Search

Background: The contribution of sex as an independent risk factor for cardiovascular disease still remains controversial. The present study investigated the impact of sex on long-term clinical outcomes in Korean acute myocardial infarction (AMI) patients with a history of current smoking on admission after drug-eluting stents (DESs). Methods: A total of 12,565 AMI patients (male: n = 11767 vs. female: n = 798) were enrolled. Major adverse cardiac events (MACEs) comprising all-cause death, recurrent myocardial infarction (Re-MI), and any repeat revascularization were the primary outcomes that were compared between the two groups. Probable or definite stent thrombosis (ST) was the secondary outcome. Results: After adjustment, the early (30 days) cumulative incidences of MACEs (adjusted hazard ratio [aHR]: 1.457; 95% confidence interval [CI]: 1.021–2.216; p = 0.035) and all-cause death (aHR: 1.699; 95% CI: 1.074–2.687; p = 0.023) were significantly higher in the female group than in the male group. At 2 years, the cumulative incidences of all-cause death (aHR: 1.561; 95% CI: 1.103–2.210; p = 0.012) and Re-MI (aHR: 1.880; 95% CI: 1.089–2.974; p = 0.022) were significantly higher in the female group than in the male group. However, the cumulative incidences of ST were similar between the two groups (aHR: 1.207; 95% CI: 0.583–2.497; p = 0.613). Conclusions: The female group showed worse short-term and long-term clinical outcomes compared with the male group comprised of Korean AMI patients with a history of current smoking after successful DES implantation. However, further studies are required to confirm these results.

Because of paucity of published data, we evaluated the 2-year major clinical outcomes between early invasive (EI) and delayed invasive (DI) strategies according to the stage of chronic kidney disease (CKD) in patients with non-ST-segment elevation myocardial infarction (NSTEMI), who underwent a successful newer-generation drug-eluting stent (DES) implantation.A total of 8241 NSTEMI patients were recruited from the Korea Acute Myocardial Infarction Registry (KAMIR). Based on baseline estimated glomerular filtration rate (eGFR; ≥90, 60-89, 30-59, and30 mL/min/1.73 mAfter multivariable-adjusted and propensity score-adjusted analyses, the cumulative incidence of MACE (group A, p = 0.139 and p = 0.103, respectively; group B, p = 0.968 and p = 0.608, respectively; group C, p = 0.111 and p = 0.196, respectively; group D, p = 0.882 and p = 0.571, respectively), all-cause death, re-MI, and any repeat revascularization was similar between the EI and DI groups in the 4 different renal function groups.In the era of newer-generation DES, EI and DI strategies showed comparable major clinical outcomes in patients with NSTEMI and CKD during a 2-year follow-up period. However, to confirm these results, further randomized, large-scale, long-term follow-up studies are needed.

Objectives This study sought to evaluate the impact of post-stent optical coherence tomography (OCT) findings, including severe malapposition, on long-term clinical outcomes. Background Suboptimal OCT findings following percutaneous coronary intervention (PCI) are highly prevalent; however, their clinical implications remain controversial. Methods Of the patients registered in the Yonsei OCT registry, a total of 1,290 patients with 1,348 lesions, who underwent OCT immediately post-stenting, were consecutively enrolled for this study. All patients underwent implantation of drug-eluting stents. Post-stent OCT findings were assessed to identify predictors of device-oriented clinical endpoints (DoCE), including cardiac death, target vessel-related myocardial infarction (MI) or stent thrombosis, and target lesion revascularization (TLR). Significant malapposition criteria associated with major safety events (MSE) were also investigated, such as cardiac death, target vessel-related MI, or stent thrombosis. Results The median follow-up period was 43.0 months (interquartile range [IQR] 21.4 to 56.0 months). The incidence rates of stent edge dissection, tissue prolapse, thrombus, and malapposition after intervention were not associated with occurrence of DoCE. However, patients with significant malapposition (total malapposition volume [TMV] ≥7.0 mm3] exhibited more frequent MSE. A smaller minimal stent area (MSA) was identified as an independent predictor for DoCE (hazard ratio [HR]: 1.20 [95% confidence interval [CI]: 1.00 to 1.43]; p = 0.045). Malapposition with TMV ≥7.0 mm3 was found to be an independent predictor of MSE (HR: 6.12 [95% CI: 1.88 to 19.95]; p = 0.003). Follow-up OCT at 3, 6, or 9 months after PCI showed that post-stent TMV ≥7.0 mm3 was related to a greater occurrence of late malapposition and uncovered struts. Conclusions Although most suboptimal OCT findings were not associated with clinical outcomes, a smaller MSA was associated with DoCE, driven mainly by TLR, and significant malapposition with TMV ≥7.0 mm3 was associated with more MSE after PCI. (Yonsei OCT [Optical Coherence Tomography] Registry for Evaluation of Efficacy and Safety of Coronary Stenting; Yonsei OCT registry; NCT02099162 )

BACKGROUND There are concerns that Asian patients respond differently to some medications. This study evaluated the efficacy and safety of evolocumab among Asian vs. other subjects in the FOURIER trial, which randomized stable atherosclerosis patients to receive either evolocumab or placebo.Methods and Results:Effects of adding evolocumab vs. placebo to background statin therapy on low-density lipoprotein cholesterol (LDL-C) reductions, cardiovascular outcomes, and adverse events were compared among 27,564 participants with atherosclerotic disease, according to self-reported Asian (n=2,723) vs. other (n=24,841) races followed for a median of 2.2 years in the FOURIER trial. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. At randomization, Asians had slightly lower LDL-C (median 89 [IQR 78-104] mg/dL vs. 92 [80-109] mg/dL; P

Objectives The purpose of this study was to test whether the success rate of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) increased with pre-procedural coronary computed tomography angiography (CTA). Background Coronary CTA provides valuable information before and during CTO-PCI. However, there are no randomized data that explore whether coronary CTA increases its success rate. Methods In this multicenter, randomized trial, a total of 400 patients with CTO were randomized to receive PCI with pre-procedural coronary CTA (coronary CTA–guided group; n = 200) or without coronary CTA (angiography-guided group; n = 200) between January 2014 and September 2019. The primary endpoint was the successful recanalization rate, a final TIMI (Thrombolysis In Myocardial Infarction) grade ≥2, and ≤30% residual stenosis on the final angiogram. Results A total of 10 operators performed PCI. Successful recanalization was achieved in 187 patients (93.5%) in the coronary CTA–guided group and in 168 patients (84.0%) in the angiography-guided group (absolute difference, 9.5% [95% confidence interval: 3.4% to 15.6%]; p = 0.003). When comparing the success rates according to the Multicenter CTO Registry of Japan score (J-CTO), the coronary CTA guidance was favored over the angiography-guidance in the subset of J-CTO ≥2 versus in the subset of J-CTO Conclusions Pre-procedural coronary CTA-guidance for CTO resulted in higher success rates with numerically fewer immediate periprocedural complications such as coronary perforations or periprocedural myocardial infarction than angiography guidance. Higher success rates were more prominently observed in patients with CTO who had a high J-CTO score than those who did not. (Role of CT Scan for the Successful Recanalization of Chronic Total Occlusion; a Randomized Comparison Between 3D CT-guided PCI vs. Conventional Treatment [CT-CTO Trial]; NCT02037698 )

Author's summary We investigated the association between body mass index and clinical outcomes of peripheral artery disease (PAD) after endovascular therapy (EVT). A total of 2914 PAD patients undergoing EVT were participated according to body mass index groups. Underweight was significantly associated with increased risk of major adverse cardiovascular events (MACE) (adjusted hazard ratio [HR], 1.540; 95% confidence interval [CI], 1.091–2.173) and major adverse limb events (MALE) (adjusted HR, 1.523; 95% CI, 1.066–2.177) compared with normal weight. Plus, overweight was associated with lower risk of MACE and not with MALE. However, obesity showed no significant association with MACE or MALE., Background and Objectives Few studies have investigated the obesity paradox in clinical outcomes of peripheral artery disease (PAD). We investigated the association between body mass index (BMI) and clinical outcomes in PAD patients undergoing endovascular therapy (EVT). Methods Patients (n=2,914) from the retrospective Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Disease registry were categorized according to BMI: underweight (

We investigated the impact of pre-percutaneous coronary intervention (pre-PCI) thrombolysis in myocardial infarction (TIMI) flow grade (pre-TIMI) on 3-month (3-mo) and 12-mo of dual antiplatelet therapy (DAPT) in patients with acute myocardial infarction (AMI). This was a post hoc analysis of the TICO trial. A total of 2083 patients with AMI (pre-TIMI 0/1: n = 1143; pre-TIMI 2/3: n = 940) were evaluated. The primary outcome was the occurrence of net adverse clinical events (NACE), defined as a composite of TIMI major bleeding and major adverse cardiac and cerebrovascular events (MACCE) within 12-mo following PCI. The secondary outcomes were the occurrence of the individual components of TIMI bleedings and MACCE. In the pre-TIMI 0/1 group, the primary and second outcomes were not significantly different between the 3-mo and 12-mo DAPT groups. However, in the pre-TIMI 2/3 group, the occurrences of TIMI minor (adjusted hazard ratio [aHR]: 0.294; p = 0.016) and major or minor bleeding (aHR: 0.483; p = 0.014) on intention-to-treat analysis were significantly higher in the 12-mo than in the 3-mo DAPT group. The occurrence of MACCE was similar between the two groups. A higher bleeding tendency in 12-mo DAPT compared with 3-mo DAPT was more obvious in the pre-TIMI 2/3 group than in the pre-TIMI 0/1 group.Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02494895.

