Search

Background: Current guidelines recommend the perioperative continuation of aspirin in patients with coronary drug-eluting stents (DES) undergoing noncardiac surgery. However, supporting evidence is limited., Objectives: This study aimed to compare continuing aspirin monotherapy vs temporarily holding all antiplatelet therapy before noncardiac surgery in patients with previous DES implantation., Methods: We randomly assigned patients who had received a DES >1 year previously and were undergoing elective noncardiac surgery either to continue aspirin or to discontinue all antiplatelet agents 5 days before noncardiac surgery. Antiplatelet therapy was recommended to be resumed no later than 48 hours after surgery, unless contraindicated. The primary outcome was a composite of death from any cause, myocardial infarction, stent thrombosis, or stroke between 5 days before and 30 days after noncardiac surgery., Results: A total of 1,010 patients underwent randomization. Among 926 patients in the modified intention-to-treat population (462 patients in aspirin monotherapy group and 464 patients in the no-antiplatelet therapy group), the primary composite outcome occurred in 3 patients (0.6%) in the aspirin monotherapy group and 4 patients (0.9%) in the no antiplatelet group (difference, -0.2 percentage points; 95% CI: -1.3 to 0.9; P > 0.99). There was no stent thrombosis in either group. The incidence of major bleeding did not differ significantly between groups (6.5% vs 5.2%; P = 0.39), whereas minor bleeding was significantly more frequent in the aspirin group (14.9% vs 10.1%; P = 0.027)., Conclusions: Among patients undergoing low-to-intermediate risk noncardiac surgery >1 year after stent implantation primarily with a DES, in the setting of lower-than-expected event rates, we failed to identify a significant difference between perioperative aspirin monotherapy and no antiplatelet therapy with respect to ischemic outcomes or major bleeding. (Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery [ASSURE-DES]; NCT02797548)., Competing Interests: Funding Support and Author Disclosures This research was supported by the CardioVascular Research Foundation (Seoul, Korea) (grant number: AMCCV2016-10), a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health and Welfare, Republic of Korea (grant number: HC19C0022), and Medtronic. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Optical coherence tomography (OCT) and intravascular ultrasound (IVUS) have shown comparable outcomes in guiding percutaneous coronary intervention (PCI). However, their comparative effectiveness in complex coronary artery lesions remains unclear., Objectives: This study compared the effectiveness and safety of OCT-guided vs IVUS-guided PCI for complex coronary artery lesions., Methods: This was a prespecified, main subgroup analysis of complex coronary artery lesions in the OCTIVUS (Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention) trial, which included unprotected left main disease, bifurcation disease, an aorto-ostial lesion, a chronic total occlusion, a severely calcified lesion, an in-stent restenotic lesion, a diffuse long lesion, or multivessel PCI. The primary endpoint was a composite of death from cardiac causes, target vessel-related myocardial infarction, or ischemia-driven target vessel revascularization., Results: In 2,008 randomized patients, 1,475 (73.5%) underwent imaging-guided PCI for complex coronary artery lesions; 719 (48.7%) received OCT-guided and 756 (51.3%) IVUS-guided PCI. At a median follow-up of 2.0 years, primary endpoint event had occurred in 47 patients (6.5%) in the OCT-guided group and in 56 patients (7.4%) in the IVUS-guided group (HR: 0.87; 95% CI: 0.59-1.29; P = 0.50). These findings were consistent in adjusted analyses. The incidence of contrast-induced nephropathy was similar between the 2 groups (1.9% vs 1.5%; P = 0.46). The incidence of major procedural complications was lower in the OCT-guided group than in the IVUS-guided group (1.7% vs 3.4%; P = 0.03)., Conclusions: Among patients with complex coronary artery lesions, OCT-guided PCI showed a similar risk of primary composite event of death from cardiac causes, target vessel-related myocardial infarction, or target vessel revascularization as compared with IVUS-guided PCI. (Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention [OCTIVUS]; NCT03394079)., Competing Interests: Funding Support and Author Disclosures This study was an investigator-initiated trial and was funded by the CardioVascular Research Foundation, Abbott Vascular, and Medtronic. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. Dr S.-J. Park has received research grants or speaker fees from Abbott Vascular, Medtronic, Daiichi-Sankyo, ChongKunDang Pharm, Daewoong Pharm, and Edwards. Dr D.-W. Park has received research grants or speaker fees from Abbott Vascular, Medtronic, and Daiichi-Sankyo; and has received grants from ChongKunDang Pharm and Daewoong Pharm. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Although target lesion revascularization (TLR) after percutaneous coronary intervention (PCI) for unprotected left main coronary artery (LMCA) disease is not rare, its timing of occurrence and prognostic impact on long-term mortality is uncertain., Objectives: This study sought to investigate TLR incidence over time and its impact on mortality after PCI with drug-eluting stents (DES) for LMCA disease., Methods: Using a pooled data from 4 multicenter observational registries (IRIS-DES [Interventional Cardiology Research Incorporation Society-Drug-Eluting Stents], IRIS-MAIN [Interventional Cardiology Research Incorporation Society-Left MAIN Revascularization], MAIN-COMPARE [Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization], and PRECOMBAT [PREmier of Randomized COMparison of Bypass Surgery versus AngioplasTy Using Drug-Eluting Stent in Patients with Left Main Coronary Artery Disease]), we evaluated 1,397 patients with LMCA disease treated with DES and available long-term mortality data. The association between TLR and the 10-year risk of mortality was examined by multivariable Cox proportional hazards regression, with TLR as a time-varying covariate., Results: During maximum follow-up of 10 years (median 6.8 years), TLR occurred in 118 patients and its 10-year cumulative incidence was 10.8%. TLR mostly occurred within 2 years after initial PCI and decreased over time: early-stage TLR (within 2 years) in 73 (61.9%) patients and late-stage TLR (beyond 2 years) in 45 (38.1%) patients. Among all TLR patients, 23 patients underwent coronary artery bypass grafting and 95 underwent repeat PCI. In the time-varying multivariable Cox model, the presence of TLR was not significantly associated with an increased risk of mortality (adjusted HR: 0.90; 95% CI: 0.50-1.63; P = 0.73)., Conclusions: Although the incidence of ischemia-driven TLR was mostly common within 2 years after left main PCI, TLR occurred steadily during the 10-year follow-up period. However, given that such patients were optimally revascularized, the prognostic impact of TLR on mortality was not substantial. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133; Observational Study for Left Main Disease Treatment [IRIS-MAIN]; NCT01341327; Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease [MAIN COMPARE]; NCT02791412; Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT]; NCT00422968)., Competing Interests: Funding Support and Author Disclosures This work was partly supported by a grant from the Cardiovascular Research Foundation of South Korea. The sponsors played no role in this study. There was no industry involvement in the design or conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; or decision to submit the manuscript for publication. The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: We previously reported the use of minimal stent area to predict angiographic in-stent restenosis after drug-eluting stent implantation for unprotected left main (LM) disease. We aimed to evaluate the optimal minimal stent area criteria for up-front LM 2-stenting based on long-term clinical outcomes., Methods: We identified 292 consecutive patients with LM bifurcation stenosis who were treated using the crush technique. The final minimal stent area was measured in the ostial left anterior descending artery (LAD), ostial left circumflex artery (LCX), and distal LM. The primary outcome was 5-year major adverse cardiac events, including all-cause death, myocardial infarction, and target lesion revascularization., Results: The minimal stent area cutoff values that best predicted the 5-year major adverse cardiac events were 11.8 mm 2 for distal LM (area under the curve, 0.57; P =0.15), 8.3 mm 2 for LAD ostium (area under the curve, 0.62; P =0.02), and 5.7 mm 2 for LCX ostium (area under the curve, 0.64; P =0.01). Using these criteria, the risk of 5-year major adverse cardiac events was significantly associated with stent underexpansion in the LAD ostium (hazard ratio, 3.14; [95% CI, 1.23-8.06]; P =0.02) and LCX ostium (hazard ratio, 2.60 [95% CI, 1.11-6.07]; P =0.03) but not in the distal LM (hazard ratio, 0.81 [95% CI, 0.34-1.91]; P =0.63). Patients with stent underexpansion in both ostial LAD and LCX had a significantly higher rate of 5-year major adverse cardiac events than those with no or 1 underexpanded stent of either ostium ( P <0.01)., Conclusions: Stent underexpansion in the LAD and LCX ostium was significantly associated with long-term outcomes in patients who underwent up-front 2-stenting for LM bifurcation stenosis., Competing Interests: Disclosures None.

Background: Intravascular imaging-guided percutaneous coronary intervention (PCI) with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) showed superior clinical outcomes compared with angiography-guided PCI. However, the comparative effectiveness of OCT-guided and IVUS-guided PCI regarding clinical outcomes is unknown., Methods: In this prospective, multicenter, open-label, pragmatic trial, we randomly assigned 2008 patients with significant coronary artery lesions undergoing PCI in a 1:1 ratio to undergo either an OCT-guided or IVUS-guided PCI. The primary end point was a composite of death from cardiac causes, target vessel-related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year, which was powered for noninferiority of the OCT group compared with the IVUS group. Safety outcomes were also assessed., Results: At 1 year, primary end point events occurred in 25 of 1005 patients (Kaplan-Meier estimate, 2.5%) in the OCT group and in 31 of 1003 patients (Kaplan-Meier estimate, 3.1%) in the IVUS group (absolute difference, -0.6 percentage points; upper boundary of one-sided 97.5% CI, 0.97 percentage points; P <0.001 for noninferiority). The incidence of contrast-induced nephropathy was similar (14 patients [1.4%] in the OCT group versus 15 patients [1.5%] in the IVUS group; P =0.85). The incidence of major procedural complications was lower in the OCT group than in the IVUS group (22 [2.2%] versus 37 [3.7%]; P =0.047), although imaging procedure-related complications were not observed., Conclusions: In patients with significant coronary artery lesions, OCT-guided PCI was noninferior to IVUS-guided PCI with respect to the incidence of a composite of death from cardiac causes, target vessel-related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year. The selected study population and lower-than-expected event rates should be considered in interpreting the trial., Registration: URL: https://www., Clinicaltrials: gov; Unique number: NCT03394079., Competing Interests: Disclosures Dr D.-W. Park reports research grants or speaker fees from Abbott Vascular, Medtronic, and Daiichi-Sankyo; grants from ChongKunDang Pharm and Daewoong Pharm. Dr. S.-J. Park reports research grants or speaker fees from Abbott Vascular, Medtronic, Daiichi-Sankyo, ChongKunDang Pharm, Daewoong Pharm, and Edwards. All other authors declare no competing interests.

