Effect of comprehensive remote ischemic conditioning in anterior ST‐elevation myocardial infarction undergoing primary percutaneous coronary intervention: Design and rationale of the CORIC‐MI randomized trial

Remote ischemic conditioning (RIC) applied during or after ST‐segment elevation myocardial infarction (STEMI) is currently the most promising adjuvant therapy to reduce reperfusion injury. Recent animal studies showed that RIC may help the myocardium recover if applied daily during the month after STEMI. The Comprehensive Remote Ischemic Conditioning in Myocardial Infarction (CORIC‐MI) trial is a single‐center randomized controlled study in which 200 patients undergoing primary percutaneous coronary intervention (PPCI) for anterior STEMI will be randomized in a 1:1 ratio into comprehensive RIC (CORIC) or no intervention (control) groups. CORIC consists of per‐RIC (5 cycles of 5‐minute ischemia and 5‐minute reperfusion of the lower limb immediately after randomization and before reperfusion), post‐RIC (5 cycles of 5‐minute ischemia and 5‐minute reperfusion of the lower limb immediately post‐PPCI), and delayed RIC (5 cycles of 5‐minute ischemia and 5‐minute reperfusion of the lower limb once daily on 2–28 days). Primary endpoint is left ventricular ejection fraction assessed by cardiac magnetic resonance imaging at 30 days. Major secondary endpoints include infarct size and left ventricular volume assessed by cardiac magnetic resonance imaging at 30 days, left ventricular ejection fraction assessed by echocardiography, and major adverse cardiovascular events up to 12 months. This report presents the baseline characteristics of 93 patients (CORIC group, n = 49; control group, n = 44) enrolled into the study as of March 31, 2018. The CORIC‐MI trial aims to test the hypothesis that CORIC will improve cardiac function and remodeling in patients with anterior STEMI undergoing PPCI.     

Culprit plaque characteristics in women vs men with a first ST‐segment elevation myocardial infarction: In vivo optical coherence tomography insights

Background

It is unclear whether more severe coronary atherosclerosis is a prerequisite to an initial acute coronary event in women vs men.

Hypothesis

Women may have more severe coronary atherosclerosis than men in patients with acute coronary event.

Methods

We used intravascular optical coherence tomography (OCT) to evaluate gender differences in culprit‐plaque morphology in patients with a first ST‐segment elevation myocardial infarction (STEMI).We retrospectively enrolled 211 consecutive patients who experienced a first STEMI and underwent an OCT examination of their infarct‐related artery before primary percutaneous coronary intervention.

Results

Of the 211 patients enrolled, 162 (76.7%) were men and 49 (23.2%) were women. The women were significantly older than the men (mean age, 60.2 ± 8.2 vs 55.7 ± 11.2 years; P = 0.01) and less likely to be current smokers (P = 0.02). Moreover, the delay from symptom onset to reperfusion was longer in women than in men (7.6 ± 6.1 vs 5.5 ± 4.4 hours; P = 0.01). The OCT data indicated that there were no gender differences in culprit‐plaque morphology, including lipid length, lipid arc, minimum fibrous cap thickness, or minimum lumen area. Additionally, no gender differences were found in the prevalence of plaque rupture, thin‐cap fibroatheroma, residual thrombus, microvessels, macrophages, cholesterol crystals, or calcification.

Conclusions

Among patients presenting with a first STEMI, there were no differences in culprit plaque features between women and men.

     

Bone Marrow Stem Cells for the Treatment of Ischemic Heart Disease: A Clinical Trial Review

Cardiovascular disease continues to represent a significant and growing source of morbidity and mortality despite advances in traditional treatments. As a result, increasing interest and research in regenerative therapies has emerged in recent years. Among them, cell therapy represents an area of significant potential. An expanding clinical literature now exists involving the use of bone marrow-derived stem cells in the treatment of ischemic heart disease. These early studies appear to provide promising results in patient populations that include those with refractory angina, ischemic cardiomyopathy with left ventricular dysfunction, and end-stage heart failure. This review serves to provide a comprehensive examination of these clinical trials focused on several components including cell preparation, cell delivery, safety, and efficacy of these trials.     

Study of young patients with myocardial infarction: Design and rationale of the YOUNG‐MI Registry

The YOUNG‐MI registry is a retrospective study examining a cohort of young adults age ≤ 50 years with a first‐time myocardial infarction. The study will use the robust electronic health records of 2 large academic medical centers, as well as detailed chart review of all patients, to generate high‐quality longitudinal data regarding the clinical characteristics, management, and outcomes of patients who experience a myocardial infarction at a young age. Our findings will provide important insights regarding prevention, risk stratification, treatment, and outcomes of cardiovascular disease in this understudied population, as well as identify disparities which, if addressed, can lead to further improvement in patient outcomes.     

