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Background: It remains unclear whether P2Y 12 monotherapy, especially clopidogrel, following short-duration dual antiplatelet therapy (DAPT) is associated with favorable outcomes in patients undergoing complex percutaneous coronary intervention (PCI). Therefore, this study analyzed the efficacy and safety of P2Y 12 inhibitor monotherapy, mostly clopidogrel (78%), in complex PCI following short-term DAPT. Methods: The post-hoc analysis of the SMART-CHOICE trial involving 2,993 patients included 498 cases of complex PCIs, defined by at least one of the following features: 3 vessels treated, ≥ 3 stents implanted, ≥ 3 lesions treated, bifurcation with ≥ 2 stents implanted, and a total stent length of ≥ 60 mm. The primary endpoint was major adverse cardiac and cerebrovascular event (MACCE), defined as the composite of all-cause death, myocardial infarction, and stroke. The primary safety endpoint included bleeding, defined as Bleeding Academic Research Consortium (BARC) types 2 to 5. Results: Complex PCI group had a higher risk of MACCE (4.0% vs. 2.3%, hazard ratio [HR] = 1.74, 95% confidence interval [CI]: 1.05–2.89, p = 0.033) and a similar risk of BARC types 2–5 bleeding (2.6% vs. 2.6%, HR = 1.02, 95% CI: 0.56–1.86, p = 0.939) compared with those without complex PCIs. Patients undergoing complex PCIs, followed by P2Y 12 inhibitor monotherapy and 12 months of DAPT exhibited similar rates of MACCE (3.8% vs. 4.2%, HR = 0.92, 95% CI: 0.38–2.21, p = 0.853). Conclusions: P2Y 12 inhibitor monotherapy, mostly clopidogrel, following 3 months of DAPT did not increase ischemic events in patients with complex PCIs.

Purpose We compared the efficacy and safety of third-standard-dose triple and third-standard-dose dual antihypertensive combination therapies in patients with mild to moderate hypertension. Methods This was a phase II multicenter, randomized, double-blind, parallel-group trial. After a 4-week placebo run-in period, 245 participants were randomized to the third-dose triple combination (ALC group; amlodipine 1.67 mg + losartan potassium 16.67 mg + chlorthalidone 4.17 mg) or third-dose dual combination (AL group; amlodipine 1.67 mg + losartan potassium 16.67 mg, LC group; losartan potassium 16.67 mg + chlorthalidone 4.17 mg, AC group; amlodipine 1.67 mg + chlorthalidone 4.17 mg) therapy groups and followed up after 8 weeks. Results The mean systolic blood pressure (BP) reduction was − 18.3 ± 13.2, -13.0 ± 13.3, -16.3 ± 12.4, and − 13.8 ± 13.2 mmHg in the ALC, AL, LC, and AC groups, respectively. The ALC group showed significant systolic BP reduction compared to the AL and AC groups at weeks 4 (p = 0.010 and p = 0.018, respectively) and 8 (p = 0.017 and p = 0.036, respectively). The proportion of systolic BP responders was significantly higher in the ALC group (42.6%) than in the AL (22.0%), LC (23.3%), and AC (27.1%) groups (p = 0.013, p = 0.021 and p = 0.045, respectively) at week 4. The proportion of systolic and diastolic BP responders was significantly higher in the ALC group (59.7%) than in the AL (39.3%) and AC (42.4%) groups (p = 0.022 and p = 0.049, respectively) at week 8. Conclusion Third-standard-dose triple antihypertensive combination therapy demonstrated early effective BP control compared to third-standard-dose dual combination therapies, without increasing adverse drug reactions in patients with mild-to-moderate hypertension. Trial Registration NCT04959305

Controversy remains regarding the optimal antiplatelet regimen in patients with acute coronary syndrome (ACS). This study sought to investigate the efficacy and safety of P2Y12 inhibitor monotherapy compared with conventional dual antiplatelet therapy (DAPT) and aspirin monotherapy in patients with ACS undergoing percutaneous coronary intervention. Data on 4,453 patients were pooled from SMART-DATE and SMART-CHOICE randomized trials. Antiplatelet therapy regimens were categorized as P2Y12 inhibitor monotherapy (P2Y12 inhibitor monotherapy after 3-month DAPT), conventional DAPT (12-month or longer DAPT), and aspirin monotherapy (aspirin monotherapy after 6-month DAPT). The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE, a composite of all-cause death, myocardial infarction, and stroke). Inverse-probability of treatment-weighted (IPTW) analysis was performed. At 1 year, patients in the P2Y12 inhibitor monotherapy had a comparable risk of MACCE compared with those in the conventional DAPT (IPTW-adjusted hazard ratio [HR], 0.655; 95% confidence interval [CI] 0.393 to 1.094; p = 0.106), and tended to have a lower risk of MACCE than those in the aspirin monotherapy (IPTW-adjusted HR, 0.606; 95% CI, 0.347 to 1.058; p = 0.078). The adjusted hazard for the Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding was significantly lower in P2Y12 inhibitor monotherapy than in conventional DAPT (IPTW-adjusted HR, 0.341; 95% CI, 0.190 to 0.614; p0.001) and in aspirin monotherapy (IPTW-adjusted HR, 0.359; 95% CI, 0.182 to 0.708; p = 0.003). In conclusion, among patients with ACS undergoing PCI, P2Y12 inhibitor monotherapy after 3-month DAPT reduced risk of bleeding compared with conventional DAPT and aspirin monotherapy after 6-month DAPT without increasing MACCE.

