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Background@#In patients undergoing percutaneous coronary intervention (PCI) in the SMART-CHOICE trial, P2Y12 inhibitor monotherapy after three months of dual antiplatelet therapy (DAPT) achieved clinical outcomes comparable to those of 12 months of DAPT.Nonetheless, the effects of sex on these outcomes remain unknown. @*Methods@#This open-label, non-inferiority, randomized study, conducted in 33 hospitals in South Korea, included 2,993 patients undergoing PCI with drug-eluting stents. Patients were randomly assigned to receive DAPT (aspirin plus a P2Y12 inhibitor) for three months then P2Y12 inhibitor alone for nine months, or DAPT for the entire 12 months. The primary endpoints were major adverse cardiac and cerebrovascular events (a composite of all-cause death, myocardial infarction, or stroke) 12 months after the index procedure. The bleeding endpoints were Bleeding Academic Research Consortium (BARC) bleeding types 2 to 5. @*Results@#Of the patients, 795 (26.6%) were women, who were older and had a higher prevalence of hypertension, diabetes, and dyslipidemia than men. The sexes exhibited comparable primary endpoints (adjusted hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.55–1.55; P = 0.770) and bleeding endpoints (adjusted HR, 1.07; 95% CI, 0.63–1.81; P = 0.811). P2Y12 inhibitor monotherapy vs DAPT was associated with lower risk of BARC type 2 to 5 bleeding in women (adjusted HR, 0.40; 95% CI, 0.16–0.98; P = 0.045) but the difference was not statistically significant when using the Bonferroni correction. The primary endpoints were similar between treatment groups in both sexes. @*Conclusion@#In both sexes undergoing PCI, P2Y12 inhibitor monotherapy after three months of DAPT achieved similar risks of the primary endpoints and the bleeding events compared with prolonged DAPT. Therefore, the benefits of early aspirin withdrawal with ongoing P2Y12 inhibitors may be comparable in women and men.
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Background@#s: Fimasartan is the most recently developed, potent, and long-acting angiotensin II receptor blocker (ARB). However, data are limited regarding treatment effects of fimasartan in patients with heart failure. @*Methods@#Between 2010 and 2016, patients who underwent coronary revascularization for myocardial infarction (MI) with heart failure and prescription of ARB at hospital discharge were enrolled from the Korean nationwide medical insurance data. Clinical outcomes were compared between patients receiving fimasartan and those receiving other ARBs (candesartan, valsartan, losartan, telmisartan, olmesartan, and irbesartan). The primary outcome was a composite of all-cause death, recurrent MI, hospitalization for heart failure, and stroke. @*Results@#Of 2,802 eligible patients, fimasartan was prescribed to 124 patients (4.4%). During a median follow-up of 2.2 years (interquartile range, 1.0–3.9), 613 events of the primary outcome occurred. There was no significant difference in the primary outcome between patients receiving fimasartan and those receiving other ARBs (adjusted hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.46–1.45). Compared with patients receiving other ARBs, those receiving fimasartan had comparable incidence of all-cause death (adjusted HR, 0.70; 95% CI, 0.30–1.63), recurrent MI (adjusted HR, 1.28; 95% CI, 0.49–3.34), hospitalization for heart failure (adjusted HR, 0.70; 95% CI, 0.27–1.84), and stroke (adjusted HR, 0.59; 95% CI, 0.18–1.96). @*Conclusion@#In this nationwide cohort, fimasartan, compared with other ARBs, had comparable treatment effects for a composite of all-cause death, recurrent MI, hospitalization for heart failure, and stroke in patients with heart failure after MI.