Background: Diabetes mellitus is associated with more complex coronary artery diseases. Coronary artery bypass grafting (CABG) is a preferred revascularization strategy over percutaneous coronary intervention (PCI) in diabetics with multivessel coronary artery disease (MVD)., Objectives: This study sought to examine the different prognostic effects of revascularization strategies according to the diabetes status from the randomized BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) trial., Methods: Patients (n = 880) with MVD were randomly assigned to undergo PCI with an everolimus-eluting stent vs CABG stratified by diabetics (n = 363) and nondiabetics (n = 517). The primary endpoint was the composite of death, myocardial infarction, or target vessel revascularization during a median follow-up of 11.8 years (IQR: 10.6-12.5 years)., Results: In diabetics, the primary endpoint rate was significantly higher in the PCI group than in the CABG group (43% and 32%; HR: 1.53; 95% CI: 1.12-2.08; P = 0.008). However, in nondiabetics, no significant difference was found between the groups (PCI group, 29%; CABG group, 29%; HR: 0.97; 95% CI: 0.67-1.39; P = 0.86; P interaction = 0.009). Irrespective of the presence of diabetes, no significant between-group differences were found in the rate of a safety composite of death, myocardial infarction, or stroke and mortality rate. However, the rate of any repeat revascularization was significantly higher in the PCI group than in the CABG group., Conclusions: In diabetics with MVD, CABG was associated with better clinical outcomes than PCI. However, the mortality rate was similar between PCI and CABG irrespective of diabetes status during an extended follow-up. (Ten-Year Outcomes of Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease [BEST Extended], NCT05125367; Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease [BEST], NCT00997828)., Competing Interests: Funding Support and Author Disclosures This research was supported by a grant from the Korea Health Technology R and D Project through the Korea Health Industry Development Institute funded by the Ministry of Health and Welfare, Republic of Korea (grant number HC19C0022). The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Long-term comparative outcomes after percutaneous coronary intervention (PCI) with everolimus-eluting stents and coronary artery bypass grafting (CABG) are limited in patients with multivessel coronary artery disease., Methods: This prospective, multicenter, randomized controlled trial was conducted in 27 international heart centers and was designed to randomly assign 1776 patients with angiographic multivessel coronary artery disease to receive PCI with everolimus-eluting stents or CABG. After inclusion of 880 patients (438 in the PCI group and 442 in the CABG group) between July 2008 and September 2013, the study was terminated early because of slow enrollment. The primary end point was the composite of death from any cause, myocardial infarction, or target vessel revascularization., Results: During a median follow-up of 11.8 years (interquartile range, 10.6-12.5 years; maximum, 13.7 years), the primary end point occurred in 151 patients (34.5%) in the PCI group and 134 patients (30.3%) in the CABG group (hazard ratio [HR], 1.18 [95% CI, 0.88-1.56]; P =0.26). No significant differences were seen in the occurrence of a safety composite of death, myocardial infarction, or stroke between groups (28.8% and 27.1%; HR, 1.07 [95% CI, 0.75-1.53]; P =0.70), as well as the occurrence of death from any cause (20.5% and 19.9%; HR, 1.04 [95% CI, 0.65-1.67]; P =0.86). However, spontaneous myocardial infarction (7.1% and 3.8%; HR, 1.86 [95% CI, 1.06-3.27]; P =0.031) and any repeat revascularization (22.6% and 12.7%; HR, 1.92 [95% CI, 1.58-2.32]; P <0.001) were more frequent after PCI than after CABG., Conclusions: In patients with multivessel coronary artery disease, there were no significant differences between PCI and CABG in the incidence of major adverse cardiac events, the safety composite end point, and all-cause mortality during the extended follow-up., Registration: URL: https://www., Clinicaltrials: gov; Unique identifiers: NCT05125367 and NCT00997828.

Traditionally, the treatment of left main coronary artery disease is recommended coronary artery bypass grafting because of its superior long-term outcomes compared with medical treatment and plain old balloon angioplasty. However, improvement of percutaneous coronary intervention technique and introduction of drug-eluting stent led to change of treatment strategy of left main coronary artery disease through cumulative data for revascularization that based on clinical evidence., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: There are limited data from randomized trials to guide a specific follow-up surveillance approach after myocardial revascularization. Whether a follow-up strategy that includes routine functional testing improves clinical outcomes among high-risk patients who have undergone percutaneous coronary intervention (PCI) is uncertain., Methods: We randomly assigned 1706 patients with high-risk anatomical or clinical characteristics who had undergone PCI to a follow-up strategy of routine functional testing (nuclear stress testing, exercise electrocardiography, or stress echocardiography) at 1 year after PCI or to standard care alone. The primary outcome was a composite of death from any cause, myocardial infarction, or hospitalization for unstable angina at 2 years. Key secondary outcomes included invasive coronary angiography and repeat revascularization., Results: The mean age of the patients was 64.7 years, 21.0% had left main disease, 43.5% had bifurcation disease, 69.8% had multivessel disease, 70.1% had diffuse long lesions, 38.7% had diabetes, and 96.4% had been treated with drug-eluting stents. At 2 years, a primary-outcome event had occurred in 46 of 849 patients (Kaplan-Meier estimate, 5.5%) in the functional-testing group and in 51 of 857 (Kaplan-Meier estimate, 6.0%) in the standard-care group (hazard ratio, 0.90; 95% confidence interval [CI], 0.61 to 1.35; P = 0.62). There were no between-group differences with respect to the components of the primary outcome. At 2 years, 12.3% of the patients in the functional-testing group and 9.3% in the standard-care group had undergone invasive coronary angiography (difference, 2.99 percentage points; 95% CI, -0.01 to 5.99), and 8.1% and 5.8% of patients, respectively, had undergone repeat revascularization (difference, 2.23 percentage points; 95% CI, -0.22 to 4.68)., Conclusions: Among high-risk patients who had undergone PCI, a follow-up strategy of routine functional testing, as compared with standard care alone, did not improve clinical outcomes at 2 years. (Funded by the CardioVascular Research Foundation and Daewoong Pharmaceutical; POST-PCI ClinicalTrials.gov number, NCT03217877.)., (Copyright © 2022 Massachusetts Medical Society.)