ObjectiveTo compare P2Y12 inhibitor monotherapy after 3-month dual antiplatelet therapy (DAPT) with 12-month DAPT according to the type of P2Y12 inhibitor in patients undergoing percutaneous coronary intervention (PCI).MethodsThe Smart Angioplasty Research Team: Comparison Between P2Y12 Antagonist Monotherapy vs Dual Antiplatelet Therapy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents (SMART-CHOICE) randomised trial compared 3-month DAPT followed by P2Y12 inhibitor monotherapy with 12-month DAPT. In this trial, 2993 patients undergoing successful PCI with drug-eluting stent were enrolled in Korea. As a prespecified analysis, P2Y12 inhibitor monotherapy after 3-month DAPT versus 12-month DAPT were compared among patients receiving clopidogrel and those receiving potent P2Y12 inhibitor (ticagrelor or prasugrel), respectively. The primary endpoint was a composite of all-cause death, myocardial infarction or stroke at 12 months after the index procedure.ResultsAmong 2993 patients (mean age 64 years), 58.2% presented with acute coronary syndrome. Clopidogrel was prescribed in 2312 patients (77.2%) and a potent P2Y12 inhibitor in 681 (22.8%). There were no significant differences in the primary endpoint between the P2Y12 inhibitor monotherapy group and the DAPT group among patients receiving clopidogrel (3.0% vs 3.0%; HR: 1.02; 95% CI 0.64 to 1.65; p=0.93) as well as among patients receiving potent P2Y12 inhibitors (2.4% vs 0.7%; HR: 3.37; 95% CI 0.77 to 14.78; p=0.11; interaction p=0.1). Among patients receiving clopidogrel, P2Y12 inhibitor monotherapy compared with DAPT showed consistent treatment effects across various subgroups for the primary endpoint. Among patients receiving potent P2Y12 inhibitors, the rate of bleeding (Bleeding Academic Research Consortium types 2– 5) was significantly lower in the P2Y12 inhibitor monotherapy group than in the DAPT group (1.5% vs 5.0%; HR: 0.33; 95% CI 0.12 to 0.87; p=0.03).ConclusionsCompared with 12-month DAPT, clopidogrel monotherapy after 3-month DAPT showed comparable cardiovascular outcomes in patients undergoing PCI.Trial registration numberNCT02079194.

Evidence for the role of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) in patients at high ischemic risk of acute myocardial infarction (AMI) is lacking. This study aimed to investigate the long-term clinical impact of IVUS-guided PCI in patients at high ischemic risk of AMI.Among 13 104 patients with AMI enrolled in the Korea Acute Myocardial Infarction Registry-National Institutes of Health, we selected 8890 patients who underwent successful PCI with second-generation drug-eluting stent implantation and classified them into 2 groups based on whether or not they were at high ischemic risk or not, defined as any of the following: number of stents implanted ≥ 3, 3 vessels treated, ≥ 3 lesions treated, total stent length60mm, left main PCI, diabetes mellitus, and chronic kidney disease. The primary outcome was target lesion failure including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 3 years.In 4070 AMI patients at high ischemic risk, IVUS-guided PCI (21.6%) was associated with a significantly lower risk of target lesion failure at 3 years (6.7% vs 12.0%; HR, 0.54; 95%CI, 0.41-0.72; P.001) than angiography-guided PCI. The results were consistent after confounder adjustment, inversed probability weighting, and propensity score matching.In patients at high ischemic risk of AMI who underwent PCI with second-generation drug-eluting stent implantation, use of IVUS guidance was associated with a significant reduction in 3-year target lesion failure. iCreaT study No. C110016.

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 )

Renexin® is a combination pill of cilostazol and Ginkgo biloba leaf extract that is used for the improvement of ischemic symptoms associated with peripheral arterial disease (PAD). SID142 is a controlled-release tablet of cilostazol (200 mg) and G biloba leaf extract (160 mg) that was developed to address the limitation of BID administration with Renexin. This study aimed to verify that SID142 was not inferior to Renexin in the treatment of patients with PAD.This was a multicenter, randomized, double-blind, active-controlled, parallel-group, Phase III clinical trial. Study subjects were randomized to receive SID142 once daily or Renexin twice a day for 12 weeks. The primary end point was a change in the patient assessment of lower leg pain intensity with the use of a visual analog scale (VAS) after 12 weeks of treatment. If the lower limit of the two-sided 95% CI was greater than -10, the study drug was declared noninferior to the reference drug. Secondary efficacy end points included cold sensation, ankle-brachial index, ankle systolic pressure, maximum walking distance, pain-free walking distance, and investigator's global assessment. Study group results were compared 4, 8, and 12 weeks after treatment. Adverse events were assessed as a safety end point.In total, 344 subjects from 19 medical centers were screened, and a total of 170 subjects were randomly assigned to either the SID142 (n = 86) or the Renexin (n = 84) group. Analysis of the change in lower extremity pain at 12 weeks compared with baseline revealed that SID142 was not inferior to Renexin (21.44 [19.23] vs 22.30 [17.75]; 95% CI, -7.70 to 5.97; P = 0.5942). No significant differences were found between groups in any secondary efficacy end point. However, the incidence of adverse reactions was significantly lower in the SID142 group (22.35% vs 39.29%; P = 0.0171).SID142 once daily was not inferior to Renexin twice a day for efficacy in patients with PAD. SID142 had a favorable safety profile.gov identifier: NCT03318276.

