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Author Interview: Giampaolo Niccoli, Md, PhD
Interventional Cardiologist
Assistant Professor of Cardiology
Catholic University of the Sacred Heart
Rome, Italy
address L.go F. Vito 1, 00136, Rome
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Publication:
Author Interview: Giampaolo Niccoli, Md, PhD
Impact of gender on clinical outcomes after mTOR-inhibitor drug-eluting stent implantation in patients with first manifestation of ischaemic heart disease.
Niccoli G, Sgueglia GA, Cosentino N, Piro M, Toma A, Cataneo L, Fracassi F, Porto I, Leone AM, Burzotta F, Trani C, Crea F.
Catholic University of Sacred Heart, Rome, Italy.
Eur J Cardiovasc Prev Rehabil. 2011 Aug 12
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What are the main findings of the study?
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In our study, we found that among patients undergoing implantation of mTOR-inhibitor drug-eluting stent at their first clinical manifestation of coronary artery disease, female gender is an independent predictor of adverse outcome.
Differently from previous studies, we included consecutive patients undergoing percutaneous coronary intervention at their first presentation of coronary artery disease, thus avoiding the bias introduced by previous revascularization procedures.
Moreover, being target vessel revascularization rate prevalent in the composite endpoint in our study when compared with death or myocardial infarction, our findings should be mainly applied to this endpoint. Finally, whether the worse outcome observed after percutaneous coronary intervention in women in comparison with men can be explained by factors inherent to the female sex in unclear.
However, it is worth noting that, in our study, female sex was still the strongest independent predictor of a worse outcome even after adjustment for other variables associated with an increased risk which are known to be clustered in the female sex, including age, diabetes mellitus and arterial hypertension.
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Were any of the findings unexpected?
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Women have been reported to have a worse short- and long-term prognosis than men, after percutaneous coronary intervention with balloon angioplasty or bare-metal stent implantation, both in the setting of acute or chronic obstructive coronary artery disease.
However, limited data exist that assess prognosis in women undergoing percutaneous coronary intervention with drug-eluting stent.
In particular, in drug-eluting stent era, revascularization in women appeared as safe as in men, when adjusted for the risk factors, with similar success rate, reduction of the restenosis and subsequent target lesion and target vessel revascularization with the use of drug-eluting stents and no increase in the negative effects of the modern adjunctive antithrombotic therapy.
Thus, demonstrating that female sex itself is an independent predictor of worse outcome in a drug-eluting stent population was not totally expected, although already acknowledging the different pathophysiological backgrounds between both gender.
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What should clinicians and patients take away from this study?
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m-TOR inhibitor drug eluting stent implantation may be associatd with a higher rate of repeated revascularization in women. However, dure to the low event rate, failure of such stents is probably confined to a low percentage of women. A more strict follow-up may be reccomended in women after m-TOR inhibitor drug eluting stent implantation.
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What recommendations do you have for nephrology health care providers as a result of your study?
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Despite dramatic declines in mortality, coronary artery disease remains the leading cause of mortality, both in men and women, in developed countries, and around 25% of myocardial revascularizations is performed on women.
Cardiology providers should continue to weigh the risk-benefit ratio of coronary angiography and percutaneous intervention in their patients and be cognizant of the worse prognosis carried by female patient undergoing percutaneous coronary intervention and drug-eluting stent implantation.
Further studies should focus on possible adjunctive therapies aiming at reducing the prognostic gap between male and female patients undergoing coronary drug-eluting stent deployment.
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Abstract: |
Background: Women have a worse outcome than men after percutaneous coronary intervention (PCI).
However, in the drug-eluting stent (DES) era, limited data are available about the impact of gender-related differences on clinical outcome.
Furthermore, many series have also included patients previously treated by coronary-artery bypass grafts or PCI, which may bias the evaluation of DES-related clinical events at follow up.
We aimed to assess the impact of gender on clinical outcomes in a consecutive series of patients at first manifestation of coronary artery disease (CAD) undergoing PCI with mTOR-inhibitor DES.
