Cheol Hyun Lee

Generalizability of Excel and Noble results to a large registry population with unprotected left main coronary artery disease

Objective The aim of this study was to determine how trial-based findings of EXCEL and NOBLE might be interpreted and generalizable in ‘real-world’ settings with comparison of data from the large-scaled, all-comer Interventional Research Incorporation Society−Left MAIN Revascularization (IRIS–MAIN) registry. Patients and methods We compared baseline clinical and procedural characteristics and also determined how the relative treatment effect of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) was different in EXCEL and NOBLE, compared with those of the multicenter, IRIS–MAIN registry (n=2481). The primary outcome for between-study comparison was a composite of death, myocardial infarction (MI), or stroke. Results There were between-study differences in patient risk profiles (age, BMI, diabetes, and clinical presentation), lesion complexities, and procedural characteristics (stent type, the use of off-pump surgery, and radial artery); the proportion of diabetes and acute coronary syndrome was particularly lower in NOBLE than in other studies. Although there was interstudy heterogeneity for the protocol definition of MI, the risks for serious composite outcome of death, MI, or stroke were similar between PCI and CABG in EXCEL [hazard ratio (HR): 1.00; 95% confidence interval (CI): 0.79–1.26; P=0.98] and in the matched cohort of IRIS–MAIN (HR: 1.08; 95%CI: 0.85–1.38; P=0.53), whereas it was significantly higher after PCI than after CABG in NOBLE (HR: 1.47; 95%CI: 1.06–2.05; P=0.02), which was driven by more common MI and stroke after PCI. Conclusion In the comparison of a large-sized, all-comer registry, the EXCEL trial might represent better generalizability with respect to baseline characteristics and observed clinical outcomes compared with the NOBLE trial.

Comparative determinants of 5-year cardiovascular event rates in patients with unprotected left main coronary artery disease

Background Diabetes mellitus (DM), low ejection fraction (EF), and the extent of coronary artery disease (CAD) have all been identified as predictors of cardiovascular events in multivessel disease, but their comparative contributions to future risk remain unclear in patients with unprotected left main coronary artery (ULMCA) disease. Through this study we aimed to categorize the risk for cardiovascular events in patients with ULMCA disease using simple clinical descriptors. Patients and methods Our study included a total of 5975 patients with ULMCA disease from the Interventional Research Incorporation Society-Left MAIN Revascularization registry who were treated with percutaneous coronary intervention (n=2850), coronary artery bypass grafting (n=2337), or medical therapy alone (n=608). We categorized the risk for cardiovascular events using simple clinical descriptors (DM, low EF, and the extent of CAD). The primary outcome was a major adverse cardiac or cerebrovascular event (MACCE) (i.e. death from any cause, stroke, myocardial infarction, or repeat revascularization). Results Overall, the 5-year rate of MACCE was highest in the medical group, lower in the percutaneous coronary intervention group, and lowest in the coronary artery bypass grafting group (42.5, 25.7, and 19.9%, respectively; P<0.001). In multivariable modeling, the presence of DM [hazard ratio (HR): 1.25; 95% confidence interval (CI): 1.12–1.40; P<0.001], low EF of 40% or less (HR: 1.83; 95% CI: 1.56–2.15; P<0.001), and the extent of CAD (HR: 1.14; 95% CI: 1.08–1.21; P<0.001) were independent predictors of MACCE; in addition, these factors were consistently associated with a significantly higher risk for MACCE, regardless of index treatment strategies. Conclusion Simple clinical descriptors can assist clinicians in identifying high-risk patients and in predicting future cardiovascular events within the broad range of risk factors for ULMCA disease.

Differential Event Rates and Independent Predictors of Long-Term Major Cardiovascular Events and Death in 5795 Patients With Unprotected Left Main Coronary Artery Disease Treated With Stents, Bypass Surgery, or Medication: Insights From a Large International Multicenter Registry

Background— Identifying predictive factors for major cardiovascular events and death in patients with unprotected left main coronary artery disease is of great clinical value for risk stratification and possible guidance for tailored preventive strategies. Methods and Results— The Interventional Research Incorporation Society-Left MAIN Revascularization registry included 5795 patients with unprotected left main coronary artery disease (percutaneous coronary intervention, n=2850; coronary-artery bypass grafting, n=2337; medication alone, n=608). We analyzed the incidence and independent predictors of major adverse cardiac and cerebrovascular events (MACCE; a composite of death, MI, stroke, or repeat revascularization) and all-cause mortality in each treatment stratum. During follow-up (median, 4.3 years), the rates of MACCE and death were substantially higher in the medical group than in the percutaneous coronary intervention and coronary-artery bypass grafting groups (P<0.001). In the percutaneous coronary intervention group, the 3 strongest predictors for MACCE were chronic renal failure, old age (≥65 years), and previous heart failure; those for all-cause mortality were chronic renal failure, old age, and low ejection fraction. In the coronary-artery bypass grafting group, old age, chronic renal failure, and low ejection fraction were the 3 strongest predictors of MACCE and death. In the medication group, old age, low ejection fraction, and diabetes mellitus were the 3 strongest predictors of MACCE and death. Conclusions— Among patients with unprotected left main coronary artery disease, the key clinical predictors for MACCE and death were generally similar regardless of index treatment. This study provides effect estimates for clinically relevant predictors of long-term clinical outcomes in real-world left main coronary artery patients, providing possible guidance for tailored preventive strategies. Clinical Trial Registration— URL: https://clinicaltrials.gov. Unique identifier: NCT01341327.

