Clinical safety and effectiveness of the Genoss drug-eluting stent in real-world clinical practice.

BACKGROUND/AIMS: The Genoss DES™ is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt- chromium stent platform and thin strut. Although the safety and effectiveness of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the aim of this prospective, multicenter trial was to evaluate the clinical safety and effectiveness of the Genoss DES™ in all-comer patients undergoing percutaneous coronary intervention. METHODS: The Genoss DES registry is a prospective, single-arm, observational trial for evaluation of clinical outcomes after Genoss DES™ implantation in all-comer patients undergoing percutaneous coronary intervention from 17 sites in South Korea. The primary endpoint was a device-oriented composite outcome of cardiac death, target vessel-related myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) at 12 months. RESULTS: A total of 1,999 patients (66.4 ± 11.1 years of age; 72.8% male) were analyzed. At baseline, 62.8% and 36.7% of patients had hypertension and diabetes, respectively. The implanted stent number, diameter, and length per patient were 1.5 ± 0.8, 3.1 ± 0.5 mm, and 37.0 ± 25.0 mm, respectively. The primary endpoint occurred in 1.8% patients, with a cardiac death rate of 1.1%, target vessel-related MI rate of 0.2%, and clinically driven TLR rate of 0.8%. CONCLUSION: In this real-world registry, the Genoss DES™ demonstrated excellent safety and effectiveness at 12 months among all-comer patients undergoing percutaneous coronary intervention. These findings suggest that the Genoss DES™ may be a viable treatment option for patients with coronary artery disease.

Safety and Efficacy of a New Ultrathin Sirolimus-Eluting Stent with Abluminal Biodegradable Polymer in Real-World Practice.

BACKGROUND AND OBJECTIVES: Recently, Genoss drug-eluting stent (DES)™ stent comprising cobalt-chromium platform with an ultrathin strut thickness, sirolimus, and an abluminal biodegradable polymer was developed. Owing to the lack of substantial evidence for the safety and efficacy of this stent, we report 12-month results of the Genoss DES™ stent. METHODS: We analyzed subjects who were eligible for a 12-month follow-up from the ongoing Genoss DES™ registry, which is a prospective, single-arm, observational, multicenter trial to investigate the clinical outcomes after the successful Genoss DES™ stent implantation among all-comers. The primary endpoint was a device-oriented composite outcome, defined as cardiac death, target vessel-related myocardial infarction, and target lesion revascularization at 12-month follow-up. RESULTS: Among 622 subjects, the mean age of subjects was 66.5±10.4 years, 70.6% were males, 67.5% had hypertension, and 38.3% had diabetes. The implanted stent number, diameter, and length per patient were 1.5±0.8, 3.1±0.4 mm, and 36.0±23.3 mm, respectively. At 12-month clinical follow-up, the primary endpoint occurred only in 4 (0.6%) subjects. CONCLUSIONS: The novel Genoss DES™ stent exhibited excellent safety and efficacy in real-world practice.

Clinical feasibility of catheter-directed selective intracoronary computed tomography angiography using an extremely low dose of iodine in patients with coronary artery disease.

OBJECTIVE: This study aimed to evaluate the clinical feasibility of catheter-directed selective computed tomography angiography (S-CTA) in patients with coronary artery disease (CAD). METHODS: We prospectively enrolled 65 patients diagnosed with CAD who underwent conventional computed tomography angiography (C-CTA). C-CTA was performed with 60-90 mL of contrast medium (370 mg iodine/mL), whereas S-CTA was performed with 15 mL of contrast medium and 17.19 mg iodine/mL. Luminal enhancement range, homogeneity of luminal enhancement, image quality, plaque volume (PV), and percent aggregate plaque volume (%APV) were measured. Paired Student's t test, Wilcoxon rank-sum test, and Pearson's correlation coefficient were used to compare two methods. RESULTS: Luminal enhancement was significantly higher on S-CTA than on C-CTA (324.4 ± 8.0 Hounsfield unit (HU) vs. 312.0 ± 8.0 HU, p < 0.0001 in the per-vessel analysis). Transluminal attenuation gradient showed a significantly slower reduction pattern on S-CTA than on C-CTA (-0.65 HU/10 mm vs. -0.89 HU/10 mm, p < 0.0001 in the per-vessel analysis). Image noise was significantly lower on S-CTA than on C-CTA (39.6 ± 10.0 HU vs. 43.9 ± 9.4 HU, p < 0.0001). There was excellent correlation between S-CTA and C-CTA with respect to PV and %APV (r = 0.99, r = 0.98, respectively). CONCLUSIONS: S-CTA might be useful in facilitating atherosclerotic plaque analysis and providing guidance for complex lesions such as chronic total occlusion, particularly in cases in which on-site procedure planning is required. KEY POINTS: • Selective computed tomography angiography (S-CTA) can serve as an intraprocedural computed tomography angiography protocol. • S-CTA was performed with low dose of iodine compared with conventional computed tomography angiography. • S-CTA enables on-site atherosclerotic plaque analysis.

