Neostigmine induced coronary artery spasm: A case report and literature review.

Neostigmine is a cholinesterase inhibitor which does not cross the blood brain barrier and a commonly used for reversal of nondepolarizing muscle relaxants. In the following case report, we present a patient who developed coronary artery spasm, after the administration of repeated doses of neostigmine. Ours is the first case to demonstrate such a longstanding coronary artery vasospasm that lasted several hours in response to neostigmine, resulting in myocardial damage and left ventricular dysfunction. We would like to draw the attention of the anesthesiologists to this rare effect that may lead to perioperative cardiac complications.

What is the best ST-segment recovery parameter to predict clinical outcome and myocardial infarct size? Amplitude, speed, and completeness of ST-segment recovery after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.

AIMS: ST-segment recovery (STR) is a strong mechanistic correlate of infarct size (IS) and outcome in ST-segment elevation myocardial infarction (STEMI). Characterizing measures of speed, amplitude, and completeness of STR may extend the use of this noninvasive biomarker. METHODS AND RESULTS: Core laboratory continuous 24-h 12-lead Holter ECG monitoring, IS by single-photon emission computed tomography (SPECT), and 30-day mortality of 2 clinical trials of primary percutaneous coronary intervention in STEMI were combined. Multiple ST measures (STR at last contrast injection (LC) measured from peak value; 30, 60, 90, 120, and 240min, residual deviation; time to steady ST recovery; and the 3-h area under the time trend curve [ST-AUC] from LC) were univariably correlated with IS and predictive of mortality. After multivariable adjustment for ST-parameters and GRACE risk factors, STR at 240min remained an additive predictor of mortality. Early STR, residual deviation, and ST-AUC remained associated with IS. CONCLUSIONS: Multiple parameters that quantify the speed, amplitude, and completeness of STR predict mortality and correlate with IS.

Association between statin treatment and LDL-cholesterol levels on the rate of ST-elevation myocardial infarction among patients with acute coronary syndromes: ACS Israeli Survey (ACSIS) 2002-2010.

BACKGROUND: STEMI is thought to occur as a result of a vulnerable coronary plaque rupture. Statins possess hypolipidemic and pleotropic effects that stabilize coronary plaque. We sought to determine the association between LDL-C levels, statin use prior to the index event on the type of acute coronary syndrome (ACS) presentation: STEMI vs. non-STEMI/unstable angina. METHODS: Data was drawn from the ACS Israeli Survey (ACSIS), a biennial prospective survey of ACS patients hospitalized in all CCU/Cardiology departments during 2002-2010. RESULTS: Among 6790 patients, 2760 (41%) reported statin use prior to the index ACS event. The proportion of STEMI was significantly lower among statin treated vs. statin naive patients (36% vs. 57%, p<0.0001). At each LDL-C level, the proportion of STEMI was significantly lower only among statin treated patients (p<0.0001). LDL-C<70 mg/dL was associated with a lower proportion of STEMI only among statin treated but not among statin naive patients (33% vs. 57%, p<0.0001). Multivariate analysis revealed that statin use was independently associated with a lower probability of presenting with STEMI (ORadj=0.73, p=0.007), but not LDL-C<70 mg/dL (ORadj=1.13, p=0.32). Patients on high-intensity statin therapy (HIST) were less likely to present with STEMI as compared with low-intensity statin therapy (LIST) or statin naive patients (27%, 38%, 56%, respectively, p for trend <0.0001; HIST ORadj=0.28, p=0.01; LIST ORadj=0.48, p=0.026). CONCLUSIONS: Among patients admitted with ACS, statin use but not LDL-C level, was associated with a lower probability of presenting with STEMI. Patients on HIST had the lowest likelihood of presenting with STEMI.

Aspiration thrombectomy in patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention (from the Acute Coronary Syndrome Israeli Survey 2010).