The 2-year clinical outcomes according to pre-percutaneous coronary intervention (PCI) thrombolysis in myocardial infarction (TIMI) flow grade and reperfusion timing were investigated in patients with non-ST-segment elevation myocardial infarction (NSTEMI) who received newer-generation drug-eluting stents. A total of 7506 NSTEMI patients were divided into 2 groups: early (PCI ≤ 24 hours: n = 6398; pre-PCI TIMI 0/1 [n = 2729], pre-PCI TIMI 2/3 [n = 3669]) and delayed (PCI > 24 hours: n = 1108; pre-PCI TIMI 0/1 [n = 428], pre-PCI TIMI 2/3 [n = 680]) invasive groups. Major adverse cardiac events were defined as all-cause death, recurrent myocardial infarction, or any repeat revascularization. All-cause death ( P = 0.005 and 0.009, respectively) and cardiac death ( P = .003 and 0.046, respectively) were significantly higher in pre-PCI TIMI 0/1 patients than in pre-PCI TIMI 2/3 patients both in the early and delayed invasive groups. In pre-PCI TIMI 0/1 patients, all-cause death rate was significantly higher in the delayed group ( P = .023). In pre-PCI TIMI 2/3 patients, the clinical end point was similar between the 2 groups. An early invasive strategy is preferred to a delayed invasive strategy in reducing all-cause death in patients with pre-PCI TIMI 0/1. However, in patients with pre-PCI TIMI 2/3, both treatment strategies are acceptable.

Objectives The aim of this study was to investigate whether earlier extracorporeal membrane oxygenation (ECMO) support is associated with improved clinical outcomes in patients with refractory cardiogenic shock (CS). Background The prognosis of patients with refractory CS receiving ECMO remains poor. However, little is known about the association between the timing of ECMO implantation and clinical outcomes in these patients. Methods From a multicenter registry, 362 patients with refractory CS who underwent ECMO between January 2014 and December 2018 were identified. Participants were classified into 3 groups according to tertiles of shock-to-ECMO time (early, intermediate, and late ECMO). Inverse probability of treatment weighting was conducted to adjust for baseline differences among the groups, followed by a weighted Cox proportional hazards regression analysis to calculate hazard ratios and 95% confidence intervals for 30-day mortality associated with each ECMO time group. Results The overall 30-day mortality rate was 40.9%. The risk for 30-day mortality was lower in the early group than in the late group (hazard ratio: 0.53; 95% confidence interval: 0.28 to 0.99). Early ECMO support was also associated with lower risk for in-hospital mortality, ECMO weaning failure, composite of all-cause mortality or rehospitalization for heart failure at 1 year, all-cause mortality at 1 year, and poor neurological outcome at discharge. However, the incidence of adverse events, including stroke, limb ischemia, ECMO-site bleeding, and gastrointestinal bleeding, did not differ significantly among the groups. Conclusions Earlier ECMO support was associated with improved clinical outcomes in patients with refractory CS.

Objective The comparative long-term clinical outcomes between patients with prediabetes and diabetes in patients with non-ST-elevation myocardial infarction (NSTEMI) and multivessel disease (MVD) who were undergoing percutaneous coronary intervention (PCI) are not well known. We therefore compared the 2-year clinical outcomes in such patients. Methods A total of 2963 patients with NSTEMI and MVD [normoglycemia (group A, n = 629), prediabetes (group B, n = 802), and diabetes (group C, n = 1532)] were evaluated. The primary outcomes were the occurrence of major adverse cardiac events (MACE) defined as all-cause death, recurrent myocardial infarction (Re-MI), and any repeat revascularization. The secondary outcome was stent thrombosis. Results The cumulative incidence of MACE as well as for death or MI in group B and C were similar when compared to each other. However, they (P = 0.048 and P = 0.017, respectively and P = 0.022 and P = 0.001, respectively) were significantly higher than in group A. The cumulative incidence of all-cause death in group B (P = 0.042) and all-cause death and cardiac death in group C (P = 0.001 and P = 0.028, respectively) were significantly higher than in group A. However, those of all-cause death, cardiac death, Re-MI, any repeat revascularization, and ST were not significantly different between groups B and C. Conclusion In this study, patients with NSTEMI and MVD who underwent successful implantation of newer-generation DES and were prediabetic had worse outcomes compared to normoglycemics and comparable to those with diabetes.

Objectives The aim of this study was to assess whether the effects of ticagrelor monotherapy after 3-month dual-antiplatelet therapy (DAPT) are consistent among patients presenting with ST-segment elevation myocardial infarction (STEMI), non–ST-segment elevation myocardial infarction, and unstable angina treated with drug-eluting stents. Background Ticagrelor monotherapy after short-term DAPT has not been investigated in patients with STEMI. Methods This was a pre-specified, stratified, subgroup analysis of the STEMI cohort from the TICO (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome) trial, which constituted 36% of the total population. The primary outcome was a composite of major bleeding and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction, stent thrombosis, stroke, or target vessel revascularization). The secondary outcomes were major bleeding and MACCE. Results The incidence of the primary outcome was 4.4% in patients with STEMI (n = 1,103), 6.0% in those with non–ST-segment elevation myocardial infarction (n = 1,027), and 4.1% in those with unstable angina (n = 926), without statistical significance (p = 0.09). Compared with ticagrelor-based 12-month DAPT, ticagrelor monotherapy after 3-month DAPT showed consistent effects on the primary outcome across clinical presentations (p for interaction [pint] = 0.64). Furthermore, the effect of ticagrelor monotherapy on the reduction of major bleeding was consistent across clinical presentations (pint = 0.36). The effect of ticagrelor monotherapy on MACCE was also consistent in patients with STEMI, without evidence of a higher risk for MACCE (pint = 0.14). Conclusions This pre-specified subgroup analysis revealed no heterogeneity in the effects of ticagrelor monotherapy after 3-month DAPT, compared with 12-month DAPT, for the primary outcome, major bleeding, and MACCE across clinical presentations including STEMI, though larger studies are needed to demonstrate these findings with adequate power. (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome [TICO Study]; NCT02494895 )

Background and objectives The EPIC™ stent is a self-expanding, nitinol stent that has been designed to enhance flexibility and provide expansion within vessels. The aim of the present study was to investigate the clinical efficacy and safety of the EPIC™ stent when used to treat iliac artery diseases in a prospective Korean multicenter registry. Methods A total of 138 patients with iliac artery diseases who received endovascular treatment with EPIC™ stents at 9 Korean sites were enrolled in a prospective cohort and followed for 1 year. The primary endpoint was the 1-year freedom from target lesion revascularization (TLR). The secondary endpoints were 1-year clinical patency and freedom from major adverse events (MAEs). Results The mean age of the study subjects was 66.8±8.5 years and most subjects were male (86.2%). The most frequent lesion type was Trans-Atlantic Inter-Society Consensus B (43.5%) and the majority (56.5%) of the target lesions were located in the common iliac artery. Procedural success was obtained in 99.3% of patients. The freedom from TLR and the clinical patency at 1-year follow-up were 94.9% and 92.3%, respectively. The 1-year rate of MAEs was 5.1%. Combined coronary artery disease (hazard ratio [HR], 5.91; 95% confidence interval [CI], 1.13-30.89; p=0.035) and smaller stent diameter (HR, 0.38; 95% CI, 0.17-0.88; p=0.023) were identified as independent risk factors of TLR after EPIC™ stent implantation. Conclusions The EPIC™ stents demonstrated excellent immediate and 1-year efficacy and safety outcomes in iliac artery lesions in this multicenter, prospective, registry-based study.

Aims Optimal timing and strategy of antiplatelet monotherapy after dual-antiplatelet therapy (DAPT) consisting of aspirin and P2Y12 inhibitor for patients who underwent percutaneous coronary intervention (PCI) is still being debated. The aim of this study was to evaluate the effect of ticagrelor monotherapy after short-term DAPT after PCI on mortality. Methods and results A systematic review and meta-analysis was performed using PubMed to search for ticagrelor monotherapy after short-term DAPT comparing conventional DAPT in patients who underwent PCI. Three randomized trials encompassing 26 143 patients [ticagrelor monotherapy after 1–3 months of DAPT (n = 13 062) vs. conventional therapy (n = 13 081)] were included. The efficacy endpoint of all-cause mortality was significantly lower with the ticagrelor monotherapy group vs. the conventional therapy group [risk ratio (RR) = 0.80, 95% confidence interval (CI) 0.65–0.98; P = 0.03; I2 = 0%; number needed to treat for benefit (NNTB) = 320]. The safety endpoint of Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding was also significantly lower with the ticagrelor monotherapy group vs. the conventional therapy group (RR = 0.67, 95% CI 0.49–0.92; P = 0.01; I2 = 65%; NNTB = 156). There were no significant differences in ischaemic stroke, acute myocardial infarction, and stent thrombosis. The favourable effects of the ticagrelor monotherapy vs. the conventional therapy on all-cause mortality and BARC type 3 or 5 bleeding were consistent in the subset of patients presenting acute coronary syndromes (n = 15 157). Conclusion Ticagrelor monotherapy after short-term DAPT of 1–3 months was associated with decreased all-cause mortality and BARC type 3 or 5 bleeding not offset by increase of cardiac death, ischaemic stroke, acute myocardial infarction, and stent thrombosis.

