Purpose: We sought to assess whether stenting is a better treatment strategy than percutaneous transluminal coronary angioplasty (PTCA) for lesions in small coronary vessels of diabetic patients.
Methods: We studied the 100 diabetic patients who were enrolled in the Intracoronary Stenting or Angioplasty for Restenosis Reduction in Small Arteries trial; 51 patients were randomly assigned to receive a stent and 49 to PTCA alone. Small vessels were considered those with a reference diameter of 2.0 to 2.8 mm. The primary endpoint of the study was the incidence of restenosis, defined as 50% or greater diameter stenosis at follow-up angiography (performed in 83 of the 100 patients). The secondary endpoint was clinical restenosis, defined as the need for target vessel revascularization within 1 year.
Results: Angiographic restenosis occurred in 18 (44%) of the patients who received a stent and in 19 (45%) of the PTCA patients (P = 0.90). Target vessel revascularization was needed in 13 (25%) of the stent patients and 10 (20%) of the PTCA patients (P = 0.55). During the 1-year follow-up, 5 (10%) of the stent patients died or incurred myocardial infarction, compared with 3 (6%) of the PTCA patients (P = 0.50).
Conclusions: Patients with diabetes who undergo percutaneous coronary interventions for lesions in small vessels have an especially high risk of restenosis that does not appear to be attenuated by stenting.