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.
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.
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.
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.
Psychopathology; Eating Disorders; Binge Eating Disorder
To examine associations between vasomotor symptoms and lipids over 8 years, controlling for other cardiovascular risk factors, estradiol (E2) and follicle-stimulating hormone (FSH).
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.
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.
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.
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.
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.
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.
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).
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.
Coronary Disease; Stents; Restenosis
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.
Drug-eluting; Bare metal; Stents; Renal dysfunction
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.
percutaneous coronary intervention; outcomes; re-admission
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.
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.
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.
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.
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.
Menopause; vasomotor symptoms; hot flashes; inflammation; coagulation; hemostasis
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.
Peripheral arterial disease; stents; catheterization
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.
Drug-eluting stents; elderly; age; clinical outcomes
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.
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.
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.
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.
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.
calcified lesion; percutaneous coronary intervention; stents
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.
This was a multicenter prospective cohort study
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.
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).
These results support the routine use of statin therapy after PCI.
mortality; propensity score; repeat revascularization; stent
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.
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.
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.
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.
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.
Patients with diabetes mellitus (DM) are at higher risk for adverse outcomes following percutaneous coronary intervention (PCI).
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.
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.
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.
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.
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.
Percutaneous coronary intervention; temporal trend; angina; registries
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).
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.
Percutaneous coronary intervention; temporal trend; registries
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.
Stents; Coronary bypass surgery; Registries
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.
Age and gender may influence the association of the INSIG2 obesity SNP with PVD and cerebrovascular disease in patients with pre-existing CVD.
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.
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.
angioplasty; catheterization; restenosis; revascularization; systemic lupus erythematosus
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).
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.
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.
Sequence variation in gene promoters is often associated with disease risk. In this study, we tested the hypothesis that common promoter variation in the APOH gene (encoding for β2-glycoprotein I) is associated with systemic lupus erythematosus (SLE) risk and SLE-related clinical phenotypes in a Caucasian cohort.
We used a case-control design and genotyped 345 SLE women and 454 healthy control women for 8 APOH promoter single nucleotide polymorphisms (SNPs) (−1284C>G, −1219G>A, −1190G>C, −759 A>G, − 700C>A, −643T>C, −38G>A, and −32C>A). Association analyses were performed on single SNPs and haplotypes. Haplotype analyses were performed using EH (Estimate Haplotype-frequencies) and Haploview programs. In vitro reporter gene assay was performed in COS-1 cells. Electrophoretic mobility shift assay (EMSA) was performed using HepG2 nuclear cells.
Overall haplotype distribution of the APOH promoter SNPs was significantly different between cases and controls (P = 0.009). The −643C allele was found to be protective against carotid plaque formation (adjusted OR = 0.37, P = 0.013) among SLE patients. The −643C allele was associated with a ~ 2-fold decrease in promoter activity as compared to wild-type −643T allele (mean ± standard deviation: 3.94 ± 0.05 vs. 6.99 ± 0.68, P = 0.016). EMSA showed that the −643T>C SNP harbors a binding site for a nuclear factor. The −1219G>A SNP showed a significant association with the risk of lupus nephritis (age-adjusted OR = 0.36, P = 0.016).
Our data indicate that APOH promoter variants may be involved in the etiology of SLE, especially the risk for autoimmune-mediated cardiovascular disease.
APOH; β2-glycoprotein I; promoter; SLE; lupus; polymorphism
Although prior studies have demonstrated that Hispanic patients have a higher cardiovascular risk profile than Caucasians and present at an earlier age for percutaneous coronary intervention (PCI), limited studies exist examining the outcomes of Hispanics post PCI and potential explanations for differences noted. Utilizing patients from the National Heart, Lung, and Blood Institute Dynamic Registry Waves 1–5 (1997 to 2006), demographic features, angiographic data, and one year outcomes of Hispanic (n= 542) versus Caucasian patients (n=1357) undergoing PCI were evaluated. Compared with Caucasians, Hispanic patients were younger, and had more hypertension and diabetes mellitus, including more insulin treated diabetes mellitus. While the mean lesion length was longer in Hispanics (15.4 mm versus 14.1 mm, p<0.001), there were no differences in the number of significant lesions, or in the use of drug-eluting stents. At follow-up, Hispanics were more likely to report recent anginal symptoms, but had a similar incidence of one year hospitalizations for angina. Adjusted one year hazard ratios for adverse events for Hispanics versus Caucasians revealed lower rates of coronary artery bypass graft (CABG) surgery (HR 0.43, 0.22 – 0.85, p=0.02), and a trend toward lower rates of repeat revascularization (HR 0.76, CI 0.57 – 1.03, p=0.08). In conclusion, despite the presence of diabetes in almost 50% of Hispanic patients and longer lesion lengths than Caucasians, Hispanic patients were less likely to undergo CABG one year post PCI, and had a trend toward lower rates of repeat revascularization.
Percutaneous Coronary Intervention; Hispanics; Restenosis
to determine whether poorer outcomes in patients undergoing primary percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (MI) during off-hours are related to delays in treatment, circadian changes in biology, or differences in operator-related quality of care.
Previous investigation has suggested that patients undergoing primary PCI during off-hours are more likely to have adverse cardiac events than routine-hours patients, but the reasons for this remain poorly defined.
