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1.  Trends in Major Entry Site Complications from Percutaneous Coronary Intervention (From the Dynamic Registry) 
The American journal of cardiology  2013;113(4):626-630.
Several factors contribute to the risk of percutaneous coronary intervention (PCI) related major entry site complications (MES). We sought to examine the trends in MES among unselected patients during the stent era. Data from the Dynamic Registry including five distinct recruitment waves from 1997 to 2006 (N=10,932) were used to assess baseline characteristics and MES among consecutive patients undergoing PCI. MES was defined as bleeding requiring transfusion, pseudoaneurysm, arterial thrombosis or dissection, vascular complication requiring surgery, or retroperitoneal bleed. Uncomplicated hematomas were not included. Several trends were observed in baseline characteristics including an increase from wave 1 to wave 5 in BMI >30 kg/m2 (30.2% to 40.4%), renal disease (3.5% to 9.1%), diabetes (28.0% to 34.1%), and hypertension (59.4% to 78%) (ptrend <0.001 for all). Use of a thienopyridine increased significantly from wave 1 (49.7%) to wave 5 (84%) whereas glycoprotein (GP) IIbIIIa inhibitor use peaked in wave 3 (53.1%) and then decreased (p<0.001). Access site was predominately femoral but radial access increased over time (0.3% wave 1, 6.6% wave 5) (p=<.0001). The rates of MES (2.8% to 2.2%, ptrend =0.01) and MES requiring transfusion (2.0% to 0.74%, ptrend <0.001) were low and decreased with time. The trend in lower risk for MES in later time periods remained after adjustment. In conclusion, MES has decreased over time however opportunity for bleeding avoidance strategies still exists.
doi:10.1016/j.amjcard.2013.11.005
PMCID: PMC3946580  PMID: 24355309
percutaneous coronary intervention; complications; bleeding; arterial access
2.  Five-year Follow-up of Patients Treated for Coronary Artery Disease in the Face of an Increasing Burden of Co-morbidity and Disease Complexity (From the NHLBI Dynamic Registry) 
The American journal of cardiology  2013;113(4):573-579.
Management of coronary artery disease (CAD) has evolved over the past decade, but there are few prospective studies evaluating long-term outcomes in a real-world setting of evolving technical approaches and secondary prevention. The aim of this study was to determine how the mortality and morbidity of coronary artery disease has changed in patients who have undergone percutaneous coronary intervention (PCI), in the setting of co-morbidities and evolving management. The National Heart, Lung, and Blood Institute Dynamic Registry was a cohort study of patients undergoing PCI at various time points. Cohorts were enrolled in 1999 (cohort 2, n=2105), 2004 (cohort 4, n=2112), and 2006 (cohort 5, n= 2176), and each was followed out to 5 years. Primary outcomes were death, myocardial infarction (MI), coronary artery bypass grafting (CABG), repeat PCI, and repeat revascularization. Secondary outcomes were PCI for new obstructive lesions at 5 years, 5-year rate of death and MI stratified by the severity of coronary artery and co-morbid disease. Over time, patients were more likely to have multiple co-morbidities and more severe CAD. Despite greater disease severity, there was no significant difference in death (16.5% vs. 17.6%, adjusted hazard ratio (HR) 0.89 (0.74–1.08)), MI (11.0% vs. 10.6%, adjusted HR 0.87 (0.70–1.08)), or repeat PCI (20.4% vs. 22.2%, adjusted HR 0.98 (0.85–1.17)) at 5-year follow-up, but there was a significant decline inCABG (9.1% vs. 4.3%, adjusted HR 0.44 (0.32–0.59)). Patients with 5 co-morbidities had a 40–60% death rate at 5 years. There was a modestly high rate of repeat PCI for new lesions, indicating a potential failure of secondary prevention for this population in the face of increasing co-morbidity. Overall 5-year rates of death, MI, repeat PCI, and repeat PCI for new lesions did not change significantly in the context of increased co-morbidities and complex disease.
doi:10.1016/j.amjcard.2013.10.039
PMCID: PMC3946649  PMID: 24388624
coronary artery disease; percutaneous coronary intervention; outcomes
3.  Benefit of Long-Term Dual Anti-Platelet Therapy in Patients Treated with Drug-Eluting Stents: From the NHLBI Dynamic Registry 
The American journal of cardiology  2012;111(4):486-492.
The optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is an important, unanswered question. This study was designed to evaluate the association of varying durations of DAPT on clinical outcomes after DES implantation for the treatment of coronary artery disease. Using the National Heart, Lung and Blood Institute (NHLBI) Dynamic Registry, patients enrolled in the last two waves after index percutaneous coronary intervention (PCI) with DES and who were event free at time of landmark analysis were included. Landmark analysis was performed at 12 and 24 months after PCI and patients stratified according to continued use of DAPT or not. Subjects were evaluated for rates of death, myocardial infarction (MI) and stent thrombosis (ST) at 4 years from their index procedure. The number of evaluable patients was 2157 and 1918 for the 12- and 24-month landmarks, respectively. In both landmark analyses, there was a significantly lower 4-year rate of death/MI in the group that continued DAPT compared to the group that did not (12-month: 10.5% vs. 14.5%, p=0.01; 24-month: 5.7% vs. 8.6%, p=0.02). Beneficial differences in the group that continued on DAPT were preserved after multivariate and propensity adjustment. There were no significant differences in definite stent thrombosis in either landmark analysis. In conclusion, at 12-months and 24-months following DES implantation, continued use of DAPT, was associated with lower 4-year risk of death and myocardial infarction.
doi:10.1016/j.amjcard.2012.10.030
PMCID: PMC3579582  PMID: 23211356
Coronary disease; Stents; Mortality; Thrombosis
4.  Outcomes of Small Coronary Artery Stenting with Bare-Metal Stents vs. Drug-Eluting Stents: Results from the NHLBI Dynamic Registry 
Objectives
Examine one year outcomes of patients with small coronary arteries in the National Heart, Lung and Blood Institute Dynamic Registry (NHLBI) undergoing drug-eluting stent (DES) vs. bare-metal stent (BMS) placement.
