Twelve-Month Outcomes With a Paclitaxel-Eluting Stent Transitioning from Controlled Trials to Clinical Practice (the WISDOM Registry)

The WISDOM Registry tracked clinical outcomes in patients receiving a slow-release, polymer-based, paclitaxel-eluting stent during the transition from randomized trials to commercial use in everyday interventional cardiology practice. Although randomized trials of drug-eluting stents have demonstrated the safety and effectiveness of these devices in less complicated, de novo lesions, observation of long-term clinical outcomes is required to monitor safety as use of this revolutionary technology expands to broader patient populations. In total, 778 patients were enrolled at 22 sites in 9 countries where the TAXUS paclitaxel-eluting stent first received market approval. Patients with de novo or restenotic coronary lesions eligible for stenting were enrolled. Clinical follow-up was conducted by telephone at 3, 6, 9, and 12 months after the procedure to capture reported stent thrombosis and major cardiac events (death, myocardial infarction, and reintervention on the target lesion). Clinical follow-up at 12 months was completed for 92% of patients. The 12-month rate of physician-reported major cardiac events was 5.2%, with a target lesion reintervention rate of 2.0%. The low overall stent thrombosis rate of 0.6% included no stent thromboses >30 days after the index procedure. Low target lesion reintervention rates were also observed in the high-risk subgroups: patients with diabetes (4.0%), vessels <2.5 mm (2.5%), lesions >20 mm (3.6%), and multiple stents in a lesion (1.4%). In conclusion, the paclitaxel-eluting TAXUS slow-release stent exhibits long-term safety and efficacy in uncomplicated and higher risk patients and lesions seen in everyday clinical practice.