Publications by authors named "Woong-Gil Choi"

46 Publications

P2Y12 inhibitor monotherapy in complex percutaneous coronary intervention: A post-hoc analysis of SMART-CHOICE randomized clinical trial.

Cardiol J 2021 Sep 15. Epub 2021 Sep 15.

Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

Background: It remains unclear whether P2Y₁₂ monotherapy, especially clopidogrel, following short-duration dual antiplatelet therapy (DAPT) is associated with favorable outcomes in patients undergoing complex percutaneous coronary intervention (PCI). Therefore, this study analyzed the efficacy and safety of P2Y₁₂ inhibitor monotherapy, mostly clopidogrel (78%), in complex PCI following short-term DAPT.

Methods: The post-hoc analysis of the SMART-CHOICE trial involving 2,993 patients included 498 cases of complex PCIs, defined by at least one of the following features: 3 vessels treated, ≥ 3 stents implanted, ≥ 3 lesions treated, bifurcation with ≥ 2 stents implanted, and a total stent length of ≥ 60 mm. The primary endpoint was major adverse cardiac and cerebrovascular event (MACCE), defined as the composite of all-cause death, myocardial infarction, and stroke. The primary safety endpoint included bleeding, defined as Bleeding Academic Research Consortium (BARC) types 2 to 5.

Results: Complex PCI group had a higher risk of MACCE (4.0% vs. 2.3%, hazard ratio [HR] = 1.74, 95% confidence interval [CI]: 1.05-2.89, p = 0.033) and a similar risk of BARC types 2-5 bleeding (2.6% vs. 2.6%, HR = 1.02, 95% CI: 0.56-1.86, p = 0.939) compared with those without complex PCIs. Patients undergoing complex PCIs, followed by P2Y₁₂ inhibitor monotherapy and 12 months of DAPT exhibited similar rates of MACCE (3.8% vs. 4.2%, HR = 0.92, 95% CI: 0.38-2.21, p = 0.853).

Conclusions: P2Y₁₂ inhibitor monotherapy, mostly clopidogrel, following 3 months of DAPT did not increase ischemic events in patients with complex PCIs.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.5603/CJ.a2021.0101DOI Listing
September 2021

Impact of initial very low-level low-density lipoprotein cholesterol on the prognosis of acute myocardial infarction patients.

Coron Artery Dis 2021 Aug 3. Epub 2021 Aug 3.

Department of Internal Medicine, Konkuk University School of Medicine, Chungju Department of Thoracic and Cardiovascular Surgery, Korea University Guro Hospital Cardiovascular Center, Korea University Guro Hospital, Seoul, Korea Heart Center of Chonnam, National University Hospital, Gwangju, Republic of Korea.

Background: Cholesterol control with statins has been shown to have beneficial effects in coronary artery disease. However, the relationship between initial very low low-density lipoprotein (LDL) cholesterol levels and long-term clinical outcomes in patients with acute myocardial infarction (AMI) remains unclear.

Methods: A total of 8741 (mean age: 64.6 ± 12.7 years, men) consecutive AMI patients treated with drug-eluting stents were entered into the Korea Acute Myocardial Infarction Registry from November 2011 to December 2015. Patients were divided into six groups according to whether they were taking statins (on-statin group) or not (statin naive group) and depending on their LDL cholesterol level at admission (<70, 70-99, 100-129, 130-159, >160 mg/dl). Clinical outcomes at 24 months in patients with AMI were examined.

Results: The incidence of risk factors including hypertension, diabetes, coronary artery disease and heart failure was lower as LDL cholesterol increased, except in the on-statin group. Clinical outcomes, including total mortality at 24 months, showed better outcomes in those with high LDL cholesterol than those with low LDL cholesterol, except in the statin group. In the statin-naïve group, the higher the LDL cholesterol level, the higher the rate of 24-month survival. In a Cox regression model, initial low LDL cholesterol was an independent predictor of mortality at 24 months after adjusting for baseline confounding factors.

Conclusions: At admission, a very low LDL cholesterol level (<70 mg/dL) in statin-naïve AMI patients undergoing percutaneous coronary intervention was independently associated with higher mortality at 24 months.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/MCA.0000000000001085DOI Listing
August 2021

Clinical Impact of after-consult clinic blood pressure: comparison with automated office blood pressure.

Clin Hypertens 2021 Aug 1;27(1):15. Epub 2021 Aug 1.

Internal medicine, School of Medicine, Konkuk University, 82, Gugwon-dearo, Chungju, Chungbuk, 27376, Chungju, South Korea.

Background: It is most important to measure blood pressure (BP) exactly in treating hypertension. Recent recommendations for diagnosing hypertension clearly acknowledge that an increase in BP attributable to the "whitecoat response" is frequently associated with manual BP recordings performed in community-based practice. However, there was no data about after-consult (AC) BP that could reduce whitecoat effect. So we evaluated before-consult (BC) and AC routine clinic BP and research based automated office blood pressure (AOBP) measured.

Methods: The study population consisted of 82 consecutive patients with hypertension between April 2019 and December 2019. We measured routine clinic BP and AOBP before and after see a doctor, respectively. Seated blood pressure and pulse are measured at each time after a rest period using an automated device as it offers reduced potential for observer biases. AOBP was measured and measuring BP 3 times un-observed. We compared each BP parameter for identifying exact resting BP state.

Results: There was significant difference between BC and AC systolic BP (135.37 ± 16.90 vs. 131.95 ± 16.40 mmHg, p = 0.015). However there was no difference in the BC and AC diastolic blood pressure (73.75 ± 11.85 vs. 74.42 ± 11.71 mmHg, p = 0.415). In the AOBP comparison, there was also significant difference (BC systolic AOBP vs. AC systolic AOBP, 125.17 ± 14.41 vs. 122.98 ± 14.09 mmHg, p = 0.006; BC diastolic ABOB vs. AC diastolic AOBP, 71.99 ± 10.49 vs. 70.99 ± 9.83, p = 0.038).

Conclusions: In our study, AC AOBP was most lowest representing resting state. Although AC BP was higher than BC AOBP, it might be used as alternative measurement for reducing whitecoat effect in the routine clinical practice.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s40885-021-00171-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8325846PMC
August 2021

Impact of chronic outward force on arterial responses of proximal and distal of long superficial femoral artery stent.

BMC Cardiovasc Disord 2021 06 30;21(1):323. Epub 2021 Jun 30.

Cardiovascular Center, Korea University Guro Hospital, 148, Gurodong-ro, Guro-gu, Seoul, 08308, Republic of Korea.

Background: Self-expanding nitinol stent (SENS) implantation is commonly oversized in the superficial femoral artery (SFA), and leads to chronic outward force (COF) and in-stent restenosis (ISR). This study aimed to investigate the impact of COF of oversizing SENS on ISR of SFA.

Methods: In patients with implanted SENS in SFA, intimal hyperplasia especially between proximal segment and distal segment was evaluated by quantitative angiography, and the impact of COF on mid-term angiographic outcomes was investigated. In addition, porcine model with implanted SENS was used to evaluate the impact of COF on angiographic and histopathologic outcomes at 1 month. Excised stented arteries were evaluated by histopathologic analysis.

