Roll-in experience from the Cardiovascular Outcomes with Renal Atherosclerotic Lesions (CORAL) study.

PURPOSE: To describe the experience and results from the roll-in phase of the Cardiovascular Outcomes with Renal Atherosclerotic Lesions (CORAL) study. MATERIALS AND METHODS: The CORAL roll-in database was used to describe the baseline characteristics of the patients in the roll-in cohort, all of whom underwent renal artery stent placement; to evaluate CORAL site performance; to compare estimates of lesion (stenosis) severity made by site interventionalists with the central CORAL angiographic core laboratory readings; and to report outcomes after renal artery stent placement. During the roll-in phase, 239 patients (mean age, 70.2 y ± 9.0; 49% male) underwent renal artery stent procedures. Angiographic core laboratory analysis of renal arteriograms was done, and participants were followed at 1 month and 9 months. RESULTS: Major angiographic complications were identified in 28 (13%) subjects. Kidney function remained unchanged at the short (2-4 weeks) follow-up interval. Improvement in systolic blood pressure with use of distal embolic protection devices (n = 161) did not show any clinical benefit over nonuse of such devices (n = 78) in this small series. At 9 months, there were significantly more endpoints reported by site in subjects with bilateral renal artery stenosis (P = .01) and prior history of stroke (P = .03). CONCLUSIONS: In the roll-in phase of the CORAL study, a significant number of angiographic complications were identified. No effect was seen on estimated glomerular filtration rate after renal artery stent placement, but systolic blood pressure decreased significantly.

Statin therapy in patients with chronic kidney disease undergoing percutaneous coronary intervention (from the Evaluation of Drug Eluting Stents and Ischemic Events Registry).

Secondary prevention trials have demonstrated the efficacy of statins in reducing cardiovascular morbidity and mortality in patients with coronary artery disease and events after percutaneous coronary intervention (PCI). However, there are few data describing the clinical value of statins in patients with coronary artery disease and chronic kidney disease (CKD) undergoing PCI. Of 10,148 patients who entered into Evaluation of Drug Eluting Stents and Ischemic Events, a multicenter registry of unselected patients undergoing PCI from July 2004 to December 2007, we studied 2,306 patients with CKD (estimated glomerular filtration rate ≤60 ml/min based on the Modified Diet in Renal Disease calculation). Patients were stratified into those receiving statins at discharge (n = 1,833, 79%) or not (n = 473, 21%). Patients in the statin group had a greater prevalence of hypertension, recent myocardial infarction (MI), and use of ß blockers and angiotensin-converting enzyme inhibitors. Outcomes were assessed from discharge through 1-year follow-up. One-year all-cause mortality was 5.7% in statin group versus 8.7% in the no statin group (adjusted hazard ratio 0.55, 95% confidence interval 0.34 to 0.88). The composite of death, MI, and repeat revascularization was lower in statin group (adjusted hazard ratio 0.71, 95% confidence interval 0.51 to 0.99). In conclusion, among patients with CKD undergoing PCI, the prescription of statins at hospital discharge was associated with a significant improvement in subsequent outcomes including mortality and composite end point of death, MI, and repeat revascularization.

Impact of drug eluting stent length on outcomes of percutaneous coronary intervention (from the EVENT registry).

In randomized trials, longer drug-eluting stent (DES) length has been associated with adverse clinical events. We used data from the EVENT registry to examine the impact of DES length on outcomes in routine clinical practice. We identified 5,425 unselected consecutive patients from the EVENT registry who had a single vessel treated with DES for nonemergency indications from 2004 through 2007. The association between stented length and short- and long-term outcomes was analyzed in ordinal categories (<15, 15 to 19, 20 to 24, and >24 mm) and as a continuous variable. There were few differences in baseline characteristics across categories. At 1 year, there was a stepwise increase in major adverse cardiac events (composite of death, myocardial infarction [MI], and target lesion revascularization [TLR]) with increasing stent length (8.0%, 10.1%, 11.8%, and 14.8%, p <0.001) and a similar relation with TLR (3.0%, 3.1%, 3.3%, and 5.0%, p = 0.02). After adjusting for demographic, clinical, angiographic, and treatment characteristics, longer stent length remained associated with 1-year major adverse cardiac events (adjusted hazard ratio 1.17 per 10-mm increase stent length) and TLR (hazard ratio 1.20 per 10 mm), but not with stent thrombosis. In conclusion, longer DES length is associated with increased adverse events, predominantly periprocedural MI, but also an increased rate of TLR.

Troponin criteria for myocardial infarction after percutaneous coronary intervention.

