Faculty Bibliography

BACKGROUND: Drug eluting stents (DES) reduce the risk of restenosis but are associated with increase in the risk of very late stent thrombosis, especially when antiplatelet therapy is held. The trend in DES use across the US is not fully defined. METHODS: Data from the 2001-2011 Nationwide Inpatient Sample for patients undergoing PCI were used. The trend in DES use was analyzed overall and in subgroups at risk of restenosis (those with diabetes, chronic kidney disease or prior PCI), stent thrombosis (those with acute coronary syndrome) or bleeding (those with history of bleeding peptic ulcer or atrial fibrillation). RESULTS: Among the 8,150,763 PCI procedures performed, DES use peaked in 2005 at 89% in all patients including groups with a low risk of restenosis, high risk of stent thrombosis or bleeding. A steep drop to 66% was noted in 2007 followed by a progressive rise to 73% in 2011 (P<0.0001). The 2011 DES use patterns indicate increased DES use in subgroups at risk of restenosis, decreased use in subgroups at risk of thrombosis or bleeding but also lower use in groups at risk for discriminant care such as African Americans, the elderly and patients with Medicaid/self-pay. CONCLUSIONS: DES trends indicate rapid and broad initial use followed by a sharp decline in 2007 and a progressive rise in 2011. DES use in 2011 seemed based on risk category, but was lower in groups at risk for discriminant care.

Current guidelines recommend 12 months of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation in the absence of increased bleeding risk. Studies have suggested that early discontinuation of DAPT can result in an increased risk of stent thrombosis. However, given the potential for major bleeding, the optimal duration of DAPT after DES implantation remains uncertain. We searched PubMed, EMBASE, Scopus, and ClinicalTrials.gov databases from inception until October 2013 for randomized controlled trials that compared shorter versus longer DAPT duration after DES implantation. Four randomized controlled trials were included. A total of 4,081 patients received DAPT for 3 to 6 months, and 4,076 patients were treated with DAPT for 12 to 24 months. Oral DAPT consisted of aspirin and clopidogrel. There was no significant difference in the rate of the composite outcome of cardiac death or myocardial infarction between the short (3.3%) and prolonged (3.0%) DAPT groups (odds ratio 1.11, 95% confidence interval 0.87 to 1.43, p = 0.41). A landmark analysis performed at the time of discontinuation of DAPT in the short DAPT group demonstrated a nonsignificant higher rate of stent thrombosis in patients treated with a short course of DAPT (0.35% vs 0.20%, p = 0.22). Major bleeding was significantly higher in the group of patients treated with prolonged DAPT (0.29% vs 0.71%, p = 0.01). In conclusion, prolonged DAPT compared with short-term treatment is associated with increased major bleeding but is not associated with a decrease in the composite rates of death or myocardial infarction.

Recent trials have highlighted the comparable mortality benefits and durability of the results for patients with severe aortic stenosis (AS) and high surgical risk managed with either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (AVR). Various national guidelines and international regulatory bodies have approved TAVR, thereby leading to potential wide usage and dissemination of this technique worldwide. Quality-of-life outcomes, in spite of being an important measure of success and acceptability of the procedure, have not been publicized as extensively. For high risk patients with severe AS, implementation of TAVR has resulted in comparable survival, but different and novel adverse events compared with AVR. We present an updated review focusing on the quality-of-life outcomes and issues with this new and important procedural approach.

BACKGROUND:: Epidemiological studies have observed protective effects of mid-upper arm circumference (MUAC) against all-cause mortality mostly in Western populations. However, evidence on cause-specific mortality is limited. METHODS:: The sample included 19 575 adults from a population-based cohort study in rural Bangladesh, who were followed up for an average of 7.9 years for mortality. Cox proportional hazards regression was used to evaluate the effect of MUAC, as well as the joint effect of body mass index (BMI) and MUAC, on the risk of death from any cause, cancer and cardiovascular disease (CVD). RESULTS:: During 154 664 person-years of follow-up, 744 deaths including 312 deaths due to CVD and 125 deaths due to cancer were observed. There was a linear inverse relationship of MUAC with total and CVD mortality. Each 1-cm increase in MUAC was associated a reduced risk of death from any cause [hazard ratio (HR) = 0.85; 95% confidence interval (C), 0.81-0.89) and CVD (HR = 0.87; 95% CI, 0.80-0.94), after controlling for potential confounders. No apparent relationship between MUAC and the risk of death from cancer was observed. Among individuals with a low BMI (<18.5 kg/m2), a MUAC less than 24 cm was associated with increased risk for all-cause (HR = 1.81; 95% CI, 1.52-2.17) and CVD mortality (HR = 1.45; 95% CI, 1.11-1.91). CONCLUSIONS:: MUAC may play a critical role on all-cause and CVD mortality in lean Asians.

