Prasugrel-based De-Escalation of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With STEMI

Background and Objectives@#De-escalation of dual-antiplatelet therapy through dose reduction of prasugrel improved net adverse clinical events (NACEs) after acute coronary syndrome (ACS), mainly through the reduction of bleeding without an increase in ischemic outcomes. Whether the benefits of de-escalation are sustained in highly thrombotic conditions such as ST-elevation myocardial infarction (STEMI) is unknown. We aimed to assess the efficacy and safety of de-escalation therapy in patients with STEMI or non-STsegment elevation ACS (NSTE-ACS). @*Methods@#This is a pre-specified subgroup analysis of the HOST-REDUCE-POLYTECH-ACS trial. ACS patients were randomized to prasugrel de-escalation (5 mg daily) or conventional dose (10 mg daily) at 1-month post-percutaneous coronary intervention. The primary endpoint was a NACE, defined as a composite of all-cause death, non-fatal myocardial infarction, stent thrombosis, clinically driven revascularization, stroke, and bleeding events of grade ≥2 Bleeding Academic Research Consortium (BARC) criteria at 1 year. @*Results@#Among 2,338 patients included in the randomization, 326 patients were diagnosed with STEMI. In patients with NSTE-ACS, the risk of the primary endpoint was significantly reduced with de-escalation (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.48– 0.89; p=0.006 for de-escalation vs. conventional), mainly driven by a reduced bleeding. However, in those with STEMI, there was no difference in the occurrence of the primary outcome (HR, 1.04; 95% CI, 0.48–2.26; p=0.915; p for interaction=0.271). @*Conclusions@#Prasugrel dose de-escalation reduced the rate of NACE and bleeding, without increasing the rate of ischemic events in NSTE-ACS patients but not in STEMI patients.

Effect of Low-Dose Nebivolol in Patients with Acute Myocardial Infarction: A Multi-Center Observational Study / 전남의대학술지

The optimal dose of beta blockers after acute myocardial infarction (MI) remains uncertain. We evaluated the effectiveness of low-dose nebivolol, a beta1 blocker and a vasodilator, in patients with acute MI. A total of 625 patients with acute MI from 14 teaching hospitals in Korea were divided into 2 groups according to the dose of nebivolol (nebistol®, Elyson Pharmaceutical Co., Ltd., Seoul, Korea): low-dose group (1.25 mg daily, n=219) and usual- to high-dose group (≥2.5 mg daily, n=406). The primary endpoints were major adverse cardiac and cerebrovascular events (MACCE, composite of death from any cause, non-fatal MI, stroke, repeat revascularization, rehospitalization for unstable angina or heart failure) at 12 months. After adjustment using inverse probability of treatment weighting, the rates of MACCE were not different between the low-dose and the usual- to high-dose groups (2.8% and 3.1%, respectively; hazard ratio: 0.92, 95% confidence interval: 0.38 to 2.24, p=0.860). The low-dose nebivolol group showed higher rates of MI than the usual- to high-dose group (1.2% and 0%, p=0.008). The 2 groups had similar rates of death from any cause (1.1% and 0.3%, p=0.273), stroke (0.4% and 1.1%, p=0.384), repeat PCI (1.2% and 0.8%, p=0.428), rehospitalization for unstable angina (1.2% and 1.0%, p=0.743) and for heart failure (0.6% and 0.7%, p=0.832). In patients with acute MI, the rates of MACCE for low-dose and usual- to high-dose nebivolol were not significantly different at 12-month follow-up.

The Current Status of Percutaneous Coronary Intervention in Korea: Based on Year 2014 & 2016 Cohort of Korean Percutaneous Coronary Intervention (K-PCI) Registry

