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COMPLEX PCI 2020 Virtual

Provisional or Double-Kissing for Bifurcation PCI: Interventionalists Review the Who, What, When, Wh...

PCI for left main bifurcation lesions requires a high level of technical and strategic maneuvering – two aspects that experts broke down in concrete detail during a COMPLEX PCI 2020 virtual training session on Nov. 26. Bifurcation PCI - a continually evolving field supplemented by ongoing research - requires technical expertise of the operator as well as strategic planning that tailors the approach to lesion complexity. The variability in choice ultimately results in heterogeneity in outcome across different operators, institutions, and even country borders. To reduce variability in outcome, Shao-liang Chen, MD, PhD (Nanjing First Hospital, Nanjing Medical University, China) outlined the importance of correctly defining complex bifurcation lesions, choosing the better stenting technique particularly for the upfront two-stent route, and the question of how to treat the side branch (SB). Interventional experts discuss strategies for left main and bifurcation PCI at COMPLEX PCI 2020 Virtual on Nov. 26. Top row, from left to right: Park Duk-woo (Asan Medical Center), Alan C. Yeung (Stanford School of Medicine), Sunao Nakamura (New Tokyo Hospital). Middle row: Park Seung-jeung (Asan Medical Center), Kenji Wagatsuma (Tsukuba Memorial Hospital), Shao-liang Chen (Nanjing First Hospital). Bottom row: Ahn Jung-min (Asan Medical Center), Koo Bon-kwon (Seoul National University Hospital), Teguh Santoso (Medistra Hospital, Indonesia). Correct classification goes a long way Accumulated data has shown a strong correlation between lesion complexity and clinical outcome as evidenced by the CACTUS, BBC-ONE, NORDIC trials that included CTO lesions, left main, and AMI, among others - emphasizing the need for correct lesion classification. Furthermore, results from the NORDIC study indicated a strong correlation between lesion complexity and worse clinical outcomes and demonstrated that provisional stenting does not work equally across both simple and complex lesions. Despite the need for a robust classification system, Dr. Chen pointed out the lack of a unifying and evidence-strong classification method for complex bifurcation lesions. Current recommendations propose the use of the upfront two-stent approach where provisional stenting may not be the answer. For instance, the 2018 European Society of Cardiology (ESC) guidelines, states the two-stent approach may be preferable for complex coronary bifurcations that have an SB diameter greater than 2.75 mm, SB lesion length greater than 5 mm, and are difficult to access the SB after main vessel (MV) stenting. Before the 2018 ESC guidelines, Chen and his team worked on defining bifurcation lesions for treatment with drug-eluting stents (DES) in the DEFINITION trial published in the Journal of the American College of Cardiology in 2014.1 “We had questions about the criteria for complex coronary bifurcation,” Chen said. “With this inquiry, we sought to address the issue of defining complex bifurcations.” The research team built the definition criteria for differentiating simple bifurcation lesions from complex bifurcation lesions by pooling data from 1,500 patients with bifurcation lesions and then further validated the criteria by utilizing an external validation sample of another 3,660 patients. True bifurcation lesions with at least one Medina 1,1,1 or 0,1,1 coronary bifurcation lesion and an SB diameter of at least 2.5 mm were included. The research team found eight confounding factors that correlated with one-year major adverse cardiac events (MACE) and thereupon established two major and six minor criteria for differentiating simple from complex bifurcation lesions. Of the eight confounders, two parameters proved to be strongly correlated with MACE with the highest sensitivity (80 percent) and specificity (72~74 percent) and were consequently designated as major: for distal left main bifurcation: SB diameter stenosis (DS) ≥70 percent and SB lesion length (LL) ≥10 mm for non-left main bifurcation: SB diameter stenosis ≥90 percent and SB lesion length ≥10 mm Another six parameters with p values

November 26, 2020 57905

COMPLEX PCI 2020 Virtual

Coronary CTA Before PCI Proves Beneficial for Chronic Total Occlusion Patients in Latest Study

