Real‐life experience of a stent‐less revascularization strategy using a combination of excimer laser and drug‐coated balloon for patients with acute coronary syndrome

Objectives

We aimed to test a novel stent‐less revascularization strategy using a combination of excimer laser coronary angioplasty (ELCA) and drug‐coated balloon (DCB) for patients with acute coronary syndrome (ACS).

Background

Percutaneous coronary intervention with drug eluting stents is a standard invasive treatment for ACS. Some unsolved issues however remain, such as stent thrombosis and bleeding risks associated with dual antiplatelet therapy.

Methods

Consecutive ACS patients were planned to receive either a DCB application following ELCA without a stent implantation or conventional revascularization with a coronary stent. The endpoints were (i) major cardiac adverse events (MACEs), defined as the composite of cardiac death, myocardial infarctions, and target lesion revascularization; (ii) target vessel revascularization (TVR); and (iii) angiographic outcome.

Results

Since a greater than expected number of patients allocated to the stent‐less treatment arm eventually received a bailout stenting, the following 3 as‐treated groups were compared; DCB with ELCA group (N = 60), Stent with ELCA group (N = 23), and Stent without ELCA group (N = 85). During a mean follow‐up period of 420 ± 137 days, and with angiographic 6‐ and 12‐month‐follow‐up rates of 96.7%, 87%, and 81.2%, and 50%, 65.2%, and 45.9%, respectively, the MACE rate did not differ across the groups (10%, 4.3%, and 3.5%; P = 0.22) while an incidence of TVR was more common (15%, 0, and 4.7%; P = 0.02) and the diameter stenosis at 6‐months of follow‐up was greater (25.7 ± 18.2, 14.9 ± 13.1 and 16.2 ± 15.4%; P = 0.002) in the DCB with ELCA group.

Conclusions

The stent‐less revascularization strategy with DCB and ELCA was associated with a higher occurrence of restenosis in ACS patients.

     

Threshold level of low-density lipoprotein cholesterol for the short-term benefit of statin therapy in the acute phase of myocardial infarction

Background:

Little is known about the threshold level of low‐density lipoprotein cholesterol (LDL‐C) for statin therapy in acute myocardial infarction (AMI).

Hypothesis:

The aim of this study was to investigate the short‐term benefit of the statin in post‐MI patients with low LDL‐C levels.

Methods:

Between November 2005 and January 2008, 6866 statin‐naive patients were selected from the Korea AMI registry. Major adverse cardiac event (MACE) was defined as a composite of death, recurrent MI, and revascularizations.

Results:

The 6‐month MACE and mortality showed a U‐shaped curve, with the lowest rate at 114–122 mg/dL. Propensity scores for statin use were calculated for patients with LDL‐C ≤ 113 mg/dL, and they were used to match the patients who received statin (statin user, n = 1031) with those who did not receive it (statin nonuser, n = 1031). The 6‐month MACE was not significantly different between statin users and statin nonusers (9.4% vs 11.0%; hazard ratio [HR]: 0.847, 95% confidence interval [CI]: 0.646‐1.111, P = 0.230), whereas the 6‐month mortality was significantly lower in statin users (7.2% vs 9.7%; HR: 0.728, 95% CI: 0.539–0.984, P = 0.039). However, when the analyses were repeated in the patients with LDL‐C ≤ 105 mg/dL, not only the 6‐month MACE (9.5% vs 9.9%; HR: 0.945, 95% CI: 0.700–1.277, P = 0.713) but also the 6‐month mortality (7.0% vs 8.7%; HR: 0.793, 95% CI: 0.566–1.111, P = 0.177) was not significantly different between statin users and statin nonusers (n = 876 in each group).

Conclusions:

The beneficial effects of statin therapy seem to vanish when LDL‐C is below a certain level in AMI patients. © 2011 Wiley Periodicals, Inc. Jeong, Kim and Chae received funding from the Korean Society of Cardiology. J.H. Lee, Yang, H.S. Park and Chae received grants from GlaxoSmithKline and Pfizer.     

Different patients,different outcomes: A case‐control study of spontaneous coronary artery dissection versus acute coronary syndrome

Introduction

There is progressive interest worldwide in spontaneous coronary artery dissection (SCAD). To identify a SCAD cohort and compare risk factors, presentation, and management outcomes compared to acute coronary syndrome (ACS) matched controls.

