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Medication-releasing stent reduces risk of artery re-narrowing following angioplasty
September 14, 2005Compared to bare metal stents, placement of stents that release the medication paclitaxel reduces the risk of the artery re-narrowing nine months following angioplasty for patients with complex coronary artery lesions, according to an article in the September 14 issue of JAMA.
Drug-eluting stents have revolutionized the treatment of atherosclerotic coronary artery disease, according to background information in the article. These stents (which release medications, such as sirolimus and paclitaxel) have been shown to safely reduce clinical and angiographic restenosis (narrowing again of the artery after treatment) compared with bare metal stents. Enrollment in the trials for these stents, however, was restricted to relatively simple stenoses (vessel diameter of 2.5-3.75 mm with lesion length 30 mm or less). More than 55 percent of lesions currently treated with these bioactive devices may fall outside this range. The efficacy of drug-eluting stents has not been established for small vessels (in which the utility of stents as a class is still uncertain), large vessels (in which outcomes with bare metal stents are favorable), or in long lesions requiring multiple stents.
Gregg W. Stone, M.D., of Columbia University Medical Center and Cardiovascular Research Foundation, New York, and colleagues conducted a study (the TAXUS V trial) to investigate the safety and efficacy of a paclitaxel-eluting stent in a patient population with more complex coronary lesions than previously studied. The trial, conducted from February 2003 to March 2004 at 66 academic and community-based institutions, included 1,156 patients who underwent stent implantation in a single coronary artery stenosis (vessel diameter, 2.25-4.0 mm; lesion length, 10-46 mm), including 664 patients (57.4 percent) with complex or previously unstudied lesions (requiring 2.25-mm, 4.0-mm, and/or multiple stents) and had 9-month clinical and angiographic follow-up. Patients were randomly assigned to receive 1 or more bare metal stents (n = 579) or identical-appearing paclitaxel-eluting stents (n = 577).
The average reference vessel diameter was 2.69 mm, the reference lesion length was 17.2 mm. An average of 1.38 stents (total average length, 28.4 mm) were implanted per lesion. Stents of 2.25 mm and 4.0 mm in diameter were used in 18 percent and 17 percent of lesions, respectively; multiple stents were used in 33 percent of lesions.
"Compared with bare metal stents, implantation of paclitaxel-eluting stents reduced the 9-month rate of target lesion revascularization from 15.7 percent to 8.6 percent and target vessel revascularization from 17.3 percent to 12.1 percent. Among patients receiving the paclitaxel-eluting stent compared with a bare metal stent, the rate of in-stent restenosis was reduced with from 31.9 percent to 13.7 percent and analysis segment angiographic restenosis was reduced from 33.9 percent to 18.9 percent," the authors write.
"By multivariate analysis, randomization to the paclitaxel-eluting stent was an independent predictor of freedom from 9-month target lesion revascularization [2.2 times more likely], target vessel revascularization [1.7 times more likely], and restenosis [2.9 times more likely]. These benefits were achieved with comparable safety in both groups, with similar rates of cardiac death, myocardial infarction, and stent thrombosis at 1 and 9 months."
Angiographic restenosis was also reduced among patients receiving 2.25-mm stents (49.4 percent vs. 31.2 percent), 4.0-mm stents (14.4 percent vs. 3.5 percent), and multiple stents (57.8 percent vs. 27.2 percent).
"In conclusion, the TAXUS V trial investigated the use of paclitaxel-eluting stents in a patient population with more complex lesions than had been previously studied. Angiographic restenosis and target vessel revascularization were significantly reduced in the entire cohort, as well as in those patients with complex disease," the authors write.
JAMA and Archives Journals
The average reference vessel diameter was 2.69 mm, the reference lesion length was 17.2 mm. An average of 1.38 stents (total average length, 28.4 mm) were implanted per lesion. Stents of 2.25 mm and 4.0 mm in diameter were used in 18 percent and 17 percent of lesions, respectively; multiple stents were used in 33 percent of lesions.
