Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease.
BACKGROUND
Percutaneous coronary intervention (PCI) involving drug-eluting stents is increasingly used to treat complex coronary artery disease, although coronary-artery bypass grafting (CABG) has been the treatment of choice historically. Our trial compared PCI and CABG for treating patients with previously untreated three-vessel or left main coronary artery disease (or both).


METHODS
We randomly assigned 1800 patients with three-vessel or left main coronary artery disease to undergo CABG or PCI (in a 1:1 ratio). For all these patients, the local cardiac surgeon and interventional cardiologist determined that equivalent anatomical revascularization could be achieved with either treatment. A noninferiority comparison of the two groups was performed for the primary end point--a major adverse cardiac or cerebrovascular event (i.e., death from any cause, stroke, myocardial infarction, or repeat revascularization) during the 12-month period after randomization. Patients for whom only one of the two treatment options would be beneficial, because of anatomical features or clinical conditions, were entered into a parallel, nested CABG or PCI registry.


RESULTS
Most of the preoperative characteristics were similar in the two groups. Rates of major adverse cardiac or cerebrovascular events at 12 months were significantly higher in the PCI group (17.8%, vs. 12.4% for CABG; P=0.002), in large part because of an increased rate of repeat revascularization (13.5% vs. 5.9%, P<0.001); as a result, the criterion for noninferiority was not met. At 12 months, the rates of death and myocardial infarction were similar between the two groups; stroke was significantly more likely to occur with CABG (2.2%, vs. 0.6% with PCI; P=0.003).


CONCLUSIONS
CABG remains the standard of care for patients with three-vessel or left main coronary artery disease, since the use of CABG, as compared with PCI, resulted in lower rates of the combined end point of major adverse cardiac or cerebrovascular events at 1 year. (ClinicalTrials.gov number, NCT00114972.)
Serruys
Patrick W
PW
Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands. p.w.j.c.serruys@erasmusmc.nl
Morice
Marie-Claude
MC
Kappetein
A Pieter
AP
Colombo
Antonio
A
Holmes
David R
DR
Mack
Michael J
MJ
Ståhle
Elisabeth
E
Feldman
Ted E
TE
van den Brand
Marcel
M
Bass
Eric J
EJ
Van Dyck
Nic
N
Leadley
Katrin
K
Dawkins
Keith D
KD
Mohr
Friedrich W
FW
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D002318:Cardiovascular Diseases / Q000453:epidemiology; D001026:Coronary Artery Bypass / Q000009:adverse effects; D003324:Coronary Artery Disease / Q000145:classification / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality; D011446:Prospective Studies; D019233:Retreatment / Q000706:statistics & numerical data; D012720:Severity of Illness Index; D020521:Stroke / Q000401:mortality; D016896:Treatment Outcome