Methods

Retrospective analysis was performed from 2000 to 2015. Clinical data included a neuropsychiatric history, with management and clinical outcomes assessed at 12 months. Patients were matched on a 1:3 case‐control basis according to type of ACS. Twenty‐two SCAD patients were matched to 66 controls by ACS type (ST‐elevation myocardial infarction 45%, Non‐ST‐elevation myocardial infarction 41%, unstable angina 14%).

Results

The SCAD group were more likely female (77.3% vs 19.7%, P < 0.0001), of younger age (48.7 ± 10.7 years vs 61.3 ± 10.6 years, P < 0.0001) with no cases of diabetes (0% vs 33.3%, P = 0.002), compared to controls. SCAD patients had a high prevalence of anxiety, depression or previous neuropsychiatric history (52.4% SCAD vs 1.5% ACS, P < 0.0001). A conservative revascularization strategy with stenting was performed in a minority of SCAD patients (13.6% SCAD vs 83.3% ACS, P < 0.0001), with no significant difference in cumulative major adverse cardiac or cerebrovascular events (MACCE) of death, stroke, re‐admission, or repeat angiography rates between both groups (13.6% SCAD vs 27.3% ACS P = NS).

Conclusion

SCAD affects young females with a paucity of cardiovascular risk factors. The major risk factor for SCAD was a history of anxiety, depression, or neuropsychiatric illness. A conservative approach to SCAD revascularization led to similar MACCE when compared to ACS controls undergoing guideline revascularization at 12 months.     

Sitagliptin improves beta‐cell function in patients with acute coronary syndromes and newly diagnosed glucose abnormalities–the BEGAMI study

Background

Newly detected impaired glucose tolerance (IGT) or type 2 diabetes mellitus (T2DM) are common in patients with acute coronary syndrome (ACS; i.e. unstable angina/myocardial infarction) and related to disturbed beta‐cell function. The aim of this study is to test the hypothesis that treatment with a dipeptidyl peptidase‐4 inhibitor initiated soon after a coronary event improves beta‐cell function.

Methods

Acute coronary syndromeACS patients with IGT or T2DM (n = 71), screened by oral glucose tolerance test (OGTT) 4–23 days (median 6 days) after hospital admission, were randomly assigned to sitagliptin 100 mg (n = 34) or placebo (n = 37) and treated for a duration of 12 weeks. All patients received lifestyle advice but no glucose‐lowering agents other than the study drug. The study end‐point was beta‐cell function assessed using the insulinogenic index (IGI = ΔInsulin₃₀/ΔGlucose₃₀), derived from an OGTT, and acute insulin response to glucose (AIRg) assessed by a frequently sampled intravenous glucose tolerance test.

Results

The IGI and AIRg did not differ at baseline between the sitagliptin and placebo groups (69.9 vs. 66.4 pmol mmol^?1 and 1394 vs. 1106 pmol L^?1 min^?1 respectively). After 12 weeks, the IGI was 85.0 in the sitagliptin and 58.1 pmol/mmol in the placebo group (P = 0.013) and AIRg was 1909 and 1043 pmol L^?1 min^?1 (P < 0.0001) in the sitagliptin and placebo groups respectively. Fasting glucose at baseline was 6.1 mmol L^?1 in sitagliptin‐treated patients and 6.0 mmol L^?1 in those who received placebo compared with 5.8 and 5.9 mmol L^?1 respectively, after 12 weeks of treatment. Post load glucose metabolism improved in significantly more sitagliptin‐treated patients compared with the placebo group (P = 0.003). Sitagliptin was well tolerated.

Conclusion

Sitagliptin improved beta‐cell function and glucose perturbations in patients with ACS and newly diagnosed glucose disturbances.

     

Early intensive statin treatment for six months improves long-term clinical outcomes in patients with acute coronary syndrome (Extended-ESTABLISH trial): A follow-up study

Background

The ESTABLISH trial found using volumetric intravascular ultrasound that atorvastatin therapy started early and continued for 6 months significantly reduced plaque volume in patients with acute coronary syndrome (ACS). However, the benefits of early statin administration on long-term outcomes remain unclear. We therefore examined whether the early initiation of statin in patients with ACS improves long-term prognosis.

