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SAN FRANCISCO -- Surgery still trumps stenting for treatment of patients with three-vessel coronary artery disease (CAD), but for patients with left-main disease stents offer "similar health outcomes as CABG at a lower long-term cost," researchers reported here.
That was the take home at 5 years from the SYNTAX (Synergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery) trial reported during a twilight session at the Transcatheter Cardiovascular Therapeutics meeting.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
- For most patients with three-vessel CAD, CABG provides better long-term clinical outcomes than drug eluting stent PCI at a reasonable cost. However, for patients with less complex CAD (including left-main disease), PCI with drug eluting stents provides similar health outcomes as CABG at a lower long-term cost.
The goal of this "final" analysis was to compare cost-effectiveness for U.S. patients expressed as cost per quality adjusted life-year gained, said
Cohen estimated that the U.S. spends roughly $15 billion for surgery or stenting of coronary artery disease.
For example, in SYNTAX each stent cost about $1,500 and each patient received four to five stents, thus the procedural costs for stenting were higher than the procedural costs for surgery: $11,919 ± $6,162 versus $8,504± $1,972.
But surgery required a longer hospitalization and had a higher rate of early complications (including a higher early stroke rate) so the out-the-door cost for CABG was significantly higher -- $33,190, which was $10,036 more than the total bill for stent patients (P<0.001).
At 5 years, looking at cost alone, the numbers still favored stenting, but the difference had narrowed to $5,619 because stented patients were more likely to require repeat procedures.
However, the big advantage for bypass was in life-years gained, "0.100 versus 0.44 at 5 years," Cohen said.
The conclusion, therefore, was undeniable: "for the majority of patients with three-vessel CAD, CABG provides better long-term clinical outcomes than DES-PCI at a cost that represents an attractive use of societal healthcare resources."
One subset of patients with less severe disease -- including those with left-main disease -- did have 5 year outcomes that mirrored those of the bypass patients, Cohen said, noting that this same pattern was shown in early SYNTAX follow-up analyses.
of Erasmus University in Rotterdam, who moderated the panel where Cohen reported the analysis, suggested that future analyses might benefit from using real world comparisons such as "dealing with the discomfort from surgery for several months versus concerns about repeat procedures." Serruys chaired the SYNTAX trial.
SYNTAX was an all-comers trial that recruited 3,075 patients, but only 1,800 met the criterion of being healthy enough to have either stenting or surgery. The other 1,275 patients were assigned to registry arms -- 1,077 to CABG and 198 to stenting.
Stent patients were treated with a first generation paclitaxel-eluting stent (TAXUS), made by Boston Scientific, which funded the trial.
At 12 months in SYNTAX, 17.8% of percutaneous intervention patients reached the combined endpoint -- myocardial infarction, stroke, death, or revascularization -- versus 12.1% of the CABG patients, a 5.7% difference that was statistically significant (P=0.0015).
That difference was significantly less than previous studies comparing surgery to PCI, but it did not meet the prespecified 8.3% difference required for non-inferiority, the "holy grail" for interventionalists.
Disclosures
SYNTAX was funded by Boston Scientific.
Cohen and Surreys were both investigators for SYNTAX.
Primary Source
Transcatheter Cardiovascular Therapeutics
Source Reference: Cohen, D et al "Cost-effectiveness of pci with DES vs. CABG for patients with 3-vessel and left main disease: Final results from the SYNTAX trial" TCT 2013.