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TCTAP 2024

DCB Use in Your PCI Practice: Adjunctive Therapy or Standard of Care?

Bruno Scheller, MD University of Saarland, Germany Despite advancements in interventional procedures, that began with the development of balloon angioplasty by Andreas Grüntzig in 1977, stent-related adverse events occur in approximately 2-3% of cases every year. DCB was developed based on its unique, "leave nothing behind" philosophy. Since co-developing the first DCB with Ulrich Speck in the late 1990s, Sheller’s innovations have significantly advanced the field of interventional cardiology. DCBs are expected to reduce the number and length of stents without causing stent-related adverse events, and much research is currently being conducted. Efficacy of DCBs compared to DES At the conference, recent studies will be presented, which demonstrate that DCBs are equivalent to drug-eluting stents (DES) for stent restenosis when appropriate lesion preparation is performed. Based on this research, DCBs were recommended as an option for the treatment of in-stent restenosis (ISR) in the 2018 European Society of Cardiology (ESC) Guideline. On the contrary, the use of DCB for de novo lesions of small coronary artery lesions has not yet been included in the guidelines, due to the lack of data. The benefits of DCB application in de novo vessels will be introduced through studies such as the BASKET-SMALL 2 trial and DEBUT trial. In the BASKET-SMALL 2 trial, which investigated non-inferiority for treatment with DCB compared with DES in patients undergoing PCI for de novo lesions in small coronary arteries, 8 patients presented with a complete thrombotic vessel occlusion after undergoing stent implantation compared to none after a DCB intervention. Meanwhile, there was no difference in the estimates of the cumulative probabilities of major adverse cardiac events (MACE) in the two study groups over 3 years. Optimal lesion preparation has been mentioned as the most important factor in applying DCB strategy. It is necessary to assess whether lesion preparation for DCB is adequate. DCB may be a good alternative to DES for cases where the residual stenosis is ≤ 30% and fractional flow reserve (FFR) is > 0.8, with absence of flow limiting dissection during the lesion preparation process (Figure 1). The choice of DCB and DES should be determined based on whether optimal angiographic findings are obtained after lesion preparation. Additional strengths of DCB Post-procedural late lumen enlargement (LLE) and vasomotion will be presented as additional strengths of DCB. According to a study assessing intravascular geometric and compositional characteristic changes induced by DCB in de novo lesions, LLE after DCB treatment for de novo coronary artery disease (CAD) was caused by both vessel enlargement and plaque regression. Similarly, according to a study which compared coronary vasomotion in patients with small CAD treated with DCB versus DES, vasoconstriction after acetylcholine infusion in the peri-treated region was less pronounced in the DCB arm than in the DES arm. This suggests that endothelial function in treated coronary vessels could be better preserved by DCB than by new-generation DES. In case of patients with multivessel CAD, the application of DCB provided benefits compared to utilizing DES only with regard to the risk of MACE over 2 years. Due to these strengths and developments in DCB, the adoption rate of DCB is gradually increasing worldwide. According to the coronary DCB to DES ratio in PCI worldwide, in 2020 this ratio was 1:25 in Europe, which has increased to 1:4 in 2023. This trend reflects growing confidence in the efficacy and safety of DCBs due to successful clinical outcomes and growing support from the medical community. The presentation will highlight the historical advancements and current achievements of DCB technology, as well as its potential to revolutionize cardiac care. Based on the studies presented, it can be expected that DCB will develop into a standard of care rather than simply adjunctive therapy. As the field seeks less invasive and more effective treatments, ongoing research, including Scheller's, and advocacy for DCB will likely play a pivotal role in setting new standards in cardiovascular medicine. Figure 1. DCB-only strategy for PCI in CAD TCTAP Workshops Evolving PCI Devices: Coronary DES, BRS, and DCB Thursday, April 25, 4:50 PM ~ 5:50 PM Presentation Room 1, Level 1 Check The Session

April 25, 2024 752

TCTAP 2024

What Are Novel and Future Antithrombotic Drugs in ACS and PCI? Are There Still Unmet Needs?