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Background@#The risk of device thrombosis and device-oriented clinical outcomes with bioresorbable vascular scaffold (BVS) was reported to be significantly higher than with contemporary drug-eluting stents (DESs). However, optimal device implantation may improve clinical outcomes in patients receiving BVS. The current study evaluated mid-term safety and efficacy of Absorb BVS with meticulous device optimization under intravascular imaging guidance. @*Methods@#The SMART-REWARD and PERSPECTIVE-PCI registries in Korea prospectively enrolled 390 patients with BVS and 675 patients with DES, respectively. The primary endpoint was target vessel failure (TVF) at 2 years and the secondary major endpoint was patientoriented composite outcome (POCO) at 2 years. @*Results@#Patient-level pooled analysis evaluated 1,003 patients (377 patients with BVS and 626 patients with DES). Mean scaffold diameter per lesion was 3.24 ± 0.30 mm in BVS group.Most BVSs were implanted with pre-dilatation (90.9%), intravascular imaging guidance (74.9%), and post-dilatation (73.1%) at proximal to mid segment (81.9%) in target vessel.Patients treated with BVS showed comparable risks of 2-year TVF (2.9% vs. 3.7%, adjusted hazard ratio [HR], 1.283, 95% confidence interval [CI], 0.487–3.378, P = 0.615) and 2-year POCO (4.5% vs. 5.9%, adjusted HR, 1.413, 95% CI, 0.663–3.012,P = 0.370) than those with DES. The rate of 2-year definite or probable device thrombosis (0.3% vs. 0.5%, P = 0.424) was also similar. The sensitivity analyses consistently showed comparable risk of TVF and POCO between the 2 groups. @*Conclusion@#With meticulous device optimization under imaging guidance and avoidance of implantation in small vessels, BVS showed comparable risks of 2-year TVF and device thrombosis with DES.
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The prevalence of ischemic heart disease is steadily growing as populations age. Antithrombotic treatment is a key therapeutic modality for the prevention of secondary cerebro-cardiovascular disease. Patients with acute coronary syndrome or who are undergoing percutaneous coronary intervention must be treated with dual antiplatelet therapy for a mandatory period. The optimal perioperative antithrombotic regimen remains debatable; antithrombotics can cause bleeding. Inadequate antithrombotic regimens are associated with perioperative ischemic events, but continuation of therapy may increase the risks of perioperative hemorrhagic complications (including mortality). Many guidelines on the perioperative management of antithrombotic agents have been established by academic societies. However, the existing guidelines do not cover all specialties, nor do they describe the thrombotic and hemorrhagic risks associated with various surgical interventions. Moreover, few practical recommendations on the modification of antithrombotic regimens in patients who require non-deferrable interventions/surgeries or procedures associated with a high risk of hemorrhage have appeared. Therefore, cardiologists, specialists performing invasive procedures, surgeons, dentists, and anesthesiologists have not come to a consensus on optimal perioperative antithrombotic regimens. The Korean Platelet-Thrombosis Research Group presented a positioning paper on perioperative antithrombotic management. We here discuss commonly encountered clinical scenarios and engage in evidence-based discussion to assist individualized, perioperative antithrombotic management in clinical practice.
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Given the progressive improvements in antithrombotic strategies, management of cardiovascular disease has become sophisticated/refined. However, the optimal perioperative management of antithrombotic therapy in patients with acute coronary syndrome or who are scheduled for percutaneous coronary intervention remains unclear. Assessments of the thrombotic and hemorrhagic risks are essential to reduce the rates of mortality and major cardiac events. However, the existing guidelines do not mention these topics. This case-based consensus document deals with common clinical scenarios and offers evidence-based guidelines for individualized perioperative management of antithrombotic therapy in the real world.
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Purpose@#Platelet function test (PFT) results and genotype hold unique prognostic implications in East Asian patients. The aim of the PTRG-DES (Platelet function and genoType-Related long-term proGnosis in Drug-Eluting Stent-treated Patients with coronary artery disease) consortium is to assess the clinical impact thereof on long-term clinical outcomes in Korean patients with coronary artery disease during dual antiplatelet therapy (DAPT) including clopidogrel. @*Materials and Methods@#Searching publications on the PubMed, we reviewed clopidogrel treatment studies with PFT and/or genotype data for potential inclusion in this study. Lead investigators were invited to share PFT/genotype results, patient characteristics, and clinical outcomes to evaluate relationships among them. @*Results@#Nine registries from 32 academic centers participated in the PTRG-DES consortium, contributing individual patient data from 13160 patients who underwent DES implantation between July 2003 and August 2018. The PTRG-PFT cohort was composed of 11714 patients with available VerifyNow assay results. Platelet reactivity levels reached 218±79 P2Y12 reaction units (PRU), and high on-clopidogrel platelet reactivity based on a consensus-recommended cutoff (PRU >208) was observed in 55.9%. The PTRGGenotype cohort consisted of 8163 patients with candidate genotypes related with clopidogrel responsiveness. Of those with cytochrome P450 (CYP) 2C19 genotype, frequencies of carrying one and two loss-of-function allele (s) (*2 or *3) were 47.9% (intermediate metabolizers) and 14.2% (poor metabolizers), respectively. @*Conclusion@#The PTRG-DES consortium highlights unique values for on-clopidogrel platelet reactivity and CYP2C19 phenotype that may be important to developing optimal antiplatelet regimens in East Asian patients.
