Team-Based Coaching Intervention to Improve Contrast-Associated Acute Kidney Injury: A Cluster-Randomized Trial.

BACKGROUND: Up to 14% of patients in the United States undergoing cardiac catheterization each year experience AKI. Consistent use of risk minimization preventive strategies may improve outcomes. We hypothesized that team-based coaching in a Virtual Learning Collaborative (Collaborative) would reduce postprocedural AKI compared with Technical Assistance (Assistance), both with and without Automated Surveillance Reporting (Surveillance). METHODS: The IMPROVE AKI trial was a 2×2 factorial cluster-randomized trial across 20 Veterans Affairs medical centers (VAMCs). Participating VAMCs received Assistance, Assistance with Surveillance, Collaborative, or Collaborative with Surveillance for 18 months to implement AKI prevention strategies. The Assistance and Collaborative approaches promoted hydration and limited NPO and contrast dye dosing. We fit logistic regression models for AKI with site-level random effects accounting for the clustering of patients within medical centers with a prespecified interest in exploring differences across the four intervention arms. RESULTS: Among VAMCs' 4517 patients, 510 experienced AKI (235 AKI events among 1314 patients with preexisting CKD). AKI events in each intervention cluster were 110 (13%) in Assistance, 122 (11%) in Assistance with Surveillance, 190 (13%) in Collaborative, and 88 (8%) in Collaborative with Surveillance. Compared with sites receiving Assistance alone, case-mix-adjusted differences in AKI event proportions were -3% (95% confidence interval [CI], -4 to -3) for Assistance with Surveillance, -3% (95% CI, -3 to -2) for Collaborative, and -5% (95% CI, -6 to -5) for Collaborative with Surveillance. The Collaborative with Surveillance intervention cluster had a substantial 46% reduction in AKI compared with Assistance alone (adjusted odds ratio=0.54; 0.40-0.74). CONCLUSIONS: This implementation trial estimates that the combination of Collaborative with Surveillance reduced the odds of AKI by 46% at VAMCs and is suggestive of a reduction among patients with CKD. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: IMPROVE AKI Cluster-Randomized Trial (IMPROVE-AKI), NCT03556293.

Outcomes of cardiac catheterization and percutaneous coronary intervention for in-hospital ventricular tachycardia or fibrillation cardiac arrest.

OBJECTIVE: This study examined outcomes of patients with sudden cardiac death attributable to primary ventricular tachycardia (VT) or ventricular fibrillation (VF) that underwent cardiac catheterization with or without percutaneous coronary intervention (PCI). BACKGROUND: The decision to perform cardiac catheterization and PCI in resuscitated patients with sudden cardiac death remains controversial. Prior data suggest a potential benefit from percutaneous revascularization. METHODS: All patients with an in-hospital pulseless VT or VF cardiac arrest from August 2002 to February 2008 who underwent cardiac catheterization were included. Retrospective chart review was performed to obtain clinical, neurologic, and angiographic data. Primary endpoints were all-cause mortality and neurologic outcome. RESULTS: Two thousand and thirty-four patients had in-hospital cardiac arrest, of these 116 had pulseless VT or VF and were resuscitated and 93 (80%) underwent coronary angiography. The median time to follow-up was 1.3 years (IQR: 0.5-2.9 years). Obstructive coronary artery disease (CAD) was observed in 74 (79%) individuals, of whom 37 underwent PCI. Thirty-five patients with obstructive CAD (47%) died compared to 41% with nonobstructive CAD. In unadjusted and multivariable adjusted analysis PCI was not associated with lower mortality (adjusted hazard ratio: 1.54, 95% CI, 0.79-3.02, P = 0.20). No significant differences were noted in neurologic status at discharge (P = 0.49). CONCLUSION: In this study, an aggressive revascularization strategy with PCI did not confer a survival advantage nor was it associated with improved neurologic outcomes. There was no suggestion of harm with PCI and further studies are necessary to identify potential subgroups that may benefit from revascularization.

Clinical trial experience with transcatheter aortic valve insertion.

