P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy After Deployment of a Drug-Eluting Stent: The SHARE Randomized Clinical Trial.

Importance: P2Y12 inhibitor monotherapy after dual antiplatelet therapy (DAPT; a P2Y12 inhibitor plus aspirin) for a brief duration has recently emerged as an attractive alternative for patients undergoing percutaneous coronary intervention (PCI) with a drug-eluting stent. Objective: To investigate whether P2Y12 inhibitor monotherapy after 3 months of DAPT was noninferior to 12 months of DAPT following PCI with a drug-eluting stent. Design, Setting, and Participants: The Short-Term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-Eluting Stent (SHARE) open-label, noninferiority randomized clinical trial was conducted from December 15, 2017, through December 14, 2020. Final 1-year clinical follow-up was completed in January 2022. This study was a multicenter trial that was conducted at 20 hospitals in South Korea. Patients who underwent successful PCI with bioabsorbable polymer everolimus-eluting stents were enrolled. Interventions: Patients were randomly assigned to receive P2Y12 inhibitor monotherapy after 3 months of DAPT (n = 694) or 12 months of DAPT (n = 693). Main Outcomes and Measures: The primary outcome was a net adverse clinical event, a composite of major bleeding (based on Bleeding Academic Research Consortium type 3 or type 5 bleeding) and major adverse cardiac and cerebrovascular events (cardiac death, myocardial infarction, stent thrombosis, stroke, or ischemia-driven target lesion revascularization) between 3 and 12 months after the index PCI. The major secondary outcomes were major adverse cardiac and cerebrovascular events and major bleeding. The noninferiority margin was 3.0%. Results: Of the total 1452 eligible patients, 65 patients were excluded before the 3-month follow-up, and 1387 patients (mean [SD] age, 63.0 [10.7] years; 1055 men [76.1%]) were assigned to P2Y12 inhibitor monotherapy (n = 694) or DAPT (n = 693). Between 3 and 12 months of follow-up, the primary outcome (using Kaplan-Meier estimates) occurred in 9 patients (1.7%) in the P2Y12 inhibitor monotherapy group and in 16 patients (2.6%) in the DAPT group (absolute difference, -0.93 [1-sided 95% CI, -2.64 to 0.77] percentage points; P < .001 for noninferiority). For the major secondary outcomes (using Kaplan-Meier estimates), major adverse cardiac and cerebrovascular events occurred in 8 patients (1.5%) in the P2Y12 inhibitor monotherapy group and in 12 patients (2.0%) in the DAPT group (absolute difference, -0.49 [95% CI, -2.07 to 1.09] percentage points; P = .54). Major bleeding occurred in 1 patient (0.2%) in the P2Y12 inhibitor monotherapy group and in 5 patients (0.8%) in the DAPT group (absolute difference, -0.60 [95% CI, -1.33 to 0.12] percentage points; P = .10). Conclusions and Relevance: In patients with coronary artery disease undergoing PCI with the latest generation of drug-eluting stents, P2Y12 inhibitor monotherapy after 3-month DAPT was not inferior to 12-month DAPT for net adverse clinical events. Considering the study population and lower-than-expected event rates, further research is required in other populations. Trial Registration: ClinicalTrials.gov Identifier: NCT03447379.

Diagnostic and Prognostic Value of Ergonovine Echocardiography for Noninvasive Diagnosis of Coronary Vasospasm.

