Publications by Year: 2019

BACKGROUND: The cost-effectiveness of newer drug-eluting stents (DES) such as biodegradable-polymer or polymer-free stents with shorter dual antiplatelet therapy (DAPT) duration is unknown. We evaluated the cost-effectiveness of treatment with newer DES that may allow for shorter DAPT duration.

PATIENTS AND METHODS: We performed a cost-effectiveness analysis of treatment with newer DES platforms followed by 1 or 3 months of DAPT compared with standard second-generation DES followed by 6 or 12 months of DAPT in patients with stable coronary disease. A Markov model simulated distinct health states over a lifetime. Probabilistic sensitivity analysis and one-way sensitivity analyses were performed. A high-risk bleeding scenario was also evaluated.

RESULTS: Among patients with typical bleeding risk, second-generation DES and 6 months of DAPT was less expensive and resulted in marginally higher quality-adjusted life years compared with other strategies. A newer DES platform and 3 months of DAPT was preferred when the risk of fatal bleeding was two times greater than baseline, or when bleeding increased long-term mortality by a factor of 1.5. In a probabilistic sensitivity analysis, second-generation DES and 6 months of DAPT was preferred in 58% of iterations, whereas in a high-risk bleeding patient scenario, a newer DES and 3 months of DAPT was preferred in 52% of iterations.

CONCLUSION: A DES that allows 3 months of DAPT without increasing stent-related events is likely to be cost-effective among patients at elevated risk of bleeding, but not in patients with average bleeding risk.

BACKGROUND: Appearance-based messages have shown promise in improving sun protection habits among Caucasians but have scarcely been investigated in Hispanic populations.

OBJECTIVE: To compare the effectiveness of appearance-based vs health-based messages in an ethnic patient population, where hyperpigmentation disorders are prevalent and often cosmetically concerning.

METHODS: One hundred thirty-seven patients were randomized to receive images of (a) skin cancer, (b) hyperpigmentation, or (c) wrinkles. Analysis of variance tests for repeated measures were used to estimate the effects of the different stimuli on participants' knowledge and intention to sun protect.

RESULTS: Appearance-based interventions were more effective in improving intentions to sun protect among both Hispanics and non-Hispanic Whites (P < 0.05). They were furthermore more effective among younger patient populations (≤40 years old) and patients who thought that a tanned appearance is attractive (P < 0.05).

CONCLUSIONS: Appearance-based photos of sun damage were more effective than health-based messages among Hispanics, younger patient populations, and those who find tanned appearances to be attractive.

BACKGROUND: Advances in chronic total occlusion percutaneous coronary intervention (CTO PCI) techniques have led to increased procedural success rates among operators. While utilization of CTO PCI has disseminated widely, the learning curve for new operators has not been well-defined.

METHODS: Between July 2009 and December 2015, 93 875 CTO PCI cases were extracted from the CathPCI Registry. We delineated a cohort of new CTO operators performing <10 CTO PCI cases per given year. In-hospital outcomes for subsequent CTO PCIs were stratified by the number of prior cases accrued by each operator. Multivariable regression models were used to estimate differences in outcomes with increasing experience. The primary outcome was major adverse cardiovascular events defined as the composite of death, myocardial infarction, stroke, tamponade, or urgent coronary artery bypass grafting.

RESULTS: Among 70 916 cases performed by 7251 new operators, procedure success rate was 61.4% and major adverse cardiovascular event rate was 4.2%. Meanwhile, the rate of major bleeding was 4.0%, myocardial infarction 2.0%, mortality 0.6%, tamponade 0.3%, and renal failure 0.2%. Adjusted regression models demonstrated piecewise linear improvements in guidewire crossing, stent placement, and procedure success with accrued volume, albeit with increased contrast use, fluoroscopy time, and bleeding. Major adverse cardiovascular event rates were stable beyond the 12th case (odds ratio per 5 case increase 1.00; 95% CI, 0.98-1.03, P=0.7980).

CONCLUSIONS: Among a large number of new CTO PCI operators in the United States, there exists an experiential learning curve for procedural success. However, there were higher rates of bleeding despite case experience, while major adverse cardiovascular events remained relatively unchanged after initiation.

PURPOSE OF REVIEW: Paclitaxel-based endovascular devices have become the standard of care in symptomatic, medication-refractory peripheral artery disease (PAD) and in critical limb ischemia (CLI). This review examines the data on the efficacy and safety of these devices relative to standard balloon angioplasty (PTA) and bare metal stents (BMS).