Background
While randomized trials of DES vs. BMS demonstrate reduced target vessel revascularization, it is unclear if similar outcomes are seen in unselected patients after percutaneous coronary intervention (PCI) for small coronary arteries.
Methods
Utilizing patients from the NHLBI Registry Waves 1–3 for BMS (1997–2002) and Waves 4–5 for DES (2004 and 2006), demographic, angiographic, in-hospital and one-year outcome data of patients with small coronary arteries treated with BMS (n= 686) vs. DES (n= 669) were evaluated. Small coronary artery was defined as 2.50 – 3.00 mm in diameter.
Results
Compared to BMS-treated patients, the mean lesion length of treated lesions was longer in the DES treated group (16.7 vs. 13.1 mm, p<0.001) and the mean reference vessel size of attempted lesions was smaller (2.6 vs. 2.7 mm, p<0.001). Adjusted analyses of one year outcomes revealed that DES patients were at lower risk to undergo coronary artery bypass graft surgery (Hazard Ratio [HR] 0.40, 95% Confidence Interval [CI] 0.17–0.95, p=0.04), repeat PCI (HR 0.53, 95% CI 0.35–0.82, p=0.004), and experience the combined major adverse cardiovascular event rate (HR 0.59, 95% CI 0.42–0.83, p=0.002). There was no difference in the risk of death and myocardial infarction (MI) (HR 0.78, 95% CI 0.46–1.35, p=0.38).
Conclusions
In this real-world registry, patients with small coronary arteries treated with DES had significantly lower rates of repeat revascularization and major adverse cardiovascular events at one year compared to patients treated with BMS, with no increase in the risk of death and MI. These data confirm the efficacy and safety of DES over BMS in the treatment of small coronary arteries in routine clinical practice.
doi:10.1002/ccd.23194
PMCID: PMC3193907  PMID: 21735515
Coronary Disease; Stents; Restenosis
5.  Adding Chemoprophylaxis to Sequential Compression May Not Reduce the Risk of Venous Thromboembolism in Bariatric Surgery Patients 
Background
Anticoagulation, the use of sequential compression devices on lower extremities peri-operatively, and early ambulation are thought to reduce venous thromboembolism (VTE) postoperatively and are recommended to reduce VTE risk. However, the evidence upon which this recommendation is based is not particularly strong. We demonstrate that even a large, multi-center cohort with carefully collected prospective data is inadequate to provide sufficient evidence to support, or refute, this recommendation.
Methods
The Longitudinal Assessment of Bariatric Surgery (LABS) participants from 10 centers in the United States who underwent their first bariatric surgery between March, 2005 and December, 2007 comprise the study group. We examined the ability to address the question of whether anti-coagulation therapy, in addition to sequential compression, reduces the 30 day incidence of VTE or death sufficiently to recommend the use of prophylactic anticoagulation, a therapy that is not without risk.
Results
Of 4416 patients, 396 (9.0%) received sequential compression alone, while the others also received anticoagulation therapy. The incidence of VTE within 30 days of surgery was small (0.25% among those receiving sequential compression alone, 0.47% when anticoagulation therapy was added), and the 30 days incidence of death was also small (0.25% vs. 0.34%, p = 0.76, for sequential compression alone vs. sequential compression plus anticoagulation therapy). Estimates of the number of cases required to address the question of whether there is a difference in outcome related to VTE chemoprophylaxis, or whether the outcome rates are equivalent, range from 13,680 to at least 35,760 patients, depending upon whether superiority or equivalence is being analyzed.
Conclusion
Sufficient evidence from a clinical trial study to determine whether prophylactic anticoagulation added to compression devices further prevents VTEs is not available and such a trial is likely to be impractical. The data presented are insufficient to make a final recommendation concerning prophylactic treatment to prevent VTE in the 30 days following bariatric surgery.
doi:10.1016/j.soard.2012.07.008
PMCID: PMC3498574  PMID: 22963819
bariatric surgery; thromboembolism; pulmonary emboli; chemoprophylaxis; deep vein thrombosis; sequential compression
6.  Clinical Presentation and Predictors of Target Vessel Revascularization after Drug-Eluting Stent Implantation 
Background
Drug eluting stent (DES) failure including restenosis and stent thrombosis, or disease progression may result in target vessel revascularization (TVR) but the relative contribution of these mechanisms in the DES era is not well described. We sought to examine the predictors and presentations of patients with clinically driven TVR after DES.
Methods
Patients with all lesions treated with a DES in the Dynamic Registry from 2004 to 2006 were analyzed. Included were 2691 patients with 3401 lesions. Patients with and without incident clinically driven TVR at 2 years were compared according to baseline clinical, procedural, and angiographic characteristics and independent predictors of TVR and target lesion revascularization (TLR) were determined by multivariate analysis.
Results
By 2-years, TVR occurred in 7.2% of patients and TLR in 3.8%, with 71.6% and 82.5% of repeat revascularization events occurring in the first year, respectively. The indication for first TVR was myocardial infarction in 18.6 % (n=34), unstable angina in 42.6 % (n=78), stable coronary disease in 25.7% (n=47) and other/unknown 13.1% (n=24). Disease progression was responsible for 47% of TVR. Among patients with TLR, restenosis was the mechanism in 86.6% and stent thrombosis in 13.4%. Independent predictors of TVR included younger age, diabetes, attempted graft lesion, lesion length >30mm and prior lesion intervention. Independent predictors of TVR and TLR were similar.
Conclusion
The incidence of clinically driven TVR is low in patients treated with DES and nearly half is attributable to disease progression, which along with the low rate of in-stent restenosis explains why the mode of presentation is often an acute coronary syndrome.
doi:10.1016/j.carrev.2012.10.003
PMCID: PMC3504351  PMID: 23164476
Predictors; revascularization; restenosis; stent thrombosis
7.  Psychopathology Prior to Surgery in the Longitudinal Assessment of Bariatric Surgery-3 (LABS-3) Psychosocial Study 
Background
Current and prior psychopathology in bariatric surgery candidates is believed to be common. Accurate prevalence estimates, however, are difficult to obtain given that bariatric surgery candidates often wish to appear psychiatrically healthy when they are undergoing psychiatric evaluation prior to being approved for the surgery. Also, structured diagnostic assessments have been utilized infrequently.
