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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, Dr. Do-Yoon Kang 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. Dr. Kang 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, Dr. Kang 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, Dr. Kang 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

December 01, 2023 2821

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AP VALVES & SH 2023

14-Year¡¯s Journey of AMC TAVR

Seung-Jung Park, MD, PhD (Asan Medical Center) presents the 14-year journey of TAVR in the opening session during the 12th AP VALVES & STRUCTURAL HEART 2023 held at the Grand Walkerhill Seoul, South Korea on August 10. As of 2023, the 2020 ACC/AHA guideline recommends TAVR for severe symptomatic Aortic Stenosis (AS) patients over the age of 65, while those under 65 are considered for Surgical Aortic Valve Replacement (SAVR) based on their age. However, the 2021 ESC/EACTS guidelines recommend TAVR for patients over 75 years of age, with all other patients evaluated for either TAVR or SAVR based on their specific condition. Dr. Park now suggested that TAVR is the primary choice for patients in need of a tissue valve, with SAVR considered for those deemed unsuitable for the TAVR procedure. Asan Medical Center, which initiated TAVR procedures in 2010 and currently performs approximately 300 TAVR cases per year, totaling over 1500 cases, has achieved promising outcomes. These outcomes include procedural success rates of 99.5%, with low mortality (1.3%), stroke (0.3%), vascular complications (4.2%), permanent pacemaker insertion (6.8%), moderate to severe paravalvular regurgitation (0.4%), and more, showcasing the effectiveness of their approach. This success can be attributed to a collaborative heart team approach, a minimalist approach known as MAC (Monitored Anesthesia Care), and a meticulous AMC CT algorithm for device selection. The AMC CT Algorithm is a major key to achieving a procedural success rate of 99.5%. This algorithm can identify various anatomical factors, including annulus area, calcium distribution, and coronary height, which are measured to determine the size of the valve and its suitability for TAVR. The choice of TAVR device and balloon volume is determined by the level of calcium and other structural factors. The data from AMC¡¯s TAVR procedure show favorable 30-day and 1-year outcomes, including all deaths (1.5%, 8.4%, respectively), cardiac death (1.1%, 2.2%, respectively), and disabling stroke (1.3%, 1.4%, respectively). In conclusion, Dr. Park emphasizes that TAVR has become the standard of care for patients with symptomatic severe aortic stenosis, regardless of age or specific cases. SAVR is considered primarily for patients who are unsuitable for TAVR. The data and experience of AMC presented to support the effectiveness of the heart team approach, the minimalist MAC procedure, and the CT algorithm for valve size selection, highlighting their key factors for success.

November 10, 2023 2814

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AP VALVES & SH 2023

RENOVATE Trial

The introduction of valve replacement surgery in the early 1960s dramatically improved the outcomes for patients with valvular heart disease. Currently, approximately 300,000 valve substitutes are implanted worldwide each year, with about half being mechanical valves and the other half bioprosthetic valves. This number is projected to rise to 850,000 per year by 2050. Bioprosthetic valves pose a higher risk of reoperation due to structural valve deterioration, whereas mechanical valves typically require lifelong anticoagulation to prevent thromboembolism, leading to an increased risk of hemorrhage. The risk-benefit ratio between mechanical and bioprosthetic valves has led American and European guidelines on valvular heart disease to consistently recommend mechanical valves for patients under 60 years of age due to their more favorable long-term survival rates in younger patients. Despite these recommendations, the use of bioprosthetic valves has significantly increased across all age groups over the past decades, mainly due to the advantage of avoiding long-term anticoagulation. In the current guidelines, oral anticoagulation using a vitamin K antagonist is recommended lifelong for all patients with mechanical valves. However, the use of vitamin K antagonists requires frequent blood testing, dosage adjustments, and restrictions on food, alcohol, and relevant drugs. To address these limitations, the Randomized, Phase II study to Evaluate the Safety and Pharmacokinetics of Oral Dabigatran Etexilate in Patients after Heart Valve Replacement (RE-ALIGN) trial was conducted. This trial aimed to compare the anticoagulation regimen between dabigatran and vitamin K antagonist(warfarin) in patients who had undergone mechanical heart valve replacement, evaluating the efficacy and safety of dabigatran, one of the non-vitamin K antagonist oral anticoagulants (NOACs), in patients with mechanical valves. Unfortunately, the trial was terminated prematurely due to an excess of thromboembolic and bleeding events among patients in the dabigatran group. Consequently, the current guidelines contraindicate the use of NOACs in patients with mechanical valves. Despite this setback, revisiting the RE-ALIGN trial has provided valuable insights for future clinical trials. The major limitations of the RE-ALIGN trial include dose adjustments of dabigatran aiming for a trough plasma level of at least 50 ng/mL, often administering the drug above standard dosages, inclusion of mitral mechanical valve replacement cases (29%), which entail much higher thrombogenic conditions than aortic valve replacement, enrollment of patients in the early phase of the postoperative period (

