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Clinical research

Appraising the effectiveness and safety of paclitaxel-eluting stents in over 1,000 very high-risk patients: overall results of the Taxus in Real-life Usage Evaluation (TRUE) Registry

1. EMO Centro Cuore Columbus, Milan, Italy; 2. Interventional Cardiology Unit, San Raffaele Hospital, Milan, Italy; 3. Interventional Cardiology, Division of Cardiology, University of Turin, Turin, Italy; 4. Antwerp Cardiovascular Institute, AZ Middelheim, Antwerp, Belgium; 5. Division of Cardiology, Careggi Hospital, Florence, Italy; 6. Department of Cardiology, Heart Center Siegburg, Siegburg, Germany; 7. Department of Cardiology, Royal Brompton Hospital, London, United Kingdom; 8. Cardiology Department, Mirano Hospital, Mirano, Italy; 9. Clinical Division of Cardiology, Ferrarotto Hospital, Catania, Italy

Aims: Paclitaxel-eluting stents (PES) have been proved safe and effective in selected patients undergoing percutaneous coronary interventions (PCI). However, there is uncertainty on the performance of PES in real-world patients at higher risk for major adverse cardiovascular events (MACE) or restenosis. We conducted a multicentre registry enrolling very high-risk subjects treated with PES.

Methods and results: We enrolled 1,065 consecutive patients undergoing PES implantation, provided that the target lesion treated with the PES was an unprotected left main (N=113), a true bifurcation (N=219), a chronic total occlusion (CTO, N=183), a long lesion (>28 mm, N=283), in a small vessel (<2.75 mm, N=417), or the patient had medically-treated diabetes mellitus (N=315). Clinical events were adjudicated at 1 and 7 months, and 4 to 8-month angiographic follow-up was recommended for core-lab quantitative coronary angiography. The primary end-point was the 7-month occurrence of MACE, i.e., the composite of cardiac death, non-fatal myocardial infarction (MI), coronary artery bypass grafting (CABG) and percutaneous target vessel revascularisation (TVR). A total of 2,116 lesions were treated with 2.0±1.2 Taxus per patient and 46.4±30 total Taxus length per patient. One total Taxus length per patient. One-month MACE occurred in 4.3% of patients, with 0.4% cardiac death, 3.3% myocardial infarction (MI), 0.1% coronary artery bypass grafting (CABG), and 0.8% target vessel revascularisation (TVR) PCI. Seven-month events were as follows: MACE 20.4%, cardiac death 1.2%, MI 4.2%, CABG 1.2%, TVR-PCI 15.4% and target lesion revascularisation (TLR)-PCI 10.9%. Binary restenosis occurred in 20.7% out of the 1,071 lesions undergoing follow-up angiography. Finally. stent thrombosis (ST) was reported with a 0.8% 12-month cumulative rate (0.3% acute, 0.3% subacute, and 0.2% <6 months, but no thrombosis >6 months).

Conclusions: This registry, enrolling 1,065 high-risk patients treated with PES, confirms the satisfactory performance of this device, especially given the overall profile of enrolled subjects and the limited number of stent thromboses.

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