Effect of Low-Dose Versus Standard-Dose Ticagrelor and Clopidogrel on Platelet Inhibition in Acute Coronary Syndromes

Because of different risk profiles and genetic backgrounds, East Asian populations are regarded as more susceptible to bleeding events but relatively resistant to atherothrombosis compared with Western populations (the so-called “East Asian paradox”) [(1)][1]. Thus, we sought to determine

TCT-498 Lower mortality in patients with vasospastic angina who receive statin therapy: Data from the Asan Vasospastic Angina Registry

Statin therapy is the standard treatment for atherosclerotic cardiovascular disease. However, the benefits of statin therapy in patients with vasospastic angina (VSA) remains unknown. This study investigated the long-term benefits of statin therapy in patients with VSA. Between March 1996 and

TCT-242 Temporal Changes in Outcomes after Stent or Coronary Artery Bypass Grafting for Left Main Coronary Artery Disease by Diabetes Status.

nos: 242 249 TCT-242 Temporal Changes in Outcomes after Stent or Coronary Artery Bypass Grafting for Left Main Coronary Artery Disease by Diabetes Status Min Soo Cho, Ungjeong Do, Kyusup Lee, Jung Ae Hong, Osung Kwon, Do-yoon Kang, Jaeseokf Bae, Cheol Hyun Lee, Yu Na Kim, Se Hun Kang, Sung-Han Yoon, Pil Hyung Lee, Jung-Min Ahn, Duk-Woo Park, Soo-Jin Kang, Seung-Whan Lee, Young-Hak Kim, Cheol Whan Lee, Seong-Wook Park, Seung-Jung Park Asan medical center, Seoul, Korea, Republic of; Seoul National University Hospital, Seoul, Korea, Republic of; AMC, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan medical center, Seoul, Korea, Republic of; Asan medical center, seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Columbia University Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of BACKGROUND Diabetes mellitus is a well-known determinant of outcomes after coronary revascularization. The secular trend in the relative treatment effects of stenting and coronary-artery bypass grafting (CABG) by diabetes status remains unknown in patients with unprotected left main coronary artery (ULMCA) disease. METHODS We analyzed 5217 consecutive patients with ULMCA treated with stenting (n 1⁄4 2866) or CABG (n 1⁄4 2351) enrolled in the Interventional Research Incorporation Society – Left MAIN Revascularization registry. Participants were classified by time period based on stent type: wave 1, 1995–2002 (bare-metal stents); wave 2, 2003–2006 (first-generation drug-eluting stents [DES]); and wave 3, 2007–2013 (second-generation DES). The primary outcome was a major adverse cardiac or cerebrovascular event (MACCE), defined as composite of death, myocardial infarction, stroke, or repeat revascularization. J O U R N A L O F T H E A M E R I C A N C O L L E G E O F C A R D I O L O G Y , V O L . 6 8 , N O . 1 8 , S U P P L B , 2 0 1 6 B99 RESULTS Overall, patients without diabetes treated with stenting compared with CABG had higher 3-year rates of MACCE (17.3% vs. 13.4%; P 1⁄4 0.002), but a trend toward markedly improving outcomes of stenting compared to CABG was observed over time (wave 1, 30.5% vs. 14.3%; wave 2, 20.7% vs. 13.4%; and wave 3, 12.1% vs. 12.2%, respectively). Among patients with diabetes, the 3-year rates of MACCE were significantly higher in the stenting than in the CABG group (23.5% vs. 16.5%; P < 0.001) and this trend did not change over time (wave 1, 25.9% vs. 16.4%; wave 2, 23.4% vs. 16.2%; and wave 3, 23.5% vs. 17.0%, respectively). After multivariate adjustment, the hazard ratios for MACCE after stenting compared with CABG substantially changed over time in non-diabetic population (wave 1, 3.05; wave 2, 2.16; and wave 3, 1.13; respectively; P < 0.001), but not in diabetic population (wave 1, 2.58; wave 2, 1.94; and wave 3, 1.72, respectively; P 1⁄4 0.75). CONCLUSION In non-diabetic patients with ULMCA disease, treatment effect of stenting has been much improved over time and comparable to CABG in the current era. However, in diabetic population, CABG was consistently better than stenting. CATEGORIES CORONARY: Angioplasty Overview and Outcomes TCT-243 Second generation drug-eluting stents or coronary bypass surgery in patients with three-vessel coronary disease Reo Hata, Kazushige Kadota, Yusuke Hyodo, Suguru Otsuru, Seiji Habara, Hiroyuki Tanaka, Yasushi Fuku, Tsuyoshi Goto Kurashiki Central Hospital, Kurashiki, Japan; Kurashiki Central Hospital, Kurashiki, Japan; Kurashiki central hospital; Kurashiki City, Japan; Kurashiki central hospital, Okayama, Japan; Kurashiki Central Hospital, Kurashiki, Japan; Kurashiki Central Hospital, Kurashiki, Japan; Kurashiku, Okayama, Japan BACKGROUND Few studies comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with three-vessel coronary disease (3VD) have made use of second generation drug-eluting stents (G2DES). METHODS We analyzed Japanese patients with 3VD undergoing first PCI with G2DES or CABG between 2010 and 2014. The primary outcome was a compisite of all-cause death, non-fatal myocardial infarction (MI), and stroke, and the secondary outcome was target vessel revascularisation (TVR). Propensity-score matching was used to adjust a cohort of patients with similar baseline characteristics. RESULTS Among 469 eligible patients (298 patients, PCI group; 171 patients, CABG group), 128 patients undergoing PCI with G2DES and 128 patients undergoing CABG had similar propensity scores and were included in the analysis. The median follow-up interval was 998 days, and the patient characteristics were shown in the table. At 2 years, the unajusted primary outcome event rates in the PCI and CABG groups were 10.8% and 11.8% (log-rank p1⁄40.60), and the rates of TVR were 22.0% and 5.3% (log-rank p<0.001). After propensity-score matching, PCI with G2DES was associated with similar risk of a composite outcome of death, MI, and stroke as compared with CABG (hazard ratio, 1.02; 95% confidence interval [CI], 0.52 to 2.03; p1⁄40.95), and higher risk of TVR (hazard ratio, 3.49; 95% CI, 1.58 to 7.71; p1⁄40.002). Variables PCI(n[298) CABG (n[171) p value Age, yrs 71.1 11.4 68.1 9.6 0.004 Men, n (%) 217 (73) 192 (80) 0.08 Hypertension, n (%) 238 (80) 200 (84) 0.71 Diabetes mellitus, n (%) 157 (53) 97 (57) 0.40

