%) in the PCI group and 277 (24%) in the medical-therapy group (adjusted hazard ratio, 1.03; 95% confidence interval, 0.83 to 1.21; P=0.76).
Conclusions:
During an extended-follow-up of up to 15 years, we did not find a difference in survival between an initial strategy of PCI plus medical therapy and medical therapy alone in patients with stable ischemic heart disease. (Funded by the VA Cooperative Studies Program and others; COURAGE ClinicalTrials.gov number, NCT00007657.).
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