Methods
This report concerns the 199 patients who were enrolled in the Longitudinal Assessment of Bariatric Surgery (LABS) study who also participated in the LABS-3 Psychopathology sub-study. All were interviewed independent of the usual preoperative psychosocial evaluation process. Patients were explicitly told that the data would not be shared with the surgical team unless certain high risk behaviors such as suicidality that could lead to adverse peri-operative outcomes were reported.
Results
The majority of the sample was female (82.9%) and Caucasian (non-white 7.6%, Hispanic 5.0%). The median age was 46.0 years with a median body mass index (BMI) of 44.9 kg/m2; 33.7% had at least one current Axis I disorder and 68.8% at least one lifetime Axis I disorder. Of note, 38.7% had a lifetime history of major depressive disorder, and 33.2% had a lifetime diagnosis of alcohol abuse or dependence, all much higher than population-based prevalence rates obtained for this age group in the National Comorbidity Survey--Replication Study. With respect to binge eating disorder, 13.1% had a lifetime diagnosis, while 10.1% had a current diagnosis.
Conclusion
Current and lifetime rates of psychopathology are high in bariatric surgery candidates, and lifetime rates of affective disorder and alcohol use disorders are particularly prominent. Binge eating disorder is present in approximately 1 in 10 bariatric surgery candidates.
doi:10.1016/j.soard.2012.07.001
PMCID: PMC3584713  PMID: 22920965
Psychopathology; Eating Disorders; Binge Eating Disorder
8.  Vasomotor Symptoms and Lipid Profiles in Women Transitioning Through Menopause 
Obstetrics and Gynecology  2012;119(4):753-761.
Objective
To examine associations between vasomotor symptoms and lipids over 8 years, controlling for other cardiovascular risk factors, estradiol (E2) and follicle-stimulating hormone (FSH).
Methods
Study of Women’s Health Across the Nation participants (N=3201), aged 42–52 at entry, completed interviews on frequency of hot flushes and night sweats (none, 1–5 days, 6 days or more, in the past 2 weeks) physical measures (blood pressure, height, weight), and blood draws (low-density lipoprotein [LDL], high-density lipoprotein [HDL], apolipoproteinA-1, apolipoprotein B [apoB], lipoprotein(a), trigycerides, serum E2, FSH) yearly for 8 years. Relations between symptoms and lipids were examined in linear mixed models adjusting for cardiovascular risk factors, medications, and hormones.
Results
Compared to no flushes, experiencing hot flushes was associated with significantly higher LDL [1–5 days: beta (β) (standard error (SE)) =1.48(.47), p<0.01; 6 days or more: β(SE)=2.13(.62), p<.001], HDL [1–5 days: β(SE)=.30(.18),; 6 days or more: β(SE)=.77(.24), p<.01], apolipoproteinA-1 [1–5 days: β(SE)=.92(.47), p<.10; 6 days or more: β(SE)=1.97(.62), p<.01], apolipoproteinB [1–5 days: β(SE)=1.41(.41), p<.001; 6 days or more: β(SE)=2.51(.54), p<.001], and triglycerides [1–5 days: percent change(95%CI)=2.91(1.41–4.43), p<.001; 6 days or more: percent change(95%CI)=5.90(3.86–7.97), p<.001] in multivariable models. Findings largely persisted adjusting for hormones. Estimated mean differences between hot flashes 6 days or more compared with no days ranged from less than 1 (HDL) to 10 mg/dL (triglycerides). Night sweats were similar. Associations were strongest for lean women.
Conclusions
Vasomotor symptoms were associated with higher LDL, HDL, apolipoproteinA-1, apolipoproteinB, and triglycerides. Lipids should be considered in links between hot flushes and cardiovascular risk.
doi:10.1097/AOG.0b013e31824a09ec
PMCID: PMC3343636  PMID: 22433339
9.  Comparison of Bare Metal and Drug-Eluting Stents in Patients with Chronic Kidney Disease (From the NHLBI Dynamic Registry) 
The American journal of cardiology  2011;108(11):1658-1664.
Patients with chronic kidney disease (CKD) have a disproportionate burden of coronary artery disease and commonly undergo revascularization. The role and safety of percutaneous coronary intervention (PCI) using drug eluting stents (DES) verses bare metal stents (BMS) in CKD patients not on renal replacement therapy has not been fully evaluated. This study investigated the efficacy and safety of DES in patients with CKD not on renal replacement therapy. Patients where drawn from the National Heart, Lung, and Blood Institute Dynamic Registry and were stratified by renal function based on estimated glomerular filtration rate (GFR). Of the 4157 participants, 1108 had CKD (“low-GFR” <60 ml/min/1.73m2), while 3049 patients had normal renal function (“normal-GFR”≥60 ml/min/1.73m2). For each strata of renal function, we compared the risk of death, myocardial infarction (MI), or repeat revascularization between subjects who received DES and BMS at the index procedure. Patients with low-GFR had higher one-year rates of death and MI and a decreased rate of repeat revascularization when compared to patients with a normal-GFR. The use of DES was associated with a decreased need for repeat revascularization in the normal-GFR group (adjusted hazard ratio [HR] 0.63, 95% CI 0.50–0.79, p<0.001) but not in the low-GFR group (HR 0.69, 95% CI 0.45–1.06, p=0.09). The risks of death and MI were not different between the two stents in either patient population. In conclusion, the presence of CKD predicted poor outcomes after PCI with high rates of mortality regardless of stent type. The effect of DES in reducing repeat revascularization appeared to be attenuated in these patients.
doi:10.1016/j.amjcard.2011.07.029
PMCID: PMC3215900  PMID: 21890077
Drug-eluting; Bare metal; Stents; Renal dysfunction
10.  Incidence and Predictors of 30-Day Hospital Re-Admission Rate Following Percutaneous Coronary Intervention (From the National Heart, Lung, and Blood Institute Dynamic Registry) 
The American journal of cardiology  2012;110(10):1389-1396.