The authors developed and validated a diagnostic algorithm using the optimal upper and lower cut‐off values of office and home BP at which ambulatory BP measurements need to be applied. Patients presenting with high BP (≥140/90 mm Hg) at the outpatient clinic were referred to measure office, home, and ambulatory BP. Office and home BP were divided into hypertension, intermediate (requiring diagnosis using ambulatory BP), and normotension zones. The upper and lower BP cut‐off levels of intermediate zone were determined corresponding to a level of 95% specificity and 95% sensitivity for detecting daytime ambulatory hypertension by using the receiver operator characteristic curve. A diagnostic algorithm using three methods, OBP‐ABP: office BP measurement and subsequent ambulatory BP measurements if office BP is intermediate zone; OBP‐HBP‐ABP: office BP, subsequent home BP measurement if office BP is within intermediate zone and subsequent ambulatory BP measurement if home BP is within intermediate zone; and HBP‐ABP: home BP measurement and subsequent ambulatory BP measurements if home BP is within intermediate zone, were developed and validated. In the development population (n = 256), the developed algorithm yielded better diagnostic accuracies than 75.8% (95%CI 70.1–80.9) for office BP alone and 76.2% (95%CI 70.5–81.3) for home BP alone as follows: 96.5% (95%CI: 93.4–98.4) for OBP‐ABP, 93.4% (95%CI: 89.6–96.1) for OBP‐HBP‐ABP, and 94.9% (95%CI: 91.5–97.3%) for HBP‐ABP. In the validation population (n = 399), the developed algorithm showed similarly improved diagnostic accuracy. The developed algorithm applying ambulatory BP measurement to the intermediate zone of office and home BP improves the diagnostic accuracy for hypertension.

ImportanceAlthough P2Y12 inhibitor monotherapy after a minimum period of dual antiplatelet therapy (DAPT) is a well-known way to reduce the risk of bleeding after percutaneous coronary intervention (PCI), data comparing long-term clinical outcomes between P2Y12 inhibitor monotherapy and extended DAPT in patients undergoing PCI have been unavailable.ObjectiveTo identify the long-term safety and efficacy of P2Y12 inhibitor monotherapy following 3 months of DAPT after PCI.Design, Setting, and ParticipantsThe Smart Angioplasty Research Team: Comparison Between P2Y12 Antagonist Monotherapy and Dual Antiplatelet Therapy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents (SMART-CHOICE) trial was an open-label, noninferiority, randomized clinical trial, enrolling patients who underwent PCI with drug-eluting stent at 33 hospitals in Korea from March 2014 through July 2017. Clinical follow-up was extended to 3 years and completed in August 2020.InterventionsPatients were randomly assigned to either P2Y12 inhibitor monotherapy after 3 months of DAPT or DAPT for 12 months or longer.Main Outcomes and MeasuresThe primary end point was major adverse cardiac and cerebrovascular events (a composite of all-cause death, myocardial infarction, or stroke) at 3 years. The secondary end points included the components of the primary end point, bleeding (defined as Bleeding Academic Research Consortium [BARC] types 2-5), and major bleeding (BARC types 3-5).ResultsIn total, 2993 patients were randomly assigned to receive P2Y12 inhibitor monotherapy after 3 months of DAPT (1495 patients [50%]; mean [SD] age, 64.6 [10.7] years; 1087 [72.7%] male) or prolonged DAPT (1498 patients [50%]; mean [SD] age, 64.6 [10.7] years; 1111 [74.2%] male) after PCI. At 3 years, the primary end point occurred in 87 individuals (6.3%) in the P2Y12 inhibitor monotherapy group and 83 (6.1%) in the prolonged DAPT group (hazard ratio [HR], 1.06 [95% CI, 0.79-1.44]; P = .69). P2Y12 inhibitor monotherapy significantly reduced the risk of bleeding (BARC types 2-5: 112 [3.2%] vs 44 [8.2%]; HR, 0.39 [95% CI, 0.28-0.55]; P P = .048), compared with prolonged DAPT. The landmark analyses between 3 months and 3 years and per-protocol analyses showed consistent results.Conclusions and RelevanceAmong patients who underwent PCI and completed 3-month DAPT, P2Y12 inhibitor monotherapy was associated with a lower risk of clinically relevant major bleeding than prolonged DAPT. Although the 3-year risk of ischemic cardiovascular events was comparable between the 2 groups, this result should be interpreted with caution owing to the limited number of events and sample size.Trial RegistrationClinicalTrials.gov Identifier: NCT02079194

Recently, the left distal radial approach (DRA) for percutaneous coronary intervention (PCI) has been shown to be a feasible option, but there are limited data regarding the feasibility of performing bifurcation PCI via the left DRA. Therefore, this study aimed to describe our experience with the contemporary left DRA to perform PCI of bifurcation lesions. Between December 2017 and December 2019, we identified 106 patients treated with bifurcation PCI via the left DRA. We evaluated the success rate of PCI, access-site complications including major bleeding requiring surgery or transfusion, hematoma, distal and forearm radial artery occlusion, and 30-day mortality. Eleven patients (10.4%) treated with left main bifurcation and true bifurcations accounted for 39.6% of cases, with the left anterior descending artery/diagonal branch being the most frequent bifurcation site (57.5%, 61/106). PCI was performed using a 6-French guiding catheter in 101 (95.3%) cases. Successful PCI for bifurcation lesions via the left DRA was achieved in all 106 patients without access-site cross-over. There was no major bleeding, distal and forearm radial artery occlusion, forearm hematoma, or mortality at 30 days. The left DRA is a safe and feasible alternative access site for bifurcation PCI in selected patients.

