Direct stenting compared to conventional stenting in Diabetic Patients Undergoing Elective Angioplasty for Coronary Artery Disease (DECIDE): a multicenter, open label, randomized, controlled efficacy study.

Background: Direct stenting (DS) has been shown to be associated with reduced radiation exposure and procedural costs but has a restenosis rate and clinical outcomes similar to conventional stenting (CS) with balloon predilatation. Whether DS confers benefit in diabetic patients, who have been shown to have high restenosis risk after stent implantation, remains unknown.

Methods: In a multicenter randomized trial, diabetic patients undergoing elective coronary stent implantation for a de novo lesion in a native coronary artery between April 2001 and October 2002 were randomized into DS or CS treatment groups. All patients received NirElite stents (SciMed, Boston Scientific, Maple Grove, Minn). They were scheduled to undergo a 6-month angiographic follow-up with quantitative coronary analysis evaluation. The primary end point was a 6-month binary restenosis rate and the secondary end point involved 6-month all-cause mortality, nonfatal acute myocardial infarction, or target vessel revascularization rates.

Results: A total of 128 diabetic patients were randomized into DS or CS treatment groups (n = 64, both groups). The 2 groups were well matched in baseline and lesion characteristics. The procedural success rate was similar (DC vs CS; 98.4% vs 96.9%). Nineteen patients (29.7%) crossed over from DS to CS. Six-month angiographic follow-up showed similar restenosis rates, minimum luminal diameter and late lumen loss. The binary restenosis rate was 43% in DS and 52% in CS groups (P = NS). The 6-month all-cause mortality, nonfatal acute myocardial infarction, or target vessel revascularization rates were also similar in both groups.

Conclusions: Among diabetic patients undergoing elective coronary stent implantation, DS is safe and feasible. However, it is not associated with reduction in restenosis rate or improvement in clinical outcomes when compared with CS.