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.

     

Bone Marrow Cell Therapy After Acute Myocardial Infarction. Back to Bench, or Ready for an Outcome Trial

Meta-analyses and some randomized clinical trials have shown modest improvement in left ventricular function after intracoronary injection of bone marrow cells (BMC) in patients with acute myocardial infarction (AMI). This has been shown even though several limitations like ignorance about the best cell(s) to use, the optimal dose, an effective administration mode, and the mechanism of action remain. The potential of BMC therapy will not be realized until these hurdles are passed. And even though BMC therapy seems to be relatively safe, it is invasive and expose the patients to the possibility of procedure-related complications. Thus, at the current stage of development, it will probably be better to use resources on more basic research and small- to intermediate-sized clinical trials instead of a large-scale outcome trial.     

Thrombus aspiration in late presenters with ST‐elevation myocardial infarction: A single‐center randomized trial

Objectives

To examine whether routine thrombus aspiration (TA) is associated with improved myocardial salvage in patients with ST‐elevation myocardial infarction (STEMI) presenting ≥12 h after onset of symptoms.

Background

TA is a recognized treatment option in patients with STEMI undergoing primary percutaneous coronary intervention (PPCI) especially in the setting of heavy thrombus burden. However, data on the role of TA in STEMI patients presenting late after onset of symptoms are limited.

Methods

In this single‐center prospective randomized study, patients with subacute STEMI presenting ≥12 and ≤48 h after symptom onset were randomized to primary PCI with or without manual TA in a 1:1 ratio. The primary endpoint was the myocardial salvage index assessed with Single Photon Emission Computed Tomography (SPECT) on admission and 4 days later.

Results

A total of 60 patients underwent randomization. Baseline characteristics were comparable between groups. TA was associated with improved myocardial salvage index compared with control group (60.1 ± 11.1% vs 28.1 ± 21.3%; P = <0.001). Furthermore, TA was associated with improved post‐procedural TIMI flow (2.9 ± 0.3 vs 2.5 ± 0.6; P = 0.003), myocardial blush grade (2.9 ± 0.3 vs 2.2 ± 0.8, P = <0.001), and reduction in left ventricular end‐diastolic dimensions (50.4 ± 4.3 mm vs 54.4 ± 5.8 mm, P = 0.004) compared with the control group. Clinical outcomes at 30 days and 6 months were similar between both groups.

Conclusions

TA might be associated with improved reperfusion and myocardial salvage especially in STEMI patients presenting after 12 h from symptom onset who are likely to have a heavy thrombus burden.

     

The effect of fasting status on lipids,lipoproteins, and inflammatory biomarkers assessed after hospitalization for an acute coronary syndrome: Insights from PROVE IT–TIMI 22

Background

For decades, fasting for 8 to 12 hours has been recommended for measurement of lipid profiles. The effect of fasting on low‐density lipoprotein cholesterol (LDL‐C) and triglycerides (TG) has been described in healthy cohorts and those with stable disease states. Recently, guidelines suggested that fasting may not be necessary due to its small effect on lipid measures. Little is known, however, regarding whether the impact of fasting is altered in the setting of an acute coronary syndrome (ACS).

Hypothesis

We hypothesized that the post‐ACS period would minimally effect the impact of fasting status on lipid measurements.

Methods

We evaluated the association of fasting on lipid and other biomarkers at the randomization visit, which occurred at a median of 7 days after the onset of an ACS, as well as during follow‐up, in a cohort of 4177 subjects from the Pravastatin or Atorvastatin Evaluation and Infection Therapy–Thrombolysis In Myocardial Infarction 22 (PROVE IT–TIMI 22) trial.

Results

Fasting samples were independently associated with a higher LDL‐C of 4.1 mg/dL and apolipoprotein‐B 100 of 2.6 mg/dL as well as a lower TG of 21.0 mg/dL and high‐sensitivity C‐reactive protein of 0.48 mg/dL. The relative difference was 3.8% for LDL‐C and ?11.3% for TG. Fasting did not change total cholesterol, high‐density lipoprotein cholesterol, apolipoprotein A‐I, lipoprotein(a), or apolipoprotein C‐III.

Conclusions

Although fasting does impact lipid measurements, the effect on LDL‐C is small (about 4 mg/dL), both early after ACS and during follow‐up. These data provide support for recent guidelines that no longer advocate for fasting lipid samples, including in the setting of ACS.

     

A randomized study of prourokinase during primary percutaneous coronary intervention in acute ST‐segment elevation myocardial infarction

Objectives

To evaluate the efficacy and safety of intracoronary administration of prourokinase via balloon catheter during primary percutaneous coronary interventions (PCI) in patients with acute ST‐segment elevation myocardial infarction (STEMI).

