Biomarkers improved prediction of mortality in patients with STEMI undergoing primary PCI
Damman P. J Am Coll Cardiol. 2011;57:29-36.
The addition of a multimarker to a model that included established risk factors benefited the prediction of mortality in patients with STEMI who were undergoing primary percutaneous coronary intervention.
“This is one of the first studies to evaluate a multimarker approach for the prediction of baseline risk of long-term death in patients undergoing primary PCI for STEMI,” the researchers wrote. “Incorporation of … three predictive biomarkers in the multimarker risk score yields important information regarding baseline risk and mortality.”
The study included 1,034 patients with STEMI undergoing primary PCI from an intervention center in the Netherlands between Jan. 1, 2005, and Jan. 1, 2007. Researchers tested whether combining N-terminal pro-brain natriuretic peptide, CRP, glucose, cardiac troponin T and estimated glomerular filtration rate improved mortality prediction.
During a mean follow-up of 901 days, 120 patients died. Statistically significant predictors of mortality included glucose, N-terminal pro-brain natriuretic peptide and estimated glomerular filtration rate.
According to researchers, a risk score that incorporated these three biomarkers identified a high-risk STEMI subgroup with a higher mortality vs. an intermediate- or low-risk subgroup (P<.001). Additionally, the three biomarkers, when added to established prognostic factors, improved mortality prediction, which was indicated by the net reclassification improvement (P<.001) and integrated discrimination improvement (P<.01).
“The study provides important pathophysiological information confirming the common roots of ACS, either ST segment elevation or non-ST elevation, and promising clinical improvements in STEMI treatment,” Luigi M. Biasucci, MD, and Roberta Della Bona, MD,both with the department of cardiology, Catholic University of the Sacred Heart, Rome, wrote in an accompanying editorial. “Although their efforts fell short of the objectives, we hope that they will contribute to a more accurate and individualized prognostication and therapy, with consequent reduction in events and the flourishing of novel pathophysiological information.”
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Paclitaxel-eluting stent benefits comparable between men, women
Mehran R. J Am Coll Cardiol Intv. 2010;3:1260-1261.
Mikhail GW. J Am Coll Cardiol Intv. 2010;3:1250-1259.
Women undergoing percutaneous coronary intervention treated with a paclitaxel-eluting stent had similar benefits to men who underwent the same procedure, study data indicated.
“To our knowledge, the ‘TAXUS Woman’ analysis, which included more than 3,000 women, is the largest evaluation to date that examines the influence of sex on long-term performance of a single drug-eluting stent across low- to high-risk patient/lesion characteristics,” the researchers wrote. “This analysis demonstrated that women had significantly more adverse baseline risk factors, yet had comparable safety and efficacy outcomes to men.”
The study included 3,114 women and 6,649 men from five randomized trials and two “real-world” registries who were undergoing PCI with a paclitaxel-eluting stent (Taxus, Boston Scientific). Researchers used outcomes of women (n=395) from the trials treated with bare metal stents as a comparison.
Data specific to the randomized trials revealed that women treated with a paclitaxel-eluting stent had a lower rate of target lesion revascularization than women treated with a bare metal stent (11.5% vs. 22.6%; P<.001). Between both stent groups, there were no significant sex-based differences in death, target lesion revascularization, stent thrombosis and MI at 5 years.
When data from both the trials and registries were analyzed, researchers found that women had similar outcomes as men despite having more adverse baseline characteristics, including advanced age, hypertension and diabetes. Conversely, in the expanded-use cohort — those considered to have patient and/or lesion characteristics considered outside the simple-use population, such as lesion length >28 mm and reference vessel diameter <2.5 mm — women had significantly higher rates of death and target lesion revascularization, although only target lesion revascularization remained higher after multivariate analysis.
In an accompanying editorial, Roxana Mehran, MD, and Annapoorna S. Kini, MD, of the Mount Sinai School of Medicine, New York, said they questioned whether this study was powered enough to provide a definitive conclusion regarding the effectiveness of paclitaxel-eluting stents in women compared with men.
“Although close to 10,000 patients were studied in these well-controlled trials, women represented only a small minority of the population. Therefore, the true comparative effectiveness study of paclitaxel-eluting stent vs. bare metal stent in women was based on only 1,050 female subjects (655 paclitaxel-eluting stent vs. 395 bare metal stent) and was hardly powered to answer the question of safety and efficacy of paclitaxel-eluting stent in women,” they wrote.
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NanoCross catheters recalled
The company ev3 has initiated a voluntary recall of the NanoCross .014” OTW PTA Dilation Catheter because of the potential of cracking or breaking during use. The FDA has classified this as a class I recall.
A cracked or broken catheter shaft could result in the inability to inflate or deflate the balloon, resulting in material separation and possible embolization. This could cause unplanned intravascular or open surgery, vasospasm, prolonged tissue ischemia, bleeding and/or death.
The NanoCross .014” OTW PTA Dilation Catheter is used to dilate stenosis in the iliac, femoral, iliofemoral, popliteal, infra-popliteal and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The recall affects certain lots of the NanoCross .014” OTW PTA Dilation Catheters manufactured between May 27, 2010 and October 18, 2010. Only the catheters from the lots specified on this site are affected by the recall.