Fluoroscopy-to-device time Assessment of a Single, Universal Catheter vs Two Catheters for Efficient Reperfusion during Percutaneous Coronary Intervention (FASTER-PCI): A Prospective, Multi-Center, Randomized Controlled Trial

Timely reperfusion remains the cornerstone of effective management in STEMI, with delays in revascularization directly correlating with increased morbidity and mortality. While system-level optimizations have reduced D2B times, procedural inefficiencies within the catheterization laboratory continue to be an underappreciated contributor to total ischemic time. The FASTER-PCI trial aims to address this gap by evaluating whether the procedural efficiency of the Ikari guiding catheter can meaningfully reduce intraprocedural delays, and thereby exert measurable impacts on clinical outcomes.

Our previous retrospective analysis demonstrated that the use of a single, universal Ikari Left (IL) guiding catheter significantly reduced Fluoroscopy-to-Device (FluTD) time compared to the conventional two-catheter strategy (Unpublished Data, 2025). Specifically, the IL catheter achieved a median FluTD time of 3 minutes versus 10 minutes with the conventional approach, without compromising procedural safety or efficacy. Patients in the Ikari group also exhibited superior myocardial perfusion, as evidenced by higher rates of myocardial blush grade 3 (Unpublished Data, 2025). These findings suggest that procedural modifications, such as catheter selection, have the potential to yield tangible improvements in reperfusion metrics, particularly in resource-constrained settings where system delays are pronounced. Further, quantifying the degree of improvement in left ventricular (LV) function as a direct result of reduced time to intervention of the culprit vessel has not been investigated previously.

The FASTER-PCI trial builds on these preliminary observations through a prospective, randomized controlled design to rigorously assess the impact of the Ikari catheter on both procedural efficiency and clinical outcomes. By incorporating endpoints such as GLS and LVEF at 24h and 3 months post-PCI, alongside traditional metrics such as D2B time and major adverse cardiac events (MACE), the proposed trial seeks to establish a comprehensive understanding of how procedural efficiency translates into long-term patient outcomes. Within this context, the introduction of the first FluTD time provides a granular lens through which to evaluate procedural delays, distinct from system-related variables that traditionally confound analyses of D2B times. However, several limitations warrant consideration. The retrospective analysis that informed this study was limited by its observational design and potential confounding factors. This trial is designed to overcome previous limitations through randomization, the inclusion of multiple study centers, and thorough data collection to examine differences in clinical outcomes. However, the ability to apply these findings broadly may be influenced by variations in operator experience with the Ikari catheter across different institutions and healthcare systems.

Should the FASTER-PCI trial confirm the superiority of the Ikari catheter in reducing procedural delays and improve clinical outcomes without compromising safety, it could prompt a paradigm shift in STEMI management protocols. This is of paramount importance in low and middle income countries (LMICs) where procedural delays still exist and need to be minimized, in parallel with other efforts to reduce pre-hospital and other in-hospital delays. The adoption of a single, universal guiding catheter strategy may reduce intraprocedural delays and could contribute to improved myocardial salvage and long-term cardiac function, underscoring the importance of procedural efficiency as a modifiable determinant of STEMI outcomes.