Conducted over the course of eight years at 69 medical centers in the U.S. and Canada, the RESPECT study followed 980 participants who had suffered a cryptogenic stroke that was confirmed by stroke neurologists using routine imaging technologies. The average age of the patients in this trial was 46-years old. The trial was a prospective, controlled, randomized (1:1) study in which patients were randomly assigned to either the device group or the medical group. The primary efficacy endpoint was defined as the composite rate of recurrent nonfatal stroke, fatal ischemic stroke or death after randomization. Enrollment was stopped once 25 events occurred, all of which were non-fatal recurrent stroke, as measured across all patients in the study.Patients in the device group underwent a procedure in which their PFO was closed with the Amplatzer PFO Occluder followed by six months of medication therapy. In the medical group, four standard-of-care medical therapy regimens were used throughout the study: aspirin, warfarin, clopidogrel and aspirin combined with extended release dipyridamole. Analyses were conducted on the intent-to-treat population, which included all patients according to the group to which they were randomly assigned, though some patients in the device group did not receive the randomized treatment. A difference in the dropout rate between the medical therapy group and the device group challenged the validity of the primary intent-to-treat raw count analysis, which did not meet statistical significance. Using the same intent-to-treat cohort in a time-to-event analysis demonstrated a risk reduction of greater than 50 percent, which trended towards statistical superiority with a p-value of 0.08. The study protocol also prespecified that if dropout rates differed significantly between the medication and device groups that analyses of two additional cohorts would be evaluated. These included:
- Per-protocol cohort – patients who received the randomly assigned treatment and adhered to the protocol-mandated medical treatment
- As-treated cohort – patients who received and adhered to a protocol-approved treatment and were classified according to the treatment they actually received
“The analysis of the data from patients in the per-protocol group and the as-treated group provide compelling evidence that PFO closure with the AMPLATZER PFO Occluder is superior to medical management from both clinical and statistical perspectives,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “The totality of evidence from this study, including the strong performance and safety profile of the device, demonstrates the compelling clinical benefits of closure versus medical management in reducing the likelihood of recurrent stroke in this patient population.”According to the World Health Organization (WHO) an estimated 15 million people worldwide suffer from stroke each year. Of these, 5 million die and another 5 million are left permanently disabled, placing a burden on families and communities. It is estimated that 87 percent of all strokes are ischemic strokes, which occur when blood clots block the blood vessels to the brain. Up to 40 percent of ischemic strokes are classified as cryptogenic, which means the cause of the stroke is unknown. About St. Jude Medical St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn., and has four major focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com. Forward-Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 29, 2012. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.