Coronary Artery Bypass Grafting vs. Percutaneous Coronary Intervention for Patients With Three-vessel Disease: Final Five-year Follow-up of the SYNTAX Trial

Stuart J. Head; Piroze M. Davierwala; Patrick W. Serruys; Simon R. Redwood; Antonio Colombo; Michael J. Mack; Marie-Claude Morice; David R. Holmes Jr; Ted E. Feldman; Elisabeth Ståhle; Paul Underwood; Keith D. Dawkins; A. Pieter Kappetein; Friedrich W. Mohr

Disclosures

Eur Heart J. 2014;35:2821-2830. 

In This Article

Abstract and Introduction

Abstract

Aims Coronary artery bypass grafting (CABG) has been considered the standard of care for patients with three-vessel disease (3VD), but long-term comparative results from randomized trials of CABG vs. percutaneous coronary intervention (PCI) using drug-eluting stents (DES) remain limited.

Methods and results Patients with de novo 3VD or left main disease were randomly assigned to PCI with the paclitaxel-eluting first-generation stent or CABG in the SYNTAX trial. This pre-specified analysis presents the 5-year outcomes of patients with 3VD (n = 1095). The rate of major adverse cardiac and cerebrovascular events (MACCE) was significantly higher in patients with PCI compared with CABG (37.5 vs. 24.2%, respectively; P < 0.001). Percutaneous coronary intervention as opposed to CABG resulted in significantly higher rates of the composite of death/stroke/myocardial infarction (MI) (22.0 vs. 14.0%, respectively; P < 0.001), all-cause death (14.6 vs. 9.2%, respectively; P = 0.006), MI (9.2 vs. 4.0%, respectively; P = 0.001), and repeat revascularization (25.4 vs. 12.6%, respectively; P < 0.001); however, stroke was similar between groups at 5 years (3.0 vs. 3.5%, respectively; P = 0.66). Results were dependent on lesion complexity (P for interaction = 0.12); in patients with a low (0–22) SYNTAX score, PCI vs. CABG resulted in similar rates of MACCE (33.3% vs. 26.8%, respectively; P = 0.21) but significantly more repeat revascularization (25.4% vs. 12.6%, respectively; P = 0.038), while in intermediate (23–32) or high (≥33) SYNTAX score terciles, CABG demonstrated clear superiority in terms of MACCE, death, MI, and repeat revascularization. Differences in MACCE between PCI and CABG were larger in diabetics [hazard ratio (HR) = 2.30] than non-diabetics (HR = 1.51), although the P for interaction failed to reach significance for MACCE (P for interaction = 0.095) or any of the other endpoints.

Conclusion Five-year results of patients with 3VD treated with CABG or PCI using the first-generation paclitaxel-eluting DES suggest that CABG should remain the standard of care as it resulted in significantly lower rates of death, MI, and repeat revascularization, while stroke rates were similar. For patients with low SYNTAX scores, PCI is an acceptable revascularization strategy, although at a price of significantly higher rates of repeat revascularization.

Introduction

Because of the rapid progress in percutaneous coronary intervention (PCI) technology from balloon angioplasty to bare-metal stents (BMS) and subsequently drug-eluting stents (DES), several randomized clinical trials have been conducted over the last two decades to compare the outcomes of PCI with coronary artery bypass grafting (CABG), which has been considered the 'gold standard' for treatment of multivessel stable coronary artery disease (CAD).[1,2] Consistent improvements in outcomes of PCI led to a wider spectrum of patients being treated with PCI, including those with more complex CAD.

The SYNTAX trial, which is one of the most recent and largest randomized controlled trials comparing PCI using the paclitaxel-eluting first-generation stent with CABG, aimed at providing the best possible evidence to determine the most appropriate treatment option for patients encountered by surgeons and interventional cardiologists in their 'real-world' daily practice. The trial failed to establish non-inferiority of PCI to CABG for the treatment of left main (LM) and/or three-vessel disease (3VD) at 1 year, because of significantly higher rates of major adverse cardiac and cerebrovascular events (MACCE) after PCI.[3] However, the data demonstrated considerable variation in the treatment effect of PCI, especially with reference to the pre-specified subgroups of LM or 3VD, and complexity of CAD as determined by the SYNTAX score.[3] Based on these 1 year results, both European and North-American guidelines recommend PCI as a valuable treatment option for patients with LM disease and an alternative to CABG in patients with less complex 3VD (SYNTAX score < 23).[4,5]

For judicious decision-making, it is essential to consider the risk/benefit ratios of PCI and CABG for 3VD; weighing procedural invasiveness and the associated short-term complications against long-term event rates of death, myocardial infarction (MI), repeat revascularization, and improvements in health-related quality of life.[6] The present report therefore presents a comprehensive analysis of the 5-year outcomes of the predefined 3VD subgroup of patients receiving PCI or CABG in the SYNTAX trial.

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