CX 31- Is drug elution “dead in the water” in recession?


“Easy math” shows that drug-eluting stents (DES) do not constitute a viable treatment option for the superficial femoral artery in the current economic climate, according to Marc Bosiers of AZ St-Blasius, Dendermonde, Belgium, who will argue the case at the CX Symposium on Saturday 4 April.

Bosiers will take on Lindsay Machan, Associate Professor, Faculty of Medicine, University of British Columbia, and co-inventor of the Taxus DES (Angiotech), to debate whether or not there is any future for DES in the superficial femoral artery.

Bosiers points to the SIROCCO (Sirolimus coated cordis self-expandable stent) trial that provided the first published outcomes following the use of drug-eluting stents in the infrainguinal vasculature. This double-blind randomised controlled trial evaluated the efficacy of sirolimus-eluting self-expanding nitinol stents vs. the same commercially available bare metal stents (SMART, Cordis) in the superficial femoral artery. No significant differences were observed in either the peak velocity ratios or anklebrachial pressure index (ABPI) or in-stent restenosis rate. The authors concluded that that no significant difference could be found between the bare and the sirolimus-eluting SMART stents.

Though Bosiers says that he is interested to see the results of the STRIDES and ZILVER PTX trials, he will demonstrate at the CX Symposium that the “tremendously high price” of drug-eluting stents technology means that it cannot be considered as a realistic treatment option. “The cost of treatment with drug-eluting stents is more than twice the cost of bare stents, for TASC A and B lesions,” Bosiers said. Also, treatment with drug-eluting stent costs twice as much as surgery for TASC C and D lesions. The relative increase in primary patency for drug-eluting stents does not justify this high increase in costs. In other words, there is no cost benefit for drug-eluting stents treatment.”

“In times of economic crisis, like today,” he said, “it is the responsibility of physicians to administer the healthcare budget with due diligence.”

Machan will argue that SIROCCO used early-generation technology, designed originally for the coronary artery, and that the “superb results” with drug-eluting stent in the coronary circulation are unlikely to be repeated in the femoropopliteal segment by employing the same dose and delivery methods.

“There has only been one completed trial of drug-eluting stents so far. That trial (SIROCCO indicated a transient benefit seen at six months that was lost by 18 months. We eagerly await the outcome of three new trials using different drugs on stents of newer design in the superficial femoral artery. Cook are sponsoring two trials evaluating nonpolymeric paclitaxel on the Zilver stent. The first is a 480 patient FDA prospective randomised trial comparing the Zilver PTX stent to angioplasty in the superficial femoral artery. The trial is fully enrolled and six month data on the first 60 patients only are available. Not surprisingly this indicates a significant advantage of the Zilver PTX stent over angioplasty,” explains Machan.

Dr Michael Jenkins, St Mary’s Hospital, London, UK, and Shaun Samuels, Miami, Florida, USA, will also be debating the value of stents in the superficial femoral artery.


Supervised exercise for intermittent claudication


David Bergqvist of Malmoe General Hospital, Sweden, will evaluate the extent to which exercise improves the walking distance in patients with intermittent claudication, and whether or not supervised exercise is better than nonsupervised. Bergvist will describe how symptomatic fluctuations over time mean that it is important that all treatment options are assessed through randomised controlled trials and present a review of the extant evidence for supervised and nonsupervised exercise. “But the evidence is clear,” said Bergqvist, “training is important and [Ed ] Housley’s advice should be taken seriously: stop smoking and keep walking.”

Crural vein bypass

“Optimal treatment of critical limb ischaemia has been the subject of much debate,” said John Wolfe, St Mary’s Hospital, London, UK, “and no convincing evidence currently exists as to which techniques are superior.” In order to help to clarify this situation, Wolfe will present an argument for crural bypass as the first-choice treatment in this indication at the CX Symposium. Wolfe acknowledges that there is a wide consensus that, before considering amputation, a revascularisation procedure should be attempted, but says that, with resources scarce, staged procedures are not the best option. He will argue that crural bypass is not just cost-effective, but also has much to offer the patient. In certain cases, however, primary amputation must be considered as the best option.


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