A RANDOMIZED COMPARISON OF CORONARY-STENT PLACEMENT AND BALLOON ANGIOPLASTY IN THE TREATMENT OF CORONARY-ARTERY DISEASE

Background. Coronary-stent placement is a new technique in which a bal loon-expandable, stainless-steel, slotted tube is implanted at the sit e of a coronary stenosis. The purpose of this study was to compare the effects of stent placement and standard balloon angioplasty on angiog raphically detected restenosis and clinical outcomes. Methods. We rand omly assigned 410 patients with symptomatic coronary disease to electi ve placement of a Palmaz-Schatz stent or to standard balloon angioplas ty. Coronary angiography was performed at base line, immediately after the procedure, and six months later. Results. The patients who underw ent stenting had a higher rate of procedural success than those who un derwent standard balloon angioplasty (96.1 percent vs. 89.6 percent, P = 0.011), a larger immediate increase in the diameter of the lumen (1 .72+/-0.46 vs. 1.23+/-0.48 mm, P<0.001), and a larger luminal diameter immediately after the procedure (2.49+/-0.43 vs. 1.99+/-0.47 mm, P<0. 001). At six months, the patients with stented lesions continued to ha ve a larger luminal diameter (1.74+/-0.60 vs. 1.56+/-0.65 mm, P = 0.00 7) and a lower rate of restenosis (31.6 percent vs. 42.1 percent, P = 0.046) than those treated with balloon angioplasty. There were no coro nary events (death; myocardial infarction; coronary-artery bypass surg ery; vessel closure, including stent thrombosis; or repeated angioplas ty) in 80.5 percent of the patients in the stent group and 76.2 percen t of those in the angioplasty group (P = 0.16). Revascularization of t he original target lesion because of recurrent myocardial ischemia was performed less frequently in the stent group than in the angioplasty group (10.2 percent vs. 15.4 percent, P = 0.06). Conclusions. Inselect ed patients, placement of an intracoronary stent, as compared with bal loon angioplasty, results in an improved rate of procedural success, a lower rate of angiographically detected restenosis, a similar rate of clinical events after six months, and a less frequent need for revasc ularization of the original coronary lesion.