Coronary CT angiography (CTA) proved to be a promising strategy for increasing the success rate of percutaneous coronary interventions (PCI) in patients with chronic total occlusion (CTO), according to CT-CTO study findings presented at COMPLEX PCI 2020. Findings from the domestically-conducted randomized trial showed CTO patients who underwent coronary CTA before PCI had better clinical outcomes than those who underwent PCI without a coronary CTA. Kim Byeong-Keuk, MD, PhD (Yonsei University College of Medicine, Severance Hospital, Korea) presented these findings at COMPLEX PCI 2020, which ran online for two days from Nov. 26 to 27. Kim Byeong-Keuk, MD, PhD (Yonsei University College of Medicine, Severance Hospital, Korea) presents CT-CTO trial findings at COMPLEX PCI 2020 VIRTUAL on Nov. 26 Lack of randomized data for coronary CTA in CTO-PCI Although innovative techniques and devices have opened the door to a minimally invasive treatment beyond medication or open heart surgery, patient characteristics - lesion length, presence of plaques, and side branch (SB) occlusion, among others – often influence clinical outcomes. For these reasons, interventionalists emphasize the importance of planning a treatment strategy that incorporates preprocedural angiograms and CT-based imaging tests in particular. Coronary CTAs can be utilized to identify CTO while also predicting the level of difficulty with which an operator can cross a CTO. The imaging technique can also aid in preprocedural planning, visualization during the procedure, and long-term follow-up of recanalized coronary segments, among others. Although experts have signaled that coronary CTAs could play a larger role in predicting the prognosis of post-PCI CTO patients and in selecting a procedural strategy to improve CTO-PCI success rates, the lack of definitive randomized evidence for coronary CTAs in the CTO-PCI sphere has created some uncertainty. Prior to the CT-CTO study, non-randomized data came from a 2013 study, led by German researchers, that discovered a 90 percent success rate in the 30-person CTO-preprocedural coronary CTA group versus a 63 percent success rate in the 43-person control group.1 Coronary CTA proves higher recanalization rate than angiography The CT-CTO study –led by researchers from Severance Hospital –is the first randomized study to prove the usefulness of coronary CTA performed prior to PCI in 400 Korean CTO patients at 12 domestic medical institutions. Investigators enrolled CTO patients eligible for PCI who were 19 years or older with a TIMI grade flow of 0 and a coronary artery occlusion period of at least three months. Patients were randomly assigned in a 1:1 ratio to either a preoperative coronary CTA group or an angiography group. The primary endpoint was the recanalization rate, defined as residual stenosis in final coronary angiography (CAG) < 30 percent and TIMI grade flow ≥2. Upon investigating the superiority of preprocedural coronary CTA to preprocedural angiography alone, the coronary CTA group demonstrated a roughly 10 percentage point higher rate of recanalization than the angiography group (94% vs. 84%, 95% CI 3.4-15.6). Sub-analysis based on 257 patients with a J-CTO score ≥2 showed the coronary CTA arm had a recanalization rate of 93 percent while the angiography group had a rate of 77 percent (P

November 26, 2020 25187

SummitMD

ViV TAVR For Failing Surgical Valves Shows Promising Longer-Term Data

PARTNER II ViV investigators presented promising five-year data on valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) for severe aortic stenosis patients with failing surgical bioprosthetic valves (SBV) at TCT Connect 2020 this year to raise confidence in the procedure but still leaving low-risk groups up in the air. The five-year data may serve as the latest catalyst for shifting the rate of physician selection for ViV TAVR over redo surgery and patient preference for bioprosthetic valves in what is becoming an increasingly complex decision-making process for patients with aortic stenosis. ViV TAVR – in earlier studies1 – was associated with acceptable mortality, improved valve hemodynamics, and excellent quality of life outcomes at three years for patients with failing surgical valves, but lacked data attesting to longer-term clinical outcomes, valve function, and durability. Rebecca T. Hahn, MD (NewYork-Presbyterian/Columbia University Irving Medical Center), who presented the results of the PARTNER II ViV study on Oct. 17 at TCT Connect 2020, explained that the lack of long-term data spurred investigators to conduct a five-year follow-up study of the prospective, multicenter PARTNER aortic ViV registries. And the team found, Hahn said, ViV TAVR mortality in high-risk patients at five years was comparable to that of native TAVR mortality in intermediate-risk patients. Early improvement in functional status and quality of life were maintained throughout five years among survivors and valve hemodynamics were stable over five years. Rates of hemodynamic valve deterioration (HVD) and bioprosthetic valve failure (BVF) were also consistent with those reported for native SAPIEN XT valves in intermediate-risk patients. PARTNER 2 ViV raises TAVR confidence, leaves low-risk patients in grey zone The prospective, multicenter PARTNER II ViV trial pulled 365 patients from two ViV registries – Nested Registry (NR3) and Continued Access Nested Registry (CANR) – that were nested in the PARTNER II trial. Investigators included patients with symptomatic severe stenosis or regurgitation of a surgical aortic bioprosthetic valve and a high- and extreme-risk for re-operation (estimated surgical mortality or major morbidity ≥50 percent). Patients with surgical bioprostheses smaller than 21-mm were excluded, and instead included patients eligible for treatment with a 23-mm or 26-mm SAPIEN XT THV. Mean patient age was 79 years old and 64 percent were male. Between studies, the five-year all-cause mortality rate was 50.6 percent, which was significantly lower than the 73.0 percent of inoperable patients treated with native valve TAVR in PARTNER II cohort B (P

