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FFR- and IVUS-Guided PCI Do Not Reduce Mortality Long-Term: Observational Study

 

 

 

LONDON, UK — The use of fractional flow reserve (FFR) or intravascular ultrasound (IVUS) during PCI is not associated with improved long-term mortality rates when compared with standard angiography-guided PCI, according to a new observational study[1].

 

The results are based on an analysis of 41 688 patients with stable angina and non-ST-segment-elevation MI (NSTEMI) included in the Pan-London (United Kingdom) PCI Registry. Compared with conventional PCI, there was no statistically significant difference in mortality among those treated with FFR- and IVUS-guided PCI after a median of 3.3 years.

 

"It is perhaps too optimistic to expect a survival advantage from the use of a purely diagnostic procedure," write Dr Georg Fröhlich (University College London Hospital, UK) and colleagues in the August 2014 issue of the Journal of American Medical Association: Internal Medicine. "This is particularly true in patients with stable coronary artery disease, for whom PCI has never demonstrated a clear survival benefit."

 

Commenting on the results for heartwire , Dr Sanjit Jolly (McMaster University, Hamilton, ON) said the mortality rates observed in the registry are very low, at less than 1%. He echoed the sentiment of the researchers in that there was never any real belief that FFR-guided procedures would confer a survival advantage over conventional angiographic PCI.

 

In the St Jude Medical-sponsored FAME II trial, stable patients who got a stent to treat a functionally significant coronary lesion were less likely to need an urgent reintervention than those treated with medical therapy alone, but the FFR-guided approach did not show a survival benefit. Similarly, FAME showed a benefit of FFR on the primary end point of major adverse cardiovascular events (MACE), a benefit that was largely driven by the need for repeat revascularizations.

 

"FFR is a clinical tool to help decide whether a lesion is significant," said Jolly, who is not connected to the study. "Potentially, you would avoid performing PCI when it's unnecessary and do PCI when you're unsure if it's appropriate."

 

The American Heart Association (AHA) recommends FFR be used for a hemodynamic assessment in patients with stable angina if the coronary lesion is considered of intermediate severity (class IIa). The AHA guidelines also recommend the use of IVUS to assess intermediate lesions in the left main artery (class IIa).

 

The Data From the PCI Registry

 

In the UK PCI Registry, 2767 patients underwent FFR-guided PCI, and IVUS was used in 1831 patients. After adjustment for multiple variables, the FFR-guided mortality rate after 3.3 years was not significantly different from that of angiography-guided PCI (hazard ratio 0.88; 95% CI 0.67–1.16). Similarly, IVUS-guided PCI did not confer a mortality benefit compared with angiography-guided PCI (hazard ratio 1.39; 95% CI 1.09-1.78). A propensity-matched analysis showed similar results.

 

Complications and Other Outcome Measures

 

Outcome

Angiography (n=37 090)

FFR (n=2767)

IVUS (n=1831)

p

Stents implanted (n)

1.7

1.1

1.2

<0.001

Procedural complications

 

 

 

0.009

Side-branch occlusion (%)

0.4

0.2

0.4

Coronary dissection (%)

1.2

0.6

1.8

Coronary perforation (%)

0.2

0.1

0.3

No reflow (%)

0.4

0.1

0.3

 

Individuals in the FFR group received significantly fewer implanted stents than those treated with IVUS and conventional PCI. "These data are in line with results from previous randomized trials suggesting that FFR-guided PCI may have a stent-sparing effect, but this did not translate into a survival benefit," write the investigators.

 

 

 

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ワイヤレス、モバイル、ICT,ブルーツース、クラウド、遠隔、小型、生体情報、バイタルサイン、連続波形、タブレット、医療ソフトウエア、ロボット、インターベンション、非観血、電池式、心電図、血圧、血流、体温、呼吸、SPO2,聴診音、自律神経、先天性心疾患、植え込みセンサー、FFT,エコー、最先端、当の情報に関心がございます。