OBJECTIVES: This study sought to obtain large-scale evidence supporting the clinical usefulness of ergonovine echocardiography. BACKGROUND: The role of noninvasive ergonovine provocation testing with echocardiographic monitoring of ventricular wall motion (ergonovine echocardiography) needs to be defined. METHODS: Clinical data of patients who underwent ergonovine echocardiography in 3 tertiary referral hospitals in South Korea were analyzed. RESULTS: Ergonovine echocardiography was performed in 14,012 patients (mean age 52.8 ± 11.1 years; 6,213 [44.3%] women) after exclusion of significant coronary arterial stenosis by functional (treadmill or perfusion scan, n = 9,824) or anatomic test (invasive or computerized tomographic coronary angiography, n = 4,188). Premature termination developed in 0.4% (n = 51), and a positive result was observed in 2,144 patients (15.3%), with variable frequencies according to the diagnosis (acute coronary syndrome [38.2%], variant angina [31.8%], effort angina [14.9%], aborted sudden cardiac death [17.6%], syncope [9.9%]). There was no mortality or development of myocardial infarction during the test. During median follow-up of 11.4 (interquartile range: 7.2 to 15.8) years, death of any cause and cardiovascular death occurred in 494 and 143 patients, respectively. The 10-year overall (96.7 ± 0.2% vs. 91.5 ± 0.6%; p < 0.0001) and cardiovascular mortality-free (99.2 ± 0.1% vs. 96.7 ± 0.4%; p < 0.0001) survival rates were lower in patients with positive ergonovine echocardiography. Regarding patients with positive test results, the functional test group and the anatomic test group did not show a significant difference in the survival rates. After adjustment of age and male sex, a positive test was an independent risk factor associated with all-cause mortality (hazard ratio: 1.879, 95% confidence interval: 1.548 to 2.280; p < 0.001) and cardiovascular death (hazard ratio: 2.903, 95% confidence interval: 2.061 to 4.089; p < 0.001). CONCLUSIONS: Ergonovine echocardiography for coronary vasospasm diagnosis could be safely performed even without angiographic documentation of fixed coronary stenosis depending on the clinical presentation, and provided important prognostic implication. Ergonovine echocardiography can replace the invasive spasm provocation testing, which has been overlooked unfairly.

Randomized Trial Evaluating Percutaneous Coronary Intervention for the Treatment of Chronic Total Occlusion.

BACKGROUND: Procedural results for percutaneous coronary intervention (PCI) in coronary vessels with chronic total occlusion (CTO) have improved in recent years, and PCI strategies have moved toward more complete revascularization with more liberal use of CTO-PCI. However, evidence evaluating CTO-PCI is limited to observational studies and small clinical trials. METHODS: In this open-label, multicenter, randomized, noninferiority trial, PCI-eligible patients were assigned to receive either 1 of 2 strategies: PCI or no PCI for the qualifying de novo CTO lesion with the option for PCI of obstructive non-CTO lesions at the discretion of the operator. The primary end point was a composite of death, myocardial infarction, stroke, or any revascularization. Health-related quality of life was assessed at baseline and at 1, 6, 12, 24, and 36 months. Because of slow recruitment, the trial was stopped before completion of the 1284 planned enrollments. RESULTS: Between March 2010 and September 2016, 834 patients were randomly assigned to the CTO-PCI (n=417) or no CTO-PCI (n=398) strategy. Among the patients assigned to the no CTO-PCI strategy, 78 (19.6%) crossed over to receive staged CTO-PCI within 3 days of randomization. The overall CTO-PCI success rate was 90.6%. Serious nonfatal complications associated with CTO-PCI occurred in 3 patients (1 stroke, 1 cardiac tamponade, and 1 patient with recurrent episodes of ventricular tachyarrhythmia induced by intracoronary thrombus). Approximately half of the patients in each group underwent PCI for an average of 1.3 non-CTO lesions, resulting in a comparable residual SYNTAX score (Synergy Between PCI With TAXUS and Cardiac Surgery; 3.7±5.4 versus 4.0±5.9, P=0.42) confined to non-CTO vessels. During a median follow-up of 4.0 years (interquartile range, 2.4 to 5.1 years), there was no significant difference between the CTO-PCI and the no CTO-PCI strategies in the incidence of the primary end point (22.3% versus 22.4%, hazard ratio, 1.03; 95% CI, 0.77 to 1.37; P=0.86). Both CTO-PCI and no CTO-PCI strategy were associated with significant improvements but without between-group differences in disease-specific health status that was sustained through 36 months. CONCLUSIONS: CTO-PCI was feasible with high success rates. There was no difference in the incidence of major adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the study was limited by low power for clinical end points and high crossover rates between groups. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01078051.

