A prospective randomized trial comparing stenting to internal mammary artery grafting for proximal, isolated de novo left anterior coronary artery stenosis: The SIMA trial

Objective: To compare coronary artery bypass grafting (CABG) with percutane ous transluminal coronary angioplasty (PTCA) in patients with proximal, iso lated de novo left anterior descending coronary artery disease and left ven tricular ejection fraction of 45 %. Patients and Methods: In the multicenter Stenting vs Internal Mammary Arter y (SIMA) study, patients were randomly assigned to PTCA and stent implantat ion or to CABG (using the internal mammary artery). The primary clinical co mposite end point was event-free survival, including death, myocardial infa rction, and the need for additional revascularization, Secondary end points were Functional class, antianginal treatment, and quality of life, Analyse s were by intention to treat. Results: Of 123 patients who accepted randomization, 59 underwent CABG, and 62 were treated with stent implantation (2 patients were excluded because of protocol violation), At a mean +/- SD follow-up of 2.4+/-9 years, a prim ary end point had occurred in 19 patients (31%) in the stent group and in 4 (7%) in the CABG group (P<.001). This significant difference in clinical o utcome is due to a higher incidence of additional revascularization in the stent group, the incidence of death and myocardial infarction being similar (7% vs 7%, respectively; P=.90). The functional class, need for antiangina l drug, and quality-of-life assessment show ed no significant differences. Conclusions: Both stent implantation and CABG are safe and highly effective treatments to relieve symptoms in patients with isolated, proximal left an terior descending coronary artery stenosis, Both are associated with a low and comparable incidence of death and myocardial infarction, However, simil ar to PTCA alone, a percutaneous approach using elective stent placement re mains hampered by a higher need for repeated intervention because of resten osis.