Johnson & Johnson’s drug-eluting Cypher stent may offer diabetic patients a less invasive alternative to coronary artery bypass in treating cardiovascular disease, according to new data from the aptly named DIABETES trial – an independent study.
The study enrolled 160 diabetic patients, including high-risk individuals, to compare J&J’s Cypher with traditional bare metal stents in angioplasty. During angioplasty a small wire mesh tube (stent) is placed in the coronary artery, but diabetics tend to have smaller diameter arteries which places them at a higher risk of recurrent narrowing – or restenosis.
The Cypher stent elutes the immune suppressant agent sirolimus, which is designed to protect the lining of the artery and allow it to heal following angioplasty. After nine months, there was an 88% reduction in late lumen loss – a marker for healing of the arterial lining – amongst Cypher receivers versus just 4% in those given a bare metal stent. Furthermore, only 7.7% had reblockage (restenosis) compared to 33% of patients receiving the bare metal stent.
Meanwhile, another independent study, known as ISAR-DIABETES, compared the Cypher stent with Boston Scientific’s Taxus – a rival offering that elutes the anticancer agent paclitaxel. Assessment of 250 diabetic patients in this trial showed that Cypher stents were more effective than Taxus in preventing restenosis in diabetic patients, with a 58% relative reduction in restenosis. Adnan Kastrati of the Technische Universitat in Munich, Germany, says: “We set out to demonstrate in ISAR-DIABETES that Taxus was not inferior to the Cypher stent. However, the Cypher stent outperformed Taxus in this complex group of patients, showing consistently better results in all major parameters.” And, across two further studies, Taxus patients were 74% more likely to have a serious cardiac event or undergo subsequent surgery than those treated with Cypher. Furthermore, in follow up angiography after nine months, fewer Cypher patients suffered restenosis (3.2%) than those with Taxus stents (7.6%).
The World Health Organisation has predicted an increase in the worldwide prevalence of diabetes of epidemic proportions, with a massive 80% of diabetics expected to die from cardiovascular complications. In fact, diabetics are four to six times more likely to die of coronary artery disease than non-diabetics.