TCT-344 Impact of Body Mass Index on the Clinical outcomes of patients with Angiographic High-risk Coronary Artery Disease underwent Percutaneous Coronary Intervention: data from the Asan multi-vessel registry and IRISMAIN registry

Withdrawn

TCT-258 Clinical significance of peri-procedural myocardial infarction following percutaneous coronary intervention for multi-vessel coronary artery disease.

The prevalence and prognostic implications of current peri-procedural myocardial infarction (periMI) definitions in real-world practice were not well evaluated to date. The Asan-MV registry was consisted of consecutive patients whose peri-procedural creatinine kinase-MB mass was routinely measured

TCT-223 A randomized, placebo controlled, double-blind, phase 4 study to evaluate efficacy and safety of triple anti-platelet therapy compared with dual antiplatelet therapy in patients treated with drug-eluting stent for coronary artery disease

TCT-223 A randomized, placebo controlled, double-blind, phase 4 study to evaluate efficacy and safety of triple anti-platelet therapy compared with dual antiplatelet therapy in patients treated with drug-eluting stent for coronary artery disease Cheol Hyun Lee, Osung Kwon, Ungjeong Do, Jung Ae Hong, Kyusup Lee, Min Soo Cho, Jaeseok Bae, Do-yoon Kang, Se Hun Kang, Pil Hyung Lee, Sung-Han Yoon, Jung-Min Ahn, Duk-Woo Park, Soo-Jin Kang, Seung-Whan Lee, Young-Hak Kim, Cheol Whan Lee, Seong-Wook Park, Seung-Jung Park Asan medical center, seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Seoul National University Hospital, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; AMC, Seoul, Korea, Republic of; Asan medical center, Seoul, Korea, Republic of; Asan medical center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Columbia University Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of; Asan Medical Center, Seoul, Korea, Republic of

TCT-783 Angiosome-target single-vessel angioplasty is not inferior to multi-vessel angioplasty in patients

RESULTS All submassive patients survived (see table). Major complications included: 2 intracranial bleeds, 2 hematomas requiring evacuation, 2 access site complications requiring surgery, 2 pseudoaneurysms treated successfully with thrombin injection, 6 hematomas requiring transfusion, and 2 self-limiting GI bleeds requiring transfusion. Factors associated with complications were advanced age (p<0.01), massive PE presentation (p1⁄40.02), and IVC filter placement (p<0.01), but not total thrombolytic dose administered.