Randomized comparison of coronary stent implantation and balloon angioplasty in the treatment of de novo coronary artery lesions (START): a four-year follow-up.

OBJECTIVE The purpose of this study was to test the hypothesis that stent implantation in de novo coronary artery lesions would result in lower restenosis rates and better long-term clinical outcomes than balloon angioplasty. BACKGROUND Placement of an intracoronary stent, as compared with balloon angioplasty, has proven to reduce the rate of restenosis. However, the long-term clinical benefit of stenting over angioplasty has not been assessed in large randomized trials. METHODS We randomly assigned 452 patients with either stable (129 patients) or unstable (323 patients) angina pectoris to elective stent implantation (229 patients) or standard balloon angioplasty (223 patients). Coronary angiography was performed at baseline, immediately after the procedure and six months later. End points were the rate of restenosis at six months and a composite of death, myocardial infarction (MI) and target vessel revascularization over four years of follow-up. RESULTS Procedural success rate was achieved in 84% and 95% (balloon angioplasty vs. stent, respectively). The increase in the minimal luminal diameter was greater in the stent group both after the intervention (2.02 +/- 0.6 mm vs. 1.43 +/- 0.6 mm in the angioplasty group; p < 0.0001), and at six-month follow-up (1.98 +/- 0.7 mm vs. 1.63 +/- 0.7 mm; p < 0.001). The corresponding restenosis rates were 22% and 37%, respectively (p < 0.002). After four years, no differences in mortality (2.7% vs. 2.4%) and nonfatal MI (2.2% vs. 2.8%) were found between the stent and the angioplasty groups, respectively. However, the requirement for further revascularization procedures of the target lesions was significantly reduced in the stent group (12% vs. 25% in the angioplasty group; relative risk 0.49, 95% confidence interval 0.32 to 0.75, p = 0.0006); most of the repeat procedures (84%) were carried out within six months of entry into the study. CONCLUSIONS Patients who received an intracoronary stent showed a lower rate of restenosis than those treated with conventional balloon angioplasty. The benefit of stenting was maintained four years after implantation, as manifested by a significant reduction in the need for repeat revascularization.