Surgical aortic valve replacement has long been considered the standard of care for patients with severe symptomatic aortic stenosis, however, an aging population with increasing complex comorbidities now represents a growing population of patients that is often considered inoperable for a traditional surgical approach. Transcatheter aortic valve implantation is a developing technology that offers an alternative treatment modality for these very high risk patients. This manuscript will review the currently available clinical trial data with transcatheter aortic valve implantation and offer perspective as to the future of this novel technology.

The optimal treatment of carotid atherosclerosis: a 2008 update and literature review.

Carotid and cerebrovascular disease have major public health implications given the associated morbidity and mortality. However, the best treatment for this disease is uncertain. Carotid endarterectomy has proven useful in primary and secondary prevention of strokes for patients with significant internal carotid artery stenoses. Many patients are considered at high risk for such surgical procedures and therefore have relatively few treatment options. Carotid stenting is currently being investigated as an alternative therapeutic intervention for these patients. This article reviews the literature pertaining to carotid intervention and its current status in 2008.

The effect of drug-eluting stents on intermediate angiographic and clinical outcomes in diabetic patients: insights from randomized clinical trials.

OBJECTIVE: Implantation of drug-eluting stents has emerged as the predominant percutaneous revascularization strategy in diabetic patients, despite limited outcomes data. Accordingly, our aim was to conduct a meta-analysis to assess the benefit and safety profile of drug-eluting stents in diabetic patients. METHODS: We included randomized trials comparing either the paclitaxel- or sirolimus-eluting stent with a bare-metal stent or with each other in diabetic patients during a follow-up of at least 6 months. RESULTS: A total of 16 studies were identified, which included 2951 diabetic patients who were followed up for 6 to 12 months. Target lesion revascularization was less frequently performed in patients who received drug-eluting stents compared with bare-metal stents (risk ratio [RR] 0.35, 95% CI 0.27-0.46, P < .0001). Similar reductions were noted in the incidence of major adverse cardiovascular events (RR 0.42, 95% CI 0.31-0.56, P < .0001), in-segment restenosis (RR 0.31, 95% CI 0.25-0.40, P < .0001), and non-Q-wave myocardial infarction (RR 0.57, 95% CI 0.32-0.99, P = .046). Event rates were similar for Q-wave myocardial infarction (RR 0.72, 95% CI 0.25-2.07, P = .54), death (RR 0.64, 95% CI 0.32-1.28, P = .20), and stent thrombosis (RR 0.41, 95% CI 0.13-1.27, P = .12). CONCLUSIONS: In conclusion, diabetic patients who receive drug-eluting stents have a significantly lower incidence of target lesion revascularization, in-segment restenosis and myocardial infarction at 6 to 12 months, compared with bare-metal stents. The rates of mortality and stent thrombosis are similar.

Incremental effect of clopidogrel on important outcomes in patients with cardiovascular disease: a meta-analysis of randomized trials.

OBJECTIVES: To quantify the impact of clopidogrel plus aspirin on the individual outcomes of death, myocardial infarction, or stroke in patients with established cardiovascular disease, or in patients with multiple risk factors for vascular disease. BACKGROUND: Randomized trials have demonstrated a reduction in composite outcomes when clopidogrel is added to aspirin therapy in patients with coronary artery disease; however, the magnitude of benefit on individual outcomes is unknown. METHODS: We conducted a meta-analysis on randomized, controlled trials that compared aspirin plus clopidogrel with aspirin plus placebo for the treatment of coronary artery disease. RESULTS: This analysis included five randomized trials (CURE, CREDO, CLARITY, COMMIT, and CHARISMA) in 79 624 patients. The incidence of all-cause mortality was 6.3% in the aspirin plus clopidogrel group versus 6.7% in the aspirin group (odds ratio [OR] 0.94; 95% CI 0.89, 0.99; p = 0.026). The incidence of myocardial infarction was 2.7% and 3.3% (OR 0.82; 95% CI 0.75, 0.89; p < 0.0001), and stroke was 1.2% and 1.4% (OR 0.82; 95% CI 0.73, 0.93; p = 0.002). Similarly, the incidence of major bleeding was 1.6% and 1.3% (OR 1.26; 95% CI 1.11, 1.41; p < 0.0001), and fatal bleeding was 0.28% and 0.27% (OR 1.04; 95% CI 0.76, 1.43; p = 0.79). CONCLUSION: The addition of clopidogrel to aspirin results in a small reduction in all-cause mortality in patients with ST-elevation myocardial infarction and a modest reduction in myocardial infarction and stroke in patients with cardiovascular disease. The overall incidence of major bleeding however is increased, although there is no excess of fatal bleeds or hemorrhagic strokes.

Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials.

PURPOSE: Drug-eluting stents are commonly used for percutaneous coronary intervention. Despite excellent clinical efficacy, the association between drug-eluting stents and the risk for late thrombosis remains imprecisely defined. METHODS: We performed a meta-analysis on 14 contemporary clinical trials that randomized 6675 patients to drug-eluting stents (paclitaxel or sirolimus) compared with bare metal stents. Eight of these trials have reported more than a year of clinical follow-up. RESULTS: The incidence of very late thrombosis (>1 year after the index procedure) was 5.0 events per 1000 drug-eluting stent patients, with no events in bare metal stent patients (risk ratio [RR]=5.02, 95% confidence interval [CI], 1.29 to 19.52, P=.02). Among sirolimus trials, the incidence of very late thrombosis was 3.6 events per 1000 sirolimus stent patients, with no events in bare metal stent patients (RR=3.99, 95% CI, .45 to 35.62, P=.22). The median time of late sirolimus stent thrombosis was 15.5 months, whereas with bare metal stents it was 4 months. Among paclitaxel trials, the incidence of very late thrombosis was 5.9 events per 1000 paclitaxel stent patients, with no events in bare metal stent patients (RR=5.72, 95% CI, 1.08 to 32.45, P=.049). The median time of late paclitaxel stent thrombosis was 18 months, whereas it was 3.5 months in bare metal stent patients. CONCLUSIONS: Although the incidence of very late stent thrombosis more than 1 year after coronary revascularization is low, drug-eluting stents appear to increase the risk for late thrombosis. Although more of this risk was seen with paclitaxel stents, it remains possible that sirolimus stents similarly increase the risk for late thrombosis compared with bare metal stents.

Risk of thrombosis with the use of sirolimus-eluting stents for percutaneous coronary intervention (from registry and clinical trial data).

We conducted a meta-analysis on 6 studies in 2,963 patients who had coronary artery disease and received a sirolimus-eluting stent or a bare metal stent for revascularization. Compared with bare metal stents, sirolimus-eluting stents did not appear to increase the risk for thrombosis up to 13.5 months after coronary intervention (risk ratio 0.49, 95% confidence interval 0.22 to 1.12, p = 0.09).

What is the risk of stent thrombosis associated with the use of paclitaxel-eluting stents for percutaneous coronary intervention?: a meta-analysis.

OBJECTIVES: This study investigated the risk of stent thrombosis associated with the use of paclitaxel-eluting stents (PES) compared to bare-metal stents (BMS). BACKGROUND: Clinical experience with coronary drug-eluting stents (DES) is relatively limited. There is concern that DES used for percutaneous coronary intervention may result in subsequent thrombosis. METHODS: We conducted a meta-analysis on eight trials (total of 13 study arms) in 3,817 patients with coronary artery disease who were randomized to either PES or BMS. RESULTS: As compared with BMS, PES do not increase the hazard for thrombosis up to 12 months (risk ratio [RR] = 1.06, 95% confidence interval [CI] 0.55 to 2.04, p = 0.86]). There was no evidence of heterogeneity among the studies (chi-square value for Q-statistic = 5.90 [10 degrees of freedom], p = 0.82). Similar results were obtained when the analysis was restricted to trials with a polymeric stent platform (Treatment of de novo coronary disease using a single pAclitaXel elUting Stent [TAXUS]-I, -II, -IV, and -VI) (RR = 1.01, 95% CI 0.40 to 2.53, p = 0.99), trials with longer lesions (TAXUS-IV and -VI) (RR = 0.62, 95% CI 0.2 to 1.91, p = 0.41), and trials that used a higher dose of paclitaxel (ASian Paclitaxel-Eluting Stent Clinical trial [ASPECT], European evaLUaTion of paclitaxel Eluting Stents [ELUTES], and DELIVER-I) (RR = 1.87, 95% CI 0.52 to 6.81, p = 0.34). CONCLUSIONS: Current evidence suggests that standard dose PES do not increase the hazard of stent thrombosis compared to BMS.