Individualization of antithrombotic therapy Roxana Mehran, MD Icahn School of Medicine at Mount Sinai, USA Deciding on the appropriate antithrombotic therapy after percutaneous coronary intervention (PCI) requires a multifaceted approach that takes into consideration various patient factors, clinical presentations, comorbidities, concomitant medications, and procedural aspects. The ultimate goal is to strike a delicate balance between reducing ischemic events and minimizing bleeding risk. When tailoring antithrombotic therapy for individual patients, it’s essential to assess their unique characteristics and weigh the potential benefits against the risks. One crucial aspect in optimizing antithrombotic therapy post-PCI is risk stratification. Several tools and scoring systems are available to help clinicians accurately assess bleeding and ischemic risks. These include a validated scoring system, platelet function testing and genetic testing, which can provide valuable insights into antiplatelet responsiveness. The journey towards determining the optimal duration of antiplatelet therapy post-PCI has been marked by significant milestones, from the early focus on preventing thrombosis to the growing recognition of bleeding risks associated with antiplatelet use. Recent years have witnessed a surge in studies exploring the timing and duration of dual antiplatelet therapy (DAPT) cessation, leading to more nuanced approaches to post-PCI management. Emerging strategies for managing acute coronary syndrome (ACS) patients offer new avenues for tailoring antithrombotic therapy. These strategies encompass P2Y12 monotherapy, de-escalation approaches and dual pathway inhibition, each with its unique considerations and potential benefits. Recent randomized controlled trials (RCTs) have provided valuable insights into the efficacy and safety of novel antithrombotic strategies. In the TWILIGHT trial, conducted among 9,000 high-risk PCI patients, participants were administered ticagrelor monotherapy for 1 year, following a 3-month period of DAPT with ticagrelor and aspirin. The trial aimed to compare the outcomes between ticagrelor monotherapy and DAPT with ticagrelor and aspirin. The results revealed a 34% reduction in the bleeding risk in the ticagrelor monotherapy group compared to the DAPT group, specifically in Bleeding Academic Research Consortium (BARC) 2, 3 or 5 events. However, no significant differences were observed in the incidence of death, myocardial infarction (MI) or stroke, which were set as the ischemic outcome endpoints. De-escalation strategies and P2Y12 monotherapy Implementing P2Y12 monotherapy for all patients requires careful consideration of various factors, including ischemic and bleeding risk, comorbidities, and concomitant medications. While certain patient subgroups, such as those with ACS, complex PCI, or diabetes may benefit from intensified antiplatelet therapy, others, such as those on oral anticoagulants or at high bleeding risk, may require more conservative approaches. In the TWILIGHT-ACS trial, which enrolled 5,739 patients with ACS, ticagrelor monotherapy was compared to the DAPT with ticagrelor and aspirin after 3 months. The results showed that ticagrelor monotherapy reduced bleeding events by 53% while showing no significant difference in ischemic outcomes. In the STOPDAPT-2 ACS trial, patients who underwent PCI due to ACS were compared after 1 month, where one group received clopidogrel monotherapy and the other group continued with DAPT. The outcomes were assessed over a 5-year period, revealing no significant differences in the bleeding outcomes between the two groups. The ischemic outcomes were also non-inferior. Similarly, in the STOPDAPT-3 trial, patients undergoing PCI were compared between prasugrel monotherapy and DAPT. Results showed no significant differences in bleeding or ischemic endpoints between the two treatment groups. De-escalation strategies offer additional opportunities for personalized therapy, by incorporating platelet function testing, genetic testing, dose adjustments, or changing to clopidogrel. A meta-analysis of RCTs, including TROPICAL-ACS, POPular Genetics, HOST-REDUCE POLYTECH-ACS, and the TALOS-AMI trial, examining the effects of four de-escalation strategies, reveals compelling findings. The analysis demonstrated that patients receiving de-escalation DAPT experienced a reduction, not only in bleeding events, but also in ischemic events compared to those on standard DAPT. Potential for dual pathway inhibition Dual pathway inhibition aims to address the residual risk of major adverse cardiovascular event (MACE), which remains at approximately 3% despite the use of antiplatelet agents alone. The rationale behind this approach is to further reduce this risk by inhibiting the coagulation pathway in addition to antiplatelet therapy. Notably, factor XI inhibition has garnered attention for its potential to decrease thrombosis without interfering with hemostasis. Clinical trials utilizing factor XI inhibitors are currently underway in various patient populations, including those with atrial fibrillation (AF), stroke, end-stage renal disease (ESRD), or ACS. In the PACIFIC phase 2 trial, the addition of asundexian to DAPT did not significantly increase bleeding through dose-dependent XIa inhibition. However, no clear benefit was observed in terms of reducing MACE. Therefore, a larger trial is required to establish the safety and efficacy of asundexian 50mg. Meanwhile, the LIBREXIA program, which employs milvexian, is conducting a large-scale phase 3 trial comparing the safety and efficacy of milvexian in patients with secondary stroke prevention, ACS or AF. Furthermore, ongoing areas of research that require attention include triple therapy, management of thrombotic risk despite the use of antiplatelet therapy, and left ventricular thrombus management, especially in patients who underwent recent PCI or are facing impending surgery. These areas underscore the need for additional investigation to enhance our understanding and management of thrombotic complications in these patient populations. TCTAP Workshops Antithrombotic Hot Issues in ACS/PCI: What Are New in 2024? Thursday, April 25, 3:40 PM ~ 4:45 PM Presentation Room 1, Level 1 Check The Session