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).

Background The benefits and risks of prolonged dual antiplatelet therapy (DAPT) have not been studied extensively across a broad spectrum of acute coronary syndromes. In this study we investigated whether treatment effects of prolonged DAPT were consistent in patients presenting with ST-segment elevation myocardial infarction (STEMI) vs. non-STEMI (NSTEMI).Methods and Results:As a post hoc analysis of the SMART-DATE trial, effects of ≥12 vs. 6 months DAPT were compared among 1,023 patients presenting with STEMI and 853 NSTEMI patients. The primary outcome was a composite of recurrent myocardial infarction (MI) or stent thrombosis at 18 months after the index procedure. Compared with the 6-month DAPT group, the rate of the composite endpoint was significantly lower in the ≥12-month DAPT group (1.2% vs. 3.8%; hazard ratio [HR] 0.31, 95% confidence interval [CI] 0.12-0.77; P=0.012). The treatment effect of ≥12- vs. 6-month DAPT on the composite endpoint was consistent among NSTEMI patients (0.2% vs. 1.2%, respectively; HR 0.20, 95% CI 0.02-1.70; P=0.140; Pinteraction=0.718). In addition, ≥12-month DAPT increased Bleeding Academic Research Consortium (BARC) Type 2-5 bleeding among both STEMI (4.4% vs. 2.0%; HR 2.18, 95% CI 1.03-4.60; P=0.041) and NSTEMI (5.1% vs. 2.2%; HR 2.37, 95% CI 1.08-5.17; P=0.031; Pinteraction=0.885) patients. Conclusions Compared with 6-month DAPT, ≥12-month DAPT reduced recurrent MI or stent thrombosis regardless of the type of MI at presentation.

Background: Although the current guidelines endorse the PRECISE-DAPT score (Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy) to inform clinical decisions regarding duration of DAPT in patients undergoing percutaneous coronary intervention, use of the PRECISE-DAPT score to guide duration of DAPT has not been properly validated by randomized trials focused on the population with acute coronary syndrome. This study aimed to evaluate the usefulness of the PRECISE-DAPT score for predicting future bleeding and ischemic events and to compare clinical outcomes of short-term and long-term DAPT duration according to the PRECISE-DAPT score in patients with acute coronary syndrome. Methods: This was a substudy of the SMART-DATE trial (6- Versus 12-Month or Longer Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome), in which patients with acute coronary syndrome undergoing percutaneous coronary intervention were randomly assigned to either 6- (n=1357) or 12-month or longer DAPT (n=1355). Major bleeding (Bleeding Academic Research Consortium type 3–5) and ischemic (myocardial infarction, stent thrombosis, or ischemic stroke) events at 18 months after the index procedure were compared between the 6- and 12-month or longer DAPT groups, according to PRECISE-DAPT score. Results: The PRECISE-DAPT score was moderately effective at predicting bleeding events (area under the curve, 0.754 [95% CI, 0.655–0.854]; P P =0.040; absolute risk difference, +1.3%; P =0.035) with similar bleeding risk (0.4% versus 0.3%; HR, 2.00 [95% CI, 0.37–10.94]; P =0.422; absolute risk difference, +0.2%; P =0.498), compared with 12-month or longer DAPT. Among patients with high PRECISE-DAPT score (≥25, n=745 [27.5%]), 6-month DAPT presented a similar ischemic risk (4.8% versus 3.4%; HR, 1.43 [95% CI, 0.68–2.98], P =0.348; absolute risk difference, +1.5%; P =0.327) but significantly reduced major bleeding risk (0.6% versus 2.3%; HR, 0.25 [95% CI, 0.05–1.17]; P =0.079; absolute risk difference, −1.7%; P =0.045). Conclusions: Consistent with current guidelines, determination of the duration of DAPT according to PRECISE-DAPT score could improve the clinical outcomes in patients with acute coronary syndrome after percutaneous coronary intervention with current-generation drug-eluting stents. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01701453.

