Obstructive Sleep Apnea and Cardiovascular Events After Percutaneous Coronary Intervention.

BACKGROUND: There is a paucity of data from large cohort studies examining the prognostic significance of obstructive sleep apnea (OSA) in patients with coronary artery disease. We hypothesized that OSA predicts subsequent major adverse cardiac and cerebrovascular events (MACCEs) in patients undergoing percutaneous coronary intervention. METHODS AND RESULTS: The Sleep and Stent Study was a prospective, multicenter registry of patients successfully treated with percutaneous coronary intervention in 5 countries. Between December 2011 and April 2014, 1748 eligible patients were prospectively enrolled. The 1311 patients who completed a sleep study within 7 days of percutaneous coronary intervention formed the cohort for this analysis. Drug-eluting stents were used in 80.1% and bioresorbable vascular scaffolds in 6.3% of the patients, and OSA, defined as an apnea-hypopnea index of ≥15 events per hour, was found in 45.3%. MACCEs, a composite of cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, and unplanned revascularization, occurred in 141 patients during the median follow-up of 1.9 years (interquartile range, 0.8 years). The crude incidence of an MACCEs was higher in the OSA than the non-OSA group (3-year estimate, 18.9% versus 14.0%; p=0.001). Multivariate Cox regression analysis indicated that OSA was a predictor of MACCEs, with an adjusted hazard ratio of 1.57 (95% confidence interval, 1.10-2.24; P=0.013), independently of age, sex, ethnicity, body mass index, diabetes mellitus, and hypertension. CONCLUSIONS: OSA is independently associated with subsequent MACCEs in patients undergoing percutaneous coronary intervention. Evaluation of therapeutic approaches to mitigate OSA-associated risk is warranted. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01306526.

Angiographic study of the clinical liaison of drug-eluting stent and paclitaxel-eluting balloon in unifocal side branch ostium stenosis (ASCLEPIUS).

A reliable stenting strategy for treating isolated side branch (SB) ostium stenosis is not well established. The purpose of this study was to examine the 6-month angiographic outcome of a novel technique, called the shoulder technique, on this lesion subtype. Symptomatic patients with isolated SB ostium stenosis, defined as ≥75% diameter stenosis at SB ostium and <50% diameter stenosis in main vessel (MV), were treated with paclitaxel-eluting balloon in MV and drug-eluting stent in SB using the shoulder technique. Angiographic restudy was performed at 5-9 months and clinical follow-up was scheduled regularly every 3 months. There were 46 patients of age 66 ± 12 years with male predominance (76%) recruited. Diagonal ostium (67%) was the most frequent target lesion site. The size and length of paclitaxel-eluting balloon and drug-eluting stent used in MV and SB were 3.01 ± 0.25 and 20 ± 4 mm, and 2.39 ± 0.25 and 17 ± 6 mm, respectively. Angiographic restudy was performed on 43 (93.5%) patients at 6.5 ± 1.6 months. The late loss in MV and SB were 0.04 ± 0.19 and 0.19 ± 0.32 mm, respectively. Angiographic restensosis was seen in 2 (4.7%) patients at SB, whereas no stenosis was induced in MV. Improvement of symptom was reported in 36 (78%) patients. At 1-year follow-up, no death, myocardial infarction, and stent thrombosis was observed; target vessel revascularization was performed on 3 (6.5%) patients. Treatment of isolated SB ostium stenosis using the shoulder technique is associated with a favorable short-term angiographic outcome.

Effects of Ethnicity on the Prevalence of Obstructive Sleep Apnoea in Patients with Acute Coronary Syndrome: A Pooled Analysis of the ISAACC Trial and Sleep and Stent Study.