Results: We analyzed 65 SENS in 61 patients with follow-up angiography at 6 months to 1 year. The baseline diameter was 6.8 ± 0.71 mm and length were 97.0 ± 33.8 mm for the SENS. The ratio of the diameter of the stent to the reference vessel was 1.3 ± 0.24 at the proximal portion and 1.53 ± 0.27 at the distal portion (P < 0.001). In the long SFA stent, stent-to-vessel ratio was significantly higher in the distal stent than in the proximal stent (1.3 ± 0.2 vs. 1.55 ± 0.25, P = 0.001). ISR incidence was higher at the distal stent (37.3% vs 52.6%, P = 0.029). All 11 pigs survived for 4 weeks after SENS implantation. The vessel diameter was 4.04 ± 0.40 mm (control group) vs 4.45 ± 0.63 mm (oversized group), and the implanted stent diameter was 5.27 ± 0.46 mm vs. 7.18 ± 0.4 mm (P = 0.001). The stent-to-vessel diameter ratio was 1.31 ± 0.12 versus 1.63 ± 0.20 (P < 0.001). After 4 weeks, restenosis % was 29.5 ± 12.9% versus 46.8 ± 21.5% (P = 0.016). The neointimal area was 5.37 ± 1.15 mm vs. 8.53 ± 5.18 mm (P = 0.05). The restenosis % was 39.34 ± 8.53% versus 63.97 ± 17.1% (P = 0.001).

Conclusions: COF is an important cause of restenosis in the distal portion of the SFA stent. Optimal sizing of the SFA stent is important to reduce the incidence of restenosis. Therefore, COF was an important factor of restenosis following distal SFA stenting.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12872-021-02141-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8246708PMC
June 2021

Stenting versus balloon angioplasty alone in patients with below-the-knee disease: A propensity score-matched analysis.

PLoS One 2021 10;16(6):e0251755. Epub 2021 Jun 10.

Cardiovascular Center, Korea University Guro Hospital, Seoul, Korea.

Percutaneous transluminal angioplasty (PTA) is considered an effective treatment in patients with critical limb ischemia (CLI). However, the long-term durability of below-the-knee (BTK) PTA is known to be limited. This study sought to compare the 1-year clinical outcomes following stenting versus balloon angioplasty alone in BTK lesions. This study included 357 consecutive patients (400 limbs, 697 lesions) with BTK lesions who underwent PTA from September 2010 to December 2016. All enrolled patients were treated either by stenting (stent group; 111 limbs of 102 patients) or plain old balloon angioplasty (POBA group; 289 limbs of 255 patients). Stent group includes both primary and provisional stenting. Angiographic outcomes, procedural success, complications, and clinical outcomes were compared between the two groups up to 1 year. After propensity score matching (PSM) analysis, 56 pairs were generated, and the baseline and angiographic characteristics were balanced. The procedural success and complications were similar between the two groups; however, the incidence of procedure-related perforation was higher in the POBA group than in the stenting group [5(11.9%) vs.1 (0.9%), P = 0.009]. Six- to 9-month computed tomography or angiographic follow-up showed similar incidences of binary restenosis, primary patency, and secondary patency. In the 1-year clinical follow-up, there were similar incidences of individual hard endpoints, including mortality, myocardial infarction, limb salvage, and amputation rate, with the exception of target extremity revascularization (TER), which tended to be higher in the stenting group than in the POBA group [21 (20.8%) vs. 11 (10.9%), P = 0.054]. Although there was a trend toward a higher incidence of TER risk in the stenting group, stent implantation, particularly in bail-out stenting seemed to have acceptable 1-year safety and efficacy compared to POBA alone in patients undergoing BTK PTA.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0251755PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8191955PMC
October 2021

P2Y12 inhibitor monotherapy after coronary stenting according to type of P2Y12 inhibitor.

Heart 2021 Mar 23. Epub 2021 Mar 23.

Department of Cardiology, Korea University Guro Hospital, Seoul, Korea (the Republic of).

Objective: To compare P2Y12 inhibitor monotherapy after 3-month dual antiplatelet therapy (DAPT) with 12-month DAPT according to the type of P2Y12 inhibitor in patients undergoing percutaneous coronary intervention (PCI).

Methods: The Smart Angioplasty Research Team: Comparison Between P2Y12 Antagonist Monotherapy vs Dual Antiplatelet Therapy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents (SMART-CHOICE) randomised trial compared 3-month DAPT followed by P2Y12 inhibitor monotherapy with 12-month DAPT. In this trial, 2993 patients undergoing successful PCI with drug-eluting stent were enrolled in Korea. As a prespecified analysis, P2Y12 inhibitor monotherapy after 3-month DAPT versus 12-month DAPT were compared among patients receiving clopidogrel and those receiving potent P2Y12 inhibitor (ticagrelor or prasugrel), respectively. The primary endpoint was a composite of all-cause death, myocardial infarction or stroke at 12 months after the index procedure.

Results: Among 2993 patients (mean age 64 years), 58.2% presented with acute coronary syndrome. Clopidogrel was prescribed in 2312 patients (77.2%) and a potent P2Y12 inhibitor in 681 (22.8%). There were no significant differences in the primary endpoint between the P2Y12 inhibitor monotherapy group and the DAPT group among patients receiving clopidogrel (3.0% vs 3.0%; HR: 1.02; 95% CI 0.64 to 1.65; p=0.93) as well as among patients receiving potent P2Y12 inhibitors (2.4% vs 0.7%; HR: 3.37; 95% CI 0.77 to 14.78; p=0.11; interaction p=0.1). Among patients receiving clopidogrel, P2Y12 inhibitor monotherapy compared with DAPT showed consistent treatment effects across various subgroups for the primary endpoint. Among patients receiving potent P2Y12 inhibitors, the rate of bleeding (Bleeding Academic Research Consortium types 2- 5) was significantly lower in the P2Y12 inhibitor monotherapy group than in the DAPT group (1.5% vs 5.0%; HR: 0.33; 95% CI 0.12 to 0.87; p=0.03).

Conclusions: Compared with 12-month DAPT, clopidogrel monotherapy after 3-month DAPT showed comparable cardiovascular outcomes in patients undergoing PCI.

Trial Registration Number: NCT02079194.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/heartjnl-2020-318821DOI Listing
March 2021

Impact of genetic variants on clinical outcome after percutaneous coronary intervention in elderly patients.

Aging (Albany NY) 2021 03 12;13(5):6506-6524. Epub 2021 Mar 12.

Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Korea University College of Medicine, Seoul, South Korea.

Elderly patients treated with percutaneous coronary intervention (PCI) have a higher risk of both ischemic and bleeding complications than younger patients. However, few studies have reported how genetic information of elderly patients treated with PCI affects clinical outcomes. We investigated the impact of genetic variants on clinical outcomes in elderly patients. Correlations between single-nucleotide polymorphisms (CYP2C19 and P2Y12 receptor gene G52T polymorphism) and clinical outcomes were analyzed in 811 elderly patients (≥75 years of age) from a prospective multicenter registry. The primary endpoint was a composite of myocardial infarction and death. Secondary endpoints were an individual event of death, cardiac death, myocardial infarction, stent thrombosis, target lesion revascularization, stroke, and major bleeding (Bleeding Academic Research Consortium ≥3). Regarding CYP2C19, patients with poor metabolizers had a significantly higher risk for the primary endpoint (hazard ratio [HR] 2.43; 95% confidence interval [95% CI] 1.12-5.24; p=0.024) and secondary endpoints (death and cardiac death). Regarding P2Y12 G52T, the TT group had a significantly higher occurrence of major bleeding than the other groups (HR 3.87; 95% CI 1.41-10.68; p=0.009). In conclusion, poor metabolizers of CYP2C19 and TT groups of P2Y12 G52T may be significant predictors of poor clinical outcomes in elderly patients.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.18632/aging.202799DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7993709PMC
March 2021

Effects of Prolonged Dual Antiplatelet Therapy in ST-Segment Elevation vs. Non-ST-Segment Elevation Myocardial Infarction.