November 10, 2023 1963

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SummitMD

Advancements in Intravascular Imaging Explored at ESC 2023

AMSTERDAM, the Netherlands — The European Society of Cardiology (ESC) Congress 2023 has cast a spotlight on the evolving role of intravascular imaging (IVI) in percutaneous coronary intervention (PCI), revealing both the potential benefits and challenges associated with this advanced technology. Thus far, no definitive research has established the superiority of either technique. IVI is eagerly anticipated for its capability to enhance the precision of stent placement, reduce complications, and mitigate the risk of stent thrombosis. The medical community is abuzz with excitement, eagerly anticipating the transformative potential that IVI holds in the realm of interventional cardiology. The spotlight of the conference was on the groundbreaking OCTIVUS Trial, which meticulously categorized patients undergoing PCI between 2018 and 2022 into two cohorts based on the intravascular imaging device employed: 1,003 patients underwent intravascular ultrasound (IVUS), while 1,005 patients were guided by optical coherence tomography (OCT). The study meticulously compared and analyzed major clinical events occurring within one year, including myocardial infarction, ischemia requiring reintervention, or cardiac death. Remarkably, the results unveiled no statistically significant disparities in the incidence of major clinical events between the two groups, registering rates of 3.1% in the IVUS group and 2.5% in the OCT group. Similarly, intervention-related complications exhibited no substantial differences, standing at 3.7% and 2.2% respectively. Dr. Do-Yoon Kang, the First Author of the trial, remarked, 'Among the two commonly used adjunct imaging devices in stent procedures, intravascular ultrasound (IVUS), which was developed first, has been considered the standard. Optical coherence tomography (OCT) had only been proven safe through small-scale studies.' Kang continued, 'Through this large-scale study, it was demonstrated that there was no significant difference in the safety profiles between the devices, with a major adverse clinical event rate of less than 3% annually. Duk-Woo Park, MD, PhD (Asan Medical Center) is presenting during a Hot Line Session at ESC Congress 2023, held in Amsterdam, Netherlands It is widely acknowledged that the utilization of IVI significantly enhances clinical outcomes, particularly in complex PCI cases. OCTIVUS Trial demonstrates that if you have some experience of IVUS or OCT, you can choose either one. Emphasized Dr. Duk-Woo Park, who presented the study's findings on Sunday, the 27th, during the 'Hotline' session, the flagship event of the European Society of Cardiology Annual Congress 2023, the preeminent cardiology conference held in Amsterdam, Netherlands. Furthermore, the study's outcomes were concurrently published in 'Circulation,' the official journal of the American Heart Association, reinforcing the trial's significance and reach within the global cardiology community. https://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.123.066429

