July 27th, 2012
DES in Patients at Low Risk for TVR: Is the Benefit Worth the Cost? (Part II)
In a recent article in Archives of Internal Medicine, researchers performed an analysis of current use of drug-eluting stents (DES) in patients at various levels of risk for target-vessel revascularization (TVR), and estimated the cost and clinical outcomes of using BMS rather than DES in patients at low risk (see News). To gauge reaction to this report, Rick Lange and David Hillis asked a panel of experts to respond to the following questions:
1. In patients who need PCI, are drug-eluting stents (DES) overused?
2. Why or why not?
3. What drives DES use: physicians, hospitals, and/or patients?
Patrick W. Serruys, MD, PhD, FACC, FESC. Professor of Medicine and Chair, Interventional Cardiology, Erasmus University; Head, Interventional Department, Heartcenter Rotterdam, the Netherlands
In addition to the well-formulated opinions of my American friends, I would like to offer the view of a European cardiologist who has a very unambiguous view of this topic.
Having being involved during 1999–2002 in first-in-man, compassionate-use, and pivotal European randomised trials of DES, I became convinced that DES were superior to BMS. In 2002, when the CE mark was obtained for the Cypher, I convinced the upper management of our academic hospital to subsidize the cost of a full conversion from BMS to DES. The cost of conversion was 1.9 million Euros for a volume of 1600 PCIs per year.
The hospital board set the condition that all patients implanted with DES had to be followed-up for safety reasons (all-cause mortality) for the subsequent 5–10 years. These investigations had to be carried out by the independent department of cardiovascular epidemiology, together with the Dutch bureau of statistics in Den Haag. After several years, using complex statistical analyses for adjustment of baseline characteristics, the epidemiological department reported a lower mortality and lower re-intervention rates in the population treated with DES than in patients treated with BMS. This in spite of the first reported occurrence of late stent thrombosis, which we subsequently fully described in the Lancet in 2007, analyzing the Bern-Rotterdam cohort of patients treated with unrestricted use of DES.
The European Society stent thrombosis “firestorm,” however, did not affect the decision of the hospital board to continue with the unrestricted use of DES, since our own internal investigation by the epidemiological department continued to demonstrate the superiority of DES compared with BMS in terms of safety and efficacy. Our policy over the past decade has therefore been to maintain the unrestricted use of DES, with the classical contraindications for DES (±5%). In the subsequent years, we moved to the second generation of DES, and demonstrated even superior results compared with first generation DES (Bern-Rotterdam registries).
Our view has always been that following the barotrauma of PCI, the use of anti-inflammatory and cytostatic drugs is an absolute must to control the arterial response. We have never departed from that position, despite the previous “hype” of DES safety, and we are pleased to see that the Swedish national registry (SCAAR Registry) — despite initial antagonism from the Swedish researchers themselves with regard to unrestricted DES use — have step-by-step vindicated our position (see N Engl J Med articles from 2007 and 2009). Our current goal is therefore not to eliminate the drug elution, which in our view is absolutely mandatory, but rather the permanent metallic cage that serves as a platform for the drug elution — a device currently in development and clinical use (bioresorbable scaffold with a CE mark in Europe).
In terms of cost-effectiveness, we have published in the European Heart Journal an unusual way to report cost effectiveness, by correlating the price tag of the device and the efficiency of the therapy, coming to the conclusion that the price proposed by the industry had to “go down” substantially — which is what subsequently occurred. Consequently, the price of the DES in 2012 (650 Euros) is comparable to price of BMS in 2002 (700 Euros). This fact emphasizes that cost effectiveness is always a transient phenomenon that can be controlled by proper cost-effectiveness analysis of the real therapeutic value of the new therapy. Moreover, there is no doubt in my mind that the shareholders of industry are still reaping the rewards of DES use, despite the decline in price.
For us as physicians, for the community of patients that we treat, and for the academic hospital, the unrestricted use of DES has not been considered to be overuse; quite the contrary, my question is why are people still underusing DES?
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