Tratamiento de alta intensidad con estatinas para pacientes estables en monoterapia con ácido acetilsalicílico a los 12 meses de un implante de stent farmacoactivo: estudio aleatorizado / High-intensity statin treatments in clinically stable patients on aspirin monotherapy 12 months after drug-eluting stent implantation: A randomized study

Introducción y objetivos: La vigente guía de práctica clínica 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 práctica clínica tras la revascularización con SFA. Actualmente se desconoce el impacto de mantener esa terapia intensiva con estatinas en estos pacientes estables. Se estudia la reducción de eventos adversos en pacientes clínicamente estables en monoterapia con ácido acetilsalicílico tras el implante de un SFA según la terapia de alta o baja intensidad con estatinas. Métodos: Se aleatorizó a pacientes estables a los 12 meses del implante de un SFA y en monoterapia con ácido acetilsalicílico 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 clínicos adversos a los 12 meses de seguimiento (objetivo compuesto de muerte, infarto de miocardio, revascularización, trombosis del stent, accidente cerebrovascular, insuficiencia renal, necesidad de intervención arterial periférica 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 debió 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 clínicamente estables en monoterapia con ácido acetilsalicílico, el tratamiento de alta intensidad con estatinas redujo la incidencia de eventos comparado con el tratamiento de baja intensidad

Introduction and objectives: Current guidelines on the treatment of blood cholesterol recommend continuous maintenance of high-intensity statin treatment in drug-eluting stent (DES)-treated patients. However, high-intensity statin treatment is frequently underused in clinical practice after stabilization of DES-treated patients. Currently, the impact of continuous high-intensity statin treatment on the incidence of late adverse events in these patients is unknown. We investigated whether high-intensity statin treatment reduces late adverse events in clinically stable patients on aspirin monotherapy 12 months after DES implantation. Methods: Clinically stable patients who underwent DES implantation 12 months previously and received aspirin monotherapy were randomly assigned to receive either high-intensity (40 mg atorvastatin, n = 1000) or low-intensity (20 mg pravastatin, n = 1000) statin treatment. The primary endpoint was adverse clinical events at 12-month follow-up (a composite of all death, myocardial infarction, revascularization, stent thrombosis, stroke, renal deterioration, intervention for peripheral artery disease, and admission for cardiac events). Results: The primary endpoint at 12-month follow-up occurred in 25 patients (2.5%) receiving high-intensity statin treatment and in 40 patients (4.1%) receiving low-intensity statin treatment (HR, 0.58; 95%CI, 0.36-0.92; P = .018). This difference was mainly driven by a lower rate of cardiac death (0 vs 0.4%, P = .025) and nontarget vessel myocardial infarction (0.1 vs 0.7%, P = .033) in the high-intensity statin treatment group. Conclusions: Among clinically stable DES-treated patients on aspirin monotherapy, high-intensity statin treatment significantly reduced late adverse events compared with low-intensity statin treatment

High-intensity Statin Treatments in Clinically Stable Patients on Aspirin Monotherapy 12 Months After Drug-eluting Stent Implantation: A Randomized Study.

INTRODUCTION AND OBJECTIVES: Current guidelines on the treatment of blood cholesterol recommend continuous maintenance of high-intensity statin treatment in drug-eluting stent (DES)-treated patients. However, high-intensity statin treatment is frequently underused in clinical practice after stabilization of DES-treated patients. Currently, the impact of continuous high-intensity statin treatment on the incidence of late adverse events in these patients is unknown. We investigated whether high-intensity statin treatment reduces late adverse events in clinically stable patients on aspirin monotherapy 12 months after DES implantation. METHODS: Clinically stable patients who underwent DES implantation 12 months previously and received aspirin monotherapy were randomly assigned to receive either high-intensity (40mg atorvastatin, n = 1000) or low-intensity (20mg pravastatin, n = 1000) statin treatment. The primary endpoint was adverse clinical events at 12-month follow-up (a composite of all death, myocardial infarction, revascularization, stent thrombosis, stroke, renal deterioration, intervention for peripheral artery disease, and admission for cardiac events). RESULTS: The primary endpoint at 12-month follow-up occurred in 25 patients (2.5%) receiving high-intensity statin treatment and in 40 patients (4.1%) receiving low-intensity statin treatment (HR, 0.58; 95%CI, 0.36-0.92; P = .018). This difference was mainly driven by a lower rate of cardiac death (0 vs 0.4%, P = .025) and nontarget vessel myocardial infarction (0.1 vs 0.7%, P = .033) in the high-intensity statin treatment group. CONCLUSIONS: Among clinically stable DES-treated patients on aspirin monotherapy, high-intensity statin treatment significantly reduced late adverse events compared with low-intensity statin treatment. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01557075.

Comparison of Transradial and Transfemoral Approaches for Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome and Anemia.