November 12, 2020 9742

SummitMD

NIRS-IVUS Imaging Helps Detect Vulnerable Plaques, Patients at High Risk for Adverse Cardiac Events

Near-infrared spectroscopy (NIRS)-intravascular ultrasound (IVUS) intracoronary imaging can be used to identify vulnerable plaques that pose higher MACE risk in coronary artery disease, providing a potential segue into treatment that can lower cardiac event incidence. David Erlinge, MD, PhD (University of Lund, Sweden) – who presented these findings from the investigator-sponsored, multicenter, prospective, natural history PROSPECT II study at TCT Connect 2020 on Oct. 18 – reported that patients with vulnerable plaques on NIRS-IVUS had a significantly increased risk of future MACE and signaled the potential of advanced imaging techniques in identifying and reducing the risk of adverse events with patient-tailored treatment. “NIRS identified lipid-rich angiographically mild non-flow-limiting plaques that were responsible for future coronary events and data shows three-vessel intracoronary imaging with NIRS-IVUS was safe,” Erlinge said. “By combining lipid-rich plaques along with a large plaque burden and small lumen area, we can pinpoint vulnerable plaques that expose patients to future MACE risk.” “Whether prophylactic treatment of these high-risk plaques is safe and effective was investigated in the integrated PROSPECT ABSORB trial,” he added. PROSPECT ABSORB was a randomized trial nested within the PROSPECT II study that showed treating vulnerable plaques with Abbott’s discontinued Absorb bioresorbable vascular scaffold resulted in an expanded minimum lumen area (MLA) at two-year follow-up compared to untreated plaques. PROSPECT II shows benefit of combined imaging technique Plaque rupture causing acute coronary syndrome is a leading cause of global mortality. NIRS-IVUS has become a promising tool to detect rupture-prone vulnerable plaques to predict and prevent MACE with patient-tailored treatment. NIRS is a novel catheter-based intravascular imaging technique that snaps a chemogram of the coronary artery wall, helping identify the lipid core and quantify lipid accumulation, referred to as the lipid-core burden index (LCBI). Retrospective reports and prospective studies have suggested that vulnerable plaques detected by NIRS-IVUS are associated with adverse outcomes. The PROSPECT II study aimed to evaluate NIRS-IVUS usefulness in 898 individuals treated at 16 centers in Sweden, Denmark, and Norway who had a recent myocardial infarction categorized as either STEMI or troponin-positive NSTEMI. Recent MI patients included in the trial had one or more non-flow-limiting lesions with a 65 percent plaque burden and were successfully treated with PCI. Patients subsequently underwent intravascular imaging with a combination NIRS-IVUS catheter in proximal 6-10 cm of all three coronary arteries. Patients were 63 years old on average and about 20 percent were female. Investigators used IVUS to identify untreated non-culprit lesions (NCLs) and blinded NIRS to assess lipid content. The primary endpoint was designated as MACE during long-term follow-up, encompassing the composite of cardiac death, MI, unstable angina, or progressive angina either requiring revascularization or with rapid lesion progression. The study aimed to explore the relationship between high-risk features of untreated NCLs (plaques with high lipid content, large plaque burden, and minimum lumen area) and patient-level/lesion-level outcomes. Among the 898 patients with untreated NCLs, MACE occurred in 13.2 percent of patients at a median 3.7-year follow-up with 8 percent of events occurring in untreated NCLs. Culprit-lesion MACE occurred in 4.2 percent of patients, BVS lesion-related MACE in 4.3 percent, and indeterminate MACE in 2.5 percent. Analysis showed that patients who fell into the upper quartile of the maximum 4 mm lipid core burden index (LCBI) – defined as maxLCBI4mm ≥ 324.7 – had a MACE risk of 10.1 percent compared to a 4.8 percent risk in patients with lesser plaque burden, indicating MACE risk doubled in patients with a larger plaque burden (OR 2.08, 95% CI 1.18-3.69). Furthermore, MACE incidence in patients with lesions of a plaque burden ≥ 70% versus that in patients with a smaller plaque burden was 11 and 3.6 percent, respectively, which showed severe plaque burden was associated with a three-fold risk jump (OR 3.09; 95% CI 1.65-5.76). Upon combining the two high-risk features, analysis showed that MACE incidence in patients who had lesions with both large plaque burden and high lipid content was 7.0 percent, serving as a stark contrast to the 0.2 percent MACE incidence in patients who did not have the two high-risk features. In fact, statistical analysis showed patients presenting plaques with both high-risk features had an 11-fold higher risk of NCL-related MACE than other patient groups (OR 11.33; 95% CI 6.10~21.03) and a near 37 times higher risk than those with plaques without either high-risk feature – highlighting a significantly increased risk of NCL-related MACE in patients with high-risk plaques. Meanwhile, major complications of NIRS-IVUS were only reported in two patients (a case of stenosis due to spasm/dissection requiring balloon angioplasty and an acute obstruction due to air infusion during additional stenting), proving the safety of NIRS-IVUS. Upon presenting these findings, Erling concluded that “PROSPECT II showed that three-vessel intracoronary imaging with NIRS-IVUS was safe. The combination of lipid-rich plaque and large plaque burden identified vulnerable plaques that placed patients at especially high risk for future MACE.”