April 25, 2024 723

TCTAP 2024

TAVR-in-TAVR: The NEXT Challenging Issue in Lifetime TAVR Management

Philippe Garot, MD Institut Cardiovasculaire Paris-Sud, France Compared to surgical aortic valve replacement (SAVR), there is an increasing use of transcatheter aortic valve replacement (TAVR) in patients over 80 years old, as well as in those aged 65-80 years in western countries. In patients with a remaining life-expectancy of over 10 years, a considerable number of transcatheter heart valves (THVs) are expected to fail, requiring repeat intervention. According to a multicenter registry, surgical explantation after TAVR failure was associated with an overall mortality of almost 15% at 30 days and 30% at 1 year follow-up. Contrastingly, redo-TAVR is relatively safe and effective. Underexpansion of THVs may lead to hypoattenuated leaflet thickening (HALT) and early dysfunction with elevated gradients. In these patients, a staged post-dilation of the THVs may improve hemodynamics and delay a redo-TAVR procedure. Coronary access may be impaired after a redo-TAVR procedure. Factors impacting coronary access may be anatomical, or related to the device and the procedure. The design of the index TAVR implant is associated with a different risk of sinus sequestration and coronary obstruction. The risk of sinus sequestration increases up to 91% in balloon-expandable valve (BEV)-in-self-expandable valve (SEV) and 75% in SEV-in-SEV, and in these cases, leaflet interventions should be considered as a prerequisite for redo-TAVR (Figure 1 ). The optimal THV design and implantation technique for redo-TAVR are poorly understood. In the case of redo-TAVR, the leaflets of the failed THV may create a “tube graft,” where the index THV leaflets can be jailed between the two THV frames. This can create a neoskirt of tissues from the failed THV inflow to the top of the jailed leaflet, which may limit subsequent coronary access and flow. The higher the second THV, the taller the neoskirt, with a higher risk of sinus sequestration. The position of both the index and the second THV are crucial in avoiding sinus sequestration. In some patients, the second implant must be lower to avoid a tall neoskirt, causing a significant leaflet overhang in return. The width of the sinuses of Valsalva is a key for a reasonable valve-to-coronary (VTC) distance, which may be compromised by THV flaring, second implant depth and valve canting. The risk of coronary obstruction after redo-TAVR is strongly related to the index TAVR design, the implant depth of the index THV and commissural alignment of both the index and redo-THV, which can help avoiding coronary obstruction and facilitate leaflet interventions. Also, the index failed THV may expand after redo-TAVR, and this should be considered when determining the VTC distance. Figure 1. Different THV-in-THV combinations and the neoskirt heights TCTAP Workshops TAVR: Key Issues in 2024 Thursday, April 25, 10:30 AM ~ 11:25 AM Presentation Room 1, Level 1 Check The Session

April 25, 2024 666

COMPLEX PCI 2023

When to Go Retrograde?