Anemia is an independent predictor of bleeding complications and poor clinical outcomes after percutaneous coronary intervention. Percutaneous coronary transradial intervention (TRI) is better than percutaneous coronary transfemoral intervention (TFI) in terms of reducing bleeding complications that can affect the prognosis. This study aims to investigate the clinical outcomes between TRI and TFI for patients with anemia. We analyzed periprocedure complications, in-hospital mortality, and major adverse cardiac events for one year in the Korean TRI registry from January 2013 to April 2014. Patients with chronic kidney disease for whom TFI is preferred were excluded. Anemia was defined as hemoglobin <13 g/dl for men and <12 g/dl for women. A total of 1,279 patients were finally enrolled. Of these, 348 patients had anemia. Among them, 253 patients (72.7%) underwent TRI and 95 patients (27.3%) underwent TFI. There were no significant differences of baseline demographic characteristics between the TRI and TFI groups, except for the incidence of dyslipidemia (TRI 23.7% vs TFI 12.6%, p = 0.023). Multivariate logistic regression analysis revealed lower incidence of composite severe bleeding complications (hazard ratio 0.34, 95% CI 0.12 to 0.99, p = 0.049) and lower incidence of in-hospital mortality than TFI group (hazard ratio 0.74, 95% CI 0.62 to 0.88, p = 0.042). In conclusion, this study suggests that the TRI for patients with anemia may be translated into better prognosis in terms of lower rates of bleeding complications and in-hospital mortality.

Current Practice of Transradial Coronary Angiography and Intervention: Results from the Korean Transradial Intervention Prospective Registry.

BACKGROUND AND OBJECTIVES: Although increasing evidence has indicated that radial access is a beneficial technique, few studies have focused on Korean subjects. The aim of this study was to evaluate current practice of coronary angiography (CAG) and percutaneous coronary intervention (PCI) using radial access in South Korea. SUBJECTS AND METHODS: A total of 6338 subjects were analyzed from Korean Transradial Intervention prospective registry that was conducted at 20 centers in Korea. After evaluating the initial access, subjects intended for radial access were assessed for their baseline, procedure-related, and complication data. Subjects were categorized into three groups: group of overall subjects (n=5554); group of subjects who underwent PCI (n=1780); and group of subjects who underwent primary percutaneous coronary intervention (PPCI) (n=167). RESULTS: The rate of radial artery as an initial access and the rate of access site crossover was 87.6% and 4.4%, respectively, in overall subjects. Those rates were 82.4% and 8.1%, respectively, in subjects who underwent PCI, and 60.1% and 4.8%, respectively, in subjects who underwent PPCI. For subjects who underwent CAG, a 6-F introducer sheath and a 5-F angiographic catheter was the most commonly used. During PCI, a 6-F introducer sheath (90.6%) and a 6-F guiding catheter were standardly used. CONCLUSION: The large prospective registry allowed us to present the current practice of CAG and PCI using radial access. These data provides evidence to achieve consensus on radial access in CAG and PCI in the Korean population.

Impact of female gender on bleeding complications after transradial coronary intervention (from the Korean Transradial Coronary Intervention registry).

Besides poor clinical outcomes, female gender has been known as a high-risk factor for bleeding complications. This study aimed to investigate the impact of gender on clinical outcomes and bleeding complications after transradial coronary intervention (TRI). The Korean TRI registry is a retrospective multicenter registry with 4,890 patients who underwent percutaneous coronary intervention in 2009 at 12 centers. To compare clinical outcomes and bleeding complications between the male and female groups, we performed a propensity score matching in patients who received TRI. A total of 1,194 patients (597 in each group) were studied. The primary outcome was 1-year major adverse cardiac events, including all-cause mortality, myocardial infarction, target vessel revascularization, and stroke. The secondary outcome was major bleeding (composite of bleeding requiring transfusion of ≥2 units of packed cells or bleeding that was fatal). The proportion of major adverse cardiac events was similar between the 2 groups (6.2% vs 4.7%, p = 0.308). The female group had a greater incidence of major bleeding (0.3% vs 3.2%, p <0.001). On multivariate analysis, female gender (odds ratio [OR] 7.748, 95% confidence interval [CI] 1.767 to 13.399), age ≥75 years (OR 5.824, 95% CI 2.085 to 16.274), and chronic kidney disease (OR 7.264, 95% CI 2.369 to 12.276) were independent predictors of major bleeding. In conclusion, the female gender had a tendency for more bleeding complications than male gender after TRI without difference in the clinical outcome.