Circ J 2021 05 9;85(6):817-825. Epub 2021 Jan 9.

Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine.

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

Conclusions: Compared with 6-month DAPT, ≥12-month DAPT reduced recurrent MI or stent thrombosis regardless of the type of MI at presentation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1253/circj.CJ-20-0704DOI Listing
May 2021

Safety of 3-Month Dual Antiplatelet Therapy After Implantation of Ultrathin Sirolimus-Eluting Stents With Biodegradable Polymer (Orsiro): Results From the SMART-CHOICE Trial.

J Am Heart Assoc 2021 01 21;10(1):e018366. Epub 2020 Dec 21.

Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Korea.

Background This study sought to investigate the safety of 3-month dual antiplatelet therapy (DAPT) in patients receiving ultrathin sirolimus-eluting stents with biodegradable polymer (Orsiro). Methods and Results The SMART-CHOICE (Smart Angioplasty Research Team: Comparison Between P2Y12 Antagonist Monotherapy vs Dual Anti- platelet Therapy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents) randomized trial compared 3-month DAPT followed by P2Y12 inhibitor monotherapy with 12-month DAPT in 2993 patients undergoing percutaneous coronary intervention. The present analysis was a prespecified subgroup analysis for patients receiving Orsiro stents. As a post hoc analysis, comparisons between Orsiro and everolimus-eluting stents were also done among patients receiving 3-month DAPT. Of 972 patients receiving Orsiro stents, 481 patients were randomly assigned to 3-month DAPT and 491 to 12-month DAPT. At 12 months, the target vessel failure, defined as a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization, occurred in 8 patients (1.7%) in the 3-month DAPT group and in 14 patients (2.9%) in the 12-month DAPT group (hazard ratio [HR], 0.58; 95% CI, 0.24-1.39; =0.22). In whole population who were randomly assigned to receive 3-month DAPT (n=1495), there was no significant difference in the target vessel failure between the Orsiro group and the everolimus-eluting stent group (n=1014) (1.7% versus 1.8%; HR, 0.96; 95% CI, 0.41-2.22; =0.92). Conclusions In patients receiving Orsiro stents, clinical outcomes at 1 year were similar between the 3-month DAPT followed by P2Y12 inhibitor monotherapy and 12-month DAPT strategies. With 3-month DAPT, there was no significant difference in target vessel failure between Orsiro and everolimus-eluting stents. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02079194.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1161/JAHA.120.018366DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7955499PMC
January 2021

The effect of antiplatelet drug on coronary endothelial and microvascular function: comparison with ticagrelor and clopidogrel.

Korean J Intern Med 2021 03 23;36(2):352-361. Epub 2020 Jun 23.

Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, Korea.

Background/aims: Coronary endothelial and microvascular function play important roles in cardiovascular disease. We aimed to evaluate the effect of ticagrelor on coronary artery function and tested the antiplatelet effect of low dose ticagrelor in East-Asian patients.

Methods: Sixty-one consecutive patients with non-significant coronary disease were included in the study. Initially, patients were randomized in 1:1:1 ratio to receive drugs: ticagrelor 90 mg twice a day (bid; n = 22), ticagrelor 45 mg bid (n = 19) or clopidogrel 75 mg once a day (qd; n = 20) and then divided into two groups (ticagrelor vs clopidogrel) for evaluation of coronary artery function, and three groups for evaluation of antiplatelet function. Endothelial dysfunction was measured by coronary flow reserve (CFR), and changes in the levels of asymmetric dimethylarginine (ADMA), cluster of differentiation (CD) 40 ligand, and P-selectin. Microvascular function was evaluated as index of microvascular resistance (IMR). Platelet reactivity was assessed by VerifyNow P2Y12 assay.

Results: The levels of CFR, ADMA, and CD 40 ligand were not different between the two groups. However, P-selectin was lower in the ticagrelor group compared with clopidogrel group. IMR was significantly lower in the ticagrelor group compared with clopidogrel group (median, 15.0 [interquartile range, 12.0 to 21.0] vs. 47.5 [23.0 to 67.5], p = 0.014). There was significant difference in platelet inhibition among the three groups (ticagrelor 90 mg bid vs. ticagrelor 45 mg bid vs. clopidogrel 75 mg qd; 85.57 ± 47.63 vs. 120.33 ± 51.09 vs. 256.42 ± 55.10, p < 0.001).

Conclusion: It is hypothesized that ticagrelor might ameliorate the coronary microvascular function. When compared with clopidogrel, low dose ticagrelor exhibited satisfactory antiplatelet effect in the present study.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3904/kjim.2019.293DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7969081PMC
March 2021

Comparison between calcium channel blocker with angiotensin converting enzyme inhibitor or angiotensin II type 1 receptor blocker combination on the development of new-onset diabetes in hypertensive Korean patients.

J Diabetes Metab Disord 2020 Jun 3;19(1):405-413. Epub 2020 Apr 3.

Cardiovascular Center, Korea University Guro Hospital, 148, Gurodong-ro, Guro-gu, Seoul, 08308 South Korea.

Background And Purpose: Rare comparative studies investigated the relationship between combination therapy of antihypertensive drugs and the incidence of new-onset diabetes mellitus (NODM). The aim of this study was to evaluate which combination therapy, calcium channel blocker (CCB) with angiotensin converting enzyme inhibitor (ACEI) or CCB with angiotensin II type 1 receptor blocker (ARB), is best in reducing/preventing the development of NODM during 4-year follow-up periods in non-diabetic hypertensive Korean patients.

Materials And Methods: Finally, a total of 1221 consecutive hypertensive patients without a history of diabetes mellitus who had been prescribed CCB were retrospectively enrolled and divided into the two groups, an ACEI group (combination CCB with ACEI,  = 251) and an ARB group (combination CCB with ARB,  = 970). The primary endpoint was NODM, defined as a fasting blood glucose ≥126 mg/dL or hemoglobin A1c ≥ 6.5%. Secondary endpoint was major adverse cardiac events (MACE) defined as total death, non-fatal myocardial infarction (MI) and percutaneous coronary intervention (PCI).

Results: After propensity-score matched (PSM) analysis, two propensity-matched groups (243 pairs,  = 486, C-statistic = 0.696) were generated. During 4-year follow-up periods, there were similar incidence of NODM (Hazard ratio [HR]; 1.198, 95% confidence interval [CI]; 0.591-2.431,  = 0.616), MACE (HR; 1.324, 95% CI; 0.714-2.453,  = 0.373), total death, MI and PCI between the two groups after PSM analysis.

Conclusion: CCB with ACE or CCB with ARB combination strategies are equally acceptable in hypertensive Korean patients regarding the occurrence of NODM.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s40200-020-00521-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7270230PMC
June 2020

Clinical Usefulness of PRECISE-DAPT Score for Predicting Bleeding Events in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: An Analysis From the SMART-DATE Randomized Trial.

Circ Cardiovasc Interv 2020 05 1;13(5):e008530. Epub 2020 May 1.

Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea (K.H.C., Y.B.S., J.M.L., T.K.P., J.H.Y., J.-H.C., S.-H.C., H.-C.G., J.-Y.H.).

Background: Although the current guidelines endorse the PRECISE-DAPT score (Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy) to inform clinical decisions regarding duration of DAPT in patients undergoing percutaneous coronary intervention, use of the PRECISE-DAPT score to guide duration of DAPT has not been properly validated by randomized trials focused on the population with acute coronary syndrome. This study aimed to evaluate the usefulness of the PRECISE-DAPT score for predicting future bleeding and ischemic events and to compare clinical outcomes of short-term and long-term DAPT duration according to the PRECISE-DAPT score in patients with acute coronary syndrome.