The groundbreaking work of Maoto Habara, MD (Toyohashi Heart Center, Japan), took center stage as he shared insights on the optimal timing and considerations for a retrograde approach in Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI). In the dynamic realm of CTO PCI, the pivotal question of when to adopt a retrograde approach has become a focal point. Over the years, the success rate of CTO PCI has experienced a remarkable surge from 50-70% to a robust 85-90%, underscoring the evolution of techniques and technologies within this specialized field. Key contributors to this significant improvement include the refinement of equipment. Innovative techniques, such as parallel wire approaches, IVUS-guided rewiring, ADR, and retrograde methodologies, have become instrumental in achieving higher success rates. A thorough understanding of CTO pathology and the nuanced mechanics of guidewire manipulation, involving factors like deflection, and whipping motion, has proven pivotal in this advancement. Recent registry data, incorporating insights from Asian CTO experts along with data from Europe and the US, consistently show procedural success rates exceeding 85%. The retrograde approach, employed in approximately 20-30% of cases, emerges as a critical component in contemporary CTO PCI practices. Its efficacy becomes particularly evident in complex CTO scenarios where the antegrade approach encounters challenges and in cases with compromised distal vessel quality or notable side branches at the distal cap. Notably, the retrograde approach minimizes contrast consumption in patients with chronic kidney disease, adding another layer to its benefits. Critical considerations in this decision-making process encompass dual injection, thorough angiogram analysis, and confirmatory IVUS checks in the presence of ambiguity at the proximal cap or poor distal vessel quality. The angle of the retrograde channel, vessel size, and other factors play a crucial role in the assessment, guiding the decision-making process. Real-world cases vividly illustrate the retrograde approach's efficacy in scenarios like proximal cap ambiguity, distal exit uncertainty, and antegrade penetration challenges. Guideline recommendations advocate restricting antegrade guidewire manipulation to a 20-minute window due to associated risks, underscoring the importance of a thoughtful and timely approach. In conclusion, the decision of when to opt for the retrograde approach hinges on variables such as proximal cap ambiguity, distal vessel quality, and the success of antegrade wiring within a 20-minute timeframe. This nuanced decision-making process, coupled with alternatives like ADR, parallel wire, or IVUS-guided rewiring, serves as a cornerstone for optimizing success in CTO PCI procedures.

Feburary 02, 2024 3491

COMPLEX PCI 2023

Novel Antegrade Wiring for CTO PCI: Concept of OPV & PPV and Its Clinical Application

Kenya Nasu, MD (Mie Heart Center, Japan), introduced the groundbreaking "Penetration Plane Method," designed to simplify the intricate task of wire manipulation in CTO interventions. By emphasizing the optimal utilization of this method and focusing on the distal landing zone, he highlighted its ability to offer a more predictable and controllable motion for guidewires. The Penetration Plane Method operates with the assistance of the Penetration Plane View (PPV), providing a perspective where the vessel appears straight, ensuring a streamlined guidewire trajectory. Derived from a direction that flattens the plane, this viewpoint ensures the maintenance of a straight guidewire appearance. Complementing this, the Objective Perpendicular View (OPV) offersa perpendicular perspective, forming the foundational approach of the Penetration Plane Method. Ensuring precision in the approach, an accurate perpendicular view measurement was highlighted, achieved through a vector projection method. He showcased the method's effectiveness by utilizing two random projections of coronary angiograms to reconstruct the three-dimensional structure of coronary arteries. To further enhance accuracy, he discussed the development of specialized software capable of selecting the optimal angle, identifying the best vector, and calculating the perpendicular, providing a clear representation of the vessel vector on the screen. Additionally, he introduced the ongoing development of ECG-synchronized fluoroscopy, addressing limitations associated with cardiac motion during the Penetration Plane Method. This technology aims to offer nearly stationary coronary angiograms at specific points in the cardiac cycle, ensuring optimal visualization. He demonstrated the entire process through a practical example during the session, emphasizing its simplicity and effectiveness. The integration of navigation software and mapping was underscored, promising precise guidance for guidewire manipulation. Concluding the lecture, he raised expectations for the future of guidewire manipulation, hinting at evolving technologies and methodologies. He emphasized the need for adaptation to advanced devices, including the integration of plasma-mediated ablation systems for CTO procedures. His presentation marked a significant step towards reshaping the landscape of coronary interventions, offering new hope and possibilities for the field.

