The trials presented during EuroPCR 2018, re-address the role of PCI in the treatment of chronic coronary syndromes (CCS), bringing to the fore the beneficial role of this approach.
Chronic coronary syndromes (CCS), have a major societal impact, impacting the patient’s quality of life (QoL) with recurrent hospitalizations, reduced physical endurance, and mental depression. Angina pectoris is an important symptom of the syndrome.
CCS are seen as stable, differentiated from acute coronary syndromes (ACS) where the disease has become destabilized with partial or complete coronary occlusion resulting in NSTEMI or STEMI.
Until recently, there was little evidence for the prognostic impact of percutaneous coronary interventions (PCI) using modern drug-eluting stent (DES) implantation versus medical therapy in the treatment of patients presenting with CCS. However, some of these previous trials did not use the latest-generation DES technology (which offers thinner struts or limus derivatives for antiproliferation). In these trials, only modest benefits were observed in terms of survival or myocardial infarction (MI), although there was an improvement of symptoms and QoL.
Today, this is changing with new and emerging evidence coming out of trials using the latest imaging technology and devices, as well as following patients over the long term.
The recent trials that determine the role of PCI in the treatment of CCS (lesions in stable CAD, or non-culprit lesions in stabilized ACS) include:
Fractional flow reserve and instantaneous wave-free ratio as predictors of the placebo-controlled response to percutaneous coronary intervention in stable single vessel coronary artery disease: the physiology-stratified analysis of ORBITA.
Results from the physiology-stratified analysis of ORBITA presented at EuroPCR 2018, and simultaneously published in Circulation, demonstrate that PCI improves ischemia as assessed by dobutamine stress echocardiography and renders more patients free of angina than does placebo. FFR and iFR are shown to predict the strength of the PCI effect on ischemia, but this is only clearly seen on blinded stress echo evaluation and is not visible in the symptom scores or exercise times.
GZ-FFR: a randomized controlled trial of PCI vs. optimal medical therapy in patients with stable angina and Grey-Zone Fractional Flow Reserve values
Results at two months show that PCR signals a significant reduction in angina frequency and improvement of QoL, exceeding what was seen in ORBITA, but without patient blinding.
FAME 2, DANAMI-3-PRIMULTI, and COMPARE-ACUTE: a pooled, patient-level analysis of FFR-guided PCI vs. medical therapy to reduce cardiac death and myocardial infarction
Results from the first patient-level pooled analysis of all existing trials comparing FFR-guided PCI with contemporary stents, versus medical therapy alone, demonstrate improved hard outcomes. 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.
Long-term survival in patients with stable angina pectoris undergoing PCI with or without intracoronary pressure wire guidance in a report from Swedish Coronary Angiography and Angioplasty Registry (SCAAR)
This historic, large observational study involved 31,469 patients. The study looked at patients with CCS who underwent PCI – 3,460 pts with FFR/iFR guidance and 21,221 without. At 10 years, a significantly lower rate of overall mortality, restenosis and stent thrombosis was observed in the FFR/iFR-guided PCI group.
These trials demonstrate that PCI, with the latest-generation DES, are an effective strategy for the treatment of CCS in 2018, both in terms of symptom relief – patients will feel better – and in terms of hard outcomes. Together, these data point to the clear recognition of the usefulness of physiological guidance for stenting which, in the case of CCS, does have an impact on outcomes during longer-term follow-up. Physiological guidance has proven to be an important asset in planning interventions, and a reliable tool for predicting outcomes.
Important points for the treatment of CCS in 2018:
- Recent data provide a strong signal that FFR/iFR, physiology-guided PCI is superior to angio-guided PCI in terms of mortality, restenosis and stent thrombosis, for up to 10 years.
- PCI results in less angina, better QoL, fewer urgent revascularisations and fewer spontaneous MIs compared to medical treatment alone.
- The longer the observation period is after PCI, the greater the benefit shown for PCI.
- The greater the degree of ischemia that is documented for a particular coronary lesion, the greater the benefit demonstrated by PCI.
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