Randomized controlled trials (RCTs) comparing percutaneous coronary intervention (PCI) with drug-eluting stents and coronary artery bypass grafting (CABG) for patients with left main coronary artery disease (LMCAD) have reported conflicting results. We performed a systematic review up to May 23, 2021, and 1-stage reconstructed individual patient data meta-analysis (IPDMA) to compare outcomes between both groups. The primary outcome was 10-year all-cause mortality. Secondary outcomes included myocardial infarction (MI), stroke, and unplanned revascularization at 5 years. We performed individual patient data meta-analysis using published Kaplan-Meier curves to provide individual data points in coordinates and numbers at risk were used to increase the calibration accuracy of the reconstructed data. Shared frailty model or, when proportionality assumptions were not met, a restricted mean survival time model were fitted to compare outcomes between treatment groups. Of 583 articles retrieved, 5 RCTs were included. A total of 4,595 patients from these 5 RCTs were randomly assigned to PCI (n = 2,297) or CABG (n = 2,298). The cumulative 10-year all-cause mortality after PCI and CABG was 12.0% versus 10.6%, respectively (hazard ratio [HR] 1.093, 95% confidence interval [CI] 0.925 to 1.292; p = 0.296). PCI conferred similar time-to-MI (restricted mean survival time ratio 1.006, 95% CI 0.992 to 1.021, p=0.391) and stroke (restricted mean survival time ratio 1.005, 95% CI 0.998 to 1.013, p = 0.133) at 5 years. Unplanned revascularization was more frequent after PCI than CABG (HR 1.807, 95% CI 1.524 to 2.144, p <0.001) at 5 years. This meta-analysis using reconstructed participant-level time-to-event data showed no statistically significant difference in cumulative 10-year all-cause mortality between PCI versus CABG in the treatment of LMCAD., Competing Interests: Disclosures Mark Y. Chan receives speaker fees and research grants from Astra Zeneca, Abbott Technologies, and Boston Scientific. The remaining authors have nothing to disclose. The other authors have no conflict of interest to declare., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: The optimal revascularisation strategy for patients with left main coronary artery disease is uncertain. We therefore aimed to evaluate long-term outcomes for patients treated with percutaneous coronary intervention (PCI) with drug-eluting stents versus coronary artery bypass grafting (CABG)., Methods: In this individual patient data meta-analysis, we searched MEDLINE, Embase, and the Cochrane database using the search terms "left main", "percutaneous coronary intervention" or "stent", and "coronary artery bypass graft*" to identify randomised controlled trials (RCTs) published in English between database inception and Aug 31, 2021, comparing PCI with drug-eluting stents with CABG in patients with left main coronary artery disease that had at least 5 years of patient follow-up for all-cause mortality. Two authors (MSS and BAB) identified studies meeting the criteria. The primary endpoint was 5-year all-cause mortality. Secondary endpoints were cardiovascular death, spontaneous myocardial infarction, procedural myocardial infarction, stroke, and repeat revascularisation. We used a one-stage approach; event rates were calculated by use of the Kaplan-Meier method and treatment group comparisons were made by use of a Cox frailty model, with trial as a random effect. In Bayesian analyses, the probabilities of absolute risk differences in the primary endpoint between PCI and CABG being more than 0·0%, and at least 1·0%, 2·5%, or 5·0%, were calculated., Findings: Our literature search yielded 1599 results, of which four RCTs-SYNTAX, PRECOMBAT, NOBLE, and EXCEL-meeting our inclusion criteria were included in our meta-analysis. 4394 patients, with a median SYNTAX score of 25·0 (IQR 18·0-31·0), were randomly assigned to PCI (n=2197) or CABG (n=2197). The Kaplan-Meier estimate of 5-year all-cause death was 11·2% (95% CI 9·9-12·6) with PCI and 10·2% (9·0-11·6) with CABG (hazard ratio 1·10, 95% CI 0·91-1·32; p=0·33), resulting in a non-statistically significant absolute risk difference of 0·9% (95% CI -0·9 to 2·8). In Bayesian analyses, there was an 85·7% probability that death at 5 years was greater with PCI than with CABG; this difference was more likely than not less than 1·0% (<0·2% per year). The numerical difference in mortality was comprised more of non-cardiovascular than cardiovascular death. Spontaneous myocardial infarction (6·2%, 95% CI 5·2-7·3 vs 2·6%, 2·0-3·4; hazard ratio [HR] 2·35, 95% CI 1·71-3·23; p<0·0001) and repeat revascularisation (18·3%, 16·7-20·0 vs 10·7%, 9·4-12·1; HR 1·78, 1·51-2·10; p<0·0001) were more common with PCI than with CABG. Differences in procedural myocardial infarction between strategies depended on the definition used. Overall, there was no difference in the risk of stroke between PCI (2·7%, 2·0-3·5) and CABG (3·1%, 2·4-3·9; HR 0·84, 0·59-1·21; p=0·36), but the risk was lower with PCI in the first year after randomisation (HR 0·37, 0·19-0·69)., Interpretation: Among patients with left main coronary artery disease and, largely, low or intermediate coronary anatomical complexity, there was no statistically significant difference in 5-year all-cause death between PCI and CABG, although a Bayesian approach suggested a difference probably exists (more likely than not <0·2% per year) favouring CABG. There were trade-offs in terms of the risk of myocardial infarction, stroke, and revascularisation. A heart team approach to communicate expected outcome differences might be useful to assist patients in reaching a treatment decision., Funding: No external funding., Competing Interests: Declaration of interests MSS, BAB, SAM, and EB are members of the Thrombolysis in Myocardial Infarction Study Group, which has received grant support through Brigham and Women's Hospital (Boston, MA, USA) from Abbott, Amgen, Anthos Therapeutics, AstraZeneca, Bayer HealthCare Pharmaceuticals, Daiichi-Sankyo, Eisai, Intarcia, Ionis, MedImmune, Merck, Novartis, Pfizer, Quark Pharmaceuticals, Regeneron Pharmaceuticals, Roche, Siemens Healthcare Diagnostics, The Medicines Company, and Zora Biosciences. MSS declares research grant support through Brigham and Women's Hospital from Abbott, Amgen, Anthos Therapeutics, AstraZeneca, Bayer, Daiichi-Sankyo, Eisai, Intarcia, Ionis, The Medicines Company, MedImmune, Merck, Novartis, Pfizer, and Quark Pharmaceuticals, and has consulted for Althera, Amgen, Anthos Therapeutics, AstraZeneca, Bristol Myers Squibb, CVS Caremark, DalCor, Dr Reddy's Laboratories, Fibrogen, IFM Therapeutics, Intarcia, MedImmune, Merck, Moderna, Novo Nordisk, and Silence Therapeutics. BAB declares research grants through Brigham and Women's Hospital from Pfizer, Ionis, Quark, AstraZeneca/MedImmune, and Amgen, and consulting or personal fees from Philips, Abbott Vascular, CSI, Abiomed, Servier, Janssen, Quark, and Daiichi Sankyo. PWS declares consultancy or personal fees from SMT, Novartis, Philips, Xeltis, and Merillife. APK is an employee of Medtronic. S-JP declares grants from Abbott Vascular, Daiichi-Sankyo, ChongKunDang Pharm, Daewoong Pharm, and Edwards, and personal fees from Abbott Vascular and Edwards, all outside the submitted work. D-WP declares grants from Daiichi-Sankyo, ChongKunDang Pharm, Daewoong Pharm, and Abbott Vascular, and personal fees from Edwards, Abbott Vascular, and Medtronic, all outside the submitted work. EHC declares institutional research grants from Abbott, Biosensors, and Boston Scientific, and speaker fees from Abbott. NRH declares institutional research grants from Abbott, Biosensors, Bbraun, Boston Scientific, and Reva Medical, and speaker fees from Abbott, Reva Medical, and Terumo. GWS declares speaker honoraria from Cook and Infraredx; consultancy for Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Reva, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, and Gore; equity or options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and MedFocus family of funds; that Columbia University (New York, NY, USA) received payments from Abbott for research activities related and not related to EXCEL and royalties for sale of the MitraClip; and that Mount Sinai Hospital (New York, NY, USA) receives research funding from Abbott. JFS was the North American Surgical Principal Investigator in the EXCEL trial. EB declares research grants through Brigham and Women's Hospital from AstraZeneca, Daiichi-Sankyo, Merck, and Novartis, and consultancies with Amgen, Boehringer-Ingelheim/Lilly, Bristol Myers Squibb (MyoKardia), Cardurion, NovoNordisk, and Verve. All author authors declare no competing interests., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

More evidence is required with respect to the comparative effectiveness of percutaneous coronary intervention (PCI) with second-generation drug-eluting stents (DESs) versus coronary artery bypass grafting (CABG) in contemporary clinical practice. This prospective observational registry-based study compared the outcomes of 6,647 patients with multivessel disease who underwent PCI with second-generation DES (n = 3,858) or CABG (n = 2,789) between January 2006 and June 2018 and for whom follow-up data were available for at least 2 to 13 years (median 4.8). The primary outcome was a composite of death, spontaneous myocardial infarction, or stroke. Baseline differences were adjusted using propensity scores and inverse probability weighting. In the overall cohort, there were no significant between-group differences in the adjusted risks for the primary composite outcome (hazard ratio [HR] for PCI vs CABG 1.03, 95% confidence interval [CI] 0.86 to 1.25, p = 0.73) and all-cause mortality (HR 0.95, 95% CI 0.76 to 1.20, p = 0.68). This relative treatment effect on the primary outcome was similar in patients with diabetes (HR 1.15, 95% CI 0.91 to 1.46, p = 0.25) and without diabetes (HR 0.95, 95% CI 0.73 to 1.22, p = 0.67) (p for interaction = 0.24). The adjusted risk of the primary outcome was significantly greater after PCI than after CABG in patients with left main involvement (HR 1.39, 95% CI 1.01 to 1.90, p = 0.044), but not in those without left main involvement (HR 0.94, 95% CI 0.76 to 1.16, p = 0.56) (p = 0.03 for interaction). In this prospective real-world long-term registry, we observed that the risk for the primary composite of death, spontaneous myocardial infarction, or stroke was similar between PCI with contemporary DES and CABG., Competing Interests: Disclosures Dr. Duk-Woo Park reports grants from Daiichi-Sankyo, ChongKunDang Pharm, and Daewoong Pharm; personal fees from Edwards; grants and personal fees from Abbott Vascular; and personal fees from Medtronic, all outside the submitted work. Dr. Seung-Jung Park reports grants and personal fees from Abbott Vascular; grants from Daiichi-Sankyo, ChongKunDang Pharm, and Daewoong Pharm; and grants and personal fees from Edwards, all outside the submitted work. The other authors have no conflicts of interest to disclose., (Copyright © 2021 Elsevier Inc. All rights reserved.)

To compare 10-year outcomes after implantation of sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES) for left main coronary artery (LMCA) stenosis. Very long-term outcome data of patients with LMCA disease treated with drug-eluting stents (DES) have not been well described. In 10-year extended follow-up of the MAINCOMPARE registry, we evaluated 778 patients with unprotected LMCA stenosis who were treated with SES (n = 607) or PES (n = 171) between January 2000 and June 2006. The primary composite outcome (a composite of death, myocardial infarction [MI] or target-vessel revascularization [TVR]) was compared with an inverse-probability-of-treatment-weighting (IPTW) adjustment. Clinical events have linearly accumulated over 10 years. At 10 years, there were no significant differences between SES and PES in the observed rates of the primary composite outcome (42.0% vs. 47.4%; hazard ratio [HR] 0.85; 95% confidence interval [CI] 0.66-1.10), and definite stent thrombosis (ST) (1.9% vs. 1.8%; HR 1.02, 95% CI 0.28-3.64). In the IPTW-adjusted analyses, there were no significant differences between SES and PES in the risks for the primary composite outcome (HR 0.89, 95% CI 0.65-1.14) or definite ST (adjusted HR 1.05, 95% CI 0.29-3.90). In patients who underwent DES implantation, high overall adverse clinical event rates (with a linearly increasing event rate over time) were observed during extended follow-up. At 10 years, there were no measurable differences in outcomes between patients treated with SES vs. PES for LMCA disease. The incidence of stent thrombosis was quite low and comparable between the groups., (© 2021 Wiley Periodicals LLC.)

Background The long-term prognostic effect of the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS) after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for left main coronary artery disease is controversial. Methods and Results In the PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease) trial, 600 patients with left main coronary artery disease were randomized to undergo PCI with drug-eluting stents (n=300) or CABG (n=300). We compared 10-year outcomes after PCI and CABG according to SS categories and evaluated the predictive value of SS in each revascularization arm. The primary outcome was a major adverse cardiac or cerebrovascular event (composite of death, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization) at 10 years. Among 566 patients with valid SS measurement at baseline, 240 (42.4%) had low SS, 200 (35.3%) had intermediate SS, and 126 (22.3%) had high SS. The 10-year rates of major adverse cardiac or cerebrovascular events were not significantly different between PCI and CABG in low (21.6% versus 22.2%, P =0.97), intermediate (31.8% versus 22.2%; P =0.13), and high SS (46.2% versus 35.7%; P =0.31) ( P -for-interaction=0.46). There were no significant interactions between SS categories and revascularization modalities for death ( P =0.92); composite of death, myocardial infarction, or stroke ( P =0.87); and target-vessel revascularization ( P =0.06). Higher SS categories were associated with higher risks for major adverse cardiac or cerebrovascular events in the PCI arm but not in the CABG arm. Conclusions Ten-year clinical outcomes between PCI and CABG were not significantly different according to the SS. The SS was predictive of major adverse cardiac or cerebrovascular events after PCI but not after CABG. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03871127.

