St Jude Medical, a global medical device company, recently conducted a study on the benefits of fractional flow reserve (FFR)-guided stenting in India, the results of which were presented during India Live 2013, the fourth annual National Course on Cardiovascular Interventions organised by Cardiovascular Educational Research Trust. Kaustav Banerjee, Country Manager, St Jude Medical- India explains about the study and its findings, in conversation with Raelene Kambli
What were the findings of the study based on FFR-guided stenting in India?
| Kaustav Banerjee |
The detailed analysis for India was based on the results of the fractional flow reserve (FFR) vs angiography in multivessel evaluation (FAME) study, statistics from country-specific percutaneous coronary intervention (PCI) registries and from published literature. FAME is a randomised, prospective, multi-centre trial which enrolled 1,005 patients with multivessel coronary artery disease. The FAME study compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography using SJM’s PressureWire Certus technology. The 12-month results, published in the January 15, 2009 issue of the New England Journal of Medicine, demonstrated that instances of major adverse cardiac events (MACE) were reduced by 28 per cent for patients whose treatment was guided by FFR rather than by standard angiography alone.
What was the rationale behind conducting this study? What were the preparations undertaken to conduct it? What about its funding?
St. Jude Medical is driven by the vision to address epidemic diseases (such as atrial fibrillation, heart failure, hypertension, stroke, and chronic pain) with solutions that reduce the economic burden on healthcare systems worldwide. Because of this drive, we sponsor research such as the FFR cost analysis that enables a better understanding of the broader economics of technologies. As the sponsor of not only the cost analysis but the complete FAME family of studies, St Jude Medical is proud to provide the medical community with additional evidence of the important role that the PressureWire FFR measurement technologies play in improving patient care.
What are the benefits of FFR guided stenting? How does the use of FFR technology improve health outcomes for patients with multivessel coronary artery disease? Kindly elaborate.
There is a growing body of evidence demonstrating improved outcomes and cost-savings with PressureWire-guided stenting. Some clinical findings about the benefits of FFR:
F The recent economic analysis found that PressureWire FFR measurement can improve patient outcomes and potentially save a projected Rs 310 million in healthcare costs over two years. Further, in addition to improving quality of live, use of the PressureWire potentially reduces treatment cost by an average of about $1,250 (Rs 67,700 ) per patient.
F The original FAME trial sought to determine the outcomes of patients with multivessel disease whose treatment was guided by FFR to those whose treatment was guided only by angiography, and found that FFR-guided treatment was better than angiography alone. From this study we learned that instances MACE were reduced by 28 per cent for patients whose treatment was guided by FFR rather than by standard angiography alone. Two-year results demonstrated that patients with Multivessel disease who received FFR-guided treatment continued to experience improved outcomes over time, including a 34 per cent risk reduction in death or heart attack.
F The FAME II trial sought to confirm that it is beneficial for patients with one, two and three vessel disease whose ischemia has been documented by FFR. In this study, all patients received PressureWire measurements, and were then randomised into PCI plus medical treatment (MT) to MT alone. The FAME II trial demonstrated that when there is a significant blockage of blood in the heart, that stenting is better than medical treatment alone when treatment is guided by FFR measurement using the PressureWire. Initial results also suggest that there is a highly statistically significant reduction in the need for hospital readmission and urgent revascularisation – which can be considered a surrogate for a repeat heart attack or death – when FFR-guided assessment was used to direct treatment in patients.
You also say that this technology prevents heart attacks and saves lives. Kindly provide rationale for this statement.
Results from the FAME study demonstrate that after two years, patients with multivessel disease who received FFR-guided treatment had a 34 per cent risk reduction in death or heart attack when compared to the group who were treated with only angiography.
Is this a cost effective technology? If yes, how?
The PressureWire is a cost saving technology. The cost analysis in India found that an FFR-guided approach to stenting is cost-saving within the Indian healthcare system. This means that use of FFR technology improves health outcomes for patients with multivessel coronary artery disease at lower costs when compared to using only angiography. The Indian results are consistent with previous analyses, which revealed that use of the PressureWire technology to guide stenting procedures can improve patient health while significantly saving money in the context of the Australian, French, German, Italian, Swiss, Belgian, UK., and US healthcare systems. These lower healthcare costs were a result of reduced procedural costs, reduced follow-up costs for major adverse cardiac events and shorter hospital stays.
What kind of response did you receive for this study when you presented it at the India Live 2013, the fourth annual National Course on Cardiovascular Interventions?
When the study was presented by Dr Upendra Kaul, Executive Director & Dean, Fortis group of hospitals in NOIDA and New Delhi there were approximately 200 doctors present in the audience. Most of the doctors were keen on understanding how the cost savings of Rs 310 million was arrived at as per the cost effectiveness study and were discussing with Dr Kaul to understand more. We could see a healthy consensuses among the participants that FFR is unique technology which can improve outcomes in multivessel disease while at the same time being cost effective for the patient.
Are there any specific plans in the pipeline in relation with the study?
FFR is an important technology, and we expect that additional data from the FAME and FAME II studies will be presented as and when it is available.