Comparison of stenting with balloon angioplasty for lesions of small coronary vessels in patients with diabetes mellitus

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.