Methods: This was a substudy of the SMART-DATE trial (6- Versus 12-Month or Longer Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome), in which patients with acute coronary syndrome undergoing percutaneous coronary intervention were randomly assigned to either 6- (n=1357) or 12-month or longer DAPT (n=1355). Major bleeding (Bleeding Academic Research Consortium type 3-5) and ischemic (myocardial infarction, stent thrombosis, or ischemic stroke) events at 18 months after the index procedure were compared between the 6- and 12-month or longer DAPT groups, according to PRECISE-DAPT score.

Results: The PRECISE-DAPT score was moderately effective at predicting bleeding events (area under the curve, 0.754 [95% CI, 0.655-0.854]; <0.001). In patients with nonhigh PRECISE-DAPT score (<25, n=1967 [72.5%]), 6-month DAPT was associated with higher ischemic risk (2.7% versus 1.3%; HR, 2.01 [95% CI, 1.03-3.91]; =0.040; absolute risk difference, +1.3%; =0.035) with similar bleeding risk (0.4% versus 0.3%; HR, 2.00 [95% CI, 0.37-10.94]; =0.422; absolute risk difference, +0.2%; =0.498), compared with 12-month or longer DAPT. Among patients with high PRECISE-DAPT score (≥25, n=745 [27.5%]), 6-month DAPT presented a similar ischemic risk (4.8% versus 3.4%; HR, 1.43 [95% CI, 0.68-2.98], =0.348; absolute risk difference, +1.5%; =0.327) but significantly reduced major bleeding risk (0.6% versus 2.3%; HR, 0.25 [95% CI, 0.05-1.17]; =0.079; absolute risk difference, -1.7%; =0.045).

Conclusions: Consistent with current guidelines, determination of the duration of DAPT according to PRECISE-DAPT score could improve the clinical outcomes in patients with acute coronary syndrome after percutaneous coronary intervention with current-generation drug-eluting stents. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01701453.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008530DOI Listing
May 2020

Additional postdilatation using noncompliant balloons after everolimus-eluting stent implantation: Results of the PRESS trial.

Clin Cardiol 2020 Jun 16;43(6):606-613. Epub 2020 Mar 16.

Department of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, South Korea.

Background: There are limited data on the clinical value of routine postdilatation using noncompliant balloons after contemporary drug-eluting stent implantation.

Hypothesis: Additional postdilatation using noncompliant balloons after everolimus-eluting stent implantation could provide better clinical outcomes.

Methods: We randomly assigned 1774 patients with coronary artery disease to undergo additional high-pressure postdilatation using noncompliant balloons and moderate-pressure dilatation using stent balloons after everolimus-eluting stent implantation. The primary endpoint was a composite of death, myocardial infarction (MI), stent thrombosis, and target vessel revascularization (TVR) 2 years after randomization.

Results: The study was discontinued early owing to slow enrollment. In total, 810 patients (406 patients in the high pressure group and 404 in the moderate pressure group) were finally enrolled. At 2 years, the primary endpoint occurred in 3.6% of patients in the high pressure group and in 4.4% of those in the moderate pressure group (P = .537). In addition, no significant differences were observed between the two groups in the occurrence of an individual end point of death (0.8% in the high pressure group vs 1.5% in the moderate group, P = .304), MI (0.2% vs 0.5%, P = .554), stent thrombosis (0% vs 0.2%, P = .316), or TVR (2.8% vs 2.6%, P = .880).

Conclusions: The strategy of routine postdilatation using noncompliant balloons after everolimus-eluting stent implantation did not provide incremental clinical benefits.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/clc.23355DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7298980PMC
June 2020

The angiography-guided spot versus entire stenting in patients with long coronary lesions trial: Study design and rationale for a randomized controlled trial protocol.

Contemp Clin Trials Commun 2020 Mar 14;17:100523. Epub 2020 Jan 14.

Division of Cardiology, Konkuk University Chungju Hospital, Chungju, Republic of Korea.

Background: : Long-stenting, even with a second-generation drug-eluting stent (DES), is an independent predictor of restenosis and stent thrombosis in patients with long coronary lesions. Spot-stenting, i.e., selective stenting of only the most severe stenotic segments of a long lesion, may be an alternative to a DES. The purpose of this study is to compare the one-year clinical outcomes of patients with spot versus entire stenting in long coronary lesions using a second-generation DES.

Method: This study is a randomized, prospective, multi-center trial comparing long-term clinical outcomes of angiography-guided spot versus entire stenting in patients with long coronary lesions (≥25 mm in length). The primary endpoint is target vessel failure (TVF) at 12 months, a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization (TVR). A total of 470 patients are enrolled for this study according to sample size calculations. This study will be conducted to evaluate the non-inferiority of spot stenting compared to entire stenting with zotarolimus-eluting stents (ZES).

Results: This study is designed to evaluate the clinical impact of spot-stenting with ZESs for TVF due to possible edge restenosis or non-target lesion revascularization. Theoretically, spot-stenting may decrease the risk of TVR and the extent of endothelial dysfunction.

Conclusion: This SPOT trial will provide clinical insight into spot-stenting with a current second-generation DES as a new strategy for long coronary lesions.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.conctc.2020.100523DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6997810PMC
March 2020

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

Korean Circ J 2020 Apr 23;50(4):317-327. Epub 2019 Dec 23.

Division of Cardiology, Cardiovascular Center, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Korea.

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4070/kcj.2019.0258DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7067606PMC
April 2020

Five-year clinical outcomes of first-generation versus second-generation drug-eluting stents following coronary chronic total occlusion intervention.

J Geriatr Cardiol 2019 Aug;16(8):639-647

Cardiovascular Center, Korea University Guro Hospital, Seoul, South Korea.

Background: There are limited data comparing long-term clinical outcomes between first-generation (1G) and second-generation (2G) drug-eluting stents (DESs) in patients who underwent successful percutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO) lesion.

Methods: A total of 840 consecutive patients who underwent PCI with DESs for CTO lesion from January 2004 to November 2015 were enrolled. Finally, a total of 324 eligible CTO patients received 1G-DES (Paclitaxel-eluting stent or Sirolimus-eluting stent, = 157) or 2G-DES (Zotarolimus-eluting stent or Everolimus-eluting stent, = 167) were enrolled. The clinical endpoint was the occurrence of major adverse cardiac events (MACE) defined as all-cause death, recurrent myocardial infarction (re-MI), total repeat revascularization [target lesion revascularization (TLR), target vessel revascularization (TVR), and non-TVR]. We investigated the 5-year major clinical outcomes between 1G-DES and 2G-DES in patient who underwent successful CTO PCI.

Results: After propensity score matched (PSM) analysis, two well-balanced groups (111 pairs, = 222, C-statistic = 0.718) were generated. Up to the 5-year follow-up period, the cumulative incidence of all-cause death, re-MI, TLR, TVR and non-TVR were not significantly different between the two groups. Finally, MACE was also similar between the two groups (HR = 1.557, 95% CI: 0.820-2.959, = 0.176) after PSM.

Conclusions: In this study, 2G-DES was not associated with reduced long-term MACE compared with 1G-DES following successful CTO revascularization up to five years.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.11909/j.issn.1671-5411.2019.08.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6748900PMC
August 2019

Three-year major clinical outcomes of phosphorylcholine polymer- vs biolinx polymer-zotarolimus-eluting stents: A propensity score matching study.