Background Several trials reported differential outcomes after percutaneous coronary intervention with drug-eluting stents (DES) and coronary-artery bypass grafting (CABG) for multivessel coronary disease according to the presence of diabetes mellitus (DM). However, it is not well recognized how DM status affects very-long-term (10-year) outcomes after DES and CABG for left main coronary artery disease. Methods and Results In the PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) trial, patients with LMCA were randomly assigned to undergo PCI with sirolimus-eluting stents (n=300) or CABG (n=300). The primary outcome was the incidence of major adverse cardiac or cerebrovascular events (MACCE; a composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization). Outcomes were examined in patients with (n=192) and without (n=408) medically treated diabetes. The follow-up was extended to at least 10 years for all patients (median, 11.3 years). The 10-year rates of MACCE were not significantly different between DES and CABG in patients with DM (36.3% versus 26.7%, respectively; hazard ratio [HR], 1.35; 95% CI, 0.83-2.19; P =0.23) and without DM (25.3% versus 22.9%, respectively; HR, 1.15; 95% CI, 0.79-1.67; P =0.48) ( P -for-interaction=0.48). There were no significant between-group differences in composite of death, MI, or stroke, and all-cause mortality, regardless of DM status. TVR rates were consistently higher after DES than CABG. Conclusions In this 10-year extended follow-up of PRECOMBAT, we found no significant difference between DES and CABG with respect to the incidences of MACCE, serious composite outcome, and all-cause mortality in patients with and without DM with LMCA disease. However, owing to the limited number of patients and no adjustment for multiple testing, overall findings should be considered hypothesis-generating, highlighting the need for further research. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03871127 and NCT00422968.

Introduction: Distal left main (LM) bifurcation disease is one of the most challenging lesion subsets for percutaneous coronary intervention (PCI) and optimal stenting strategy for such complex lesions is still debated. This study aimed to compare clinical outcomes following single versus dual stenting for true distal LM bifurcation lesions., Methods: Patients with true distal LM bifurcation lesions (type 1,1,1 or 0,1,1: both left anterior descending and circumflex artery >2.5 mm diameter) receiving PCI with drug-eluting stents (DES) from two large clinical registries were evaluated. The primary outcome was target-lesion failure (TLF), defined as a composite of cardiac death, target-vessel myocardial infarction (MI), or target-lesion revascularization (TLR). Outcomes were compared with the use of propensity scores and inverse probability-weighting adjustment to reduce treatment selection bias., Results: Among 1,002 patients undergoing true distal LM PCI, 440 (43.9%) and 562 (56.1%) were treated with single and dual stents, respectively. The TLF rates at 3 year was 20.3% in the single-stent group and 24.1% in the dual-stenting group (log-rank p = 0.18). The adjusted risk for TLF did not differ significantly between two groups (hazard ratio [HR] with dual-stent vs. single-stent: 1.27, 95% confidence interval [CI]: 0.95-1.71). The adjusted risks for death, MI, repeat revascularization, or stent thrombosis were also similar between the single- and dual-stenting groups., Conclusions: In patients undergoing PCI for true distal LM disease, single- and dual-stent strategies showed a similar adjusted risk of TLF at 3 years. Our findings should be confirmed or refuted through large, randomized clinical trials., (© 2021 Wiley Periodicals LLC.)

Aims: There is limited information on the clinical relevance and procedural impact of coronary artery calcification (CAC) in the contemporary percutaneous coronary intervention (PCI) setting. This study sought to determine the incidence and clinical significance of procedural techniques on the outcomes in 'real-world' patients with CAC undergoing PCI with drug-eluting stents (DESs)., Methods and Results: Using patient-level data from seven stent-specific, prospective DES registries, we evaluated 17 084 patients who underwent PCI with various DES types between July 2007 and July 2015. The primary outcome was target-vessel failure (TVF), defined as a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization. Outcomes through 3 years (and between 0-1 and 1-3 years) were assessed according to CAC status (none/mild vs. moderate/severe) and stenting technique (predilation or post-dilation). Among 17 084 patients with 22 739 lesions included in the pooled dataset, moderate to severe CAC was observed in 11.3% of patients (10.1% of lesions). Older age, lower BMI, diabetes, hypertension, family history of coronary artery disease, and renal failure were independent predictors of moderate/severe CAC. The presence of moderate/severe CAC was significantly associated with an adjusted risk of TVF at 3 years [hazard ratio, 1.37; 95% confidence interval (CI), 1.19-1.58; P < 0.001]. For severe CAC, optimal lesion preparation with predilation was associated with a lower 3-year rate of TVF (no vs. yes, 22.3 vs. 12.8%), in which the effect of predilation was prominent at the late period of 1-3 years (hazard ratio, 0.28; 95% CI, 0.12-0.69; P = 0.003) than at the early period through 1 year (hazard ratio, 1.16; 95% CI, 0.37-3.71; P = 0.80). However, post-dilation (with a high-pressure noncompliant balloon) had no effect on the outcome., Conclusions: In this study, moderate/severe CAC was common (~10%) and strongly associated with TVF during 3 years of follow-up. For severe CAC, optimal lesion preparation with pre-balloon dilation has a significant effect on long-term outcomes, especially during the late period beyond 1 year. Clinical Trial Registration - URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186133.

Platelets are crucial in the pathophysiology of coronary artery disease and are a major target of antithrombotic agents in patients receiving percutaneous coronary intervention (PCI). We sought to evaluate the incidence and prognostic impact of thrombocytopenia on clinical outcomes in patients undergoing PCI with drug-eluting stents (DES). We evaluated consecutive patients who received PCI with DES in the IRIS-DES registry between April 2008 and December 2017. Patients were divided into 2 groups based on the presence of thrombocytopenia (platelet count <150 × 10 9 /L) at baseline. The primary outcome was all-cause mortality, and secondary outcomes included the composite outcome of death, myocardial infarction (MI), and stroke, and major bleeding. Complete follow-up data were available for 1 to 5 years (median, 3.1). Among 26,553 eligible patients, 1,823 (6.9%) had thrombocytopenia at baseline. At 5 years, the incidences of all-cause mortality (15.6% vs 8.1%, p <0.001), composite outcome (23.2% vs 15.6%, p <0.001), and major bleeding (3.7% vs 2.2%, p <0.001) were significantly higher in patients with thrombocytopenia than in those without thrombocytopenia. In multivariable Cox proportional-hazards models, thrombocytopenia was significantly associated with increased risks of all-cause mortality (hazard ratio 1.26, 95% confidence interval 1.07 to 1.48, p = 0.01) and major bleeding (hazard ratio 1.41, 95% confidence interval 1.04 to 1.91, P=0.03). In conclusion, among who patients underwent PCI with DES, the incidence of thrombocytopenia was 6.9%. Baseline thrombocytopenia was significantly associated with increased risks of mortality and major bleeding., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Whether the diabetic status differentially affects the clinical outcomes with different drug-eluting stents (DES) has been controversial., Methods and Results: From stent-specific, prospective DES registries, we evaluated 17,184 patients (11,428 in non-diabetics and 5,756 in diabetics) who received several contemporary DES: 3570 sirolimus-eluting stents (SES), 5,023 cobalt-chromium everolimus-eluting stents (CoCr-EES), 2,985 platinum-chromium EES (PtCr-EES), 2,913 Resolute zotarolimus-eluting stents (Re-ZES), and 2,693 biodegradable-polymer biolimus-eluting stents (BP-BES). The primary outcome was patient-oriented composite endpoint (POCE, a composite of all-cause death, any myocardial infarction, and any revascularization) at 3-year follow-up and target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization) at 3 years was also evaluated. In non-diabetics, the rates of POCE were not significantly different (CoCr-EES 14.3%, PtCr-EES 13.0%, Re-ZES 14.3%, BP-BES 13.4%, and SES 14.6%; overall p = .39). In diabetics, similar results were revealed (CoCr-EES 18.4%, PtCr-EES 20.3%, Re-ZES 17.3%, BP-BES 17.7%, and SES 17.8%; overall p = .44). In multiple treatment propensity-score weighting analysis, regardless of the diabetic status, the hazard ratios for POCE between-individual comparison were similar. Target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization) was also comparable except the higher ratio of Re-ZES than PtCr-EES (hazard ratio 1.25, 1.26, 95% confidence interval 1.00-1.55, p = .048) in patients without diabetes., Conclusions: In this clinical-practice registry study, regardless the diabetic status, the 3-year rates of the primary outcome were similar among different types of DES, suggesting no differential clinical response between contemporary DES in patients with or without diabetes., (© 2019 Wiley Periodicals, Inc.)