Optimal duration of dual antiplatelet therapy after drug-eluting stent implantation: a randomized, controlled trial.

BACKGROUND: The risks and benefits of long-term dual antiplatelet therapy remain unclear. METHODS AND RESULTS: This prospective, multicenter, open-label, randomized comparison trial was conducted in 24 clinical centers in Korea. In total, 5045 patients who received drug-eluting stents and were free of major adverse cardiovascular events and major bleeding for at least 12 months after stent placement were enrolled between July 2007 and July 2011. Patients were randomized to receive aspirin alone (n=2514) or clopidogrel plus aspirin (n=2531). The primary end point was a composite of death resulting from cardiac causes, myocardial infarction, or stroke 24 months after randomization. At 24 months, the primary end point occurred in 57 aspirin-alone group patients (2.4%) and 61 dual-therapy group patients (2.6%; hazard ratio, 0.94; 95% confidence interval, 0.66-1.35; P=0.75). The 2 groups did not differ significantly in terms of the individual risks of death resulting from any cause, myocardial infarction, stent thrombosis, or stroke. Major bleeding occurred in 24 (1.1%) and 34 (1.4%) of the aspirin-alone group and dual-therapy group patients, respectively (hazard ratio, 0.71; 95% confidence interval, 0.42-1.20; P=0.20). CONCLUSIONS: Among patients who were on 12-month dual antiplatelet therapy without complications, an additional 24 months of dual antiplatelet therapy versus aspirin alone did not reduce the risk of the composite end point of death from cardiac causes, myocardial infarction, or stroke. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186146.

Comparison of Zotarolimus-Eluting stent versus Sirolimus-Eluting stent for de novo coronary artery disease in patients with diabetes mellitus from the ESSENCE-DIABETES II trial.

Angiographic and clinical outcomes remain relatively unfavorable for diabetic patients even after the use of drug-eluting stent. This prospective, multicenter, randomized study compared the relative efficacy and safety of resolute zotarolimus-eluting stent (R-ZES) and sirolimus-eluting stent (SES) implantation in diabetic patients with coronary artery disease. The primary end point was noninferiority of angiographic in-segment late loss at 9 months. Clinical events were also monitored for at least 12 months. Patient recruitment was prematurely stopped after enrollment of 256 patients (127 in R-ZES group and 129 in SES) because of discontinuing production of SES. The R-ZES was noninferior to the SES for 9-month in-segment late loss (0.34 ± 0.30 vs 0.39 ± 0.43 mm; difference -0.048; 95% confidence interval -0.157 to 0.061; upper 1-sided 95% confidence interval 0.044; p <0.001 for noninferiority). In addition, in-stent late loss (0.22 ± 0.29 vs 0.21 ± 0.40 mm, p = 0.849) and the rates of in-segment (1.2% vs 6.7%, p = 0.119) and in-stent (1.2% vs 3.3%, p = 0.621) binary restenoses were similar between the 2 groups. At 12 months, there were no statistical differences between the 2 groups in the incidence of any clinical outcomes (death, myocardial infarction, stent thrombosis, ischemia-driven target lesion revascularization, ischemia-driven target vessel revascularization, and composite outcomes). In conclusion, despite having reduced power because of early study termination, our study suggests that the R-ZES has noninferior angiographic outcomes at 9 months to the SES in diabetic patients with coronary artery disease.

Study design and rationale of "a multicenter, open-labeled, randomized controlled trial comparing three 2nd-generation drug-eluting stents in real-world practice" (CHOICE trial).

BACKGROUND: The second-generation drug-eluting stents (DES) have shown superiority in many studies relating to safety and efficacy when compared with the first-generation DES. However, it is unclear whether there are differences in efficacy and safety among the second-generation DES after long-term follow-up. METHODS: This multicenter, prospective, randomized, open-labeled trial will directly compare the efficacy and safety among the patients treated with either everolimus-eluting stent (EES), zotarolimus-eluting stent with biolinx polymer (ZES-R), or biolimus-eluting stent (BES) with minimal exclusion criteria. The primary end point is a patient-oriented composite consisted of cardiac death, myocardial infarction not clearly attributable to a nontarget vessel and clinically indicated target lesion revascularization at 24-month clinical follow-up post-index procedure. With the hypothesis that "BES is non-inferior to EES" or "BES is non-inferior to ZES-R" in primary end point, approximately 2,600 patients will be assigned to one of the types of stents using a web-based randomization system. CONCLUSIONS: The CHOICE trial will directly compare the efficacy and safety of EES, ZES-R, and BES in everyday clinical practice for long-term follow-up.

