Objectives: To review the currently available data from studies assessing feasibility, safety, clinical outcome and cost-effectiveness of direct stenting.
Background: With technical advances of stent designs and their delivery systems a new strategy has become increasingly popular: direct stent implantation without prior balloon dilatation.
Methods: The Medline database was searched from January 1996 to March 2001 for clinical trials investigating direct stenting using the index terms direct stenting, coronary intervention, percutaneous transluminal coronary angioplasty (PTCA), PCI, angioplasty and ischemic heart disease. Studies were chosen based on the number of patients involved and endpoints mentioned. Data not yet published but presented at recent international meetings were also included. A comparison between direct stenting and stenting with predilatation was performed using for the latter results of the randomized trials supplemented with Benestent II data.
Results: At least 26 studies have investigated direct stenting, showing high primary and final success rates with few complications. Direct stenting provides a way to reduce costs, shorten procedural and fluoroscopy times and lower material consumption. Immediate and long-term clinical outcomes appear to be similar to stenting with predilatation. Preliminary results of large randomized trials with angiographic follow-up indicate that restenosis rates are similar to those of conventional stenting strategies.
Conclusions: Direct stenting compared with stenting with predilatation is feasible, safe, faster and more cost-effective. The evidence to date shows similar late outcomes.