Benefit of Prolonged Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stent for Coronary Bifurcation Lesions: Results From the Coronary Bifurcation Stenting Registry II.

BACKGROUND: Whether prolonged dual antiplatelet therapy (DAPT) improves clinical outcomes after percutaneous coronary intervention for coronary bifurcation lesion is uncertain. METHODS AND RESULTS: We evaluated 2082 patients who were treated with drug-eluting stent for bifurcation lesions and were event free (no death, myocardial infarction [MI], cerebrovascular accident, stent thrombosis, or any revascularization) at 12 months after the index procedure. Patients were divided into 2 groups: DAPT ≥12-month group (n=1776) and DAPT <12-month group (n=306). Primary outcome was all-cause death or MI. At 4 years after the index procedure, death or MI occurred less frequently in the DAPT ≥12-month group than the DAPT <12-month group (2.8% versus 12.3%; adjusted hazard ratio, 0.21; 95% confidence interval, 0.13-0.35; P<0.001). After propensity score matching, incidence of death or MI was still lower in the DAPT ≥12-month group than the DAPT <12-month group (2.6% versus 12.3%; adjusted hazard ratio, 0.22; 95% confidence interval, 0.12-0.38; P<0.001). In subgroup analysis, the treatment effect of prolonged DAPT was consistent across subgroups regardless of lesion location, stenting technique, or type of used drug-eluting stent. CONCLUSIONS: The risk of all-cause death or MI was significantly lower in the ≥12-month DAPT group than the <12-month DAPT group after percutaneous coronary intervention for bifurcation lesion using drug-eluting stent. Our results suggest that prolonged DAPT may improve long-term clinical outcomes after percutaneous coronary intervention for bifurcation lesions. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01642992.

Randomized Prospective Comparison of Everolimus-Eluting vs. Sirolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention　- 3-Year Clinical Outcomes of the EXCELLENT Randomized Trial.

BACKGROUND: Everolimus-eluting stents (EES) have equivalent short-term angiographic and clinical outcomes to sirolimus-eluting stents (SES), but EES may be superior to SES with regard to long-term clinical safety. We report the 3-year clinical outcomes of EES and SES from the prospective EXCELLENT Randomized Trial (NCT00698607).Methods and Results:We randomly assigned 1,443 patients undergoing percutaneous coronary intervention 3:1 to receive EES and SES, respectively. We investigated endpoints including target lesion failure (TLF) and individual clinical outcomes including stent thrombosis (ST) at 3 years. For EES and SES, the TLF rate was 4.82% and 4.12% (risk ratio [RR], 1.16, 95% CI: 0.65-2.06, P=0.62), respectively. Results were similar in other efficacy endpoints including target lesion revascularization. For safety endpoints, rate of all-cause death was significantly lower for EES (1.67%) than SES (3.57%; RR, 0.46; 95% CI: 0.23-0.94, P=0.03), while the incidence of cardiac death or myocardial infarction was numerically lower in EES. On 1-year landmark analysis, rates of all-cause death and major adverse cardiovascular events were significantly lower for EES than SES. Definite or probable ST was numerically 3-fold higher for SES (1.37%) compared with EES (0.46%). CONCLUSIONS: EES and SES had similar efficacy with regard to 3-year outcomes in the EXCELLENT trial, while delayed safety events all trended to favor EES.

