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- DES, drug eluting stents
- ISR, in-stent restenosis
- MACE, major adverse cardiac events
- RENO, Registry Novoste
- START, stents and radiation therapy
- WRIST, Washington radiation for in-stent restenosis trial
By the late 1990s intracoronary brachytherapy had become the gold standard therapy for the treatment of in-stent restenosis (ISR) in bare metal stents. Despite this, the “uptake” of this treatment by the interventional community worldwide, and certainly in the UK, was low. In 2005, drug eluting stents (DES) have entered the interventional armamentarium. The potential for DES to lower the primary incidence of ISR dramatically, and their potential use to treat ISR, challenges the very existence of intracoronary brachytherapy.
INTRACORONARY BRACHYTHERAPY: THE EARLY YEARS
The efficacy of intracoronary brachytherapy for the treatment of de novo coronary disease and ISR was proven in animals1,2 and subsequently in a number of human registries,3 single centre4,5 and multicentre randomised trials6,7 for both β and γ radiation. Setting up a brachytherapy programme was, however, complex because of the need for cardiologists to gain therapeutic radiation licenses in association with medical oncologists and medical physicists. This process led to a reputation that the procedure itself was “difficult and complex” and certainly limited the uptake of the technique among the interventional community, despite the compelling clinical data.
During the same period companies who were developing brachytherapy devices were keen to quickly establish its use in the treatment of de novo coronary disease. Registries and randomised trials were started at an early stage (perhaps too early) in the development of the technique. The pivotal trial in this area—the Beta Cath system trial—was probably performed at a time when many of the lessons of brachytherapy were still being learned (presentation by Richard Kuntz at the 2001 meeting of the American College of Cardiology). The trial randomised 1500 patients to β radiation or placebo following balloon angioplasty or provisional stenting in the treatment of de novo coronary disease. All of the pitfalls of brachytherapy were seen in …