Medicine (Baltimore) 2019 Aug;98(32):e16767

Cardiovascular Center, Korea University Guro Hospital.

There are limited long-term outcome data comparing BioLinx polymer (B)-zotarolimus-eluting stents (ZES) with phosphorylcholine polymer (P)-ZES. The aim of this study was to compare the efficacy and safety of B-ZES with P-ZES in patients who underwent percutaneous coronary intervention (PCI) during a 3-year follow-up period.One thousand two hundred fifty four patients who underwent PCI with P-ZES (Endeavor [ZES-E] or Endeavor sprint [ZES-S], n = 356) or B-ZES (Endeavor resolute [ZES-R] or Resolute Integrity [ZES-I], n = 889) were enrolled. The primary endpoint was major adverse cardiac events (MACE); the composite of total death, non-fatal myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), non-target vessel revascularization (Non-TVR), and the secondary endpoint was stent thrombosis (ST).After PSM, 2 propensity-matched (PSM) groups (275 pairs, n = 550, C-statistic = 0.730) were generated. During the 3-year follow-up period, the cumulative incidence of MACE (hazard ratio [HR], 1.525; 95% confidence interval [CI], 0.920-2.526; P = .101) and ST (HR, 1.248; 95% CI, 0.335-4.4649; P = .741) were similar between P-ZES and B-ZES after PSM. However, TLR rate was significantly higher in ZES-S than ZES-I (11.3% vs 3.8%, log rank P = .029) and TVR rate was higher in ZES-S than ZES-R (14.1% vs 4.8%, log rank P = .025).In this single-center, all-comer registry, despite different polymers, P-ZES, and B-ZES showed comparable safety and efficacy during a 3-year follow-up period after PCI.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/MD.0000000000016767DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6709022PMC
August 2019

Calcium channel blocker monotherapy versus combination with renin-angiotensin system inhibitors on the development of new-onset diabetes mellitus in hypertensive Korean patients.

J Geriatr Cardiol 2019 Jun;16(6):439-447

Cardiovascular Center, Korea University Guro Hospital, Seoul, South Korea.

Background: In real practice, two or more antihypertensive drugs are needed to achieve target blood pressure. We investigated the comparative beneficial actions of combination therapy of renin-angiotensin system inhibitors (RASI), with calcium channel blockers (CCB) over CCB monotherapy on the development of new-onset diabetes mellitus (NODM) in Korean patients during four-year follow-up periods.

Methods: A total of 3208 consecutive hypertensive patients without a history of diabetes mellitus who had been prescribed CCB were retrospectively enrolled from January 2004 to December 2012. These patients were divided into the two groups according to the additional use of RASI (the RASI group, = 1221 and the no RASI group, = 1987). Primary endpoint was NODM, defined as a fasting blood glucose ≥ 126 mg/dL or hemoglobin A1c ≥ 6.5%. Secondary endpoint was major adverse cardiac events (MACE) defined as total death, myocardial infarction (MI) and percutaneous coronary intervention (PCI).

Results: After propensity score-matched (PSM) analysis, two propensity-matched groups (939 pairs, = 1878, C-statistic = 0.743) were generated. The incidences of NODM (HR = 1.009, 95% CI: 0.700-1.452, = 0.962), MACE (HR = 0.877, 95% CI: 0.544-1.413, = 0.589), total death, MI, PCI were similar between the two groups after PSM during four years.

Conclusions: The use of RASI in addition to CCB showed comparable incidences of NODM and MACE compared to CCB monotherapy in non-diabetic hypertensive Korean patients during four-year follow-up period. However, large-scaled randomized controlled clinical trials will be required for a more definitive conclusion.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.11909/j.issn.1671-5411.2019.06.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6612608PMC
June 2019

Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention: The SMART-CHOICE Randomized Clinical Trial.

JAMA 2019 06;321(24):2428-2437

Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

Importance: Data on P2Y12 inhibitor monotherapy after short-duration dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention are limited.

Objective: To determine whether P2Y12 inhibitor monotherapy after 3 months of DAPT is noninferior to 12 months of DAPT in patients undergoing PCI.

Design, Setting, And Participants: The SMART-CHOICE trial was an open-label, noninferiority, randomized study that was conducted in 33 hospitals in Korea and included 2993 patients undergoing PCI with drug-eluting stents. Enrollment began March 18, 2014, and follow-up was completed July 19, 2018.

Interventions: Patients were randomly assigned to receive aspirin plus a P2Y12 inhibitor for 3 months and thereafter P2Y12 inhibitor alone (n = 1495) or DAPT for 12 months (n = 1498).

Main Outcomes And Measures: The primary end point was major adverse cardiac and cerebrovascular events (a composite of all-cause death, myocardial infarction, or stroke) at 12 months after the index procedure. Secondary end points included the components of the primary end point and bleeding defined as Bleeding Academic Research Consortium type 2 to 5. The noninferiority margin was 1.8%.

Results: Among 2993 patients who were randomized (mean age, 64 years; 795 women [26.6%]), 2912 (97.3%) completed the trial. Adherence to the study protocol was 79.3% of the P2Y12 inhibitor monotherapy group and 95.2% of the DAPT group. At 12 months, major adverse cardiac and cerebrovascular events occurred in 42 patients in the P2Y12 inhibitor monotherapy group and in 36 patients in the DAPT group (2.9% vs 2.5%; difference, 0.4% [1-sided 95% CI, -∞% to 1.3%]; P = .007 for noninferiority). There were no significant differences in all-cause death (21 [1.4%] vs 18 [1.2%]; hazard ratio [HR], 1.18; 95% CI, 0.63-2.21; P = .61), myocardial infarction (11 [0.8%] vs 17 [1.2%]; HR, 0.66; 95% CI, 0.31-1.40; P = .28), or stroke (11 [0.8%] vs 5 [0.3%]; HR, 2.23; 95% CI, 0.78-6.43; P = .14) between the 2 groups. The rate of bleeding was significantly lower in the P2Y12 inhibitor monotherapy group than in the DAPT group (2.0% vs 3.4%; HR, 0.58; 95% CI, 0.36-0.92; P = .02).

Conclusions And Relevance: Among patients undergoing percutaneous coronary intervention, P2Y12 inhibitor monotherapy after 3 months of DAPT compared with prolonged DAPT resulted in noninferior rates of major adverse cardiac and cerebrovascular events. Because of limitations in the study population and adherence, further research is needed in other populations.

Trial Registration: ClinicalTrials.gov Identifier: NCT02079194.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1001/jama.2019.8146DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6593635PMC
June 2019

Early-Stage Vascular Response between Bare Metal Stent and Drug-Free Bioresorbable Vascular Scaffold in the Small-Sized Peripheral Artery: A Preclinical Study in Porcine Femoral Arteries.

Ann Vasc Surg 2019 Oct 12;60:388-396. Epub 2019 Jun 12.

Department of Internal Medicine, Soonchunhyang University Gumi Hospital, Gumi, South Korea.

Background: The clinical benefits and outcomes of the interventional treatment of small-sized infrapopliteal arteries using stent implantation remain uncertain. The aim of this study was to compare the safety and efficacy of drug-free bioresorbable vascular scaffold (BVS) with that of bare metal stent (BMS) in endovascular treatment of small-sized peripheral arteries.

Methods: In this study, drug-free BVS and BMS were used in eight porcine models. We compared the angiographic and histomorphometric findings in the two groups at 4 weeks. In each pig, BVS and BMS of adequate sizes were implanted in the small branch (<3 mm) of the femoral artery. Angiography, intravascular ultrasound (IVUS), and histomorphometric analysis were performed at 4 weeks.