BACKGROUND: Obstructive sleep apnoea (OSA) is an emerging risk factor for acute coronary syndrome (ACS). We sought to determine the effects of ethnicity on the prevalence of OSA in patients presenting with ACS who participated in an overnight sleep study. METHODS: A pooled analysis using patient-level data from the ISAACC Trial and Sleep and Stent Study was performed. Using the same portable diagnostic device, OSA was defined as an apnoea-hypopnoea index of ≥15 events per hour. RESULTS: A total of 1961 patients were analysed, including Spanish (53.6%, n=1050), Chinese (25.5%, n=500), Indian (12.0%, n=235), Malay (6.1%, n=119), Brazilian (1.7%, n=34) and Burmese (1.2%, n=23) populations. Significant differences in body mass index (BMI) were found among the various ethnic groups, averaging from 25.3kg/m2 for Indians and 25.4kg/m2 for Chinese to 28.6kg/m2 for Spaniards. The prevalence of OSA was highest in the Spanish (63.1%), followed by the Chinese (50.2%), Malay (47.9%), Burmese (43.5%), Brazilian (41.2%), and Indian (36.1%) patients. The estimated odds ratio of BMI on OSA was highest in the Chinese population (1.17; 95% confidence interval: 1.10-1.24), but was not significant in the Spanish, Burmese or Brazilian populations. The area under the curve (AUC) for the Asian patients (ranging from 0.6365 to 0.6692) was higher than that for the Spanish patients (0.5161). CONCLUSION: There was significant ethnic variation in the prevalence of OSA in patients with ACS. The magnitude of the effect of BMI on OSA was greater in the Chinese population than in the Spanish patients.

Angiographic result of T-stenting with small protrusion using drug-eluting stents in the management of ischemic side branch: the ARTEMIS study.

The aim of this study was to examine the mid-term angiographic result of T-stenting with small protrusion (TAP) as the bailout strategy for treating coronary bifurcation lesions. From 2009 to 2012, symptomatic patients who had severe coronary bifurcation stenoses were treated with one-stent strategy using drug-eluting stents, with kissing balloon inflation performed whenever side branch (SB) impingement occurred. TAP was performed if residual diameter stenosis of SB was ≥75%, presence of ≥type B dissection or flow impairment was observed in the SB. Seventy-one patients (83% male, mean age of 61 ± 12 years) were recruited into the study. MEDINA classification 1,1,1 lesions were observed in over 60% of patients. The mean stent size and length in the main vessel (MV) and SB were 2.86 ± 0.43 and 30 ± 12, and 2.45 ± 0.26 and 16 ± 6 mm, respectively. Restudy angiography was performed on 64 (90 %) patients at 9.2 ± 3.9 months. Angiographic restenosis was observed in 8 (12.5%) patients with late lumen loss in the MV and SB being 0.22 ± 0.19 and 0.34 ± 0.37 mm, respectively. The use of TAP as the bailout technique for treating coronary bifurcation lesions is associated with good angiographic outcomes, in terms of late lumen loss and restenosis, at 9 months.

Zotarolimus-eluting stent utilization in small-vessel coronary artery disease (ZEUS).

The role of the second-generation zotarolimus-eluting stent RESOLUTE in small-vessel coronary artery disease is unclear. The aim of this study was examine the angiographic results of RESOLUTE in de novo coronary lesions of ≥50 % diameter stenosis in target vessels ≤2.5 mm. From August 2008 to April 2010, 142 symptomatic patients with 159 lesions who fitted the inclusion criteria were treated with RESOLUTE. The mean age of patients was 66 ± 10 years, with male predominance (66 %). Diabetes mellitus was found in 62 (43.7 %) patients, whereas multivessel disease was observed in 105 (73.9 %). The mean stent size and length used were 2.33 ± 0.13 and 22 ± 8 mm, respectively. Follow-up angiography was performed on 143 (89.9 %) lesions in 127 (89.4 %) patients at a mean of 10.3 ± 3.6 months. Angiographic restenosis was found in 9 (6.3 %) lesions; the late loss was 0.26 ± 0.34 mm. At 1-year follow-up there were four cardiovascular deaths, two nonfatal myocardial infarctions, and six repeated revascularizations. The resultant major adverse cardiac event rate was 8.5 %. The use of RESOLUTE to treat small-vessel disease is associated with good clinical and angiographic outcomes at 1 year.

Combined paclitaxel-eluting balloon and Genous cobalt-chromium alloy stent utilization in de novo coronary stenoses (PEGASUS).