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Background@#There are no data on comparison between clopidogrel monotherapy and prolonged dual antiplatelet therapy (DAPT) in patients at high-risk undergoing percutaneous coronary intervention (PCI). @*Methods@#Of 2,082 consecutive patients undergoing PCI using second-generation drugeluting stent (DES), we studied 637 patients at high-risk either angiographically or clinically who received clopidogrel longer than 24 months and were event-free at 12 months after index PCI. Patients were divided into 2 groups: the clopidogrel monotherapy group and the prolonged DAPT group. The primary outcome was a composite of all-cause death, non-fatal myocardial infarction (MI), definite or probable stent thrombosis, or stroke between 12 months and 36 months after the index PCI. @*Results@#In propensity score-matched population (246 pairs), the cumulative rate of primary outcome was 4.5% in the clopidogrel monotherapy group and 4.9% in the prolonged DAPT group (hazard ratio, 1.21; 95% confidence interval, 0.54–2.75; P = 0.643). There was no significant difference in all-cause death, MI, stent thrombosis, stroke between the clopidogrel monotherapy group and the prolonged DAPT group. @*Conclusion@#Compared with prolonged DAPT, clopidogrel monotherapy showed similar long-term outcomes in patients at high-risk after second-generation DES implantation.
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Background@#There are no data on comparison between clopidogrel monotherapy and prolonged dual antiplatelet therapy (DAPT) in patients at high-risk undergoing percutaneous coronary intervention (PCI). @*Methods@#Of 2,082 consecutive patients undergoing PCI using second-generation drugeluting stent (DES), we studied 637 patients at high-risk either angiographically or clinically who received clopidogrel longer than 24 months and were event-free at 12 months after index PCI. Patients were divided into 2 groups: the clopidogrel monotherapy group and the prolonged DAPT group. The primary outcome was a composite of all-cause death, non-fatal myocardial infarction (MI), definite or probable stent thrombosis, or stroke between 12 months and 36 months after the index PCI. @*Results@#In propensity score-matched population (246 pairs), the cumulative rate of primary outcome was 4.5% in the clopidogrel monotherapy group and 4.9% in the prolonged DAPT group (hazard ratio, 1.21; 95% confidence interval, 0.54–2.75; P = 0.643). There was no significant difference in all-cause death, MI, stent thrombosis, stroke between the clopidogrel monotherapy group and the prolonged DAPT group. @*Conclusion@#Compared with prolonged DAPT, clopidogrel monotherapy showed similar long-term outcomes in patients at high-risk after second-generation DES implantation.
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Background and Objectives@#In patients with perioperative cardiac troponin (cTn) I below the 99th-percentile upper range of limit (URL), mortality according to cTn I level has not been fully evaluated. This study evaluated the association between postoperative cTn I level above the lowest limit of detection but within the 99th-percentile URL and 30-day mortality after noncardiac surgery. @*Methods@#Patients with cTn I values below the 99th-percentile URL during the perioperative period were divided into a no-elevation group with cTn I at the lowest limit of detection (6 ng/L) and a minor elevation group with cTn I elevation below the 99th percentile URL (6 ng/L < cTn I < 40 ng/L). The primary outcome was 30-day mortality. @*Results@#Of the 5,312 study participants, 2,582 (48.6%) were included in the no-elevation group and 2,730 (51.4%) were included in the minor elevation group. After propensity scorematching, the minor elevation group showed significantly increased 30-day mortality (0.5% vs. 2.3%; hazard ratio, 4.30; 95% confidence interval, 2.23–8.29; p<0.001). The estimated cutoff value of cTn I to predict 30-day mortality was 6 ng/L with the area under the receiver operating characteristic curve 0.657. @*Conclusions@#A mild elevation of cTn I within the 99th-percentile URL after noncardiac surgery was significantly associated with increased 30-day mortality as compared with the lowest limit of detection.