Post-discharge outcomes following percutaneous coronary intervention (PCI) are important measures of quality of care and complement in-hospital measures. We sought to assess in-hospital and post-discharge PCI outcomes to 1) better understand the relationship between acute and 30 day outcomes, 2) identify predictors of 30-day hospital re-admission, and 3) determine the prognostic significance of 30-day hospital readmission. We analyzed in-hospital death and length of stay (LOS) and non-elective cardiac-related re-hospitalization following discharge in 10,965 patients following PCI in the Dynamic Registry. From 1999–2006, in-hospital death rate and LOS declined. The 30-day cardiac re-admission rate was 4.6%, with considerable variability over time and among hospitals. The risk of re-hospitalization was greater in women, those with CHF, unstable angina, multiple lesions and emergency PCI. Conversely, a lower risk of re-hospitalization was associated with a higher number of treated lesions. Patients re-admitted within 30 days had higher one-year mortality than those free from hospital readmission. In conclusion, while in-hospital mortality and LOS following PCI have decreased over time, the observed 30 day cardiac re-admission rate was highly variable and the risk of re-admission was more closely associated with underlying patient characteristics than procedural characteristics.
doi:10.1016/j.amjcard.2012.07.002
PMCID: PMC3483468  PMID: 22853982
percutaneous coronary intervention; outcomes; re-admission
11.  Comparison of Bare-Metal Stents and Drug-Eluting Stents in Coronary Ostial Lesions (from the National Heart, Lung, and Blood Institute Dynamic Registry) 
The American journal of cardiology  2012;110(8):1113-1118.
We compared the effectiveness of drug-eluting stents (DESs) to bare-metal stents (BMSs) in ostial lesions from an unrestricted patient cohort with 3-year follow-up. DESs have proved more effective at decreasing repeat revascularization rates compared to BMSs in patients with uncomplicated coronary artery disease. Whether DESs provide similar benefits in ostial lesions is not clearly defined. We analyzed data from 775 patients in the National, Heart, Lung, and Blood Institute Dynamic Registry undergoing stenting of ostial lesions with DESs or BMSs. Patients were followed for 3 years for the occurrence of myocardial infarction (MI), repeat revascularization (coronary bypass surgery/repeat percutaneous coronary intervention), and death. In total 439 patients had 464 ostial lesions treated with BMSs and 336 patients had 351 ostial lesions treated with DESs. Adjusted DES versus BMS 3-year hazard ratios were 1.03 (95% confidence interval 0.60 to 1.78, p = 0.90) for death, 1.40 (0.83 to 2.37, p = 0.21) for MI, and 0.81 (0.59 to 1.11, p = 0.19) for repeat revascularization. In patients undergoing percutaneous coronary intervention for aorto-ostial disease (n = 200), death and repeat revascularization did not differ between stent types, but DES-treated patients had more MI during follow-up. For coronary ostial disease (n = 574), 3-year observed rates of death or MI did not differ; however, repeat revascularization was more common in the BMS group. In conclusion, use of DESs for ostial lesions was associated with no difference in the hazard of death, MI, or overall rates of repeat revascularization compared to BMS use.
doi:10.1016/j.amjcard.2012.05.051
PMCID: PMC3462272  PMID: 22762712
12.  Are Vasomotor Symptoms Associated with Alterations in Hemostatic and Inflammatory Markers? Findings from the Study of Women’s Health Across the Nation 
Menopause (New York, N.Y.)  2011;18(10):1044-1051.
Objective
Emerging research suggests links between menopausal hot flashes and cardiovascular risk. The mechanisms underlying these associations are unclear, due in part to the incomplete understanding of the physiology of hot flashes. We aimed to examine the longitudinal associations between hot flashes/night sweats and both inflammatory and hemostatic markers, controlling for cardiovascular risk factors and estradiol concentrations.
Methods
Participants in the Study of Women’s Health Across the Nation (SWAN) (N=3199), a longitudinal cohort study, were ages 42–52 years at cohort entry. Women completed interviews (hot flashes, night sweats: none, 1–5, 6 days in past 2 weeks), physical measures (blood pressure; height; weight), and a blood draw (C-reactive protein, high sensitivity; plasminogen activator inhibitor-1; Factor VIIc, tissue plasminogen activator antigen (tPA-ag); fibrinogen; glucose; serum estradiol) yearly for 8 years. Hot flashes/night sweats were examined in relation to each inflammatory/hemostatic marker in linear mixed models adjusting for demographic factors, cardiovascular risk factors, and medication use, and additionally serum estradiol.
Results
Compared to experiencing no flashes, reporting hot flashes was associated with higher tPA-aglog (hot flashes 1–5 days: % change (95%CI): 3.88(2.22–5.58), p<0.0001; ≥6 days: % change (95%CI): 4.11(1.95–6.32), p<0.001) and higher Factor VIIclog (hot flashes ≥6 days: % change (95%CI): 2.13(0.80–3.47), p<0.01) in multivariable models. Findings persisted after adjusting for estradiol. Findings for night sweats were similar but attenuated with adjustment.
Conclusions
Frequent hot flashes were associated with higher Factor VIIc and tPA-ag. Hemostatic pathways may be relevant to understanding hot flashes physiology and links between hot flashes and cardiovascular risk.
doi:10.1097/gme.0b013e31821f5d39
PMCID: PMC3183159  PMID: 21926929
Menopause; vasomotor symptoms; hot flashes; inflammation; coagulation; hemostasis
13.  Risk of Death and Myocardial Infarction in Patients with Peripheral Arterial Disease Undergoing Percutaneous Coronary Intervention: From the National Heart, Lung and Blood Institute Dynamic Registry 
The American journal of cardiology  2011;107(7):959-964.
