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Long-term outcomes better with CABG than PCI in pts with complex CAD (SYNTAX)

Clinical Question:
Do patients with complex coronary artery disease treated with coronary artery bypass graft surgery have better long-term outcomes than patients treated with percutaneous interventions?

Bottom Line:
In patients with newly diagnosed left main and three-vessel coronary artery disease, the long-term outcomes of those treated with coronary artery bypass graft surgery (CABG) are better than those treated with percutaneous coronary interventions (PCI) with drug-eluting stents. Since this study did not include medical therapy, we can't draw any firm conclusions about the full spectrum of potential treatments. (LOE = 1b)

Reference:
Mohr FW, Morice MC, Kappetein AP, et al. Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. Lancet 2013;381(9867):629-638.  [PMID:23439102]

Study Design:
Randomized controlled trial (nonblinded)

Funding:
Industry

Setting:
Inpatient (any location) with outpatient follow-up

Synopsis:
These authors present 5-year follow-up data from the SYNTAX trial (a very tortured acronym derived from the formal title, "SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery") of patients with "de novo" three-vessel disease or left main disease who were deemed equally suitable for surgery or PCI. The authors don't define if "de novo" meant newly detected or if the patients had acute coronary syndromes. Since patients with otherwise stable coronary artery disease and normal left ventricular function fare just as well as those treated with CABG or PCI, this is an important omission. Once all the eligibility stuff took place, the researchers assigned the patients to receive either CABG or PCI. In this case, the PCI included the use of drug-eluting stents produced by the study sponsor. The investigators used intention-to-treat analysis to evaluate the composite end point (long-term readers know how I hate composite end points!) of all-cause mortality, stroke, myocardial infarction, and repeat revascularization. The initial study randomized 897 patients to CABG and 903 patients to PCI. After 5 years, the researchers were able to evaluate 90% of the CABG-treated patients and 96% of the PCI-treated patients. At that time, approximately 25% of the CABG group and 33% of the PCI group experienced the composite outcome (number needed to treat = 10). In a potentially self-serving attempt to salvage PCI, the authors did a subgroup analysis that was not reported as a goal at ClinicalTrials.gov. They used a scoring system designed to classify the complexity of coronary lesions and reported that patients with less complex disease treated with PCI might do as well as those treated with CABG. Subgroup analyses are problematic from many perspectives. First, the more analyses one performs, the more likely the results will look significant just by chance alone. Second, the literature is replete with reporting bias in favor of those subgroup analyses that are positive, but subsequently not supported by properly conducted studies. The appropriate place for these kinds of subgroup analyses is in the generation of hypotheses to guide future studies and not to guide treatment decisions.

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