Objectives: This study compared the 3-year outcomes of intracoronary imaging-guided pre-dilation, stent sizing, and post-dilation (iPSP) for patients with complex coronary artery lesions., Background: The long-term effects of the optimal drug-eluting stent implantation technique in complex coronary artery disease have not been evaluated., Methods: From the IRIS-DES (Interventional Cardiology Research In-cooperation Society-Drug-Eluting Stents) registry, the study evaluated 9,525 patients who underwent percutaneous coronary intervention for left main, bifurcation, long or diffuse (>30 mm), or angiographically severely calcified lesions. The primary outcome was a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization. The inverse probability of treatment weighting method was used to adjust for confounding factors., Results: At the index procedure, intravascular ultrasound assessment PSP were performed in 8,522 (89.5%) patients, 5,141 (54.0%) patients, and 5,531 (58.1%) patients, respectively; overall, 3,374 (35.4%) patients underwent stent implantation using all 3 parts of the iPSP strategy and were defined as the iPSP group. At 3 years, the adjusted rate of the primary outcome was significantly lower in iPSP group (5.6% vs 7.9%; adjusted hazard ratio: 0.71; 95% confidence interval: 0.63 to 0.81; p < 0.001)., Conclusions: Among patients undergoing drug-eluting stent implantation in complex coronary artery stenosis, iPSP was associated with a lower risk of cardiac events at 3 years. Therefore, physicians should apply iPSP more actively for the treatment of complex coronary artery stenoses, even in the current era. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: In patients with coronary in-stent restenosis (ISR) requiring reintervention, it is unclear if the choice of treatment should depend on whether the restenotic stent was a bare-metal stent (BMS) or a drug-eluting stent (DES)., Objectives: This study aimed to assess the comparative efficacy and safety of the 2 most frequently used treatments - angioplasty with drug-coated balloon (DCB) and repeat stenting DES - in patients with BMS-and DES-ISR., Methods: The DAEDALUS (Difference in Antirestenotic Effectiveness of Drug-Eluting Stent and Drug-Coated Balloon Angioplasty for the Occurrence of Coronary In-Stent Restenosis) study was a pooled analysis of individual patient data from all 10 existing randomized clinical trials comparing DCB angioplasty with repeat DES implantation for the treatment of coronary ISR. In this pre-specified analysis, patients were stratified according to BMS- versus DES-ISR and treatment assigned. The primary efficacy endpoint was target lesion revascularization (TLR) at 3 years. The primary safety endpoint was a composite of all-cause death, myocardial infarction, or target lesion thrombosis at 3 years. Primary analysis was performed by mixed-effects Cox models accounting for the trial of origin. Secondary analyses included nonparsimonious multivariable adjustment accounting also for multiple lesions per patient and 2-stage analyses., Results: A total of 710 patients with BMS-ISR (722 lesions) and 1,248 with DES-ISR (1,377 lesions) were included. In patients with BMS-ISR, no significant difference between treatments was observed in terms of primary efficacy (9.2% vs. 10.2%; hazard ratio [HR]: 0.83; 95% confidence interval [CI]: 0.51 to 1.37) and safety endpoints (8.7% vs. 7.5%; HR: 1.13; 95% CI: 0.65 to 1.96); results of secondary analyses were consistent. In patients with DES-ISR, the risk of the primary efficacy endpoint was higher with DCB angioplasty than with repeat DES implantation (20.3% vs. 13.4%; HR: 1.58; 95% CI: 1.16 to 2.13), whereas the risk of the primary safety endpoint was numerically lower (9.5% vs. 13.3%; HR: 0.69; 95% CI: 0.47 to 1.00); results of secondary analyses were consistent. Regardless of the treatment used, the risk of TLR was lower in BMS- versus DES-ISR (9.7% vs. 17.0%; HR: 0.56; 95% CI: 0.42 to 0.74), whereas safety was not significantly different between ISR types., Conclusions: At 3-year follow-up, DCB angioplasty and repeat stenting with DES are similarly effective and safe in the treatment of BMS-ISR, whereas DCB angioplasty is significantly less effective than repeat DES implantation in the treatment DES-ISR, and associated with a nonsignificant reduction in the primary composite safety endpoint. Overall, DES-ISR is associated with higher rates of treatment failure and similar safety compared with BMS-ISR., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Clinical benefits of bioresorbable vascular scaffold (BVS) implantation for long coronary lesions were not sufficiently evaluated. The efficacy and safety of BVS and metallic everolimus-eluting stent (EES) were compared for the treatment of long coronary narrowings. A total of 341 patients with diffuse long lesions (requiring device length ≥28 mm) were randomized to receive either BVS (n = 171) or EES (n = 170) implantation. The primary endpoint was major adverse cardiovascular events which included death from cardiac cause, myocardial infarction, device thrombosis, or ischemia-driven target-lesion revascularization at 12 months. The trial was terminated early because the manufacturer stopped supplying BVS. The mean lesion length was 32.2 ± 13.1 mm in the BVS group and 35.3 ± 13.0 mm in the EES group. The 12-month follow-up was completed in 332 patients (97.4%). At 12 months, the primary endpoint events occurred in 2 patients (1.2%) in the BVS group and in 4 patients (2.4%) in the EES group (hazard ratio = 0.49, 95% confidence interval = 0.09 to 2.67, p = 0.398). Definite or probable device thrombosis occurred in 1 patient (0.6%) in the BVS group and 1 patient (0.6%) in the EES group (hazard ratio = 1.00, 95% confidence interval = 0.06 to 15.94, p = 0.998). In conclusion, in patients with long native coronary artery disease, significant differences between BVS and EES were not observed regarding the primary composite endpoint of death from cardiac cause, myocardial infarction, device thrombosis, or target-lesion revascularization at 12 months. However, due to the early termination of this trial and a low number of events, the results cannot be considered clinically relevant (clinicalTrials.gov Identifier: NCT02796157)., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Although the need to detect restenosis has diminished in the contemporary practice of percutaneous coronary intervention (PCI) with drug-eluting stents (DES), the surveillance of ischemia owing to restenosis or disease progression deserves attention in high-risk PCI settings. It is unknown whether follow-up strategy of routine noninvasive functional testing potentially reduces the risk of major cardiovascular events in high-risk PCI patients., Methods: The POST-PCI study is an investigator-initiated, multicenter, prospective randomized trial comparing the effectiveness of two follow-up strategies in patients with high-risk anatomic or clinical characteristics who underwent PCI. Study participants were randomly assigned to either (1) the routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing. In the routine stress testing group, depending on the testing results, all clinical decisions regarding subsequent diagnostic or therapeutic procedures were at the treating physician's discretion. The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI., Results: More than 1700 high-risk PCI patients have been randomized over 2.0 years at 11 major cardiac centers in Korea., Conclusion: This pragmatic POST-PCI trial will provide valuable clinical evidence on the effectiveness of follow-up strategy of routine noninvasive stress testing in high-risk PCI patients., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Long-term comparative outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents and coronary-artery bypass grafting (CABG) for left main coronary artery disease are highly debated., Methods: In the PRECOMBAT trial (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease), patients with unprotected left main coronary artery disease were randomly assigned to undergo PCI with sirolimus-eluting stents (n=300) or CABG (n=300) in 13 hospitals in Korea from April 2004 to August 2009. The follow-up was extended to at least 10 years for all patients (median, 11.3 years). The primary outcome was the incidence of major adverse cardiac or cerebrovascular events (composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization)., Results: At 10 years, a primary outcome event occurred in 29.8% of the PCI group and in 24.7% of the CABG group (hazard ratio [HR] with PCI vs CABG, 1.25 [95% CI, 0.93-1.69]). The 10-year incidence of the composite of death, myocardial infarction, or stroke (18.2% vs 17.5%; HR 1.00 [95% CI, 0.70-1.44]) and all-cause mortality (14.5% vs 13.8%; HR 1.13 [95% CI, 0.75-1.70]) were not significantly different between the PCI and CABG groups. Ischemia-driven target-vessel revascularization was more frequent after PCI than after CABG (16.1% vs 8.0%; HR 1.98 [95% CI, 1.21-3.21)., Conclusions: Ten-year follow-up of the PRECOMBAT trial of patients with left main coronary artery disease randomized to PCI or CABG did not demonstrate significant difference in the incidence of major adverse cardiac or cerebrovascular events. Because the study was underpowered, the results should be considered hypothesis-generating, highlighting the need for further research. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03871127 and NCT00422968.

Objective: The goal of this study was to determine the impact of late-acquired stent malapposition (LASM) on long-term clinical outcomes in patients treated with coronary stent implantation. Approach and Results: We investigated major adverse cardiac event during 10 years after 6-month intravascular ultrasound examination using our previous studies database. A total of 732 patients treated with bare-metal stent (54 LASM versus 678 non-LASM) and 529 patients treated with first-generation drug-eluting stent (82 LASM versus 447 non-LASM), who did not have clinical event or censoring at the time of follow-up intravascular ultrasound, were included for the present analysis. major adverse cardiac event was defined as the composite of cardiac death, target vessel-related myocardial infarction, target lesion revascularization and stent thrombosis. Multivariable adjustment and inverse probability weight were performed to consider baseline differences. After multivariable adjustment, LASM was related to a greater risk of major adverse cardiac event (hazard ratio, 1.666 [95% CI, 1.041-2.665]; P =0.0333) and very-late stent thrombosis (hazard ratio, 3.529 [95% CI, 1.153-10.798]; P =0.0271) than non-LASM in patients treated with first-generation drug-eluting stent, but not in those treated with bare-metal stent. Results were consistent after inverse probability weight. Among patients with LASM of first-generation drug-eluting stent, no late stent thrombosis occurred in patients who continued to receive dual antiplatelet therapy., Conclusions: The relationship between LASM and major adverse cardiac event might depend on the type of implanted stents during the long-term follow-up, highlighting the clinical significance of polymers and drugs in drug-eluting stent system.

Background: Little is known about how the relative treatment effect of percutaneous coronary intervention (PCI) and coronary-artery bypass grafting (CABG) on clinical outcomes in ostial or shaft left main coronary artery (LMCA) disease has evolved over time., Methods: This study included 2,112 patients with ostial or shaft LMCA disease from IRIS-MAIN registry who underwent PCI (n = 1,329) or CABG (n = 783). Patients were stratified by time period based on stent type availability: wave 1 (1995-2002, bare-metal stent [BMS] era); wave 2 (2003-2006, first-generation drug-eluting stent [DES] era); and wave 3 (2007-2014, second-generation DES era)., Results: Compared to CABG, PCI has been used more frequently from wave 1 to wave 3. PCI showed substantial improvements over time with respect to death (P for trend = 0.012); the composite of death, myocardial infarction (MI), or stroke (P for trend = 0.047); repeat revascularization (P for trend < 0.001); and major adverse cardiac and cerebrovascular events (MACCE; a composite of death, MI, stroke, or repeat revascularization) (P for trend < 0.001). By contrast, outcomes of CABG remained relatively stable over time. The gap between the treatment effects of CABG vs PCI for MACCE has narrowed over time; the adjusted hazard ratios for CABG compared to PCI during wave 1, 2, and 3 were 0.41 (95% confidence interval [CI]: 0.22-0.76), 0.47 (95% CI: 0.31-0.71), and 0.78 (95% CI: 0.50-1.20), respectively., Conclusions: In patients with ostial or shaft LMCA disease, significant improvements in PCI outcomes resulted in a progressive decline in the gap between the outcomes of CABG and PCI., (© 2019 Wiley Periodicals, Inc.)

Objective: Data on the comparative effectiveness of contemporary drug-eluting stents (DES) in the unrestricted, real-world setting are limited. We investigated the long-term effectiveness and safety of contemporary different drug-eluting stents by means of multiple treatment propensity score weighting., Patients and Methods: From seven stent-specific, prospective DES registries conducted between July 2007 and July 2015, we evaluated 17 196 patients who received several contemporary DES and first-generation DES: 3053 treated with cobalt-chromium everolimus-eluting stents (CoCr-EES), 2985 with platinum-chromium EES (PtCr-EES), 2922 with Resolute zotarolimus-eluting stents (Re-ZES), 789 with Biomatrix biolimus-eluting stents (Bi-BES), 1907 with Nobori biolimus-eluting stents (No-BES), 1970 with Xience Prime cobalt-chromium everolimus-eluting stents (Pr-CoCr-EES), and 3570 with sirolimus-eluting stents (SES). The primary outcome was target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization) at 3 years of follow-up and major cardiovascular adverse events (a composite of all-cause death, any myocardial infarction, or any revascularization) was also evaluated., Results: The observed 3-year rates of target-vessel failure were not significantly different among different second-generation DES and SES (CoCr-EES 9.8%, PtCr-EES 9.5%, Re-ZES 9.3%, Bi-BES 9.8%, No-BES 7.7%, Pr-CoCr-EES 10.4%, SES 10.2%; overall P=0.07). In multiple treatment propensity score analysis, adjusted hazard ratios for target-vessel failure were similar in between-group comparisons of several contemporary DES. In addition, no significant differences were observed with respect of the adjusted risk of major adverse cardiac events., Conclusion: In this comparative effectiveness research using stent-specific, clinical practice registries involving unrestricted use of several contemporary DES, there were no significant between-group differences in the 3-year rates of target-vessel failure.