November 12, 2020 3994

SummitMD

Coronary CTA on Asymptomatic Patients Provides Little to No Clinical Benefit

A cardiology research team from Asan Medical Center (AMC) has discovered that carrying out coronary computed tomography angiographies (CTA) on asymptomatic patients does not increase the diagnostic rate or mortality rate of obstructive coronary artery disease (CAD). The team, led by Professor Park Duk-woo from Asan Medical Center, department of cardiology, found that despite the increasing number of coronary CTAs performed on domestic asymptomatic individuals without CAD, the rate of diagnosis was strikingly low. Based on study findings, Park and colleagues strongly suggested that coronary CTAs would be justified on asymptomatic patients only after pre-test risk stratification and analysis on results from symptom-based optimal decision-making algorithms while warning against excessive coronary CTAs. This study was published in the Journal of the American Heart Association on September 8, 2020.1 Coronary CTA on asymptomatic patients increasing despite lack of evidence Coronary CTA is a heart imaging test that diagnoses CAD and is known to be more accurate than functional testing. As a non-invasive test, CTAs are being used extensively in Korea, with the number of performed tests on the rise. According to the AMC study, the overall number of coronary CTAs performed increased steeply from 2007 to 2013. Data gathered on 39,906 patients without known CAD who received a coronary CTA at AMC showed an increase from 1,587 CTAs in 2007 to 7,416 in 2013, indicating more than a three-fold increase. The number of CTAs on asymptomatic patients also rose significantly from 42.6 percent in 2007 to 60.3 percent in 2013 (P for trend

October 22, 2020 7407

SummitMD

Aspirin Alone Better for Post-TAVI Patients not on Anticoagulation: POPular TAVI

Aspirin alone is better than the dual antiplatelet therapy with aspirin and clopidogrel for patients undergoing transcatheter aortic valve implantation (TAVI) not on oral anticoagulation and without recent coronary stenting, POPular TAVI findings showed. The study results, presented at the European Society of Cardiology Congress 2020 (ESC 2020), showed aspirin alone compared to an aspirin+clopidogrel combo after TAVI significantly cut bleeding risk more without increasing the risk of thrombotic events. “Aspirin alone compared to aspirin with clopidogrel reduced the bleeding rate significantly, with an absolute reduction of more than 10 percent,” POPular TAVI coordinating investigator Jorn Brouwer, MD (St. Antonius Hospital, Netherlands) said. “At the same time, aspirin alone versus aspirin with clopidogrel did not increase thromboembolic events as captured in the secondary outcomes.” The findings have challenged current European guideline recommendations on antiplatelet treatment and is expected to impact future updates. The European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) had recommended a three- to six-month aspirin and clopidogrel therapy for initial antiplatelet treatment followed by aspirin or clopidogrel monotherapy since 2012. Despite current recommendations, explorative studies have shown that adding clopidogrel to aspirin is linked with a higher rate of major bleeding without a decreased risk of thromboembolic complications. The evidence for aspirin alone has also been lacking: only small-scale studies have suggested that aspirin alone could be effective for the patient group. Against this backdrop, the two-cohort POPular TAVI trial sought to address the best therapy to counter the relatively high risks of bleeding and ischaemic complications after TAVI that are associated with increased mortality. Results from POPular TAVI’s cohort A were presented at ESC 2020 on Aug. 30 and simultaneously published in the New England Journal of Medicine (NEJM)1. Findings simplify, outline antithrombotic therapy after TAVI Cohort A of POPular TAVI studied patients not on chronic oral anticoagulation while cohort B looked at patients on chronic anticoagulation. Cohort B results - presented at the American College of Cardiology’s annual conference (ACC 2020) last March and simultaneously published in the NEJM2 - showed anticoagulant treatment without clopidogrel reduced the risk of bleeding without increasing thrombotic events. Both cohorts were powered separately for study outcomes, investigators said. The study findings recently presented at ESC 2020 pertain to that of cohort A. Cohort A originally recruited 690 patients from the Netherlands, Belgium, Luxembourg, and the Czech Republic who were not indicated for oral anticoagulation. Investigators then excluded patients who had undergone coronary artery stenting using a drug-eluting stent within three months or a bare-metal stent within one month before TAVI, leaving a total of 665 patients in the cohort. Investigators randomly allocated the 665 patients not indicated for oral anticoagulation to take either aspirin alone (331 patients) or aspirin with clopidogrel for three months (334 patients) after undergoing TAVI. Patients in both arms were 80 years old on average. The primary endpoint was designed to test the potential superiority of aspirin alone. To see whether aspirin alone compared to aspirin+clopidogrel for three months would reduce the rate of bleeding at one year, co-primary endpoints were defined as 1) all bleeding including non-major, major, and life-threatening bleeds (procedural and non-procedural) and 2) non-procedural bleeding. Also tested was the hypothesis that aspirin alone would be non-inferior to aspirin+clopidgorel with respect to two secondary endpoints at one year, defined as 1) a composite of cardiovascular mortality, non-procedural bleeding, all-cause stroke, or myocardial infarction (bleeding and thromboembolic events) and 2) a combination of cardiovascular mortality, ischaemic stroke, or myocardial infarction (only thromboembolic events). Results showed that aspirin alone resulted in a significantly lower incidence of bleeding compared to aspirin+clopidogrel at one year. All bleeding occurred in about 15 percent of the aspirin monotherapy group and 27 percent in the aspirin+clopidogrel group, indicating a 45 percent lower risk of all bleeding (RR 0.57, 95% CI 0.42-0.77, p=0.001). Non-procedural bleeding occurred in 15 percent versus 25 percent of the aspirin monotherapy and combination therapy groups, respectively (RR 0.61, 0.44-0.83, p=0.005). For the secondary outcome on bleeding and thromboembolic events, aspirin alone proved both non-inferiority and superiority compared to the aspirin+clopidogrel combination. The outcome occurred in 23 percent in patients receiving aspirin alone compared to 31 percent receiving aspirin+clopidogrel (difference -8.2%p, 95% CI for noninferiority -14.9 to -1.5, p