Feburary 02, 2024 2822

COMPLEX PCI 2023

Be Provisional!
Optimal Provisional Strategy for LM PCI

Hyeon-Cheol Gwon, MD, PhD (Samsung Medical Center, Korea), began his presentation by examining the prevalence of the provisional approach in LM bifurcation, referencing the IRIS-MAIN and COBIS II registries. These registries revealed a high prevalence of the provisional approach, with respective rates of 91.9% and 78.8%, indicating its widespread acceptance in the medical community. He further expanded on this by referencing various trials, including EBC Main and DK-CRUSH V. These trials compared the provisional approach with systematic two-stent strategies, highlighting that the simpler provisional approach yields outcomes comparable to the more complex two-stent strategies. Building on this foundation, he emphasized that stepwise layered provisional stenting is recommended as the preferred strategy for treating left main coronary bifurcation lesions. This approach, which balances efficacy with minimal invasiveness, is crucial for optimizing patient outcomes. A key aspect of his presentation was the emphasis on the proximal optimization technique (POT) as an essential element in stenting optimization. He stressed that POT is a critical step in ensuring the stent is optimally placed and expandedto match the vessel's anatomy, which can significantly enhance the long-term success of the procedure. Another important point he made was regarding the treatment of the Left Circumflex (LCX) ostium. He noted that opening the LCX ostium does not show superior results compared to a simple crossover technique in a one-stent strategy, particularly in terms of long-term outcomes. This finding suggests that in many cases, a more conservative approach to LCX treatment might be preferable, avoiding unnecessary complexity in the stenting procedure. He concluded that bifurcation lesions may be the only type of lesion that shows a better outcome when treated conservatively. This insight underscores the importance of a measured and thoughtful approach in interventional cardiology, particularly in the context of complex procedures like left main coronary bifurcation stenting. Overall, his lecture provided a comprehensive view of the current strategies and data in treating left main coronary bifurcation lesions. His emphasis on a conservative, strategic approach, supported by substantial clinical data, presents a compelling argument for the provisional approach in interventional cardiology. These insights are poised to influence treatment strategies significantly, potentially leading to improved patient outcomes in complex coronary interventions.

January 26, 2024 2232

COMPLEX PCI 2023

Double Trouble or Double Success?
Upfront 2-Stent PCI for LM

Ho Lam, MD, FHKAM (Tuen Mun Hospital, Hong Kong, China), delved into the intricate world of percutaneous coronary intervention (PCI) for Left Main (LM) coronary artery bifurcation, providing a comprehensive exploration of the challenges and strategies inherent in this critical aspect of interventional cardiology. Emphasizing the nuanced nature of LM bifurcation PCI, he distinguished between simple and complex bifurcations. He stressed the importance of tailoring the approach to the specific characteristics of the lesion, advocating for a straightforward strategy in simple cases and a more individualized approach for complex bifurcations. Decision-Making Dilemma: Provisional vs. Upfront 2-Stent The heart of his presentation focused on the pivotal decision-making process between provisional and upfront 2-stent strategies. He vividly illustrated the risks associated with the provisional approach, particularly the closure of the left circumflex artery (LCX), emphasizing the potential for severe consequences. Incorrectly selecting a provisional approach, according to him, could lead to what he termed "double trouble," involving complications like the stressful wiring of LCX and increased stent thrombosis rates. Double Trouble: The Pitfalls of Wrongly Choosing Provisional He highlights the potential pitfalls if the provisional approach is incorrectly chosen. Closure of the vessel and the stressful process of wiring under challenging conditions are described. The presentation emphasizes the stressful nature of such procedures, requiring experienced operators to handle critical situations. Double Success: Benefits of Choosing Upfront Stenting Correctly Conversely, he outlined the advantages associated with correctly selecting and performing upfront 2-stent implantation, which he referred to as "double success." This approach, he highlighted, offers experiential learning opportunities in wiring, stenting, and imaging, along with cost reductions due to shorter cath lab times and decreased need for extended care. He also presented compelling data on stent thrombosis rates, showcasing the significantly lower incidence with upfront 2-stent procedures compared to provisional approaches that later required conversion to two stents. The lecture highlighted a 0.4% vs. 4.1% rate in definite or probable stent thrombosis over three years between the two methods. Reducing Costs and Achieving Full Revascularization: The Triple Success The lecture concluded with a strong emphasis on the pivotal role of operator experience and the ability to achieve full revascularization with a low residual SYNTAX score in Left Main PCI. His insights and data-driven approach contribute invaluable knowledge to the evolving landscape of LM bifurcation PCI, providing a comprehensive guide for interventional cardiologists navigating this intricate terrain. In summary, the choice between "Double Trouble or Double Success" in LM PCI is a spectrum that depends on patient characteristics, lesion complexity, and operator expertise. He suggests that, in general, the prognosis is largely determined by the severity of the LM lesion, making the correct decision pivotal for successful outcomes.

