Vankeepuram S. Srinivas

Liberal versus restrictive transfusion thresholds for patients with symptomatic coronary artery disease.

BACKGROUND Prior trials suggest it is safe to defer transfusion at hemoglobin levels above 7 to 8 g/dL in most patients. Patients with acute coronary syndrome may benefit from higher hemoglobin levels. METHODS We performed a pilot trial in 110 patients with acute coronary syndrome or stable angina undergoing cardiac catheterization and a hemoglobin <10 g/dL. Patients in the liberal transfusion strategy received one or more units of blood to raise the hemoglobin level ≥10 g/dL. Patients in the restrictive transfusion strategy were permitted to receive blood for symptoms from anemia or for a hemoglobin <8 g/dL. The predefined primary outcome was the composite of death, myocardial infarction, or unscheduled revascularization 30 days post randomization. RESULTS Baseline characteristics were similar between groups except age (liberal, 67.3; restrictive, 74.3). The mean number of units transfused was 1.6 in the liberal group and 0.6 in the restrictive group. The primary outcome occurred in 6 patients (10.9%) in the liberal group and 14 (25.5%) in the restrictive group (risk difference = 15.0%; 95% confidence interval of difference 0.7% to 29.3%; P = .054 and adjusted for age P = .076). Death at 30 days was less frequent in liberal group (n = 1, 1.8%) compared to restrictive group (n = 7, 13.0%; P = .032). CONCLUSIONS The liberal transfusion strategy was associated with a trend for fewer major cardiac events and deaths than a more restrictive strategy. These results support the feasibility of and the need for a definitive trial.

Contemporary Percutaneous Coronary Intervention Versus Balloon Angioplasty for Multivessel Coronary Artery Disease A Comparison of the National Heart, Lung and Blood Institute Dynamic Registry and the Bypass Angioplasty Revascularization Investigation (BARI) Study

Background—This investigation compares the results of contemporary percutaneous coronary intervention (PCI) with standard balloon angioplasty among patients with multivessel coronary disease. Patients having balloon angioplasty in the Bypass Angioplasty Revascularization Investigation (BARI) and those within the Dynamic Registry meeting BARI eligibility criteria were studied. Methods and Results—Clinical features and in-hospital and 1-year outcomes of 857 BARI-eligible patients in the Dynamic Registry (contemporary PCI) were compared with the 904 randomized patients who underwent percutaneous transluminal coronary angioplasty in BARI. Compared with BARI patients, Registry patients had fewer lesions attempted (1.53 versus 2.56, P =0.001), more frequent single-vessel PCI (76% versus 33%, P <0.001), greater use of intracoronary stents (76% versus 1%, P <0.001), and GP IIb/IIIa receptor antagonist (24% versus 0%, P <0.001). Angiographic success was achieved more often among Registry patients (91% versus 72%, P <0.001), whereas abrupt closure (1.5% versus 9.5%, P <0.001) and in-hospital coronary artery bypass graft (CABG) (1.9% versus 10.2%, P <0.001) and myocardial infarction (0.8% versus 2.1%, P =0.025) were less common. No differences were observed in either in-hospital or 1-year death, but 1-year death/myocardial infarction was lower in the Registry. Registry patients had lower 1-year rates of subsequent CABG (8.6% versus 22.7%, P <0.001) and PCI (12.4% versus 22.5%, P <0.001). By multivariate analysis, contemporary PCI was independently associated with reduced risk for in-hospital CABG, 1-year CABG, and 1-year PCI. Conclusions—Among patients with multivessel disease, contemporary PCI resulted in safer and more durable revascularization. These results support the role of PCI for selected patients with multivessel coronary artery disease.

Effect of Physician Volume on the Relationship Between Hospital Volume and Mortality During Primary Angioplasty

