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Aspirin shown to greatly reduce death and suffering from Ischemic Complications following heart bypass surgery
SAN FRANCISCO, CA (ots) -
Landmark study published in the New England Journal of Medicine identifies safe, inexpensive therapy to save lives and healthcare costs
Led by Dr. Dennis T. Mangano and the Ischemia Research & Education Foundation, a massive, worldwide study involving 17 countries, 70 medical centers and more than 5'000 patients has shown that early aspirin use following cardiac bypass surgery is associated with greatly reduced risk of dying and suffering from ischemic (inadequate blood supply) complications involving the heart, brain, kidney and gastrointestinal tract. Furthermore, use of aspirin immediately following surgery was found to be safe and cost-effective, allowing for its immediate and widespread use.
Dr. Dennis T. Mangano, Ph.D., M.D., a world-renowned investigator in association with investigators of the Ischemia Research and Education Foundation (IREF) in San Francisco, and the Multicenter Study of Perioperative Ischemia (McSPI) Research Group located throughout the world conducted the groundbreaking EPI II Study. The study appears as the lead article entitled "Aspirin and Mortality from Cardiac Bypass Surgery" in tomorrow's New England Journal of Medicine.
"For the first time, we have identified a therapy that can substantially reduce both fatal and non-fatal outcomes associated with cardiac surgery," said Dr. Mangano. "What's more, its use is both safe and extremely cost-effective. If the clinical effect found in EPI II were repeated, then every year 27'000 lives could be saved and more than 51'000 serious ischemic events such as stroke or kidney failure could be prevented through aspirin use immediately following cardiac bypass surgery," he added.
Among patients receiving aspirin (up to 650 mg) within 48 hours of coronary artery bypass graft (CABG) surgery, there was a 67% reduction in subsequent mortality (1.3% versus 4.0%; P < 0.001) compared with the non-aspirin group. Nonfatal ischemic complications were also greatly reduced. The aspirin group experienced a 49% reduction in myocardial infarctions (2.8% versus 5.4%; P < 0.001), a 48% reduction for stroke (1.3% versus 2.6%; P < 0.01), a 74% reduction in for renal failure (0.87% versus 3.4%; P < 0.001), and a 68% reduction for bowel infarction (0.27% versus 0.84%; P = 0.01).
The aspirin benefit was similar among diverse subsets of patients, including gender, race, age, disease acuity, insurance-type and country. Multivariate analysis of the trial results showed that no other factor or medication was independently associated with reduced outcome. Most importantly, this analysis also showed that the risk for hemorrhage, gastritis, infection or impaired wound healing was not increased with aspirin use (odds ratio, 0.63; 95% confidence interval, 0.54 - 0.74).
"The EPI II study is extremely noteworthy for a number of reasons. First, it is the most comprehensive study ever performed in medicine, collecting more than 7'500 pieces of data from every one of the 5'000 patients, or 40 million pieces of data. Second, the entire study was privately (non-profit) funded, and included medical centers of the United States, Canada, Mexico, South America, Europe, Eastern Europe, the Middle East, India and the Far East. Third, and most importantly, the breadth of effects shown by early aspirin use after cardiac bypass surgery was very substantial," said Dr. Mangano. "Aspirin use was shown to substantially mitigate both fatal and nonfatal damage not only to the heart, but also other major organs. These findings suggest a fundamental role of the platelet in orchestrating the ischemic response to reperfusion injury among multiple organs in this setting," he added.
The EPI II Study was prospective and longitudinal, including 5'436 patients admitted with medically refractory coronary artery disease and scheduled for CABG surgery at 70 medical institutions among 17 countries in North and South America, Europe, the Middle East, and Asia. It was designed to determine the incidence of fatal and nonfatal major ischemic events involving the heart, brain, kidney and gastrointestinal tract and assess the impact of aspirin use immediately following surgery on these outcomes, as well as estimate any effect on healthcare costs.