Background: Stent parameters (length and diameter) are well-known risk factors for adverse outcomes after percutaneous coronary intervention (PCI) with stenting. This study aimed to investigate the differential cutoff criteria and clinical impact of the length and diameter of various drug-eluting stents (DES) for predicting major cardiovascular events., Methods: Using patient-level data from seven stent-specific, prospective DES registries, we evaluated 17,068 patients who underwent PCI with either various contemporary DES or first-generation DES between July 2007 and July 2015: 3053 treated with cobalt-chromium everolimus-eluting stents (CoCr-EES), 2976 with platinum-chromium EES (PtCr-EES), 2888 with Resolute zotarolimus-eluting stents (Re-ZES), 782 with Biomatrix biolimus-eluting stents (Bi-BES), 1868 with Nobori BES (No-BES), 1934 with Xience Prime cobalt-chromium EES (Pr-CoCr-EES), and 3567 with first-generation sirolimus-eluting stents (SES). Two clinical outcomes were assessed: target-vessel failure (TVF; a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization [TVR]) and TVR., Results: Stent length and stent diameter were important factors for predicting TVF or TVR in the entire cohort and in each DES cohort. For TVF risk prediction, the Youden index-based cutoff of stent length was highest with Bi-BES (45.0 mm) and lowest with No-BES (29.0 mm), and the cutoff of stent diameter was smallest with Pr-CoCr-EES (2.78 mm) and largest with No-BES (3.20 mm). For TVR risk prediction, the cutoff of stent length was the highest with PtCr-EES (48.0 mm) and the lowest with No-BES (29.0 mm), and the cutoff of stent diameter was smallest with CoCr-EES (2.72 mm) and largest with first-generation SES (3.30 mm). The 3-year TVF and TVR rates were substantially different according to the presence or absence of long lesions and small vessels determined using these cutoff points., Conclusions: For contemporary PCI practice involving diverse types of DES, we identified differential cutoff points of stent length and diameter for predicting adverse clinical outcomes. The clinical impact of these stent parameters on outcomes and its magnitude varied according to different DES. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186133., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: Outcomes for stent-based coronary intervention of lesions with long diseased segments remain relatively unfavorable. This study sought to compare the efficacy of Resolute zotarolimus-eluting stents (R-ZES) and Xience everolimus-eluting stents (EES) for very long coronary lesions., Methods and Results: This randomized, multicenter, prospective trial compared the use of R-ZES with EES for very long (≥50 mm) native coronary lesions. The primary end point was in-segment late luminal loss at 12-month angiographic follow-up. A total of 400 patients were needed to assess the primary end point. However, owing to very slow enrollment of patients, this trial was early terminated (302 patients were enrolled), and thus, this report provides descriptive information on primary and secondary end points. The R-ZES and EES groups had similar baseline characteristics. Lesion length was 49.6±10.2 and 50.6±13.3 mm in the R-ZES and EES groups, respectively (P=0.47). The number of stents used at the target lesion was 2.1±0.3 and 2.2±0.5, respectively. Twelve-month angiographic follow-up was performed in 50% of eligible patients. In-segment late luminal loss did not significantly differ between the R-ZES and EES groups (0.17±0.57 vs. 0.09±0.43 mm, P=0.32). In-segment binary restenosis rates were 8.1 and 5.3% in the R-ZES and EES groups, respectively (P=0.49). There were no significant between-group differences in the rate of adverse events (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes)., Conclusion: For patients with very long native coronary artery disease, R-ZES and EES implantation showed comparable angiographic and clinical outcomes through 1 year of follow-up.

Background/aims: Compared with metallic drug-eluting stents (DES), bioresorbable vascular scaffolds (BVS) may further improve long-term outcomes of percutaneous coronary intervention (PCI) in patients with coronary artery disease. We report our early experience with BVS in Korea., Methods: We evaluated 105 consecutive patients with BVS implanted at Asan Medical Center, Korea between October 21, 2015 and June 3, 2016. Angiographic results, and in-hospital and 6-month clinical outcomes were assessed., Results: A total of 134 BVS were implanted to treat 115 lesions. The mean age was 62 ± 10.5 years; 85 patients (81%) were males, 26 patients (25%) were presented with acute coronary syndrome. Among 115 lesions treated with BVS, 76 (66.1%) were B2/C type, 27 (23.5%) were bifurcation lesions, and four (3.5%) were chronic total occlusion. Pre-dilation and post-dilation using high-pressure non-compliant balloon was performed in 104 lesions (90.4%) and 113 lesions (98.2%), respectively. During the procedure, intravascular imaging was used for all patients (100%; intravascular ultrasound 89 and optical coherence tomography 40 patients). Device success rate was 100%. In-segment and in-scaffold acute again were 1.1 ± 0.6 and 1.3 ± 0.5 mm, respectively. Periprocedural myocardial infraction occurred in four patients (3.8%). No deaths, stent thrombosis, or urgent revascularizations occurred either during hospitalization or the follow-up period., Conclusion: In this single-center experience, implantation of BVS with intravascular imaging support was feasible and early clinical outcomes were excellent. Evaluation of long-term efficacy and safety of BVS and its feasibility in clinical use for a broader range of lesions is warranted.

Objective: To evaluate the long-term mortality according to obesity in patients with chronic total occlusion (CTO) lesions after successful percutaneous coronary intervention (PCI)., Background: Despite the potential impact of coronary revascularization and lesion severity on the obesity paradox, the long-term survival according to obesity in CTO patients after successful PCI has been unknown., Methods and Results: Between January 2003 and September 2014, we examined 1,172 consecutive Korean patients with 1,190 CTO lesions who underwent successful drug-eluting stent (DES) implantation in two tertiary academic medical centers. The primary and secondary endpoints were all-cause and cardiac death, respectively. Obesity was defined as a body mass index ≥25.0 kg/m 2 , based on the criteria for Asians. The median follow-up time was 4.4 years. The prevalence of obesity was 54.4%. During the follow-up periods, the occurrence of all-cause (6.1 vs. 10.7%) and cardiac death (3.8 vs. 6.7%) was lower in obese patients than in non-obese patients (P <0.05, respectively). Kaplan-Meier analysis showed that obese patients had lower cumulative rates of all-cause and cardiac death than did non-obese patients (log-rank P <0.05, respectively). Univariate Cox regression analysis showed that age ≥65 years (hazard ratio [HR], 3.62), diabetes mellitus (HR, 1.94), renal dysfunction (HR, 7.03), systolic heart failure (HR, 2.61), and obesity (HR, 0.58) were associated with all-cause death (P <0.05). Multivariate Cox regression models showed that high BMI was independently associated with the decreased risk of all-cause death., Conclusions: Obese patients appear to have a lower long-term mortality than do non-obese patients in CTO after successful PCI using DES. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

Background: This study sought to evaluate the optimal treatment for in-stent restenosis (ISR) of drug-eluting stents (DESs)., Methods: This is a prospective, multicenter, open-label, randomized study comparing the use of drug-eluting balloon (DEB) versus second-generation everolimus-eluting stent for the treatment of DES ISR. The primary end point was in-segment late loss at 9-month routine angiographic follow-up., Results: A total of 172 patients were enrolled, and 74 (43.0%) patients underwent the angiographic follow-up. The primary end point was not different between the 2 treatment groups (DEB group 0.15±0.49 mm vs DES group 0.19±0.41 mm, P=.54). The secondary end points of in-segment minimal luminal diameter (MLD) (1.80±0.69 mm vs 2.09±0.46 mm, P=.03), in-stent MLD (1.90±0.71 mm vs 2.29±0.48 mm, P=.005), in-segment percent diameter stenosis (34%±21% vs 26%±15%, P=.05), and in-stent percent diameter stenosis (33%±21% vs 21%±15%, P=.002) were more favorable in the DES group. The composite of death, myocardial infarction, or target lesion revascularization at 1 year was comparable between the 2 groups (DEB group 7.0% vs DES group 4.7%, P=.51)., Conclusions: Treatment of DES ISR using DEB or second-generation DES did not differ in terms of late loss at 9-month angiographic follow-up, whereas DES showed better angiographic results regarding minimal MLD and percent diameter stenosis. Both treatment strategies were safe and effective up to 1year after the procedure., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Limited data are available on the relative performances between different types of drug-eluting stents (DES) for obstructive left main coronary artery disease (LMCAD)., Objectives: This study sought to compare effectiveness and safety profiles of various second-generation DES for LMCAD in real-world clinical practice., Methods: Among 4,470 patients in 3, multicenter, prospective registries (IRIS-DES [Interventional Cardiology Research Incorporation Society-Drug-Eluting Stents] registry, the IRIS-MAIN [Interventional Cardiology Research Incorporation Society-Left MAIN Revascularization] registry, and the PRECOMBAT [PREmier of Randomized COMparison of Bypass Surgery versus AngioplasTy Using Drug-Eluting Stent in Patients with Left Main Coronary Artery Disease] study) treated between July 2007 and July 2015, the authors identified 2,692 patients with significant LMCAD who received second-generation DES; 1,254 with cobalt-chromium everolimus-eluting stents (CoCr-EES), 232 with biodegradable polymer biolimus-eluting stents (BP-BES), 616 with platinum-chromium EES (PtCr-EES), and 590 with Resolute zotarolimus-eluting stent (Re-ZES). The primary outcome was target-vessel failure., Results: The observed 3-year rates of target-vessel failure were not significantly different for the different types of DES (16.7% for the CoCr-EES, 13.2% for the BP-BES, 18.7% for the PtCr-EES, and 14.7% for the Re-ZES; p = 0.15). In multiple treatment propensity score analysis, the adjusted hazard ratios (HRs) for target-vessel failure were similar in between-group comparisons of the different DES, except for the PtCr-EES versus the BP-BES (reference; HR: 1.60; 95% confidence interval: 1.01 to 2.54; p = 0.046). There were no significant differences in risk of composite of all-cause death, any myocardial infarction, or any revascularization and its individual components according to the different types of DES. Although the 3-year incidence of stent thrombosis was considerably low (≤1.0%) for all types of DES, between-group differences were observed, generally favoring the EES platforms., Conclusions: In this pooled analysis of 3 prospective registries involving unrestricted use of various second-generation DES for LMCAD, we found no significant between-group differences in 3-year risk of target-vessel failure, except for a higher risk of primary outcome with PtCr-EES compared to BP-BES. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133)., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

