SYNTAX: have drug-eluting stents removed the “death penalty” associated with diabetes and multivessel PCI? Reply

A study of the 1-year results of diabetics enrolled in SYNTAX shows, as expected, that diabetic patients treated with a Taxus stent have a higher rate of revascularization than their counterparts randomized to surgery, but has somewhat unexpectedly found no significant differences in the composite safety end point of death, stroke, or MI. “Although further study is needed,” write the SYNTAX investigators, “these exploratory results may extend the evidence base for DES use (particularly PES) in selected diabetic and nondiabetic patients with left main and/or 3-vessel disease.” The new SYNTAX diabetes paper appears in JACC.

Diabetic patients account for 452 of the 1,800 patients randomized to the ongoing, 5-year SYNTAX (SYNergy Between Percutaneous Coronary Intervention With TAXus and Cardiac Surgery) study. The significance of the one-year and two-year results have been hotly debated.

Here are the main results of the new report:

CABG vs PES: Death/stroke/MI

  • nondiabetics: 6.8% vs 6.8%
  • diabetics: 10.3% vs 10.1%

CABG vs PES: mortality in diabetics with highly complex lesions

  • 4.1% vs 13.5%

CABG vs PES: revascularization

  • nondiabetics: 5.7% vs 11.1%
  • diabeteics: 6.4% vs 20.3%

On the basis of SYNTAX, asks  Harold Dauerman in an accompanying editorial, have drug eluting stents “removed the ‘death penalty’ associated with diabetes and multivessel PCI?” He notes that multivessel PCI is already being performed in diabetic patients, in many cases because of a fear of stroke if CABG is chosen or because of anatomic challenges to CABG. “The SYNTAX study diabetes analysis does not tell those clinicians to stop doing PCI in diabetic patients,” he writes. However, it should only be done in patients in whom “there is no reasonable surgical option.” He further notes that “it is possible that a death penalty is not seen at 1 year but will appear at longer follow-up periods.”

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