Results: In the 4-week follow-up angiography and IVUS examination, the minimal luminal diameter was smaller and diameter stenosis was more severe in the BVS group. Histomorphometric findings indicated that the lumen area in the BVS group was smaller (0.34 ± 0.28 mm vs. 1.40 ± 0.52 mm, P < 0.001), whereas the neointimal area (2.70 ± 1.28 mm vs. 1.76 ± 0.66 mm, P = 0.013), area stenosis (85.18 ± 13.14 % vs. 54.99 ± 16.13 %, P < 0.001), inflammatory score (2.07 ± 0.861 vs. 28 ± 0.39, P = 0.003), and fibrin scores (1.24 ± 0.70 vs. 0.79 ± 0.72, P = 0.043) were significantly higher in the BVS group. The injury score was higher in the BMS group. In histopathologic findings, restenosis was mainly due to recoil and distortion of the scaffold in the BVS group.

Conclusions: Compared with BMS, drug-free BVS was not feasible for small-sized peripheral arteries based on the angiographic, IVUS, and histomorphometric results primarily due to insufficient mechanical support.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.avsg.2019.03.034DOI Listing
October 2019

Five-year major clinical outcomes between first-generation and second-generation drug-eluting stents in acute myocardial infarction patients underwent percutaneous coronary intervention.

J Geriatr Cardiol 2018 Aug;15(8):523-533

Cardiovascular Center, Korea University, Guro Hospital, Seoul, South Korea.

Background: There were limited data comparing the major clinical outcomes between first-generation (1G)-drug eluting stents (DES) and second-generation (2G)-DES in patients with acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI) during very long follow-up periods. We thought to investigate the comparative efficacy and safety of 2G-DES compared with 1G-DES in AMI patients during 5-year follow-up periods.

Method: A total of 1016 eligible AMI patients who underwent PCI with 1G-DES [paclitaxel-, sirolimus-, 1G-zotarolimus-eluting stent (endeavor or endeavor sprint), = 554] or 2G-DES [2G-zotarolimus (endeavor resolute)- or everolimus-eluting stent, = 462] were enrolled. The primary endpoint was the occurrence of major adverse cardiac events (MACE) defined as total death, non-fatal myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), non-target vessel revascularization (Non-TVR) and the secondary endpoint was stent thrombosis (ST) at 5 years.

Results: Two propensity score-matched (PSM) groups (232 pairs, = 464, C-statistic = 0.802) were generated. During the 5-year follow-up period, the cumulative incidence of TLR [hazard ratio (HR): 3.133; 95% confidence interval (CI): 1.539-6.376; = 0.002], TVR (HR: 3.144; 95% CI: 1.596-6.192; = 0.001) and total revascularization rate (HR: 1.874; 95% CI: 1.086-3.140; = 0.023) were significantly higher in 1G-DES compared with 2G-DES after PSM. However, the incidence of total death, non-fatal MI and ST were similar between the two groups.

Conclusion: In this single-center and all-comers registry, 2G-DES's superiorities for TLR, TVR and total revascularization in AMI patients suggested during 5-year clinical follow-up periods.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.11909/j.issn.1671-5411.2018.08.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6188943PMC
August 2018

The Impact of Prediabetes on Two-Year Clinical Outcomes in Patients Undergoing Elective Percutaneous Coronary Intervention.

Yonsei Med J 2018 Jun;59(4):489-494

Cardiovascular Center, Korea University Guro Hospital, Seoul, Korea.

Purpose: Prediabetes is an independent risk factor for cardiovascular disease. However, data on the long term adverse clinical outcomes of prediabetic patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) are scarce.

Materials And Methods: The study population comprised 674 consecutive non-diabetic patients who underwent elective PCI between April 2007 and November 2010. Prediabetes was defined as hemoglobin A1c (HbA1c) of 5.7% to 6.4%. Two-year cumulative clinical outcomes of prediabetic patients (HbA1c of 5.7% to 6.4%, n=242) were compared with those of a normoglycemic group (<5.7%, n=432).

Results: Baseline clinical and angiographic characteristics were similar between the two groups, except for higher glucose levels (104.8±51.27 mg/dL vs. 131.0±47.22 mg/dL, p<0.001) on admission in the prediabetes group. There was no significant difference between the two groups in coronary angiographic parameters, except for a higher incidence of diffuse long lesion in the prediabetes group. For prediabetic patients, trends toward higher incidences of binary restenosis (15.6% vs. 9.8 %, p=0.066) and late loss (0.71±0.70 mm vs. 0.59±0.62 mm, p=0.076) were noted. During the 24 months of follow up, the incidence of mortality in prediabetic patients was higher than that in normoglycemic patients (5.5% vs. 1.5%, p=0.007).

Conclusion: In our study, a higher death rate and a trend toward a higher incidence of restenosis in patients with prediabetes up to 2 years, compared to those in normoglycemic patients, undergoing elective PCI with contemporary DESs.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3349/ymj.2018.59.4.489DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5949290PMC
June 2018

6-month versus 12-month or longer dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (SMART-DATE): a randomised, open-label, non-inferiority trial.

Lancet 2018 03 12;391(10127):1274-1284. Epub 2018 Mar 12.

Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address:

Background: Current guidelines recommend dual antiplatelet therapy (DAPT) of aspirin plus a P2Y12 inhibitor for at least 12 months after implantation of drug-eluting stents (DES) in patients with acute coronary syndrome. However, available data about the optimal duration of DAPT in patients with acute coronary syndrome undergoing percutaneous coronary intervention are scant. We aimed to investigate whether a 6-month duration of DAPT would be non-inferior to the conventional 12-month or longer duration of DAPT in this population.

Methods: We did a randomised, open-label, non-inferiority trial at 31 centres in South Korea. Patients were eligible if they had unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction, and underwent percutaneous coronary intervention. Enrolled patients were randomly assigned, via a web-based system by computer-generated block randomisation, to either the 6-month DAPT group or to the 12-month or longer DAPT group, with stratification by site, clinical presentation, and diabetes. Assessors were masked to treatment allocation. The primary endpoint was a composite of all-cause death, myocardial infarction, or stroke at 18 months after the index procedure in the intention-to-treat population. Secondary endpoints were the individual components of the primary endpoint; definite or probable stent thrombosis as defined by the Academic Research Consortium; and Bleeding Academic Research Consortium (BARC) type 2-5 bleeding at 18 months after the index procedure. The primary endpoint was also analysed per protocol. This trial is registered with ClinicalTrials.gov, number NCT01701453.