Delayed left atrial appendage contrast filling in computed tomograms after percutaneous left atrial appendage occlusion.

BACKGROUND: The gold standard for the follow-up of left atrial appendage occlusion (LAAO) is performing transesophageal echocardiogram (TEE) at 45 days after LAAO; however, the duration for complete LAA seal-off after percutaneous LAAO is unknown in humans. We retrospectively evaluated the LAA contrast-filling (CF) rate in follow-up cardiac computed tomography (CT) scans after LAAO. METHODS: We included 35 patients (age 67.5±10.9 years, CHA2DS2VASc 4.2±1.6, HAS-BLED 3.7±1.5) who underwent LAAO [16 WATCHMAN, 19 Amplatzer cardiac plug (ACP)] and follow-up cardiac CT within 6 months after LAAO, and evaluated the LAA-CF rates. Eighteen patients (51.4%) underwent multiple episodes of CT follow-up. RESULTS: 1. The proportions of patients with LAA-CF were 54.2% (19/35) at 6 months, 55.5% (5/9) at 6-18 months, and 33.3% (3/9) at >18 months after LAAO. 2. Among 23 patients with no peridevice leak at the 2 months TEE, LAA-CFs were found in 12 patients at 2.8±1.5 months (66.6% in WATCHMAN and 36.3% in ACP; p=0.158). 3. Among eight patients with consecutive follow-up CT (≥3 times), LAA-CFs were partially reduced in three; however, there was no complete LAA seal-off at 19.0±11.3 months. 4. A larger LAA landing zone diameter was independently associated with LAA-CF in follow-up CT [OR 1.45 (1.08-1.96), p=0.013, adjusted for age, sex, and device type]. CONCLUSIONS: Delayed LAA-CF is common after LAAO, with considerable discrepancies between cardiac CT and TEE findings. Although the clinical significance of LAA-CF is unclear, 45 days seem to be insufficient for complete LAA seal-off after LAAO.

Relationship between time to treatment and mortality among patients undergoing primary percutaneous coronary intervention according to Korea Acute Myocardial Infarction Registry.

BACKGROUND: Despite large reductions in door-to-balloon times over the period, several studies from regional and national data showed that annual mortality rates were not decreased among patients who underwent primary percutaneous coronary intervention (PCI). However, these studies mostly focused on door-to-balloon time, and there was no consideration of total ischemic time in a trend of mortality. The aim of this study was to assess the annual trend between time to treatment and 1-month mortality among patients undergoing primary PCI. METHODS AND RESULTS: The study population consisted of 8040 patients who underwent primary PCI at hospitals participating in the nationwide prospective Korea Acute Myocardial Infarction Registry (KAMIR) between January 2008 and December 2011. The primary end point of this study was 1-month all-cause mortality, and time to treatment (door-to-balloon time, symptom-to-balloon time). One-month death occurred in 452 patients (5.6%) from 2008 to 2011. Additional reductions in door-to-balloon time were not translated into parallel reductions in mortality rate and total ischemic time. After adjustment using clinical risk, shorter total ischemic time was an independent predictor of 1-month mortality [adjusted odds ratio (OR) 0.78, 95% confidential interval (CI) 0.62-0.99, p=0.04]. Total ischemic time could be reduced by using emergency medical services. CONCLUSION: Despite improvements in door-to-balloon time, no parallel reductions in mortality rate and total ischemic time were observed. Total ischemic time was associated with mortality. The present study suggests that additional efforts are needed to shorten total ischemic time including patient and pre-hospital systemic delay for better prognosis after primary PCI.

Clinical outcomes of the intra-aortic balloon pump for resuscitated patients with acute myocardial infarction complicated by cardiac arrest.