October 27, 2023 3333

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TCTAP 2023

Physiologic Approach for Non-LM Bifurcation Lesions

Bon-Kwon Koo Seoul National University Hospital, Korea A recent lecture at TCTAP 2023, ¡®All Bifurcation PCI¡¯ highlighted the clinical relevance of side branches and emphasized the importance of weighing risk and benefit when guiding the bifurcation percutaneous coronary intervention (PCI) strategy. Bon-kwon Koo, MD (Seoul National University Hospital, Korea) introduced a novel algorithm for a physiological approach, developed collaboratively by the Korean, Japanese, and European Bifurcation Clubs. This algorithm aims to provide a comprehensive framework for managing coronary bifurcation lesions. According to the algorithm, if the side branch is deemed not clinically relevant, the primary objective is just to maintain thrombolysis in myocardial infarction (TIMI) 3 flow in the side branch. This determination is primarily based on angiographic assessment. He also introduced the SNuH score, which was developed a decade ago and incorporated into the Bifurcation Academic Research Consortium (Bif-ARC) in 2022 to assess the clinical significance of side branches. The score takes into account vessel size (diameter >2.5 mm), the number of diagonal branches (¡Â2), and the absence of branches below the target branch. Furthermore, a simple decision tree approach was also introduced which is based on the analysis of over a thousand cases (Figure 1). It revealed that only 15% of side branches supply more than 10% of the entire myocardium. However, the likelihood of a diagonal branch supplying more than 10% of the entire myocardium varies according to the coronary anatomy. If a single diagonal branch is present without left circumflex dominance, the likelihood of supplying more than 10% of the myocardium rises to 74%. Figure 1. Decision tree approach for significant side branch In cases where the side branch is clinically relevant, the proposed algorithm by Korean, Japanese, and European Bifurcation Clubs recommends provisional side branch stenting. Following stenting, functional assessments such as fractional flow reserve (FFR) or non-hyperemic methods are required. Additional side branch intervention is indicated if these values fall below the thresholds. In a previous retrospective analysis, FFR data of jailed left circumflex artery (LCX) after left main-left anterior descending artery (LM-LAD) crossover stenting revealed that a low FFR value (

June 20, 2023 4019

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TCTAP 2023

Statistical and clinical interpretation of the "PROTECTED-TAVR" trial and my take-home messages

Samir R. Kapadia Cleveland Clinic, USA According to Samir R. Kapadia, MD (Cleveland Clinic, USA) the trial revealed a lower incidence of disabling strokes with protection, and the procedure itself was safe; hence this signifies that it is not the end of the story. Stroke remains frequent post-transcatheter aortic valve replacement (TAVR), in about 3% to 5% at 1 year, with 50% of events occurring within 3 days and being procedure-related. Stroke post-TAVR is probably under-reported, and its real frequency increases when a neurologist is involved in patient assessment. Half of the strokes are covert events and could have a delayed impact on depression, cognitive function, and quality of life. Though prior studies have shown that deploying the Sentinel system captures debris in nearly all patients undergoing TAVR and have suggested that doing so may reduce stroke in intermediate- or high-risk cohorts, definitive evidence of a reduction in events remains elusive. Those who were hoping that the PROTECTED-TAVAR trial would give a clear-cut result and bring closure to the question of whether cerebral embolic protection (CEP) reduces stroke in patients undergoing TAVR were disappointed when the findings were published on NEJM in September 2022. Figure 1. Comparison in the rate of strokes within 72 hours and prior to discharge The trial did not meet its primary endpoint, failing to demonstrate a significant difference in the rate of stroke within 72 hours of the procedure or prior to discharge¤Ñ2.3% with the use of the Sentinel CEP system (Boston Scientific) versus 2.9% without (P = 0.30) (Figure 1.). But that¡¯s not the end of the story, according to Kapadia, a global principal investigator, because with CEP there was a lower rate of disabling stroke, a secondary endpoint for which the trial was not powered (0.5% vs 1.3%; P = 0.02). He told TCTAP 2023 that the trial also showed that the using of CEP was safe with no major complications, and that stroke was an unpredictable event¤Ñno specific factors that could be used to identify a patient group most likely to benefit from protection emerged. ¡°I wouldn¡¯t say it¡¯s negative,¡± Kapadia said about the trial, adding that it was possible that a larger study could have shown a significant advantage for protection on the primary endpoint. Moreover, he added, ¡°Disabling stroke is a more meaningful outcome for patients.¡± The use of a CEP device during TAVR did not lead to a significantly lower incidence of periprocedural stroke. Based on the 95% confidence interval around this outcome, however, the results may not rule out a benefit of CEP during TAVR. He concluded that the use of protection with the Sentinel device should be considered for all patients undergoing TAVR to reduce disabling strokes (Figure 2). The number needed to treat for this purpose was 125. Figure 2. A take-home message from Kapadia¡¯s lecture Hot Topics Game of Thrones, TAVR vs. SAVR Sunday, May 7, 4:10 PM - 5:30 PM Valve & Endovascular Theater, Vista 1, B2 CHECK THE SESSION