For each enrolled patient, approximately 7'500 fields of data were collected throughout the patient's hospitalization period by independent investigators, with treating physicians blinded to research data. Fatal and nonfatal outcomes occurring more than 48 hours after surgery and during the hospitalization were classified as cardiac (myocardial infarction, heart failure), cerebral (stroke, encephalopathy), renal (dysfunction, failure), gastrointestinal (ischemia, infarction), or other (such as infections or pulmonary).
Clinical decisions were not controlled by study protocol, and all patients qualifying for enrollment within the pre-specified enrollment period were entered. Of the 5,436 patients enrolled in the study, 371 were excluded due to either patient withdrawal, death prior to surgery, cancellation of surgery, or incomplete data. Of the remaining 5'065 patients, 3'001 received aspirin (from a total of 80 mg to 650 mg) within 48 hours of revascularization (restoration of blood flow to the heart). All potential side effects associated with aspirin use, such as blood loss, gastric irritation, infection and impaired wound healing, were recorded daily by blinded investigators.
During the hospitalization period defined by the trial, 164 patients (3.2%) died, all of whom were associated with one or more adverse ischemic events. Seventy-four percent of the deaths (involving 121 patients) and 65% of the nonfatal ischemic events (involving 539 additional patients) occurred after 48 hours of surgery.
First use of aspirin after 48 hours was not associated with a significant reduction in subsequent mortality. The practices of discontinuing aspirin use prior to surgery, transfusing platelets (small blood cells that control bleeding) after reperfusion, and using anti-fibrinolytic agents (blood clot stabilizers) to reduce blood loss during hospitalization, were all associated with increased risk of dying and suffering ischemic complications. Those risks are substantially reduced, but still significant, when aspirin was used.
Pharmacoeconomic Clinical Implications
The pharmacoeconomic implications of the EPI II study results mean that for every 1'000 CABG patients treated with aspirin within the first 48 hours after surgery, 81 lives could be saved. Worldwide, if the clinical effect found in EPI II were repeated, 26'700 lives could be saved every year. Additionally, in 51'300 other patients, serious ischemic events such as stroke or kidney failure could be prevented each year resulting in savings of approximately 1'402'800 hospital days, or approximately $3.3 billion annually. Given a hospital cost of five cents per aspirin, the added cost of treating these patients would be only $100,000 per year.
Using reasonable assumptions for life expectancy, the effect of aspirin therapy on mortality alone would result in annual savings of approximately 267'000 life-years, or 38 cents per life-year saved. This is less than one percent of that associated with fibrinolytic therapy and less than one-tenth of one percent of that associated with kidney dialysis.
Coronary Artery Bypass Graft Surgery
First performed nearly four decades ago, CABG surgery now is performed in nearly one million patients per year worldwide - a growth rate likely to accelerate given worldwide aging and greater availability of this therapy in India and China. Although substantial advances have evolved for surgical techniques, heart preservation, monitoring and intensive care, complication rates continue to be troubling - especially for the older and sicker patients and those not indicated for angioplasty (percutaneous coronary transluminal angioplasty or PCTA). These high-risk patients now represent the majority of surgical patients giving rise to complication rates of 15% or more.
The Ischemia Research and Education Foundation (IREF) is a nonprofit, privately endowed research institution based in San Francisco. IREF's mission is to improve the health and quality of life throughout the world by conducting and publishing high quality clinical research for the public benefit. Founded in 1987 by Dennis T. Mangano, MD, PhD, IREF has 13 MDs, PhDs and PharmDs among its 19 full-time staff and a network of nearly 300 clinical sites internationally. IREF has unique research capabilities in the areas of cardiovascular medicine and anesthesiology and has specifically addressed the problem of morbidity and mortality through the study of perioperative ischemia. You may find out more about IREF on the web at www.iref.org/
ots Originaltext: IREF - Ischemia Research and Education Foundation
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