OBJECTIVES: The aim of this study was to examine the angiographic result and its outcome predictors using the combination of paclitaxel-eluting balloon (PEB) and Genous stent. BACKGROUND: This approach to treat coronary stenoses is a logical strategy to strike a balance between minimizing restenosis and stent thrombosis. METHODS: From November 2010 to June 2012, 40 symptomatic patients with 44 de novo coronary lesions of diameter stenosis ≥ 50% were treated with the combination of PEB and Genous stents. Angiographic and clinical follow-up were intended at 6 and 9 months, respectively. RESULTS: The mean age of patients was 61 ± 11 years, with male predominance (83%). Diabetes mellitus and end-stage renal failure on peritoneal dialysis were found in 15 (38%) and 10 (25%) patients, respectively. Patients received dual antiplatelet therapy for 5.1 ± 1.5 months post procedure. The size and length of PEB used was larger than the stents (3.13 ± 0.46 mm and 28 ± 9 mm vs. 2.98 ± 0.36 mm and 23 ± 7 mm). Restudy angiography was performed on 41 (95%) lesions in 37 (93%) patients at 5.9 ± 1.7 months. Angiographic restenosis was seen in 5 (12%) lesions, and significantly associated with diabetes mellitus and dialysis dependency; the late lumen loss was 0.38 ± 0.37 mm. At 9-month follow-up, no stent thrombosis was observed. CONCLUSIONS: The use of PEB combined with Genous stent is associated with a reasonably low restenosis and late lumen loss, whereas diabetes mellitus and renal failure with dialysis are poor predictors of angiographic restenosis.

Angiographic and clinical outcomes of everolimus-eluting stent in the treatment of extra long stenoses (AEETES).

OBJECTIVES: The purpose of this study was to examine the angiographic and clinical results of stent full metal jacket in treating long lesions using everolimus-eluting stents (EES). BACKGROUND: Data are lacking regarding the use of EES for this lesion subgroup. METHODS: From 2007 to 2011, 77 symptomatic patients who had severe coronary stenoses necessitating implantation of stents with total length longer than 60 mm were treated with overlapping EES. RESULTS: The mean age of patient was 61 ± 11 years with male predominance (66%). Diabetes mellitus was seen in 35 (45.5%) patients. Majority of patients had class III angina with normal heart function. On average, 3.1 stents were implanted per lesion; the mean stent size and length were 2.70 ± 0.28 mm and 82 ± 16 mm. Restudy angiography was performed on 71 patients (72 lesions) at 8.9 ± 2.5 months. Angiographic restenosis was seen in 9 (12.5%) lesions; the lesion length and late loss were 67 ± 15 mm and 0.4 ± 0.6 mm, respectively. The use of intravascular ultrasound has been found to be a predictor of less restenosis (P = 0.02; HR: 0.02; CI: 0.01-0.59). The in-hospital and 1 year major adverse cardiac event rates were 7.8% and 13%. The annual cardiac death rates were 2.6%, 3.4%, and 5.3% in the first 3 years. CONCLUSIONS: The use of EES full metal jacket for long lesions is only associated with good short-term clinical and angiographic outcomes. Long-term follow-up has revealed a high cardiac death rate which may necessitate prolongation of dual antiplatelet therapy.

Hyperthyroidism-induced left ventricular diastolic dysfunction: implication in hyperthyroidism-related heart failure.