Resumen Introduccion y objetivos La vigente guia de practica clinica para el tratamiento de la hipercolesterolemia recomienda mantener la terapia intensiva con estatinas de los pacientes tratados con implante de stent farmacoactivo (SFA). Sin embargo, el tratamiento intensivo con estatinas, una vez estabilizado el paciente, con frecuencia no se lleva a cabo en la practica clinica tras la revascularizacion con SFA. Actualmente se desconoce el impacto de mantener esa terapia intensiva con estatinas en estos pacientes estables. Se estudia la reduccion de eventos adversos en pacientes clinicamente estables en monoterapia con acido acetilsalicilico tras el implante de un SFA segun la terapia de alta o baja intensidad con estatinas. Metodos Se aleatorizo a pacientes estables a los 12 meses del implante de un SFA y en monoterapia con acido acetilsalicilico a recibir terapia de alta intensidad con estatinas (atorvastatina 40 mg; n = 1.000) o terapia de baja intensidad (pravastatina 20 mg; n = 1.000). El objetivo primario fueron los eventos clinicos adversos a los 12 meses de seguimiento (objetivo compuesto de muerte, infarto de miocardio, revascularizacion, trombosis del stent, accidente cerebrovascular, insuficiencia renal, necesidad de intervencion arterial periferica y nuevo ingreso hospitalario por eventos cardiacos). Resultados El objetivo primario a los 12 meses de seguimiento se produjo en 25 pacientes (2,5%) en tratamiento de alta intensidad con estatinas y en 40 (4,1%) en tratamiento de baja intensidad (HR = 0,58; IC95%, 0,36-0,92; p = 0,018). Esta diferencia se debio principalmente a la menor incidencia de muerte cardiaca (0 frente al 0,4%; p = 0,025) y de infarto de miocardio no relacionado con el vaso diana (el 0,1 frente al 0,7%; p = 0,033) en el grupo de tratamiento de alta intensidad con estatinas. Conclusiones Entre los pacientes clinicamente estables en monoterapia con acido acetilsalicilico, el tratamiento de alta intensidad con estatinas redujo la incidencia de eventos comparado con el tratamiento de baja intensidad. Registro de ensayos clinicos: URL: http://www.clinicaltrials.gov . Identificador unico: NCT01557075 .

Summary Introduction Fatty liver disease (FLD) is correlated with cardiovascular disease. Carotid intima–media thickness (CIMT) and coronary artery calcium score (CACS) can noninvasively identify subclinical atherosclerosis and predict risk for cardiovascular events. This study evaluated CIMT and CACS measurements to detect subclinical atherosclerosis in patients with and without FLD. Methods Patients who underwent carotid and abdominal ultrasounds as well as cardiac computed tomography (CT) scans were evaluated retrospectively. The differences between the mean CIMT value and CACS measurements in patients with FLD and those with normal livers were estimated. Results Among 819 patients (average age of 53.3 ± 11.2 years), 330 had FLD. The CIMT was greater in patients with FLD compared to the controls (0.79 ± 0.17 vs 0.76 ± 0.17 mm, p = 0.012), and carotid plaques were more commonly seen in patients with FLD. The incidence of a composite of larger CIMT (≥ 75th percentile) plus plaque presence was higher in FLD patients (43.3 vs 36.0%, p = 0.041). Particularly among young patients (≤ 50), the CIMT was larger in patients with FLD than in the controls. FLD increased the risk of a composite of large CIMT plus plaque presence in young patients (odds ratio 1.92, 95% confidence interval 1.05–3.49, p = 0.034). However, patients with FLD had no greater incidence of CACS of over 100 than the controls. Conclusion CIMT was a better marker of underlying subclinical atherosclerotic risk among patients with FLD than CACS. FLD particularly, increases the risk of subclinical atherosclerosis in patients younger than 50 years of age. These patients should undergo screening CIMT to detect atherosclerosis and modify risk factors.

Identifying patients with high bleeding risk (HBR) is important when making decisions for antiplatelet therapy strategy. This study evaluated the impact of ticagrelor monotherapy after 3-month dual antiplatelet therapy (DAPT) according to HBR in acute coronary syndrome (ACS) patients treated with drug eluting stents (DESs).In this post-hoc analysis of the TICO trial, HBR was defined by 2 approaches: meeting Academic Research Consortium for HBR (ARC-HBR) criteria or Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent DAPT (PRECISE-DAPT) score ≥25. The primary outcome was a 3-12 months net adverse clinical event (composite of major bleeding and adverse cardiac and cerebrovascular events).Of the 2,980 patients without adverse events during the first 3 months after DES implantation, 453 (15.2%) were HBR by ARC-HBR criteria and 504 (16.9%) were HBR by PRECISE-DAPT score. The primary outcome rate was higher in HBR versus non-HBR patients (by ARC-HBR criteria: hazard ratio [HR], 2.87; 95% confidence interval [CI], 1.76-4.69; p0.001; by PRECISE-DAPT score: HR, 3.09; 95% CI, 1.92-4.98; p0.001). Ticagrelor monotherapy after 3-month DAPT was associated with lower primary outcome rate than ticagrelor-based 12-month DAPT regardless of HBR by ARC-HBR criteria, with similar magnitudes of therapy effect for HBR and non-HBR patients (p-interaction=0.400). Results were consistent by PRECISE-DAPT score (p-interaction=0.178).In ACS patients treated with DESs, ticagrelor monotherapy after 3-month DAPT was associated with lower rate of adverse clinical outcomes regardless of HBR, with similar magnitudes of therapy effect between HBR and non-HBR.ClinicalTrials.gov Identifier: NCT02494895.