BACKGROUND AND OBJECTIVES: In this second report from Korean percutaneous coronary intervention (K-PCI) registry, we sought to describe the updated information of PCI practices and Korean practice pattern of PCI (KP3). METHODS: In addition to K-PCI registry of 2014, new cohort of 2016 from 92 participating centers was appended. Demographic and procedural information, as well as in-hospital outcomes, of PCI was collected using a web-based reporting system. KP3 class C was defined as any strategy with less evidence from randomized trials and more aggressive for PCI than medical therapy or bypass-surgery. RESULTS: In 2016, total 48,823 PCI procedures were performed at 92 participating centers. Mean age of the patients was 65.7±11.6 years, and 71.7% were males. Overall patient characteristics and PCI practices in 2016 were similar to those in 2014. The biggest change was the decrease in the in-hospital occurrence of myocardial infarction (MI;1.6%→0.7%, p<0.001). Many associations between PCI volumes and demographic/procedural characteristics observed in 2014 have disappeared. The median of door-to-balloon time was 62 minutes, and 83.3% of ST-elevation MI patients received primary PCI within 90 minutes, while the median of total ischemic time was 168 minutes and patients who had total ischemic time within 120 and 180 minutes were 29.1% and 54.1%, respectively. The proportion of KP3 class C cases in non-acute coronary syndrome patients decreased from 13.5% in 2014 to 12.1% in 2016 (p<0.001). CONCLUSIONS: In this second report from K-PCI registry, we described the current practices of PCI and changes from 2014 to 2016 in Korea.

The Current Status of Percutaneous Coronary Intervention in Korea: Based on Year 2014 & 2016 Cohort of Korean Percutaneous Coronary Intervention (K-PCI) Registry

BACKGROUND AND OBJECTIVES@#In this second report from Korean percutaneous coronary intervention (K-PCI) registry, we sought to describe the updated information of PCI practices and Korean practice pattern of PCI (KP3).@*METHODS@#In addition to K-PCI registry of 2014, new cohort of 2016 from 92 participating centers was appended. Demographic and procedural information, as well as in-hospital outcomes, of PCI was collected using a web-based reporting system. KP3 class C was defined as any strategy with less evidence from randomized trials and more aggressive for PCI than medical therapy or bypass-surgery.@*RESULTS@#In 2016, total 48,823 PCI procedures were performed at 92 participating centers. Mean age of the patients was 65.7±11.6 years, and 71.7% were males. Overall patient characteristics and PCI practices in 2016 were similar to those in 2014. The biggest change was the decrease in the in-hospital occurrence of myocardial infarction (MI;1.6%→0.7%, p<0.001). Many associations between PCI volumes and demographic/procedural characteristics observed in 2014 have disappeared. The median of door-to-balloon time was 62 minutes, and 83.3% of ST-elevation MI patients received primary PCI within 90 minutes, while the median of total ischemic time was 168 minutes and patients who had total ischemic time within 120 and 180 minutes were 29.1% and 54.1%, respectively. The proportion of KP3 class C cases in non-acute coronary syndrome patients decreased from 13.5% in 2014 to 12.1% in 2016 (p<0.001).@*CONCLUSIONS@#In this second report from K-PCI registry, we described the current practices of PCI and changes from 2014 to 2016 in Korea.

Erratum: The Practice Pattern of Percutaneous Coronary Intervention in Korea: Based on Year 2014 Cohort of Korean Percutaneous Coronary Intervention (K-PCI) Registry

In the article, “The Practice Pattern of Percutaneous Coronary Intervention in Korea.Based on Year 2014 Cohort of Korean Percutaneous Coronary Intervention (K-PCI) Registry.” in Volume 47(3), page 320-327, indexed color of Class A and Class C has been changed.

The Practice Pattern of Percutaneous Coronary Intervention in Korea: Based on Year 2014 Cohort of Korean Percutaneous Coronary Intervention (K-PCI) Registry

BACKGROUND AND OBJECTIVES: Appropriate use criteria (AUC) was developed to improve the quality of percutaneous coronary intervention (PCI). However, these criteria should consider the current practice pattern in the country where they are being applied. MATERIALS AND METHODS: The algorithm for the Korean PCI practice pattern (KP3) was developed by modifying the United States-derived AUC in expert consensus meetings. KP3 class A was defined as any strategy with evidence from randomized trials that was more conservative for PCI than medical therapy or coronary artery bypass graft (CABG). Class C was defined as any strategy with less evidence from randomized trials and more aggressive for PCI than medical therapy or CABG. Class B was defined as a strategy that was partly class A and partly class C. We applied the KP3 classification system to the Korean PCI registry. RESULTS: The KP3 class A was noted in 67.7% of patients, class B in 28.8%, and class C in 3.5%. The median proportion of class C cases per center was 2.0%. The distribution of KP3 classes varied significantly depending on clinical and angiographic characteristics. The proportion of KP3 class C cases per center was not significantly dependent on PCI volume, but rather on the percentage of ACS cases in each center. CONCLUSION: We report the current PCI practice pattern by applying the new KP3 classification in a nationwide PCI registry. The results should be interpreted carefully with due regard for the complex relationships between the determining variables and the healthcare system in Korea.