Methods and results

The Extended-ESTABLISH trial included 180 patients with ACS who underwent emergency percutaneous coronary intervention (PCI). These patients were randomized here to groups given either early intensive lipid-lowering therapy (n = 90; atorvastatin 20 mg/day) or standard care (control, n = 90) within 48 h of events. Baseline characteristics between the two groups did not significantly differ at the time of ACS onset. Six months after PCI, all patients were treated with statins to achieve an LDL-C value of <100 mg/dL. We compared the first occurrence of major adverse cardiac and cerebrovascular events (MACCE). Prognostic data were fully documented during the entire follow-up period (mean, 1538 ± 707 days). Cumulative event-free survival was significantly higher in the atorvastatin, than in the control group (p = 0.041; log-rank test). Furthermore, by adjusting for validated prognosticators, early statin administration was identified as a good predictor of MACCE (HR 0.46, 95%CI 0.23–0.86; p = 0.015).

Conclusions

In-hospital initiation of statin therapy immediately after ACS conferred long-term benefits and 6 months of intensive lipid-lowering therapy improved long-term clinical outcomes after PCI in patients with ACS.     

Patients using statin treatment within 24 h after admission for ST-elevation acute coronary syndromes had lower mortality than non-users: a report from the first Euro Heart Survey on acute coronary syndromes.

AIMS: Statins provide effective secondary prevention in cardiovascular disease. However, it remains uncertain how soon statins should be started after an acute coronary syndrome (ACS). Recently published trials suggest starting before discharge. We hypothesize that statins should be initiated without delay. METHODS AND RESULTS: Data from a large cohort of 10,484 consecutive patients with an ACS were analysed. Of this cohort, 1426 first-time statin receivers and survivors of the first 24 h were compared with 6771 first-day survivors not receiving statin therapy. A propensity score for the likelihood of receiving statin therapy within 24 h was developed and used with other established risk factors in a multivariable analysis. There was a significantly reduced all-cause 7-day mortality in patients receiving early statin therapy [0.4 vs. 2.6%, unadjusted hazard ratio (HR) 0.16, 95% confidence interval (CI) 0.08-0.37, adjusted HR 0.34, 95% CI 0.15-0.79]. Statistical significance was observed in patients presenting with STE-ACS (adjusted HR 0.17, 95% CI 0.04-0.70) and not in NSTE-ACS patients. However, no statistical evidence of heterogeneity in treatment effect was observed between these groups. CONCLUSION: These data suggest that very early statin therapy is associated with reduced mortality in patients presenting with STE-ACS; however, these findings have to be confirmed by prospective, randomized controlled trials before firm treatment recommendations can be given.     

Left atrial volume index is an independent predictor of major adverse cardiovascular events in acute coronary syndrome

Background

Left atrial volume index (LAVI) is well proven to be a reliable method of determining left atrial size, which has prognostic implications in cardiovascular diseases. Studies demonstrate that increased LAVI is a predictor of mortality in myocardial infarction, but its association with other major adverse cardiovascular events (MACEs) among patients post acute coronary syndrome (ACS) has not been adequately evaluated.

Methods

We calculated the baseline LAVI for all patients who were admitted with ACS between December 2010 and August 2011. The patients were stratified into 2 arms: normal LAVI and increased LAVI, with a cutoff value of 28 mL/m². All patients were prospectively followed up during 6 months for development of MACEs.

Results

Of the 75 patients who completed the study, 32 had increased LAVI, and 43 had normal LAVI. More than half (55%) of the patients were diagnosed with unstable angina. During the follow-up period of 6 months, 30 patients (93.8%) in the increased-LAVI arm and 23 patients (53.5%) in the normal-LAVI arm developed at least a single MACE. Patients with increased LAVI had significantly more MACEs (P = 0.021). The occurrence of MACE remained significantly higher in the increased-LAVI group even when atrial fibrillation was excluded (P = 0.016). After adjusting for confounding variables by multivariate analysis, LAVI was found to have a significant association with MACEs (P = 0.030, odds ratio = 1.229 (95% confidence interval, 1.020-1.481).

Conclusion

LAVI is a useful tool for prognostication and an independent predictor of MACEs post ACS.     

