MILAN (ITALPRESS) – Shorter procedures, use of a lower amount of contrast medium and clinical results at a year not lower than those obtained with intravascular ultrasound (IVUS). These are the data of the P4 (Precise Procedurel and PCI Plan), presented at the TCT – Transcatheter Cardiovascular Therapeutics 2026 in San Diego and published in the New England Journal of Medicine, which compared the percutaneous displacement of coronary stenosis (PCI) led by the coronary TAC (CCTA) with a guided by the IVUS. Principal investigator of the study is Professor Daniele Andreini (pictured), head of the University Cardiology and Cardiological Imaging of the IRCCCS Hospital Galeazzi-Sant’Ambrogio in Milan (Gruppo San Donato) and ordinary professor of diseases of the cardiovascular apparatus of the University of Milan. Involved as part of the steering committee also Professor Antonio Bartorelli, Head of the Operational Unit of IRCCCS Interventistica Universitaria dell’IRCCS Hospital Galeazzi-Sant’Ambrogio. The percutane displacement of coronary stenosis (PCI) with stent plant requires an accurate assessment of the lesion in terms of the severity of stenosis, extension and morphology of the plaque, amount of calcification and size of the vase. These parameters depend on the choice of the treatment strategy, the size of the stent and, ultimately, clinical outcomes. Intravascular imaging with ultrasound (IVUS), based on the intraproceural use of an ultrasound probe positioned in the coronary lumen, is the reference standard for the guidance of the PCI, but remains little widespread on a large scale as the operator requires a specific training. The P4 study assessed whether a pre-procedural planning strategy based on coronary angiography with computerized tomography (CCTA), integrated by the non-invasive estimate of the fractional flow reserve (FFR-CT), could ensure comparable clinical outcomes, configuring itself as a more sustainable alternative. The randomized international study involved 1,105 patients in 23 centres of 8 countries. All patients had an indication of Rivascolarization and at least one lesion with shrinkage of more than 70% and FFR-CT equal to or less than 0,80. The middle age was 65 and 21.7% were women. Patients were assigned by draw to a CPI led by TAC (556) or IVUS (549). At 12 months, serious problems to the treated vase (morte heart, infarction of the target vase or new Rivascolarization for ischemia) occurred in 4.1% of the patients of the TAC group and in 4.6% of the IVUS group. The TAC-based strategy therefore met the criterion of no inferiority compared to ultrasound. The clinical procedural complications were 6 in the TAC group and 9 in the IVUS group. The procedures planned with the TAC were shorter than 17 minutes (46 versus 63 minutes) and required less contrast medium (150 versus 170 ml). As the TAC shows in advance the calcium present in the arteries, operators could plan to crush it with shock waves (litotrixia) or to remove it with a dedicated device (aterectomy), and they did it 2.5 times more often than the IVUS group (9.2% versus 3.8%), without extending the time of the procedure. “The P4 study demonstrates the inferiority of a PCI strategy led by CCTA and FFR-CT compared to the IVUS. The results clearly support the integration of non-invasive imaging into intervention planning,” says Professor Andreini. “The benefits are important especially for patients but also for cardiologists. Today, in most cases – more than 90% – PCI is guided by the coronary angiography alone, because intravascular ultrasound, in Italy as in the rest of the world, is used in less than 10% of procedures, for reasons of costs and specific skillsask the operator. The coronary TAC, instead, is a more accessible and widespread technology, this means being able to offer many more patients a more targeted, effective and safer procedure. A precision planning, so far reserved to a few specialized centres, can now enter the daily practice of many more hospitals. The international moderators of the late-breaking clinical trial session in which the study was presented defined as ‘disruptcy, for the highly innovative character, and stressed the possibility of affecting the international guidelines for the management of the coronaropathy, the first cause of death in the world’ concludes Professor Andreini.The results suggest that the coronary TAC can take a role not only diagnostic but also guide to pre-procement planning. The study is already programmed to prolong the surveillance of patients enrolled up to 5 years and will therefore provide further data in the near future to support this innovative approach to the treatment of ischemic cardiopathy.
– IRCCS IRCCS Hospital Galeazzi-Sant’Ambrogio di Milano (Gruppo San Donato) –
(ITALPRESS).