BACKGROUND: Heart failure occurs in 6% of hyperthyroid patients. Nonetheless, only half of those with hyperthyroidism-related heart failure have impaired left ventricular (LV) systolic function. Thus, diastolic dysfunction may play an important role in the pathogenesis. METHODS AND RESULTS: We performed serial echocardiographic examinations in 70 consecutive patients with hyperthyroidism (39 ± 2 years, 47 women) to determine their diastolic function and repeated the examinations 6 months after achieving a euthyroid state. All patients had normal LV systolic function, but diastolic dysfunction was detected in 22 cases (mild: 3, moderate: 15 and severe: 4). The prevalence of diastolic dysfunction increased with age from 17·9 % in patients <40 years to 100% in those >60 years. Increasing age was the only independent predictor for diastolic dysfunction in hyperthyroid patients. After achievement of a euthyroid state, most patients (16/22, 72%) had completely normalized diastolic function: 100% of patients <40 years, 33·3 % of those ≥ 60 years. Further analyses revealed significant age-related differences in the cardiovascular response to hyperthyroidism. Among patients <40 years, hyperthyroidism resulted in a marked reduction in total peripheral vascular resistance, increased cardiac output and enhanced diastolic function as determined by E'. No such significant change in total peripheral vascular resistance or cardiac output was observed in hyperthyroid patients ≥ 40 years. In addition, hyperthyroidism was associated with reduced E', signifying diastolic dysfunction in older hyperthyroid patients. CONCLUSION: Hyperthyroidism is associated with diastolic dysfunction, particularly in older patients. It is partly reversible following achievement of a euthyroid state.

Factors associated with long-term major adverse cardiac events of coronary bioresorbable vascular scaffold.

The long-term clinical outcomes after implantation of bioresorbable vascular scaffolds (BVS) in a real-world cohort were not well described. To identify factors associated with major adverse cardiovascular events (MACE) on long-term follow-up after implantation of BVS in patients undergoing elective percutaneous coronary intervention (PCI). This was an observational study based on a hospital registry of percutaneous coronary intervention. Participants were consecutive patients who underwent PCI and implanted with at least one everolimus-eluting BVS (Absorb®) in a single center between 2014 and 2017. Among the 170 cases analyzed (mean age 60.4 ± 10.7), a total of 203 Absorb BVS were implanted. MACE developed in 33 (19.4%) patients over a median follow-up period of 61 months, including 9 (5.3%) deaths, 13 (7.6%) non-fatal myocardial infarction and 19 (11.2%) ischemia driven target vessel revascularization. Definite or probable stent thrombosis developed in 4 (2.4%) patients. In crude analysis, history of smoking and initial presentation of non-ST elevation-acute coronary syndrome (NSTE-ACS) were predictors of long-term MACE. In adjusted analysis, presentation with NSTE-ACS was an independent predictor of long-term MACE [adjusted odds ratio (OR) 4.52; 95% confidence interval (95% CI) 1.50 to 13.6, P = 0.007]. Among patients receiving implantation of ABSORB BVS, presentation with NSTE-ACS was an independent predictor of MACE after a median follow-up period of 61 months. Future research is needed to confirm these findings and to determine the long-term safety of BVS in patients with NSTE-ACS.

Association Between Radial Versus Femoral Access for Percutaneous Coronary Intervention and Long-Term Mortality.

Background Percutaneous coronary intervention with radial arterial access has been associated with fewer occurrences of major bleeding. However, published data on the long-term mortality and major adverse cardiac events after percutaneous coronary intervention with radial or femoral arterial access are inconclusive. Method and Results This was a territory-wide retrospective cohort study including 26 022 patients who underwent first-ever percutaneous coronary intervention between January 1, 2010 and December 31, 2017 in Hong Kong. Among the 14 614 patients matched by propensity score (7307 patients in each group), 558 (7.6%) and 787 (10.8%) patients died during the observation period in the radial group and femoral group, respectively, resulting in annualized all-cause mortality rates of 2.69% and 3.87%, respectively. The radial group had a lower risk of all-cause mortality compared with the femoral group up to 3 years after percutaneous coronary intervention (hazard ratio [HR], 0.70; 95% CI, 0.63-0.78; P<0.001). Radial access was associated with a lower risk of major adverse cardiac events (HR, 0.78; 95% CI, 0.73-0.83, P<0.001), myocardial infarction after hospital discharge (HR, 0.78; 95% CI, 0.70-0.87, P<0.001), and unplanned revascularization (HR, 0.76; 95% CI, 0.68-0.85, P<0.001). The risks of stroke were similar across the 2 groups (HR, 0.96; 95% CI, 0.82-1.13, P=0.655). Conclusions Radial access was associated with a significant reduction in all-cause mortality at 3 years compared with femoral access. Radial access was associated with reduced risks of myocardial infarction and unplanned revascularization, but not stroke. The benefits were sustained beyond the early postoperative period.

