Brachytherapy and In-Stent Restenosis
Five years after the beginning of the Washington Radiation for In-Stent Restenosis Trial (WRIST), a double-blind, randomized study to evaluate the effect of intracoronary radiation therapy for patients with in-stent restenosis, the treatment remains effective in reducing target-lesion restenosis and the need for target-lesion and target-vessel revascularization, said investigators reporting the trial in the present issue of Circulation (Circulation. 2004;109:340–344OpenUrl). However, the effect, first reported 6 months after the radiation treatment, declined in the remaining 41/2 years, according to the authors, who were led by Ron Waksman, MD, of Washington Hospital Center in Washington, DC.
At 6 months, target-lesion revascularization was 14% in the irradiated patients, compared with 62% in the patients who received placebo. Between 6 and 60 months, however, target-lesion revascularization was 21.6% in the irradiated patients versus 4.7% in the group that received placebo. The composite major adverse cardiac event rate during the period between 6 and 60 months was 27.7% in the irradiated group versus 6.1% in the placebo group.
The late thrombosis rate at 6 months was 7.7% in the irradiated group versus 3.3% in the placebo group. At 24 months, however, the late thrombosis rate was 12.3% in the irradiated group versus 6.2% in the placebo group. However, there was no further late thrombosis in either group, and the authors felt that this might reflect the need for long antiplatelet therapy. The subjects in the WRIST trial received only 1 month of antiplatelet therapy.
The authors wrote: “Despite increases in late recurrences in the irradiated group between 6 and 60 months, the clinical benefit of radiation for this cohort remains statistically significant at 5 years. The encouraging results from the clinical trials have established intracoronary radiation as a standard of care for patients with ISR [in-stent restenosis].”
Thiol-Containing Antioxidant and Risk Factors in Patients With End-Stage Renal Disease
Hemodialysis combined with intravenous administration of acetylcysteine, a thiol-containing antioxidant, dramatically reduced levels of homocysteine in 20 patients with end-stage renal failure, said researchers in a report in this week’s issue of the journal Circulation (Circulation. 2004;109:369–374OpenUrl).
In this prospective, randomized, placebo-controlled crossover study, researchers from Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Med. Klinik IV, Berlin, and Severi-Med Muenster, Germany, found that hemodialysis alone reduced homocysteine levels in the blood to an average of 58±22% of the predialysis level. When acetylcysteine was added, the levels dropped to 12±7% of the predialysis level, according to the authors, who were led by Alexandra Scholze, MD.
According to the authors, a 10% decrease in plasma homocysteine concentration was associated with a decrease of 2.5 mm Hg in pulse pressure. They concluded: “Intravenous administration of acetylcysteine during the hemodialysis session might be a novel, promising approach to reduce arteriosclerotic risk in patients with end-stage renal failure.”
Reducing Angina, Increasing Exercise Capacity
Ranolazine, a partial fatty acid oxidation (pFOX) inhibitor, reduced the number of angina attacks and increased the exercise ability of patients with severe angina who added the new drug to their other antianginal medications, said researchers in a report in the January 21, 2004, issue of The Journal of the American Medical Association (JAMA. 2004;291:309–316OpenUrlCrossRefPubMed).
In the Combined Assessment of Ranolazine In Stable Angina (CARISA) trial, 823 patients with symptomatic chronic angina were enrolled in the randomized, double-blind, placebo-controlled study. They were randomly assigned to receive 750 mg or 1000 mg of ranolazine twice daily or placebo. At 2, 6, and 12 weeks of treatment, patients were assessed by treadmill exercise 4 and 12 hours after dosing. They continued treatment with atenolol, amlodipine, and diltiazem.
The decrease in angina attacks was less than 1 per week for those who received 750 mg of ranolazine and slightly more than 1 per week for those who received 1000 mg of the new drug. Exercise duration increased 115.6 seconds for those who took ranolazine and 91.7 seconds for those on placebo.
In an accompanying editorial, Peter Berger, MD, of Duke University Medical Center in Durham, NC, said that ranolazine adds another possibility in the always-difficult treatment of patients who cannot undergo invasive treatment for their disease (JAMA. 2004;291:365–367OpenUrlCrossRefPubMed).
“Thus, the availability of another effective and apparently safe antianginal medication such as ranolazine is particularly important for such patients with angina who are not candidates for revascularization. Use of ranolazine most likely will influence the frequency and timing with which PCI [percutaneous coronary intervention] and coronary artery bypass graft are performed in the far greater number of patients with angina who are suitable for revascularization procedures,” he wrote.
Universal Health Coverage Needed by 2010: Institute of Medicine
With the number of Americans lacking health insurance (more than 43 million) approaching critical mass, the Institute of Medicine of the National Academies of Science is calling for universal health coverage by the year 2010 in a report issued January 14, 2004.
Although the group did not specify the mechanism by which the nation’s leaders should attain that goal, they did list 5 guiding principles by which such solutions should be judged:
Healthcare coverage should be universal.
Healthcare coverage should be continuous.
Healthcare coverage should be affordable to individuals and families.
The health insurance strategy should be affordable and sustainable to society.
Healthcare coverage should enhance health and well-being by promoting access to high-quality care that is effective, efficient, safe, timely, patient centered, and equitable.
Citing the problems associated with lack of health insurance, the report noted that Americans without health insurance get half the medical care of those with insurance.
“As a result, they tend to be sicker and to die sooner,” the report’s authors noted. “About 18 000 unnecessary deaths occur each year because of lack of health insurance.”
Youngsters suffer from lack of insurance as well, jeopardizing the nation’s future, they wrote.
“Only half of uninsured children visited the physician during 2001, compared with three quarters of insured children. Lack of regular care can result in more expensive care for preventable or treatable conditions, and disruptions in learning and development. When even one family member is uninsured, the entire family is at risk for the financial consequences of a catastrophic illness or injury,” they wrote.
“In light of the adverse consequences that uninsurance has for individuals, families, communities, and society as a whole, it should be painfully clear that our nation can no longer afford to ignore this problem,” said committee cochair Arthur Kellermann, MD, MPH, Professor and Chair of Emergency Medicine at Emory University School of Medicine, Atlanta, Ga. “We must find a way to cover the uninsured.”