OBJECTIVES We sought to examine the combined effect of hospital and physician volume of primary percutaneous coronary intervention (PCI) on in-hospital mortality. BACKGROUND An inverse relationship between volume and outcome has been observed for both hospitals and physicians after primary PCI for acute myocardial infarction. METHODS Using the New York State PCI registry, we examined yearly hospital volume, physician volume, and risk-adjusted mortality in 7,321 patients undergoing primary PCI for acute myocardial infarction. Risk-adjusted mortality rates for high-volume hospitals (>50 cases/year) and high-volume physicians (>10 cases/year) were compared with their respective low-volume counterparts. RESULTS Primary PCI by high-volume hospitals (odds ratio [OR]: 0.58; 95% confidence interval [CI]: 0.38 to 0.88) and high-volume physicians (OR: 0.66; 95% CI: 0.48 to 0.92) was associated with lower odds of mortality. Furthermore, there was a significant interaction between hospital and physician volume on adjusted mortality (p = 0.02). Although unadjusted mortality was lower when primary PCI was performed by high-volume physicians in high-volume hospitals compared with low-volume physicians in low-volume hospitals (3.2% vs. 6.7%, p = 0.03), the risk-adjusted mortality rate was not statistically significant (3.8% vs. 8.4%, p = 0.09). In low-volume hospitals, the average risk-adjusted mortality rate for low-volume physicians was 8.4% versus 4.8% for high-volume physicians (OR: 1.44; 95% CI: 0.68 to 3.03). However, in high-volume hospitals, the risk-adjusted mortality rate for high-volume physicians was 3.8% versus 6.5% for low-volume physicians (OR: 0.58; 95% CI: 0.39 to 0.86). CONCLUSIONS During primary PCI, physician experience significantly modifies the hospital volume-outcome relationship. Therefore, policymakers need to consider physician experience when developing strategies to improve access to primary PCI.

Vitamin D status and risk of cardiovascular events: lessons learned via systematic review and meta-analysis.

Accumulating data linking hypovitaminosis D to cardiovascular (CV) events has contributed to large increases in vitamin D testing and supplementation. To evaluate the merits of this practice, we conducted a systematic review with meta-analysis providing a framework for interpreting the literature associating hypovitaminosis D with increased CV events. Prospective studies were identified by search of MEDLINE and EMBASE from inception to January 2010, restricted to English language publications. Two authors independently extracted data and graded study quality. Pooled relative risks (RR) were calculated using a random effects model. Ten studies met criteria for review and 7 were included in meta-analysis. Pooled RR for CV events using FAIR and GOOD quality studies was 1.67 (95% confidence interval, 1.23–2.28) during an average follow-up of 11.8 years. There was evidence of significant heterogeneity across studies (Q statistics = 16.6, P = 0.01, I2 = 63.8%), which was eliminated after omitting 2 studies identified by sensitivity analysis (RR, 1.34 [1.08–1.67]; P for heterogeneity =0.33). When restricting analysis to GOOD quality studies (RR, 1.27 [1.04–1.56]), no significant heterogeneity was found (P = 0.602). Systematic review identified significant shortcomings in the literature, including variability in defining vitamin D status, seasonal adjustments, defining and determining CV outcomes, and the use of baseline vitamin D levels. In conclusion, a modest increased risk of CV events associated with hypovitaminosis D is tempered by significant limitations within the current literature. These findings underscore the importance of critical appraisal of the literature, looking beyond reported risk estimates before translating results into clinical practice.

The effects of vitamin D repletion on endothelial function and inflammation in patients with coronary artery disease.

Adequate vitamin D levels may promote cardiovascular health by improving endothelial function and down-regulating inflammation. The objective of this pilot trial was to investigate the effects of vitamin D repletion on endothelial function and inflammation in patients with coronary artery disease (CAD). Using a double-blind placebo wait-list control design, 90 subjects with CAD and vitamin D deficiency (< 20 ng/ml) were randomized 1:1 to 50,000 IU of oral ergocalciferol or placebo weekly for 12 weeks. Endothelial function (reactive hyperemia peripheral arterial tonometry, RH-PAT), circulating adhesion molecules, and pro-inflammatory cytokines were measured at baseline and 12 weeks. The median increase in serum 25-vitamin D from baseline was 26 ± 17 ng/ml in the active group and 4 ± 8 ng/ml in the placebo group (between-group difference = 22 ng/ml, p < 0.001). The median within-subject change in RH-PAT score was 0.13 ± 0.73 with active treatment and −0.04 ± 0.63 with placebo (between-group difference = 0.17, p = 0.44). Within-group and between-group differences in intercellular adhesion molecule levels were greater with placebo (between-group difference = 6 ng/ml, p = 0.048). Vascular cell adhesion molecule levels decreased in both groups by a similar magnitude (median difference between groups = 8.5 ng/ml, p = 0.79). There was no difference between groups in magnitude of reduction in interleukin (IL)-12 (−8.6 ng/ml, p = 0.72) and interferon-gamma (0.52 ng/ml, p = 0.88). No significant differences in blood pressure, e-selectin, high-sensitivity c-reactive protein, IL-6 or the chemokine CXCL-10 were found with treatment. In conclusion, repleting vitamin D levels in subjects with CAD failed to demonstrate any benefits on surrogate markers of cardiovascular health. These results question the role of vitamin D supplementation in modifying cardiovascular disease.