Patients with peripheral arterial disease (PAD) undergoing percutaneous coronary intervention (PCI) are at high risk for adverse cardiovascular events. Trends over time in outcomes with advances in PCI and medical therapy are unknown. We evaluated 866 patients with PAD in the National Heart, Lung, and Blood Institute (NHLBI) Dynamic Registry undergoing PCI according to treatment eras: the early bare metal stent (BMS) era (Wave 1: 1997-1998, n=180), the BMS era (Waves 2 and 3; 1999 and 2001-2002; n=339), and the drug-eluting stent (DES) era (Waves 4 and 5: 2004 and 2006; n=347). We compared in-hospital and 1-year outcomes by recruitment era. In-hospital coronary artery bypass graft surgery (CABG) rates were significantly lower in the later eras (3.9%, 0.9%, 0.6%, early BMS, BMS, and DES eras respectively, ptrend=0.005), and an increasing percentage of patients were discharged on aspirin, beta blockers, statins, and thienopyridines (all ptrend<0.001). Cumulative 1-year event rates in patients with PAD in the early BMS era, BMS era, and DES era of death were 13.7%, 10.5%, and 9.8% (ptrend = 0.21), of myocardial infarction (MI) were 9.8%, 8.8%, and 10.0% (ptrend = 0.95), and repeat revascularization were 26.8%, 21.0%, and 17.2% (ptrend = 0.008). The 1-year adjusted hazard ratios (HR) of adverse events in patients with PAD using the early BMS era as the reference are as follows: Death: BMS era HR=0.84 (95% CI 0.46-1.55, p=0.58) and DES era HR=1.35 (95% CI 0.71-2.56, p=0.36); MI: BMS era HR=0.89 (95% CI 0.48-1.66, p=0.72) and DES era HR=1.02 (95% CI 0.55-1.87, p=0.95); and repeat revascularization: BMS era HR=0.63 (95% CI 0.41-0.97, p=0.04) and DES era HR=0.46 (95% CI 0.29-0.73, p=0.001). In conclusion, despite significant improvements in medical therapy and a reduction in repeat revascularization over time, patients with PAD who undergo PCI have a persistent high rate of death and MI.
doi:10.1016/j.amjcard.2010.11.019
PMCID: PMC3071613  PMID: 21256469
Peripheral arterial disease; stents; catheterization
14.  Comparison in Three Age Groups Regarding the Safety and Efficacy of Drug-Eluting Stents (From the National Heart, Lung and Blood Institute Dynamic Registry) 
The American Journal of Cardiology  2011;109(2):195-201.
Limited data exist regarding DES versus BMS use in older patients. From the NHLBI Dynamic Registry 5089 percutaneous coronary intervention (PCI) treated patients were studied (October 2001–August 2006). Differences in one-year safety (death, myocardial infarction [MI] and their composite) and efficacy (target vessel revascularization [TVR] with PCI and repeat revascularization) outcomes were compared between patients who received DES versus BMS within each age group: <65 years (n=2680); 65–79 years (n= 1942); ≥80 years (n=443). There were no differences in safety outcomes by stent type in any age group at one-year. As for effectiveness, lower rates of TVR with PCI and repeat revascularization were observed in DES patients across all age groups. After propensity adjusted analysis, the risk of TVR with PCI and repeat revascularization favored DES versus BMS with patients < 65 years (7.4% vs. 14.6%; HR=0.44; 95% CI 0.32–0.60, 12.3% vs. 17.4%; HR=0.65; 95% CI 0.51–0.84) 65–79 years (4.8% vs. 9.5%; HR=0.50; 95% CI 0.31–0.80, 7.6% vs. 12.3%; HR=0.62; 95% CI 0.44–0.88) and ≥ 80 years (4.5% vs. 10.4%; HR=0.15; 95% CI 0.05–0.44, 6.0% vs. 14.5%, HR=0.18, 95% CI 0.08–0.40). In conclusion, significant reductions in TVR with PCI and repeat revascularization were noted in all three age groups without increases in death or MI in this large multi-center PCI registry. Our data support the use of DES regardless of age.
doi:10.1016/j.amjcard.2011.08.028
PMCID: PMC3259254  PMID: 22000774
Drug-eluting stents; elderly; age; clinical outcomes
15.  Percutaneous Coronary Intervention of Moderate to Severe Calcified Coronary Lesions: Insights from the National Heart, Lung and Blood Institute Dynamic Registry 
Objectives
To evaluate the efficacy and safety of drug-eluting stents (DES) when compared with bare metal stents (BMS) in patients with moderate to severe calcified coronary lesions.
Background
Calcified coronary lesions present unique technical challenges during percutaneous coronary intervention (PCI) and it is not known if drug eluting stents (DES) are as safe and as effective in the presence of calcium, as randomized trials typically exclude this common patient subset.
Methods
We evaluated patients with PCI of a single calcified lesion enrolled across five recruitment waves in the NHLBI Dynamic Registry between 1997 and 2006. Patients were divided into two groups based on the stent type- BMS and DES. The primary efficacy outcome was the need for repeat revascularization at 1 year and the primary safety outcome was a composite of death and myocardial infarction at 1 year.
Results
Among the 1537 patients included in the analysis, 884 (57%) underwent PCI with BMS and 653 (43%) with DES. DES use was associated with a significant reduction in the risk of repeat revascularization (10.0% vs. 15.3%; p = 0.003) with no significant higher risk of primary safety outcome (9.3% vs. 10.5%; p = 0.45) when compared to the BMS group. In a propensity score adjusted analysis, DES use was associated with a significantly lower risk in repeat revascularization (HR = 0.57, 95% CI 0.40-0.82; p = 0.002) and no significant difference in the risk of death and myocardial infarction (HR = 0.78; 95% 0.53-1.15; p = 0.20) compared to BMS group.