Comparison Between Bare-Metal Stents, First-Generation Drug-Eluting Stents, and Bioresorbable Vascular Scaffolds.

BACKGROUND: The long-term clinical outcomes after bioresorbable vascular scaffold (BVS) implantation have been extensively compared with second-generation drug-eluting stent (DES) implantation, but not with bare-metal stent (BMS) or first-generation DES options. OBJECTIVE: To compare the major adverse cardiovascular event (MACE) rates after implantation of BVS, first-generation DES, and BMS. METHODS: This was a single-center observational study based on a registry of percutaneous coronary intervention (PCI). The primary endpoint was MACE at 3 years, defined as a composite endpoint of death, non-fatal myocardial infarction, and target-vessel revascularization. RESULTS: A total of 170 consecutive patients who underwent PCI with implantation of everolimus-eluting BVS (Absorb; Abbott Cardiovascular) between 2014 and 2017 were compared with a control group of 622 patients implanted with BMS and 604 patients implanted with first-generation DES from 2001 to 2005. In adjusted analysis, DES had a lower risk of MACE at 3 years compared with BMS (adjusted odds ratio [OR], 0.58; 95% confidence interval [CI], 0.41-0.81; P<.01), while BVS had a similar risk of MACE compared with BMS (adjusted OR, 0.91; 95% CI, 0.55-1.52; P=.72). When compared with DES, BVS had a similar risk of MACE (adjusted OR, 1.45; 95% CI, 0.83-2.53; P=.19). CONCLUSIONS: In patients with BVS implantation, the risk of the composite outcome of MACE at 3 years was not significantly different when compared with patients with BMS or first-generation DES implantation.

Paclitaxel-Eluting Stents for Chronically Occluded Saphenous Vein Grafts (EOS) Study.

Objectives:The aim of this study was to report the feasibility, short- and medium-term results of percutaneous coronary intervention (PCI) on saphenous vein graft (SVG) chronic total occlusions (CTO) using paclitaxel-eluting stents (PES). Background:In postbypass patients, PCI on SVG CTO, rather than native vessel CTO, is another treatment option. However, the acute procedural and medium-term outcomes are unknown. Methods:Twenty-two consecutive, symptomatic postbypass patients underwent PCI on SVG CTO; angiographic success was seen in 16 patients (73%). The successful cases were evaluated at 1 year; restudy angiography was performed at 11 +/- 5 months in 15 patients (94%). Results:The patients had a mean age of 73 years with predominance of male (68%); the mean SVG age was 14 years. On average, patients received 3.4 PESs per lesion; the stent size was 3.5 +/- 0.4 mm with a total stent length of 98 +/- 34 mm. The use of embolic protection devices and glycoprotein IIb/ IIIa inhibitors was observed in 6 (38%) and 5 (31%) patients, respectively. The in-hospital major adverse cardiac event (MACE) was 13%, accountable by 2 patients with postprocedure myocardial infarction. At follow-up, 6 patients had angiographic restenosis (40%); there was 1 noncardiac death and 3 target vessel revascularizations. The 1-year MACE was 25%; the graft survival free of occlusion and revascularization was 56%. Conclusions:PCI on SVG CTO is a feasible approach with a fairly high success and low in-hospital complication. However, it is associated with a relatively high angiographic restenosis and MACE at 1 year. (J Interven Cardiol 2010;**:1-6).

Paclitaxel-eluting stents for chronically occluded saphenous vein grafts (EOS) study.