The objective of the study was to investigate aortic remodeling and clinical outcomes after thoracic endovascular aortic repair (TEVAR) for type B aortic dissection (AD) according to timing of the procedure.A total of 87 patients with type B AD who underwent TEVAR at 2 centers were included in this retrospective analysis. Patients were divided into acute/subacute (≤6 weeks, n = 35), early chronic (6 weeks to 1 year, n = 20), and late chronic (1 year, n = 32) groups according to the timing of TEVAR after symptom onset. Changes in aorta dimensions on serial computed tomography angiograms and clinical outcomes were evaluated.AD complications were the most common indication for TEVAR in the acute/subacute group, whereas aortic expansion was the main reason in the early and late chronic groups. Maximum total aorta diameter (46.6 ± 10.6 vs. 54.8 ± 9.8 vs. 56.7 ± 10.1 mm, P 0.001) and false lumen diameter (30.9 ± 11.0 vs. 35.2 ± 12.0 vs. 39.9 ± 13.4 mm, P = 0.013) were smaller in the acute/subacute group than in the early and late chronic groups. At 1-year follow-up, maximum total aorta diameter was decreased in the acute/subacute and early chronic groups and increased in the late chronic group (-4.3 ± 9.3 vs. -5.2 ± 6.9 vs. 2.5 ± 4.6 mm, P 0.001). Survival free from the major adverse aortic event (death, aortic rupture, or reintervention) at 5 years after TEVAR was lowest in the late chronic group (92.6% vs. 88.2% vs. 73.1%, P = 0.033) but not significantly different between the acute/subacute and early chronic groups (P = 0.680).TEVAR in the acute/subacute and early chronic phases of type B AD resulted in similar aortic remodeling and clinical outcomes, which were more favorable than those with TEVAR performed during late chronic AD. This finding suggests 1 year after the onset of type B AD symptoms as the upper time threshold for TEVAR to achieve optimal aortic remodeling and safety.

Hyperglycemia is an important risk factor for poor clinical outcomes in patients with acute myocardial infarction (AMI). The relative superiority of the long-term clinical outcomes of durable-polymer (DP) -based and biodegradable-polymer (BP) -based newer-generation drug-eluting stents (DESs) after successful percutaneous coronary intervention (PCI) in patients with AMI and prediabetes is not well established. We compared the clinical outcomes in such patients between DP-based and BP-based newer-generation DESs.A total of 4,377 patients with AMI and prediabetes were divided into the following two groups: the DP-DES group (n = 3,775; zotarolimus-eluting stents [ZES; n = 1,546] and everolimus-eluting stents [EES; n = 2,229]) and the BP-DES group (n = 602; biolimus-eluting stents [BES]). The primary endpoint was the occurrence of major adverse cardiac events (MACEs), defined as all-cause death, recurrent myocardial infarction (re-MI), or any repeat revascularization. The secondary endpoint was the occurrence of stent thrombosis (ST).The 2-year adjusted hazard ratio (aHR) of MACEs for ZES versus EES, ZES versus BES, EES versus BES, and ZES/EES versus BES (aHR: 1.125; 95% confidence interval [CI], 0.834-1.518; P = 0.440) were similar. The cumulative incidence of ST was also comparable between the DP-DES and BP-DES groups (aHR: 1.407; 95% CI, 0.476-4.158; P = 0.537). Moreover, the 2-year aHRs of all-cause death, CD, re-MI, target lesion revascularization (TLR), target vessel revascularization (TVR), and non-TVR were similar.Patients with AMI and prediabetes who received DP-DES or BP-DES during PCI showed comparable safety and efficacy during the 2-year follow-up period.

Determining the optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is an important clinical issue. We evaluated the effects of ischemia (by DAPT score) and bleeding (by PRECISE-DAPT score), as well as the impact of DAPT duration, on clinical outcomes. From pooled analysis of four randomized clinical trials, 5131 patients undergoing second-generation DES implantation were randomized to short-duration (n = 2575; ≤ 6 months) or standard-duration (n = 2556; ≥ 12 months) DAPT groups. This population was further divided into four subgroups according to PRECISE-DAPT (high bleeding risk ≥ 25) and DAPT (high ischemic risk ≥ 2) scores. Net clinical outcomes (1.3% vs. 1.3%; p = 0.89) and ischemic events (5.0% vs. 4.5%; p = 0.44) did not differ between the two duration groups, although bleeding events were more frequent in patients with standard-duration DAPT (0.4% vs. 0.9%; p = 0.04). Standard-duration DAPT was associated with fewer ischemic events (6.9% vs. 4.0%; p = 0.02) and no increase in bleeding events only among patients at low bleeding risk and high ischemic risk. The other groups show no differences in net clinical outcomes, ischemic events, or bleeding events according to DAPT duration. Compared with short-duration DAPT, standard-duration DAPT was associated with similar net clinical outcomes and ischemic events, but more bleeding events at 12 months after second-generation DES implantation. However, standard-duration DAPT reduced ischemic events without increasing bleeding events among patients at low bleeding and high ischemic risk. When determining DAPT duration, considering both ischemic and bleeding risk can help optimize patient benefits. EXCELLENT (NCT00698607), RESET (NCT01145079), IVUS-XPL (NCT01308281), OPTIMA-C (NCT03056118)

A low lymphocyte count puts immune-compromised patients at risk of mortality. hIL-7-hyFc is a homodimeric interleukin-7 (IL-7), a potent T-cell amplifier, fused to the hybridizing IgD/IgG4 immunoglobulin domain. We performed a randomized, double-blind, placebo-controlled, dose-escalation, phase I study to assess the pharmacokinetic, pharmacodynamic, safety, tolerability, and immunogenicity profiles of hIL-7-hyFc administered s.c. and i.m. to healthy volunteers. Thirty subjects randomly received hIL-7-hyFc or its matching placebo in an 8:2 ratio at 20, 60 μg/kg s.c., or 60 μg/kg i.m. The hIL-7-hyFc was slowly absorbed and its terminal half-life was 63.26 hours after i.m. administration. The hIL-7-hyFc increased absolute lymphocyte count, mostly in T-cells, which peaked 3 weeks after administration and then lasted for several additional weeks. The hIL-7-hyFc was well-tolerated after a single s.c. and i.m. administration. Injection site reaction was the most common treatment-emergent adverse event, which resolved spontaneously without treatment. The hIL-7-hyFc can be developed into a beneficial treatment option for patients with compromised T-cell immunity. This trial was registered at www.clinicaltrials.gov as #NCT02860715.

Background and aims The long-term comparative results between culprit-only percutaneous coronary intervention (C–PCI) and multivessel PCI (M-PCI) or those between complete revascularization (CR) and incomplete revascularization (IR) in patients with non-ST-elevation myocardial infarction (NSTEMI) and multivessel disease (MVD) after successful newer-generation drug-eluting stent (DES) implantation are limited. Therefore, we compared the 2-year clinical outcomes in such patients. Methods A total of 4588 patients with NSTEMI and MVD (C–PCI, n = 2055; M-PCI, n = 2533; CR, n = 2029; IR, n = 504) were evaluated. The primary outcome was major adverse cardiac events (MACEs) defined as all-cause death, recurrent myocardial infarction MI, and any repeat coronary revascularization. The secondary outcome was stent thrombosis (ST). Results The cumulative incidences of the primary and secondary outcomes were similar in the three comparison groups (C–PCI vs. M-PCI, CR vs. IR, or CR vs. C–PCI). However, the cumulative incidence of non-target vessel revascularization (non-TVR) was higher in the C–PCI group than in the M-PCI group (adjusted hazard ratio [aHR]: 2.011; 95% confidence interval [CI]: 1.942–3.985; p = 0.012), higher in the IR group than in the CR group (aHR: 2.051; 95% CI: 1.216–4.183; p = 0.043), and higher in the C–PCI group than in the CR group (aHR: 2.099; 95% CI: 1.237–3.564; p = 0.006). Conclusions Regarding the higher cumulative incidence of non-TVR, M-PCI and CR were preferred compared to C–PCI or IR in patients with NSTEMI and MVD. However, further randomized studies are required to confirm these findings.