BACKGROUND: The aim of this study was to investigate the clinical effects of intra-aortic balloon pump (IABP) in patients who received cardiopulmonary resuscitation (CPR) before procedure. METHODS AND RESULTS: Between November 2005 and April 2014, 49,542 patients were enrolled in a prospective cohort study for acute myocardial infarction (AMI) in Korea (KAMIR). CPR was performed in 1700 patients with cardiac arrest. Patients were excluded from the study if they had not undergone a coronary angiogram, if extracorporeal membrane oxygenation or thrombolysis was performed, and if mechanical complications presented. The primary end point was 1-month all-cause mortality. A total of 883 patients in the IABP group and 476 in the control group were included. During the 1-month follow-up, all-cause death occurred in 749 patients (55.1%). The IABP group was predominantly male and had a higher prevalence of ST-segment elevation MI and a higher risk of coronary lesions including left main disease and three-vessel disease. Glycoprotein IIb/IIIa inhibitor was administered less in the non-IABP group. In the total population, the IABP group had worse outcomes in terms of mortality rates after multivariate analysis [hazard ratio (HR) 1.22, 95% confidence interval (CI) 1.02-1.47, p=0.034] without increasing the incidence of recurrent MI, stroke, and major bleeding. After propensity matching with a pair of 452 patients, no significant differences were observed in baseline characteristics or clinical outcomes (HR 1.21, 95% CI 0.93-1.57, p=0.158). CONCLUSION: The use of IABP did not show clinical benefits in patients with AMI complicated by severe cardiogenic shock after propensity matching analysis.

Clinical Characteristics and Outcomes of Acute ST-Segment Elevation Myocardial Infarction in Younger Korean Adults.

BACKGROUND AND OBJECTIVES: This study aims to investigate the clinical features, angiographic findings, and outcomes of younger Korean ST-segment elevation myocardial infarction (STEMI) patients. SUBJECTS AND METHODS: We analyzed major adverse cardiac events (MACE) in the Korea Acute Myocardial Infarction Registry from November 2005 to October 2010. The registered patients were divided into two groups; young age group (<65 years) and old age group (≥65 years). RESULTS: The young age group included 5281 patients (age, 53±7.8 years), and the old age group included 4896 patients (age, 74.3±6.5 years). Male gender, smoking, family history, dyslipidemia, and metabolic syndrome were more frequently observed in the young age group than in the old age group (89.5% vs. 59.3%, p<0.001; 77.3% vs. 47.2%, p<0.001; 11% vs. 4.6%, p<0.001; 11.2% vs. 7.7%, p<0.001; 67.6% vs. 62.9%, p<0.001). Most of the young Korean adults with STEMI complained of typical chest pain (89.8%), and they had a shorter symptom-to-door time (12±53.2 hours vs. 17.3±132 hours, p=0.010). The young age group showed a favorable prognosis, which was represented by the MACE, compared with the old age group at one month (1.8% vs. 2.8%, p=0.028), six months (6.8% vs. 8.2%, p<0.001), and twelve months (10.1% vs. 11.9%, p=0.025). However, there was no significant difference in the adjusted MACE rate at one month {hazard ratio (HR) 0.95, 95% confidence interval (CI) 0.60-1.51, p=0.828} and twelve months (HR 0.86, 95% CI 0.68-1.10, p=0.233). CONCLUSION: Younger Korean adults with STEMI have clinical outcomes similar to old aged patients, and therefore, they should be treated intensively like the elderly patients.

Comparison of clinical outcomes between culprit vessel only and multivessel percutaneous coronary intervention for ST-segment elevation myocardial infarction patients with multivessel coronary diseases.

