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INSIDE THIS ISSUE

Inside This Issue

	Quarterly Focus Issue: Prevention/Outcomes

Top Quarterly Focus Issue:... Interventional Cardiology Pre-Clinical Research

Mark A. Hlatky, Paul Heidenreich

In this paper, Hlatky and Heidenreich summarize a few of the highlights in the fields of epidemiology, health services research, and outcomes research published between April 2008 and June 2009. Included are synopses of a range of articles, from those that link obesity to cardiac events, to the cost-effectiveness of percutaneous coronary intervention for patients with stable angina, to understanding and reducing the effects of racial disparities in cardiac care.

Lipid-Lowering and Total Cardiovascular Burden.   Benefits of Intensive Lipid Lowering Extend Beyond Reductions in the Time to First Event

2353

Matti J. Tikkanen, Michael Szarek, Rana Fayyad, Ingar Holme, Nilo B. Cater, Ole Faergeman, John J. P. Kastelein, Anders G. Olsson, Mogens Lytken Larsen, Christina Lindahl, Terje R. Pedersen, for the IDEAL Investigators

This post-hoc analysis of the IDEAL (Incremental Decrease in End Points Through Aggressive Lipid Lowering) trial by Tikkanen and colleagues compared the efficacy of high-dose atorvastatin and usual-dose simvastatin for the prevention of all cardiovascular (CV) events, rather than just the first event that was the primary end point of the trial. The authors used the Wei, Lin, and Weissfeld method, which may be more informative because during the course of long-term trials, a large number of events may occur subsequent to the first event. The relative risk of a first CV event in those treated with atorvastatin was reduced by 17%, of a second by 24%, of a third by 19%, of a fourth by 24%, and of a fifth by 28%. These results indicate that the benefits of intensive statin therapy continue beyond the first event.

Lipid-Lowering and Total Cardiovascular Burden.   Reduction in First and Subsequent Events With Atorvastatin in the PROVE IT–TIMI 22 Trial

2358

Sabina A. Murphy, Christopher P. Cannon, Stephen D. Wiviott, Carolyn H. McCabe, Eugene Braunwald

The PROVE IT–TIMI 22 (Pravastatin and Atorvastatin in Evaluation and Infection Therapy–Thrombolysis In Myocardial Infarction 22) trial showed that atorvastatin 80 mg reduced the incidence of a first primary end point by 16% compared with pravastatin 40 mg in subjects presenting with an acute coronary syndrome. Murphy and colleagues reanalyzed the data to determine if there were similar reductions in recurrent and total events throughout the duration of the study using the Poisson regression analysis. Using the standard statistical technique of counting first events, atorvastatin prevented only 73 events. However, subsequent events were also reduced with atorvastatin 80 mg, resulting in 138 fewer total primary events during the study (rate ratio: 0.85). Based on the primary end point results, the number needed to treat is 26; however, the number needed to prevent 1 event is much lower at 14 when all events are considered.

Editorial Comment: Steven E. Nissen, p. 2363

Cardiovascular Risk and Menopause.   Significant Increase in Cardiac Risk Factors at Time of Menopause

2366

Karen A. Matthews, Sybil L. Crawford, Claudia U. Chae, Susan A. Everson-Rose, Mary Fran Sowers, Barbara Sternfeld, Kim Sutton-Tyrrell

This prospective study by Matthews and colleagues sought to determine whether changes in traditional and novel coronary heart disease (CHD) risk factors can be temporally related to menopause or are gradual changes associated with aging. SWAN (Study of Women's Health across the Nation) is a prospective study of the menopausal transition in 3,302 women of multiple ethnicities. Women were surveyed annually, were asked about their menstrual cycles, and had their CHD risk factors measured. Total cholesterol, low-density lipoprotein cholesterol (LDL-C), and apolipoprotein-B demonstrated substantial increases within the 1-year interval before and after the final menstrual period (FMP), consistent with menopause-induced changes. Other risk factors, including other lipoproteins, glucose, insulin, blood pressure, fibrinogen, and C-reactive protein, changed gradually indicative of chronological aging. This suggests that women experience a rise in apolipoprotein-B–containing lipids at the time of their FMP.

Editorial Comment: Vera Bittner, p. 2374

Cardiovascular Risk and Diet and Smoking.   Effect of Weight Loss and Regain on Cardiac Structure and Function

2376

Lisa de las Fuentes, Alan D. Waggoner, B. Selma Mohammed, Richard I. Stein, Bernard V. Miller III, Gary D. Foster, Holly Wyatt, Samuel Klein, Victor G. Davila-Roman

de las Fuentes and colleagues performed a 2-year dietary intervention study to evaluate the effects of moderate weight reduction and subsequent partial weight regain on cardiovascular structure and function. In the 47 subjects who completed the entire 2-year follow-up, average weight loss was 7%, 9%, 8%, and 4% at 3, 6, 12, and 24 months, respectively. There were significant improvements and strong correlations between the change in weight and changes in left ventricular mass, carotid intima-media thickness, and left ventricular diastolic (E') and systolic (S') function. Partial weight regain diminished the beneficial effects of weight loss. Diet-induced moderate weight loss in obese subjects is associated with beneficial changes in cardiovascular structure and function.