Methods

Acute STEMI patients underwent primary PCI were randomly divided into two groups: intracoronary prourokinase (IP) group (n = 118) and control group (n = 112). During primary PCI, prourokinase or saline were injected to the distal end of the culprit lesion via balloon catheter after balloon catheter dilatation. Demographic and clinical characteristics, infarct size, myocardial reperfusion, and cardiac functions were evaluated and compared between two groups. Hemorrhagic complications and MACE occurred in the 6‐months follow up were recorded.

Results

No significant differences were observed between two groups with respect to baseline demographic, clinical, and angiographic characteristics (P > 0.05). In IP group, more patients had complete ST segment resolution (>70%) compared with control group (P < 0.05). Patients in IP group showed lower levels of serum CK, CK‐MB and TnI, and a much higher myocardial blood flow (MBF) than those in control group (P < 0.05). No significant differences of TIMI major or minor bleeding complications were observed between the two groups (P > 0.05). At 6‐months follow‐up, there was a trend that patients in the IP group had a less chance to have MACE, though it was not statistically different (8.5% vs 12.5%, P > 0.05).

Conclusions

Intracoronary administration of prourokinase via balloon catheter during primary PCI effectively improved myocardial perfusion in STEMI patients.     

ST‐segment elevation on intracoronary electrocardiogram after percutaneous coronary intervention is associated with worse outcome in patients with non‐ST‐segment elevation myocardial infarction

The AMPLATZER^TM Vascular Plug 4 (AVP4) is a self‐expandable, replaceable occluder made of Nitinol wire mesh, which allows the safe and effective interventional occlusion of medium size vessels. This report describes an infant diagnosed with pulmonary atresia, ventricular septal defect, and multifocal collateral lung perfusion through four major aortopulmonary collateral arteries (MAPCAs). A central aorto‐pulmonary shunt was performed at 4 months of age. Because of postoperative pulmonary hyperperfusion, one of the MAPCAs was closed interventionally using a 5 mm AVP4. This MAPCA originated from the descending aorta (DAO) near the fifth thoracic vertebra and ran behind the esophagus to the lower lobe of the right lung. The MAPCA was closed near its origin from the DAO. Four weeks later, the patient presented with severe gastrointestinal bleeding, caused by perforation of the AVP4 into the esophagus. The occluder was extracted surgically, the MAPCA was clipped and the esophageal injury was sutured. To date, there have been no reports describing esophageal perforation due to an AVP4. The perforation in this patient may have been due to implantation of the AVP4 near the aorta in a MAPCA segment located directly in front of the spine and behind the esophagus. Another possible factor may have been the requirement for a gastrointestinal feeding tube. Although the occluder is soft and flexible, the spindle‐shaped ends may cause trauma if they are located close to other structures. © 2016 Wiley Periodicals, Inc.     

Clinical outcomes according to symptom presentation in patients with acute myocardial infarction: Results from the FAST‐MI 2010 registry

Background

Atypical clinical presentation in acute myocardial infarction (AMI) patients is not uncommon; most studies suggest that it is associated with unfavorable prognosis.

Hypothesis

Long‐term clinical impact differs according to predominant symptom presentation (typical chest pain, atypical chest pain, syncope, cardiac arrest, or dyspnea) in AMI patients.

Methods

FAST‐MI 2010, a nationwide French registry, included 4169 patients with AMI in 213 centers at the end of 2010 (76% of active centers). Demographics, medical history, hospital management, and outcomes were compared according to predominant symptom presentation.

Results

Typical chest pain with no other symptom was reported in 3020 patients (68% in STEMI patients, 76% in NSTEMI patients). Atypical chest pain, dyspnea, syncope, and cardiac arrest were reported in 11%, 11%, 5%, and 1%, respectively. Patients with atypical clinical presentation had a higher cardiovascular risk profile and received fewer medications and a less invasive strategy. Using Cox multivariate analysis, atypical chest pain was not associated with higher death rate at 3 years (HR: 0.96, 95% CI: 0.69‐1.33, P = 0.78), whereas cardiac arrest (HR: 2.44, 95% CI: 1.00‐5.97, P = 0.05), syncope (HR: 1.70, 95% CI: 1.18‐2.46, P = 0.005), and dyspnea (HR: 1.66, 95% CI: 1.31‐2.10, P < 0.001) were associated with higher long‐term mortality compared with patients with typical isolated chest pain. Similar trends were observed in STEMI and NSTEMI populations.

Conclusions

Atypical clinical presentation is observed in about 20% of AMI patients. Cardiac arrest, dyspnea, and syncope represent independent predictors of long‐term mortality in STEMI and NSTEMI populations.