BACKGROUND: The clinical significance of complete revascularization for ST segment elevation myocardial infarction (STEMI) patients during admission is still debatable. METHODS: A total of 1406 STEMI patients from the Korean Myocardial Infarction Registry with multivessel diseases without cardiogenic shock who underwent primary percutaneous coronary intervention (PPCI) were analyzed. We used propensity score matching (PSM) to control differences of baseline characteristics between culprit only intervention (CP) and multivessel percutaneous coronary interventions (MP), and between double vessel disease (DVD) and triple vessel disease (TVD). The major adverse cardiac event (MACE) was analyzed for one year after discharge. RESULTS: TVD patients showed higher incidence of MACE (14.2% vs. 8.6%, P = 0.01), any cause of revascularization (10.6% vs. 5.9%, P = 0.01), and repeated PCI (9.5% vs. 5.7%, P = 0.02), as compared to DVD patients during one year after discharge. MP reduced MACE effectively (7.3% vs. 13.8%, P = 0.03), as compared to CP for one year, but all cause of death (1.6% vs. 3.2%, P = 0.38), MI (0.4% vs. 0.8%, P = 1.00), and any cause of revascularization (5.3% vs. 9.7%, P = 0.09) were comparable in the two treatment groups. CONCLUSIONS: STEMI patients with TVD showed higher rate of MACE, as compared to DVD. MP performed during PPCI or ad hoc during admission for STEMI patients without cardiogenic shock showed lower rate of MACE in this large scaled database. Therefore, MP could be considered as an effective treatment option for STEMI patients without cardiogenic shock.

Clinical influence of early follow-up glycosylated hemoglobin levels on cardiovascular outcomes in diabetic patients with ST-segment elevation myocardial infarction after coronary reperfusion.

OBJECTIVE: Recent studies have shown continuous control of diabetes is important for favorable outcomes in patients with ST-segment elevation myocardial infarction (STEMI). This study aimed to evaluate the clinical influence of postprocedural glycosylated hemoglobin A1c (HbA1c) levels on major adverse cardiac events (MACE) in diabetic patients with STEMI after coronary reperfusion. PATIENTS AND METHODS: A total of 303 patients with diabetes and STEMI undergoing a primary percutaneous coronary intervention were enrolled in this study. All eligible patients were divided into the following three groups on the basis of follow-up HbA1c (FU-HbA1c) levels, which were measured at a median of 85 days after the procedure: optimal, FU-HbA1c<7%; suboptimal, 7%≤FU-HbA1c<9%; and poor, FU-HbA1c≥9%. We analyzed the 12-month cumulative MACE, defined as mortality, nonfatal myocardial infarction, and revascularization. In addition, we investigated FU-HbA1c levels as a predictor of MACE. RESULTS: The incidence rates of MACE differed significantly between groups (6.4 vs. 13.6 vs. 19.6%; P=0.048). Moreover, the risk was increased in each successive group (hazard ratio: 1.00 vs. 2.19 vs. 3.68; P=0.046). Each 1% increase in the FU-HbA1c level posed a 26.6% relative increased risk of MACE (P=0.031). The optimal cutoff value for FU-HbA1c in predicting MACE was 7.45%. CONCLUSION: This study showed that higher levels of early FU-HbA1c after reperfusion in diabetic patients with STEMI were associated with increased 12-month MACE, suggesting continuous serum glucose level control even after reperfusion is important for a better outcome. FU-HbA1c seems to be a useful marker for predicting clinical outcome.

A fibrin-supported myocardial organ culture for isolation of cardiac stem cells via the recapitulation of cardiac homeostasis.

There is great interest in the development of cardiac stem cells (CSCs) cell-based therapeutics; thus, clinical translation requires an efficient method for attaining therapeutic quantities of these cells. Furthermore, an in vitro model to investigate the mechanisms regulating the cardiac homeostasis is crucial. We sought to develop a simple myocardial culture method for enabling both the recapitulation of myocardial homeostasis and the simultaneous isolation of CSCs. The intact myocardial fragments were encapsulated 3-dimensionally into the fibrin and cultured under dynamic conditions. The fibrin provided secure physical support and substratum to the myocardium, which mediated integrin-mediated cell signaling that allowed in situ renewal, outgrowth and cardiomyogenic differentiation of CSCs, mimicking myocardial homeostasis. Since our culture maintained the myocardial CSCs niches, it was possible to define the identity of in vitro renewed CSCs that situated in the interstitium between cardiomyocytes and microvessels. Lastly, the use of matrix-restricted fibrinolysis enabled the selective isolation of outgrown CSCs that retained the clonogenicity, long-term growth competency and cardiovascular commitment potential. Collectively, this myocardial culture might be used as an alternative tool for studying cardiac biology and developing cell-based therapeutics.