OBJECTIVES: The aim of this study was to report the feasibility, short- and medium-term results of percutaneous coronary intervention (PCI) on saphenous vein graft (SVG) chronic total occlusions (CTO) using paclitaxel-eluting stents (PES). BACKGROUND: In postbypass patients, PCI on SVG CTO, rather than native vessel CTO, is another treatment option. However, the acute procedural and medium-term outcomes are unknown. METHODS: Twenty-two consecutive, symptomatic postbypass patients underwent PCI on SVG CTO; angiographic success was seen in 16 patients (73%). The successful cases were evaluated at 1 year; restudy angiography was performed at 11 +/- 5 months in 15 patients (94%). RESULTS: The patients had a mean age of 73 years with predominance of male (68%); the mean SVG age was 14 years. On average, patients received 3.4 PESs per lesion; the stent size was 3.5 +/- 0.4 mm with a total stent length of 98 +/- 34 mm. The use of embolic protection devices and glycoprotein IIb/ IIIa inhibitors was observed in 6 (38%) and 5 (31%) patients, respectively. The in-hospital major adverse cardiac event (MACE) was 13%, accountable by 2 patients with postprocedure myocardial infarction. At follow-up, 6 patients had angiographic restenosis (40%); there was 1 noncardiac death and 3 target vessel revascularizations. The 1-year MACE was 25%; the graft survival free of occlusion and revascularization was 56%. CONCLUSIONS: PCI on SVG CTO is a feasible approach with a fairly high success and low in-hospital complication. However, it is associated with a relatively high angiographic restenosis and MACE at 1 year.

Beta-blocker in post-myocardial infarct survivors with preserved left ventricular systolic function.

BACKGROUND: Long-term beta-blockade therapy is beneficial in post-myocardial infarct (MI) patients with left ventricular (LV) dysfunction; nevertheless, its benefit in post-MI patients with preserved LV function remains unclear. The objective of this study is to investigate the effects of long-term beta-blockade therapy on the clinical outcomes in post-MI patients with preserved LV function. HYPOTHESIS: The beneficial effects of long-term beta-blockade therapy in post-MI patients with impaired LV function may extend to those with preserved LV function. METHODS: Of 617 consecutive post-MI patients referred for cardiac rehabilitation program, 208 patients (age: 62.7 +/- 0.8 years; male: 76%) with preserved LV function (ejection fraction >or= 50%), negative exercise stress test, and on angiotensin-converting enzyme inhibition were studied. RESULTS: Baseline characteristics were comparable between patients on beta-blocker (n = 154) and not on beta-blocker (n = 54). After a mean follow-up of 58.5 +/- 2.7 months, 14 patients not on beta-blocker (26%) and 14 patients on beta-blocker (9%) died with hazard ratio (HR) of 2.5 (95% confidence interval [CI]: 1.25-6.42, P = 0.01). Likewise, patients not on beta-blocker had a higher incidence of cardiac death (HR: 3.0, 95% CI: 1.07-12.10, P = 0.04), and non-sudden cardiac death (HR: 10.1, 95% CI: 1.82-89.65, P = 0.01), but not sudden cardiac death compared with patients on beta-blocker (HR: 1.6, 95% CI: 0.34-7.61, P = 0.54). A Cox regression analysis revealed that only advanced age (>or=75 years; HR: 2.55, 95% CI: 1.18-5.49, P = 0.02) and the absence of beta-blocker (HR: 2.41, 95% CI: 1.14-5.09, P = 0.02) were independent predictors for mortality. CONCLUSION: beta-blocker use was associated with a decrease in overall mortality and cardiac death in post-MI patients with preserved LV function.

Virtual histology by intravascular ultrasound study on degenerative aortocoronary saphenous vein grafts.

Data of virtual histology (VH) acquired by intravascular ultrasound (IVUS) on saphenous vein graft (SVG) lesions is lacking. This study sought to report the VH IVUS findings in degenerative aortocoronary SVG lesions and correlate various types of plaque compositions (fibrous, fibro-fatty, dense calcium, and necrotic core) with different clinical and lesion characteristics. Virtual histology IVUS was performed on SVG in 38 symptomatic patients with a history of coronary artery bypass grafting, who underwent percutaneous coronary intervention on either native vessels or SVG. Measurements were made at the image slice with the smallest lumen. A total of 54 SVG lesions were analyzed; the mean graft age was 13.7 +/- 4.0 years. The mean vessel size was 5.0 +/- 1.0 mm; plaque area was 13.4 +/- 7.3 mm(2), and plaque burden was 63.0% +/- 15.0%. Fibrous tissue represented the major plaque component (62.1% +/- 17.1%). Lesions with a plaque burden of >or=70% were associated with positive remodeling, larger vessel size, higher percentage of fibro-fatty tissue, but lower percentage of dense calcium. Plaque burden was found to be positively correlated with remodeling index (r = 0.37, P = 0.01) and % fibro-fatty tissue (r = 0.49, P < 0.001) but negatively correlated with % dense calcium (r= -0.31, P = 0.03). The severity of SVG atherosclerosis paralleled with a proportional increase in fibro-fatty tissue. Unstable plaques in SVG were associated with positive remodeling, lipid-rich atheroma, and less calcium deposition, similar to the VH IVUS findings in native coronary arteries.