The Current Status of Percutaneous Coronary Intervention in Korea: Based on Year 2014 Cohort of Korean Percutaneous Coronary Intervention (K-PCI) Registry

BACKGROUND AND OBJECTIVES: Although several multicenter registries have evaluated percutaneous coronary intervention (PCI) procedures in Korea, those databases have been limited by non-standardized data collection and lack of uniform reporting methods. We aimed to collect and report data from a standardized database to analyze PCI procedures throughout the country. MATERIALS AND METHODS: Both clinical and procedural data, as well as clinical outcomes data during hospital stay, were collected based on case report forms that used a standard set of 54 data elements. This report is based on 2014 Korean PCI registry cohort data. RESULTS: A total of 92 hospitals offered data on 44967 PCI procedures. The median age was 66.0 interquartile range 57.0-74.0 years, and 70.3% were men. Thirty-eight percent of patients presented with acute myocardial infarction and one-third of all PCI procedures were performed in an urgent or emergency setting. Non-invasive stress tests were performed in 13.9% of cases, while coronary computed tomography angiography was used in 13.7% of cases prior to PCI. Radial artery access was used in 56.1% of all PCI procedures. Devices that used PCI included drug-eluting stent, plain old balloon angioplasty, drug-eluting balloon, and bare-metal stent (around 91%, 19%, 6%, and 1% of all procedures, respectively). The incidences of in-hospital death, non-fatal myocardial infarction, and stroke were 2.3%, 1.6%, and 0.2%, respectively. CONCLUSION: These data may provide an overview of the current PCI practices and in-hospital outcomes in Korea and could be used as a foundation for developing treatment guidelines and nationwide clinical research.

Systematic Review of Treatment for Trapped Thrombus in Patent Foramen Ovale

BACKGROUND AND OBJECTIVES: Trapped thrombus in patent foramen ovale (PFO) is a rare complication of pulmonary embolism that may lead to tragic clinical events. The aim of this study was to identify the optimal treatment for different clinical situations in patients with trapped thrombus in a PFO by conducting a literature review. SUBJECTS AND METHODS: A PubMed database search was conducted from 1991 through 2015, and 194 patients (185 articles) with trapped thrombus in a PFO were identified. Patient characteristics, paradoxical embolic events, and factors affecting 60-day mortality were analyzed retrospectively. RESULTS: Among all patients, 112 (57.7%) were treated with surgery, 28 with thrombolysis, and 54 with anticoagulation alone. Dyspnea (79.4%), chest pain (33.0%), and syncope (17.5%) were the most common presenting symptoms. Pretreatment embolism was found in 37.6% of cases, and stroke (24.7%) was the most common event. Surgery was associated with fewer post-treatment embolic events than were other treatment options (p=0.044). In the multivariate analysis, initial shock or arrest, and thrombolysis were independent predictors of 60-day mortality. Thrombolysis was related with higher 60-day mortality compared with surgery in patients who had no initial shock or arrest. CONCLUSION: This systematic review showed that surgery was associated with a lower overall incidence of post-treatment embolic events and a lower 60-day mortality in patients with trapped thrombus in a PFO. In patients without initial shock or arrest, thrombolysis was related with a higher 60-day mortality compared with surgery.

The Prognostic Value of the Left Ventricular Ejection Fraction Is Dependent upon the Severity of Mitral Regurgitation in Patients with Acute Myocardial Infarction

The prognostic value of the left ventricle ejection fraction (LVEF) after acute myocardial infarction (AMI) has been questioned even though it is an accurate marker of left ventricle (LV) systolic dysfunction. This study aimed to examine the prognostic impact of LVEF in patients with AMI with or without high-grade mitral regurgitation (MR). A total of 15,097 patients with AMI who received echocardiography were registered in the Korean Acute Myocardial Infarction Registry (KAMIR) between January 2005 and July 2011. Patients with low-grade MR (grades 0-2) and high-grade MR (grades 3-4) were divided into the following two sub-groups according to LVEF: LVEF 40% (n = 12,252 and 226, respectively). The primary endpoints were major adverse cardiac events (MACE), cardiac death, and all-cause death during the first year after registration. Independent predictors of mortality in the multivariate analysis in AMI patients with low-grade MR were age > or = 75 yr, Killip class > or = III, N-terminal pro-B-type natriuretic peptide > 4,000 pg/mL, high-sensitivity C-reactive protein > or = 2.59 mg/L, LVEF 40% were noted. MR is a predictor of a poor outcome regardless of ejection fraction. LVEF is an inadequate method to evaluate contractile function of the ischemic heart in the face of significant MR.