BACKGROUND: The universal definition of myocardial infarction specifies creatine kinase-MB fraction (CKMB) or troponin values more than 3 times the 99th percentile of the upper reference limit as diagnostic after percutaneous coronary intervention, with a preference for the use of troponin. METHODS: Outcomes of 4930 patients with elective coronary stent placement between July 1, 2004, and September 30, 2007, as part of the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry were analyzed to test the association between 1-year mortality and postprocedure elevation of either CKMB or troponin. All values were normalized to the individual clinical center myocardial infarction diagnostic levels. RESULTS: Myocardial infarction occurred in 7.2% of patients by the CKMB criteria and in 24.3% of patients by the troponin criteria of greater than 3 times the diagnostic level. Both CKMB (hazard ratio [HR], 1.38; 95% CI, 1.22-1.55) and troponin (HR, 1.35; 95% CI, 1.18-1.54) as continuous values were associated with 1-year mortality. The mortality effect of a more than 3-fold increase was greater for CKMB (adjusted HR, 2.5; 95% CI, 1.5-4.1) than for troponin (adjusted HR, 1.7; 95% CI, 1.1-2.5). A troponin threshold more than 20 times the diagnostic level provided similar frequency (7.0%) and mortality risk (adjusted HR, 2.6; 95% CI, 1.6-4.3) as a 3-fold increase in CKMB. A regression spline model of the relationship between troponin and 1-year mortality demonstrated that the hazard of mortality increased from 1.02 at 3-fold to 1.67 at 20-fold troponin elevation. CONCLUSION: Troponin and CKMB elevations after percutaneous coronary intervention are associated with increased 1-year mortality rates, but thresholds for similar event frequency and mortality hazard are much higher for troponin than for CKMB.

Incidence and clinical outcome of minor surgery in the year after drug-eluting stent implantation: results from the Evaluation of Drug-Eluting Stents and Ischemic Events Registry.

BACKGROUND: The aim of the study was to describe the incidence and consequences of minor surgery after drug-eluting stent (DES) implantation. METHODS: The Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) Registry prospectively enrolled unselected patients undergoing percutaneous coronary intervention at 47 US centers between July 2004 and December 2007. We examined 8,323 patients who received a DES in EVENT to determine the frequencies of minor surgery and postoperative adverse events. RESULTS: Minor surgery (defined as procedures not requiring a major surgical incision) was performed in 164 (2.0%) of 8,323 patients <1 year after stenting, as follows: pacemaker/defibrillator implantation (46%), eye surgery (17%), orthopedic (9%), dermatologic (8%), endovascular (6%), and gastrointestinal procedures (5%). Compared with patients who did not undergo minor surgery, those who did were older, had more comorbidities, had more extensive coronary disease, and were more likely to have received warfarin after stenting. Only 1 (0.6%, 95% CI 0.0%-3.4%) of 164 patients had an event (stent thrombosis causing myocardial infarction) during the first week after minor surgery; this rate was slightly higher than the background rate of ischemic events in the study population (exact mid P = .01). Clopidogrel use at 12 months was similar between patients who did and those who did not undergo minor surgery (65.2% vs 65.5%, P = .95). CONCLUSIONS: In the EVENT Registry, minor surgery was performed in 2% of patients in the first year after DES implantation. The risk of stent thrombosis during the first week after surgery was increased slightly compared with background rates, but the absolute event rate was low (0.6%).

In-hospital and 1-year outcomes among unselected percutaneous coronary intervention patients treated with either sirolimus- or paclitaxel-eluting stents: results from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry.

OBJECTIVES: The aim of this study was to compare outcomes among unselected patients undergoing percutaneous coronary intervention (PCI) with either sirolimus-eluting (SES) or paclitaxel-eluting stents (PES). BACKGROUND: Although the benefits of both SES and PES are well-established, studies comparing these stents directly have yielded conflicting results. METHODS: We used data from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry to compare in-hospital and 1-year outcomes among unselected patients undergoing nonemergent PCI with either SES or PES implantation. RESULTS: Between July 2004 and June 2006, 6,035 patients underwent PCI with either SES (n = 3,443) or PES (n = 2,592) at 47 U.S. centers. Baseline clinical and angiographic characteristics were generally similar for the 2 stent types. At 1-year, there were no differences in the primary end point of cardiac death or myocardial infarction (MI) between the SES and PES groups (9.1% vs. 10.0%, p = 0.11) or in any individual end points including cardiac death, nonfatal MI, or stent thrombosis. In unadjusted analyses, target lesion revascularization (TLR) was slightly more common with SES than with PES (4.4% vs. 3.3%, p = 0.048), but this difference was no longer apparent after adjusting for baseline characteristics as well as site-related factors (adjusted hazard ratio: 1.09, 95% confidence interval: 0.78 to 1.50). CONCLUSIONS: Among unselected patients undergoing PCI, adjusted rates of both ischemic complications as well as clinically important restenosis were similar for SES and PES. The unexpected finding that TLR was influenced by site characteristics suggests that the correlation between TLR and angiographic restenosis might be weaker than previously described and warrants further study.