One-year clinical outcomes of everolimus- versus sirolimus-eluting stents in patients with acute myocardial infarction.

BACKGROUND: In contrast to many studies comparing everolimus-eluting stent (EES) with paclitaxel-eluting stent (PES), data directly comparing EES with sirolimus-eluting stent (SES) are limited, especially in patients with acute myocardial infarction (AMI). METHODS: This study includes 2911 AMI patients treated with SES (n=1264) or EES (n=1701) in Korea Acute Myocardial Infarction Registry (KAMIR). Propensity score matching was applied to adjust for baseline imbalance in clinical and angiographic characteristics, yielding a total of 2400 well-matched patients (1200 receiving SES and 1200 receiving EES). One-year clinical outcomes were compared between the two propensity score matched groups. RESULTS: Baseline clinical and angiographic characteristics were similar between the two propensity score matched groups. One-year clinical outcomes of the propensity score matched cohort were comparable between the EES versus the SES groups including the rates of cardiac death (4.8% vs. 4.8%, P=1.000), recurrent myocardial infarction (1.4% vs. 1.7%, P=0.619), target lesion revascularization (1.4% vs. 1.6%, P=0.737), target lesion failure (7.0% vs. 7.3%, P=0.752), and probable or definite stent thrombosis (0.5% vs. 0.9%, P=0.224) except for a trend toward lower incidence of target vessel revascularization (1.9% vs. 3.0%, P=0.087) and a lower rate of total major adverse cardiac events (9.3% vs. 11.9%, P=0.034) in the EES group. CONCLUSIONS: The present propensity score matched analysis performed in a large-scale, prospective, multicenter registry suggests that the second-generation drug-eluting stent EES has at least comparable or even better safety and efficacy profiles as compared with SES in the setting of AMI.

Effect of statin treatment in patients with acute myocardial infarction and left ventricular systolic dysfunction according to the level of high-sensitivity C-reactive protein.

The effects of statins on the prognosis of patients with left ventricular (LV) systolic dysfunction remain controversial. The aim of this study was to assess the effect of statin treatment on clinical outcomes in acute myocardial infarction (AMI) patients with LV systolic dysfunction. A total of 5,119 AMI patients with LV ejection fraction less than 50% on the initial echocardiogram were analyzed in the Korean Acute Myocardial Infarction Registry. The study population was divided into 4 groups according to the level of high sensitivity C-reactive protein (hs-CRP) and statin treatment: low hs-CRP (hs-CRP ≤ 2.0 mg/L) and high hs-CRP (hs-CRP > 2 mg/L) with or without statin therapy. We evaluated the incidence of major adverse cardiac events (MACEs) including cardiac death, reinfarction, target lesion revascularization, and coronary artery bypass grafting during a 12-month period in each group. Statin therapy did not significantly prevent the MACEs in the low hs-CRP groups (with statin: 10.1% versus without statin: 12.0%, P = 0.249). In the high hs-CRP groups, however, the incidence of MACEs was significantly decreased with statin treatment (with statin: 11.3%, without statin: 20.8%, P < 0.001). These findings were consistently observed in all subgroups of the high-hs CRP group, including the subgroup with an LV ejection fraction less than 40%. In a multivariable logistic regression analysis of the high hs-CRP group, lack of statin therapy was a significant predictor of MACE incidence (odds ratio: 1.573, 95% confidence interval: 1.079-2.293, P = 0.018). The statin treatment was associated with better outcome in AMI and LV dysfunction patients with hs-CRP ≥ 2 mg/dL.

A randomized, open-label, multicenter trial for the safety and efficacy of adult mesenchymal stem cells after acute myocardial infarction.