Impact of a national smoking ban on hospital admission for acute coronary syndromes: a longitudinal study

Background:

A ban on smoking in the workplace was introduced in Ireland on March 29, 2004. As exposure to secondhand smoke has been implicated in the development of coronary disease, this might impact the incidence of acute coronary syndromes (ACS).

Hypothesis:

The smoking ban was associated with a decreased rate of hospital admissions for ACS.

Methods:

We analyzed data collected in a registry of all patients admitted to hospital with ACS in the southwest of Ireland, catchment population 620 525, from March 2003 until March 2007.

Results:

In the year following implementation of the ban, there was a significant 12% reduction in ACS admissions (177.9 vs 205.9/100,000; 95% confidence interval [CI]: 164.0‐185.1, P = 0.002). This reduction was due to fewer events occurring among men (281.5 vs 233.5, P = 0.0011) and current smokers (408 vs 302 admissions, P < 0.0001). There was no change in the rate of admissions for ACS in the following year (174.3/100,000; 95% CI: 164.0‐185.1, P > 0.1). However, a further 13% reduction was observed between March 2006 and March 2007 (149.2; 95% CI: 139.7‐159.2). Variation in admissions with time as a continuous variable also demonstrated a reduction on implementation of the smoking ban.

Conclusions:

A national ban on smoking in public places was associated with an early significant decrease in hospital admissions for ACS, suggesting a rapid effect of banning smoking in public places on ACS. A further reduction of similar magnitude 2 years after implementation of the ban is consistent with a longer‐term effect that should be further examined in long‐term studies. No funding was received for this study. The Coronary Heart Attack Ireland Registry (CHAIR) is funded by the Department of Health and Children, which had no role in the design, data collection, data analysis, data interpretation, writing or revising of the report. IJP is chairman of the Research Institute for a Tobacco Free Society. The other authors have no funding, financial relationships, or conflicts of interest to disclose.     

In‐hospital outcomes in invasively managed acute myocardial infarction patients who receive morphine

Objective

We aimed to analyze the association between morphine and in‐hospital outcomes in invasively managed ST elevation myocardial infarction (STEMI) and non‐ST elevation acute coronary syndrome (NSTE‐ACS) patients.

Background

Morphine is commonly used for analgesia in the setting of acute coronary syndromes (ACS); however, recently its utility in ACS has come under closer scrutiny.

Methods

We identified all STEMI and NSTE‐ACS patients undergoing coronary angiogram +/? percutaneous intervention between January 2009 and July 2016 in our center and recorded patient characteristics and inpatient outcomes.

Results

Overall, 3027 patients were examined. Overall, STEMI patients who received morphine had no difference in in‐hospital mortality [4.18% vs. 7.54%, odds ratio (OR): 0.36, P = 0.19], infarct size (mean troponin level 0.75 ng/mL vs. 1.29 ng/mL, P = 0.32) or length of hospital stay (P = 0.61). The NSTE‐ACS patients who received morphine had a longer hospital stay (mean 6.58 days vs. 4.78 days, P < 0.0001) and larger infarct size (mean troponin 1.16 ng/mL vs. 0.90 ng/mL, P = 0.02). Comparing matched patients, the use of morphine was associated with larger infarct size (mean troponin 1.14 ± 1.92 ng/mL vs. 0.83 ± 1.49 ng/mL, P = 0.01), longer hospital stay (6.5 ± 6.82 days vs. 4.89 ± 5.36 days, P = 0.004) and a trend towards increased mortality (5% vs. 2%, OR: 2.55, P = 0.06) in NSTE‐ACS patients but morphine did not affect outcomes in the propensity matched STEMI patients.

Conclusion

In a large retrospective study, morphine was associated with larger infarct size, a longer hospital stay and a trend towards increased mortality in invasively managed NSTE‐ACS patients even after adjustment for clinical characteristics.

     

Baseline anemia in patients undergoing percutaneous coronary intervention after an acute coronary syndrome—A paradox of high bleeding risk,high ischemic risk,and complex coronary disease

Objectives

To define more clearly the associations between baseline anemia, bleeding/ischemia risk, coronary disease severity, and outcomes by revascularization completeness.

Background

Anemia is associated with adverse outcomes in patients presenting with an acute coronary syndrome (ACS).