We assessed the impact of aspiration thrombectomy (AT) in patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention (PPCI) on major adverse cardiac events at 30 days and 1-year mortality in 517 consecutive patients who were included in the prospective, nationwide, multicenter, observational Acute Coronary Syndrome Israeli Survey in 2010. Two hundred seventeen patients (42%) underwent AT (AT-PPCI) and 300 patients conventional (C) PPCI. Both groups had similar infarct-related artery distribution and ostial or proximal culprit lesion. Patients in AT-PPCI versus C-PPCI had lower systolic blood pressure and worse Killip class on admission, more frequent Thrombolysis In Myocardial Infarction flow 0 or 1 before PPCI (80% vs 56%), less frequent restoration of flow after indwelling a guidewire in the infarct-related artery (32% vs 52%), and more use of IIb/IIIa glycoprotein inhibitors (69% vs 49%), respectively (p ≤0.05 for all comparisons). Thirty-day major adverse cardiac events was similar in the AT-PPCI and C-PPCI groups, 10.6% versus 9.7%, p = 0.73; adjusted odds ratio 0.97, 95% confidence interval 0.45 to 2.10, p = 0.95. One-year mortality was lower in the AT-PPCI versus C-PPCI group, 3.7% versus 6.7%, p = 0.13; adjusted hazard ratio 0.31, 95% confidence interval 0.10 to 0.96, p = 0.042. In conclusion, this study of consecutive patients with ST elevation myocardial infarction undergoing PPCI demonstrates that AT was an independent predictor of reduced 1-year mortality.

Incidence and risk factors of cerebrovascular events following cardiac catheterization.

BACKGROUND: One of the most daunting complications of cardiac catheterization is a cerebrovascular event (CVE). We aimed to assess the real-life incidence, etiology, and risk factors of cardiac catheterization-related acute CVEs in a large cohort of patients treated in a single center. METHODS AND RESULTS: We undertook a retrospective analysis of 43,350 coronary procedures performed on 30,907 procedure days over the period 1992-2011 and compared patient and procedural characteristics of procedures complicated by CVEs with the remaining cohort. CVEs occurred in 47 cases: 43 were ischemic, 3 intracerebral hemorrhages, and 1 undetermined. The overall CVE rate was 0.15%, with percutaneous coronary intervention (PCI) and diagnostic coronary angiography rates 0.23% and 0.09%, respectively. Using a forward stepwise multivariate logistic regression model including patient demographic and procedural characteristics, a total of 5 significant predictors were defined: prior stroke (OR=15.09, 95% CI [8.11 to 28.08], P<0.0001), presence of coronary arterial thrombus (OR=2.79, 95% CI [1.25 to 6.22], P=0.012), age >75 years (OR=3.33, 95% CI [1.79 to 6.19], P<0.0001), triple vessel disease (OR=2.24, 95% CI [1.20 to 4.18], P=0.011), and performance of intervention (OR=2.21, 95% CI [1.12 to 4.33], P=0.021). An additional analysis excluded any temporal change of CVE rates but demonstrated a significant increase of all high-risk patient features. CONCLUSION: In a single-center, retrospective assessment over nearly 20 years, cardiac catheterization-related CVEs were very rare and nearly exclusively ischemic. The independent predictors for these events were found to be the performance of an intervention and those associated with increased atherosclerotic burden, specifically older age, triple vessel disease, and prior stroke. The presence of intracoronary thrombus appears also to raise the risk of procedure-related CVE.

Early safety of the Amplatzer Cardiac Plug™ for left atrial appendage occlusion.

OBJECTIVE: To assess the cumulative experience of a single operator using a strict set of deployment and release criteria for the Amplatzer Cardiac Plug™ (ACP) and the impact of these criteria on procedural success and complications. BACKGROUND: Following strong evidence that the left atrial appendage (LAA) is the site of the majority of thrombus formation within the left atrium in patients with non-valvular atrial fibrillation, non-pharmacological approaches to LAA exclusion have been developed and shown to be effective. METHODS: Procedural and in-hospital outcomes of LAA occlusion performed by or under the supervision of a single operator using the ACP™ in 100 anticoagulant ineligible patients with a high stroke risk were assessed. RESULTS: One hundred patients with a mean CHADS2 score of 3.21 ± 1.23 underwent catheterization for closure of LAA with the ACP™. The mean landing zone as assessed by TEE was 20.01 ± 3.21 mm, and 20.8 ± 3.19 mm by fluoroscopy. The mean difference between the TEE and the fluoroscopic measurements was 0.8 ± 1.13 mm. Device deployment was successful in 100/100 attempted cases with a mean deployed device size of 24.36 ± 3.27 mm. Procedural complications were limited to a single case of pericardial tamponade and one post-procedural pulmonary edema both of which were adequately treated with no long-term sequelae. CONCLUSIONS: In this single operator report, LAA occlusion using the double element ACP™ can be safely performed with excellent success rates. Using very specific deployment success, stability and release criteria, this device can achieve LAA occlusion with extremely low complication rates in an extremely frail oral anticoagulant ineligible population with multiple co-morbidities.