October 15, 2020 4589

SummitMD

2nd SGLT-2 Inhibitor Scores in HF as Empagliflozin Reduces Hospitalization, CV Death in HFrEF

Adding SGLT-2 inhibitor empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) to standard of care cut the risk of serious HF events by about 30 percent and reduced adverse renal outcomes in heart failure with reduced ejection fraction (HFrEF) patients regardless of diabetes status, EMPEROR-Reduced results showed in late August. Following the initial HF success of fellow diabetes drug dapagliflozin (Forxiga, AstraZeneca) in the DAPA-HF trial, empagliflozin is now on the upswing for entering the HF treatment arena. The results of the randomized, double-blind EMPEROR-Reduced trial that evaluated empagliflozin 10 mg on HFrEF patients were presented at the virtual ESC 2020 Hot Line session and simultaneously published in the New England Journal of Medicine1 on Aug. 29. “Based on the combined results of our trial (together with the earlier trial with dapagliflozin), we believe that SGLT-2 inhibition with empagliflozin and dapagliflozin will become a new standard of care for patients with heart failure with reduced ejection fraction (HFrEF),” Milton Packer, MD (Baylor University Medical Centre, Houston, Texas) said at ESC 2020. Commenting on the findings, Dong-ju Choi, MD, PhD (Seoul National University Bundang Hospital, Korean Society of Heart Failure President) who participated in the trial noted that, “EMPEROR-Reduced - by encompassing patients from 12 domestic hospitals including Seoul National University Hospital - also reflects results the treatment of Korean heart failure patients. We also look forward to additional sub-analyses.” With EMPEROR-Reduced findings substantially strengthening the rationale for SGLT-2 inhibitors in HFrEF, Packer pointed to the rising significance of both SGLT-2 inhibitors and sacubitril/valsartan (Entresto, Novartis) in the HFrEF sphere. Empagliflozin hits major endpoints for HFrEF The double-blind EMPEROR-Reduced trial was designed to evaluate the effects of empagliflozin 10 mg once daily versus placebo in HFrEF patients with or without diabetes who were already receiving HF treatment. The primary endpoint was designated as the composite of CV death or HF-related hospitalization. Secondary endpoints included adverse renal outcomes defined as chronic dialysis, renal transplant, or a change in the estimated glomerular filtration rate (eGFR). The trial enrolled 3,730 HFrEF patients regardless of diabetes status with a focus on enrolling patients with a left ventricular ejection fraction (LVEF) below 30 percent. The trial also enrolled patients with high levels of NT-proBNP or history of HF hospitalization within 12 months if LVEF was between 31 and 40 percent. Investigators noted that, by adjusting eligibility based on natriuretic peptide levels to the baseline ejection fraction, the trial preferentially enrolled higher-risk patients who were not well-represented in previous studies such as DAPA-HF. At baseline, the empagliflozin arm had an average LVEF of 27.7 percent and the placebo arm had an average LVEF of 27.2 percent. NT-proBNP levels were 1,887 pg/mL in the empagliflozin group and 1,926 pg/mL in the placebo group. The average eGFR in the empagliflozin arm was 61.8 mL/min/1.73 m2 and 62.2 mL/min/1.73 m2 in the placebo arm. For perspective, patients in the DAPA-HF trial had a mean LVEF of 31.2 percent. DAPA-HF trial results also showed NT-proBNP levels in the dapagliflozin arm was 1428 pg/mL, eGFR was 66.0mL/min/1.73㎡. About 10.5 percent of patients in DAPA-HF were on RAS and neprilysin inhibitors. In EMPEROR-Reduced, patients were randomized to receive either empagliflozin 10 mg (n=1,863) or placebo (n=1,867). Around half of the patients did not have type 2 diabetes and - at the time of enrollment - patients on RAS inhibitors and neprilysin inhibitors together accounted for about 20 percent. During a median follow-up of 16 months, the primary endpoint occurred in 361 patients in the empagliflozin group and 462 patients in the placebo group (HR 0.75, 95% CI 0.65-0.86, p