Methods and Results

Data was sourced from hospital databases for patients admitted with an ACS to a single center between 2011 and 2014. Using WHO anemia criteria, 468 (26.9%) of 1731 patients were anemic. In anemic patients, the mean CRUSADE score (34.6 ± 16.9 vs 24.6 ± 13.4, P < 0.0001), mean GRACE scores (165.8 ± 44.9 vs 141.6 ± 40.1, P < 0.0001), and percentage of patients with a high/very high CRUSADE score combined with a high GRACE score (69.3 vs 48.3%, P < 0.0001) was much greater than non‐anemic patients. Patients with baseline anemia were more likely to have left main or chronic occlusive disease, and more diseased vessels. The percentage of patients with residual disease (41.2 vs 30.7%, P < 0.0001), the number of residual diseased vessels (0.59 ± 0.83 vs 0.42 ± 0.72, P < 0.0001), and the percentage with a residual CTO (62.4 vs 56.4%, P = 0.036) were all higher than in non‐anemic patients. The duration of anti‐platelet therapy was significantly shorter in anemic patients (7.8 ± 4.3 vs 11.2 ± 2.4 months, P < 0.001). At 12‐months, mortality and stent thrombosis were more likely to occur in anemic patients, with the number of residual vessels associated with adverse survival regardless of anemia status.

Conclusions

Patients with anemia present with high ischemia and bleed risk scores, complex coronary disease, and have adverse outcomes. Incomplete revascularization was associated with worse survival regardless of anemia status.

     

Prevalence,Correlation and Clinical Outcome of Intra‐Procedural Stent Thrombosis in Patients Undergoing Primary Percutaneous Coronary Intervention for Acute Coronary Syndrome

Objectives

To assess the occurrence, correlation, and clinical outcome of intraprocedural stent thrombosis (IPST) in patients undergoing primary percutaneous coronary intervention (PCI) in the setting of acute coronary syndromes (ACSs).

Background

Stent thrombosis (ST), a rare complication of PCI, is more common in the setting of ACS. It is not known whether IPST carries the same prognosis as postprocedural ST.

Methods

This retrospective study comprised a review of 1,901 consecutive ACS patients who received primary PCI in our center from January 2006 to January 2011. IPST was defined as new, reappearing or increased thrombus within the deployed stent before the index PCI procedure was completed. All angiograms were independently reviewed frame by frame for the incidence of IPST. Patients with and without IPST were compared with respect to clinical characteristics, angiographic parameters, and major adverse cardiac events (MACEs) at 30 days and 1‐year follow‐up.

Results

Overall, there were 23 cases of IPST detected, thus, the prevalence of IPST was 1.2%. There were no significant differences in baseline clinical characteristics between the 2 groups. Patients with compared to those without IPST had significantly more bifurcation lesions involved, and more thrombus burden at baseline. IPST group compared to no IPST group had more MACEs on 30 days (26.1% vs. 8.7%, P = 0.01) and 1‐year follow‐up (30.4% vs. 14.4%, P = 0.02).

Conclusions

IPST was a rare complication of PCI in the setting of ACS. It correlated with lesion morphology, presence of thrombus at baseline and was more likely to cause MACEs in 30 days and 1‐year follow‐up. (J Interven Cardiol 2013;26:215–220)

     

Acute kidney injury requiring dialysis and in‐hospital mortality in patients with chronic kidney disease and non–ST‐segment elevation acute coronary syndrome undergoing early vs delayed percutaneous coronary intervention: A nationwide analysis

Background

Chronic kidney disease (CKD) is a well‐known risk factor for coronary artery disease and is associated with poor outcomes following an acute coronary syndrome (NSTE‐ACS). The optimal timing of an invasive strategy in patients with CKD and NSTE‐ACS is unclear.

Hypothesis

Timing of PCI in CKD patients will not affect the risk of mortality or incidence of dialysis.

Methods

We queried the National Inpatient Sample database (NIS) to identify cases with NSTEMI and CKD. Patients who underwent percutaneous coronary intervention (PCI) day 0 or 1 vs day 2 or 3 after admission were categorized as early vs delayed PCI, respectively. The primary outcomes of the study were in‐hospital mortality and acute kidney injury requiring hemodialysis (AKI‐D). The secondary outcomes were length of stay and hospital charges. Baseline characteristics were balanced using propensity score matching (PSM).