Diagnosis and treatment of early bioprosthetic malfunction in the mitral valve position due to thrombus formation.

Bioprosthetic valve thrombosis is uncommon and the diagnosis is often elusive and may be confused with valve degeneration. We report our experience with mitral bioprosthetic valve thrombosis and suggest a therapeutic approach. From 2002 to 2011, 149 consecutive patients who underwent mitral valve replacement with a bioprosthesis at a single center were retrospectively screened for clinical or echocardiographic evidence of valve malfunction. Nine were found to have valve thrombus. All 9 patients had their native valve preserved, representing 24% of those with preserved native valves. Five patients (group 1) presented with symptoms of congestive heart failure at 16.4 ± 12.4 months after surgery. Echocardiogram revealed homogenous echo-dense film on the ventricular surface of the bioprosthesis with elevated transvalvular gradient, resembling early degeneration. The first 2 patients underwent reoperation: valve thrombus was found and confirmed by histologic examination. Based on these, the subsequent 3 patients received anticoagulation treatment with complete thrombus resolution: mean mitral gradient decreased from 23 ± 4 to 6 ± 1 mm Hg and tricuspid regurgitation gradient decreased from 83 ± 20 to 49 ± 5 mm Hg. Four patients (group 2) were asymptomatic, but routine echocardiogram showed a discrete mass on the ventricular aspect of the valve: 1 underwent reoperation to replace the valve and 3 received anticoagulation with complete resolution of the echocardiographic findings. In conclusion, bioprosthetic mitral thrombosis occurs in about 6% of cases. In our experience, onset is early, before anticipated valve degeneration. Clinical awareness followed by an initial trial with anticoagulation is warranted. Surgery should be reserved for those who are not responsive or patients in whom the hemodynamic status does not allow delay. Nonresection of the native valve at the initial operation may play a role in the origin of this entity.

Comparison of twelve-lead electrocardiogram using a glove-based recording system with standard methodology.

We tested the clinically relevant diagnostic accuracy of a new electrocardiographic (ECG) recording system incorporating all 10 ECG electrodes in a single-size glove worn on the patient's left arm and placed on the chest. The PhysioGlove (PG) was designed to allow fast, reproducible, electrode placement with only minimal training. The American College of Cardiology/American Heart Association ECG recording guidelines and others have repeatedly highlighted the unacceptable progressive deterioration in ECG accuracy mainly resulting from a performer's lack of proficiency and diligence, leading to frequent electrode misplacement. We studied 428 consenting adult patients with a broad spectrum of anthropomorphic characteristics and ECG and cardiovascular pathologic entities. The chest girth was measured to ascertain the single-size PG clinical diagnostic accuracy in ≥90% of this patient population. For each patient, a PG and standard-cable electrocardiogram were consecutively recorded and interpreted by experienced electrocardiographers. The study included 3 phases: phase 1, run-in (n = 120); phase 2, comparative diagnostic accuracy (n = 208); and phase 3, randomized, blinded, diagnostic accuracy (n = 100). Of the entire study population (n = 428), 92% fit the chest girth range of 85 to 118 cm (34 to 47 in.), representing the reference standard clinical diagnostic PG chest girth range. The phase 2 PG diagnostic accuracy was 91.3% for entire chest girth range and 95.7% for the 89.4% of patients with a chest girth within the reference range. The mean PG diagnostic accuracy in phase 3 was 93% (95% confidence interval 89% to 95%). In conclusion, compared with standard-cable electrocardiograms, the PG demonstrated excellent diagnostic accuracy (93% to 95.7%) in ≥90% of a typical western adult patient population. The PG's ease of use and minimal training requirements offer a promising tool to markedly improve ECG clinical diagnostic accuracy in most adult western patients.

