Studies Support Growing Use Of New Technology To Improve Stenting

In recent years interventional cardiologists have started to use a new catheter technique, called fractional flow reserve (FFR), in an attempt to assess which blocked vessels might benefit from a stent.Two studies presented at the European Society of Cardiology meeting in Barcelona offered new support for FFR, which has been slowly but surely gaining traction in the interventional cardiology community.

Bernard De Bruyne presented 2-year results from the FAME 2 (Fractional flow reserve versus Angiography for Multivessel Evaluation 2) study (simultaneously published in theNew England Journal of Medicine). FAME 2 was designed to find out whether PCI, with the help of FFR, can reduce the rate of hard endpoints in stable coronary artery disease compared to medical therapy. (FAME 2 was sponsored by St. Jude Medical, which makes an FFR pressure wire. Another major player in the field is the Volcano Corporation.)

1220 patients with stable CAD underwent angiography with FFR. 27% of the group had no ischemic lesions on FFR (>.80 pressure gradient) and were entered in a separate registry. 73% had at least one stenosis with a pressure gradient of .80 or under and were randomized to PCI and medical therapy or medical therapy alone.

At 2 years the rate of the composite of death, nonfatal MI, or urgent revascularization was 8.1% in the PCI group compared with 19.5% in the medical therapy group (HR 0.39, CI 0.26-0.57, p<0.001). There were no significant differences in the rates of death and MI but the difference in urgent revascularization was large and highly significant (4% versus 16.3%, HR 0.23, CI 0.14-0.38, p<0.001).

After the first week, according to a landmark analysis, the rate of death and MI was significantly lower in the PCI group: 4.6% versus 8% (p=0.04). The investigators said that most MIs in the first week were likely related to procedures and were clinically unimportant while events later on were more likely to be clinically significant.

FFR In NSTEMI Patients

Although FFR has been gradually creating a role for itself in the catheterization lab, its use in acute coronary syndromes has not been previously studied. Results of FAMOUS NSTEMI (presented by Colin Berry andpublished simultaneously in theEuropean Heart Journal)offer the first evidence in support of its use in this population.

350 NSTEMI patients referred for coronary angiography with at least one stenosis amenable to revascularization were randomized to receive treatment based on FFR or standard care with conventional visual assessment of stenosis severity. 22% of patients in the FFR group changed treatment as a result of the FFR results. 22.7% of FFR-guided patients and 13.2% of standard care patients received medical therapy alone. At 1 year 79% of patients in the FFR group and 86.8% of patients in the standard care group had been revascularized (p=0.054). There were 2 cases of coronary artery dissection that were attributed to the pressure wire.

Overall hospitals costs were about the same in each group. There was a trend toward more procedural MIs in the standard care group while other major adverse cardiac events that were not related to procedures appeared to occur more frequently in the FFR group. Compared with the angiography-guided group,the increased adoption of medical therapy at the expense of revascularization in the FFR disclosure group was associated with similar overall health outcomes and quality of life at 1 year. Representing a balance of competing risks, the reduction in procedure-related MI events in the FFR group should be considered against the increasein spontaneous cardiac events during the follow-up.

In an accompanying editorial, Bernard De Bruyne and Julien Adjedj write that the message of the FAMOUS trial goes beyond the simple less is more. The data suggest a pivotal role of the cath lab in ACS, provided the procedure is comprehensive and of good quality This approach provides all the elements for a complete diagnosis, optimal treatment, and thorough risk stratification. Moreover, this one-stop-shop renders the non-invasive diagnostic work-up largely obsolete.

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Studies Support Growing Use Of New Technology To Improve Stenting