Comparison of the efficacy and safety of paclitaxel-eluting coroflex please stents and paclitaxel-eluting stents in patients with coronary artery disease: a randomized PIPA trial.

OBJECTIVES: To compare the safety and efficacy of the new Coroflex™ Please stents with conventional Taxus™ Liberte stents in patients with coronary artery lesions. BACKGROUND: The Coroflex™ Please stent is a new version of paclitaxel-eluting stent, and observational cohort studies have reported similar angiographic and clinical outcomes as with the first-generation stents. However, it has not been directly compared with the early generation paclitaxel-eluting stents in a multicenter, prospective, and randomized study. METHODS: We randomly assigned 319 patients to receive Coroflex™ Please stents (159 patients; 198 lesions) or Taxus™ Liberte stents (160 patients; 232 lesions). The primary end point was angiographic in-segment late luminal loss at 9 months. RESULTS: Most baseline clinical and angiographic characteristics were similar between these two groups. The Coroflex™ Please and Taxus™ Liberte stents showed similar in-segment late loss (0.40 ± 0.53 mm vs. 0.39 ± 0.52 mm, P = 0.98) and rates of in-segment binary restenosis (22.2% vs. 18.8%, P = 0.48) at 9 months. After clinical follow-up for 12 months, the two groups had similar rates of death (1.3% vs. 1.3%, P > 0.99), myocardial infarction (3.8% vs. 7.5%, P = 0.22), stent thrombosis (2.5% vs. 1.9%, P = 0.72), and target-lesion revascularization (7.5% vs. 7.5%, P = 0.99). CONCLUSIONS: The Coroflex™ Please stent resulted in similar angiographic and clinical outcomes as the Taxus™ Liberte stent in patients with coronary artery lesions.

Comparison of everolimus- and sirolimus-eluting stents in patients with long coronary artery lesions: a randomized LONG-DES-III (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III) Trial.

OBJECTIVES: This study compared everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) for long coronary lesions. BACKGROUND: Outcomes remain relatively unfavorable for stent-based coronary intervention of lesions with long diseased segments. METHODS: This randomized, multicenter, prospective trial compared the use of long EES with SES in 450 patients with long (≥ 25 mm) native coronary lesions. The primary endpoint of the trial was in-segment late luminal loss at 9-month angiographic follow-up. RESULTS: The EES and SES groups had similar baseline characteristics. Lesion length was 34.0 ± 15.4 mm in the EES group and 34.3 ± 13.5 mm in the SES group (p = 0.85). Nine-month angiographic follow-up was performed in 80% of the EES group and 81% of the SES group (p = 0.69). In-segment late loss as the primary study endpoint was significantly larger in the EES group than in the SES group (0.17 ± 0.41 mm vs. 0.09 ± 0.30 mm, p for noninferiority = 0.96, p for superiority = 0.04). The in-segment binary restenosis rate was also higher in the EES group than in the SES group (7.3% vs. 2.7%, p = 0.046). However, in-stent late loss (0.22 ± 0.43 mm vs. 0.18 ± 0.28 mm, p = 0.29) and in-stent binary restenosis rate (3.9% vs. 2.7%, p = 0.53) were similar among the 2 groups. The incidence of any clinical outcomes (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes) was not statistically different between the 2 groups. CONCLUSIONS: For patients with long native coronary artery disease, EES implantation was associated with greater angiographic in-segment late loss and higher rates of in-segment restenosis compared with SES implantation. However, clinical outcomes were both excellent and not statistically different.

Randomized comparison of everolimus-eluting stent versus sirolimus-eluting stent implantation for de novo coronary artery disease in patients with diabetes mellitus (ESSENCE-DIABETES): results from the ESSENCE-DIABETES trial.

