Medtronic announces ‘largest ever’ stent comparison study

Medtronic has announced that it is to begin large-scale trials focussing on the safety of drug-eluting stents by evaluating the safety measures of two drugs.

Comparing Medtronic Endeavor zotraolimus-eluting coronary stent system and Johnson and Johnson’s Cypher sirolimus-eluting stent will form part of the Protect study, involving 8,000 patients at 200 centres in Europe and elsewhere.

According to the firm, the aim of the trial is to investigate overall stent thrombosis, including non-fatal myocardial infarction, by assessing a broad range of “complex medical conditions” treated by physicians.

Dr William Wijns, co-director if the Cardiovascular Centre, OLV Ziekenhuis Aslst and co-principal investigator of the Protect trial, comments: “Until the Protect trial, there have been no large, randomised clinical trials that have focused primarily on the safety of drug-eluting stents or that have provided head-to-head analysis with a specific safety outcome as a primary endpoint.”

Medtronic says that its Endeavor stent has a “favourable” safety profile, while trials have found that 94 per cent of patients receiving Endeavor did not need a further procedure.

The firm claims that five million people each year benefit from its technology, including those with diabetes and heart disease.