January 26, 2024 2234

COMPLEX PCI 2023

Precision in Stent Sizing: Insights from Imaging-Guided LM PCI

Jung-Min Ahn, MD, PhD (Asan Medical Center, Korea), delivered an enlightening study on Left Main (LM) percutaneous coronary intervention (PCI), focusing on optimizing two-stent techniques for LM bifurcation stenting, especially in the Left Anterior Descending (LAD) and Left Circumflex (LCX) arteries. Delving into the challenge of determining significant LM disease, he highlighted the difficulty in measuring fractional flow reserve (FFR), particularly in cases involving distal downstream disease. His research demonstrated a significant correlation between the minimum lumen area (MLA) in the LM and FFR values. An MLA less than 4.5 showed a high positive predictive value for FFR values less than 80, providing a potential criterion for identifying functionally significant disease. His research contributes significantly to the field, considering the default strategy for treating bifurcation lesions in Left Main Coronary Artery Disease (LMCAD) has been a simple crossover from the LM to the LAD artery. However, instances where two-stenting cannot be avoided were noted. The ongoing debate on provisional versus two-stent techniques, as seen in trials like DK-CRUSH V and EBC-MAIN, emphasized the need for clearer criteria, especially as a substantial proportion of patients initially categorized for provisional stenting end up receiving two stents. The necessity for this approach is evident from various trials on LMCAD, including PRECOMBAT, EXCEL, and NOBLE, where a significant proportion of patients received two-stent techniques. Even in the EBC-MAIN trial, which generally favored one stenting, about 22% of patients in the provisional stenting group ended up receiving two stents, underscoring the importance of understanding how to optimize the two-stent technique for better clinical outcomes. Addressing the ambiguity in defining when to choose between the two techniques, he discussed the current lack of definitive criteria. While angiographic criteria have been suggested, the absence of Intravascular Ultrasound (IVUS) criteria remains a gap. He proposed integrating IVUS criteria into decision-making processes, referencing studies indicating the predictive value of minimal lumen area and plaque burden for functional outcomes. He revisited the criteria established by Kang in 2011 while exploring the optimization of two-stent techniques. Kang et al. (2011) reported on minimal stent area (MSA) criteria for LM intravascular ultrasound (IVUS) from a diverse group of 403 patients undergoing LM PCI. However, the study's heterogeneity called for more specific MSA criteria, particularly concerning the LM crush technique. It's noteworthy that the EXCEL trial suggested a larger MSA compared to the established LM IVUS MSA criteria. Emphasizing the necessity of refining these criteria, especially considering the heterogeneity of various stenting techniques, his recent analysis indicated that achieving larger minimum stent areas, particularly in the complex ostium of the Left Main, correlates with improved long-term outcomes. These findings offer potential benchmarks for optimizing stent size and contribute to the ongoing discussion on refining criteria for LM PCI. The lecture provided insights into the ongoing debate about event rates between simple crossover and two-stent techniques. He presented data from his center's registry, demonstrating that proximal Left Main stent area significantly impacts clinical outcomes. Larger minimum stent areas correlated with favorable long-term outcomes, challenging the conventional belief that simple crossover stenting inherently results in lower event rates. Addressing this gap, he presented new MSA criteria based on a study of 292 patients with unprotected LMCAD treated with the crush technique. This study focused on major adverse cardiovascular events (MACE), a composite of death, myocardial infarction, or repeat revascularization. His analysis revealed a linear relationship between MSA of LAD and LCX with MACEs. Larger IVUS-MSAs were associated with improved clinical outcomes, underlining the significance of this parameter in guiding interventions. He concluded his presentation by recommending optimal IVUS-MSA criteria for predicting 5-year MACE: 11.8 mm2 for the distal LM, 8.3 mm2 for the LAD ostium, and 5.7 mm2 for the LCX ostium. His findings stress the paramount importance of achieving an adequately large MSA under IVUS guidance during LM two-stenting procedures to mitigate adverse clinical events. These conclusions offer invaluable guidance for interventionists, enhancing the precision and effectiveness of treatment for patients undergoing LM two-stenting procedures.

