“Six million people in the world have been implanted with DES, yet their long-term safety and efficacy is unknown,” said Yusuf. “I’ve a feeling the data we’re seeing today is only the tip of the iceberg. We need to encourage more public access to the data.”
Edoardo Camenzind
Presenter, Edoardo Camenzind (Geneva, Switzerland), said recent case reports had flagged up the problem of in-stent thrombosis resulting from DES. The BASKET-LATE data showed that the rate of cardiac death and nonfatal myocardial infarction (MI) was higher in patients with DES than in those with bare metal stents (BMS) (p=0.01). “The problem is likely to be significantly under-reported, since if people die on the street they don’t fulfil the angiographic criteria to be classified as in-stent thrombosis.”
The second presenter, Alain Nordmann (Basel, Switzerland), had concerns that DES accounted for more than 90% of stents used in the USA and Switzerland now. Camenzind undertook a meta-analysis looking at death and Q-wave MI in all randomised DES trials where data were available. Results at the latest available followup (four years) showed the incidence of death or MI was 6.3% for the sirolimus stent and 3.9% for the control BMS stent (p=0.03). For the paclitaxel stent, rates were 2.6% compared to 2.3% for the BMS stent (p=0.68). He concluded that death and Q-wave MI were higher in firstgeneration DES than BMS. He stressed that the problem was in first-generation DES – sirolimus and paclitaxel – and might not arise in the second-generation.
In the second study, Nordmann undertook a meta-analysis of all randomised, controlled, first-generation DES trials comparing cardiac and non-cardiac deaths in DES versus BMS. At four years overall mortality was higher for both cardiac and non-cardiac deaths in DES patients. Of the 36 non-cardiac deaths identified, 15 were due to cancer, including lymphoma and cancers of the lung, prostate, pancreas, GI, kidney and rectum.
“At this time, we can’t prove a causal relationship, only a statistical association. What makes me concerned is how difficult it was to obtain this data from the manufacturer,” said Nordmann. He speculated that the increase in cancer might be due to a rapid impairment of the immune system.
Yusuf widened the debate to include percutaneous coronary intervention (PCI). “The overuse of PCI is an insidious change in the culture of cardiology that needs to be reversed,” he said. The use of PCI was established in MI, high-risk unstable angina and cardiogenic shock. However, its use in stable disease was a totally different question.
“There’s no beneficial influence on mortality – PCI does nothing to prevent heart attack. All we are doing is providing short-term relief of chest pain. It’s not re-stenosis that kills but the thousands of lesions you can’t see. Stable angina can be controlled with full medical management.” Yusuf said vested interests included pharmaceutical companies, who have invested billions of dollars in DES, and cardiologists in the US and Canada who are reimbursed according to PCI procedures undertaken. He called for Euro Heart Surveys to provide clear evidence on when PCI was needed, predicting the majority of indications would be uncertain.
Jean Marco, chairperson of the PCI Euro Heart Survey, said that the Euro Heart Survey had outlined evidence-based indications for PCI. “These meta-analyses shouldn’t be viewed as detracting from the value of PCI and DES, but promoting a precautionary attitude towards the indiscriminate use of first generation DES.”
Related Report and Slides Available