Carotid Artery Bypass Graft Better Than Percutaneous Coronary Intervention for Patients With Left Main Disease and/or Severe 3-Vessel Disease: Presented at ESC

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Title: Carotid Artery Bypass Graft Better Than Percutaneous Coronary Intervention for Patients With Left Main Disease and/or Severe 3-Vessel Disease: Presented at ESC
URL: http://www.pslgroup.com/dg/22A986.htm
Doctor's Guide
September 3, 2008

By Chris Berrie

MUNICH, Germany -- September 3, 2008 -- Percutaneous coronary intervention (PCI) does not meet noninferiority criteria versus carotid artery bypass graft (CABG) revascularisation in an all-comers patient population, according to a randomised trial presented here at the European Society of Cardiology 2008 Congress (ESC).

Patrick Serruys, MD, PhD, Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, Netherlands, presented the study results on behalf of the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) investigators.

Recent improvements in both CABG and PCI, "have made it important to reassess the respective values of these 2 revascularisation techniques in an all-comers population," Dr. Serruys said during his presentation on September 1.

With PCI representing around one-third of revascularisation procedures, the aim of the study was to provide an evidence base to determine whether this currently practiced approach is indeed valid.

Patients enrolled in the study had de novo disease, acute myocardial infarction (MI), or concomitant cardiac surgery, and no previous intervention.

Disease was classified according to left-main disease (isolated, +1, +2, or +3 vessels) or 3-vessel disease (revascularisation of all 3 vascular territories).

Initially, 3,075 patients were assessed according to their operative risk and coronary lesion complexity according to new SYNTAX score to indicate optimal revascularisation strategy. Those patients available for both treatment options (n = 1,800) were randomised to CABG or PCI (with paclitaxel-eluting coronary stent).

The 897 patients in the CABG cohort were a mean of 65.0 years old and 78.9% were male; the 903 patients in the PCI cohort were a mean of 65.2 years old and 76.4% were male.

Of note, those selectively assessed for CABG or PCI were entered into 2 registries (CABG, 1,077; PCI, 198) for further separate analysis.

For these randomised patients, the primary clinical endpoint was 12-month major cardiovascular or cerebrovascular event rate (MACCE), defined as all-cause death, cerebrovascular accident (CVA)/ stroke, MI, or repeat vascularisation.

Patients' baseline characteristics were well balanced between the 2 randomised cohorts, Dr. Serruys said, and noted that the total SYNTAX scores were 29.1 for the CABG group and 28.4 for the PCI group.

In the CABG group, 15% had off-pump surgery, with a mean of 2.8 grafts and 3.2 distal anastomoses per patient. In the PCI group, 14.1% had staged procedures, with means of 3.6 lesions treated and 4.6 stents implanted per patient.

At the 12-month assessment for the CABG/PCI groups, significant differences were seen for CVA (2.2%/0.6%; P = .003), repeat revascularisation (5.9%/13.7%; P < .0001), and MACCE (12.1%/17.8%; P = .0015).

Significance was not reached for MI (3.2%/4.8%), all-cause death/CVA/MI (7.7%/7.6%), and symptomatic graft occlusion and stent thrombosis (3.4%/3.3%).

Criteria for the noninferiority analysis were not met for the primary endpoint of MACCE to 12 months for PCI versus CABG.

In an observational subgroup analysis, the primary outcome according to diabetes status (n = 452) showed significantly improved benefit with PCI for patients with diabetes (26.0% vs 14.2%; P = .0025).

"The SYNTAX score will help us in the future to stratify patients for the appropriate revascularisation option," Dr. Serruys concluded.

[Presentation title: The Synergy Between Percutaneous Coronary Intervention and Cardiac Surgery (SYNTAX) Study. Primary Endpoint Results at One Year in the Randomised Cohort. Abstract 1691]

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