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BACKGROUND AND OBJECTIVES@#Although percutaneous coronary intervention (PCI) is recommended to improve symptoms in patients with stable ischemic heart disease (SIHD), improvement of exercise performance is controversial. This study aimed to investigate changes in exercise duration after PCI according to functional completeness of revascularization by comparing pre- and post-PCI exercise stress test (EST).@*METHODS@#Patients with SIHD were enrolled from a prospective PCI registry, and divided into 2 groups: 1) functional complete revascularization (CR) group had a positive EST before PCI and negative EST after PCI, 2) functional incomplete revascularization (IR) group had positive EST before and after PCI. Primary outcome was change in exercise duration after PCI and secondary outcome was major adverse cardiac events (MACE, a composite of any death, any myocardial infarction, and any ischemia-driven revascularization) at 3 years after PCI.@*RESULTS@#A total of 256 patients (149 for CR group, and 107 for IR group) were eligible for analysis. Before PCI, exercise duration was not significantly different between the functional CR and IR groups (median 540 [interquartile range; IQR, 414, 602] vs. 480 [402, 589] seconds, p=0.091). After PCI, however, the CR group had a significantly higher increment of exercise duration than the IR group (median 62.0 [IQR, 12.0, 141.0] vs. 30.0 [−11.0, 103.5] seconds, p=0.011). The functional CR group also had a significantly lower risk of 3-year MACE (6.2% vs. 26.1%; adjusted hazard ratio, 0.19; 95% confidence interval, 0.09–0.41; p<0.001).@*CONCLUSIONS@#Functional CR showed a higher increment of exercise duration than functional IR.
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Background@#Limited data are available on the clinical meaning of early routine exercise treadmill testing (ETT) after percutaneous coronary intervention (PCI) in the drug-eluting stent era. We aimed to determine the clinical utility and implications of early routine ETT after PCI. @*Methods@#This was a single-center, prospective cohort study. A total of 776 patients underwent ETT within 3 months after index PCI were analyzed. We classified patients into ETT positive (+) and negative (−) groups and compared major adverse cardiac events (MACE) including all-cause death, myocardial infarction, and coronary revascularization. @*Results@#The median follow-up duration was 19.6 months (interquartile range, 15.4 to 33.5 months). ETT was positive for 63 patients (17.1%) with single-vessel disease (VD) and 150 patients (36.9%) with multi-VD. Previous PCI, absence of thrombotic lesion, multi-VD, and residual Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score > 8 were independent predictors of ETT (+). Compared with the ETT (−) group, the ETT (+) group was associated with increased risk of MACE for patients with single-VD (18.1% vs. 52.3%; adjusted hazard ratio [HR], 2.67; 95% confidence interval [CI], 1.10–6.49; P = 0.03) and residual SYNTAX score ≤ 8 (26.5% vs. 42.1%; adjusted HR, 1.90; 95% CI, 1.09–3.30; P = 0.02), but not for patients with multi-VD and residual SYNTAX score > 8. @*Conclusion@#Early routine ETT after PCI might be helpful for predicting clinical outcomes in patients with single-VD and residual SYNTAX score ≤ 8 but not multi-VD and residual SYNTAX score > 8.
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BACKGROUND AND OBJECTIVES: Although percutaneous coronary intervention (PCI) is recommended to improve symptoms in patients with stable ischemic heart disease (SIHD), improvement of exercise performance is controversial. This study aimed to investigate changes in exercise duration after PCI according to functional completeness of revascularization by comparing pre- and post-PCI exercise stress test (EST).METHODS: Patients with SIHD were enrolled from a prospective PCI registry, and divided into 2 groups: 1) functional complete revascularization (CR) group had a positive EST before PCI and negative EST after PCI, 2) functional incomplete revascularization (IR) group had positive EST before and after PCI. Primary outcome was change in exercise duration after PCI and secondary outcome was major adverse cardiac events (MACE, a composite of any death, any myocardial infarction, and any ischemia-driven revascularization) at 3 years after PCI.RESULTS: A total of 256 patients (149 for CR group, and 107 for IR group) were eligible for analysis. Before PCI, exercise duration was not significantly different between the functional CR and IR groups (median 540 [interquartile range; IQR, 414, 602] vs. 480 [402, 589] seconds, p=0.091). After PCI, however, the CR group had a significantly higher increment of exercise duration than the IR group (median 62.0 [IQR, 12.0, 141.0] vs. 30.0 [−11.0, 103.5] seconds, p=0.011). The functional CR group also had a significantly lower risk of 3-year MACE (6.2% vs. 26.1%; adjusted hazard ratio, 0.19; 95% confidence interval, 0.09–0.41; p<0.001).CONCLUSIONS: Functional CR showed a higher increment of exercise duration than functional IR.