Numerous clinical trials testing the efficacy of aspirin for the secondary prevention of cardiovascular disease have been published. We reviewed the literature pertaining to aspirin dose in acute coronary syndrome patients. Clinical trials assessing the comparative efficacy of different doses of aspirin are scarce. This complex antiplatelet therapy landscape makes it difficult to identify the best aspirin dose for optimizing efficacy and minimizing risk of adverse events, while complying with the various guidelines and recommendations. Despite this fact, current evidence suggests that aspirin doses of 75-100 mg/day may offer the optimal benefit:risk ratio in acute coronary syndrome patients.

Objectives: We sought to update our meta-analysis on clinical outcomes with aspiration thrombectomy prior to primary percutaneous coronary intervention (PPCI) compared with conventional PPCI alone due to the availability of additional trial data. Background: The clinical efficacy of adjunctive aspiration thrombectomy in ST-elevation myocardial infarction (STEMI) patients undergoing PPCI remains controversial. A recent large-scale randomized trial showed no benefit in terms of mortality at 30 days. Methods: Clinical trials that randomized STEMI patients to aspiration thrombectomy prior to PPCI compared with conventional PPCI alone were included. Results: A total of 11,321 patients from 20 randomized controlled trials were included. The composite major adverse cardiac event (MACE) endpoint was lower in the aspiration thrombectomy arm compared with conventional PPCI alone (Risk Ratio [RR]=0.81, 95% CI 0.70-0.94; p=0.006). Although all-cause mortality was similar between the adjunctive aspiration thrombectomy arm and PPCI arms (RR=0.83, 95% CI 0.67-1.01; p=0.06), late mortality (6-12 months) was significantly reduced (RR=0.64; 95% CI 0.44-0.92; p=0.016). Reinfarction (RR=0.64, 95% CI 0.44-0.92; p=0.017) and stent thrombosis (RR=0.54; 95% CI 0.32-0.91; p=0.021) were similarly lower. Differences in target vessel revascularization were of borderline significance (RR=0.83, 95% CI 0.68-1.01; p=0.06) Conclusions: Our meta-analysis including all randomized controlled trials on aspiration thrombectomy to date demonstrates a significant reduction in adverse clinical outcomes including stent thrombosis compared with conventional PCI alone. (c) 2014 Wiley Periodicals, Inc.

A recent study has shown an association between high-potency statins and risk of acute kidney injury. However, these data are from observational studies, and it is not clear if similar signal is seen from randomized controlled trials. We evaluated the risk of renal-associated serious adverse events (SAEs) using statins versus placebo trials and the high-dose versus low-dose statin trials that were available to us. The outcome of interest was renal-related SAEs. The incidence of adverse events relating to kidney injury was determined through review of the adverse event database. The following outcomes were evaluated: (1) renal-related SAEs within 120 days of randomization (primary outcome), (2) renal-related SAEs after 120 days of randomization (secondary), and (3) drug discontinuation due to renal-related SAEs (secondary). There was no difference in the incidence of renal-related SAEs at 120 days (0.04% vs 0.10%, p = 0.162) between atorvastatin and placebo in the 24 placebo-controlled trials (10,345 patients on atorvastatin (10 to 80 mg/day) versus 8,945 patients on placebo) or in the high-dose versus low-dose statin trials including the Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) study (0.05% vs 0.02%, p = 0.625) or the Treating to New Targets (TNT) trial (0.0% vs 0.04%, p = 0.500) trial. Results were similar for renal-related SAEs after 120 days (placebo controlled trials [0.38% vs 0.36%, p = 0.905], IDEAL trial [0.56% vs 0.65%, p = 0.683], or the TNT trial [0.76% vs 1.04%, p = 0.168]) and for drug withdrawal due to renal-related SAE (placebo controlled trials [0.05% vs 0.04%, p = 1.00], IDEAL trial [0.02% vs 0.0%, p = 0.499], or the TNT trial [0.08% vs 0.12%, p = 0.754]). In conclusion, the results from clinical trials with data from 149,882 patient-years of follow-up fail to show any increase in renal-related SAEs with statins compared with controls.