Philips Announces Class IA Recommendations for IVUS and iFR for PCI in ESC Guidelines

October 7, 2024—Royal Philips recently announced the latest classification updates for the company’s key imaging and physiology technology in new guidelines for managing chronic coronary syndromes from the European Society of Cardiology (ESC).

According to the company, the updates to the ESC guidelines emphasize the robust clinical evidence supporting the use of intravascular ultrasound (IVUS) and instantaneous wave-free ratio (iFR). Both modalities have demonstrated significant benefits in improving patient outcomes through numerous large-scale randomized trials like DEFINE FLAIR and iFR SWEDEHEART, stated Philips.

The updates were announced at the ESC Congress 2024 held August 30 to September 2 in London, United Kingdom, and simultaneously published by Professor Christiaan Vrints, MD, et al in the European Heart Journal. (2024;45:3415–3537). The ESC guidelines were last updated in 2019.

The company advised that several Philips technologies for coronary artery disease were covered by the 2024 ESC Guidelines for the management of chronic coronary syndromes, reflecting the level of evidence and the evolution of clinical science establishing standards of care to optimize patient outcomes.

As explained in the press release, class guidelines denote the evidence a treatment or procedure is recommended or indicated for use, whereas the level of evidence is based on the amount of data available from randomized clinical trials and meta-analyses.

Philips stated that the IVUS technology has been upgraded to Class 1, Level of Evidence A, reflecting the growing body of evidence showing that intravascular imaging improves patient outcomes. With the updated guidelines, IVUS is now recommended for percutaneous coronary intervention (PCI) on anatomically complex lesions, in particular left main stem, true bifurcations, and long lesions.

“[A] meta-analysis of randomized clinical trials (Stone et al. The Lancet. 2024;403:824-837) had already shown that intracoronary image guidance of PCI improves patient outcomes and saves lives,” commented Professor Javier Escaned, MD, in Philips’ press release. “But the IA recommendation for IVUS in the updated ESC guidelines is crucial, as it reflects expert consensus based on a definite body of evidence supporting the positive impact of IVUS, specifically for patients with anatomically complex lesions treated with PCI.” Prof. Escaned is Head of the Interventional Cardiology Section at Hospital Clinico San Carlos in Madrid, Spain.

The use of Philips’ iFR technology remains a Class IA recommendation for physiologic measurement during PCI. This classification is attributed to findings from the DEFINE FLAIR and iFR SWEDEHEART physiologic studies, which involved more than 4,500 patients combined and evaluated the safety and effectiveness of iFR, demonstrating its noninferiority to fractional flow reserve.

Additionally, coronary function testing, such as coronary flow reserve, has been elevated to Class 1, Level of Evidence B, for patients with nonobstructive CAD. This technology identifies potentially treatable endotypes and offers a definitive diagnosis of microvascular disease that can direct medical treatment strategies for these patients. This change to the guidelines validates the growing prevalence and diagnosis of microvascular disease, stated Philips.