Design of a registry to characterize "real-world" outcomes of percutaneous coronary revascularization in the drug-eluting stent era.

BACKGROUND: Clinical trials have shown drug-eluting stents (DES) to be superior to bare metal stents (BMS) in preventing in-stent restenosis and target vessel revascularization. Although these results have ushered in a sea change in the practice of myocardial revascularization, important questions remain unanswered concerning rates of ischemic complications when DES are used in a broader population not represented in the clinical trials. STUDY DESIGN: The EVENT registry will include 7500 to 10,000 patients enrolled at approximately 60 sites across the United States. The intent of the registry is to characterize a population of consecutive patients undergoing percutaneous coronary intervention with stent deployment using BMS and DES in terms of processes and outcomes of care. A unique aspect of EVENT is the prospective assessment of rates of periprocedural myocardial infarction among all patients. These data will allow us to compare rates of periprocedural myocardial infarction and other ischemic complications between patients receiving DES and BMS. In addition, the EVENT registry will characterize temporal changes in the patterns of DES use and the relationship between any such changes and both short- and long-term outcomes.

Cutting balloon angioplasty for the prevention of restenosis: results of the Cutting Balloon Global Randomized Trial.

The cutting balloon (CB) is a specialized device designed to create discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Such controlled dilatation theoretically reduces the force needed to dilate an obstructive lesion compared with standard percutaneous transluminal coronary angioplasty (PTCA). We report a multicenter, randomized trial comparing the incidence of restenosis after CB angioplasty versus conventional balloon angioplasty in 1,238 patients. Six hundred seventeen patients were randomized to CB treatment, and 621 to PTCA. The mean reference vessel diameter was 2.86 +/- 0.49 mm, mean lesion length 8.9 +/- 4.3 mm, and prevalence of diabetes mellitus in patients was 13%. The primary end point, the 6-month binary angiographic restenosis rate, was 31.4% for CB and 30.4% for PTCA (p = 0.75). Acute procedural success, defined as the attainment of <50% diameter stenosis without in-hospital major adverse cardiac events, was 92.9% for CB and 94.7% for PTCA (p = 0.24). Freedom from target vessel revascularization was slightly higher in the CB arm (88.5% vs 84.6%, log-rank p = 0.04). Five coronary perforations occurred in the CB arm only (0.8% vs 0%, p = 0.03). At 270 days, rates of myocardial infarction, death, and total major adverse cardiac events for CB and PTCA were 4.7% versus 2.4% (p = 0.03), 1.3% versus 0.3% (p = 0.06), and 13.6% versus 15.1% (p = 0.34), respectively. In summary, the proposed mechanism of controlled dilatation did not reduce the rate of angiographic restenosis for the CB compared with conventional balloon angioplasty. CB angioplasty should be reserved for difficult lesions in which controlled dilatation is believed to provide a better acute result compared with balloon angioplasty alone.