Background For diabetic patients with multivessel coronary artery disease (MVD), limited data exist on the long-term outcomes of percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) according to clinical presentation [stable coronary artery disease (SCAD) or non-ST-elevation acute coronary syndrome (NSTE-ACS)]. Patients and methods From a Korean multicenter registry, we analyzed 1135 diabetic patients with MVD treated with PCI (n = 660) or CABG (n = 475). After propensity score matching, 8-year major adverse cardiovascular and cerebrovascular events [MACCE; composite of all-cause death, myocardial infarction (MI), or stroke] were compared between PCI and CABG according to clinical presentation. Results After matching, MACCE was not different between PCI and CABG for SCAD patients [15.6 vs. 17.2%, hazard ratio (HR) = 0.94, 95% confidence interval (CI) = 0.55-1.63, P = 0.837], whereas it was higher in PCI than in CABG for NSTE-ACS patients (31.1 vs. 22.4%, HR = 1.63, 95% CI = 1.03-2.59, P = 0.036), mainly driven by the higher MI occurrence (HR = 2.18, 95% CI = 1.04-4.59, P = 0.035). A significant interaction between revascularization strategy and clinical presentation was observed for MACCE (P-interaction = 0.022). However, when PCI was further classified according to revascularization completeness, the treatment gap between PCI and CABG with respect to MI in NSTE-ACS patients was improved by complete-revascularization PCI. Conclusion Among diabetic patients with MVD, the long-term outcomes of PCI versus CABG differed according to clinical presentation. CABG may be more beneficial for NSTE-ACS patients with MVD in reducing MACCE and MI, whereas PCI was as effective as CABG for SCAD patients with MVD. Therefore, clinical presentation must be considered when choosing revascularization strategies in these patients.

Background Intensive statin therapy reduces cardiovascular events in acute coronary syndrome. The data concerning the long-term clinical impacts of statin therapy between ST-segment elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) after drug-eluting stent implantation are limited. We compared the 2-year clinical outcomes between these 2 groups after statin therapy. Materials and Methods A total of 30,616 Korean patients with acute myocardial infarction (AMI) were enrolled. Among them, 13,686 patients were classified as group A (STEMI statin user), 3,824 patients were as group B (STEMI statin nonuser), 10,398 patients were as group C (NSTEMI statin user), and 2,708 patients were as group D (NSTEMI statin nonuser). The major clinical endpoint was the occurrence of major adverse cardiac events (MACE) defined as all-cause death, recurrent myocardial infarction (re-MI), and any repeat revascularization during a 2-year follow-up period. Results After adjustment, the cumulative risks of MACE (adjusted hazard ratio [aHR] = 1.112 [1.002-1.235]; P = 0.047), all-cause death (aHR = 1.271 [1.054-1.532]; P = 0.012), and target vessel revascularization (TVR, aHR = 1.262 [1.049-1.518]; P = 0.014) in group C were significantly higher than group A. The cumulative risks of MACE, all-cause death, and cardiac death of the statin nonuser group (groups B and D) were significantly higher compared with statin user group (groups A and C). Conclusions Statin therapy was more effective in reducing the cumulative risks of MACE, all-cause death, and TVR in the STEMI group than NSTEMI group in Korean patients with AMI after successful drug-eluting stent implantation.

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: Triple therapy is the combination of dual antiplatelet therapy plus oral anticoagulant after stent implantation. Current guidelines recommend triple therapy for acute coronary syndrome with atrial fibrillation (AF). This study aimed to identify temporal trends of antithrombotic therapy in patients with acute myocardial infarction (AMI) and AF.Methods: Among 13,104 consecutive patients from the Korea Acute Myocardial Infarction Registry-National Institute of Health (KAMIR-NIH) registry, we identified 453 patients with AF after stent implantation for AMI; these patients were then divided into those who did and did not use oral anticoagulant (OAC) [OAC group (n = 71) vs. non-OAC group (n = 382), respectively].Results: The results showed that the prevalence of AF in AMI patients was 5.4% (712/13,104). Among 453 patients, only 15.7% (71/453) were treated with OAC while dual or single antiplatelet therapy was provided for 84.7% (382/453) of patients. In patients with high stroke risk (CHA2DS2-VASc score ≥ 2), OACs were used only in 17% (69/406). Multivariate analysis revealed that female sex [odds ratio (OR) 2.11; 95% CI: 1.17–3.79], diabetes mellitus (DM) (OR 2.37; 95% CI: 1.35–4.17), prior cerebrovascular accident (CVA) (OR 4.19; 95% CI: 2–8.75), and congestive heart failure (CHF) (OR 1.89; 95% CI: 1.09–3.3) as the significant determinants of OAC use.Conclusion: The study concluded that OAC was underused. Approximately, 15%, of AMI patients with AF undergoing PCI with stent and female gender, DM, prior CVA history, and a history of CHF or the presence of moderate to severe left ventricle systolic impairment were significant determinants of OAC use.

Because available data are limited, we compared the 2-year clinical outcomes among different reperfusion strategies (culprit-only percutaneous coronary intervention (C-PCI), multivessel PCI (M-PCI), complete revascularization (CR) and incomplete revascularization (IR)) of multivessel disease (MVD) undergoing newer-generation drug-eluting stent implantation in patients with non-ST-elevation myocardial infarction (NSTEMI) and chronic kidney disease (CKD). In this nonrandomized, multicenter, retrospective cohort study, a total of 1042 patients (C-PCI, n = 470, M-PCI, n = 572, CR, n = 432, IR, n = 140) were recruited from the Korea Acute Myocardial Infarction Registry (KAMIR) and evaluated. The primary outcome was the occurrence of major adverse cardiac events, defined as all-cause death, recurrent myocardial infarction and any repeat coronary revascularization. The secondary outcome was probable or definite stent thrombosis. During the 2-year follow-up period, the cumulative incidences of the primary (C-PCI vs. M-PCI, adjusted hazard ratio (aHR), 1.020, p = 0.924, CR vs. IR, aHR, 1.012, p = 0.967, C-PCI vs. CR, aHR, 1.042, p = 0.863, or C-PCI vs. IR, aHR, 1.060, p = 0.844) and secondary outcomes were statistically insignificant in the four comparison groups. In the contemporary newer-generation DES era, C-PCI may be a better reperfusion option for patients with NSTEMI with MVD and CKD rather than M-PCI, including CR and IR, with regard to the procedure time and the risk of contrast-induced nephropathy. However, further well-designed, large-scale randomized studies are warranted to confirm these results.

Background: Because limited data are available, the present study investigated 2-year major clinical outcomes after angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II type 1 receptor blockers (ARBs) therapy in patients with acute myocardial infarction (AMI) and prediabetes after successful implantation of newer-generation drug-eluting stents (DESs). Methods: Overall, 2932 patients with AMI and prediabetes were classified into two groups — the ACEIs group (n = 2059) and the ARBs group (n = 873). The primary endpoint was the occurrence of patient-oriented composite outcome (POCO), defined as all-cause death, recurrent myocardial infarction (Re-MI), or any repeat revascularization. The secondary endpoint was definite or probable stent thrombosis (ST). Results: The cumulative incidences of POCO (adjusted hazard ratio [aHR]: 1.020; 95% confidence interval [CI]: 0.740–1.404; p = 0.906), all-cause death (aHR: 1.394; 95% CI: 0.803–2.419; p = 0.238), Re-MI (aHR: 1.210; 95% CI: 0.626–2.340; p = 0.570), any repeat revascularization (aHR: 1.150; 95% CI: 0.713–1.855; p = 0.568), and ST (aHR: 1.736; 95% CI: 0.445–6.766; p = 0.427) were similar between the groups. These results were confirmed after propensity score-adjusted analysis. Conclusions: In this study, patients with AMI and prediabetes who received ACEIs or ARBs showed comparable clinical outcomes during the 2-year follow-up period.

Background: In patients with acute coronary syndrome (ACS) with a high risk of ischemia, the impact of ticagrelor monotherapy after short-term dual antiplatelet therapy (DAPT) has not been clearly elucidated. Methods: This post hoc analysis of the TICO trial (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus-Eluting Stent for Acute Coronary Syndrome) compared the impact of ticagrelor monotherapy after 3-month DAPT versus ticagrelor-based 12-month DAPT in patients with high-ischemic risk ACS, defined as any of the following: number of stents implanted ≥3, total stent length >60 mm, complex procedures (chronic total occlusion, left main occlusion, or bifurcation plaques remedied using the 2-stent technique), or a history of diabetes or chronic kidney disease. Ischemic (composite of death, myocardial infarction, stent thrombosis, stroke, and target vessel revascularization) and bleeding outcomes (major bleeding) were evaluated at 12 months. Results: Of the total population (N=3056), 1473 (48.2%) patients were identified as having high-ischemic risk ACS. The rate of the ischemic outcome was significantly higher in high-ischemic risk ACS patients than in nonhigh-ischemic risk ACS patients (3.9% versus 1.9%, hazard ratio, 2.14 [95% CI, 1.37–3.35], P =0.001). Furthermore, the risk of major bleeding (3.2% versus 1.5%, hazard ratio, 2.23 [95% CI, 1.36–3.68], P =0.001) and the composite ischemic and bleeding outcome (6.6% versus 3.3%, hazard ratio, 2.02 [95% CI, 1.44–2.84], P P int =0.718), bleeding ( P int =0.092), and composite outcomes ( P int =0.094) without significant interactions. Conclusions: There were no significant heterogeneities in the impact of ticagrelor monotherapy after 3-month DAPT compared with that of ticagrelor-based 12-month DAPT on clinical outcomes according to the presence of high-ischemic risk. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02494895.