Clinical, angiographic and procedural characteristics were compared in consecutive patients (n=685) undergoing primary PCI in the NHLBI Dynamic Registry between 1997 and 2006 were classified as routine hours (0700 to 1859) or off-hours (1900 to 0659). The primary endpoint was in-hospital death, MI and target vessel revascularization (TVR).
Median time from symptom onset to PCI was similar (off-hours 3.4 hours versus routine-hours 3.3 hours). Patients presenting in off hours were more likely to present with cardiogenic shock and multivessel coronary artery disease, but equally likely to present with complete occlusion of the infarct related artery. Procedural complications including dissection were more frequent in off-hours patients. In-hospital death, MI, and TVR was significantly higher in off-hours patients (adjusted odds ratio [OR] 2.66, p=0.001), and differences in outcomes were worse even if the procedure was immediately successful (adjusted OR 2.58, p=0.005, adjusting for angiographic success). Patients undergoing PCI on weekends had better outcomes during the daytime than nighttime.
Patients undergoing primary PCI for acute MI during off-hours are at significantly higher risk for in-hospital death, MI and TVR; these findings appear related to both diurnal differences in presentation and lesion characteristics, as well as differences in procedural complication and success rates that extend beyond differences in symptom to balloon time.
PCI; primary angioplasty; off-hours; myocardial infarction
Recent reports suggest that off-label use of drug-eluting stents is associated with an increased incidence of adverse events. Whether the use of bare-metal stents would yield different results is unknown.
We analyzed data from 6551 patients in the National Heart, Lung, and Blood Institute Dynamic Registry according to whether they were treated with drug-eluting stents or bare-metal stents and whether use was standard or off-label. Patients were followed for 1 year for the occurrence of cardiovascular events and death. Off-label use was defined as use in restenotic lesions, lesions in a bypass graft, left main coronary artery disease, or ostial, bifurcated, or totally occluded lesions, as well as use in patients with a reference-vessel diameter of less than 2.5 mm or greater than 3.75 mm or a lesion length of more than 30 mm.
Off-label use occurred in 54.7% of all patients with bare-metal stents and 48.7% of patients with drug-eluting stents. As compared with patients with bare-metal stents, patients with drug-eluting stents had a higher prevalence of diabetes, hypertension, renal disease, previous percutaneous coronary intervention and coronary-artery bypass grafting, and multivessel coronary artery disease. One year after intervention, however, there were no significant differences in the adjusted risk of death or myocardial infarction in patients with drug-eluting stents as compared with those with bare-metal stents, whereas the risk of repeat revascularization was significantly lower among patients with drug-eluting stents.
Among patients with off-label indications, the use of drug-eluting stents was not associated with an increased risk of death or myocardial infarction but was associated with a lower rate of repeat revascularization at 1 year, as compared with bare-metal stents. These findings support the use of drug-eluting stents for off-label indications.
To evaluate the safety and efficacy of drug-eluting stents (DES) compared with bare metal stents (BMS) in patients with insulin-treated and non-insulin-treated diabetes.
Diabetes is a powerful predictor of adverse events following percutaneous coronary interventions (PCI), and insulin-treated diabetic patients have worse outcomes. DES are efficacious among patients with diabetes; however, their safety and efficacy, compared to BMS, among insulin-treated versus non-insulin-treated diabetic patients is not well established.
Using the NHLBI Dynamic Registry, we evaluated 1-year outcomes of insulin-treated (n=817) and non-insulin-treated (n=1749) patients with diabetes who underwent PCI with DES versus BMS.
The use of DES, compared to BMS, was associated with a lower risk for repeat revascularization for both non-insulin-treated patients (adjusted HR=0.59, 95% CI 0.45–0.76) and insulin-treated subjects (adjusted HR=0.63, 95% CI 0.44–0.90). With respect to safety in the overall diabetic population, DES use was associated with a reduction of death or MI (adjusted HR=0.75, 95% CI 0.58–0.96). However, this benefit was confined to the population of non-insulin-treated patients (adjusted HR=0.57, 95% CI 0.41–0.81). Among insulin-treated patients, there was no difference in death or MI risk between DES- and BMS-treated patients (adjusted HR=0.95, 95% CI 0.65–1.39).
Drug-eluting stents are associated with lower risk for repeat revascularization compared with BMS in treating coronary artery disease among patients with either insulin-treated or non-insulin-treated diabetes. In addition, DES use is not associated with any significant increased safety risk compared to BMS. These findings suggest that DES should be the preferred strategy for diabetic patients.
Insulin-treated patients with diabetes mellitus have worse outcomes following percutaneous coronary intervention (PCI) compared with non-insulin-treated patients. The present study from the NHLBI Dynamic Registry evaluates the safety and efficacy of drug-eluting stents (DES) compared with bare metal stents (BMS), among insulin-treated and non-insulin-treated patients with diabetes. Our results suggest that over a 1-year follow-up period, DES are both efficacious and safe compared with BMS in both non-insulin-treated as well as insulin-treated patients. These findings suggest that DES should be the preferred strategy for diabetic patients.
Diabetes; Insulin; Drug-eluting stents; Percutaneous coronary intervention