BACKGROUND: Drug-eluting stents significantly improved angiographic and clinical outcomes compared with bare metal stents in diabetic patients. However, a comparison of everolimus-eluting stents and sirolimus-eluting stents in diabetic patients has not been evaluated. Therefore we compared effectiveness of everolimus-eluting stents and sirolimus-eluting stents in patients with diabetes mellitus. METHODS AND RESULTS: This prospective, multicenter, randomized study compared everolimus-eluting stent (n=149) and sirolimus-eluting stent (n=151) implantation in diabetic patients. The primary end point was noninferiority of angiographic in-segment late loss at 8 months. Clinical events were also monitored for at least 12 months. Everolimus-eluting stents were noninferior to sirolimus-eluting stents for 8-month in-segment late loss (0.23 ± 0.27 versus 0.37 ± 0.52 mm; difference, -0.13 mm; 95% confidence interval, -0.25 to -0.02; upper 1-sided 95% confidence interval, -0.04; P<0.001 for noninferiority), with reductions in in-stent restenosis (0% versus 4.7%; P=0.029) and in-segment restenosis (0.9% versus 6.5%; P=0.035). However, in-stent late loss (0.11 ± 0.26 versus 0.20 ± 0.49 mm; P=0.114) was not statistically different between the 2 groups. At 12 months, ischemia-driven target lesion revascularization (0.7% versus 2.6%; P=0.317), death (1.3% versus 3.3%; P=0.448), and myocardial infarction (0% versus 1.3%; P=0.498) were not statistically different between the 2 groups. Major adverse cardiac events, including death, myocardial infarction, and ischemia-driven target lesion revascularization (2.0% versus 5.3%; P=0.218), were also not statistically different between the 2 groups. CONCLUSION: Everolimus-eluting stents were noninferior to sirolimus-eluting stents in reducing in-segment late loss and reduced angiographic restenosis at 8 months in patients with diabetes mellitus and coronary artery disease.

Progressive familial heart block type I in a korean patient.

A 29-year-old man was referred to the emergency department with a complaint of abdominal pain and dizziness. He had experienced two previous syncopal episodes. His family history revealed that his mother and his two uncles had received permanent pacemaker implantation. His initial heart rate was 49 beats per minute. The electrocardiography (ECG) showed atrial flutter and right bundle branch block (RBBB) with left anterior fascicular block (LAFB). On admission, 24-hour Holter showed ventricular pause up to 16 seconds during syncope. Radio frequency catheter ablation (RFCA) of atrial flutter was performed. The ECG revealed bifascicular block (RBBB and LAFB) and first-degree atrioventricular block. He received a permanent pacemaker implantation. His brother's and his sister's ECGs also showed trifascicular block and the pedigree showed autosomal dominant inheritance. This patient was diagnosed with a progressive familial heart block (PFHB) type I. This would be the first report of a PFHB type I case documented in Korea.

Preventive strategies of renal insufficiency in patients with diabetes undergoing intervention or arteriography (the PREVENT Trial).

Few studies have compared the ability of sodium bicarbonate plus N-acetylcysteine (NAC) and sodium chloride plus NAC to prevent contrast-induced nephropathy (CIN) in diabetic patients with impaired renal function undergoing coronary or endovascular angiography or intervention. Diabetic patients (n = 382) with renal disease (serum creatinine ≥1.1 mg/dl and estimated glomerular filtration rate <60 ml/min/1.73 m(2)) were randomly assigned to receive prophylactic sodium chloride (saline group, n = 189) or sodium bicarbonate (bicarbonate group, n = 193) before elective coronary or endovascular angiography or intervention. All patients received oral NAC 1,200 mg 2 times/day for 2 days. The primary end point was CIN, defined as an increase in serum creatinine >25% or an absolute increase in serum creatinine ≥0.5 mg/dl within 48 hours after contrast exposure. There were no significant between-group differences in baseline characteristics. The primary end point was met in 10 patients (5.3%) in the saline group and 17 (9.0%) in the bicarbonate group (p = 0.17), with 2 (1.1%) and 4 (2.1%), respectively, requiring hemodialysis (p = 0.69). Rates of death, myocardial infarction, and stroke did not differ significantly at 1 month and 6 months after contrast exposure. In conclusion, hydration with sodium bicarbonate is not superior to hydration with sodium chloride in preventing CIN in patients with diabetic nephropathy undergoing coronary or endovascular angiography or intervention.

Paroxysmal atrial fibrillation presenting as acute lower limb ischemia.