In-hospital and 1-year outcomes among percutaneous coronary intervention patients with chronic kidney disease in the era of drug-eluting stents: a report from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry.

OBJECTIVES: This study sought to evaluate ischemic and bleeding outcomes in patients with chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). BACKGROUND: Previous studies have shown that CKD is associated with poor outcomes after PCI. However, these studies were largely conducted before the introduction of DES and aggressive antithrombotic therapy or were performed in the setting of randomized trials. With data from a contemporary registry, we evaluated the influence of CKD on major cardiovascular events and bleeding complications in unselected "real-world" patients undergoing PCI. METHODS: Data from 4,791 patients enrolled in the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) Registry between July 2004 and September 2005 were analyzed. Patients were stratified into 4 groups: creatinine clearance (CrCl) >75, 50 to 75, 30 to 49 and <30 ml/min. RESULTS: During the index hospital stay, there was a step-wise increase in bleeding complications with decreasing CrCl (3.3%, 5.0%, 8.8%, and 14.3%; p < 0.0001 for trend). Lower CrCl was also associated with more frequent death or myocardial infarction (MI) during the initial hospital stay (p = 0.001) and at 1 year (p < 0.001). These findings were confirmed in multivariate analyses that adjusted for baseline differences in demographic, clinical, and angiographic factors. Use of guideline-recommended medications at 1 year, including aspirin, clopidogrel, angiotensin-converting enzyme inhibitors, and statins, also decreased with declining renal function. CONCLUSIONS: Renal function is an independent and powerful predictor of bleeding and ischemic complications in the era of DES and contemporary antithrombotic therapy in patients undergoing PCI. The low use of guideline-recommended drugs among patients with CKD undergoing PCI might contribute to these adverse outcomes and warrants further evaluation.

Outcome predictors for severe obsessive-compulsive patients in intensive residential treatment.

Intensive residential treatment (IRT) is an effective management approach for those with severe obsessive-compulsive disorder (OCD). This study aimed to identify IRT response predictors for clinical and research use. Consecutive subjects admitted to the Massachusetts General Hospital/McLean OCD Institute (OCDI) between February 1997 and June 2003 were included (N=476). IRT responder and non-responder group characteristics were compared using t-tests and chi(2) analyses. Multiple regression analysis modeled relationships between final OCD severity (Yale-Brown Obsessive-Compulsive scale scores) and predictor variables, while accounting for multicollinearity and potential outliers. Treatment responders comprised 59.3% of the treatment sample. Responders had significantly fewer males (p=0.02), lower depression severity (p=0.03), poorer psychosocial functioning (p=0.03) and fewer tic disorders (0.04), but were not different with respect to admission length, age, marital or employment status, OCD onset, family OCD history, treatment or admission history. In the final regression model, decreased initial OCD severity (p<0.001), female gender (p=0.003) and better initial psychosocial functioning (Work and Social Adjustment scale scores) (p=0.003) were predictors of less severe OCD at discharge (adjusted R-square=0.28). Depression severity (Beck Depression Inventory scores) and insight were not predictive of treatment outcome. Future research is necessary to elucidate putative relationships between gender and OCD psychopathology, and to understand the interplay of psychosocial factors, OCD severity and treatment outcome.

A discordant sib-pair linkage analysis of age-related macular degeneration.

BACKGROUND: Age-related macular degeneration (AMD) is the leading cause of visual impairment and blindness among older adults in the United States and throughout the developed world. Etiological research implicates both genetic and environmental components. Our prior genome scan in 511 affected sib-pairs and other relative pairs identified significant or suggestive linkage signals on chromosomes 1, 2, 3, 6, 8, 10, 12, 16, and 22. PURPOSE: To search for genetic loci for AMD using the extremely discordant sib-pair (EDSP) method of linkage analysis, which until now has never been applied to the study of AMD. METHODS: The EDSP method is a more powerful approach than standard methods which rely on relative pairs selected at random or pairs concordant for the phenotype. The EDSP approach has also been characterized as the only design that is uniformly powerful in nearly all genetic situations. Thus, substantial reductions in sample size can be achieved. STUDY POPULATION: The study sample for analysis included 110 EDSPs from 40 families that comprise a subset of the 158 families studied in a prior genome-wide scan using affected relative pairs. RESULTS: Evidence for linkage was found on chromosomes 1q, 2q, 6q, 19p, and 20q. The regions identified on chromosomes 1q and 2q were the same regions identified in our prior analysis, whereas the identified region on 6q was approximately 80 cM distal to our previous signal. DISCUSSION: Within this study population, we have narrowed the focus to chromosomes 1q, 2q, 6q, 19p, and 20q in our search for AMD loci. However, given the fact that a gene was recently identified on chromosome 1q, future family- and population-based analyses should concentrate on testing for associations with candidate gene variants in the other identified chromosomal regions in searches for additional AMD loci.