Methods and results: A total of 138 consecutive patients (age 64 ± 13 years, female gender 29%) undergoing successful mTOR-inhibitor DES implantation [sirolimus-eluting stent (SES); zotarolimus-eluting stent (ZES); and everolimus-eluting stent (EES)] for the treatment of stable chronic angina or an acute coronary syndrome, as their first clinical manifestation of CAD, were prospectively enrolled between February 2008 and May 2009. Major adverse cardiac events (MACE), defined as a combination of cardiac death, myocardial infarction (MI), and clinically driven target lesion revascularization (TVR) at 12-month follow up, constituted the endpoint of the study. Fifty-one (37%) patients received SES; 46 (33%) patients received ZES; and 41 (30%) patients received EES. At follow up, 21 (15%) patients experienced a MACE. Three (2%) patients had cardiac death, five (4%) had MI, while 13 (9%) patients underwent clinically driven TVR. MACE occurred more frequently in females than males [10 (25%) vs. 11 (11%), p = 0.05].
At Cox regression analysis, the only independent predictors of MACE were female gender and implantation of more than one stent [hazard ratio (HR) 3.70, 95% confidence interval (CI) 1.46-9.36, p = 0.006; HR 1.26, 95% CI 0.99-2.74, p = 0.01, respectively]
Conclusions: In conclusion, our finding suggests that women may have a worse outcome as compared with men after mTOR-inhibitor DES implantation.
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Featured Angina| Acute Coronary Syndrome and Heart Disease Interviews
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Highlights of Article by Dr. Erik Hess et of Mayo Clinic ;CIRCOUTCOMES 2012
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Chest pain is the 2nd most common reason patients come to EDs across the United States
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Initial testing – including information obtained from the history, physical exam, electrocardiogram, and cardiac troponin – identifies > 98% of heart attacks
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To avoid missing a diagnosis of heart attack or pre-heart attack symptoms, emergency physicians often admit patients to observation units or to the hospital for extensive diagnostic testing, including stress testing
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This results in false positive test results, unnecessary exposure to radiation, and unnecessary downstream procedures such as stent placement in arteries of the heart
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Decision aids are evidence-based tools designed to educate and engage patients in decisions regarding their care
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We hypothesized that patients who were educated regarding their future risk for a heart attack and engaged in the decision of whether to be admitted to the observation unit for stress testing or to follow-up with a Mayo Clinic heart doctor in the next 72 hours would have greater knowledge about their short-term risk for heart attack, be more aware of the management options, and choose less intensive approaches to evaluation
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We randomly assigned 204 patients who came to the ED with chest pain and were being considered for observation unit admission to the decision aid or to usual care
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Decision aid patients:
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Had greater knowledge regarding their short-term risk for a heart attack
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Less frequently decided to be admitted to the observation unit for stress testing
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Had 4 times greater engagement in the decision making process
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Had no adverse events within 30 days of the ED visit
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Take home points
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Patients want to be educated and engaged in decisions regarding their care
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Once properly informed and engaged in treatment decisions, patients often choose less intensive treatment options
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Integrated health systems like the Mayo Clinic in which physicians collaboratively work together to provide ER patients ready access to outpatient follow-up have potential to improve the value of Emergency care
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Glucose, Insulin and Potassium (“GIK”) TO MINIMIZE IMPACT OF HEART ATTACKS BEFORE PATIENTS GET TO THE HOSPITAL
Study puts life-saving drugs in the hands of paramedics, decreasing rate of cardiac arrest and death from heart attacks
CHICAGO (March 27, 2012) — Paramedics can potentially reduce someone’s chances of having a cardiac arrest or dying by 50 percent by immediately administering a mixture of glucose, insulin and potassium (“GIK”) to people having a heart attack, according to research presented today at the American College of Cardiology’s 61st Annual Scientific Session. The Scientific Session, the premier cardiovascular medical meeting, brings cardiovascular professionals together to further advances in the field.
The study showed that patients who received GIK immediately after being diagnosed with acute coronary syndrome — which indicates a possible heart attack is either in progress or on the way — were 50 percent less likely to have cardiac arrest (a condition in which the heart suddenly stops beating) or die than those who received a placebo, although the treatment did not prevent the heart attack from occurring. The reduction in in-hospital cardiac arrest or death was a “secondary endpoint”, so statistically was not definitive, but was consistent with how GIK seems to work in experimental models of heart attack.