High-frequency QRS analysis improves the specificity of exercise ECG testing in women referred for angiography.

BACKGROUND: Exercise ECG testing in women for the diagnosis of coronary artery disease (CAD) has a higher false-positive rate compared to men. Consequently, women referred for coronary angiography following a positive exercise test often have normal coronary arteries or non-obstructive lesions. Analysis of the high-frequency components of the QRS complexes (HFQRS) has been reported to provide a sensitive means of detecting myocardial ischemia, independent of gender. The aim of the present study was to prospectively test the diagnostic performance of HFQRS and conventional exercise ECG in detecting stress-induced ischemia in women referred for coronary angiography. METHODS: The study included 113 female patients (age 64 ± 9 years) referred for non-urgent angiography. Patients performed a symptom-limited treadmill exercise test prior to angiography. High-resolution ECG was acquired during the test and used for both HFQRS and conventional ST-segment analyses. HFQRS diagnosis was determined by computerized analysis, measuring the stress-induced reduction in HFQRS intensity. The diagnostic performance of HFQRS, ST-segment analysis and clinical interpretation of the exercise test were compared, using angiography as a gold standard. RESULTS: HFQRS provided sensitivity of 70% and specificity of 80% for detection of angiographically significant coronary obstruction (≥ 70% stenosis in a single vessel or ≥ 50% in the left main artery). HFQRS was more specific than exercise ECG test (80% vs. 55%, P<.005), as well as more accurate (76% vs. 62%, P<.01). The number of ECG leads with ischemic HFQRS response correlated with the severity of CAD. HFQRS was highly specific (93%) in patients who achieved their age-predicted target heart rate, and retained its diagnostic accuracy in subgroups of patients with resting ECG abnormalities or inconclusive exercise ECG. CONCLUSIONS: HFQRS analysis, as an adjunct technology to exercise stress testing, may improve the diagnostic value of the ECG, and reduce the number of unnecessary imaging and invasive procedures.

Cryo-Balloon Ablation of the Right Superior Pulmonary Vein Involving the Anterior Right Ganglionated Plexus for Speech and Breathing Induced Atrial Tachycardia.

Targeting ganglionated plexi (GP) during catheter ablation of atrial fibrillation (AF) is associated with improved outcome. We present a patient with speech and breathing induced atrial tachycardia (AT) originating in the superior vena cava (SVC) and the right superior pulmonary vein (RSPV), near the anatomical location of the anterior right GP (ARGP). The trigger for the arrhythmia appeared to be vagal discharge from the GP, possibly induced by local stretch. Ablation with a 28 mm cryo-balloon advanced to the RSPV orifice through a patent foramen ovale (PFO) abolished the arrhythmia, probably involving the underlying parasympathetic influx to the SVC and RSPV myocardial sleeves.

Age differences in the adherence to treatment guidelines and outcome in patients with ST-elevation myocardial infarction.

The aim of this study was to assess age differences in the utilization of class-I treatment guidelines and its effect on mortality in patients with ST-elevation myocardial infarction (STEMI). The study included 1026 consecutive patients from the prospective nationwide Acute Coronary Syndrome Israeli Survey (ACSIS). Primary reperfusion was used less often among elderly (age>75 years) patients than among those aged 65-74 and <65 years (46%, 63%, 64%, respectively, p (for trend)=0.004). Class-I evidence-based medications (EBM) at discharge (aspirin, ß-blockers, angiotensin converting-enzyme inhibitors=ACEI, angiotensin receptor-blockers=ARBs and statins) were less frequently prescribed to elderly compared to younger age-subgroup (44%, 61%, 57%, respectively; adjusted odds ratio (OR)=0.62; 0.40-0.97 for age ≥ 75 vs. age<65 years). Early and 1-year mortality rates were 3-5-fold higher among the elderly compared to patients <65 years. In the entire cohort use of primary reperfusion was associated with lower 1-year mortality (OR=0.69; 0.47-1.01), as was the use of EBM (OR=0.26; 0.17-0.41). These effects were similar across all age-subgroups but with a greater impact among the elderly, as the number of patients needed to treat (NNT) was significantly lower with advancing age. Better adherence to treatment guidelines may improve the prognosis of elderly patients with STEMI.