Results

After PSM, 3708 cases from the delayed PCI group were matched with 3708 cases from the early PCI group. The standardized mean differences between the 2 groups were substantially reduced after PSM. All other recorded variables were balanced between the 2 groups. In the early and delayed PCI groups, the incidence of AKI‐D (2.5% vs 2.3%; P = 0.54) and in‐hospital mortality (1.9% vs 1.4%; P = 0.12) was similar. Hospital charges and length of stay were higher in the delayed PCI group.

Conclusions

The incidence of AKI‐D and in‐hospital mortality among patients with CKD and NSTE‐ACS were not significantly affected by the timing of PCI. However, delayed PCI added significant cost and length of stay. A prospective randomized study is required to validate this concept.

     

Effects of patient‐tailored atorvastatin therapy on ameliorating the levels of atherogenic lipids and inflammation beyond lowering low‐density lipoprotein cholesterol in patients with type 2 diabetes

Aims/Introduction

Recently, patient‐tailored statin therapy was proven effective for achieving target low‐density lipoprotein (LDL) cholesterol levels. It is unclear, however, whether this therapeutic modality would be effective for atherogenic lipid profiles and inflammation in patients with type 2 diabetes.

Materials and Methods

The present study was an 8‐week, multicenter, single‐step titration trial of patient‐tailored atorvastatin therapy (10, 20 and 40 mg) according to baseline LDL cholesterol levels in 440 patients with type 2 diabetes. We measured the LDL particle size by polyacrylamide gel electrophoresis, and used high‐sensitivity C‐reactive protein (hsCRP) and adiponectin as surrogate markers of inflammation.

Results

In the intention‐to‐treat analysis, 91% of the patients achieved their LDL cholesterol targets (<2.6 mmol/L) at week 8. There were significant reductions at week 8 in total cholesterol, triglycerides, non‐high‐density lipoprotein cholesterol (HDL) cholesterol, and the total cholesterol:HDL cholesterol ratio compared with the baseline values for all of the doses. The mean LDL particle size was significantly increased, and the small, dense LDL cholesterol levels were decreased in a dose‐dependent manner over the study period. In addition, the hsCRP levels were decreased in those high‐risk patients with baseline hsCRP levels over 3 mg/L (P < 0.001), and the adiponectin levels tended to increase with all of the doses (P = 0.004) at 8 weeks.

Conclusions

Patient‐tailored atorvastatin therapy based on LDL cholesterol at baseline was effective in ameliorating atherogenic LDL particle size and inflammation, in addition to achieving the target LDL cholesterol level without an undesirable effect on glycemic control in patients with type 2 diabetes. This trial was registered with ClinicalTrials.gov (no. NCT01239849).     

Efficacy and safety of alirocumab in insulin‐treated individuals with type 1 or type 2 diabetes and high cardiovascular risk: The ODYSSEY DM‐INSULIN randomized trial

Aims

To investigate the efficacy and safety of alirocumab in participants with type 2 (T2D) or type 1 diabetes (T1D) treated with insulin who have elevated LDL cholesterol levels despite maximally tolerated statin therapy.

Methods

Participants at high cardiovascular risk with T2D (n = 441) or T1D (n = 76) and LDL cholesterol levels ≥1.8 mmol/L (≥70 mg/dL) were randomized 2:1 to alirocumab:placebo administered subcutaneously every 2 weeks, for 24 weeks' double‐blind treatment. Alirocumab‐treated participants received 75 mg every 2 weeks, with blinded dose increase to 150 mg every 2 weeks at week 12 if week 8 LDL cholesterol levels were ≥1.8 mmol/L. Primary endpoints were percentage change in calculated LDL cholesterol from baseline to week 24, and safety assessments.

Results

Alirocumab reduced LDL cholesterol from baseline to week 24 by a mean ± standard error of 49.0% ± 2.7% and 47.8% ± 6.5% vs placebo (both P < .0001) in participants with T2D and T1D, respectively. Significant reductions were observed in non‐HDL cholesterol (P < .0001), apolipoprotein B (P < .0001) and lipoprotein (a) (P ≤ .0039). At week 24, 76.4% and 70.2% of the alirocumab group achieved LDL cholesterol <1.8 mmol/L in the T2D and T1D populations (P < .0001), respectively. Glycated haemoglobin and fasting plasma glucose levels remained stable for the study duration. Treatment‐emergent adverse events were observed in 64.5% of alirocumab‐ vs 64.1% of placebo‐treated individuals (overall population).

