Results from the first patient-level pooled analysis of all existing trials comparing FFR-guided PCI with contemporary stents versus medical therapy demonstrates improved hard outcomes.
Paris, France, 22 May 2018. Ongoing controversy exists today regarding the role of percutaneous coronary intervention (PCI) for stable coronary lesions to improve hard outcomes. Stable lesions include both patients with stable coronary artery disease as well as non-culprit lesions in haemodynamically stabilised acute coronary syndrome (ACS) patients.
Three randomised controlled trials have compared fractional flow reserve (FFR)-guided PCI using modern drug-eluting stents versus medical therapy for stable lesions: FAME 2, DANAMI-3-PRIMULTI, and COMPARE-ACUTE.
What are the new insights gained from these trials?
Each study demonstrated a clinical benefit in favour of FFR-guided PCI, including (urgent) revascularisation in the primary endpoint. However, each trial by itself was not powered for the endpoint of cardiac death or myocardial infarction. For this reason, a pooled, patient-level analysis including 2,400 patients was performed to address adequately whether FFR-guided modern PCI reduces cardiac death or myocardial infarction versus medical therapy.
What new data are being presented?
This is the first pooled analysis on a patient level which includes all existing trials comparing FFR-guided PCI with contemporary stents versus medical therapy. In addition, this analysis extended follow-up for both the FAME 2 and DANAMI-3-PRIMULTI trials.
"Our results," Frederik M. Zimmermann explained, "show for the first time that modern PCI, when guided by FFR, reduces so-called "hard endpoints" – the composite outcome of cardiac death or myocardial infarction – when compared to an initial strategy using medical therapy. Importantly, we found a relative risk reduction of approximately 30% when using FFR-guided treatment, which corresponded to an estimated absolute risk reduction of ~4.5% at 5 years. Our analyses also favoured FFR-guided PCI when examining the composite of all-cause death or myocardial infarction. Differences between groups were driven by a reduction in myocardial infarction. No differences were observed for deaths from cardiac causes or deaths from any cause".
What role do innovation, devices or technology play in these results?
This pooled analysis demonstrates that key technology innovations (pressure wire fractional flow reserve to guide PCI and contemporary drug-eluting stents) have enabled PCI to improve patient outcomes.
What is the take-home message for the clinician?
"In patients with stable coronary lesions, contemporary PCI – i.e., guided by FFR – reduces the risk of future myocardial infarction or cardiac death independently of its impact on symptoms."
For the public?
"Medicine has two broad goals: making you feel better now and avoiding problems in the future. Widening narrowed heart arteries with stents has long been used to treat symptoms and stop ongoing heart attacks. However, whether stents can help avoid problems in the distant future has remained controversial. Pressure measurements inside the heart arteries can identify coronary arteries that should be widened. Our results show for the first time that stents reduce the chances of having a future heart attack in clinically stable patients with such arteries".
KEY DATA
- – 2,400 patients in pooled, patient-level analysis from FAME 2, DANAMI-3-PRIMULTI, and COMPARE-ACUTE trials
– FFR-guided modern PCI versus optimal medical therapy
– 30% approximate relative risk reduction of the composite of cardiac death or myocardial infarction using FFR-guided treatment, corresponding to an estimated absolute risk reduction of ~4.5% at 5 years.
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CONTACT INFORMATION:
Frederik M. Zimmermann, MD
Department of Cardiology
Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 EJ Eindhoven, the Netherlands
+31 (0)40-2397004
E-mail: [email protected]
Nico H.J. Pijls, MD, PhD
Professor of Cardiology
Department of Cardiology
Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 EJ Eindhoven, the Netherlands
+31 (0)40-2397004
E-mail: [email protected]
CORRESPONDING SESSION
EuroPCR 2018 session: Tuesday 22 May – Main Arena 12:20-14:00 (Presentation 13:05-13:15)
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NOTES TO EDITORS
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