June 20, 2023 2920

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TCTAP 2023

My 30 Years Story - Caring for Patients with Symptomatic Vascular Disease

John Robert Laird, Jr. MD Adventist Heart & Vascular Institute, USA John Robert Laird, Jr. MD (Adventist Heart & Vascular Institute, USA)shared his journey as a cardiologist in search of surgical strategies for symptomatic vascular disease. ¡°When reflecting on my past 30-plus years of peripheral intervention as a cardiologist, I couldn't help but think about the people that helped me along the way including my early mentors Dr. Christopher White, Stephen Ramee, and Tyrone Collins at Walter Reed Army Medical Center who were mentors during my cardiology fellowship and first introduced me to peripheral intervention, and then the group at the Washington Hospital Center and Cardiovascular Research Foundation where my colleagues and mentors in my early years as a practicing Interventional cardiologist¡¦(Figure 1).¡± Figure 1.Group members of the Cardiovascular Research Foundation in the early years During Laird¡¯s early career, from 1987 to 1990, only balloon angioplasty was available. There were no FDA-approved stents, other devices, or as well as dual antiplatelet therapy. At that time, technical success rates were only 80 to 85% with balloon angioplasty. Problems with acute dissection and elastic recoil made acute vessel closure in 3 to 8% of cases, with significant consequences that were a need for emergency backup bypass surgery were 2 to 5% of cases. Restenosis rates even with successful angioplasty initially were 30 to 50% with balloon angioplasty, so those good old days were not so good. When it comes to iliac artery angioplasty, the results revealed around 90% in 1-month clinical success, but a significant drop off in patency over time-related to restenosis and to disease progression in the iliac arteries. Then, there was a lot of enthusiasm about the new devices that were introduced in the early 1990s including the atherectomy devices and stents. When the stent era began in the 1990s a time frame, the original Palmas 308 iliac balloon stent was presented as 30 mm in length, expandable tubular slotted stent, and could be expanded from 8 to 12 mm in diameter (Figure 2). Figure 2. Equipment needed for the iliac artery stenting Over the ensuing years, continued improvements were observed with our stents, both, balloon-expandable and self-expanding stents, and covered stents for iliac artery use and with a good technique such as using intravascular ultrasound guidance. The long-term results of the iliac artery stenting are remarkably good with 15-year primary and secondary patency rates that were over 90%, and we could treat very complex cases such as chronic occlusions (CTO) of both two iliac arteries. As a consequence of excellent angiographic results and good clinical outcomes, we've gone from an era of the bifemoral bypass which was a very commonly performed procedure to an era where it's a very rarely needed procedure because of the excellent results we achieved with treatments in the iliac artery endovascular treatments in the iliac arteries. Superficial femoral artery (SFA) disease has been much more challenged due to the nature of the disease with diffuse, long, and heavy calcified lesions associated with disease of the infra-popliteal runoff vessels and then the complex mechanical forces that complicate the placement of endovascular prostheses. Because of these challenges, we've seen a host of different technologies, multiple different balloons such as hot balloons, cold balloons, cutting balloons, scoring balloons, and more recently drug-eluting balloons (DEB). There are a whole host of CTO devices that have been developed laser as well as atherectomy devices and a variety of different stents, including, standard laser-cut nitinol stents, covered stents, a woven nitinol stent, and most recently paclitaxel-eluting stents for the SFA and popliteal arteries. Probably the biggest advance that we've undergone procedures in the SFA has been the advent of the DEB. This was the initial paper from 2004 by Dr. Sheller and Dr. Speck who were able to demonstrate that if you took paclitaxel and mixed it with iodinated contrast, you could then coat a balloon and allow the paclitaxel to come off the balloon and effectively deliver the drug into the vessel wall to inhibit subsequent new intimal proliferation. Dr. Laird was one of the co-principal investigators for the impact SFA drug-coated balloon trial where we saw three years by duplex ultrasound dramatically better results with the Impact-Admiral drug-coated balloon compared to standard balloon angioplasty. We learned better angioplasty techniques because DEB uses long balloon inflations and appropriately sized balloons to avoid geographic mismatch. We could see outstanding results even in complex morphologies in the SFA and popliteal arteries. And we now have data out to five years from the randomized trial as well as the global registry showing sustained benefit with Impact-Admiral drug-coated balloon for complex lesions in the SFA. Regarding better devices for calcium, atherectomy devices can be used in a very complex calcified lesion followed by DEB angioplasty. The woven nitinol stent from Abbott Supra stent is an excellent stent for complex calcified lesions, particularly in the popliteal artery where if we use a proper technique, we can get outstanding and good durable results. More recently, we have shockwave intravascular lithotripsy which has been demonstrated to be effective in multiple vascular beds including the SFA and popliteal artery as noted in the Disrupt PAD III study less need for stents and better patency when shockwave intravascular lithotripsy was used. Probably one of the most exciting advances again over the past 30 years has been the significant improvements and techniques for limb salvage in patients with complex infra popliteal occlusive disease, distal and multi-vessel intervention, pedal and tibial access, advanced CTO techniques with controlled antegrade and retrograde subintimal tracking (CART), reverse CART and Rendezvous techniques, recanalization through collaterals, plantar artery recanalization, and more recently transcatheter arterialization of the deep veins. About 25 years ago we would never have occurred to puncture one of the distal pedal vessels trying to a retrograde crossing of tibial occlusions, but now that has become commonplace. The importance of what we do for our patients, how significant an impact it is to save someone's leg, and how important work really is highlighted. Hot Topics EVAR, TEVAR, Peripheral Monday, May 8, 4:00 PM - 5:20 PM Presentation Theater 1, Vista 3, B2 CHECK THE SESSION

