Impact of in-stent minimal lumen area at 9 months poststent implantation on 3-year target lesion revascularization-free survival: a serial intravascular ultrasound analysis from the TAXUS IV, V, and VI trials.

BACKGROUND Intravascular ultrasound (IVUS) is used to assess intermediate lesions in native coronary arteries; minimum lumen area (MLA) <4.0 mm(2) is accepted as a cutoff for a significant stenosis. We evaluated the IVUS in-stent MLA at 9-month follow-up that best predicted subsequent target lesion revascularization (TLR)-free survival in patients from the TAXUS IV, V, and VI studies. METHODS AND RESULTS In the combined TAXUS IV, V, and VI randomized trials, 9-month IVUS was available in 635 patients (331 treated with paclitaxel-eluting stents [PES] and 304 treated with bare-metal stents [BMS]) who did not require TLR in the first 9 months postintervention and who were followed for 3 years. The in-stent MLA that best predicted 3-year TLR-free survival was determined. At 9-months follow-up, IVUS-measured in-stent MLA was 5.7 + or -2.3 mm(2) in the PES group and 4.8 + or - 2.3 mm(2) in the BMS group. Between 9 months and 3 years, TLR was required in 4.9% of patients who were treated with PES and 6.7% of patients who were treated with BMS. Multivariate analysis identified MLA at 9 months as a significant predictor of late TLR (hazard ratio, 0.63 [0.43-0.93]; P = 0.02). The ability of MLA to predict late TLR was further assessed using receiver operating characteristic analysis. MLA was found to be an acceptable discriminator for both PES (c = 0.7448) and BMS (c = 0.7329). Finally, the optimal thresholds of MLA that best predicted subsequent TLR-free survival were determined to be 4.2 mm(2) for PES and 4.0 mm(2) for BMS. CONCLUSIONS In the combined IVUS analysis of TAXUS IV, V, and VI, patients who did not require TLR within the first 9 months had a high subsequent TLR-free survival rate whether treated with PES or BMS. MLA measured by IVUS at 9 months predicted subsequent TLR with a cutoff similar to intermediate, de novo lesions in native coronary arteries.