St. Jude Medical (NYSE:STJ) said it’s halting its Fame II trial after an independent safety advisory board recommended the trial be stopped due to strong positive results.
It’s good news for St. Jude and its fractional flow reserve business – and for its main FFR rival, Volcano Corp. (NSDQ:VOLC) and for the major players in the drug-eluting stent market, Boston Scientific (NYSE:BSX), Abbott (NYSE:ABT) and Medtronic (NYSE:MDT).
The trial, which compared stenting accompanied by FFR measurement with optimal medical care in treating coronary artery disease, was stopped because of "a highly statistically significant reduction in the need for hospital readmission and urgent revascularization" for the FFR patients, according to a press release.
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"As a result of the positive interim analysis, the Fame II independent Data Safety Monitoring Board has recommended investigators stop patient enrollment in this trial, as the DSMB considers it unethical to continue to randomize patients to OMT alone," according to the release. "In particular, patients receiving OMT alone experienced a highly statistically significant increased risk of hospital readmission and urgent revascularization, and the DSMB determined that this difference was highly unlikely to change with inclusion of more patients. The data currently reflect no observed difference in the rates of death or heart attack."
FFR is used to measure how severe the narrowing of an artery is, allowing cardiologists to target those lesions for stenting. The trial examined the use of STJ’s PressureWire Aeris and PressureWire Certus FFR devices during percutaneous coronoary interventions in patients with stable coronary artery disease. The DSMB for the trial judged that the risk of major adverse events for the patients in the control arm was too great for the trial to continue. It will continue to track the 1,219 patients who’ve already enrolled, according to St. Jude, with the interim results slated for publication some time this year.
The results could roll back some of the conclusions drawn after the 2006-2007 Courage trial found no significant difference between stenting and OMT. But, because that trial did not include the use of FFR technology, the Fame II results may partially refute the Courage conclusions.
"These Fame II results could essentially ‘repeal’ the Courage trial data," wrote Leerink Swann analyst Rick Wise in a note to investors. "[S]ince Courage did not include the use of a pressurewire, the Fame II data – which includes single, double, and triple vessel disease – possibly invalidates some Courage conclusions and suggests that using the right diagnostic tool like FFR as well as DES (PCI procedure) provides patients a better outcome."
STJ shares were up 1.4% to $37.50 as of about 11:50 this morning. VOLC shares also rose, climbing 3.5% to $25.90. Shares of BSX stock rose 1% to $5.59; ABT shares slipped to $55.21, down 0.9%, and MDT shares were flat at $39.02.