The twin-pass dual access catheter for assessment of the no-reflow phenomenon.

UNLABELLED: The absence of antegrade flow in a coronary artery during an intervention is an ominous finding requiring diagnosis of the underlying cause and rapid treatment to limit myocardial necrosis. The Twin-Pass dual access catheter allows for distal coronary contrast injection without loss of wire position. The aim of this analysis was to determine the opacification and flow features of patients with abrupt arrest of antegrade flow to determine the underlying pathology. METHODS: Coronary angiograms of patients with abrupt arrest of antegrade flow during an intervention that underwent distal vessel contrast injection with the Twin-Pass catheter were retrospectively analyzed for five features: antegrade flow, retrograde flow, myocardial blush, presence of contrast stasis in the vessel wall and evidence of an intraluminal filling defect. The features were then correlated with the underlying pathological process and treatment. RESULTS: Seven patients underwent distal contrast injections. Four specific pathological processes were identified: presence of a proximal occlusive lesion; no-reflow due to distal vascular bed dysfunction; long dissection of the vessel with the distal wire residing in the true lumen or alternatively in the dissection plane. The patients were treated according to the pathology with stenting, intracoronary adenosine or wire repositioning. CONCLUSIONS: Distal vessel contrast injection using the Twin-Pass catheter in the presence of no-reflow is a simple and rapid technique that allows for the definition of four distinct clinical scenarios. This allows for rapid treatment of the underlying pathological process, reducing the period of end-organ ischemia, limiting occasional unnecessary stent deployment and further improving procedural results.

Reperfusion ventricular arrhythmia 'bursts' predict larger infarct size despite TIMI 3 flow restoration with primary angioplasty for anterior ST-elevation myocardial infarction.

Aims Successful epicardial reperfusion with primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) can paradoxically evoke myocardial reperfusion injury, which may be signalled by temporally associated ventricular arrhythmias (VAs). We correlated reperfusion VA 'bursts' with final infarct size (IS) in patients with restored TIMI 3 flow following PCI for anterior STEMI. Methods and results All 128 anterior STEMI patients with final TIMI 3 flow had continuous 24 h digital 12-lead ECG with simultaneous Holter recording initiated prior to PCI, and Day 7/discharge SPECT imaging IS assessment. Angiography, SPECT imaging, continuous ST recovery, and quantitative rhythm analyses were performed. Reperfusion VA bursts were defined against patient-specific background VA rates and timed as concomitant with or following first angiographic TIMI 3 flow restoration associated with > or =50% stable ST recovery; they were then correlated with IS and global left ventricular ejection fraction (LVEF) at Day 7/discharge. Bursts occurred in 81/128 (63%) patients and were significantly correlated with larger IS and worse LVEF (median: 21.0 vs. 10.0%, P < 0.001; 35.5 vs. 46.5%, P < 0.001, respectively). In multivariable analyses that adjusted for known predictors of IS, the association of bursts with larger IS remained significant; similar results were seen for worse LVEF. Conclusion Reperfusion VA bursts predict larger IS despite TIMI 3 flow restoration with > or =50% stable ST recovery following PCI for anterior STEMI. Well-characterized reperfusion VAs may provide a novel biomarker of reperfusion injury.

Effect of caldaret on the incidence of severe left ventricular dysfunction in patients with ST-elevation myocardial infarction undergoing primary coronary intervention.

