SYNTAX at 4 Years: PCI and CABG Equivalent in Left Main Disease

SAN FRANCISCO, CALIF.—Four-year results from the SYNTAX trial show that most patients with three-vessel disease continue to derive more benefit from CABG than from PCI. But in patients with left main disease, both treatments remain equally safe and effective over the same period, according to two clinical trial presentations at TCT 2011.

Marie Claude Morice, MD, of Institute Hospitalier Jacques Cartier, Massy, France, concluded that for patients with left main disease, “revascularization with PCI has comparable safety and efficacy outcomes to CABG. PCI is therefore a reasonable treatment alternative in this patient population, in particular, when the Syntax score is low or intermediate.”

SYNTAX-enrolled patients who were eligible for either surgery or PCI were randomized to receive CABG (n=897) or a paclitaxel-eluting stent (n=903; Taxus, Boston Scientific). Initial results from the trial suggested that the overall combined cohort had a significantly higher rate of major adverse cardiac and cerebrovascular events (MACCE) — the primary endpoint; defined as death, stroke, MI and repeat revascularization — with PCI compared with  CABG at 1 year. Therefore, PCI did not meet non-inferiority compared with surgery.

In her presentation of the left main data, Morice showed results similar to the 3-year data in the left main cohort with PCI and CABG producing comparable overall outcomes at 4 years. The rate of stroke was higher with CABG, but repeat revascularization was increased with PCI (see Table 1). The majority of new events occurred in patients with higher Syntax scores.

PCI still inferior with three-vessel disease

Presenting overall results with a breakdown of patients with three-vessel disease, Patrick W. Serruys, MD, PhD, of Erasmus Medical Center, Rotterdam, the Netherlands, showed that CABG patients experienced superior results at 4 years. Repeat revascularization, death and MI were all higher with PCI. These differences translated into a significantly increased MACCE rate vs. CABG (see Table 2).

Similar to 3-year results, three-vessel disease patients with intermediate (23-32) and high (≥ 33) Syntax scores also experienced higher rates of death, MI and repeat revascularization compared with PCI (see Table 3). Surgical results were unaffected by lesion complexity.

TCT Course Director and session moderator Gregg W. Stone, MD, of Columbia University Medical Center, New York, NY, called the three-vessel results “relatively sobering,” and Dr. Serruys concluded that CABG should remain the standard of care for patients with complex disease, or those with intermediate or high Syntax scores. “However, PCI may be an acceptable alternative revascularization method to CABG when treating patients with lower Syntax scores and less complex disease, including left main disease,” he said, adding that SYNTAX patients will continue to be followed for 1 more year.