We investigated the 2-year efficacy of statin treatment according to baseline renal function in patients with acute myocardial infarction (AMI) not requiring dialysis undergoing newer-generation drug-eluting stent (DES) implantation. A total of 18,875 AMI patients were classified into group A (statin users, n = 16,055) and group B (statin nonusers, n = 2820). According to the baseline estimated glomerular filtration rate (eGFR, ≥90, 60–89, 30–59 and &lt, 30 mL/min/1.73 m2), these two groups were sub-classified into groups A1, A2, A3 and A4 and groups B1, B2, B3 and B4. The major adverse cardiac events (MACE), defined as all-cause death, recurrent MI (re-MI) and any repeat revascularization, were evaluated. The MACE (group A1 vs. B1, p = 0.002, group A2 vs. B2, p = 0.007, group A3 vs. B3, p &lt, 0.001, group A4 vs. B4, p &lt, 0.001), all-cause death (p = 0.006, p &lt, 0.001, p &lt, 0.001, respectively) and cardiac death (p = 0.004, p &lt, 0.001, respectively) rates were significantly higher in statin nonusers than those in statin users. Despite the beneficial effects of statin treatment, the MACE (group A1 vs. A2 vs. A3 vs. A4: 5.2%, 6.4%, 10.1% and 18.5%, respectively), all-cause mortality (0.9%, 1.8%, 4.6% and 12.9%, respectively) and cardiac death (0.4%, 1.0%, 2.6% and 6.8%, respectively) rates were significantly increased as eGFR decreased in group A. These results may be related to the peculiar characteristics of chronic kidney disease, including increased vascular calcification and traditional or nontraditional cardiovascular risk factors. In the era of newer-generation DESs, although statin treatment was effective in reducing mortality, this beneficial effect was diminished in accordance with the deterioration of baseline renal function.

Background Comparative studies regarding the long-term clinical outcomes of statin intensity between acute myocardial infarction (AMI) patients with prediabetes and those with type 2 diabetes mellitus (T2DM), after successful implantation of newer-generation drug-eluting stents (DES) with statin treatment, are limited. We compared the 2-year clinical outcomes between these patients. Methods A total of 11,612 AMI patients were classified as statin users (n = 9893) and non-users (n = 1719). Thereafter, statin users were further divided into high-intensity (n = 2984) or low-moderate-intensity statin (n = 6909) treatment groups. Those in these two groups were further classified into patients with normoglycemia, prediabetes, and T2DM. The major outcomes were the occurrence of major adverse cardiac events (MACE), defined as all-cause death, recurrent myocardial infarction (Re-MI), or any repeat coronary revascularization. Results After adjusting for both high-intensity and low-moderate-intensity statin users, the cumulative incidences of MACE (p = 0.737, p = 0.062, respectively), all-cause death, Re-MI, and any repeat revascularization were similar between the prediabetes and T2DM groups. In the total study population, both high-intensity and low-moderate-intensity statin treatments showed comparable results. However, in the patients who enrolled after October 2012, the cumulative incidences of MACE (aHR 1.533; 95% CI 1.144–2.053; p = 0.004) and any repeat revascularization (aHR, 1.587; 95% CI 1.026–2.456; p = 0.038) were significantly lower in high-intensity statin users than in low-moderate intensity statin users. The beneficial effects of high-intensity compared to low-moderate-intensity statin therapy were more apparent in the normoglycemia group than hyperglycemia group, as it reduced the cumulative incidences of MACE (aHR 1.903; 95% CI 1.203–3.010; p = 0.006) and any repeat revascularization (aHR 3.248; 95% CI 1.539–6.854; p = 0.002). Conclusions In this retrospective registry study, prediabetes and T2DM groups showed comparable clinical outcomes, after administering both high-intensity and low-moderate-intensity statin treatments. However, these results are likely to be clearly proved by further studies, especially in patients with AMI who are being treated in contemporary practice. Trial registration Retrospectively registered.

Atherectomy as a pretreatment has the potential to improve the outcomes of drug-coated balloon (DCB) treatment by reducing and modifying atherosclerotic plaques. The present study investigated the outcomes of atherectomy plus DCB (A+DCB) compared with DCB alone for the treatment of femoropopliteal artery disease.A total of 311 patients (348 limbs) underwent endovascular therapy using DCB for native femoropopliteal artery lesions at two endovascular centers. Of these, 82 limbs were treated with A+DCB and 266 limbs with DCB alone. After propensity score matching based on clinical and lesion characteristics, a total of 82 pairs was compared for immediate and mid-term outcomes.For the matched study groups, the lesion length was 172.7±111.2 mm, and severe calcification was observed in 43.3%. The technical success rate was higher in the A+DCB group than in the DCB group (80.5% vs. 62.2%, p=0.015). However, the A+DCB group showed more procedure-related minor complications (37.0% vs. 13.4%, p=0.047). At 2-year follow-up, primary clinical patency (73.8% vs. 82.6%, p=0.158) and the target lesion revascularization (TLR)-free survival (84.3% vs. 88.2%, p=0.261) did not differ between the two groups. In Cox proportional hazard analysis, atherectomy showed no significant impact on the outcome of DCB treatments.The pretreatment with atherectomy improved technical success of DCB treatment; however, it was associated with increased minor complications. In this study, A+DCB showed no clinical benefit in terms of TLR-free survival or clinical patency compared with DCB treatment alone.

Hypertension and diabetes mellitus (DM) are major risk factors for the cardiovascular disease. In this retrospective cohort study, we compared the long-term clinical outcomes between antecedent hypertension and DM in acute myocardial infarction (AMI) patients after stent implantation.A total of 32 938 eligible AMI patients were enrolled and divided into the four groups according to the presence or absence of hypertension and DM (hypertension -/DM -[group A, 13 773 patients], hypertension +/DM -[group B, 10 395 patients], hypertension -/DM + [group C, 3050 patients], and hypertension +/DM + [group D, 5720 patients]). The clinical endpoint was the cumulative incidence of major adverse cardiac events (MACEs) defined as all-cause death, recurrent myocardial infarction (Re-MI) and any repeat revascularization during the 2-year follow-up period.After adjustment, the cumulative incidence of MACEs (adjusted hazard ratio [aHR], 1.232; 95% confidence interval [CI], 0.982-1.567; P = .071), all-cause death, and e-MI Re-MI were similar between the group B and C. However, the cumulative incidences of any repeat revascularization (aHR, 1.438; 95% CI, 1.062-1.997; P = .007), target lesion revascularization (TLR) (aHR, 2.467; 95% CI, 1.552-3.922; P .001), and target vessel revascularization (TVR) (aHR, 1.671; 95% CI, 1.256-2.222; P .001) were significantly higher in group C compared with group B.This large number of a nonrandomized and multicenter cohort study clearly demonstrated the detrimental impacts of the hypertension and diabetes on long-term clinical outcomes. Moreover, higher incidence of repeat revascularization after PCI in diabetic AMI patients a major concern until recently.背景: 高血压和糖尿病(diabetes mellitus, DM)是心血管疾病的主要危险因素。在这项回顾性队列研究中, 我们比较了高血压和DM患者在因急性心肌梗死(acute myocardial infarction, AMI)接受支架置入术后的长期临床结局。 方法: 共入选了32 938名符合条件的AMI患者, 根据有无高血压和DM分为4组(高血压−/DM−[A组, 13 773例患者]；高血压+/DM−[B组, 10 395例患者]；高血压−/DM+[C组, 3050例患者]；以及高血压+/DM+[D组, 5720例患者])。临床终点为2年随访期间的主要不良心血管事件[MACEs, 定义全因死亡、复发性心肌梗死(Re-MI)和任何再次血运重建术]的累计发生率。 结果: 经过校正后, 发现B组C组之间的MACEs(校正后风险比[aHR], 1.232；95%置信区间[CI], 0.982-1.567；P=0.071)、全因死亡和e-MI Re-MI的累积发生率均相似。然而, 与B组相比, C组的任何再次血运重建术(aHR, 1.438；95% CI, 1.062-1.997；P=0.007)、靶病变血运重建术(target lesion revascularization, TLR)(aHR, 2.467；95% CI, 1.552-3.922；P0.001)以及靶血管血运重建术(target vessel revascularization, TVR)(aHR, 1.671；95% CI, 1.256-2.222；P0.001)的累积发生率均显著更高。 结论: 这项大型的非随机、多中心队列研究明确显示了高血压和糖尿病对长期临床结局的不利影响。此外, 糖尿病AMI患者接受PCI术后需要再次血运重建术的可能性更高, 这一点直到最近才引起关注。.