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.

Myocardial Ischemia by Aggravation of Myocardial Bridging

Myocardial bridging (MB) occurs when the myocardium covers a segment of a major epicardial coronary artery, resulting in a tunneled arterial segment. Although MB is generally considered benign, it has been associated with myocardial ischemia. A 70-year-old man with MB (50% luminal narrowing during systole) at the mid-left anterior descending artery (LAD) on previous coronary angiography (CAG) visited our hospital with worsening chest pain. His blood pressure (BP) was not well controlled because of poor compliance. Follow-up CAG showed that MB at the mid-LAD progressed to severe stenosis (>90% luminal narrowing during systole) and the total length of tunneled artery extended from 22.5 to 23.9 mm. His chest pain was relieved by BP control. This is the first report of myocardial ischemia secondary to progression of MB demonstrated by CAG in Korea.

Myocardial Contrast Echocardiography for the Detection of Coronary Artery Disease in Patients with Global Hypokinesis Admitted for First-Onset Acute Heart Failure: Pilot Study

BACKGROUND: The non-invasive differentiation of ischemic and nonischemic acute heart failure (AHF) not resulting from acute myocardial infarction is difficult and has therapeutic and prognostic implications. The aim of this study was to assess whether resting myocardial contrast echocardiography (MCE) can detect coronary artery disease (CAD) in patients with decreased left ventricular (LV) systolic function and global hypokinesis presenting with AHF. METHODS: Twenty-one consecutive patients underwent low-power real-time MCE based on color-coded pulse inversion Doppler. Standard apical LV views were acquired during contrast IV infusion of Definity(R). Following transient microbubbles destruction, the contrast replenishment rate (beta), reflecting myocardial blood flow velocity, was derived by plotting signal intensity vs. time and fitting data to the exponential function: y (t) = A (1 - e(-beta(t-t0))) + C. RESULTS: Of the 21 (mean age 56.6 +/- 13.6 years) patients, 5 (23.8%) demonstrated flow-limiting CAD (> 70% of luminal diameter narrowing). The mean +/- standard deviation of LV ejection fraction was 29.6 +/- 8.6%. Quantitative MCE analysis was feasible in 258 of 378 segments (68.3%). There were no significant difference in "beta" and "Abeta" in patients without and with CAD (0.48 +/- 0.27 vs. 0.45 +/- 0.25, p = 0.453 for beta and 2.99 +/- 2.23 vs. 3.68 +/- 3.13, p = 0.059 for Abeta, respectively). No contrast-related side effects were reported. CONCLUSION: Resting quantitative MCE analysis in patients with AHF was feasible, however, the parameters did not aid in detecting of CAD.

Acquired Long QT Syndrome Manifesting with Torsades de Pointes in a Patient with Panhypopituitarism due to Radiotherapy

We describe a 64-year-old male patient with panhypopituitarism who experienced polymorphic ventricular tachycardia (VT) associated with long QT intervals. The panhypopituitarism developed as a sequelae of radiation therapy administered 20 years prior to his current presentation and was recently aggravated by urinary tract infection with sepsis. In this case, polymorphic VT was resistant to conventional therapy (including magnesium infusion), and QT prolongation and T wave inversion were normalized after the administration of steroid and thyroid hormones. Thyroid hormone is generally known to be associated with torsades de pointes (TdP), but steroid or other hormones may also provoke TdP. Hormonal disorders should be considered as a cause of polymorphic VT with long QT intervals. Some arrhythmias can be life-threatening, and they can be prevented with supplementation of the insufficient hormone.

Reversible dilated cardiomyopathy caused by idiopathic hypoparathyroidism

Dilated cardiomyopathy (DCM) is usually an idiopathic disease with a poor prognosis. Hypocalcemia is a rare and reversible cause of DCM. Here, we report a 50-year-old female with DCM, induced by idiopathic hypoparathyroidism, that improved after treatment with calcium.