Summary Background: Following femur fracture, medullary fat enters the systemic circulation and altered pulmonary haemodynamics may contribute to pulmonary complications. This study evaluated the association between right ventricular (RV) function and pulmonary complications in patients with femur fracture. Methods: Patients with a femur fracture who had undergone pre-operative echocardiography that included RV peak global longitudinal strain (RV GLS) were evaluated retrospectively between March 2015 and February 2016. Pulmonary complications were defined as the development of pneumonia or pulmonary thromboembolism during the first postoperative month. Results: Among 78 patients, pulmonary complications developed in eight (10.3%). The RV GLS value of all patients was lower than the normal range. In addition, the RV GLS value of patients with pulmonary complications was significantly lower than that of patients without pulmonary complications. Multivariate regression analyses found that worse RV GLS values independently predicted pulmonary complications [odds ratio (OR) 2.09, 95% confidence interval (CI) 1.047–4.151, p = 0.037]. Receiver operating characteristic curve analysis found that a RV GLS value of –14.85% was the best cut-off value to predict pulmonary complications; sensitivity: 75.0%; specificity: 62.9%. Moreover, patients with RV GLS values > –14.85% had significantly lower pulmonary complication-free survival. Conclusions: In patients with femur fracture, RV GLS values could help predict pulmonary complications. Therefore, patients with RV GLS values > –14.85 should be monitored closely before and after surgery for femur fracture.

Background Differences between the recently suggested outcome-driven diagnostic threshold of home blood pressure (HBP) measurements and the currently recommended diagnostic threshold of HBP measurements may cause a disagreement between 24-hour ambulatory blood pressure (ABP) and HBP measurements in the diagnosis of hypertension. We evaluated the agreement of various HBP diagnostic thresholds (135/85, 130/85, and 130/80 mm Hg) to ABP measurements, as a reference method. Methods Patients who were confirmed to have high BP (≥140/90 mm Hg) at the outpatient clinic were referred. HBP measurement was performed for 7 days in triplicates every morning and evening. The 24-hour ABP measurement was performed on the 8th day. Using 24-hour ABP measurement as a reference method, we analyzed HBP diagnostic thresholds at 135/85, 130/85, and 130/80 mm Hg. Results Among 319 patients, 256 patients (mean age, 51.8 ± 9.7 years; 119 men) with valid HBP measurements and 24-hour ABP measurements were enrolled. The threshold of 130/80 mm Hg showed the highest diagnostic sensitivity (P = 0.001) with diagnostic agreement by Kappa statistics. Using 130/80 mm Hg as a diagnostic threshold of hypertension, the prevalence of masked hypertension was significantly lower than 130/85 and 135/85 mm Hg (7.8, 15.2, and 18.4%, respectively, P = 0.002). Conclusions The present study suggests that lowering the diagnostic thresholds of HBP measurement from 135/85 mm Hg to 130/80 mm Hg may improve diagnostic accuracy for hypertension.

Background and purpose Based on the data of patients who measured office BP (OBP) in controlled condition, home BP (HBP), and 24-hour ambulatory BP (24hABP) for diagnosis of hypertension, we developed and validated a diagnostic algorithm for hypertension. Methods Patients who have high BP (≥140/90 mmHg) at the outpatient clinic were referred to measure OBP in controlled condition, HBP and 24hABP. The OBP was measured three times at each visit for 3 days in controlled condition by using a validated oscillometric device. HBP was measured for 7 days in triplicates every morning and evening. The 24hABP was measured on the 8th day. Same study protocol was used for development and validation population. Results In the development of algorithm, 319 patients were recruited and data of 256 patients (51.8±9.7 years, 119 men) with valid HBP and 24hABP measurements were analyzed. In the validation of algorithm, 300 patients were recruited and data of 257 patients (52.4±9.8 years, 126 men) with valid HBP and 24hABP measurements were analyzed. In the development population, the prevalence of masked hypertension was 19.5% (n=50) and most of them (n=47, 94%) was in the range of 130–139/80–89 mmHg. The BP in the range of 130–144/80–94 mmHg was defined as the grey zone of OBP, because prevalence of white-coat hypertension was lowered to 1.6% from 4.3% with threshold of 145/95 mmHg. The diagnostic sensitivity, specificity, positive and negative predictive value of OBP was improved to 97.4%, 76.5, 96.5% and 81.3% after excluding the grey zone of OBP (n=125). The diagnostic agreement between 24hABP and HBP in the grey zone of OBP was 64%. The diagnostic sensitivity, specificity, positive and negative predictive value of HBP were 88.8%, 74.7, 93.5% and 61.5% after excluding the grey zone of HBP (130–134/80–84 mmHg, n=28). Based upon these results, we developed a diagnostic algorithm for hypertension by using on out-of-office BP measurements to improved diagnostic accuracy of hypertension (Figure). In the validation population, the developed algorithm showed similar diagnostic accuracy. Diagnostic algorithm for hypertension Conclusion For accurate diagnosis of hypertension, OBP measurement according to guidelines and 24hABP measurement to grey zone of OBP is preferred. To improve diagnostic accuracy of HBP measurement, 24hABP measurement to grey zone of HBP is required. Acknowledgement/Funding Part of this study was supported by a grand from Dong-A ST Co. Ltd., Seoul, Korea.

