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SYNTAXES: No mortality difference at 10 years with PCI or CABG

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PARIS — Ten-year follow-up data from the SYNTAXES trial highlight no significant difference in all-cause death among patients who underwent PCI using first-generation paclitaxel-eluting stents or CABG.

At 10 years, the rate of all-cause death was 27% following PCI vs. 24% following CABG (HR = 1.17; 95% CI, 0.97-1.41; P = .092) in the overall cohort of 1,800 randomized patients, Daniel J.F.M. Thuijs, MD, MSc, from the department of cardiothoracic surgery at Erasmus Medical Center in Rotterdam, the Netherlands, reported at the European Society of Cardiology Congress.

However, at 10 years, “CABG provided a significant survival benefit in patients with three-vessel disease compared with PCI,” Thuijs said during a press conference.

In patients with three-vessel disease, 28% died following PCI vs. 21% following CABG (HR = 1.41; 95% CI, 1.1-1.8). The same benefit was not observed in patients with left main CAD, 26% of whom died following PCI vs. 28% following CABG (HR = 0.9; 95 CI, 0.68-1.2; P for interaction = .019).

Additionally, the researchers found no interaction in subgroups including patients with diabetes (P for interaction = .66), nor did they find a linear trend across SYNTAX score tertiles (P for trend = .03), according to the results.

SYNTAX was a noninferiority trial that compared PCI and CABG in patients with de novo three-vessel or left main CAD. A total of 1,800 patients were randomly assigned to undergo PCI with first-generation paclitaxel-eluting stents (Taxus, Boston Scientific) or CABG from March 2005 to April 2007. The trial was conducted at 85 hospitals in 18 countries in North America and Europe.

The SYNTAX Extended Survival, or SYNTAXES, trial is the investigator-initiated extended follow-up of SYNTAX.

The 10-year extended survival data build upon previous data, which showed that 13.9% of the PCI group and 11.4% of the CABG group had died at 5 years (P = .1). Further, preliminary 10-year results of SYNTAXES on 72.3% of the cohort, previously presented at TCT 2018 and reported by Healio, demonstrated no significant difference in survival between CABG and PCI, with the same CABG survival benefit in patients with three-vessel disease.

At ESC Congress, Thiujs presented data for 94% of the overall cohort.

“This is the first and largest randomized trial that reports 10-year all-cause death after PCI with drug-eluting stents vs. CABG in patients with de novo three-vessel and/or left main disease,” he said here. “More longer-term follow-up of contemporaneous trials on PCI vs. CABG is warranted.” – by Katie Kalvaitis

References:

Thuijs DJFM. Hot Line Session 4. Presented at: European Society of Cardiology Congress; Aug. 31-Sept. 4, 2019; Paris.

Thuijs DJFM, et al. Lancet. 2019;doi:10.1016/S0140-6736(19)31997-X.

Disclosures: Thuijs reports no relevant financial disclosures. Please see the full study for the other authors’ relevant financial disclosures.