Patients with in-stent restenoses

Summary

Aims: We compared the intracoronary β-brachytherapy using a liquid rhenium-188 filled balloon with the slow-release, polymer-based, paclitaxel-eluting Taxus-Express stent for treatment of in-stent restenoses. Patients, methods: During the same study period, patients with restenoses in bare-metal stents were either treated with Taxus- Express stents (n = 50) or β-brachytherapy after successful angioplasty (n = 51). For brachytherapy 30 Gy in 0.5 mm tissue depth were administered. The irradiated segment exceeded the traumatized segment 7.5 mm on both sides. Primary endpoint was the minimal lumen diameter (MLD) at the target lesion at six months follow-up. Angiographic follow-up was available in 78% (n = 79/101) and clinical follow-up in all patients. Results: Baseline parameters did not differ statistically. The Taxus-Express stent resulted in a significantly larger MLD and a significantly lower percent diameter stenosis post intervention compared to β-brachytherapy, which both maintained until angiographic follow-up (primary endpoint 2.44 ± 0.74 mm versus 1.73 ± 0.74 mm, p <0.0001). Therefore, Taxus- Express stents were associated with a lower angiographic restenosis rate compared with β-brachytherapy, both for the target lesion (6.1% versus 17.4%) and the total segment (9.1% versus 23.9%). Moreover, use of Taxus-stent was associated with a clinical benefit based on a significantly lower MACE rate compared with β-brachytherapy (p <0.05). Conclusions: Paclitaxel-eluting Taxus- Express stents resulted in superior clinical and angiographic outcomes compared to intracoronary β-brachytherapy with a liquid 188Re filled balloon for treatment of restenosis within a bare-metal stent.

Zusammenfassung

Ziel: Wir verglichen die intrakoronare β-Brachytherapie durch einen mit flussigem Rhenium-188 gefullten Ballonkatheter mit dem „slow-release”, polymerbasierten Paclitaxel- freisetzenden Taxus-Express-Stent zur Behandlung von In-Stent-Restenosen. Patienten, Methodik: Patienten mit Restenosen in nicht medikamentenfreisetzenden Koronarstents wurden entweder mit Taxus-Express-Stents (n = 50) oder mittels β-Brachytherapie nach erfolgreicher Angioplastie (n = 51) behandelt. Die Patienten wurden während des gleichen Studienzeitraums therapiert. Zur Brachytherapie wurden 30 Gy in 0,5 mm Gewebetiefe appliziert. Das bestrahlte Segment uberlappte das durch die Intervention traumatisierte Areal um 7,5 mm auf beiden Seiten. Der primare Endpunkt war der minimale Lumendiameter (MLD) im Zielsegment nach sechs Monaten. Ein angiographischer Follow-up wurde in 78% (n = 79/101), ein klinischer Follow-up bei allen Patienten nach sechs Monaten erhoben. Ergebnisse: Die Basisdaten der Gruppen waren nicht unterschiedlich. In der Taxus-Express-Gruppe zeigte sich ein signifikant größerer MLD und eine signifikant geringere prozentuale Diameterstenose im Vergleich zur intrakoronaren β-Brachytherapie nach der Intervention und auch im Follow-up nach sechs Monaten (primärer Endpunkt 2,44 ± 0,74 mm versus 1,73 ± 0,74 mm, p <0,0001). Dies resultierte in einer geringeren binären Restenoserate in der Taxus-Express-Gruppe im Vergleich zur β-Brachytherapie, sowohl in der Zielläsion (6,1% versus 17,4%) als auch im Gesamtsegment (9,1% versus 23,9%). Schwerwiegende, unerwünschte kardiale Ereignisse waren in der Taxus- Express-Gruppe signifikant niedriger als im Therapiearm mit intrakoronarer β-Brachytherapie (p <0,05). Schlussfolgerung: In der Therapie von Restenosen in nicht medikamentenfreisetzenden Stents war die Implantation von Paclitaxel-freisetzenden Taxus-Express-Stents hinsichtlich angiographischer und klinischer Ergebnisse der intrakoronaren β-Brachytherapie mit einem mit flüssigem Rhenium- 188 gefüllten Ballonkatheter überlegen.

Keywords

Rhenium-188 - restenosis - percutaneous transluminal coronary intervention - clinical trial - radionuclide therapy

Schlüsselwörter

Rhenium-188 - Restenose - perkutane transluminale koronare Angioplastie - klinische Studie - Radionuklidtherapie

^* Authors contributed equally.

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