Recent studies suggest that the intracoronary administration of bone marrow (BM)-derived mesenchymal stem cells (MSCs) may improve left ventricular function in patients with acute myocardial infarction (AMI). However, there is still argumentative for the safety and efficacy of MSCs in the AMI setting. We thus performed a randomized pilot study to investigate the safety and efficacy of MSCs in patients with AMI. Eighty patients with AMI after successful reperfusion therapy were randomly assigned and received an intracoronary administration of autologous BM-derived MSCs into the infarct related artery at 1 month. During follow-up period, 58 patients completed the trial. The primary endpoint was changes in left ventricular ejection fraction (LVEF) by single-photon emission computed tomography (SPECT) at 6 month. We also evaluated treatment-related adverse events. The absolute improvement in the LVEF by SPECT at 6 month was greater in the BM-derived MSCs group than in the control group (5.9% ± 8.5% vs 1.6% ± 7.0%; P=0.037). There was no treatment-related toxicity during intracoronary administration of MSCs. No significant adverse cardiovascular events occurred during follow-up. In conclusion, the intracoronary infusion of human BM-derived MSCs at 1 month is tolerable and safe with modest improvement in LVEF at 6-month follow-up by SPECT. (ClinicalTrials.gov registration number: NCT01392105).

Comparative assessment of angiotensin II type 1 receptor blockers in the treatment of acute myocardial infarction: surmountable vs. insurmountable antagonist.

BACKGROUND: The mechanisms of antagonism vary between the angiotensin II type 1 receptor blockers (ARBs): insurmountable antagonism and surmountable antagonism. Recent retrospective observational studies suggest that ARBs may not have equivalent benefits in various clinical situations. The aim of this study was to compare the effect of two categories of ARBs on the long-term clinical outcomes of patients with acute myocardial infarction (AMI). METHODS: We analyzed the large-scale, prospective, observational Korea Acute Myocardial Infarction Registry study, which enrolled 2740 AMI patients. They divided by the prescription of surmountable ARBs or insurmountable ARBs at discharge. Primary outcome was major adverse cardiac events (MACEs), defined as a composite of cardiac death, nonfatal MI, and re-percutaneous coronary intervention, coronary artery bypass graft surgery. RESULTS: In the overall population, the MACEs rate in 1 year was significantly higher in the surmountable ARB group (14.3% vs. 11.2%, p=0.025), which was mainly due to increased cardiac death (3.3% vs. 1.9%, p=0.031). Matching by propensity-score showed consistent results (MACEs rate: 14.9% vs. 11.4%, p=0.037). In subgroup analysis, the insurmountable ARB treatment significantly reduced the incidence of MACEs in patients with left ventricular ejection fraction greater than 40%, with a low killip class, with ST segment elevation MI, and with normal renal function. CONCLUSIONS: In our study, insurmountable ARBs were more effective on long-term clinical outcomes than surmountable ARBs in patients with AMI.

Impact of family history on the presentation and clinical outcomes of coronary heart disease: data from the Korea Acute Myocardial Infarction Registry.

BACKGROUND/AIMS: Family history (FHx) of coronary heart disease (CHD) is a well-known risk factor for CHD. However, the prognostic implication of FHx has not been established clearly in patients with acute myocardial infarction (AMI). METHODS: In total, 11,612 patients (8,132 males [70%], age 63 ± 13 years) with first-onset AMI between November 2005 and June 2008 in a nationwide, prospective, multicenter, online registry (the Korea AMI Registry) were analyzed. Clinical characteristics and outcomes (cardiac death and major adverse cardiac events [MACEs]) were assessed according to the presence of FHx. RESULTS: The patients with FHx were younger and included more males. Male patients with FHx included more current smokers and individuals with poor lipid profiles. In all patients, after adjustment using the Cox proportional hazard model, FHx was related to the risk of MACEs (hazard ratio [HR], 1.41; p = 0.009) and cardiac death (HR, 1.56; p = 0.080). The poor prognostic implication of FHx was further augmented in females and a low risk subset of patients. A significant interaction was only found between male and female patients for composite MACEs (p for interaction = 0.057), and between patients with more risk factors (≥ 2 risk factors) and fewer risk factors for cardiac deaths (p for interaction = 0.008). CONCLUSIONS: FHx may be an independent prognostic predictor, especially in female patients and patients with low-risk profile.

In vivo diagnosis of plaque erosion and calcified nodule in patients with acute coronary syndrome by intravascular optical coherence tomography.

