FAME II cost-effectiveness data

New data from St. Jude Medical Inc.’s FAME II trial evaluating the benefits of fractional flow reserve (FFR) as a guide to cardiac stenting show that the strategy is cost effective when compared to medical therapy alone, according to results presented last week at the annual Transcatheter Cardiovascular Therapeutics (TCT) symposium in Miami. Researchers found that at 12 months, the cost of FFR-guided up-front percutaneous coronary intervention (PCI) using St. Jude’s PressureWire Aeris or Certus FFR devices was $2,508 more expensive than medical therapy. But the FFR-guided strategy, in which patients found to have ischemia on the scan were randomized to stenting or medical therapy, was deemed cost effective due to the quality-of-life improvements observed with PCI. The overall cost-effectiveness of up-front PCI was $53,000 per quality-adjusted life year. The three-year projected cost for the FFR-guided PCI approach was $32,000 per quality-adjusted life year. “The cost gap narrows more than 50% by one year,” said lead investigator William Fearon, associate professor of medicine at Stanford University School of Medicine. “Since angina and quality of life are significantly improved by PCI, results of this study indicate that FFR-guided PCI appears to be economically attractive in an analysis of cost-effectiveness.”

FAME II’s full clinical results were first presented in August at the European Society of Cardiology Congress in Munich, showing that the rate of urgent revascularization was 86% lower for FFR-guided PCI patients treated with the St. Jude devices compared to medical therapy alone in those found to have ischemia. (See Also see "St. Jude’s FAME II FFR Study Successful, But Impact Is Debated" - Medtech Insight, 3 September, 2012..) The firm touted the findings as a win for FFR devices, but some questioned the significance of the data, partly because the primary endpoint was driven largely by the revascularization rate only. Some of those concerns resurfaced again at last week’s TCT meeting, though in the end most cardiologists agreed that the cost-effectiveness study results will likely increase their use of FFR going forward.

During a panel discussion, David Cohen, a Torrance, Calif.-based cardiologist, argued that the study still doesn’t prove that it’s cost effective to use the FFR devices in the first place, because patients were only randomized after the procedure was performed, but he concluded that “nonetheless this is a very important contribution to our understanding of the technique.”

InspireMD’s MGuard stent trial results

InspireMD Inc.’s next-generation MGuard stent system with embolic protection technology outperformed both bare-metal and drug-eluting stents in its ability to improve blood flow restoration in heart attack patients undergoing angioplasty, according to results of the MASTER trial that were reported Oct. 24 at TCT. The primary endpoint was the rate of complete (at least 70%) ST-segment resolution on an electrocardiogram at 60-90 minutes following the procedure. In the group of patients with the mesh-covered stent, the rate of complete ST-segment resolution was 57.8%; the rate was 44.7% for control-group patients. The Israeli firm’s technology consists of a stent covered in a micro-net mesh that is designed to prevent or reduce downstream embolization by holding plaque or thrombus in place against the wall of the blocked artery. The trial enrolled 433 heart attack patients at 50 sites in nine countries. “A larger randomized trial is warranted to verify these findings, and determine whether these benefits result in reduced infarct size and/or improved clinical outcomes,” said study chairman Gregg Stone, professor of medicine at Columbia University in New York.

InspireMD, which generated 2011 sales of $6 million, plans to pursue FDA approval of the device for coronary indications and anticipates a U.S. launch in 2016. Meanwhile, the firm is also developing its MGuard stent technology for peripheral and carotid applications, and plans a version with a drug-eluting bio-absorbable mesh for coronary applications.

Stents in the knee

A randomized trial comparing CR Bard Inc.’s nitinol LifeStent with balloon angioplasty alone in treating blockages of the popliteal artery, which runs through the leg behind the knee, found that the stent performed better in treating the lesions, according to results of the ETAP trial, announced Oct. 24 at the Miami meeting. The one-year primary patency rate was significantly higher in the stent group (67.4%) than in the balloon angioplasty group (44.9%). Due to its location behind the mobile knee joint, controversy remains over whether to implant a stent in the popliteal artery for all cases or only for cases in which balloon angioplasty alone results in a suboptimal result, researchers say. But, “results from this trial indicate that treatment of popliteal artery obstructive lesions with a nitinol self-expanding stent is safe,” said lead investigator Thomas Zeller, professor of clinic cardiology and angiology at Universitäts-Herzzentrum Freiburg Bad Krozingen in Germany. Bard gained PMA approval to market LifeStent for treating occluded leg arteries in 2009. (See Also see "Bard’s LifeStent Gets Legs: PMA Approved For Femoral, Popliteal Arteries" - Medtech Insight, 23 February, 2009..)

Pivotal trial for Stentys' self-apposing stent

Stentys SAS expects to begin enrollment early next year in a U.S. pivotal trial of its Stentys Self-Apposing stent to treat acute myocardial infarction, the French firm said Oct. 22 in announcing FDA investigational device exemption approval at the TCT meeting in Miami. The randomized APPOSITION V trial will compare the Stentys device to Abbott's PMA-approved Multi-Link Vision stent in the treatment of de novo stenotic lesions in coronary arteries in 880 patients undergoing primary revascularization due to ST-elevation myocardial infarction. The primary endpoint is target vessel failure, defined as a composite of cardiac death, target vessel recurrent myocardial infarction or target vessel revascularization at 12 months post-procedure.

The Stentys stent is designed to adjust in shape and diameter as the coronary vessel dilates and the initial clot dissolves after the acute heart attack phase. To demonstrate this ability of the stent to fit snugly and properly within the vessel, or "self-appose," the study will include a secondary endpoint of acute stent malapposition assessed by intravascular ultrasound.

Also at TCT, Stentys presented interim results from its APPOSITION III European trial, assessing the long-term performance of the Stentys stent in routine clinical practice in 1,000 acute myocardial infarction patients. Among the first 600 patients treated, the one-year death rate was 1.7% and the revascularization rate was 5.8%; results the firm claimed are below the average death rate for conventional stents and "in line with or better than" conventional balloon-expandable stents on the revascularization measure.

TAVR data

Multiple studies were presented last week at TCT on transcatheter aortic valve replacement devices. The highest-profile TAVR data at the meeting was the three-year results from Edwards Lifesciences Corp. PARTNER cohort B study, comparing its Sapien valve to standard medical therapy in patients deemed inoperable for open heart surgery. The substantial survival benefit reported at the one- and two-year marks was maintained after three years in the Sapien group, investigators reported Oct. 23 in Miami. All-cause mortality at three years was 54.1% in the valve group compared to 80.9% in the control group.

Medtronic PLC, whose CoreValve transcatheter valve goes head-to-head with Sapien in Europe, also reported data out of the meeting from its European ADVANCE registry. Specifically, investigators reported a one-year survival rate of 82.1% among the 1,015 patients enrolled in the study, which compares favorably to prior one-year rates, suggesting more experience with the procedure, the researchers said. They also reported improvements from baseline in patients’ quality of life.

Meanwhile, California-based startup Direct Flow Medical Inc. announced positive data that brings it a step closer to competing with Edwards and Medtronic, as well as the smaller firms Symetis SA and JenaValve Technology GMBH, overseas. The Direct Flow Medical transcatheter aortic valve system met its primary mortality endpoint in the firm’s DISCOVER CE Mark trial – of 33 patients treated, 97% experienced freedom from all-cause mortality at 30 days. The system is designed with a novel inflatable cuff to conform and seal above the native valve “to virtually eliminate aortic regurgitation,” the firm says.

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