June 13, 2023 2490

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TCTAP 2023

The MitraClip Shows Promising Results in 5-Year COAPT Trial for Heart Failure Patients

Gregg W. Stone, MD Mount Sinai Healthcare System in New York City, USA Gregg W. Stone, MD (Mount Sinai Healthcare System in New York City, USA) discussed the final 5-year results of the COAPT trial, which examined the effectiveness of the MitraClip in patients with secondary mitral regurgitation (MR) and heart failure on May 8th at TCTAP 2023. Considered the largest randomized trial to date for patients with MR, the COAPT trial involved 614 heart failure patients who were already receiving guideline-directed medical therapy (GDMT). These patients experienced moderate to severe MR, leading to left ventricular dilatation and mitral leaflet tethering caused by papillary muscle displacement. The trial aimed to determine whether addressing the underlying abnormal left ventricle would improve patient outcomes. The participants were randomly assigned to receive either GDMT alone or treatment with the MitraClip. Earlier publications presented the 2-year results, which revealed a substantial reduction of approximately 50% in heart failure hospitalizations (HFH) among patients receiving medical therapy. The recent 5-year results, published in a NEJM, demonstrated a sustained 50% reduction in HFH. Specifically, the patients treated with GDMT alone experienced 447 hospitalizations (approximately two per patient), while those treated with the MitraClip had 314 HFH in 151 patients, resulting in an average reduction from 57% to 33% per year. This marked a statistically significant overall reduction of 47% in hazards. The trial also prioritized safety outcomes, employing a composite measure recommended by the FDA that encompassed device-specific events and progressive heart failure necessitating a heart transplant. The results indicated that within the first year, the measure remained below 12%, achieving a rate of 3.3%. Moreover, only four device-related events (1.4%) occurred in the MitraClip group. The MitraClip procedure is well-known for its safety, and this analysis further substantiated its favorable safety profile. Extending the safety assessment to one year, no abnormal safety events related to the MitraClip, such as device detachment, embolization, endocarditis, severe mitral stenosis requiring surgery, or any other device-related complications, were reported in the MitraClip group. An analysis of the composite outcome of death or HFH demonstrated a significant 47% reduction at the 5-year mark for patients who received the MitraClip in comparison to GDMT alone (Figure 1). Importantly, this reduction remained consistent across all pre-specified subgroups, including age, gender, surgical risk, ventricular size, and other factors analyzed. When examining the time to the first HFH, a Kaplan-Meier analysis revealed a remarkable 51% reduction. Notably, the majority of this reduction occurred within the first three years, after which no significant differences were observed between the two groups. Regarding all-cause mortality, the trial demonstrated a notable absolute reduction of 10% and a relative reduction of 28% over the 5-year duration. However, a landmark analysis unveiled that the mortality reduction was primarily observed within the first two years, with minimal differences between years two and five. This observation could be attributed to the crossover permitted in the trial, whereby patients in the control group who survived for two years and still exhibited severe MR became eligible for treatment with the MitraClip. Stone explained, ¡°I think that's a really important secondary implication of this study. Waiting until the patients have been observed for several years is futile because a lot of them are going to die every single year. You can prevent a lot of those deaths and reduce HFH by identifying appropriate patients for the MitraClip treatment despite optimal GDMT as soon as possible.¡± In conclusion, the 5-year results of the COAPT trial provided promising evidence regarding the efficacy of the MitraClip in heart failure patients with secondary MR. The findings demonstrate that transcatheter edge-to-edge repair with the MitraClip is safe. Figure 1. Death or HFH after crossovers Hot Topics Mitral & Tricuspid Valve Therapy Monday, May 8, 11:10 AM - 12:20 AM Valve & Endovascular Theater, Vista 1, B2 CHECK THE SESSION