January 19, 2024 2184

COMPLEX PCI 2023

Celebration of LM PCI: Joy in Growth, Journeying Towards 25 Years

In an illuminating presentation at COMPLEX PCI 2023, Duk-Woo Park, MD, PhD (Asan Medical Center, Korea), provided a comprehensive overview of the growth of Left Main Percutaneous Coronary Intervention (PCI) over the last 25 years, delving into future perspectives while addressing the remaining challenges in this critical field. He presented a historical timeline of Left Main PCI, comparing two major procedures: the standard of care, Coronary Artery Bypass Graft (CABG) surgery, and the less invasive PCI treatment. Pivotal trials such as Syntax, PRECOMBAT, EXCEL, and NOBLE were highlighted, illustrating the comparative effectiveness of these interventions for Left Main and multivessel diseases. With Korea being a global leader in Left Main PCI, he traced back almost 25 years of history, mentioning early pioneers like Dr. Gudino and showcasing the first consecutive report of Left Main PCI at Asan Medical Center in 1998. The center's long-standing expertise and innovative techniques were instrumental in shaping the landscape of Left Main interventions. Addressing recent advancements, he highlighted a Lancet-published review by cardiac surgeon Mario Gudino, emphasizing the continuous revolution in both CABG and PCI procedures. This evolution includes advancements in drug-eluting stents,adjunctive drugs, and imaging- and FFR-guided PCI, leading to improved patient outcomes. He delved into long-term outcomes, discussing key trials like SYNTAX, PRECOMBAT, EXCEL, and NOBLE. He emphasized a recent combined individual patient data (IPD) meta-analysis, revealing that over 15 years, PCI and CABG showed no significant difference in mortality, with PCI demonstrating lower procedural complications and CABG having lower spontaneous myocardial infarctions. Providing insights into guideline updates, he discussed recommendations from both the American and European societies, underlining ongoing debates and controversies. He particularly addressed the ESC guideline's withdrawal of cardiac surgeon recommendations after the EXCEL trial. Future Directions: FATE-MAIN Trial and DEFINE-DM Trial Highlighting real-world practices, particularly in the Asian-Pacific region, he shed light on the preference for bypass surgery in cases with extensive non-LM coronary artery disease and diffuse three-vessel diseases. Conversely, PCI was favored for cases involving multivessel comorbidity. He introduced two upcoming trials shaping the future of Left Main PCI. The FATE-MAIN trial (Figure 1), involving over 40 Asian Pacific centers, will evaluate physiology-guided PCI versus conventional angiography-guided PCI. The DEFINE-DM trial (Figure 2) will focus on ischemic cardiomyopathy and diabetic patients, aiming to provide crucial insights into the remaining unmet issues. The presentation concluded by addressing persisting challenges in LM PCI, particularly in cases of ischemic cardiomyopathy with an ejection fraction below 40%. He highlighted two ongoing trials, STICH3C and DEFINE-DM, poised to provide insights into optimal revascularization strategies for these patient populations. Figure 1. FATE-MAIN Trial Study Design In the FATE-MAIN trial, we assume that the improved outcomes with FFR-guided PCI are likely a result of more judicious PCI whereby ischemia-inducing LMCA lesions are revascularized and non-ischemia-inducing LMCA lesions are treated with OMT alone. Figure 2. DEFINE-DM Trial Study Design In the contemporary clinical practice, the goal of PCI is to achieve complete functional revascularization of ischemic territories. Thus, the theoretical and practical concept of physiology-guided PCI will also work even in Left Main PCI setting. His lecture highlighted the rich history and advancements in Left Main PCI and outlined the current controversies and future directions, setting the stage for continued innovation in this crucial field of interventional cardiology.