Protocol, rationale and design of DAbigatran for Stroke PreVention In Atrial Fibrillation in MoDerate or Severe Mitral Stenosis (DAVID-MS): a randomised, open-label study.

INTRODUCTION: Current international guidelines recommend non-vitamin K oral anticoagulants (NOACs) for stroke prevention among patients with non-valvular atrial fibrillation (AF) at significant ischaemic stroke risk given the superior safety and comparable efficacy of NOACs over warfarin. Nonetheless, the safety and effectiveness of NOACs have not been evaluated in patients with AF with underlying moderate or severe mitral stenosis (MS), hence the recommended stroke prevention strategy remains warfarin therapy. METHOD AND ANALYSIS: MS remains disproportionately prevalent in Asian countries compared with the developed countries. This prospective, randomised, open-label trial with blinded endpoint adjudication aims to evaluate the safety and efficacy of dabigatran for stroke prevention in AF patients with moderate or severe MS. Patients with AF aged ≥18 years with moderate or severe MS not planned for valvular intervention in the coming 12 months will be randomised in a 1:1 ratio to receive dabigatran 110 mg or 150 mg two times per day or warfarin with international normalised ratio 2-3 in an open-label design. Patients with estimated creatinine clearance <30 mL/min, or with a concomitant indication for antiplatelet therapy will be excluded. The primary outcome is a composite of stroke and systemic embolism. Secondary outcomes are ischaemic stroke, systemic embolism, haemorrhagic stroke, intracranial haemorrhage, major bleeding and death. The estimated required sample size is approximately 686 participants. ETHICS AND DISSEMINATION: The study protocol has been approved by the Institutional Review Board of the University of Hong Kong and Hong Kong West Cluster, Hospital Authority, Hong Kong for Fung Yiu King Hospital, Grantham Hospital, Queen Mary Hospital and Tung Wah Hospital in Hong Kong. Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04045093); pre-results.

Amiodarone-induced thyrotoxicosis is a predictor of adverse cardiovascular outcome.

BACKGROUND: Amiodarone-induced thyrotoxicosis (AIT) is a clinical condition that is notoriously difficult to manage; the relative risk of adverse cardiovascular events in these patients compared with euthyroid patients is largely unknown. OBJECTIVE: We compared the clinical characteristics and major adverse cardiovascular events (MACE) in AIT and euthyroid patients. METHOD: Patients at a tertiary referral center who had been prescribed amiodarone for at least 3 months were retrospectively analyzed. Baseline clinical characteristics, laboratory parameters, and outcome events were evaluated. MACE was defined as cardiovascular mortality, myocardial infarction, stroke and heart failure, or ventricular arrhythmias that required hospitalization. RESULTS: A total of 354 patients (61.8 +/- 14.1 yr; 64.7% male) with a mean follow-up of 48.6 +/- 26.7 months were studied. AIT, euthyroid status, and amiodarone-induced hypothyroidism were identified in 57 (16.1%), 224 (63.3%), and 73 (20.6%) patients, respectively. No differences in baseline clinical characteristics were observed between AIT and euthyroid patients. Nonetheless AIT patients demonstrated a higher MACE rate (31.6 vs. 10.7%, P < 0.01), mostly driven by a higher rate of ventricular arrhythmias that required admission (7.0 vs. 1.3%, P = 0.03). Cox-regression multivariate analysis revealed that AIT (hazard ratio 2.68; confidence interval 1.53-4.68; P < 0.01) and left ventricular ejection fraction less than 45% (hazard ratio 2.52; confidence interval 1.43-4.42; P < 0.01) were independent predictors of MACE. CONCLUSION: In patients prescribed long-term amiodarone therapy, occurrence of AIT is associated with a 2.7-fold increased risk of MACE. Regular and close biochemical surveillance is thus advisable to identify and treat this high-risk group of patients.