Findings: Between Sept 5, 2012, and Dec 31, 2015, we randomly assigned 2712 patients; 1357 to the 6-month DAPT group and 1355 to the 12-month or longer DAPT group. Clopidogrel was used as a P2Y12 inhibitor for DAPT in 1082 (79·7%) patients in the 6-month DAPT group and in 1109 (81·8%) patients in the 12-month or longer DAPT group. The primary endpoint occurred in 63 patients in the 6-month DAPT group and in 56 patients in the 12-month or longer DAPT group (cumulative event rate 4·7% vs 4·2%; absolute risk difference 0·5%; upper limit of one-sided 95% CI 1·8%; p=0·03 with a predefined non-inferiority margin of 2·0%). Although all-cause mortality did not differ significantly between the 6-month DAPT group and the 12-month or longer DAPT group (35 [2·6%] patients vs 39 [2·9%]; hazard ratio [HR] 0·90 [95% CI 0·57-1·42]; p=0·90) and neither did stroke (11 [0·8%] patients vs 12 [0·9%]; 0·92 [0·41-2·08]; p=0·84), myocardial infarction occurred more frequently in the 6-month DAPT group than in the 12-month or longer DAPT group (24 [1·8%] patients vs ten [0·8%]; 2·41 [1·15-5·05]; p=0·02). 15 (1·1%) patients had stent thrombosis in the 6-month DAPT group compared with ten (0·7%) in the 12-month or longer DAPT group (HR 1·50 [95% CI 0·68-3·35]; p=0·32). The rate of BARC type 2-5 bleeding was 2·7% (35 patients) in the 6-month DAPT group and 3·9% (51 patients) in the 12-month or longer DAPT group (HR 0·69 [95% CI 0·45-1·05]; p=0·09). Results from the per-protocol analysis were similar to those from the intention-to-treat analysis.

Interpretation: The increased risk of myocardial infarction with 6-month DAPT and the wide non-inferiority margin prevent us from concluding that short-term DAPT is safe in patients with acute coronary syndrome undergoing percutaneous coronary intervention with current-generation DES. Prolonged DAPT in patients with acute coronary syndrome without excessive risk of bleeding should remain the standard of care.

Funding: Abbott Vascular Korea, Medtronic Vascular Korea, Biosensors Inc, and Dong-A ST.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/S0140-6736(18)30493-8DOI Listing
March 2018

Long-Term Sirolimus for Primary Immunosuppression in Heart Transplant Recipients.

J Am Coll Cardiol 2018 02;71(6):636-650

Department of Cardiovascular Diseases and Health Sciences Research and the William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic, Rochester, Minnesota. Electronic address:

Background: Small studies have reported superiority of sirolimus (SRL) over calcineurin inhibitor (CNI) in mitigating cardiac allograft vasculopathy (CAV) after heart transplantation (HT). However, data on the long-term effect on CAV progression and clinical outcomes are lacking.

Objectives: The aim of this study was to test the long-term safety and efficacy of conversion from CNI to SRL as maintenance therapy on CAV progression and outcomes after HT.

Methods: A cohort of 402 patients who underwent HT and were either treated with CNI alone (n = 134) or converted from CNI to SRL (n = 268) as primary immunosuppression was analyzed. CAV progression was assessed using serial coronary intravascular ultrasound during treatment with CNI (n = 99) and after conversion to SRL (n = 235) in patients who underwent at least 2 intravascular ultrasound studies.

Results: The progression in plaque volume (2.8 ± 2.3 mm/mm vs. 0.46 ± 1.8 mm/mm; p < 0.0001) and plaque index (plaque volume-to-vessel volume ratio) (12.2 ± 9.6% vs. 1.1 ± 7.9%; p < 0.0001) were significantly attenuated when treated with SRL compared with CNI. Over a mean follow-up period of 8.9 years from time of HT, all-cause mortality occurred in 25.6% of the patients and was lower during treatment with SRL compared with CNI (adjusted hazard ratio: 0.47; 95% confidence interval: 0.31 to 0.70; p = 0.0002), and CAV-related events were also less frequent during treatment with SRL (adjusted hazard ratio: 0.35; 95% confidence interval: 0.21 to 0.59; p < 0.0001). Further analyses suggested more attenuation of CAV and more favorable clinical outcomes with earlier conversion to SRL (≤2 years) compared with late conversion (>2 years) after HT.

Conclusions: Early conversion to SRL is associated with attenuated CAV progression and with lower long-term mortality and fewer CAV-related events compared with continued CNI use.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jacc.2017.12.005DOI Listing
February 2018

Long-term darapladib use does not affect coronary plaque composition assessed using multimodality intravascular imaging modalities: a randomized-controlled study.

Coron Artery Dis 2018 03;29(2):104-113

Department of Cardiovascular Diseases.

Background: Lipoprotein-associated phospholipase A2 (Lp-PLA2) may play a role in plaque progression and vulnerability. We aimed to define plaque characteristics on multimodality intravascular imaging in patients with coronary endothelial dysfunction in response to long-term inhibition of Lp-PLA2 by darapladib.

Patients And Methods: This is a double-blinded, randomized study screening 70 patients, and enrolling 54 patients with suspected ischemia, without obstructive disease on angiography and with coronary endothelial dysfunction by invasive assessment. Patients were randomized to receive darapladib or placebo for 6 months. Forty patients underwent multimodality intravascular imaging at baseline and after 6 months of therapy. Several parameters of plaque vulnerability were measured, including maximum value of lipid core burden index for any of the 4-mm segment (maxLCBI4 mm) by near-infrared spectroscopy. Microchannels and macrophages were assessed using optical coherence tomography and necrotic core volume by virtual histology intravascular ultrasound.

Results: There was no significant difference in maxLCBI4 mm [64.56 (7.74, 128.56) vs. 22.43 (0, 75.63), P=0.522] or in macrophage images angle [-9.5° (-25.53°, 12.68°) vs. -16.7° (-28.6°, -4.8°), P=0.489] between groups. There was a trend toward shorter microchannel length in the darapladib arm [0, (-4.4, 0.2) mm vs. 0.8 (-0.15, 1.9) mm, P=0.08]. Percentage of necrotic core volume was not significantly different.

Conclusion: Thus, long-term inhibition of endogenous Lp-PLA2 activity with darapladib was not associated with a change in plaque progression and vulnerability indices after 6 months of therapy, and the endogenous Lp-PLA2 pathway may not play a direct role in the progression of early atherosclerosis in humans.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/MCA.0000000000000573DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5796853PMC
March 2018

Impact of old age on clinical and angiographic characteristics of coronary artery spasm as assessed by acetylcholine provocation test.

J Geriatr Cardiol 2016 Oct;13(10):824-829

Cardiovascular Center, Korea University Guro Hospital, Seoul, South Korea.

Background: Smoking and other risk factors have been well known as important factors of variant angina or coronary artery spasm (CAS). However, clinical features related to age on coronary artery spasm have been rarely evaluated.

Methods: We evaluated 3155 consecutive patients with insignificant coronary artery lesion. Patients underwent Acetylcholine (Ach) provocation test for induction of CAS. CAS was defined as > 70% luminal narrowing of coronary arteries during Ach provocation test. The results of Ach provocation test were compared among age groups; < 45 years (Group 1), 45-54 years (Group 2), 55-64 years (Group 3), and ≥ 65 years (Group 4).

Results: Older patients had higher incidence of hypertension, diabetes, but lower incidence rate of current smoking, male sex compared with younger patients. Positive Ach provocation test finding was frequently showed with aging (47.36% . 58.3% . 62.6% . 61.5%; < 0.001). Multivariate logistic analysis showed that age, male, and myocardial bridge were independent predictors of CAS induced by Ach provocation test.

Conclusion: Our present study showed that old age was independent predictor for Ach-induced significant coronary artery spasm.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.11909/j.issn.1671-5411.2016.10.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5131196PMC
October 2016

Impact of Cigarette Smoking: a 3-Year Clinical Outcome of Vasospastic Angina Patients.

Korean Circ J 2016 Sep 28;46(5):632-638. Epub 2016 Sep 28.

Cardiovascular Center, Korea University Guro Hospital, Seoul, Korea.

Background And Objectives: Cigarette smoking is a risk significant factor in coronary artery disease (CAD) and vasospastic angina (VSA). However, it is largely unknown whether smoking adds to any long-term clinical risk in VSA patients.