January 19, 2024 1684

SummitMD

OCTIVUS Trial Subgroup Analysis for Complex Coronary Lesions Revealed at TCT 2023

Do-Yoon Kang, MD, PhD (Asan Medical Center) presented the Key Analysis from the OCTIVUS Trial during the 35th TCT 2023 held at the Moscone Center in San Francisco, CA on October 23. At the TCT WorldLink East Asia Featured Clinical Science, Do-Yoon Kang, MD, PhD (Asan Medical Center, Korea), unveiled pivotal findings from the key subgroup analysis of the OCTIVUS trial for the treatment of complex coronary artery lesions. The OCTIVUS trial was a prospective, multi-center, randomized, open-label trial that compared Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IVUS) in guiding Percutaneous Coronary Interventions (PCI) in a total of 2008 patients. Of those, this study compared OCT-guided PCI with IVUS-guided PCI in patients with complex coronary lesions in 1475 patients, including unprotected left main disease, bifurcation disease, aorto-ostial lesions, chronic total occlusions, severely calcified lesions, in-stent restenosis, diffuse long lesions, and multivessel disease. He highlighted the use of Cox proportional hazards models and overlap propensity-score weighting to adjust patient characteristics and reduce treatment selection bias. The mean age was about 65 years, and 21% were women. Lesion characteristics were similar in the two groups, although there was a lower proportion of left main disease and a lower mean SYNTAX score in the OCT group. Contrast dye used was greater, and total PCI time was shorter in the OCT-guided group. There was no difference in the rate of contrast-induced nephropathy between the two groups, but major procedural complications requiring intervention were less frequent in the OCT group (1.7% vs 3.4%; P = 0.03). The imaging devices showed no complications throughout the course of the study. Key findings revealed that OCT-guided PCI showed comparability to IVUS with the primary endpoint of a composite of cardiac death, target-vessel myocardial infarction (MI), or target-vessel revascularization over a median follow-up of 2 years (6.5% in the OCT group vs. 7.4% in the IVUS group; HR 0.87; 95% CI 0.59-1.29). The results remained steadfastly consistent between the groups, even after adjustments. Most secondary endpoints occurred at similar rates in the two groups, except that target-vessel MI was less common in the OCT group (0.8% vs 2.4%; P = 0.03). In subgroup analyses by lesion type, results were generally the same as in the overall analysis, except that in patients treated for in-stent restenosis, OCT guidance was associated with a lower rate of target vessel failure compared with IVUS guidance (10.5% vs 29.5%; HR 0.36; 95% CI 0.17-0.78). While presenting the findings, he astutely underscored the imperative of acknowledging the inherent constraints of the study. The number of primary-outcome events was lower than expected, and the impossibility of masking imaging modalities from patients and investigators could introduce bias. Additionally, he noted the potential for discrepancies in site-determined and core-laboratory measured imaging interpretation. In patients with complex coronary lesions, he formulated the following conclusions, OCT-guided PCI showed a similar risk of a composite of death from cardiac causes, target-vessel MI, or ischemia-driven target-vessel revascularization compared to IVUS-guided PCI during the median 2-year follow-up. However, owing to insufficient statistical power and inherent limitations from subgroup analysis, the overall finding should be hypothesis-generating, and further research is needed in this area. Do-Yoon Kang, MD, PhD

December 01, 2023 2913