June 13, 2023 4275

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TCTAP 2023

Optimal MSA for LM Crush Technique: New Criteria Any Difference in Any 2 Stent Technique?

Jung-Min Ahn, MD Asan Medical Center, Republic of Korea Jung-Min Ahn, MD (Asan Medical Center, Korea) showed the relationship between Left Anterior Descending (LAD) and Left Circumflex (LCX) depending on new criteria describing how to optimize two stents for Left-Main (LM) bifurcation stenting technique. For the bifurcation lesion of left main coronary artery disease (LMCAD), a simple crossover of the LM to LAD artery has been considered as a default strategy. ¡°However, there are many cases we cannot avoid two-stenting at bifurcation lesions,¡± Ahn said . Actually, in many trials about LMCAD including the PRECOMBAT, EXCEL, and NOBLE trials, more than one-third to up to half of patients received the two-stent technique (Figure 1). Even in the EBC-MAIN trial, which favored one-stenting, about 22% of patients in the provisional stenting group received two-stenting (Figure 2). Therefore, we should know how to optimize two stents for LM bifurcation stenting technique to improve the clinical outcomes of patients with LMCAD. Figure 1. Two Stent Technique in rRandomized Trials Figure 2. Randomized Trials for True LM Bifurcation In 2011, Kang et al. reported LM intravascular ultrasound (IVUS) minimal stent area (MSA) criteria based on the result of a total of 403 patients treated with LM percutaneous coronary intervention (PCI) (Figure 3). However, the previous study included a heterogeneous group of patients, and therefore, we needed specific MSA criteria for the LM crush technique based on the long-term follow-up data. Also, the EXCEL and Spain Registry Criteria suggested a bigger MSA compared with the LM IVUS MSA criteria. Figure 3. LM IVUS MSA criteria ¡°So, we needed new MSA criteria for the LM crush technique,¡± Ahn said (Figure 4). Figure 4. LM IVUS Optimization Criteria ¡°We included a total of 292 patients with unprotected LMCAD treated with crush technique who had completed post-stenting IVUS and analyzed a major adverse cardiovascular event (MACE), a composite of death, myocardial infarction, or repeat revascularization (Figure 5).¡± Figure 5. Optimal MSA Criteria for LM Crush Technique Based on Long-Term (5-year) Clinical Outcomes ¡°Based on the 5-year MACE outcomes, we determined the best cut-off value to predict the 5-year clinical outcomes,¡± he said (Figure 6). Figure 6. ROC Curve Analysis ¡°LM did not show any association between LM MSA and MACEs, because LM MSA was large enough not to occur any cardiovascular events (Figure 7, 8). However, the MSA of LAD and LCX was linearly associated with MACEs (Figure 9). So, according to the aforementioned criteria, there was no significant difference in clinical outcomes between LM MSA >11.8 mm2 and LM MSA

June 08, 2023 4299

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