Clinical expert consensus statement on best practices in the cardiac catheterization laboratory: Society for cardiovascular angiography and interventions

The cardiac catheterization laboratory (CCL) is a setting in which elective, urgent, and emergent percutaneous procedures are performed. This poses challenges to maintaining and prioritizing high quality care and patient safety. Nonetheless, process expectations of a high-quality CCL include appropriate periprocedural communication, clinical management, documentation, and universal protocol. Regulations primarily targeted at open surgical operating rooms have the potential to negatively impact care because they may mandate focus on performance measures that are not necessarily relevant to the cardiac catheterization laboratory. For example, routine site marking for percutaneous access is irrelevant for most patients since failure to obtain access on one side (e.g., right femoral artery) simply leads to attempting access on the other side (e.g., left femoral artery). Instead, directives should be tailored to the percutaneous procedure setting to assure quality and optimal patient safety. This document will therefore provide expert consensus opinion on a number of issues pertaining to ‘‘best practices’’ within the CCL, focusing on quality and safety during each step of the process. The writing committee acknowledges a dearth in high-quality published studies in this area, making many of the enclosed recommendations based primarily on expert consensus. Although references are provided when available, further research specifically in catheterization laboratory processes and quality improvement is needed. The document is divided into ‘‘best practices’’ that should be performed during the preprocedure, intraprocedure, and postprocedure settings for diagnostic cardiac catheterization and coronary intervention, to be consistent with the typical patient flow into and out of the CCL. Despite the long history of cardiac catheterization that dates back several decades, a document describing these ‘‘best practices’’ has not yet been written. The purpose of this document is not to represent all acceptable practices, but to provide consensus opinion on what would currently be considered ‘‘best practices’’ as future goals for catheterization laboratories.

Increased Adverse Events After Percutaneous Coronary Intervention in Patients With COPD: Insights From the National Heart, Lung, and Blood Institute Dynamic Registry

BACKGROUND Previous studies have demonstrated that patients with COPD are at higher risk for death after percutaneous coronary intervention (PCI), but other clinical outcomes and possible associations with adverse events have not been described. METHODS Using waves 1 through 5 (1999-2006) of the National Heart, Lung, and Blood Institute Dynamic Registry, patients with COPD (n = 860) and without COPD (n = 10,048) were compared. Baseline demographics, angiographic characteristics, and in-hospital and 1-year adverse events were compared. RESULTS Patients with COPD were older (mean age 66.8 vs 63.2 years, P < .001), more likely to be women, and more likely to have a history of diabetes, prior myocardial infarction, peripheral arterial disease, renal disease, and smoking. Patients with COPD also had a lower mean ejection fraction (49.1% vs 53.0%, P < .001) and a greater mean number of significant lesions (3.2 vs 3.0, P = .006). Rates of in-hospital death (2.2% vs 1.1%, P = .003) and major entry site complications (6.6% vs 4.2%, P < .001) were higher in pulmonary patients. At discharge, pulmonary patients were significantly less likely to be prescribed aspirin (92.4% vs 95.3%, P < .001), β-blockers (55.7% vs 76.2%, P < .001), and statins (60.0% vs 66.8%, P < .001). After adjustment, patients with COPD had significantly increased risk of death (hazard ratio [HR] = 1.30, 95% CI = 1.01-1.67) and repeat revascularization (HR = 1.22, 95% CI = 1.02-1.46) at 1 year, compared with patients without COPD. CONCLUSIONS COPD is associated with higher mortality rates and repeat revascularization within 1 year after PCI. These higher rates of adverse outcomes may be associated with lower rates of guideline-recommended class 1 medications prescribed at discharge.

Factors Associated With Poorer Prognosis for Patients Undergoing Primary Percutaneous Coronary Intervention During Off-Hours : Biology or Systems Failure?