October 08, 2020 10094

ACT Program

1st Virtual ACT Program Held

The ACT Program, jointly hosted by the CardioVascular Research Foundation (CVRF) and the department of cardiology at Asan Medical Center in Seoul, is a 4-day and 3-night offline education program for around 10 domestic and overseas cardiologists each month. This is a professional training course that participants can learn the latest treatment trends and know-how in the field of cardiology through live demonstrations and lectures. Since the first event held in January 2009, it has been recognized for the quality of educational content and the excellence of the curriculum for a discussion process while watching a live demonstration of world-class cardiac surgeries in particular. In the following decade, it has been held more than 100 times and solidified its status as a representative cardiovascular interventional education program in the Asia-Pacific region by transferring the know-how of cardiovascular stent treatment to about 1,400 medical representatives in 37 countries including Singapore, China, Hong Kong, etc. However, as training and seminars in hospitals were banned due to the global pandemic of COVID-19 which first began in last January and its prolongation, the ACT program that has been held in the hospital was also completely stopped. Nevertheless, in order to provide an opportunity for continuous education in the field of interventional procedures, a Virtual ACT Program was designed using a non-face-to-face platform while containing the core contents of offline education programs. The first attempt was the 1st Virtual ACT Program - TAVR (Transcatheter Aortic Valve Replacement), which was held in cooperation with Fuwai Hospital in China and Asia Pacific Structural Heart Disease Club Limited (hereinafter referred to as AP-SHD). Two leaders of cardiovascular interventions in China and Korea, Fuwai Hospital and Asan Medical Center in Seoul, had cooperated to have in-depth discussions on the rapidly developing treatment of transcatheter aortic valve replacement (TAVR). The TAVR-themed ACT Program was broadcast live on the online conference platform “ZOOM” for two days, and live-streamed on YouTube and China’s own online channels for the convenience of participants around the world. This program, sponsored by Edwards Lifesciences, focused on the detailed process of TAVR procedure using the Sapien 3 percutaneous heart valve, and problems and solutions during the procedure. In-depth lectures including "TAVR valve selection method using CT", "TAVR for bicuspid valve", "Echocardiography in TAVR", and "Reality of transapical TAVR using surgical technique" were also given, and the discussion to share the case of TAVR using Sapien 3 in China with a sense of realism was popular as a practical course of lectures. In addition, global TAVR experts including Dr. Seung-Jung Park and Dr. Duk-Woo Park (Asan Medical Center) from Korea, Dr. Yongjian Wu (Fuwai Hospital) from China, Dr. Alan C. Yeung (Stanford University School of Medicine) and Dr. Vinayak Bapat (Columbia University Medical Center) from the United States, and Dr. Jian (James) Ye (St. Paul's Hospital, University of British Columbia) from Canada participated in the discussion to talk about current situations and future prospects of TAVR procedures and share the know-how of each country. Virtual ACT programs composed of various topics such as Left Main & Bifurcation PCI Intensive Course, Coronary Physiology & Intravascular Imaging Guided PCI, CTO, TAVR, etc. will continuously be held in cooperation with various East Asian countries. For more information, visit http://www.summitmd.com/html/cvrf/education_act.html.

