Abstract 3251: Long-Term Outcomes Following Treatment of In-Stent Restenosis with Drug-Eluting Stents: Insights from the TAXUS Meta-Analysis
Objective: Drug-eluting stents (DES) substantially reduce clinical and angiographic restenosis. When in-stent restenosis (ISR) does occur after DES, the optimal treatment and long-term outcomes have not been well described. We sought to examine the clinical results after treatment of ISR with paclitaxel-eluting stent (PES) implantation with a patient-level meta-analysis of the TAXUS trials.
Methods: Indications for revascularization and long-term outcomes were examined in all pts randomized to the TAXUS arm in TAXUS II, IV and VI with ISR within the first 9 months after stent implantation. All pts were followed for 3 years.
Results: In the integrated TAXUS II, IV, and VI analysis (n=2,289 randomized pts), 9-month target lesion revascularization (TLR) was reduced from 14.6% (167/1148) with bare metal stents (BMS) to 4.6% (52/1141) with PES (p<0.0001). Angiographic follow-up was performed in 65% (n=1488) of pts. Of the 52 PES pts with TLR within the first 9 months, TLR was driven by ischemic symptoms and/or a positive stress test in 87%, whereas 13% of TLR events were solely angiographically driven (oculostenotic reflex). Initial treatment modalities for the 52 PES pts with ISR included DES in 13% (TAXUS n=5, CYPHER n=2), BMS in 23% (n=12), brachytherapy in 17% (n=9), PTCA in 25% (n=13), and CABG in 19% (n=10). In addition, 1 patient was treated with medical therapy after unsuccessful PCI. With follow-up greater than 2 years in all pts, a second TLR was required in 11.5% (6/52) of pts (at median 13.2 months after first TLR). A second TLR was required in 0% of pts after treatment with DES, 17% (2/12) after BMS, 11% (1/9) after brachytherapy, 23% (3/13) after PTCA, and 0% after CABG. Among TLR pts, 100.0 % and 94.2% respectively were free from cardiac death and MI at 3 years. In patients with TLR within 9 months, allowing for this 1 additional revascularization procedure for ISR, secondary freedom from TLR was 99.5% (1102/1108) through 3 years.
Conclusions: TAXUS is effective in reducing clinical and angiographic restenosis with a primary 9-month freedom from TLR of 95.4% of all patients. In the relatively infrequent cases when ISR requiring TLR occurs following TAXUS implantation, a high rate of long-term event-free survival is achieved after 1 additional revascularization.