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Humans , Angina, Stable , Exercise Test , Myocardial Infarction , Myocardial Ischemia , Percutaneous Coronary Intervention , Prognosis , Prospective StudiesABSTRACT
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Humans , Angina, Stable , Drug-Eluting Stents , Exercise Test , Incidence , Myocardial Infarction , Myocardial Ischemia , Percutaneous Coronary InterventionABSTRACT
BACKGROUND@#Although current guidelines recommend noninvasive stress tests prior to elective percutaneous coronary intervention (PCI), it is unknown whether antecedent exercise stress test (EST) affects the outcomes of patients undergoing PCI for stable ischemic heart disease (SIHD). This study aimed to investigate long-term outcomes in patients undergoing elective PCI with or without EST.@*METHODS@#We studied 2,674 patients undergoing elective PCI using drug-eluting stents for SIHD. Patients were divided into the 2 groups: the test group underwent EST with a positive result within 180 days prior to PCI (n = 668), whereas the non-test group did not undergo any noninvasive stress tests (n = 2,006). The primary outcome was all-cause death or myocardial infarction (MI).@*RESULTS@#Over 5 years after the index PCI, the risk of all-cause death or MI was significantly lower in the test group than in the non-test group in overall population (3.3% vs. 10.9%; adjusted hazard ratio [HR], 0.34; 95% confidence interval [CI], 0.22–0.55; P < 0.001), and in propensity score-matched population (668 pairs) (3.3% vs. 6.3%; adjusted HR, 0.52; 95% CI, 0.30–0.89; P = 0.018). However, the incidence of any revascularization was similar between the 2 groups in overall (16.7% vs. 16.8%; adjusted HR, 0.99; 95% CI, 0.79–1.25; P = 0.962) and matched population (16.7% vs. 18.3%; adjusted HR, 0.91; 95% CI, 0.70–1.19; P = 0.509).@*CONCLUSION@#Patients who underwent elective PCI with EST had a reduced risk of all-cause death or MI than those undergoing PCI without stress tests.
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BACKGROUND@#Although current guidelines recommend noninvasive stress tests prior to elective percutaneous coronary intervention (PCI), it is unknown whether antecedent exercise stress test (EST) affects the outcomes of patients undergoing PCI for stable ischemic heart disease (SIHD). This study aimed to investigate long-term outcomes in patients undergoing elective PCI with or without EST.@*METHODS@#We studied 2,674 patients undergoing elective PCI using drug-eluting stents for SIHD. Patients were divided into the 2 groups: the test group underwent EST with a positive result within 180 days prior to PCI (n = 668), whereas the non-test group did not undergo any noninvasive stress tests (n = 2,006). The primary outcome was all-cause death or myocardial infarction (MI).@*RESULTS@#Over 5 years after the index PCI, the risk of all-cause death or MI was significantly lower in the test group than in the non-test group in overall population (3.3% vs. 10.9%; adjusted hazard ratio [HR], 0.34; 95% confidence interval [CI], 0.22–0.55; P < 0.001), and in propensity score-matched population (668 pairs) (3.3% vs. 6.3%; adjusted HR, 0.52; 95% CI, 0.30–0.89; P = 0.018). However, the incidence of any revascularization was similar between the 2 groups in overall (16.7% vs. 16.8%; adjusted HR, 0.99; 95% CI, 0.79–1.25; P = 0.962) and matched population (16.7% vs. 18.3%; adjusted HR, 0.91; 95% CI, 0.70–1.19; P = 0.509).@*CONCLUSION@#Patients who underwent elective PCI with EST had a reduced risk of all-cause death or MI than those undergoing PCI without stress tests.