August 21, 2020 11016

TCTAP & AP VALVES 2020 Virtual

Choice of Stent Platforms in HBR Patients - Insights from the ONYX-ONE Trial

For a long time, a significant progress has been made to improve the ischemic outcomes after PCI with better stent platforms and more potent antiplatelet treatments, but the bleeding question emerged. It has become clear that MI is a bad thing to have, but major bleeding is certainly prognostically as important as MI. In addition to the effort to stratify patients with high ischemic versus bleeding risk and apply alternative antithrombotic strategies according to individual patient’s risk profile, another major issue is what stent platform would be appropriate for high bleeding risk (HBR) patients. Stephan Windecker, MD talks about the Choice of Stent Platforms in HBR Patients - Insights from the ONYX-ONE Trial at TCTAP & AP VALVES 2020 VIRTUAL HBR patients are a complex population which consists of nearly one-fourth of patients receiving PCI, but with little evidence to support treatment decisions. The Onyx ONE trial adds to prior data from the LEADERS-FREE trial and suggests, in PCI patients with HBR, a durable polymer-based DES combined with 1-month dual antiplatelet therapy (DAPT) is non-inferior to a polymer-free drug-coated stent combined with the same DAPT regimen. “The Onyx ONE trial was the first randomized trial comparing the new-generation Resolute Onyx zotarolimus-eluting stent with the BioFreedom polymer-free biolimus A9-coated stent” Dr. Windecker noted. The patients had to have at least one HBR criterion and routinely treated with one-month DAPT. The study was a global study carried out at 84 participating sites with a strong contribution also from the Asia-Pacific area. Patients were elderly (mean age 74 years); approximately 40% in each group were diabetic, and 50% had an acute coronary syndrome. The most common HBR features were shown for those who are 75 years or older and the use of oral anticoagulants. By two months, 92% had transitioned to monotherapy consisting of aspirin in 55.9% and a P2Y12 inhibitor in 44.1%. At 12 months, 88% remained on a single antithrombotic therapy, which remained consistent throughout the year. The study found that for the primary composite safety endpoint of cardiac death, myocardial infarction (MI), and definite/probable stent thrombosis at one year, the Resolute Onyx ZES was non-inferior to the drug-coated BioFreedom stent (17.1% vs. 16.9%; P for noninferiority = 0.011), with a risk difference of 0.2% and a one-sided upper-bound 95% CI of 3%. The cumulative incidence of the components of the primary endpoint showed no significant difference between the groups. Cardiac death was low and comparable in both groups (4.6% for Resolute Onyx vs 3.9% for BioFreedom; P = 0.40). Rates of definite/probable stent thrombosis were 1.5% with Resolute Onyx and 2.2% with BioFreedom (P = 0.21). But interestingly for MI that was similar in high rates related to the periprocedural MI, there was a significant difference for spontaneous MI in favor of the Resolute Onyx arm (4.6% vs. 7.1%, P=0.02). Accordingly, the landmark analysis set at 30-days, a time point with a majority of patients transitioned to a single antiplatelet therapy, there was no difference up to 30-days (9.9% vs. 8.7%, P=0.36) but lower incidence in favor of Resolute Onyx stent after 30-days (4.3% vs. 6.8%, P=0.01). There was no difference between the stents for the combined secondary effectiveness endpoint of target-lesion failure at one year. Bleeding rates were high in both groups, but they were not statistically different for any BARC category. Dr. Windecker summarized his talk by concluding among HBR patients treated with 1-month DAPT after PCI, Resolute Onyx was as safe and effective as Biofreedom. “Although the LEADERS FREE and ONYX ONE trials used a 1-month DAPT strategy, I think we still don’t know whether a 1-month duration of DAPT is optimal for these patients. The MASTER DAPT is ongoing and will probably provide more information” he emphasized. CHECK THE SESSION