"Compared with bare metal stents, implantation of paclitaxel-eluting stents reduced the 9-month rate of target lesion revascularization from 15.7 percent to 8.6 percent and target vessel revascularization from 17.3 percent to 12.1 percent. Among patients receiving the paclitaxel-eluting stent compared with a bare metal stent, the rate of in-stent restenosis was reduced with from 31.9 percent to 13.7 percent and analysis segment angiographic restenosis was reduced from 33.9 percent to 18.9 percent," the authors write.
"By multivariate analysis, randomization to the paclitaxel-eluting stent was an independent predictor of freedom from 9-month target lesion revascularization [2.2 times more likely], target vessel revascularization [1.7 times more likely], and restenosis [2.9 times more likely]. These benefits were achieved with comparable safety in both groups, with similar rates of cardiac death, myocardial infarction, and stent thrombosis at 1 and 9 months."
Angiographic restenosis was also reduced among patients receiving 2.25-mm stents (49.4 percent vs. 31.2 percent), 4.0-mm stents (14.4 percent vs. 3.5 percent), and multiple stents (57.8 percent vs. 27.2 percent).
"In conclusion, the TAXUS V trial investigated the use of paclitaxel-eluting stents in a patient population with more complex lesions than had been previously studied. Angiographic restenosis and target vessel revascularization were significantly reduced in the entire cohort, as well as in those patients with complex disease," the authors write.
JAMA and Archives Journals
Angioplasty Current Events and Angioplasty News RSSYour Own Stem Cells Can Treat Heart Disease
The largest national stem cell study for heart disease showed the first evidence that transplanting a potent form of adult stem cells into the heart muscle of subjects with severe angina results in less pain and an improved ability to walk. The transplant subjects also experienced fewer deaths than those who didn't receive stem cells.
Vitamin B niacin offers no extra benefit to statin therapy in seniors already diagnosed with CAD
The routine prescription of extended-release niacin, a B vitamin (1,500 milligrams daily), in combination with traditional cholesterol-lowering therapy offers no extra benefit in correcting arterial narrowing and diminishing plaque buildup in seniors who already have coronary artery disease, a new vascular imaging study from Johns Hopkins experts shows.
The heart attack myth: Study establishes that women do have same the heart attack symptoms as men
The gender difference between men and women is a lot smaller than we've been led to believe when it comes to heart attack symptoms.
Lifestyle changes remain important in fighting peripheral arterial disease
Modifying the risk of peripheral arterial disease (or PAD)-with healthy lifestyle changes-remains vital to one's health, note researchers in a recent issue of the Journal of Vascular and Interventional Radiology.
Study questions need for routine intervention in patients with renovascular disease
Some invasive procedures that are becoming increasingly common as a first line of treatment for patients diagnosed with narrowed arteries in and around the kidneys may not be necessary.
Designing drugs and their antidotes together improves patient care
Imagine a surgical patient on a blood-thinning drug who starts bleeding more than expected, and an antidote that works immediately - because the blood thinner and antidote were designed to work together.
Pre-hospital organization: The first links in the chain of survival for heart attack patients
Mortality rate following a heart attack has fallen by more than 50% in Europe over the past 25 years. However, because only minor advances in the medical treatment of AMI are expected over the next decade, it is through organisational changes in the pre-hospital phase that mortality rate will continue this decline to below 5%.
Stent for life initiative
Primary angioplasty (with stent implantation) is the most effective therapy for acute myocardial infarction (AMI), but it is not available to many patients, even though most European countries have sufficient resources (ie, catheterisation laboratories) for its wider use.
Otamixaban for the treatment of patients with non-ST-elevation acute coronary syndromes
Data from a phase II trial of an investigational intravenous drug designed to block the formation of blood clots shows potential to reduce the risk of death, a second heart attack, or other coronary complications compared with the current standard of care in patients presenting with acute coronary syndromes (heart attacks or unstable angina).
New strategies for reperfusion therapy
A new trial has begun in order to ascertain once and for all whether the best strategy for patients who cannot receive P-PCI is early fibrinolysis, together with mandated angiography.
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