Primary percutaneous coronary intervention (PCI) decreases myocardial damage in patients with ST-elevation myocardial infarction (STEMI). Cellular reperfusion injury associated with calcium overload may limit myocardial salvage. We previously showed (CASTEMI trial) that caldaret (MCC-135), which modulates myocardial calcium handling when administered before PCI in patients with STEMI, did not change residual left ventricular (LV) function. The aim of this subanalysis was to examine whether caldaret decreases the incidence of LV dysfunction (LV ejection fraction

Reperfusion ventricular arrhythmia 'bursts' in TIMI 3 flow restoration with primary angioplasty for anterior ST-elevation myocardial infarction: a more precise definition of reperfusion arrhythmias.

AIMS: We sought to define reperfusion-induced ventricular arrhythmias (VAs) more precisely through simultaneous angiography, continuous ST-segment recovery, and beat-to-beat Holter analyses in subjects with anterior ST-elevation myocardial infarction (STEMI) undergoing primary angioplasty [percutaneous coronary intervention (PCI)]. METHODS AND RESULTS: All 157 subjects with final TIMI 3 flow had continuous 12-lead electrocardiography with simultaneous Holter recording initiated prior to PCI for continuous ST-segment recovery and quantitative VA analyses. Ventricular arrhythmia bursts were detected against subject-specific background VA rates using a statistical outlier method. For temporal correlations, timing and quality of reperfusion were defined as first angiographic TIMI 3 flow with >or=50% stable ST-segment recovery. Almost all subjects had VAs [156/157 (99%)], whereas VA bursts during or subsequent to reperfusion occurred in 97/157 (62%). The majority of VA bursts (72%) arose within 20 min of reperfusion (95% CI: 26.7, 72), with onset at a median of 4 min post-reperfusion (IQR: 0-43) Bursts comprised a median of 1290 ventricular premature complexes (VPCs) (IQR: 415-4632) and persisted for a median of 105 min (IQR: 35-250). Most background VAs occurred as single VPCs; bursts typically comprised runs of three or more VPCs. Subjects with bursts had higher absolute peak ST segments and more frequent worsening of ST elevation immediately after reperfusion. CONCLUSION: Ventricular arrhythmia bursts temporally associated with TIMI 3 flow restoration and stable ST-segment recovery (reperfusion VA bursts) can be precisely defined in subjects with anterior STEMI and may constitute a unique electric biosignal of myocellular response to reperfusion.

Comparison of Troponin T to creatine kinase and to radionuclide cardiac imaging infarct size in patients with ST-elevation myocardial infarction undergoing primary angioplasty.

Troponin is used mainly for detection of minor myocardial damage, whereas repeated measurements of creatine kinase (CK) and myocardial band (CK-MB) are used for assessing infarct size in patients with myocardial infarction. The purpose of this study was to correlate peak level and area under the curve (AUC) of troponin T to that of CK and CK-MB and with single-photon emission computed tomographic infarct size and left ventricular function in patients with ST elevation myocardial infarction. In this multicenter study (29 centers, 5 countries), we included 267 patients who underwent primary coronary intervention within 6 hours of onset of symptoms. All had repeated measurements of troponin T, CK, and CK-MB. Infarct size and left ventricular function were assessed by single-photon emission computed tomography performed on days 7 and 30. Mean infarct sizes were 14% on day 7 and 10% on day 30, and mean ejection fractions were 42% on day 7 and 45% on day 30 after the acute infarct. Very high correlation (r >0.85, Spearman correlation) was found between peak level and AUC of troponin T, CK, and CK-MB. Similar high correlation was found between peak level and AUC of troponin, CK, and CK-MB with single-photon emission computed tomographic infarct size (r >0.70). In conclusion, based on the results of this multicenter study, we suggest that peak levels and AUC of troponin are as accurate as CK and CK-MB in estimating myocardial infarct size.

Contemporary treatment and adherence to guidelines in women and men with acute coronary syndromes.