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BACKGROUND AND OBJECTIVES@#There are limited data regarding the clinical efficacy of the proximal optimization technique (POT) in the treatment of coronary bifurcation lesions. We investigated the influence of POT on the clinical outcomes of patients with coronary bifurcation lesions.@*METHODS@#We enrolled a total of 1,191 patients with a bifurcation lesion with a side branch (SB) diameter ≥2.5 mm treated with a drug-eluting stent from 18 centers between January 2003 and December 2009. The primary outcome was major adverse cardiac events (MACEs: cardiac death, myocardial infarction or target lesion revascularization [TLR]). We performed one-to-many (1:N) propensity score matching with non-fixed matching ratio.@*RESULTS@#POT was performed in 252 patients. During follow-up (median 37 months), the incidence of MACE was lower in the POT group than it was in the non-POT group (adjusted hazard ratio, 0.43; 95% confidence interval [CI], 0.24–0.79; p=0.006). After propensity score matching, these were 0.34; 95% CI, 0.17–0.69; p=0.003 for MACE and 0.37; 95% CI, 0.17–0.78; p=0.01 for TLR. The use of POT was associated with significantly lower TLR in patients treated without kissing ballooning, but was not in those who underwent kissing ballooning (p for interaction=0.03).@*CONCLUSIONS@#In coronary bifurcation lesions with a large SB, POT may be beneficial to improve long-term clinical outcome, particularly in patients treated without kissing ballooning during the procedure.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01642992
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BACKGROUND AND OBJECTIVES@#Aspirin plays an important role in the maintenance of graft patency and the prevention of thrombotic event after coronary artery bypass graft surgery (CABG). However, the use of preoperative aspirin is still under debate due to the risk of bleeding.@*METHODS@#From PubMed, EMBASE, and Cochrane Central Register of Controlled Trials, data were extracted by 2 independent reviewers. Meta-analysis using random effect model was performed.@*RESULTS@#We performed a systemic meta-analysis of 17 studies (12 randomized controlled studies and 5 non-randomized registries) which compared clinical outcomes of 9,101 patients who underwent CABG with or without preoperative aspirin administration. Preoperative aspirin increased chest tube drainage (weighted mean difference 177.4 mL, 95% confidence interval [CI], 41.3–313.4; p=0.011). However, the risk of re-operation for bleeding was not different between the preoperative aspirin group and the control group (3.2% vs. 2.4%; odds ratio [OR], 1.23; 95% CI, 0.94–1.60; p=0.102). There was no difference in the rates of all-cause mortality (1.6% vs. 1.5%; OR, 0.98; 95% CI, 0.64–1.49; p=0.920) and myocardial infarction (MI) (8.7% vs. 10.4%; OR, 0.83; 95% CI, 0.66–1.04; p=0.102) between patients with and without preoperative aspirin administration.@*CONCLUSIONS@#Although aspirin increased the amount of chest tube drainage, it was not associated with increased risk of re-operation for bleeding. In addition, the risks of early postoperative all-cause mortality and MI were not reduced by using preoperative aspirin.
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BACKGROUND AND OBJECTIVES@#There are no data comparing clinical outcomes of complex percutaneous coronary intervention (PCI) between biodegradable polymer-biolimus-eluting stents (BP-BES) and durable polymer-everolimus-eluting stents (DP-EES). We sought to evaluate the safety and efficacy of BP-BES compared with DP-EES in patients undergoing complex PCI.@*METHODS@#Patients enrolled in the SMART-DESK registry were stratified into 2 categories based on the complexity of PCI. Complex PCI was defined as having at least one of the following features: unprotected left main lesion, ≥2 lesions treated, total stent length >40 mm, minimal stent diameter ≤2.5 mm, or bifurcation as target lesion. The primary outcome was target lesion failure (TLF), defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI), or target lesion revascularization (TLR) at 2 years of follow-up.@*RESULTS@#Of 1,999 patients, 1,145 (57.3%) underwent complex PCI: 521 patients were treated with BP-BES and 624 with DP-EES. In propensity-score matching analysis (481 pairs), the risks of TLF (3.8% vs. 5.2%, adjusted hazard ratio [HR], 0.578; 95% confidence interval [CI], 0.246–1.359; p=0.209), cardiac death (2.5% vs. 2.5%, adjusted HR, 0.787; 95% CI, 0.244–2.539; p=0.689), TV-MI (0.5% vs. 0.4%, adjusted HR, 1.128; 95% CI, 0.157–8.093; p=0.905), and TLR (1.1% vs. 2.9%, adjusted HR, 0.390; 95% CI, 0.139–1.095; p=0.074) did not differ between 2 stent groups after complex PCI.@*CONCLUSIONS@#Clinical outcomes of BP-BES were comparable to those of DP-EES at 2 years after complex PCI. Our data suggest that use of BP-BES is acceptable, even for complex PCI.