Conclusions

Alirocumab produced significant LDL cholesterol reductions in participants with insulin‐treated diabetes regardless of diabetes type, and was generally well tolerated. Concomitant administration of alirocumab and insulin did not raise any safety concerns (NCT02585778).     

Effect of beta-blocker dose on mortality after acute coronary syndrome

Introduction

Beta-blocker doses that have been shown to be effective in randomized clinical trials are not commonly used in daily clinical practice. The aim of this study was to analyze whether there is a prognostic benefit of high rather than low doses of beta-blockers after an acute coronary syndrome (ACS).

Clinical outcomes in real‐world patients with type 2 diabetes switching from first‐ to second‐generation basal insulin analogues: Comparative effectiveness of insulin glargine 300 units/mL and insulin degludec in the DELIVER D+ cohort study

Aims

To compare clinical outcomes in patients with type 2 diabetes (T2D) switching from insulin glargine 100 units/mL (Gla‐100) or insulin detemir (IDet) to insulin glargine 300 units/mL (Gla‐300) or insulin degludec (IDeg).

Materials and Methods

We conducted a retrospective, observational study of electronic medical records for Gla‐300/IDeg adult switchers (March 1, 2015 to January 31, 2017) with active records for 12‐month baseline (glycated haemoglobin [HbA1c] used a 6‐month baseline period) and 6‐month follow‐up periods. Gla‐300 and IDeg switchers were propensity score‐matched using baseline demographic and clinical characteristics. Outcomes were HbA1c change and goal attainment (among patients with HbA1c captured at follow‐up), and hypoglycaemia with fixed follow‐up (intention‐to‐treat [ITT]; 6 months) and variable follow‐up (on‐treatment [OT]; to discontinuation or 6 months).

Results

Each matched cohort comprised 1592 patients. The mean decrease in HbA1c and HbA1c goal (<7.0% [53 mmol/mol] and <8.0% [64 mmol/mol]) attainment rates were similar for Gla‐300 (n = 742) and IDeg (n = 727) switchers. Using fixed follow‐up (ITT method), hypoglycaemia incidence decreased significantly from baseline with Gla‐300 (all hypoglycaemia: 15.6% to 12.7%; P = .006; hypoglycaemia associated with inpatient/emergency department [ED] encounter: 5.3% to 3.5%; P = .007), but not with IDeg. After adjusting for baseline hypoglycaemia, no significant differences in hypoglycaemia incidence and event rate were found at follow‐up (ITT) for Gla‐300 vs IDeg. Using variable follow‐up (OT), hypoglycaemia incidence was similar in both groups, but Gla‐300 switchers had a lower inpatient/ED hypoglycaemia event rate at follow‐up (adjusted rate ratio 0.56; P = .016).

Conclusions

In a real‐world setting, switching from Gla‐100 or IDet to Gla‐300 or IDeg was associated with similar improvements in glycaemic control and hypoglycaemia in adult patients with T2D.     

Long‐Term Clinical Outcomes of the One‐Stent Technique versus the Two‐Stent Technique for Non‐Left Main True Coronary Bifurcation Disease in the Era of Drug‐Eluting Stents

Background

Few studies have compared the long‐term major adverse cardiac events (MACEs) between the one‐stent technique (stenting only the main branch) and the two‐stent technique (stenting of both the main and side branches) for the treatment of true coronary bifurcation lesions in the drug‐eluting stent era. Therefore, we investigated this issue using the large nationwide coronary bifurcation registry.

Methods

The 1,147 patients with non‐left main coronary true bifurcation lesions underwent percutaneous coronary intervention in the Korea Coronary Bifurcation Stent (COBIS) registry. All patients were stratified based on the stent placement technique: one stent (n = 898) versus two stents (n = 249). MACE, including death, nonfatal myocardial infarction (MI), and repeat vessel and lesion revascularization (TVR and TLR), were evaluated.