OBJECTIVES We sought to determine whether poorer outcomes in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment 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. BACKGROUND 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. METHODS Clinical, angiographic, and procedural characteristics were compared in consecutive patients (n = 685) undergoing primary PCI in the National Heart, Lung, and Blood Institute Dynamic Registry between 1997 and 2006 that were classified as occurring during routine-hours (07:00 to 18:59) or off-hours (19:00 to 06:59). The primary end points were in-hospital death, MI, and target vessel revascularization. RESULTS Median time from symptom onset to PCI was similar (off-hours 3.4 h vs. routine-hours 3.3 h). Patients presenting in off-hours were more likely to present with cardiogenic shock and multivessel coronary artery disease but were 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 target vessel revascularization were 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. CONCLUSIONS Patients undergoing primary PCI for acute MI during off-hours are at significantly higher risk for in-hospital death, MI, and target vessel revascularization. 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.

Impact of drug-eluting stents among insulin-treated diabetic patients: a report from the National Heart, Lung, and Blood Institute Dynamic Registry.

OBJECTIVES This study sought to evaluate the safety and efficacy of drug-eluting stents (DES) compared with bare-metal stents (BMS) in patients with insulin- and noninsulin-treated diabetes. BACKGROUND Diabetes is a powerful predictor of adverse events after percutaneous coronary interventions (PCI), and insulin-treated diabetic patients have worse outcomes. The DES are efficacious among patients with diabetes; however, their safety and efficacy, compared with BMS, among insulin-treated versus noninsulin-treated diabetic patients is not well established. METHODS Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated 1-year outcomes of insulin-treated (n = 817) and noninsulin-treated (n = 1,749) patients with diabetes who underwent PCI with DES versus BMS. RESULTS The use of DES, compared with BMS, was associated with a lower risk for repeat revascularization for both noninsulin-treated patients (adjusted hazard ratio [HR] = 0.59, 95% confidence interval [CI] 0.45 to 0.76) and insulin-treated subjects (adjusted HR = 0.63, 95% CI 0.44 to 0.90). With respect to safety in the overall diabetic population, DES use was associated with a reduction of death or myocardial infarction (adjusted HR = 0.75, 95% CI 0.58 to 0.96). However, this benefit was confined to the population of noninsulin-treated patients (adjusted HR = 0.57, 95% CI 0.41 to 0.81). Among insulin-treated patients, there was no difference in death or myocardial infarction risk between DES- and BMS-treated patients (adjusted HR = 0.95, 95% CI 0.65 to 1.39). CONCLUSIONS Drug-eluting stents are associated with lower risk for repeat revascularization compared with BMS in treating coronary artery disease among patients with either insulin- or noninsulin-treated diabetes. In addition, DES use is not associated with any significant increased safety risk compared with BMS. These findings suggest that DES should be the preferred strategy for diabetic patients.

Impact of National Clinical Guideline Recommendations for Revascularization of Persistently Occluded Infarct-Related Arteries on Clinical Practice in the United States

BACKGROUND The Occluded Artery Trial (OAT) was a large, randomized controlled trial published in 2006 that demonstrated no benefit to routine percutaneous coronary intervention (PCI) of persistently totally occluded infarct-related arteries (IRA) identified a minimum of 24 hours (on calendar days 3-28) after myocardial infarction (MI). The purpose of this study was to determine the impact of OAT results and consequent change in guideline recommendations for PCI for treatment of persistently occluded IRAs. METHODS We identified all patients enrolled in the CathPCI Registry, from 2005 to 2008, undergoing catheterization more than 24 hours after MI with a totally occluded native coronary artery and no major OAT exclusion criteria. We examined trends in monthly rates of PCI for occlusions after OAT publication and after guideline revisions. Because reporting of diagnostic catheterizations was not mandatory, we examined trends among hospitals in the highest quartile for reporting of diagnostic procedures. RESULTS A total of 28,780 patient visits from 896 hospitals were included. Overall, we found no significant decline in the adjusted monthly rate of PCI of occlusions after publication of OAT (odds ratio [OR], 0.997; 95% confidence interval [CI], 0.989-1.006) or after guideline revisions (OR, 1.007; 95% CI, 0.992-1.022). Among hospitals consistently reporting diagnostic catheterizations, there was no significant decline after OAT publication (OR, 1.018; 95% CI, 0.995-1.042), and there was a trend toward decline after guideline revisions (OR, 0.963; 95% CI, 0.920-1.000). CONCLUSION These findings suggest that the results of OAT and consequent guideline revisions have not, to date, been fully incorporated into clinical practice in a large cross-section of hospitals in the United States.