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BACKGROUND AND OBJECTIVES@#In this second report from Korean percutaneous coronary intervention (K-PCI) registry, we sought to describe the updated information of PCI practices and Korean practice pattern of PCI (KP3).@*METHODS@#In addition to K-PCI registry of 2014, new cohort of 2016 from 92 participating centers was appended. Demographic and procedural information, as well as in-hospital outcomes, of PCI was collected using a web-based reporting system. KP3 class C was defined as any strategy with less evidence from randomized trials and more aggressive for PCI than medical therapy or bypass-surgery.@*RESULTS@#In 2016, total 48,823 PCI procedures were performed at 92 participating centers. Mean age of the patients was 65.7±11.6 years, and 71.7% were males. Overall patient characteristics and PCI practices in 2016 were similar to those in 2014. The biggest change was the decrease in the in-hospital occurrence of myocardial infarction (MI;1.6%→0.7%, p<0.001). Many associations between PCI volumes and demographic/procedural characteristics observed in 2014 have disappeared. The median of door-to-balloon time was 62 minutes, and 83.3% of ST-elevation MI patients received primary PCI within 90 minutes, while the median of total ischemic time was 168 minutes and patients who had total ischemic time within 120 and 180 minutes were 29.1% and 54.1%, respectively. The proportion of KP3 class C cases in non-acute coronary syndrome patients decreased from 13.5% in 2014 to 12.1% in 2016 (p<0.001).@*CONCLUSIONS@#In this second report from K-PCI registry, we described the current practices of PCI and changes from 2014 to 2016 in Korea.
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BACKGROUND AND OBJECTIVES: There are no data comparing clinical outcomes of complex percutaneous coronary intervention (PCI) between biodegradable polymer-biolimus-eluting stents (BP-BES) and durable polymer-everolimus-eluting stents (DP-EES). We sought to evaluate the safety and efficacy of BP-BES compared with DP-EES in patients undergoing complex PCI. METHODS: Patients enrolled in the SMART-DESK registry were stratified into 2 categories based on the complexity of PCI. Complex PCI was defined as having at least one of the following features: unprotected left main lesion, ≥2 lesions treated, total stent length >40 mm, minimal stent diameter ≤2.5 mm, or bifurcation as target lesion. The primary outcome was target lesion failure (TLF), defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI), or target lesion revascularization (TLR) at 2 years of follow-up. RESULTS: Of 1,999 patients, 1,145 (57.3%) underwent complex PCI: 521 patients were treated with BP-BES and 624 with DP-EES. In propensity-score matching analysis (481 pairs), the risks of TLF (3.8% vs. 5.2%, adjusted hazard ratio [HR], 0.578; 95% confidence interval [CI], 0.246–1.359; p=0.209), cardiac death (2.5% vs. 2.5%, adjusted HR, 0.787; 95% CI, 0.244–2.539; p=0.689), TV-MI (0.5% vs. 0.4%, adjusted HR, 1.128; 95% CI, 0.157–8.093; p=0.905), and TLR (1.1% vs. 2.9%, adjusted HR, 0.390; 95% CI, 0.139–1.095; p=0.074) did not differ between 2 stent groups after complex PCI. CONCLUSIONS: Clinical outcomes of BP-BES were comparable to those of DP-EES at 2 years after complex PCI. Our data suggest that use of BP-BES is acceptable, even for complex PCI.