Cardiovascular Risk and Diet and Smoking.   Benefits to Quitting, Even Reducing, Cigarette Use

2382

Yariv Gerber, Laura J. Rosen, Uri Goldbourt, Yael Benyamini, Yaacov Drory, for the Israel Study Group on First Acute Myocardial Infarction

Gerber and colleagues compared long-term survival after acute myocardial infarction (AMI) of never-smokers, pre-AMI quitters, post-AMI quitters, and persistent smokers, and assessed whether cigarette reduction among persistent smokers is associated with lower mortality. Over 1,500 subjects age 65 years who survived an AMI in 1992 to 1993 were followed through 2005. The multivariable-adjusted hazard ratios (HRs) for mortality were 0.57 for never-smokers, 0.50 for pre-AMI quitters, and 0.63 for post-AMI quitters, compared with persistent smokers. Among persistent smokers, each reduction of 5 cigarettes smoked daily was associated with an 18% decline in mortality risk. Smoking cessation either before or after AMI is associated with improved survival, as is reducing the daily number of cigarettes smoked.

Treatment Implications of the JUPITER Trial.   Reanalysis of ARIC Data Confirms Elevated Cardiac Risk in Subjects With Elevated CRP, Low LDL-C
2388

Eric Y. Yang, Vijay Nambi, Zhengzheng Tang, Salim S. Virani, Eric Boerwinkle, Ron C. Hoogeveen, Brad C. Astor, Thomas H. Mosley, Josef Coresh, Lloyd Chambless, Christie M. Ballantyne

Rosuvastatin therapy was shown to reduce cardiovascular disease (CVD) events in men and women (50 and 60 years of age, respectively) with low-density lipoprotein cholesterol (LDL-C) <130 mg/dl and high-sensitivity C-reactive protein (hs-CRP) 2.0 mg/l without known CVD in the JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) trial. Yang and colleagues used data from the ARIC (Atherosclerosis Risk in Communities) study to estimate what percentage of the population would meet eligibility criteria as defined by the JUPITER trial and the cardiovascular risk in these patients. Of the nearly 9,000 appropriately-aged participants in the ARIC trial, 18% were "JUPITER-eligible." These subjects had an absolute CVD risk of 10.9% and an event rate of 1.57% per year, which was similar to the 1.36% per year in the placebo arm of the JUPITER trial. If JUPITER hazard ratios were applied to this group, the number needed to treat to prevent 1 CVD event would be 38 over 5 years and 26 over 6.9 years.

Atherosclerosis Markers and Physical Activity in Children.   Increased Physical Activity Improves BP in Pre-Pubertal Obese Children

2396

Nathalie J. Farpour-Lambert, Yacine Aggoun, Laetitia M. Marchand, Xavier E. Martin, François R. Herrmann, Maurice Beghetti

Farpour-Lambert and colleagues sought to determine the effects of physical activity on systemic blood pressure (BP) and early markers of atherosclerosis in pre-pubertal obese children. Subjects were randomized to 3 months of supervised, thrice-weekly exercise or to no intervention; all subjects then participated in supervised activity for an additional 3 months. Compared to lean control children, obese children had higher BP, arterial stiffness, insulin resistance indexes, and C-reactive protein levels and lower flow-mediated dilation, maximal oxygen consumption, and physical activity than lean subjects. After 3 months of exercise, 24-h systolic BP decreased by 7 mm Hg, and improvements were also seen in arterial stiffness and intima-media thickness. A regular physical activity program reduces BP and arterial stiffness and delays arterial wall remodeling in pre-pubertal obese children.

Editorial Comment: David S. Celermajer, p. 2407

Effectiveness of Cardiac Imaging.   Cost-Effectiveness and Clinical Utility of CCTA in Patients With Chest Pain
2409

Joseph A. Ladapo, Farouc A. Jaffer, Udo Hoffmann, Carey C. Thomson, Fabian Bamberg, William Dec, David M. Cutler, Milton C. Weinstein, G. Scott Gazelle

Ladapo and colleagues used published data to develop a computer simulation to predict clinical outcomes, health care costs, and cost-effectiveness of coronary computed tomography angiography (CCTA) compared with conventional testing modalities for a target population of 55-year-old patients with stable chest pain. All diagnostic strategies yielded similar health outcomes, but performing CCTA, with or without stress testing or performing stress single-photon emission computed tomography, marginally minimized adverse events and maximized longevity and quality-adjusted life-years (QALYs). CCTA raised overall costs, partly through the follow-up of incidental findings. When performed with stress testing, its incremental cost-effectiveness ratio ranged from $26,200 per QALY in men to $35,000 per QALY in women. These results suggest that CCTA is comparable to other diagnostic studies, but large randomized trials are needed.