This study sought to evaluate the impact of triple antiplatelet therapy on clinical outcomes in patients treated with second-generation drug-eluting stents (DES) for coronary artery disease. There are limited data regarding the impact of triple antiplatelet therapy in patients who underwent implantation of second-generation DES. We planned to randomly assign 2,110 patients treated with second-generation DES to triple (aspirin, clopidogrel, and cilostazol) and dual (aspirin, clopidogrel, and placebo) antiplatelet therapy groups. The primary end point was a composite of death, myocardial infarction, ischemic stroke, or target vessel revascularization (TVR) at 1 year since randomization. The study was stopped early owing to slow enrollment. In total, 404 patients (202 patients each in the triple and dual antiplatelet therapy groups) were finally enrolled. At 1 year, the primary end point had occurred in 3.6% and 9.4% of patients in the triple and dual antiplatelet therapy groups, respectively (hazard ratio [HR] of the triple group 0.396; 95% confidence interval [CI] 0.166 to 0.949; p = 0.038). There was no significant difference between the 2 groups regarding the occurrence of a composite of all-cause death, myocardial infarction, or ischemic stroke (HR 0.583; 95% CI 0.229 to 1.481; p = 0.256). However, the rates of TVR were significantly lower in the triple antiplatelet therapy group than in the dual antiplatelet therapy group (HR 0.118; 95% CI 0.015 to 0.930; p = 0.043). In conclusion, triple antiplatelet therapy with cilostazol after implantation of second-generation DES improved clinical outcomes, mainly by reducing TVR., (Copyright © 2017. Published by Elsevier Inc.)

Background: The clinical outcomes for women compared with men undergoing left main PCI were sparse. We compared the characteristics and long-term outcomes in women versus men after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for unprotected left main CAD., Methods: We identified 2328 patients (545 women; 1783 men) with unprotected left main CAD who received PCI with DES between January 2007 and December 2013 in the Interventional Cardiology Research In-cooperation Society-left MAIN revascularization (IRIS-MAIN) registry. The primary outcome was a composite of death from any cause, myocardial infarction, or stroke., Results: The median follow-up time was 2.9years (interquartile range: 1.0-4.1years). Women were older, had a higher incidence of insulin-requiring diabetes mellitus and hypertension, and more commonly presented with acute coronary syndrome than men. Left main ostial lesion was more common in women, whereas left main bifurcation lesion with more extensive CAD was more common in men. The incidence of primary outcome was similar between the two groups (10.8% vs. 10.8%, respectively, log-rank p=0.587). The results were similar after adjustment for baseline variables and consistent across major subgroups. The need for target lesion revascularization was significantly higher in women than in men (8.8% vs. 5.7%, respectively, p<0.05) but the sex bias was not confirmed after adjusting for confounders., Conclusions: Women, as compared to men, had different clinical and lesion characteristics but similar long-term outcomes after PCI with DES for left main CAD., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: The applicability of Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores to left main coronary artery disease (CAD) has been questioned. A simplified alternative is needed for guiding decision making., Methods and Results: We evaluated the prognostic value of a simplified angiographic classification in comparison with a Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score-based approach for patients with left main CAD undergoing drug-eluting stent implantation. The proposed approach classified left main CAD as either extensive (n=819), defined as left main bifurcation lesions with an involvement of ostial left circumflex artery or as any left main lesion plus multivessel CAD, or limited (n=453), defined as ostial/midshaft lesions or left main bifurcation lesions without an involvement of ostium of left circumflex artery, alone or plus 1-vessel disease. The databases from 4 prospective Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease studies were pooled, and the primary outcome was a major adverse cardiac event, defined as death, myocardial infarction, or repeat revascularization. During follow-up (median 38 months; interquartile range, 36-61 months), the risk for major adverse cardiac event was significantly higher with extensive than with limited left main CAD (adjusted hazard ratio, 2.13; 95% confidence interval, 1.54-2.94; P <0.001). The risk for a composite outcome of death or myocardial infarction was also higher with extensive left main CAD (adjusted hazard ratio, 1.75; 95% confidence interval, 1.08-2.85; P =0.02). However, Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score tertiles did not effectively stratify these 2 outcome measures., Conclusions: Compared with Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores, the simpler angiographic approach provided better discrimination for future cardiovascular events in patients with left main CAD undergoing drug-eluting stent implantation., (© 2018 American Heart Association, Inc.)

Background: Limited data are available on long-term mortality according to the extent of coronary artery disease (CAD) in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES). We assessed long-term mortality DES implantation according to the extent of CAD and the impact of left main CAD alone on mortality among patients undergoing PCI with DES., Methods and Results: A total of 18,716 patients were pooled from real-world PCI registries. The primary outcome was death from any cause. The median follow-up duration was 47.1 (interquartile range 32.8-57.9) months. The presence of left main CAD [adjusted hazard ratio (HR) 1.24, 95% confidence interval (CI) 1.05-1.46, p = 0.012] and the extent of diseased vessels (adjusted HR 1.17, 95% CI 1.08-1.27, p < 0.001) significantly increased the risk of all-cause mortality. Left main CAD alone was associated with a risk of all-cause mortality similar to one- and two-vessel CAD, whereas it was associated with a significantly lower risk of mortality compared with three-vessel CAD (adjusted HR 0.42, 95% CI 0.18-0.98, p = 0.044). Among patients with left main CAD, the risk of mortality tended to increase in proportion with the number of concomitant vessel CAD, but it did not achieve statistical significance., Conclusions: Among patients undergoing DES implantation, the risk of mortality increased in a stepwise manner according to the extent of coronary CAD. Left main CAD alone was associated with a risk of long-term mortality similar to one- and two-vessel CAD.

There are limited data on comparative outcomes and its determinants following coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for left main coronary artery disease (LMCAD) in a real-world setting., Methods: A total of 3,504 consecutive patients with LMCAD treated with CABG (n=1,301) or PCI with DES (n=2,203) from the IRIS-MAIN registry were analyzed. The relative treatment effect of one strategy over another was assessed by propensity-score matching method. The primary outcome was a composite of death, myocardial infarction, or stroke., Results: Median follow-up duration was 4.7 years. In the matched cohort, both groups demonstrated a similar risk for the primary outcome (adjusted hazard ratio [HR]: 0.94; 95% CI: 0.77-1.15; P=.54). Compared with CABG, PCI exhibited higher risks of myocardial infarction (HR: 2.11; 95% CI: 1.16-3.83; P=.01) and repeated revascularization (HR: 5.95; 95% CI: 3.94-8.98; P<.001). In the overall population, age, presence of chronic kidney disease, and low ejection fraction (<40%) were key clinical predictors of primary outcome regardless of the treatment strategy. However, factors deemed to be associated with perioperative morbidity were determinants of primary outcome in the CABG group, whereas those generally associated with the severity of atherosclerotic coronary artery disease were strong predictors in the PCI group., Conclusions: Among patients with significant LMCAD, the long-term risk of the composite outcome of death, myocardial infarction, or stroke was similar between CABG and PCI. Clinical variables that differentially predict adverse outcomes might be useful in triaging appropriate revascularization strategy., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objective: Patients with previous stroke are increasing among patients receiving percutaneous coronary intervention (PCI) with drug-eluting stents (DES); however, data about the influence of previous stroke on patient outcomes are limited. We evaluated whether previous stroke is associated with increased risk for mortality in coronary artery disease., Patients and Methods: A total of 18 650 patients with coronary artery disease undergoing PCI with DES were enrolled. Databases from three real-world PCI registries were merged for a patient-level meta-analysis. The primary outcome was death from any cause. The secondary outcomes were death from a cardiac cause, myocardial infarction, stent thrombosis, stroke, or repeat revascularization., Results: Patients with previous stroke (n=1361), compared with those without previous stroke (n=17 289), were older and had a higher prevalence of risk factors or comorbidities. At a median follow-up of 47.0 months, patients with previous stroke had a higher risk for death from any cause [adjusted hazard ratio (HR)=1.623; 95% confidence interval (CI): 1.342-1.962; P<0.001], death from a cardiac cause (adjusted HR=1.686; 95% CI: 1.339-2.124; P<0.001), and stroke (adjusted HR=2.456; 95% CI: 1.853-3.255; P<0.001). There were no significant differences in the risks for myocardial infarction, stent thrombosis, or repeat revascularization., Conclusion: Patients with previous stroke showed higher risks for all-cause death and stroke after PCI with DES than those without stroke. Previous stroke should be considered a risk factor for all-cause death and stroke in this patient population.

Background: Although studies have demonstrated comparable efficacy and safety profiles of everolimus- and zotarolimus-eluting stents (EES and ZES, respectively) for a broad spectrum of coronary artery diseases, there is paucity of data concerning their safety and efficacy for coronary chronic total occlusions (CTOs). This study compared the clinical performance of EES and ZES following successful percutaneous coronary intervention for CTOs., Methods: The cohort included 539 consecutive CTO patients who underwent successful PCI using EES (n=313) and ZES (n=226) between September 2006 and August 2014. The primary outcome was defined as the composite of death, myocardial infarction, and target vessel revascularization., Results: During a median follow-up of 3.3years, in both groups, the primary outcome occurred in 12.2% of patients. After multivariable adjustment, no significant difference was observed between the two groups in the risk of primary outcome [hazard ratio (HR) 1.03, 95% confidence interval (CI) 0.59-1.79, P=0.930 for ZES compared with EES]. Similarly, there were no significant differences in the risk of death (adjusted HR 0.96, 95% CI 0.43-2.15, P=925), death or myocardial infarction (adjusted HR 0.93, 95% CI 0.46-1.88, P=0.829), and target vessel failure (adjusted HR 0.96, 95% CI 0.51-1.82, P=0.902). The incidence of definite/probable stent thrombosis was relatively low [0% (ZES) vs. 1.0% (EES), P=0.19]., Conclusion: No significant differences were observed between EES and ZES in terms of clinical outcomes for coronary CTOs at 3.3years., (Copyright © 2017. Published by Elsevier B.V.)