The Impact of Vascular Access for In-Hospital Major Bleeding in Patients with Acute Coronary Syndrome at Moderate- to Very High-Bleeding Risk

The aim of our study was to determine the impact of vascular access on in-hospital major bleeding (IHMB) in acute coronary syndrome (ACS). We analyzed 995 patients with non-ST elevation myocardial infarction and unstable angina at the Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA guidelines (CRUSADE) moderate- to very high-bleeding risk scores in trans-radial intervention (TRI) retrospective registry from 16 centers in Korea. A total of 402 patients received TRI and 593 patients did trans-femoral intervention (TFI). The primary end-point was IHMB as defined in the CRUSADE. There were no significant differences in in-hospital and 1-yr mortality rates between two groups. However, TRI had lower incidences of IHMB and blood transfusion than TFI (6.0% vs 9.4%, P = 0.048; 4.5% vs 9.4%, P = 0.003). The patients suffered from IHMB had higher incidences of in-hospital and 1-yr mortality than those free from IHMB (3.1% vs 15.0%, P < 0.001; 7.2% vs 30.0%, P < 0.001). TRI was an independent negative predictor of IHMB (odds ratio, 0.305; 95% confidence interval, 0.109-0.851; P = 0.003). In conclusions, IHMB is still significantly correlated with in-hospital and 1-yr mortality. Our study suggests that compared to TFI, TRI could reduce IHMB in patients with ACS at moderate- to very high-bleeding risk.

Utility of B-Type Natriuretic Peptide for Predicting Perioperative Cardiovascular Events in Patients Without History of Cardiovascular Disease Undergoing Major Non-Cardiac Surgery

BACKGROUND AND OBJECTIVES: Patients without previous history of cardiac disease can be regarded as low-risk when undergoing major non-cardiac surgery. The aim of this study was to examine whether preoperative B-type natriuretic peptide (BNP) level predicted postoperative cardiac events in these patients. SUBJECTS AND METHODS: Preoperative BNP level was measured in 163 patients whose risk was considered low according to the Revised Cardiac Risk Index. Postoperative cardiac events, including death during hospitalization, myocardial injury, arrhythmia, cerebrovascular accidents and congestive heart failure were assessed. RESULTS: Postoperative cardiac events occurred in 8 patients (4.9%). Preoperative BNP levels were significantly higher among patients who experienced postoperative cardiac events, compared to those who did not (130.6+/-148.8 vs. 57.9+/-70.8 pg/mL, p=0.009). CONCLUSION: Preoperative BNP level may provide prognostic information in low-risk patients undergoing major non-cardiac surgery.

A Case of Mobile Thrombus in Ascending Aorta as an Embolic Source of Stroke / 대한내과학회지

Plaque in the ascending aorta can be an important embolic source of stroke. Diagnostic tests for identifying embolic sources are critical for preventing the occurrence of other devastating complications before the initiation of treatment. Here, we report the case of a patient with mobile thrombi attached to the distal ascending aortic wall that were identified by transesophageal echocardiography (TEE). The mobile thrombi in the ascending aorta were treated with anticoagulants and statins. The TEE images we obtained for this case were noteworthy because complex atheromas of the ascending aorta are very rare.

Comparing Two-Stent Strategies for Bifurcation Coronary Lesions: Which Vessel Should be Stented First, the Main Vessel or the Side Branch?

This study compared two-stent strategies for treatment of bifurcation lesions by stenting order, 'main across side first (A-family)' vs 'side branch first (S-family). The study population was patients from 16 centers in Korea who underwent drug eluting stent implantation with two-stent strategy (A-family:109, S-family:140 patients). The endpoints were cardiac death, myocardial infarction (MI), stent thrombosis (ST), and target lesion revascularization (TLR) during 3 years. During 440.8 person-years (median 20.2 months), there was 1 cardiac death, 4 MIs (including 2 STs), and 12 TLRs. Cumulative incidence of cardiac death, MI and ST was lower in A-family (0% in A-family vs 4.9% in S-family, P = 0.045). However, TLR rates were not different between the two groups (7.1% vs 6.2%, P = 0.682). Final kissing inflation (FKI) was a predictor of the hard-endpoint (hazard ratio 0.061; 95% CI 0.007-0.547, P = 0.013), but was not a predictor of TLR. The incidence of hard-endpoint of S-family with FKI was comparable to A-family, whereas S-family without FKI showed the poorest prognosis (1.1% vs 15.9%, retrospectively; P = 0.011). In conclusion, 'A-family' seems preferable to 'S-family' if both approaches are feasible. When two-stent strategy is used, every effort should be made to perform FKI, especially in 'S-family'.