Background and rationale Dual antiplatelet therapy (DAPT) is a fundamental treatment that optimizes clinical outcomes after percutaneous coronary intervention, especially in patients with acute coronary syndrome (ACS). Although current international guidelines recommend DAPT for at least 12 months after implantation of a drug-eluting stent in patients with ACS, these recommendations are not based on randomized controlled trials dedicated to ACS population. Study design The SMART-DATE trial is a prospective, multicenter, randomized, and open-label study to demonstrate the noninferiority of 6-month DAPT compared with 12 months or longer DAPT in patients with ACS undergoing percutaneous coronary intervention. A total of 2,700 patients will undergo prospective, random assignment to either of the DAPT duration groups. To minimize the bias from different stent devices, the type of stents will be randomly assigned (everolimus-eluting stents, zotarolimus-eluting stents, or biolimus A9-eluting stents). The primary end point is a composite of all-cause death, myocardial infarction, and cerebrovascular events at 18 months after the index procedure. The major secondary end points are definite/probable stent thrombosis defined by the Academic Research Consortium and bleeding defined by Bleeding Academic Research Consortium type 2-5. Conclusions The SMART-DATE randomized trial is the first study exploring the safety of 6-month DAPT compared with conventional 12-month or longer DAPT dedicated to patients with ACS after second-generation drug-eluting stent implantation.

Importance Discontinuing aspirin after short-term dual antiplatelet therapy (DAPT) was evaluated as a bleeding reduction strategy. However, the strategy of ticagrelor monotherapy has not been exclusively evaluated in patients with acute coronary syndromes (ACS). Objective To determine whether switching to ticagrelor monotherapy after 3 months of DAPT reduces net adverse clinical events compared with ticagrelor-based 12-month DAPT in patients with ACS treated with drug-eluting stents. Design, Setting, and Participants A randomized multicenter trial was conducted in 3056 patients with ACS treated with drug-eluting stents between August 2015 and October 2018 at 38 centers in South Korea. Follow-up was completed in October 2019. Interventions Patients were randomized to receive ticagrelor monotherapy (90 mg twice daily) after 3-month DAPT (n = 1527) or ticagrelor-based 12-month DAPT (n = 1529). Main Outcomes and Measures The primary outcome was a 1-year net adverse clinical event, defined as a composite of major bleeding and adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, or target-vessel revascularization). Prespecified secondary outcomes included major bleeding and major adverse cardiac and cerebrovascular events. Results Among 3056 patients who were randomized (mean age, 61 years; 628 women [20%]; 36% ST-elevation myocardial infarction), 2978 patients (97.4%) completed the trial. The primary outcome occurred in 59 patients (3.9%) receiving ticagrelor monotherapy after 3-month DAPT and in 89 patients (5.9%) receiving ticagrelor-based 12-month DAPT (absolute difference, −1.98% [95% CI, −3.50% to −0.45%]; hazard ratio [HR], 0.66 [95% CI, 0.48 to 0.92];P = .01). Of 10 prespecified secondary outcomes, 8 showed no significant difference. Major bleeding occurred in 1.7% of patients with ticagrelor monotherapy after 3-month DAPT and in 3.0% of patients with ticagrelor-based 12-month DAPT (HR, 0.56 [95% CI, 0.34 to 0.91];P = .02). The incidence of major adverse cardiac and cerebrovascular events was not significantly different between the ticagrelor monotherapy after 3-month DAPT group (2.3%) vs the ticagrelor-based 12-month DAPT group (3.4%) (HR, 0.69 [95% CI, 0.45 to 1.06];P = .09). Conclusions and Relevance Among patients with acute coronary syndromes treated with drug-eluting stents, ticagrelor monotherapy after 3 months of dual antiplatelet therapy, compared with ticagrelor-based 12-month dual antiplatelet therapy, resulted in a modest but statistically significant reduction in a composite outcome of major bleeding and cardiovascular events at 1 year. The study population and lower than expected event rates should be considered in interpreting the trial. Trial Registration ClinicalTrials.gov Identifier:NCT02494895

This paper is about use cases of congestive heart failure. The purpose of this paper is to know through the use of the congestive heart failure use cases the currently developing smart patch at some stage to apply to patients with congestive heart failure. This smart patch has a total of three sensors. The sensor is an electrocardiogram, acceleration, impedance. We examined definitions, symptoms, causes, diagnosis, and methods of congestive heart failure and we have described the process from the stage where the patient first visited the hospital to the stage where he or she is discharged to the hospital, as a total of ten stages of use cases. The smart patch currently under development can be applied at the stage of confirming the therapeutic effect of congestive heart failure patients.

Background/objectives The effect of aspirin and clopidogrel in a fixed-dose combination (FDC) on platelet function was compared with separate formulations in patients that had undergone percutaneous coronary intervention (PCI) with drug-eluting stent (DES). Methods This was a phase IV, prospective, multicenter, single-arm, non-inferiority study. Patients that had taken aspirin 100mg and clopidogrel 75mg once daily as separate formulations for >6months after PCI with DES were enrolled, and then switched to an aspirin/clopidogrel FDC once-daily for 4weeks. Platelet reactivity was determined using the VerifyNow® P2Y12 assay at baseline (immediately prior to switching) and 4weeks later. Results A total of 648 patients (the full-analysis population; age, 63.6±9.0years; male, 76.5%) finished the study, and 565 (the per-protocol population) completed without protocol violations. In the per-protocol population, the % inhibitions of P2Y12 and ARU were not significantly different between baseline and after 4weeks of FDC treatment (29.2±20.0% to 29.0±19.9%, P=0.708; 445.1±69.2 to 446.2±63.0, P=0.799, respectively) and the difference in P2Y12 inhibition observed did not exceed the predetermined limit of non-inferiority (95% CI, −0.9 to 1.3). In the full-analysis population, the % inhibitions of P2Y12, PRU, and ARU were not significantly changed after 4weeks of FDC treatment. Conclusions This study demonstrates that the efficacy of platelet inhibition by an aspirin/clopidogrel FDC was not inferior to that of separate aspirin and clopidogrel formulations in patients that had undergone PCI with DES.

