A randomized trial of stenting with or without balloon predilation for the treatment of coronary artery disease.

BACKGROUND: Stent placement has historically been preceded by predilation of the target lesion with percutaneous transluminal coronary angioplasty. Direct stent implantation, without predilation, has the potential to have a favorable impact on procedure cost by reducing the number of devices used, contrast administered, and procedure time. METHODS AND RESULTS: We conducted a prospective randomized trial to compare the economic outcome of stenting with or without predilation. Inclusion criteria included intention to treat a single lesion with a coronary stent in a vessel with a reference diameter >2.4 mm. Exclusion criteria included total occlusions, culprit lesion within a saphenous vein graft, lesion length >25 mm, patients within 48 hours of an acute myocardial infarction, and patients unable to be treated with aspirin and clopidogrel. From September 1999 to March 2000, 77 patients were randomized to direct stent implantation (n = 37) or balloon-facilitated stenting (n = 40). Stent placement was successful in all patients. Crossover to predilation was required in 2 patients in the direct stent group because of inability to deliver the stent. Compared with balloon-facilitated stenting, direct stenting used fewer catheter devices (1.4 +/- 0.7 vs 2.5 +/- 0.8, P <.001), less contrast (92.7 +/- 43.1 mL vs 117.4 +/- 61.0 mL, P =.04), and less fluoroscopy time (7.5 +/- 3.9 minutes vs 11.6 +/- 8.3 minutes, P =.006). No difference in procedural complications or predischarge outcome was found. No difference in major adverse cardiovascular events was found at 6-month follow-up. CONCLUSION: Direct stenting is a safe and successful procedure that reduces the number of devices used, fluoroscopy time, and contrast administration.