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Coronary Disease2009New England Journal of Medicine

SYNTAX

Synergy Between PCI with Taxus and Cardiac Surgery

Sample Size
1,800
Study Design
Multicenter, randomized, open-label, noninferiority trial
Year Published
2009
Category
Coronary Disease

Clinical Question

Is PCI with drug-eluting stents noninferior to CABG in patients with three-vessel or left main coronary artery disease?

Population

Patients with previously untreated three-vessel or left main coronary artery disease deemed suitable for either PCI or CABG by a Heart Team.

Intervention

PCI with first-generation paclitaxel-eluting stents (TAXUS Express)

Control

Coronary artery bypass grafting (CABG)

Primary Endpoint

Major adverse cardiac and cerebrovascular events (MACCE): death, stroke, myocardial infarction, or repeat revascularization at 12 months

Key Findings

1

PCI did not meet noninferiority: 12-month MACCE was 17.8% in PCI vs 12.4% in CABG (p=0.002 for superiority of CABG).

2

The difference was driven primarily by higher repeat revascularization rates with PCI (13.5% vs 5.9%).

3

In patients with low SYNTAX scores (0-22), outcomes were similar between PCI and CABG.

4

At 5 years, MACCE was 37.3% with PCI vs 26.9% with CABG, with higher mortality in PCI for three-vessel disease (p=0.02).

5

The SYNTAX score emerged as a validated anatomical scoring tool to guide revascularization decisions.

Impact on Clinical Practice

SYNTAX was a landmark trial that redefined the approach to complex coronary artery disease. Rather than establishing PCI as equivalent to CABG, it demonstrated that CABG remained the gold standard for patients with complex three-vessel and left main disease, particularly those with higher anatomic complexity. The trial's most enduring legacy is the SYNTAX score, an anatomical grading system that quantifies coronary lesion complexity. This score became a cornerstone of clinical decision-making, helping Heart Teams identify which patients are best served by PCI versus CABG. Low SYNTAX scores indicated favorable PCI outcomes, while high scores favored surgery. SYNTAX fundamentally established the principle that revascularization strategy should be tailored to individual anatomy and risk, rather than applied uniformly. It reinforced the role of the Heart Team in making collaborative decisions and generated a robust framework that informed all subsequent trials comparing PCI and CABG.

Guideline Impact

SYNTAX directly shaped ACC/AHA Class I recommendations for CABG in three-vessel disease and was incorporated into the ESC/EACTS guidelines for myocardial revascularization. The SYNTAX score became a required element in guideline-recommended Heart Team decision-making.

Limitations

First-generation drug-eluting stents were used; newer-generation stents have lower restenosis and thrombosis rates, potentially narrowing the gap.

The SYNTAX score does not account for clinical variables such as diabetes, left ventricular function, or patient frailty.

The open-label design may have introduced bias in the management of postprocedural care and event adjudication.

Reviewed by Sandeep M. Patel, MD
Structural & Interventional Cardiologist

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