Optimal medical therapy with or without PCI for stable coronary disease.
BACKGROUND
In patients with stable coronary artery disease, it remains unclear whether an initial management strategy of percutaneous coronary intervention (PCI) with intensive pharmacologic therapy and lifestyle intervention (optimal medical therapy) is superior to optimal medical therapy alone in reducing the risk of cardiovascular events.


METHODS
We conducted a randomized trial involving 2287 patients who had objective evidence of myocardial ischemia and significant coronary artery disease at 50 U.S. and Canadian centers. Between 1999 and 2004, we assigned 1149 patients to undergo PCI with optimal medical therapy (PCI group) and 1138 to receive optimal medical therapy alone (medical-therapy group). The primary outcome was death from any cause and nonfatal myocardial infarction during a follow-up period of 2.5 to 7.0 years (median, 4.6).


RESULTS
There were 211 primary events in the PCI group and 202 events in the medical-therapy group. The 4.6-year cumulative primary-event rates were 19.0% in the PCI group and 18.5% in the medical-therapy group (hazard ratio for the PCI group, 1.05; 95% confidence interval [CI], 0.87 to 1.27; P=0.62). There were no significant differences between the PCI group and the medical-therapy group in the composite of death, myocardial infarction, and stroke (20.0% vs. 19.5%; hazard ratio, 1.05; 95% CI, 0.87 to 1.27; P=0.62); hospitalization for acute coronary syndrome (12.4% vs. 11.8%; hazard ratio, 1.07; 95% CI, 0.84 to 1.37; P=0.56); or myocardial infarction (13.2% vs. 12.3%; hazard ratio, 1.13; 95% CI, 0.89 to 1.43; P=0.33).


CONCLUSIONS
As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy. (ClinicalTrials.gov number, NCT00007657 [ClinicalTrials.gov].).
Boden
William E
WE
Western New York Veterans Affairs Healthcare Network and Buffalo General Hospital-SUNY, Buffalo, NY 14203, USA. wboden@kaleidahealth.org
O'Rourke
Robert A
RA
Teo
Koon K
KK
Hartigan
Pamela M
PM
Maron
David J
DJ
Kostuk
William J
WJ
Knudtson
Merril
M
Dada
Marcin
M
Casperson
Paul
P
Harris
Crystal L
CL
Chaitman
Bernard R
BR
Shaw
Leslee
L
Gosselin
Gilbert
G
Nawaz
Shah
S
Title
Lawrence M
LM
Gau
Gerald
G
Blaustein
Alvin S
AS
Booth
David C
DC
Bates
Eric R
ER
Spertus
John A
JA
Berman
Daniel S
DS
Mancini
G B John
GB
Weintraub
William S
WS
D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use; D000368:Aged; D000787:Angina Pectoris / Q000628:therapy; D015906:Angioplasty, Balloon, Coronary; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D000924:Anticholesteremic Agents / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000627:therapeutic use; D003131:Combined Modality Therapy; D003327:Coronary Disease / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000517:prevention & control*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D016016:Proportional Hazards Models; D012307:Risk Factors; D020521:Stroke / Q000453:epidemiology
D000319:Adrenergic beta-Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D000924:Anticholesteremic Agents; D000959:Antihypertensive Agents; D010975:Platelet Aggregation Inhibitors