There is limited data comparing effectiveness of coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) with drug-eluting stents in patients with non-ST-elevation acute coronary syndromes (NSTE-ACS). We compared the long-term outcomes of the 2 revascularization strategies in 1,246 patients presented with NSTE-ACS for left main or multivessel coronary artery disease. Data were pooled from the Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease (BEST) trial, the Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease (PRECOMBAT) trial, and the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial. The primary outcome was a composite of death from any causes, myocardial infarction, or stroke. The baseline characteristics were similar between the 2 study groups. During the median follow-up of 60 months, the rate of the primary outcome was significantly lower with CABG than with PCI (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.56 to 0.98; p = 0.036). This difference was mainly attributed to a significant reduction in the rate of myocardial infarction (HR 0.50; 95% CI 0.31 to 0.82, p = 0.006). The superiority of CABG over PCI was consistent across the major subgroups. The individual risks of death from any causes or stroke were not different between the 2 groups. In contrast, the rate of repeat revascularization was significantly lower in the CABG group than in the PCI group (HR 0.56; 95% CI 0.41 to 0.75, p <0.001). In this study, among patients with NSTE-ACS for left main or multivessel coronary artery disease, CABG significantly reduces the risk of death from any causes, myocardial infarction, or stroke compared with PCI with drug-eluting stents., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the long-term outcomes and predictors of adverse events following successful "full metal jacket" (FMJ) (stent length ≥60 mm without gap) procedures using drug-eluting stents to treat coronary chronic total occlusions (CTOs)., Background: The FMJ stenting procedure is often required to treat CTOs, but its clinical efficacy and safety remain unknown., Methods: In total, 1,126 successful CTO procedures (1,107 consecutive patients) performed between May 2003 and March 2015 were studied. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization or reocclusion., Results: Overall, 406 patients (36.7%) underwent the FMJ procedure, increasing in frequency over time (28.5% from 2003 to 2006 and 41.7% after 2011). The mean stent length was 76.8 ± 14.6 mm (range 60 to 122 mm), and the average number of stent overlaps was 2.5 ± 0.6 (range 2 to 4). A total of 127 patients (31.3%) had persistent luminal narrowing at the distal reference segment after stenting. During the median follow-up period of 5.1 years, target lesion failure occurred in 16.0% of patients. There were 17 cases of total reocclusion and 5 cases of stent thrombosis. Multivariate analysis confirmed that the number of implanted stents (hazard ratio: 1.72; 95% confidence interval: 1.16 to 2.54; p = 0.006) and persistent distal luminal narrowing (hazard ratio: 2.73; 95% confidence interval: 1.66 to 4.47; p < 0.001) were predictors of increased risk for target lesion failure., Conclusions: The FMJ procedure using drug-eluting stents for CTOs provides acceptable long-term clinical results. Persistent distal luminal narrowing increases the future likelihood of adverse events despite procedural success., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The optimal revascularization strategy for patients with significant coronary artery disease (CAD) and severe left ventricular (LV) dysfunction (ejection fraction ≤35%) remains unclear. We compared the effects of coronary artery bypass surgery (CABG, n = 442) versus percutaneous coronary intervention (PCI) with drug-eluting stents (n = 469) on long-term mortality in 911 patients with significant CAD and severe LV dysfunction using large real-world registry data. Databases of 3 real-world registries were merged for a patient-level meta-analysis. Primary outcome was death from any cause; secondary outcomes were death from cardiac causes, myocardial infarction, stroke, or repeat revascularization. At a median follow-up of 37.3 months, the risk of all-cause death (adjusted hazard ratio [HR] 0.43; 95% confidence interval [CI] 0.31 to 0.61; p <0.001) was significantly lower in the CABG group than in the PCI group after adjustment. Similar findings were observed with regard to the risks of death from cardiac cause (adjusted HR 0.49; 95% CI 0.33 to 0.73; p <0.001) and repeat revascularization (adjusted HR 0.08; 95% CI 0.03 to 0.20; p <0.001). However, there were no significant differences in the risks of myocardial infarction and stroke between the 2 groups. The superiority of CABG over PCI was particularly pronounced in patients receiving β blockers and angiotensin-converting enzyme inhibitor or angiotensin receptor blockers than those who are not. In conclusion, among patients with significant CAD and severe LV dysfunction, CABG showed a lower risk of all-cause death, cardiac-cause death, and repeat revascularization compared with PCI with drug-eluting stents., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objectives: This study sought to investigate the incidence, management, and clinical relevance of atrial fibrillation (AF) during and after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and evaluate outcomes of different antithrombotic strategies., Background: Uncertainty exists regarding the optimal antithrombotic strategy in patients with AF who are undergoing PCI with DES., Methods: Using a consecutive series of 10,027 patients who underwent DES implantation between 2003 and 2011, we evaluated the overall prevalence and clinical impact of AF. In addition, we compared the efficacy and safety of dual antiplatelet therapy (DAPT) (aspirin plus clopidogrel) and triple therapy (DAPT plus warfarin) among patients with AF. The primary outcome was a composite of cardiovascular death, myocardial infarction, or stroke., Results: Overall, 711 (7.1%) patients had a diagnosis of AF at the index PCI. Patients with AF were older, had more comorbid conditions, and more often had a history of strokes; most patients with AF (88.4%) received DAPT rather than triple therapy (10.5%) at discharge. The rate of primary outcome after PCI during the 6-year follow-up period was significantly higher in patients with AF than in those without AF (22.1% vs. 8.0%; p < 0.001). This trend was consistent for major bleeding (4.5% vs. 1.5%; p < 0.001). After multivariable adjustment, the presence of AF was significantly associated with a higher risk of primary outcome (hazard ratio [HR]: 2.33; 95% confidence interval [CI]: 1.95 to 2.79; p < 0.001) and major bleeding (HR: 2.01; 95% CI: 1.32 to 3.06; p = 0.001). Among patients with AF, adjusted risk for the primary outcome was similar between the DAPT group and the triple therapy group (HR: 1.01; 95% CI: 0.60 to 1.69; p = 0.98), but triple therapy was associated with a significantly higher risk of hemorrhagic stroke (HR: 7.73; 95% CI: 2.14 to 27.91; p = 0.002) and major bleeding (HR: 4.48; 95% CI: 1.81 to 11.08; p = 0.001)., Conclusions: Among patients receiving DES implantation, AF was not rare and was associated with increased ischemic and bleeding risk. In patients with AF, triple therapy was not associated with decreased ischemic events but was associated with increased bleeding risk compared to DAPT., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

For nearly half a century, coronary artery bypass grafting has been the standard treatment for patients with obstructive left main coronary artery (LMCA) disease. However, there has been considerable evolution in the field of percutaneous coronary intervention, and especially, percutaneous coronary intervention for LMCA disease has been rapidly expanded with adoption of drug-eluting stents. Some, but not all randomized trials, have shown that percutaneous coronary intervention with drug-eluting stents might be a suitable alternative for selected patients with LMCA disease instead of bypass surgery. However, none of previous trials involving early-generation drug-eluting stents was sufficiently powered and comparative trials using contemporary drug-eluting stents were limited. Recently, primary results of 2 new trials of EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) and NOBLE (Nordic-Baltic-British Left Main Revascularization Study) were reported. However, these trials showed conflicting results, which might pose uncertainty on the optimal revascularization strategy for LMCA disease. In this article, with the incorporation of a key review on evolution of LMCA treatment, we summarize the similarity or disparity of the EXCEL and NOBLE trials, focus on how they relate to previous trials in the field, and finally speculate on how the treatment strategy may be changed or recommended for LMCA treatment., (© 2017 American Heart Association, Inc.)

Objectives: There are limited data comparing long-term outcomes of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in patients with high surgical risk. We evaluated 5-year outcomes following CABG versus PCI with DES in 598 patients with left main or multivessel coronary artery disease (CAD) and a high surgical risk [EuroSCORE (European system for cardiac operative risk evaluation) ≥ 6]., Methods: Databases were merged from the BEST, PRECOMBAT and SYNTAX trials. The primary outcome was a major adverse cardio-cerebral event (MACCE), defined as the composite of all-cause death, myocardial infarction, stroke or repeat revascularization., Results: During 5-year follow-up, the rates of MACCE were 29.4% in the CABG group and 43.8% in the PCI group [hazard ratio (HR), 0.64; 95% confidence interval (CI), 0.49 - 0.84; P  = 0.001]. The MACCE was significantly better with CABG than with PCI in patients with high and intermediate SYNTAX scores (34.9% vs 46.3%, P  = 0.039, and 29.7% vs 47.6%, P  = 0.010, respectively), but comparable between the two groups in those with low SYNTAX scores. The rates of all-cause death and stroke were similar between the two groups. However, CABG was associated with fewer myocardial infarctions (HR, 0.50; 95% CI, 0.27 - 0.93; P  = 0.027) and repeat revascularizations (HR, 0.32; 95% CI, 0.20 - 0.52; P  < 0.001)., Conclusions: Among high surgical risk patients with left main or multivessel CAD, CABG compared to PCI with DES was associated with a lower rate of MACCE., (© The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Little data are available to compare coronary artery bypass graft surgery (CABG) vs percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in older adults. We evaluate the long-term outcomes of CABG vs PCI with DES in older adults with left main or multivessel coronary artery disease (CAD)., Design: Individual patient-level meta-analysis., Settings: Databases from the BEST, PRECOMBAT, and SYNTAX trials were combined., Participants: A total 1,079 adults aged 70 to 89 years were pooled., Measurements: The primary outcome was a composite of death from any causes, myocardial infarction, stroke, or repeat revascularization., Results: During a total of 6.3 (median, 4.9) years of follow-up, the primary composite outcome of all-cause mortality, myocardial infarction, stroke, or repeat revascularization occurred in 26% (141/550) and 34% (179/529) of patients in the CABG and PCI groups, respectively (hazard ratio (HR), 0.75; 95% confidence interval (CI), 0.60-0.94; P = .012). CABG was associated with fewer myocardial infarction (4% vs 8% for PCI; HR, 0.48; 95% CI, 0.29-0.80; P = .037); and repeat revascularizations (8% vs 17% for PCI; HR, 044; 95% CI, 0.31-0.64; P < .001), but had little association with all-cause mortality or stroke., Conclusion: Older adults age 70 to 89 years with left main or multivessel CAD who participated in the BEST, PRECOMBAT, and SYNTAX trials; compared to PCI, CABG was associated with lower risk of primary outcome which was mostly driven by lower risk of myocardial infarction., (© 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.)