OBJECTIVES: The aim of this study was to characterize the morphological features of plaque erosion and calcified nodule in patients with acute coronary syndrome (ACS) by optical coherence tomography (OCT). BACKGROUND: Plaque erosion and calcified nodule have not been systematically investigated in vivo. METHODS: A total of 126 patients with ACS who had undergone pre-intervention OCT imaging were included. The culprit lesions were classified as plaque rupture (PR), erosion (OCT-erosion), calcified nodule (OCT-CN), or with a new set of diagnostic criteria for OCT. RESULTS: The incidences of PR, OCT-erosion, and OCT-CN were 43.7%, 31.0%, and 7.9%, respectively. Patients with OCT-erosion were the youngest, compared with those with PR and OCT-CN (53.8 ± 13.1 years vs. 60.6 ± 11.5 years, 65.1 ± 5.0 years, p = 0.005). Compared with patients with PR, presentation with non-ST-segment elevation ACS was more common in patients with OCT-erosion (61.5% vs. 29.1%, p = 0.008) and OCT-CN (100% vs. 29.1%, p < 0.001). The OCT-erosion had a lower frequency of lipid plaque (43.6% vs. 100%, p < 0.001), thicker fibrous cap (169.3 ± 99.1 µm vs. 60.4 ± 16.6 µm, p < 0.001), and smaller lipid arc (202.8 ± 73.6° vs. 275.8 ± 60.4°, p < 0.001) than PR. The diameter stenosis was least severe in OCT-erosion, followed by OCT-CN and PR (55.4 ± 14.7% vs. 66.1 ± 13.5% vs. 68.8 ± 12.9%, p < 0.001). CONCLUSIONS: Optical coherence tomography is a promising modality for identifying OCT-erosion and OCT-CN in vivo. The OCT-erosion is a frequent finding in patients with ACS, especially in those with non-ST-segment elevation ACS and younger patients. The OCT-CN is the least common etiology for ACS and is more common in older patients. (The Massachusetts General Hospital Optical Coherence Tomography Registry; NCT01110538).

Comparison of clinical outcomes between octogenarians and non-octogenarians with acute myocardial infarction in the drug-eluting stent era: analysis of the Korean Acute Myocardial Infarction Registry.

BACKGROUND AND PURPOSE: Octogenarians (age ≥ 80 years) with coronary artery disease constitute a high-risk group. However, octogenarian patients with acute myocardial infarction (AMI) in the drug-eluting stents (DES) era have not been widely reported. We aimed to identify clinical outcomes in octogenarian compared with non-octogenarian AMI patients. METHODS AND SUBJECTS: We retrospectively analyzed 9877 patients who underwent percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and who were enrolled in the Korean Acute Myocardial Infarction Registry (KAMIR). They were divided into 2 groups, octogenarians (n=1494) and non-octogenarians (n=8383), in order to compare the incidence of 1-year all-cause death and 1-year major adverse cardiac events (MACE), where MACE included all-cause death, recurrent myocardial infarction, target vessel revascularization (TVR), target lesion revascularization (TLR), and coronary artery bypass grafting (CABG). RESULTS: The clinical status was significantly inferior in octogenarians compared to non-octogenarians: Killip class ≥ II (34.8% vs. 22.5%, p<0.001), multivessel disease (65.8% vs. 53.7%, p<0.001). Rates of 1-year all-cause death were significantly higher in octogenarians than in non-octogenarians (22.3% vs. 6.5%, p<0.001). However, the rates of 1-year recurrent myocardial infarction (1.3% vs. 0.9%, p=0.68), TLR (2.4% vs. 3.1%, p=0.69), TVR (3.6% vs. 4.3%, p=0.96), and CABG (0.9% vs. 0.9%, p=0.76) did not differ significantly between the 2 groups. CONCLUSIONS: Octogenarian AMI patients have higher rates of mortality and MACE even in the DES era. According to KAMIR subgroup analysis, the TLR/TVR rates in octogenarians were comparable to those in non-octogenarian AMI patients.