A new ECG criterion to identify takotsubo cardiomyopathy from anterior myocardial infarction: role of inferior leads.

With the exception of contrast-enhanced cardiovascular magnetic resonance imaging, clear distinction of takotsubo cardiomyopathy from anterior wall myocardial infarction cannot be achieved currently by simple and noninvasive tests. The aim of this study was to examine the role of inferior ECG leads in distinguishing these two conditions. From January 2004 to June 2006, eight female patients suffering from takotsubo cardiomyopathy were identified by the Mayo Clinic criteria. The clinical and ECG features were compared with 27 consecutive sex- and age-matched patients with anterior wall myocardial infarction admitted to the Coronary Care Unit within the same period. The observed ECG features were then verified with that of 62 published cases of takotsubo cardiomyopathy. Takotsubo cardiomyopathy patients had similar left ventricular ejection fraction (35.0% +/- 5.7% vs 38.2% +/- 6.4%, P = 0.829), lower peak creatinine kinase level (461 +/- 330 U/l vs 2723 +/- 1826 U/l, P = 0.020), more ST-segment elevation in the inferior leads (50% vs 7.4%, P = 0.016), and virtually no ST-segment depression in inferior leads (0% vs 48.2%, P = 0.015) compared with patients who had anterior wall myocardial infarction. ST-segment elevation of >or=1.0 mm in lead II had 62.5% sensitivity and 92.6% specificity in detecting takotsubo cardiomyopathy. The observed ECG characteristics were comparable with those in the literature. In patients who present with anterior wall myocardial infarction, the absence of ST-segment depression or ST-segment elevation in inferior leads, especially if the ST-segment in lead II >or= III, is highly suggestive of takotsubo cardiomyopathy.

Angiographic and clinical implications of combined ST-segment elevation in anterior and inferior leads in acute myocardial infarction.

BACKGROUND: The clinical and angiographic findings of patients suffered from acute myocardial infarction (MI) and presented with combined ST elevation in both anterior and inferior leads remain unclear. HYPOTHESIS: These patients might have >/= 1 coronary arteries occluded. METHODS: From January 2002 to December 2006, 49 consecutive patients were found to have ST elevation in both anterior and inferior leads during myocardial infarction. Patients who had left circumflex artery occlusion (acute or chronic) were excluded. These patients were divided into 4 types according to the infarct-related artery (IRA) and status of the contralateral vessel patency: left anterior descending artery (LAD) as the IRA with a patent right coronary artery (RCA) (type 1A, n = 25); LAD as IRA with an occluded RCA (type 1B, n = 1); RCA as IRA with a patent LAD (type 2A, n = 19); and RCA as IRA with an occluded LAD (type 2B, n = 4). RESULTS: Single vessel occlusion (type A angiographic pattern) was found in 90% of patients. Type 1A patients had a larger infarct size than that of 2A. ST elevation in V(2) >/= V(3) identified RCA as the IRA with a high specificity (92%) and sensitivity (74%). Type 2B patients (2-vessel occlusion) had a larger infarct size than that of 2A; however, no electrocardiogram (ECG) criteria could reliably differentiate them. CONCLUSION: In a real world situation, single vessel occlusion is found in the majority of cases of combined ST elevation in anterior and inferior leads. ST elevation in V(2) >/= V(3) distinguishes RCA against LAD as the IRA with high accuracy.

Thrombus removal prior to recanalization in vein graft occlusion intervention.

A saphenous vein graft chronic total occlusion intervention is uncommonly performed, partly due to the high risk of distal embolization. We described a strategy in which after successful wiring of a saphenous vein graft chronic total occlusion, balloon dilatation was performed to create a blind sac within the lesion, followed by aspiration thrombectomy to remove all the dislodged debris. Thereafter, balloon dilatation and stenting were safely performed in the distal occluded segment, to achieve complete recanalization.