News from the NCDR.   Significant Improvements in Door-to-Balloon Time
2423

Elizabeth H. Bradley, Brahmajee K. Nallamothu, Jeph Herrin, Henry H. Ting, Amy F. Stern, Ingrid M. Nembhard, Christina T. Yuan, Jeremy C. Green, Eva Kline-Rogers, Yongfei Wang, Jeptha P. Curtis, Tashonna R. Webster, Frederick A. Masoudi, Gregg C. Fonarow, John E. Brush, Jr, Harlan M. Krumholz

The objective of this report from the National Cardiovascular Data Registry was to determine if enrollment in the Door-to-Balloon (D2B) Alliance was associated with decreased D2B time for patients undergoing primary percutaneous coronary intervention (PPCI). By March 2008, >75% of patients had D2B times <90 min, compared with only about one-half of patients 3 years earlier. Patients treated in hospitals enrolled in the D2B Alliance were significantly more likely to have D2B times <90 min than were those treated in nonenrolled hospitals. The authors conclude that the D2B Alliance reached its goal of 75% of patients with ST-segment elevation myocardial infarction having D2B times within 90 min.

	Interventional Cardiology

Top Quarterly Focus Issue:... Interventional Cardiology Pre-Clinical Research

 
Interventional Cardiology.   Impella 2.5 Device May Be Useful for Supporting High-Risk PCI
2430

Krischan D. Sjauw, Thomas Konorza, Raimund Erbel, Paolo L. Danna, Maurizio Viecca, Hans-Heinrich Minden, Christian Butter, Thomas Engstrøm, Christian Hassager, Francisco P. Machado, Giovanni Pedrazzini, Daniel R. Wagner, Rainer Schamberger, Sebastian Kerber, Detlef G. Mathey, Joachim Schofer, Annemarie E. Engstrom, Jose P. S. Henriques

This retrospective multicenter registry evaluated the safety and feasibility of left ventricular (LV) support with the Impella 2.5 device (Abiomed Europe GmbH, Aachen, Germany) during high-risk percutaneous coronary intervention (PCI). The Impella 2.5 device is a percutaneous implantable LV assist device that can be placed retrogradely into the LV. The Europella registry included 144 consecutive patients in whom the device was used to support high-risk PCI. One-half of patients had a previous myocardial infarction, one-half had an LV ejection fraction 30%, almost one-half had been refused for coronary artery bypass grafting, and one-half were undergoing left main PCI. The mean assist time was 1 h 28 min, with a 30-day mortality of 5.5% and only 1 stroke within 30 days of the procedure. There were no device-related complications except for access site issues. This registry data supports the safety, feasibility, and potential usefulness of hemodynamic support with the Impella 2.5 device in patients undergoing high-risk PCI.

	Pre-Clinical Research

Top Quarterly Focus Issue:... Interventional Cardiology Pre-Clinical Research

 
Pre-Clinical Research.   Oral Everolimus Ameliorates Post-MI Remodeling

2435

Sebastian J. Buss, Sebastian Muenz, Johannes H. Riffel, Pratima Malekar, Marco Hagenmueller, Celine S. Weiss, Florian Bea, Raffi Bekeredjian, Martina Schinke-Braun, Seigo Izumo, Hugo A. Katus, Stefan E. Hardt

Buss and colleagues investigated whether inhibition of "mammalian target of rapamycin" (mTOR) could attenuate left ventricular remodeling following myocardial infarction (MI) in a rat model because mTOR-dependent signaling mechanisms appear to be involved in the remodeling processes. Everolimus (RAD) treatment was initiated after induction of MI by left anterior descending coronary artery ligation. After 28 days, RAD-treated animals had improved left ventricular function and smaller left ventricular volumes. By histology, infarct size was significantly reduced, and there was decreased proteasome activity in the border zone of the infarcted myocardium. Inhibition of mTOR is a potential therapeutic strategy to limit infarct size and to attenuate adverse left ventricular remodeling following MI.

Related Articles

The Year in Epidemiology, Health Services Research, and Outcomes Research

Mark A. Hlatky and Paul Heidenreich
J. Am. Coll. Cardiol. 2009 54: 2343-2351. [Full Text] [PDF]

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