Conclusion
In this large multicenter registry of patients with a moderate to severe calcified coronary lesion, use of DES compared to BMS was associated with significant reduction in the risk of repeat revascularization without any increase in death and myocardial infarction.
doi:10.1002/ccd.22613
PMCID: PMC2939153  PMID: 20506328
calcified lesion; percutaneous coronary intervention; stents
16.  Beneficial effects of statins after percutaneous coronary intervention 
Background
Evidence about the efficacy of statin treatment among patients after percutaneous coronary intervention (PCI) is very limited. The rapid advancement in PCI technology and near universal use of adjunctive cardioprotective medications make it necessary to formally assess the effect of statin therapy on cardiac events after PCI.
Design
This was a multicenter prospective cohort study
Methods
Patients who received stent implantation and survived to hospital discharge from the National Heart, Lung, and Blood Institute Dynamic Registry from 2004 to 2006 formed the study cohort. Patients with cardiogenic shock, in-hospital adverse events [including myocardial infarction and coronary artery bypass graft surgery (CABG)], liver disease, renal disease, alcoholism, or drug abuse were excluded. The occurrences of death, CABG, and repeat PCI, and repeat revascularization were collected over 1-year follow-up.
Results
Of the 3227 patients evaluated, 2737 (85%) were prescribed a statin at discharge. By 1-year follow-up, incident events were 98 deaths, 44 CABG, 290 repeat PCI procedures, and 328 repeat revascularizations. After propensity score adjustment, postdischarge statin therapy was associated with lower risks of death [hazard ratio (HR)λ=λ0.58, 95% confidence interval (CI): 0.36–0.93, Pλ=λ0.02], CABG (HRλ=λ0.49, 95% CI: 0.24–1.00, Pλ=λ0.05), and repeat revascularization (HRλ=λ0.74, 95% CI: 0.56–1.00, Pλ=λ0.05).
Conclusion
These results support the routine use of statin therapy after PCI.
doi:10.1097/HJR.0b013e32832a4e3b
PMCID: PMC3219755  PMID: 19369875
mortality; propensity score; repeat revascularization; stent
17.  Differential effects of post-dilation after stent deployment in patients presenting with and without acute myocardial infarction 
American heart journal  2010;160(5):979-986.e1.
Background
In the practice of percutaneous coronary intervention (PCI), post-dilatation often is performed after stent deployment to improve stent expansion. However, aggressive mechanical expansion is a risk factor of distal embolization and microvascular injury, especially for patients with acute myocardial infarction (AMI). Few studies have investigated the effects of post-dilatation on medium-term clinical outcomes.
Methods and Results
Patients enrolled in the multicenter NHLBI Dynamic Registry between 2001 and 2006 were evaluated. Patients who were treated with ≥1 stent were studied. Patients with cardiogenic shock or history of coronary artery bypass graft surgery were excluded. Patients were followed up to 1 year. Because of the significant statistical interaction (P = .02) between post-dilatation and AMI status on the hazard of death/myocardial infarction (MI), post-dilatation effects were estimated separately for patients who did and did not present with an AMI. Among the 1,358 patients who presented with an AMI, post-dilatation was associated with a significantly higher risk of death/MI (hazard ratio [HR] = 1.78, 95% CI 1.12-2.83, P = .01), not associated with the risk of repeat revascularization (HR = 1.15, 95% CI 0.81-1.62, P = .43). Among the 2,699 patients who did not present with AMI, post-dilatation was not associated with risks of death/MI (HR = 1.08, 95% CI 0.77-1.50, P = .67) or repeat revascularization (HR = 1.17, 95% CI 0.93-1.47, P = .19). Similar effects were observed for the restricted analysis with additional adjustment for lesion characteristics among the 1,039 AMI patients and 2,179 non-AMI patients with a single lesion treated.
Conclusions
Stent post-dilatation is associated with an increased risk of death/MI in AMI patients but not in non-AMI patients. Further investigation is warranted.
doi:10.1016/j.ahj.2010.07.007
PMCID: PMC3003443  PMID: 21095289
18.  Evolution of Percutaneous Coronary Intervention in Patients with Diabetes 
Diabetes Care  2010;33(9):1976-1982.
OBJECTIVE
To evaluate the association of successive percutaneous coronary intervention (PCI) modalities with balloon angioplasty (BA), bare-metal stent (BMS), drug-eluting stents (DES), and pharmacotherapy over the last 3 decades with outcomes among patients with diabetes in routine clinical practice.
RESEARCH DESIGN AND METHODS
We examined outcomes in 1,846 patients with diabetes undergoing de novo PCI in the multicenter, National Heart, Lung, and Blood Institute–sponsored 1985–1986 Percutaneous Transluminal Coronary Angioplasty (PTCA) Registry and 1997–2006 Dynamic Registry. Multivariable Cox regression models were used to estimate the adjusted risk of events (death/myocardial infarction [MI], repeat revascularization) over 1 year.
RESULTS
Cumulative event rates for postdischarge (31–365 days) death/MI were 8% by BA, 7% by BMS, and 7% by DES use (P = 0.76) and for repeat revascularization were 19, 13, and 9% (P < 0.001), respectively. Multivariable analysis showed a significantly lower risk of repeat revascularization with DES use when compared with the use of BA (hazard ratio [HR] 0.41 [95% CI 0.29–0.58]) and BMS (HR 0.55 [95% CI 0.39–0.76]). After further adjustment for discharge medications, the lower risk for death/MI was not statistically significant for DES when compared with BA.
CONCLUSIONS
In patients with diabetes undergoing PCI, the use of DES is associated with a reduced need for repeat revascularization when compared with BA or BMS use. The associated death/MI benefit observed with the DES versus the BA group may well be due to greater use of pharmacotherapy.
doi:10.2337/dc10-0247
PMCID: PMC2928347  PMID: 20519661
19.  Temporal Changes in the Outcomes of Patients with Diabetes Mellitus Undergoing PCI in the NHLBI Dynamic Registry 
American heart journal  2011;161(2):367-403.e1.
Background
Patients with diabetes mellitus (DM) are at higher risk for adverse outcomes following percutaneous coronary intervention (PCI).