The effect was also present for patients with ST-elevation heart attacks, which require immediate treatment. For those patients, immediate GIK was associated with a 60 percent reduction in in-hospital cardiac arrest or death.
“When started immediately in the home or on the way to the hospital — even before the diagnosis is completely established — GIK appears not completely prevent any heart attack from occurring, but appeared in this trial to reduce the size of heart attacks and to reduce by half the risk of having a cardiac arrest or dying,” said Harry P. Selker, MD, MSPH, executive director of the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center, who led the study with Joni Beshansky, RN, MPH, co-principal investigator and project director. “Acute coronary syndromes represent the largest cause of death in this country. GIK is a very inexpensive treatment that appears to have promise in reducing those deaths and morbidity.”
The cost of the treatment is about $50.
“Because the trial is the first to show GIK could be effective when used by paramedics in real-world community settings, it could have important implications for the treatment of heart attacks,” Dr. Selker said. Previous clinical trials have shown no consistent effect, likely because the GIK was given too late to help. This study, the “IMMEDIATE Trial,” was the first to test the effectiveness of administering GIK at the very first signs of a threatening heart attack, in the community, rather than waiting hours until the diagnosis was well-established at a hospital, as done in previous clinical trials.
“We wanted to do something that is effective and can be used anywhere,” said Dr. Selker. “We’ve done a lot of studies of acute cardiac care in emergency departments and hospitals, but more people die of heart attacks outside the hospital than inside the hospital. Hundreds of thousands of people per year are dying out in the community; we wanted to direct our attention to those patients.”
The researchers trained paramedics in 36 Emergency Medical Services systems in 13 cities across the country to administer GIK after determining that a patient was likely having a threatened or already established heart attack using electrocardiograph-based ACI-TIPI (acute cardiac ischemia time-insensitive predictive instrument) and thrombolytic predictive instrument decision support that prints patient-specific predictions on the top of an electrocardiogram. The paramedics used these predictions to decide if a patient would likely benefit from treatment. There were 911 patients randomized to receive either the GIK treatment or a placebo.
Administering GIK immediately also reduced the severity of the damage to the heart tissue from the heart attack. On average, 2 percent of the heart tissue was destroyed by the heart attack in people receiving GIK, compared with 10 percent in those who received the placebo. Although a significant proportion of suspected heart attacks are later determined to be false alarms (23 percent in this study), administering GIK does not appear to cause any harmful effects in such patients.
The research team will follow up with study participants at six and 12 months to evaluate the longer-term benefit of the GIK treatment.
This study was funded by the NIH’s National Heart, Lung and Blood Institute.
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Keywords and tags:
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Angina | Heart Disease Resourses
| Chest Pain
Amazon.com 's Editorial Reviews
Angina: New Ways to Treat
Chronic Chest Pain
Part of the award winning public television series Healthy head
/Healthy Mind. It's one of the scariest medical symptoms for people who are generally healthy: a tightening, painful feeling in the chest known as Angina. In some cases this chest pain can be a serious warning that requires immediate treatment. But for the millions of people with chronic, stable angina the discomfort is something that can be readily managed with a variety of treatments. In this program we take a look at what generally causes angina, what can be done to prevent it and how it can be effectively treated with lifestyle changes, innovative drug therapies and medical procedures.
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Amazon.com Editorial Review:
Philips HeartStart Home Defibrillator (AED)
Be prepared for the unexpected.
When sudden cardiac arrest (SCA) strikes, the electrical system of the heart short circuits, causing the heart to quiver rather than pump in a normal rhythm. It typically results in the abnormal heart rhythm know as ventricular fibrillation (VF). It usually happens without warning and the majority of people have no previously recognized symptoms of heart disease. And it most often happens at home. For the best chance of survival from SCA caused by VF, a defibrillator should be used within 5 minutes. Yet, less than 1 in 20 people survive largely because a defibrillator does not arrive in time.
Just as seat belts or airbags do not save every life in a traffic accident, a defibrillator will not save every person who suffers a sudden cardiac arrest. Yet many lives could be saved if more people could be reached more quickly.
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