Retroinfusion-supported stenting in high-risk patients for percutaneous intervention and bypass surgery: results of the prospective randomized myoprotect I study.

The objective of this study was to assess event-free survival and total treatment costs of retroinfusion-supported stenting in high-risk patients compared to bypass surgery. An increasing number of patients with main-stem and main-stem-equivalent stenosis are treated by stent implantation, which appears to be safe in the short-term follow-up. However, there is a lack of randomized studies comparing conventional bypass surgery with stent implantation, particularly in patients with high risk for both treatments. We here report on the 1-year results of a prospective randomized single-center study in patients with symptomatic main-stem and main-stem-equivalent lesions with substantially increased risk for bypass surgery. Patients where randomized to undergo either percutaneous transluminal coronary angioplasty/stent procedure (n = 23) or bypass surgery (n = 21). Patients randomized to stent implantation were supported by selective pressure-regulated retroinfusion of the anterior cardiac vein during ischemia. Patients of the stent group and the bypass group did not differ in baseline characteristics, including Parsonnet score and quality-of-life score. Twenty-eight-day mortality and 1-year mortality rate as well as quality-of-life scores were similar in both groups. Event-free survival after 1 year was higher in the bypass group (71.4% vs. 52.3%; P = 0.02) due to a lower target lesion revascularization rate. With regard to total treatment costs, however, the stent group compared favorably to the bypass group (9,346 +/- 807 vs. 26,874 +/- 3,985 euro), predominantly as a result of a shorter intensive care and hospital stay. In this first randomized study in high-risk patients for stent implantation and bypass surgery, patients with retroinfusion-supported stent implantation had a similar 1-year outcome and quality of life compared to patients with bypass surgery. Though in the stent group event-free survival was lower and target lesion revascularization rate was higher, retroinfusion-supported stent implantation was associated with substantially lower costs and might be considered as an alternative treatment option in this selected group of high-risk patients. Copyright 2004 Wiley-Liss, Inc.

RCT Entities:   Population Interventions Outcomes