Background We assessed the frequency and severity of hypoglycemia in type 2 diabetes mellitus patients treated with sulfonylurea monotherapy or sulfonylurea+metformin. Methods We conducted a retrospective, observational, cross-sectional study in 2011 and 2012 including patients with type 2 diabetes mellitus aged ≥30 years who were treated with ≥6 months of sulfonylurea monotherapy or sulfonylurea+metformin at 20 university-affiliated hospitals in Korea. At enrollment, glycated hemoglobin (HbA1c) was assessed; participants completed self-reported questionnaires describing hypoglycemia incidents over the past 6 months. A review of medical records up to 12 months before enrollment provided data on demographics, disease history, comorbidities, laboratory results, and drug usage. Results Of 726 enrolled patients, 719 were included (55.6% male); 31.7% and 68.3% were on sulfonylurea monotherapy and sulfonylurea+metformin, respectively. Mean±standard deviation age was 65.9±10.0 years; mean HbA1c level was 7.0%±1.0%; 77.8% of patients had hypertension (89.4% used antihypertensive medication); 60.5% had lipid disorders (72.5% used lipid-lowering medication); and 52.0% had one or more micro- or macrovascular diseases. Among patients with A1c measurement (n=717), 56.4% achieved therapeutic goals (HbA1c

With technological improvements in the endovascular armamentarium, there have been tremendous advances in catheter-based femoropopliteal artery intervention during the last decade. However, standardization of the methodology for assessing outcomes has been underappreciated, and unvalidated peak systolic velocity ratios (PSVRs) of 2.0, 2.4, and 2.5 on duplex ultrasonography have been arbitrarily but routinely used for assessing restenosis. Quantitative vessel analysis (QVA) is a widely accepted method to identify restenosis in a broad spectrum of cardiovascular interventions, and PSVR needs to be validated by QVA. This multidisciplinary review is intended to disseminate the importance of QVA and a validated PSVR based on QVA for binary restenosis in contemporary femoropopliteal intervention.

Background and aims There are limited data comparing clinical outcomes among new-generation drug-eluting stents (DES) in ST-segment elevation myocardial infarction (STEMI) patients with multivessel coronary artery disease (MVD) who underwent primary percutaneous coronary intervention (PCI) with culprit-only or multivessel PCI. We investigated 1-year clinical outcomes between biodegradable-polymer (BP)-coated biolimus-eluting stent (BES) and durable-polymer (DP)-coated DES in STEMI patients with MVD who underwent two different reperfusion strategies. Methods A total of 4255 patients were enrolled and divided into two groups, a culprit-only (n = 2571, BP- [n = 264] or DP-DES [n = 2307]) or a multivessel PCI group (n = 1684, BP- [n = 145] or DP-DES [n = 1539]). The primary endpoint was major adverse cardiac events (MACE) defined as all-cause death, recurrent myocardial infarction (re-MI), and total repeat revascularization. The secondary endpoint was the incidence of definite or probable stent thrombosis (ST). Results BP-BES and DP-DES showed a similar 1-year adjusted hazard ratio (HR) for MACE (culprit-only, adjusted hazard ratio [HR], 1.114; p = 0.740; multivessel, HR, 0.564; p = 0.167) and ST (culprit-only, HR, 1.110, p = 0.891; multivessel, HR, 0.375; p = 0.402). The adjusted HR for all-cause death, re-MI, and repeat revascularization were similar between the two groups. In the total population, the culprit-only PCI group showed a higher incidence of total repeat revascularization than the multivessel PCI group. Conclusions BP-BES and DP-DES showed comparable safety and efficacy in STEMI patients with MVD who underwent primary PCI with two different reperfusion strategies during a 1-year follow-up period.

We investigated the association of perioperative antiplatelet therapy (APT) and outcomes in patients with drug-eluting stent (DES) placement for noncardiac surgery (NCS). In consecutive 23,358 patients who underwent percutaneous coronary interventions between 2005 and 2016, total of 2,179 patients that required 2,179 elective NCS after DES placement were retrospectively analyzed. A net adverse clinical event (NACE), composite of death, myocardial infarction, stent thrombosis, and major bleeding, was assessed at 30 days. Of 2,179 patients, 937 patients (43%) underwent NCS with discontinuation of APT. For overall, NACE occurred in 10 patients who discontinued APT (1.1%) and 22 patients who continued APT (1.8%) without significant differences (hazard ratio [HR] 0.60, 95% confidence interval [CI] 0.28 to 1.27, p = 0.182). Also, adjusted NACE event rates were not different between groups for overall NCSs (adjusted HR 0.76, 95% CI 0.38 to 1.52, p = 0.440), for NCSs >1, ≤12 months after DES, and for NCSs >12 months after DES. Our findings persisted (adjusted HR 1.26, 95% CI 0.51 to 3.10, p = 0.618) when those who continued dual-APT were excluded from the continuation of APT group due to a higher tendency of NACE compared with those who continued single-APT (adjusted HR 2.26, 95% CI 0.98 to 5.21, p = 0.055). However, the patients who discontinued APT for >7 days had a significantly higher NACE than those who discontinued for ≤7 days (adjusted HR 6.93, 95% CI 2.16 to 22.24, p = 0.001). In conclusion, discontinuation of APT may not be associated with higher NACEs 30 days postsurgery compared with continuation of APT, when APT was discontinued for ≤7 days in patients undergoing elective NCS after DES implantation.

Ticagrelor has been widely accepted in clinical practice for treatment of acute myocardial infarction (AMI), however its clinical safety and efficacy have not been revealed sufficiently in Asian populations.Among a total 20,270 patients (age75 years) with AMI undergoing percutaneous coronary intervention who received dual antiplatelet therapy for at least 30 days, clinical outcomes at 1 year were assessed from the database of Health Insurance Review and Assessment Service in Korea between 2013 and 2014. Ticagrelor showed a significant effect on reduction of all-cause death [stabilized inverse probability of treatment weighted (sIPTW)-adjusted odds ratio (aOR) 0.57, 95% confidence interval (CI) 0.42-0.77, p0.001]. Stroke was also reduced by using ticagrelor (sIPTW-aOR 0.58, 95% CI 0.41-0.82, p=0.002). Bleeding risk was not increased by ticagrelor use. There were nearly 30% of patients who switched from ticagrelor to different P2Y12 inhibitors. Switching P2Y12 inhibitors was associated with clinical adverse events including MI, stroke, and bleeding.Among patients aged younger than 75 years, ticagrelor was associated with lower incidence of all-cause mortality. Stroke risk was also reduced in patients with a prescription for ticagrelor without an increase in bleeding risk.

Data concerning the clinical impact of combination therapy with β-blockers (BBs) + angiotensin-converting enzyme inhibitors (ACEIs) compared with BBs + angiotensin-receptor blockers (ARBs) in patients with acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) are limited. We compared the clinical outcomes at 2 years between these two combination therapies. We enrolled 23,978 patients with AMI who underwent successful PCI with DES between January 2005 and June 2015 from the Korea AMI Registry (KAMIR) and divided them into the two groups: BB + ACEI (n = 17,310) and BB + ARB (n = 6668). The primary endpoint was major adverse cardiac events (MACE), defined as all-cause death, recurrent myocardial infarction (re-MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and non-TVR. The secondary endpoints were the cumulative incidences of individual components of MACE and target vessel failure (TVF), a composite of death related to the target vessel, re-MI, or clinically driven TVR. The relative risk of MACE was higher in the BB + ARB group than in the BB + ACEI group after propensity score-matched (PSM) analysis (hazard ratio [HR] 1.204; 95% confidence interval [CI] 1.057–1.370; p = 0.005). The relative risks of all-cause death (HR 1.435 [95% CI 1.117–1.845]; p = 0.005), cardiac death (HR 1.733 [95% CI 1.253–2.396]; p = 0.001), TVR (HR 1.437 [95% CI 1.157–1.784]; p = 0.001), and TVF (HR 1.231 [95% CI 1.065–1.424]; p = 0.005) were also higher in the BB + ARB group after PSM. The BB + ACEI group demonstrated reduced cumulative incidences of MACE, all-cause death, cardiac death, TVR, and TVF compared with the BB + ARB group in patients with AMI who underwent successful PCI with DES during a 2-year follow-up period.