Summary Background Current guidelines recommend dual antiplatelet therapy (DAPT) of aspirin plus a P2Y12 inhibitor for at least 12 months after implantation of drug-eluting stents (DES) in patients with acute coronary syndrome. However, available data about the optimal duration of DAPT in patients with acute coronary syndrome undergoing percutaneous coronary intervention are scant. We aimed to investigate whether a 6-month duration of DAPT would be non-inferior to the conventional 12-month or longer duration of DAPT in this population. Methods We did a randomised, open-label, non-inferiority trial at 31 centres in South Korea. Patients were eligible if they had unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction, and underwent percutaneous coronary intervention. Enrolled patients were randomly assigned, via a web-based system by computer-generated block randomisation, to either the 6-month DAPT group or to the 12-month or longer DAPT group, with stratification by site, clinical presentation, and diabetes. Assessors were masked to treatment allocation. The primary endpoint was a composite of all-cause death, myocardial infarction, or stroke at 18 months after the index procedure in the intention-to-treat population. Secondary endpoints were the individual components of the primary endpoint; definite or probable stent thrombosis as defined by the Academic Research Consortium; and Bleeding Academic Research Consortium (BARC) type 2–5 bleeding at 18 months after the index procedure. The primary endpoint was also analysed per protocol. This trial is registered with ClinicalTrials.gov, number NCT01701453. Findings Between Sept 5, 2012, and Dec 31, 2015, we randomly assigned 2712 patients; 1357 to the 6-month DAPT group and 1355 to the 12-month or longer DAPT group. Clopidogrel was used as a P2Y12 inhibitor for DAPT in 1082 (79·7%) patients in the 6-month DAPT group and in 1109 (81·8%) patients in the 12-month or longer DAPT group. The primary endpoint occurred in 63 patients in the 6-month DAPT group and in 56 patients in the 12-month or longer DAPT group (cumulative event rate 4·7% vs 4·2%; absolute risk difference 0·5%; upper limit of one-sided 95% CI 1·8%; p non-inferiority =0·03 with a predefined non-inferiority margin of 2·0%). Although all-cause mortality did not differ significantly between the 6-month DAPT group and the 12-month or longer DAPT group (35 [2·6%] patients vs 39 [2·9%]; hazard ratio [HR] 0·90 [95% CI 0·57–1·42]; p=0·90) and neither did stroke (11 [0·8%] patients vs 12 [0·9%]; 0·92 [0·41–2·08]; p=0·84), myocardial infarction occurred more frequently in the 6-month DAPT group than in the 12-month or longer DAPT group (24 [1·8%] patients vs ten [0·8%]; 2·41 [1·15–5·05]; p=0·02). 15 (1·1%) patients had stent thrombosis in the 6-month DAPT group compared with ten (0·7%) in the 12-month or longer DAPT group (HR 1·50 [95% CI 0·68–3·35]; p=0·32). The rate of BARC type 2–5 bleeding was 2·7% (35 patients) in the 6-month DAPT group and 3·9% (51 patients) in the 12-month or longer DAPT group (HR 0·69 [95% CI 0·45–1·05]; p=0·09). Results from the per-protocol analysis were similar to those from the intention-to-treat analysis. Interpretation The increased risk of myocardial infarction with 6-month DAPT and the wide non-inferiority margin prevent us from concluding that short-term DAPT is safe in patients with acute coronary syndrome undergoing percutaneous coronary intervention with current-generation DES. Prolonged DAPT in patients with acute coronary syndrome without excessive risk of bleeding should remain the standard of care. Funding Abbott Vascular Korea, Medtronic Vascular Korea, Biosensors Inc, and Dong-A ST.

Various home blood-pressure (HBP) measurement schedules were compared to determine the optimal schedule of HBP measurement for the diagnosis of hypertension. Out of 319 individuals who were suspected of having hypertension based on office BP measurements and who did not take antihypertensive drugs, 157 individuals who completed 42 HBP measurements over 7 days and who had a valid 24-h ambulatory blood pressure (ABP) measurement were included in this analysis. We evaluated five HBP measurement schedules to determine the optimal HBP measurement schedule for the diagnosis of hypertension. The cumulatively averaged HBP from 5 to 6 measurement days showed a Pearson correlation coefficient of >0.990 compared to HBP averaged for 6 or 7 days depending on the method. The intraclass correlation coefficient of the cumulatively averaged HBP measurements compared with the 24-h ABP measurement was excellent (≥0.75) from the average of three measurement days and increased steadily with increasing averaged days of HBP measurements. Compared with a diagnosis using a 24-h ABP measurement, the diagnostic sensitivity, specificity, and positive and negative predictive values of HBP measurements were not different among the five methods. The diagnostic agreement of cumulatively averaged HBP measurements was nearly perfect (kappa ≥ 0.9) from the average of five measurement days compared with a diagnosis based on HBP measurements averaged for 6 or 7 days and diagnosis based on averaged HBP measurements of previous days. We suggest obtaining HBP measurements over 5 days or more, in the morning and evening, taking two or more measurements per occasion, and averaging all of the readings as the optimal schedule of HBP measurement for the diagnosis of hypertension.