Methods
To determine whether outcomes have improved over time, we analyzed data from 2838 consecutive patients with medically-treated DM, including 1066 patients (37.6%) treated with insulin, in the National Heart Lung and Blood Institute Dynamic Registry undergoing PCI registered in Waves 1(1997–98), 2 (1999), 3 (2001–02), 4 (2004) and 5 (2006). We compared baseline demographics and 1-year outcomes in the overall cohort, and in analyses stratified by recruitment wave and insulin use.
Results
Crude mortality rates among those treated with insulin by chronological Wave were 9.5%, 12.5%, 8.9%, 11.6%, and 6.6% (p-valuetrend=0.33); and respectively, among patients treated by oral agents:9.7%, 6.5%, 4. 1%, 5.4%, and 4.7%, (p-valuetrend=0.006). The adjusted hazard ratios of death, myocardial infarction (MI), and overall major adverse cardiovascular events (death, MI, revascularization) in insulin treated patients with DM in waves 2–5 as compared to wave 1 were either higher or the same. In contrast, the similar adjusted hazard ratios for oral agent treated patients with DM were either similar or lower.
Conclusions
Significant improvements over time in adverse events by 1-year were detected in patients with DM treated with oral agents. In insulin-treated diabetic patients, despite lower rates of repeat revascularization over time, death and MI following PCI have not significantly improved. These findings underscore the need for continued efforts at optimizing outcomes among patients with DM undergoing PCI, especially those requiring insulin treatment.
doi:10.1016/j.ahj.2010.11.004
PMCID: PMC3073309  PMID: 21315221
20.  Temporal trends in patient-reported angina at one year following percutaneous revascularization in the stent era: a report from the NHLBI-sponsored 1997–2006 Dynamic Registry 
Background
Percutaneous coronary intervention (PCI) has witnessed rapid technological advancements resulting in improved safety and effectiveness over time. Little, however, is known about the temporal impact on patient-reported symptoms and quality of life following PCI.
Methods and Results
Temporal trends in post-PCI symptoms were analyzed using 8879 consecutive patients enrolled in the National Heart, Lung and Blood Institute-sponsored Dynamic Registry (wave 1: 1997(bare metal stents), wave 2: 1999 (uniform use of stents), wave 3: 2001 (brachytherapy), wave 4, 5: 2004, 2006 (drug eluting stents)). Patients undergoing PCI in the recent waves were older and more often reported comorbidities. However, fewer patients across the waves reported post-PCI angina at one year (wave 1–5: 24%, 23%, 18%, 20%, 20%; Ptrend:<0.001). The lower risk of angina in recent waves, however, was explained by patient characteristics including use of anti-anginal medications at discharge [relative risk (95% CI) for waves 2, 3, 4 vs 1: 1.0 (0.9–1.2), 0.9 (0.7–1.1), 1.0 (0.8–1.3), 0.9 (0.7–1.1)]. Similar trend was seen in the average quality of life scores over time (adjusted mean score for waves 1–5: 6.2, 6.5, 6.6 and 6.6; Ptrend: 0.01). Other factors associated with angina at one year included younger age, female gender, prior revascularization, need for repeat PCI and hospitalization for MI over one year.
Conclusion
Favorable temporal trends are seen in patient-reported symptoms following PCI in routine clinical practice. Specific subgroups, however, remain at risk for symptoms at one year and warrant closer attention.
doi:10.1161/CIRCOUTCOMES.109.869131
PMCID: PMC3031456  PMID: 20031899
Percutaneous coronary intervention; temporal trend; angina; registries
21.  Twenty-year evolution of Percutaneous coronary intervention and its impact on clinical outcomes a report from the NHLBI-sponsored, multicenter 1985–86 Percutaneous transluminal coronary angioplasty and 1997–2006 Dynamic Registries 
Background
Percutaneous coronary intervention has undergone rapid progress both in technology and adjunct therapy. However, documentation of long-term temporal trends in relation to contemporary practice is lacking.
Methods and Results
We analyzed PCI use and outcomes in 8976 consecutive patients in the multicenter NHLBI-sponsored 1985–86 Percutaneous coronary transluminal coronary angioplasty (PTCA) and 1997–2006 Dynamic Registries waves [wave 1: 1997–98, bare metal stents; wave 2: 1999, uniform use of stents; wave 3: 2001–02, brachytherapy; waves 4 and 5: 2004–2006, drug-eluting stents]. Patients undergoing PCI in the recent waves were older and more often reported comorbidities than those in the balloon era. PCI was more often performed for acute coronary syndromes and, in spite of the greater disease burden, was more often selective. Procedural success was achieved and maintained more often in the stent era. Significant reductions were observed in in-hospital rates (%) of myocardial infarction (PTCA Registry: 4.9, wave 1: 2.7, wave 2: 2.8, wave 3: 1.9, wave 4: 2.6, wave 5: 2, Ptrend:<0.001) and emergency CABG (PTCA Registry: 3.7, wave 1: 0.4, wave 2: 0.4, wave 3: 0.3, wave 4:0.4, wave 5: 0, Ptrend:<0.001). Compared to the PTCA Registry, risk for repeat revascularization (31–365 days following index PCI) was significantly lower in the Dynamic waves (adjusted hazard ratio, wave 1: 0.72, wave 2: 0.51, wave 3: 0.51, wave 4: 0.30, wave 5: 0.36; P< 0.05 for all).
Conclusion
Percutaneous interventions, in the last two decades, has evolved to include more urgent, comorbid cases, yet achieving high success rates with significantly reduced need for repeat revascularization.
doi:10.1161/CIRCINTERVENTIONS.108.825323
PMCID: PMC3024012  PMID: 20031687
Percutaneous coronary intervention; temporal trend; registries
22.  Comparison of Drug-eluting and Bare Metal Stents for Saphenous Vein Graft Lesions (From the National Heart, Lung, and Blood Institute Dynamic Registry) 
The American journal of cardiology  2010;106(7):946-951.
