CREDO-Kyoto: PCI associated
with more serious adverse events than CABG in patients with triple
vessel disease
Results from CREDO-Kyoto PCI/CABG Registry
Cohort-2 presented at the 2011 ESC Congress show that percutaneous
coronary intervention (PCI) was associated with significantly higher
risk for serious adverse events in patients with triple vessel disease
than coronary artery bypass grafting (CABG).
These registry findings, derived from the largest ever study population
of triple vessel disease patients with SYNTAX score assessment,
are consistent with those found in the SYNTAX randomized trial.
However, said Dr. Shiomi, while the observations were striking in
patients with triple vessel disease, the selection of revascularization
strategies in patients with less complex coronary anatomy "deserves
further consideration".
As background to the report, he explained that PCI has been widely
performed in patients with severe coronary disease (such as left
main or triple vessel coronary artery disease) following the introduction
of drug-eluting stents. However, long-term clinical outcomes of
PCI relative to CABG in such patients have not yet been adequately
evaluated. Although three-year results from the SYNTAX trial suggested
that an excess risk of PCI relative to CABG for death, myocardial
infarction or stroke was significant in the triple vessel disease
subset, there were limitations in the apparent lack of statistical
power to evaluate this composite endpoint.
The CREDO-Kyoto (Coronary REvascularization Demonstrating Outcome
Study in Kyoto) PCI/CABG registry cohort-2 is a physician-initiated
non-company sponsored 26-center registry enrolling consecutive patients
having a first coronary revascularization between January 2005 and
December 2007. The study population for the current analysis consisted
of 2981 patients with triple vessel disease (PCI 1825 patients,
and CABG 1156 patients). To ensure comparability between the PCI
and CABG groups (in an observational study), anatomic complexities
of coronary artery disease were assessed by using the SYNTAX score.
The primary endpoint of the study was a composite of all-cause
death, myocardial infarction (MI) and stroke. PCI as compared with
CABG was associated with a higher 3-year risk for this primary endpoint
(adjusted hazard ratio (HR) 1.47 [95% CI 1.13-1.92, P=0.004]) and
for MI (HR 2.39 [95% CI 1.31-4.36, P=0.004]). However, the risk
for cardiac death was not significantly different (HR 1.30 [95%
CI 0.81-2.07, P=0.28]), although the risk for all-cause death was
significantly higher after PCI (HR 1.62 [95% CI 1.16-2.27, P=0.005]).
Results also showed that the cumulative incidence of the primary
endpoint was comparable between the PCI and CABG groups in patients
with low (<23) and intermediate (23-32) SYNTAX scores, but in
patients with high SYNTAX scores (≥33) was markedly higher after
PCI than after CABG (15.8% and 12.5%, P=0.25, 18.8% and 16.7%, P=0.24,
and 27.0% and 16.4%, P=0.004, respectively).
However, the adjusted risk of PCI relative to CABG for the primary
endpoint was HR 1.66 (95% CI 1.04-2.65, P=0.03) in the low-score
category, HR 1.24 (95% CI 0.83-1.85, P=0.29) in the intermediate-score
category, and HR 1.59 (95% CI 0.998-2.54, P=0.051) in the high-score
category. "Further studies are therefore warranted to investigate
whether PCI is a viable option in patients with less complex coronary
anatomy," said Dr. Shiomi.
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