August 08, 2020 113631

TCTAP & AP VALVES 2020 Virtual

A New Algorithm from Japanese CTO-PCI Expert Registry

Chronic total occlusion (CTO) algorithms have significantly contributed to the improvement of success rate and dissemination of CTO-PCI worldwide. Since the anatomical features of CTO lesions assessed at the time of CTO-PCI considerably differ according to cultural regions; whether prioritizing PCI or CABG for coronary revascularization, the selection of CTO crossing techniques and strategies vary among societies, which consequently led to release of several regionally-based CTO algorithms in the past decade. Those are the well-known hybrid algorithm, the Asia-Pacific CTO algorithm, and the Euro CTO club algorithm. Recently, another CTO algorithm has gained attention and was presented by Toshiya Muramatsu, MD at the highlight session of TCTAP & AP VALVES 2020 VIRTUAL. This novel algorithm was derived by analyzing 5,843 patients from the Japanese CTO-PCI expert registry treated between 2014 and 2017 and incorporated the guidewire manipulation time during the antegrade wire escalation to consider switching to another strategy for the first time. In detail of their data, the 1,562 patients who were treated with a primary retrograde compared with primary antegrade approach had a higher J-CTO score; had more ostial, calcified, and tortuous CTO lesions; had more blunt or stumpless CTO entry; and were more likely to have a CTO length of ≥20 mm. The average J-CTO scores for patients treated with an antegrade approach alone, rescue retrograde approach, and primary retrograde approach were 1.6 ± 1.2, 2.1 ± 1.1, and 2.3 ± 1.1, respectively (P < 0.001). The median guidewire manipulation times associated with guidewire success and failure were 56 and 176 minutes, respectively (P < 0.001). Median guidewire manipulation time in the primary antegrade approach (39 minutes) was 28 and 128 minutes for antegrade alone and rescue antegrade approach, respectively (P < 0.001), while it was 113 minutes for the primary retrograde approach. On multivariate analysis, reattempt, greater lesion tortuosity, CTO length ≥ 20 mm, and no stump in the proximal cap all independently predicted lower antegrade guidewire success in the primary antegrade approach. Importantly, the new algorithm moves beyond anatomic and imaging features in that the guidewire manipulation time was factored in as part of the current strategy. The authors set 20 minutes as the threshold of the initial timing at which to review CTO-PCI strategies in the primary antegrade approach, and this time threshold was derived based on the following findings; 1) median successful guidewire crossing time of the antegrade single wiring was 23 minutes; and 2) the difference in the guidewire crossing time between the primary retrograde approach and the rescue retrograde approach was 19 minutes. “I would like to congratulate the authors trying to find when to switch the strategy because it is definitely not an easy task” Scott Harding, MD mentioned. But the discussants in this session had a consensus that this 20-minutes threshold is quite arbitrary and perhaps less generalizable to be included in an algorithm, given that guidewire manipulation varies considerably among operators and not every operator has the understanding of the way the wires work that the Japanese operators might. “The 20-minutes threshold was derived from the patients who ultimately had a successful CTO crossing using the antegrade wire escalation technique. For those cases there may have been some progress of wiring during that 20 minutes. We have to be flexible adopting this 20-minute limitation into our practice, for example, if you reach to that 20 minutes and you made some progress you can prolong your work on one method for a longer time, whereas if you spent 15 minutes of wiring and you achieved nothing it will be better to switch to another method more quickly.” Pil Hyung Lee, MD commented. Paul Hsien-Li Kao, MD emphasized that “The concept is that CTO-PCI is basically a dynamic game, meaning that you have to think about how your current move will affect your next move. All available techniques in the CTO toolbox are basic tools that you need to have in order to have a successful, efficient and safe procedure.” Comparing CTO Algorithms - Moving Towards a Global Consensus In line with the advent of this new Japanese CTO algorithm, Scott Harding, MD presented a lecture on the similarities and difference between the representative regional CTO algorithms and suggested a move toward a global consensus at this highlight CTO session. He explained that in all 3 algorithms (hybrid, APCTO, Euro CTO algorithms) the same three angiographic questions determine initial direction, antegrade or retrograde; that is, 1) defined or ambiguous proximal cap anatomy? 2) favorable distal target for wiring or re-entry? or 3) usable collaterals or not? The three algorithms have differences in terms of the criteria for the initial approach of wire escalation versus dissection re-entry. Apart from the APCTO and the Euro CTO algorithm, which recommends dissection re-entry as an initial approach in relatively limited situation, the hybrid algorithm suggests selecting this strategy according to the occlusion length alone (≥20 mm). Dr. Harding noted that “essentially this means that the APCTO and Euro CTO algorithms promote an antegrade wiring approach first in the majority of cases.” He also mentioned that the APCTO algorithm highlights the role of IVUS-guided entry and the Euro CTO algorithm included a couple of other strategies to overcome the proximal cap ambiguity, such as the BASE technique or Scratch and Go technique, and introduced the concept of an investment procedure. Both APCTO and Euro CTO algorithm includes the parallel wiring and the instructions of when to stop the procedure. However, he emphasized that we could see important practice patterns from the regional operators that do not exactly fit in their own algorithms. For example, several registry data indicate that antegrade wire escalation is predominantly used as the primary strategy by hybrid operators even though the CTO lesion length were more than 20 mm in majority of cases and showed outstanding results. In addition, IVUS-guided entry, which is not included in the hybrid algorithm, is adopted by many hybrid operators in daily practice. This observation may indicate that operators are getting more flexible in adopting the available techniques as they get more experienced, and shares strategies in each algorithm. Considering the purposes of algorithms, that is to standardize and promote best practice, serve as a reference for teaching, and provide a platform for discussion, all three algorithms have been and will be valuable in this field, particularly for the beginners and the intermediate operators. However, experts question the need for another regionally-based algorithm for these complex lesions and instead say the focus should be on a globally agreed one. The first step was the recent publication of global consensus expert document on CTO-PCI. Dr. Harding finished his talk concluding that “While there is agreement on a number of CTO principals, there still remain a number of questions and we need to get consensus and a global CTO algorithm” CHECK THE SESSION

August 08, 2020 23650