Subjects And Methods: A total of 2797 patients without significant CAD underwent acetylcholine (Ach) provocation test between November 2004 and October 2010. Patients were divided into three groups, based on the presence of coronary artery spasm (CAS) and smoking habits (non-CAS group: n=1188, non-smoking CAS group: n=1214, smoking CAS group: n=395). All CAS patients were prescribed with anti-anginal medications for at least 6 months. The incidence of major clinical outcomes and recurrent angina of these groups were compared up to 3 years.

Results: There were considerable differences in the baseline clinical and angiographic characteristics among the three groups, but there was no difference in the endpoints among the three groups (including individual and composite hard endpoints) such as death, myocardial infarction, de novo percutaneous coronary intervention, cerebrovascular accident, and major adverse cardiac events. However, there was a higher incidence of recurrent angina in both the non-smoking CAS group and smoking CAS group, as compared to the non-CAS group. In multivariable adjusted Cox-proportional hazards regression analysis, smoking CAS group exhibited a higher incidence of recurrent angina compared with the non-CAS group (hazard ratio [HR]; 2.46, 95% confidence interval [CI]; 1.46-4.14, p=0.001) and non-smoking CAS group (HR; 1.76, 95% CI; 1.08-2.87, p=0.021).

Conclusion: Cigarette smoking CAS group exhibited higher incidence of recurrent angina during the 3-year clinical follow-up compared with both the non-CAS group and non-smoking CAS group. Quitting of smoking, paired with intensive medical therapy and close clinical follow-up, can help to prevent recurrent angina.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4070/kcj.2016.46.5.632DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5054174PMC
September 2016

Study design and rationale of the 'Balloon-Expandable Cobalt Chromium SCUBA Stent versus Self-Expandable COMPLETE-SE Nitinol Stent for the Atherosclerotic ILIAC Arterial Disease (SENS-ILIAC Trial) Trial': study protocol for a randomized controlled trial.

Trials 2016 06 25;17(1):302. Epub 2016 Jun 25.

Department of Internal Medicine, School of Medicine, Konkuk University, Chungju, Korea.

Background: The self-expandable COMPLETE™ stent (Medtronic) has greater elasticity, allowing it to regain its shape after the compression force reduces, and has higher trackability, thus is easier to maneuver through tortuous vessels, whereas the balloon-expandable SCUBA™ stent (Medtronic) has higher radial stiffness and can afford more accurate placement without geographic miss, which is important in aortoiliac bifurcation lesions. To date, there have been no randomized control trials comparing efficacy and safety between the self-expanding stent and balloon-expandable stent in advanced atherosclerotic iliac artery disease.

Methods/design: The purpose of our study is to examine primary patency (efficacy) and incidence of stent fracture and geographic miss (safety) between two different major representative stents, the self-expanding nitinol stent (COMPLETE-SE™) and the balloon-expanding cobalt-chromium stent (SCUBA™), in stenotic or occlusive iliac arterial lesions. This trial is designed as a prospective, randomized, multicenter trial to demonstrate a noninferiority of SCUBA™ stent to COMPLETE-SE™ stent following balloon angioplasty in iliac arterial lesions, and a total of 280 patients will be enrolled. The primary end point of this study is the rate of primary patency in the treated segment at 12 months after intervention as determined by catheter angiography, computed tomography angiography, or duplex ultrasound.

Discussion: The SENS-ILIAC trial will give powerful insight into whether the stent choice according to deployment mechanics would impact stent patency, geographic miss, or stent fracture in patients undergoing stent implantation in iliac artery lesions.

Trial Registration: National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT01834495 ), registration date: May 8, 2012.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s13063-016-1435-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4920989PMC
June 2016

Comparative effect on platelet function of a fixed-dose aspirin and clopidogrel combination versus separate formulations in patients with coronary artery disease: A phase IV, multicenter, prospective, 4-week non-inferiority trial.

Int J Cardiol 2016 Jan 21;202:331-5. Epub 2015 Sep 21.

Division of Cardiology, Department of Internal Medicine, Maryknoll Medical Center, Busan, Republic of Korea.

Background/objectives: The effect of aspirin and clopidogrel in a fixed-dose combination (FDC) on platelet function was compared with separate formulations in patients that had undergone percutaneous coronary intervention (PCI) with drug-eluting stent (DES).

Methods: This was a phase IV, prospective, multicenter, single-arm, non-inferiority study. Patients that had taken aspirin 100 mg and clopidogrel 75 mg once daily as separate formulations for >6 months after PCI with DES were enrolled, and then switched to an aspirin/clopidogrel FDC once-daily for 4 weeks. Platelet reactivity was determined using the VerifyNow® P2Y12 assay at baseline (immediately prior to switching) and 4 weeks later.

Results: A total of 648 patients (the full-analysis population; age, 63.6±9.0 years; male, 76.5%) finished the study, and 565 (the per-protocol population) completed without protocol violations. In the per-protocol population, the % inhibitions of P2Y12 and ARU were not significantly different between baseline and after 4 weeks of FDC treatment (29.2±20.0% to 29.0±19.9%, P=0.708; 445.1±69.2 to 446.2±63.0, P=0.799, respectively) and the difference in P2Y12 inhibition observed did not exceed the predetermined limit of non-inferiority (95% CI, -0.9 to 1.3). In the full-analysis population, the % inhibitions of P2Y12, PRU, and ARU were not significantly changed after 4 weeks of FDC treatment.

Conclusions: This study demonstrates that the efficacy of platelet inhibition by an aspirin/clopidogrel FDC was not inferior to that of separate aspirin and clopidogrel formulations in patients that had undergone PCI with DES.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ijcard.2015.09.024DOI Listing
January 2016

Impact of an endothelial progenitor cell capturing stent on coronary microvascular function: comparison with drug-eluting stents.

Korean J Intern Med 2015 Jan 30;30(1):42-8. Epub 2014 Dec 30.

Division of Cardiology, Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Korea.

Background/aims: Although drug-eluting stents (DESs) effectively reduce restenosis following percutaneous coronary intervention (PCI), they also delay re-endothelialization and impair microvascular function, resulting in adverse clinical outcomes. Endothelial progenitor cell (EPC) capturing stents, by providing a functional endothelial layer on the stent, have beneficial effects on microvascular function. However, data on coronary microvascular function in patients with EPC stents versus DESs are lacking.

Methods: Seventy-four patients who previously underwent PCI were enrolled in this study. Microvascular function was evaluated 6 months after PCI based on the index of microvascular resistance (IMR) and the coronary flow reserve (CFR). IMR was calculated as the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of the hyperemic mean transit time (hTmn). The CFR was calculated by dividing the hTmn by the baseline mean transit time.

Results: Twenty-one patients (age, 67.2 ± 9.6 years; male:female, 15:6) with an EPC stent and 53 patients (age, 61.5 ± 14.7 years; male:female, 40:13) with second-generation DESs were included in the study. There were no significant differences in the baseline clinical and angiographic characteristics of the two groups. Angiography performed 6 months postoperatively did not show significant differences in their CFR values. However, patients with the EPC stent had a significantly lower IMR than patients with second-generation DESs (median, 25.5 [interquartile range, 12.85 to 28.18] vs. 29.0 [interquartile range, 15.42 to 39.23]; p = 0.043).

Conclusions: Microvascular dysfunction was significantly improved after 6 months in patients with EPC stents compared to those with DESs. The complete re-endothelialization achieved with the EPC stent may provide clinical benefits over DESs, especially in patients with microvascular dysfunction.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3904/kjim.2015.30.1.42DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4293562PMC
January 2015
-->