Results

The median follow‐up duration was 20 months. The MACEs did not differ between the 2 groups. Findings from the one‐stent group were similar to those of the two‐stent group in composite of death, MI, or TVR, based on analysis by crude, multivariate Cox hazard regression model, inverse‐probability‐of‐treatment weighting (hazard ratio [HR] 0.911, 95% confidence interval (CI) 0.614–1.351; HR 0.685 95% CI 0.381–1.232; HR 1.235, 95% CI 0.331–4.605, respectively). In further analysis with propensity score matching, the overall findings were consistent.

Conclusions

The findings of the present study indicate that the one‐stent technique was not inferior to the two‐stent technique for the treatment of non‐left main true coronary bifurcation lesions in terms of long‐term MACEs. (J Interven Cardiol 2013;26:245–253)

     

Effect of sex difference in clinical presentation (stable coronary artery disease vs unstable angina pectoris or non‐ST‐elevation myocardial infarction vs ST‐elevation myocardial infarction) on 2‐year outcomes in patients undergoing percutaneous coronary intervention

Objective

To determine whether there is a difference in 2‐year prognosis among patients across the spectrum of coronary artery disease undergoing percutaneous coronary intervention (PCI).

Methods

We analyzed all consecutive patients undergoing PCI at a single center from 1/1‐12/31/2013. Clinical presentations were compared between sexes according to baseline clinical, angiographic, and procedural characteristics and 2‐year (mean 730 ± 30‐day) outcomes.

Results

We grouped 10 724 consecutive patients based on sex and clinical presentation. Among patients with ST‐elevation myocardial infarction (STEMI), rates of all‐cause death (6.7% vs 1.4%) and cardiac death (3.8% vs 1.1%) were significantly higher in women than in men (P < 0.05), but these rates did not differ between men and women with stable coronary artery disease (SCAD) and non‐ST‐elevation acute coronary syndrome ((NSTE‐ACS). Incidence of major bleeding was greater than in men only in those women presenting with ACS. After multivariable adjustment, female sex was not an independent predictor of outcomes in STEMI (hazard ratio [HR] for all‐cause death: 1.33, 95% confidence interval [CI]:0.52‐3.38; P = 0.55; HR for cardiac death: 0.69, 95%CI: 0.23‐2.09, P = 0.51], but was still an independent predictor of bleeding in STEMI (HR: 3.53, 95%CI: 1.26‐9.91, P = 0.017).

Conclusion

Among STEMI patients, women had worse 2‐year mortality after PCI therapy, but female sex was not an independent predictor of mortality after adjustment for baseline characteristics. In STEMI patients, women were at higher bleeding risk than men after PCI, even after multivariable adjustment.     

Rates and causes of death from non-ST elevation acute coronary syndromes: Ten year follow-up of the PRAIS-UK registry

Background

Long term nationally representative mortality rates following acute coronary syndrome (ACS) admissions are lacking beyond 5 years. We report rates and causes of mortality at approximately 10 years from PRAIS-UK.

Methods

PRAIS-UK was a prospective registry of 1046 non-ST-elevation ACS admissions to 56 UK hospitals between 1998 and 1999. 493 patients surviving to 6 months were consented to long term follow-up. We identified deaths and causes (ICD codes) via the UK central death register and examined the influence of baseline characteristics and early revascularisation procedures. A modified GRACE risk score was constructed to determine the association of baseline score with long term risk of death.

Results

The mean age was 66 years and 40% were women. After a median follow-up of 11.6 years (IQR 6.3–11.9), 46% (225) of patients had died with 55% being classified as cardiovascular. In a multivariate analysis, the following variables were associated with higher mortality (hazard ratio [HR] and 95% confidence intervals [CI]): age (10 years increase) 2.14 (1.87 to 2.45), ST depression or bundle branch block (compared to normal ECG) 1.68 (1.06 to 2.67), and history of heart failure (compared to no HF) 1.81 (1.28 to 2.56). The HR for risk of death in patients who received a revascularisation procedure (versus those who did not) in the first 6 months was 0.41 (0.24 to 0.69). The mean adapted GRACE score was 99.3 ± 26.4, associated with approximately 50% mortality at 10 years.

Conclusions

Non-ST elevation ACS is associated with about 50% mortality over 10 years that may be improved by early revascularisation. Well designed long-term registries can provide key data to determine prognosis and burden of disease.