We compared the clinical impact of renin-angiotensin system inhibitors (RASI) on long-term clinical outcomes between ST-segment elevation (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI) after successful percutaneous coronary intervention (PCI) with drug eluting stents (DES) because of the paucity of published data.A total of 24,960 acute myocardial infarction (AMI) patients who underwent PCI with DES and were prescribed the RASI were enrolled and divided into two groups, the STEMI group (n = 14,061) and the NSTEMI group (n = 10,899). The clinical endpoint was the occurrence of major adverse cardiac events (MACE) defined as all-cause death, cardiac death (CD), recurrent myocardial infarction (re-MI), total coronary revascularization (target lesion revascularization [TLR], target vessel revascularization [TVR], non-TVR) during 2 years.After propensity score-matched (PSM) analysis, two PSM groups (6762 pairs, n = 13,524, C-statistic = 0.682) were generated. All-cause death (hazard ratio [HR], 1.386; 95% confidence interval [CI], 1.114-1.725; p = 0.003) and CD (HR, 1.358; 95% CI, 1.041-1.770; p = 0.024) rates were significantly higher in NSTEMI patients. However, the incidence of MACE, re-MI, total revascularization, TLR, TVR, non-TVR was not significantly different between the two groups. In addition, old age (≥65years), decreased left ventricular ejection fraction (50%), hypertension, creatine kinase isoenzyme level, cardiogenic shock, cardiopulmonary resuscitation on admission, and PCI within 24 h were common significant independent risk factors of all-cause death and CD.The mortality reduction capability of RASI was more prominent in the STEMI patients compared with the NSTEMI patients.

Patient preference plays an important role in daily practice; however, its implication has not been well investigated regarding treatment strategy for complex coronary artery disease. We prospectively evaluated a trend of patient-centered decision-making of revascularization strategy in patients with multivessel or unprotected left main coronary artery disease. A standardized protocol that favors coronary artery bypass graft surgery (CABG) as the primary treatment of choice, rather than percutaneous coronary intervention, was adopted. According to the protocol, patients decided whether or not they received CABG. Among the 763 consecutively enrolled patients, 293 patients (38%) consented to receive CABG. Fifty-six percent of patients with a high Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score chose CABG. SYNTAX score was independently correlated with consent to receive CABG in each patient SYNTAX score stratum. In-stent restenosis was an independent predictor of choosing CABG in patients with low and intermediate SYNTAX scores. Unprotected left main coronary artery disease was negatively correlated with the decision to choose CABG in patients with intermediate SYNTAX score. Reasons for declining CABG included refusal of open-heart surgery in 318 patients (68%), mild presentation of angina symptoms in 132 patients (28%), low self-confidence to expect long-term survival in 120 patients (26%), and economic factors in 10 patients (2%). Short-term major adverse cardiac and cerebrovascular events occurred in about 1% of patients without significant differences between the 2 groups. In conclusion, despite the preferred use of the CABG protocol, more than half of the patients declined CABG. Patient-centered decision-making as well as heart team approach should be considered in real-world practice situations.

Background The comparative clinical outcomes between prediabetes and type 2 diabetes mellitus (T2DM) in older adults with AMI in the era of newer-generation drug-eluting stents (DES) are limited. We investigated the 2-year clinical outcomes of these patients. Methods A total of 5492 AMI patients aged ≥65 years were classified into three groups according to their glycemic status: normoglycemia (group A: 1193), prediabetes (group B: 1696), and T2DM (group C: 2603). The primary outcome was the occurrence of major adverse cardiac events (MACE), defined as all-cause death, recurrent myocardial infarction (Re-MI), and any repeat revascularization. The secondary outcome was stent thrombosis (ST). Results The primary and secondary outcomes cumulative incidences were similar between the prediabetes and T2DM groups. In both the prediabetes and T2DM groups, the cumulative incidences of MACE (adjusted hazard ratio [aHR]: 1.373; p = 0.020 and aHR: 1.479; p = 0.002, respectively) and all-cause death or MI (aHR: 1.436; p = 0.022 and aHR: 1.647; p = 0.001, respectively) were significantly higher than those in the normoglycemia group. Additionally, the cumulative incidence of all-cause death in the T2DM group was significantly higher than that in the normoglycemia group (aHR, 1.666; p = 0.003). Conclusions In this retrospective study, despite the 2-year clinical outcomes of the patients with prediabetes and T2DM in the older adults were worse than those in the normoglycemia group; they were similar between the prediabetes and T2DM groups. Hence, comparable treatment strategies should be strengthened between prediabetes and T2DM in older adults with AMI. Trial registration Retrospectively registered.

Purpose Concerns have been consistently raised in regards to the considerable amount of contrast dye used during transcatheter aortic valve replacement (TAVR) in patients with renal insufficiency. In the present study, we introduced minimal contrast TAVR and compared its 30-day clinical outcomes with conventional TAVR. Materials and Methods We retrospectively investigated 369 patients who underwent TAVR between July 2011 and April 2020 in our institute. Among them, 93 patients with severe aortic stenosis and renal insufficiency (estimated glomerular filtration rate ≤50 mL/min/1.73 m2) were included and divided into a conventional TAVR group (n=56) and a minimal contrast TAVR group (n=37). In the minimal contrast TAVR group, the total amount of contrast was

Background There is a lack of data on factors that are related to clinically relevant bleeding after ticagrelor treatment. We investigated the clinical and procedural factors related to major bleeding in patients with acute coronary syndrome treated with ticagrelor after coronary stent implantation. Methods and Results From the TICO (Ticagrelor Monotherapy After 3 Months in Patients Treated With New Generation Sirolimus‐Eluting Stent for Acute Coronary Syndrome) randomized trial, a total of 2660 patients were included for the present study. Patients with major bleeding, defined by TIMI (Thrombolysis in Myocardial Infarction) major or Bleeding Academic Research Consortium type 3 or 5, were compared with those without major bleeding. On the basis of multivariable and receiver operating characteristic curve analyses, weight ≤65 kg, hemoglobin ≤12 g/dL, and estimated glomerular filtration rate 2 were associated with an increased risk of major bleeding. In contrast, 3‐month aspirin therapy with continued ticagrelor (versus 12‐month aspirin and ticagrelor) was associated with a decreased risk of major bleeding. The lower risk of a net adverse clinical event (a composite of TIMI major bleeding and major adverse cardiac and cerebrovascular events) in patients treated with 3‐month aspirin therapy reported from the TICO trial remained valid in patients with any of these risk factors (hazard ratio, 0.59; 95% CI, 0.39–0.90; P interaction =0.74). Conclusions Low body weight, anemia, and chronic kidney disease were risk factors for major bleeding after ticagrelor therapy. Early aspirin discontinuation had a net clinical benefit among patients with a bleeding risk. Registration URL: https://www.clinicaltrials.gov/ . Unique Identifier: NCT02494895.

Background: We compared the 2-year clinical outcomes between prediabetes and type 2 diabetes mellitus (T2DM) according to the pre-percutaneous coronary intervention (PCI) thrombolysis in myocardial infarction (TIMI) flow grade in patients with ST-segment elevation myocardial infarction. Methods: Overall, 6448 STEMI patients were divided into two groups: pre-PCI TIMI 0/1 group ( n = 4854) and pre-PCI TIMI 2/3 group ( n = 1594). They were further divided into patients with normoglycemia, prediabetes, and T2DM. The major endpoint was major adverse cardiac events (MACEs), defined as all-cause death, recurrent myocardial infarction, or any repeat revascularization. Results: In the pre-PCI TIMI 0/1 group, all-cause death rate was higher in both prediabetes (adjusted hazard ratio [aHR]: 1.633, p = 0.045) and T2DM (aHR: 2.064, p = 0.002) groups than in the normoglycemia group. In the pre-PCI TIMI 2/3 group, any repeat revascularization rate was also higher in both prediabetes (aHR: 2.511, p = 0.039) and T2DM (aHR: 3.156, p = 0.009) than normoglycemia. In each group (pre-PCI TIMI 0/1 or 2/3), the MACEs and all other clinical outcomes rates were similar between the prediabetes and T2DM groups. Conclusions: Prediabetes showed comparable worse clinical outcomes to those of T2DM regardless of the pre-PCI TIMI flow grade.

Recently, coronary angiography (CAG) and percutaneous coronary intervention (PCI) via the distal radial access (DRA), are gaining attention owing to fewer complications. Despite the advantages of the DRA, there is difficulty to initiate this new vascular approach. The data from 1000 patients who underwent CAG and PCI via the DRA by a single experienced radial operator were retrospectively analyzed. The primary outcome was the success rate of the DRA per 100 cases. Moreover, the predictors of the failed DRA were analyzed. Overall, 952 (95.2%) of the total 1,000 patients underwent a successful DRA. After experiencing 200 cases, the DRA success rate was well maintained at > 94%, and there was no difference in success rate per 100 cases (Ptrend = 0.216). The predictors of failure were female sex [odds ratio (OR) 1.84, 95% confidence interval (CI) 1.01–3.39, P = 0.049] and systolic blood pressure (SBP) of P = 0.036). For achieving a stable DRA with the success rate of > 94%, 200 procedures would be needed. Moreover, this new approach could fail in women and patients with low SBP.Trial registration: https://cris.nih.go.kr/cris/index/index.do (Unique identifier: KCT0005349).