An ischemic foot can be developed by acute arterial occlusion. Given proper treatment within critical time, the patient can avoid foot amputation and death. Early proper diagnosis and treatment by family physician at the initial clinical interviewing is important in saving the affected leg and the life. Thrombosis and embolism are the common causes of acute arterial occlusion. Thrombosis mostly arises from underlying cardiac disease such as arrhythmia, coronary artery disease and valvular heart disease while arterial occlusion by embolism can be shown on a narrowed artery related with systemic atherosclerosis. Because the treatment options depend on the underlying cause of the acute ischemic foot, it is important to identify the cause of acute ischemic foot. At this paper, we reported a case that the cause of acute ischemic foot of the patient proved paroxysmal atrial fibrillation after some diagnostic tests.

Comparison of zotarolimus-eluting stents with sirolimus- and paclitaxel-eluting stents for coronary revascularization: the ZEST (comparison of the efficacy and safety of zotarolimus-eluting stent with sirolimus-eluting and paclitaxel-eluting stent for coronary lesions) randomized trial.

OBJECTIVES: The aim of this study was to evaluate the relative efficacy and safety of zotarolimus-eluting stents (ZES) in comparison with the established and widely used sirolimus- (SES) and paclitaxel-eluting stents (PES) in routine clinical practice. BACKGROUND: Whether ZES might provide similar clinical and angiographic outcomes in a broad spectrum of patients compared with SES or PES is undetermined. METHODS: We performed a single-blind, multicenter, prospectively randomized trial to compare ZES with SES and PES in 2,645 patients undergoing percutaneous coronary intervention. The primary end point was a composite of major adverse cardiac events (MACE) (death, myocardial infarction, and ischemia-driven target vessel revascularization) at 12 months. A noninferiority comparison (ZES vs. SES) and a superiority comparison (ZES vs. PES) were performed for the primary end point. RESULTS: Baseline clinical and angiographic characteristics were similar in the 3 groups. At 12 months, the ZES group showed noninferior rates of MACE compared with the SES group (10.2% vs. 8.3%, p for noninferiority = 0.01, p for superiority = 0.17) and significantly fewer MACE than the PES group (10.2% vs. 14.1%, p for superiority = 0.01). The incidence of death or myocardial infarction was similar among the groups (ZES vs. SES vs. PES, 5.8% vs. 6.9% vs. 7.6%, respectively, p = 0.31). The incidence of stent thrombosis was significantly lower in the SES group (ZES vs. SES vs. PES, 0.7% vs. 0% vs. 0.8%, respectively, p = 0.02). CONCLUSIONS: In this large-scale, practical randomized trial, the use of ZES resulted in similar rates of MACE compared with SES and in fewer MACE compared with PES at 12 months. (Comparison of the Efficacy and the Safety of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent and PacliTaxel-Eluting Stent for Coronary Lesions; NCT00418067).

Long-term outcomes of intravascular ultrasound-guided stenting in coronary bifurcation lesions.

Stenting for bifurcation lesions is still challenging, and the effect of intravascular ultrasound (IVUS) guidance on long-term outcomes has not been evaluated. We assessed the long-term outcomes of IVUS-guided stenting in bifurcation lesions. We evaluated 758 patients with de novo nonleft main coronary bifurcation lesions who underwent stent implantation from January 1998 to February 2006. We compared the adverse outcomes (i.e., death, stent thrombosis, and target lesion revascularization) within 4 years, after adjustment using a multivariate Cox proportional hazard model and propensity scoring. IVUS-guided stenting significantly reduced the long-term all-cause mortality (hazard ratio [HR] 0.31, 95% confidence interval [CI] 0.13 to 0.74, p = 0.008) in the total population and in the patients receiving drug-eluting stents (DESs) (HR 0.24, 95% CI 0.06 to 0.86, p = 0.03), but not in the patients receiving bare metal stents (HR 0.41, 95% CI 0.13 to 1.26, p = 0.12). IVUS-guided stenting had no effect on the rate of stent thrombosis (HR 0.48, 95% CI 0.16 to 1.43, p = 0.19) or target lesion revascularization (HR 1.47, 95% CI 0.79 to 2.71, p = 0.21). In patients receiving DESs, however, IVUS guidance reduced the development of very late stent thrombosis (0.4% vs 2.8%, p = 0.03, log-rank test). In conclusion, in patients receiving DESs, IVUS-guided stenting for treatment of bifurcation lesions significantly reduced the 4-year mortality compared to conventional angiographically guided stenting. In addition, IVUS guidance reduced the development of very late stent thrombosis in patients receiving DESs.