RECENT FINDINGS: Randomized controlled trials (RCTs) have found that peripheral devices coated with paclitaxel result in superior patency rates and decreased target lesion revascularization (TLR) compared with non-drug-coated devices. Recently, a meta-analysis of randomized controlled trials unexpectedly reported an increase in mortality in patients treated with paclitaxel-coated devices (PCDs), resulting in the pausing of ongoing trials and a warning of safety from the FDA. Observational data that has been published since this time has not supported this safety concern. PAD is a common disease that severely impacts quality and length of life. PCDs are a promising therapy for patients with PAD, offering a more effective and durable intervention when compared with traditional PTA/BMS. A meta-analysis of RCTs identified a signal of harm with these devices which has now been replicated by the FDA. However, there is significant missing data from the trials analyzed by the meta-analysis and FDA, no plausible mechanism linking paclitaxel to death, and no correlation between paclitaxel dose and mortality. Analyses in observational data have found no safety signal. An FDA panel evaluating the validity of this late-mortality signal recently adjourned, emphasizing that the available data is incomplete. PCDs will remain on the market, and an active discussion is underway for developing an approach for improved post-market surveillance, device-labeling, and cause of death adjudication.

Lower extremity peripheral artery disease (PAD) and cerebrovascular disease (CeVD) are prevalent conditions in the United States, and both are associated with significant morbidity (eg, stroke, myocardial infarction, and limb loss) and increased mortality. With a growth in invasive procedures for PAD and CeVD, this demands a more clear responsibility and introduces an opportunity to study how patients are treated and evaluate associated outcomes. The American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry is a prospective, independent collection of data elements from individual patients at participating centers, and it is a natural extension of the already robust NCDR infrastructure. As of September 20, 2018, data have been collected on 45,316 lower extremity PVIs, 12,417 carotid artery stenting procedures, and 11,027 carotid endarterectomy procedures at 208 centers in the United States. The purpose of the present report is to describe the patient and procedural characteristics of the overall cohort and the methods used to design and implement the registry. In collecting these data, ACC and ACC PVI Registry have the opportunity to play a pivotal role in scientific evidence generation, medical device surveillance, and creation of best practices for PVI and carotid artery revascularization.

OBJECTIVE: To evaluate how patients' primary spoken language influences the understanding of their disorder and their subsequent sun-related behaviors.

METHODS: This was a cross-sectional study conducted between February 2015 and July 2016 in two outpatient dermatology clinics among 419 adults with a sun-exacerbated dermatosis. The primary outcome was a successful match between the patient-reported diagnosis on a survey and the dermatologist-determined diagnosis.

RESULTS: Of participants, 42% were native English speakers, and 68% did not know their diagnosis. Fewer non-native English speakers identified one risk factor for their condition (46% versus 54%, p < 0.01). A greater number of non-native English speakers were less familiar with medical terminology. Native English speakers were 2.5 times more likely to know their diagnosis compared to non-native speakers (adjusted odds (aOR) 2.5, 95% confidence interval, 1.32 to 4.5; p = 0.005). Additional factors associated with higher odds of knowing the diagnosis included: Higher education, sunscreen use, female gender, symptoms for 1-5 years, and diagnosis of melasma and postinflammatory hyperpigmentation (PIH).

CONCLUSIONS: Knowledge of the diagnosis and understanding of factors that may influence skin disease may promote conscious sun behavior. Patients who knew that their diagnosis was sun-exacerbated had higher odds of wearing sunscreen.

BACKGROUND: Visual imagery has been shown to improve adherence to health messages but has scarcely been investigated in sun protection campaigns.

OBJECTIVE: To determine the effectiveness of pictorial- and textual-based sun protective messages in a largely Hispanic population.

METHODS: One hundred and forty-five participants received standard of care (SOC) as defined as sun protective counseling and were then randomized to receive either (a) images of sun damage, (b) a textual pamphlet about sun damage, or (c) no further messages. Analysis-of-variance tests for repeated measures were used to estimate the effects of the different stimuli on participants' knowledge and intention to sun protect.

RESULTS: All stimulus groups demonstrated an improvement in perceived effectiveness of sun protective habits (p < 0.05). However, pictorial and textual stimuli were both more effective than SOC in improving intentions to sun protect (p < 0.05), but there was no differential effect between the two.

CONCLUSIONS: Both pictorial and textual stimuli were more effective than SOC in improving intentions to sun protect, but there was no differential effect between the two.