Because of a paucity of published data, we compared the 2-year major clinical outcomes between pre-percutaneous coronary intervention (pre-PCI) thrombolysis in myocardial infarction (TIMI) flow grade 0/1 (pre-TIMI flow grade [pre-TIMI] 0/1) group and pre-PCI TIMI flow grade 2/3 (pre-TIMI 2/3) group in patients with non-ST-segment elevation myocardial infarction (NSTEMI) who underwent successful implantation of newer-generation drug-eluting stent. A total of 7506 NSTEMI patients were divided into 2 groups: pre-TIMI 0/1 group (n = 3157) and pre-TIMI 2/3 group (n = 4349). The primary outcome was major adverse cardiac events defined as all-cause death, recurrent myocardial infarction, or any repeat revascularization. The secondary outcome was stent thrombosis (ST). After propensity score-matched (PSM) analysis, 2 PSM groups (2473 pairs, n = 4946, C-statistic = 0.684) were generated. Major adverse cardiac events (hazard ration [HR], 1.294; 95% confidence interval [CI]: 1.065–1.572; P = .009), all-cause death (HR, 1.559, P = .003), cardiac death (HR: 1.641, P = .005), and all-cause death or MI (HR: 1.531, P = .001) rates were significantly higher in the pre-TIMI 0/1 group than in the pre-TIMI 2/3 group. Moreover, these differences were more prominent during the first 1 month after the index PCI. However, the cumulative incidences of recurrent myocardial infarction, any revascularization, and ST were similar between the 2 groups. Among a contemporary cohort of NSTEMI, these data suggest that the presence of a pre-PCI patency of the infarct-related artery showed better mortality reduction capacity than those with a lack of patency.

Background and aims The prognosis of stented lesions differs according to in-stent neointimal characteristics on optical coherence tomography (OCT). In particular, patients who show in-stent heterogeneous neointima are associated with a higher incidence of target lesion revascularization (TLR) compared with those who show in-stent non-heterogeneous neointima. However, the relationship between in-stent neointimal characteristics and native coronary atherosclerosis progression has not been clearly elucidated. The study aimed to investigate the relationship between in-stent neointimal characteristics and progression of native atherosclerosis. Methods The neointimal characteristics of 377 patients with 377 drug-eluting stents (DESs) were quantitatively and qualitatively assessed using OCT. The OCT-based neointima was categorized as homogeneous (n = 207), heterogeneous (n = 93), and layered (n = 77). The relationship of non-target lesion revascularization (non-TLR) with neointimal characteristics was evaluated after OCT examination of the stents. Results After a median follow-up duration of 40.0 months, patients with heterogeneous neointima showed significantly higher non-TLR rates than those with homogeneous neointima and tended to have higher non-TLR rates than those with layered neointima (heterogeneous vs. homogeneous:14.0% vs. 8.7%, p = 0.046; heterogeneous vs. layered neointima:14.0% vs. 7.8%, p = 0.152). Multivariate analysis showed that the independent determinants for non-TLR were heterogeneous neointima (HR: 2.237, 95% CI: 1.023–4.890, p = 0.044) and chronic kidney disease (hazard ratio [HR]: 8.730, 95% CI: 2.175–35.036, p = 0.002). Conclusions The heterogeneous neointima in DES-treated lesions was associated with a higher incidence of non-TLR and target lesion failure. This finding suggests that the neointimal pattern may reflect the progression of the native lesion.

We evaluated early vascular responses after new-generation drug-eluting stent (DES) implantation. From 2 randomized trials, we identified 471 patients (138 patients with acute myocardial infarction [AMI] vs 333 patients with stable angina or unstable angina [SA/UA]) treated by DESs who underwent serial optical coherence tomography (OCT) from postprocedure to 3 months. At 3-month follow-up OCT, malapposed strut percentage was higher in AMI than in SA/UA (5.3% vs 0.7%, P < .001); it was markedly increased from postprocedure in AMI (2.0%-5.3%, P < .001), whereas it decreased in SA/UA (1.7%-0.7%, P < .001). Patients with AMI showed a higher risk of persistent (59% vs 37%; P < .001) or late-acquired malapposition (15% vs 8%; P = .04). Uncovered strut percentage at 3 months was also higher in AMI than in SA/UA (13.1% vs 6.7%, P < .001). The AMI presentation was the significant risk factor for both significant stent malapposition (SM, ≥200 μm; odds ratio [OR] = 3.45, CI = 1.85-7.14, P < .001) and uncovered stent (% uncovered struts >6.0%; OR = 2.44, CI = 1.35-4.76, P = .004), together with malapposed distance and postprocedural thrombi. Further, AMI presentation was the predictor for the occurrence of early period late-acquired and persistent malapposition. Serial OCT comparison analyses showed that patients with AMI compared with patients with SA/UA showed more delayed strut coverage, more severe degree SM or uncovered stents, and higher incidences of early period persistent or late-acquired SM.

Background Coronary interventions using drug-eluting stents (DESs) of left main coronary artery (LMCA) lesions have shown favorable clinical outcomes. However, duration of dual antiplatelet therapy (DAPT) after LMCA interventions has not yet been investigated.Methods and Results:From a multicenter Korean Multicenter Angioplasty Team (KOMATE) registry, 1,004 patients who received DES implantations for LMCA lesions and did not experience major adverse cardiovascular events (including major bleeding) for 1 year after coronary intervention were analyzed. Patients were divided into 2 groups; DAPT ≤12 (n=503) and >12 months (n=501). The primary endpoint was number of net clinical adverse events (NACEs), composite of cardiac deaths, myocardial infarctions, stent thrombosis and major bleeding events. During a 4.5-year follow-up period after LMCA interventions, the DAPT >12 months group showed a lower NACE rate than the DAPT ≤12 months group (adjusted-HR 0.53 [0.29-0.99], P=0.045). For patients who maintained DAPT >12 months, rate of cardiac deaths, myocardial infarctions, and stent thrombosis events were lower than in patients who had DAPT ≤12 months (adjusted-HR 0.35 [0.17-0.73], P=0.005) without increased major bleeding (P=0.402). Conclusions For patients who can continue DAPT without major bleeding events, prolonged DAPT (>12 months) after LMCA stenting demonstrated better long-term efficacy outcomes than DAPT ≤12 months with comparable safety.

Introduction A sufficient oxygen supply to ischemic limb tissue is the most important requirement for wound healing and limb salvage. We investigated whether partial venous occlusion in the common iliac vein (CIV) causes a further increase of venous oxygenation in a porcine model of acute hindlimb ischemia. Materials and methods In 7 pigs, the model of acute hindlimb ischemia was created with intra-vascular embolization of the common iliac artery (CIA). The arterial and venous oxygen saturation was evaluated at different moments. Oxygen saturation was evaluated at baseline (T0), just after the arterial embolization (T1), at 10 minutes (T2), at 20 minutes (T3), and at 40 minutes (T4). Next, an intentional partial venous occlusion was achieved by inflating the vascular balloon at the level of the right CIV. Then, blood sampling was repeated at 5 minutes (T5), at 15 minutes (T6), and at 25 minutes (T7). Results The arterial oxygen saturation in the right SFA was similar during all phases. In contrast, after arterial embolization, an immediate reduction of venous oxygen saturation was observed (from 85.57 ± 1.72 at T0 to 71.86 ± 7.58 at T4). After the partial venous occlusion, interestingly, the venous oxygen saturations (T5-T7) were significantly increased, again. The venous oxygen saturations evaluated in the hindlimb ischemia with partial venous occlusion and in the control limb (without partial venous occlusion) were significantly over time. Venous oxygen saturations in the experimental limbs were higher than those in the control limbs (79.28 ± 4.82 vs 59.00 ± 2.82, p-value Conclusions Partial venous occlusion results in an increase of venous oxygen saturation in the ischemic limb, while significant changes in venous oxygen saturation are not observed in the control limb. An explanation for this may be that the oxygen consumption in the limb tissue is increased because it gets congested with the partial venous occlusion in the right CIV.

Long-term clinical outcomes in patients with acute myocardial infarction (AMI) and prediabetes or diabetes who received &szlig, blockers (BB) and renin&ndash, angiotensin system inhibitor (RASI) therapy after successful newer-generation drug-eluting stent (DES) implantation are limited. We compared the two-year clinical outcomes in such patients. A total of 9466 patients with AMI in the Korea AMI Registry were classified into six groups according to their glycemic status and presence or absence of BB + RASI therapy: normoglycemia and BB + RASI users (n = 2217) or nonusers (n = 243), prediabetes and BB + RASI users (n = 2601) or nonusers (n = 306), and diabetes and BB + RASI users (n = 3682) or nonusers (n = 417). The primary endpoint was major adverse cardiac events (MACEs) defined as all-cause death, recurrent myocardial infarction (Re-MI), or any repeat revascularization, and the secondary endpoint was the cumulative incidence of hospitalization for heart failure (HHF). In patients with BB + RASI, despite similar primary and secondary clinical points between the prediabetes and diabetes groups, the cumulative incidence of Re-MI (adjusted hazard ratio: 1.660, 95% confidence interval: 1.000&ndash, 2.755, p = 0.020) was higher in the diabetes group than in the prediabetes group. In all three different glycemic groups, BB + RASI users showed reduced MACEs, cardiac death, and HHF compared to those of BB + RASI nonusers. In this retrospective observational registry study, BB + RASI therapy showed comparable clinical outcomes except for Re-MI between prediabetes and diabetes in patients with AMI during a two-year follow-up period.