The effectiveness and safety of drug eluting stents (DES) compared to bare metal stents (BMS) in saphenous vein graft (SVG) disease remains unclear. In particular, there is a paucity of data on long term outcomes. We analyzed 395 patients enrolled in the National Heart, Lung, and Blood Institute Dynamic Registry who underwent stenting of a SVG lesion with a BMS (n=192) from 1999–2006 or a DES (n=203) from 2004–2006. Patients were followed prospectively for the occurrence of cardiovascular events and death at 3 years. Patients treated with DES were more likely to have diabetes mellitus and other comorbidities, and prior percutaneous coronary intervention (PCI). Treated lesions in DES patients were more complex than in BMS patients. At 3 years of follow-up, the adjusted risk of target vessel revascularization (TVR) (HR 1.03, 95% CI 0.65–1.62, p=0.91) and death or myocardial infarction (MI) (HR 0.72, 95% CI 0.49–1.04, p=0.08) was similar in DES and BMS treated patients. The combined outcome of death, MI, or TVR excluding peri-procedural MI was also similar (adjusted HR 0.82 95% CI 0.62–1.09, p=0.16). In conclusion, this multi-center non-randomized study of unselected patients showed no benefit of DES in SVG lesions including no reduction in TVR compared to BMS at 3 years. An adequately powered randomized controlled trial is needed to determine the optimal stent type for SVG PCI.
doi:10.1016/j.amjcard.2010.05.025
PMCID: PMC2945366  PMID: 20854955
Stents; Coronary bypass surgery; Registries
23.  Association of an INSIG2 obesity allele with cardiovascular phenotypes is gender and age dependent 
Background
The INSIG2 gene has been implicated in cholesterol metabolism and a single nucleotide polymorphism (SNP) near INSIG2 has been shown to be associated with obesity. We sought to determine the relationship of the INSIG2 SNP to cardiovascular disease (CVD) related phenotypes.
Methods and Results
Nine hundred forty six patients undergoing percutaneous coronary intervention (PCI) in wave 5 of the multicenter NHLBI Dynamic Registry were genotyped using RT-PCR/TaqMan/allelic discrimination for the rs7566605 SNP near the INSIG2 gene. Clinical variables analyzed include demographics, medical history, and procedural details. The prevalence of peripheral vascular disease (PVD) was significantly higher in older men (≥65 years) who were either homozygous or carriers of the obesity/lipid risk allele ("C") compared to non-carriers (odds ratio 3.4, p = 0.013) using a logistic regression model incorporating history of hypercholesterolemia, history of hypertension, cerebrovascular disease, history of diabetes, and BMI. A similar relationship with cerebrovascular disease was found in older (>65) women (odds ratio 3.4, p = 0.013). The INSIG2 SNP was not associated with BMI, nor with other clinical variables.
Conclusion
Age and gender may influence the association of the INSIG2 obesity SNP with PVD and cerebrovascular disease in patients with pre-existing CVD.
doi:10.1186/1471-2261-10-46
PMCID: PMC2958931  PMID: 20920244
24.  Poor 1-year outcomes following percutaneous coronary interventions in systemic lupus erythematosus: Report from the National Heart, Lung and Blood Institute Dynamic Registry 
Background
Women with systemic lupus erythematosus (SLE) have premature and accelerated atherosclerosis. Although percutaneous coronary intervention (PCI) is utilized frequently to treat coronary artery disease (CAD) in SLE, little is known regarding PCI outcomes immediately post-PCI and after discharge.
Methods and Results
Baseline demographic, procedure-related and adverse outcome data on consecutive patients undergoing PCI during 5 recruitment “waves” of the National Heart, Lung, and Blood Institute Dynamic Registry across 23 clinical centers were collected. SLE patients (n= 28) were compared to nonSLE patients (n=3385). SLE patients were younger and more often female in comparison to nonSLE patients undergoing PCI. SLE patients were less likely than nonSLE patients to have hyperlipidemia, but had a similar prevalence of hypertension, diabetes mellitus, and tobacco use. The prevalence of multi-vessel disease was similar between groups. Initial intervention success (by angiographic definition) was not significantly different between groups. At one year, SLE patients were more likely to suffer a myocardial infarction (MI) (15.6% vs. 4.8%, p=0.01), and more often required repeat PCI (31.3% vs. 11.8%, p=0.009) than nonSLE patients, even following adjustment for important covariates.
Conclusions
SLE patients had significantly worse CV outcomes at one year than nonSLE patients. Even considering the small number of SLE patients, these differences were striking. Further study is warranted to explore other factors potentially accounting for this disparity, including SLE disease activity and duration, presence of hypercoagulable state, and immunosuppressive therapy.
doi:10.1161/CIRCINTERVENTIONS.108.788745
PMCID: PMC2945900  PMID: 20031679
angioplasty; catheterization; restenosis; revascularization; systemic lupus erythematosus
25.  Insulin Therapy and Glycemic Control in Hospitalized Patients With Diabetes During Enteral Nutrition Therapy 
Diabetes Care  2009;32(4):594-596.
OBJECTIVE
To compare two subcutaneous insulin strategies for glycemic management of hyperglycemia in non–critically ill hospitalized patients with diabetes during enteral nutrition therapy (ENT).
RESEARCH DESIGN AND METHODS
Fifty inpatients were prospectively randomized to receive sliding-scale regular insulin (SSRI) alone (n = 25) or in combination with insulin glargine (n = 25). NPH insulin was added for persistent hyperglycemia in the SSRI group (glucose >10 mmol/l).
RESULTS
Glycemic control was similar in the SSRI and glargine groups (mean ± SD study glucose 8.9 ± 1.6 vs. 9.2 ± 1.6 mmol/l, respectively; P = 0.71). NPH insulin was added in 48% of the SSRI group subjects. There were no group differences in frequency of hypoglycemia (1.3 ± 4.1 vs. 1.1 ± 1.8%; P = 0.35), total adverse events, or length of stay.
CONCLUSIONS
Both insulin strategies (SSRI with the addition of NPH for persistent hyperglycemia and glargine) demonstrated similar efficacy and safety in non–critically ill hospitalized patients with type 2 diabetes during ENT.
doi:10.2337/dc08-1436
PMCID: PMC2660455  PMID: 19336639

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