BACKGROUND: Historically gender differences existed in treatment and outcome of patients with acute myocardial infarction (MI). AIM: To assess gender aspects of contemporary treatment and adherence to ACC/AHA Class-I Treatment Guidelines in patients with acute coronary syndrome (ACS). METHODS: We studied 2024 consecutive patients (519 women, 26%); 1026 (51%) with ST-elevation (STE)-MI and 998 (49%) patients with non-STE (NSTE), during a nationwide ACS-survey, conducted during 2-months in 2004. RESULTS: Women were older than men (71 vs. 59 in STEMI; 71 vs. 64 years in NSTE-ACS patients), and had worse cardiovascular risk profiles. In STEMI-patients, acute reperfusion was less frequent in women than in men (53% vs. 63%, respectively, p=0.01; non-significant after age-adjustment). At discharge, fewer women received ACE-inhibitors/ARBs (71% vs. 75%, respectively; OR(age-adj)=0.69[0.48-0.98]). Among NSTE-ACS patients, fewer women received IIb/IIIa-inhibitors (12% vs. 21%, respectively, p=0.007; OR(age-adj)=0.58[0.36-0.96]) and clopidogrel at discharge (49% vs. 59%, respectively, p=0.005; OR(age-adj) 0.75[0.56-1.01]). No gender differences were noted in utilization of aspirin, beta-blockers or statins. Age-adjusted and covariate-adjusted mortality rates were comparable in women and men with STEMI (at 7-days 4.3% vs. 4.1%; OR(adj)=0.95[0.47-1.87] and at 1-year 13.8% vs. 9.8%, hazard ratio [HR(adj)]=1.11[0.73-1.70], respectively); in women and men with NSTE-ACS (at 7-days 1.3% vs. 2.1%, OR(adj)=0.65[0.20-1.76], and at 1-year 12.0% vs. 11.3%; HR(adj)=1.19[0.80-1.77], respectively). CONCLUSIONS: In 2004, adherence to ACC/AHA Class-I Treatment Guidelines in ACS-patients was satisfactory. Relative underutilization of acute reperfusion was noted among STEMI patients, without gender differences after age-adjustment. At discharge, less women received ACE-inhibitors/ARBs. Among NSTE-ACS patients, less women than men received IIb/IIIa-inhibitors, and clopidogrel at discharge. Contemporary ACS management was associated with similar adjusted outcome in women and men.

A randomized, double-blind, placebo-controlled study of the safety and efficacy of intravenous MCC-135 as an adjunct to primary percutaneous coronary intervention in patients with acute myocardial infarction: Evaluation of MCC-135 for left ventricular salvage in acute myocardial infarction (EVOLVE).

OBJECTIVES: The objective of the study was to test the hypothesis that intracellular calcium modulation by 5-methyl-2-[piperazin-1-yl] benzene sulfonic acid monohydrate (MCC-135 [Caldaret]; Mitsubishi Pharma Corporation, Osaka, Japan) would preserve left ventricular function and reduce infarct size in patients undergoing primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). BACKGROUND: Calcium overload inside myocytes during ischemia and reperfusion not only affects myocardial function but also may be related to myocyte necrosis. MCC-135 is the first in a new class of agents that modulate intracellular calcium overload. METHODS: Patients with acute STEMI undergoing primary PCI were randomized into placebo, low-dose, and high-dose MCC-135 groups. The predefined target population was those with anterior myocardial infarction and pre-PCI TIMI grade flow 0 or 1. Left ventricular ejection fraction (LVEF) on Day 5 was the primary end point. Secondary end points included infarct size measured by single photon emission computed tomography and by serum cardiac markers. Patients were followed up to 30 days for clinical outcome. RESULTS: Among 500 patients enrolled, 141 qualified as the target population. In this target population, there was no difference in the LVEF between 3 groups (placebo: 47.0% +/- 1.7% [mean +/- SEM], the low dose: 47.4% +/- 1.7%, the high dose: 45.1% +/- 2.0%). The infarct size on day 5 was not significantly different between the groups. The composite clinical outcome occurred in 25.5% in the placebo group, in 19.2% in the low-dose group, and in 34.2% in the high-dose group during a 30-day follow-up period (P = nonsignificant). MCC-135 appeared to be safe and well tolerated. CONCLUSION: There were no significant benefits of MCC-135 on preservation of LVEF and reduction of infarct size on day 5 in patients with STEMI undergoing primary PCI.