The Correlation Between Left Ventricular Failure and Right Ventricular Systolic Dysfunction Occurring in Thyrotoxicosis

BACKGROUND AND OBJECTIVES: Heart failure rarely occurs in patients with thyrotoxicosis (6%), with half of the cases having left ventricular dysfunction (LVD). Although a few studies reported isolated right heart failure in thyrotoxicosis, there has been no evaluation of relationship between LVD and right ventricular dysfunction (RVD). SUBJECTS AND METHODS: We enrolled 12 patients (mean age: 51+/-11 years, 9 females) diagnosed as having thyrotoxicosis with heart failure and LVD {left ventricular ejection fraction (LVEF) <40%}, and divided them into two groups {Group I with RVD defined as tricuspid annular plane excursion (TAPSE) less than 15 mm and Group II without RVD}. Clinical features, laboratory variables, and echocardiographic parameters were compared between two groups. RESULTS: RVD was found in 6 (50%) patients. On admission, there were no significant differences between the two groups in clinical features, laboratory variables, or echocardiographic parameters including atrial fibrillation {6 vs. 5, not significant (NS)}, heart rate (149+/-38 vs. 148+/-32/min, NS), LVEF (36.7+/-9.5 vs. 35.1+/-6.3%, NS), or the tricuspid regurgitation peak pressure gradient (TRPPG, 30.9+/-2.0 vs. 36.3+/-9.3 mmHg, NS). After antithyroid treatment, all achieved an euthyroid state and both ventricular functions were recovered. All data, including the recovery time of LVEF and the change of heart rate between two groups, displayed no significant differences. CONCLUSION: In half of patients, RVD was combined with thyrotoxicosis-associated LVD. There were no differences in clinical factors or hemodynamic parameters between patients with and without RVD. This suggests that RVD is not secondary to thyrotoxicosis-associated LVD.

Beneficial Effect of Efonidipine, an L- and T-Type Dual Calcium Channel Blocker, on Heart Rate and Blood Pressure in Patients With Mild-to-Moderate Essential Hypertension

BACKGROUND AND OBJECTIVES: Efonidipine hydrochloride, an L- and T-type dual calcium channel blocker, is suggested to have a heart rate (HR)-slowing action in addition to a blood pressure (BP)-lowering effect. The aim of this study was to determine the effect of efonidipine on HR and BP in patients with mild-to-moderate hypertension. SUBJECTS AND METHODS: In a multi-center, prospective, open-labeled, single-armed study, we enrolled 53 patients who had mild-to-moderate hypertension {sitting diastolic BP (SiDBP) 90-110 mmHg}. After a 2-week washout, eligible patients were treated with efonidipine (40 mg once daily for 12 weeks). The primary end point was the change in HR from baseline to week 12. The secondary end-point included the change in trough sitting BP and 24-hour mean BP between baseline and week 12. Laboratory and clinical adverse events were monitored at each study visit (4, 8, and 12 weeks). RESULTS: Fifty-two patients were included in the intention-to-treat analysis. After 12 weeks of treatment with efonidipine, the resting HR decreased significantly from baseline to week 12 {from 81.5+/-5.3 to 71.8+/-9.9 beats/minute (difference, -9.9+/-9.0 beats/minute), p<0.0001}. The trough BP {sitting systolic blood pressure (SiSBP) and SiDBP} and 24-hour mean BP also decreased significantly (SiSBP: from 144.6+/-8.2 to 132.9+/-13.5 mmHg, p<0.0001; SiDBP: from 96.9+/-5.4 to 88.3+/-8.6 mmHg, p<0.0001, 24-hour mean systolic BP: from 140.4+/-13.5 to 133.8+/-11.6 mmHg, p<0.0001; 24-hour mean diastolic BP: from 91.7+/-8.7 to 87.5+/-9.5 mmHg, p<0.0001). CONCLUSION: Efonidipine was effective in controlling both HR and BP in patients with mild-to-moderate hypertension.