Reducing use of triple therapy after percutaneous coronary intervention: Results from a hospital-wide quality improvement initiative.

BACKGROUND: Trials have shown that for patients on oral anticoagulants (OAC), a short course of dual antiplatelet therapy (DAPT) with OAC reduces post-percutaneous coronary intervention (PCI) bleeding without increasing ischemic events. Adoption of this strategy has been variable. We evaluated the impact of an institutional quality improvement (QI) initiative to reduce the use of triple therapy (TT, OAC + DAPT) and improve discharge communication post-PCI. METHODS: A hospital-wide QI initiative was developed to minimize time on TT post-PCI. Interventions included institutional guidelines emphasizing discharge on OAC with a P2Y12 inhibitor or reducing TT duration to ≤30 days, changes to the computerized decision-support system, and an educational curriculum for house staff. PCI patients 18 months before and after the initiative (2017-2020) were reviewed along with a faculty survey assessing prescribing practices to evaluate the efficacy of the interventions. RESULTS: Among 2797 PCIs reviewed, 431 were included based on OAC at discharge: 24.9% female, 80.1% White, and the mean age was 74 years. The most common indications for OAC were atrial fibrillation (70.1%) and left ventricular dysfunction (11.4%). Mean duration of TT decreased (58.7-37.8 days, p = 0.02) and patients discharged on TT ≤ 30 days increased (24%-37%, p = 0.019) after intervention. Of surveyed faculty (n = 20), 75.0% reported familiarity with the guidelines and 57.9% reported using them to make therapy decisions. CONCLUSIONS: Following the implementation of a QI initiative, fewer patients were discharged on TT and shorter durations of TT were used. Similar initiatives should be considered at institutions with the prevalent use of TT post-PCI.

Ipsilateral transulnar artery approach catheterizations after failure of the radial approach-Are two sheaths in the same arm safe?

AIMS: To assess the safety and feasibility of ipsilateral transulnar access (TUA) after failure of radial access (TRA), with two sheaths placed in the radial and ulnar arteries (RA and UA) in the same arm. MATERIALS AND METHODS: All consecutive patients with TUA due to inability to cross from ipsilateral TRA in the period from March 2011 until September 2020 were included in the study. We examined clinical and procedure characteristics, access site bleeding and ischemic complications and failure mode of initial TRA. Patients were assessed by duplex ultrasound post-procedure (at an average of 56 ± 31 months) and followed clinically (functional and pain assessment). RESULTS: In this period, out of 51,866 patients 112 (0.2%) had a transulnar artery approach due to inability to cross from ipsilateral radial approach. Mean age of patients was 65 ± 11 years with 44% females. Cause for crossover to ipsilateral TUA was inability to cross a RA anomaly in 107 (95%) patients, mostly due to the presence of a "360°" RA loop in 88 patients. Type 3 and 4 EASY Score hematoma was present in 3 patients (2.6%). Six (5.3%) of the patients had new ipsilateral radial artery occlusion noted on duplex on follow up. There were no ulnar artery occlusions detected. There were no clinical or ischemic hand complications seen during a median 4.3 years of follow up. CONCLUSION: Ipsilateral transulnar artery access following failed radial artery access crossing is safe and successful for coronary angiography and intervention with low rates of complications.

Expanding opportunities to understand quality and outcomes of peripheral vascular interventions: The ACC NCDR PVI Registry.

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.

Identifying Complications and Optimizing Consultations following Transradial Arterial Access for Cardiac Procedures.

BACKGROUND: The radial approach to cardiac procedures has become increasingly common. Although previous studies have suggested a favorable risk profile, serious complications can occur. The purpose of this study is to examine the incidence, subsequent treatment, and outcome of all suspected significant neurovascular complications following transradial cardiac procedures at a large US hospital. METHODS: We reviewed all patients who underwent a left heart catheterization, coronary angiogram, or percutaneous coronary intervention via the transradial approach at a single large academic medical center in the United States between 2010 and 2016. Consultations to the vascular and hand surgery services were examined to assess demographic variables, risk factors, presenting symptoms, subsequent treatment, and outcome of all serious complications. RESULTS: A total of 9,681 radial access cardiac procedures were performed during the study period. Twenty-four cases (0.25%) were suspected to have major complications and subsequently received consults. A total of 18 complications were diagnosed, including 8 vascular injuries or perforations, 4 hematomas, 4 radial artery occlusions, 1 case of compartment syndrome, and 1 severe radial artery spasm. Of the complications noted, 3 (16.7%) required operative interventions, but all recovered neurovascular function. CONCLUSIONS: Radial artery access for cardiac procedures has become increasingly common and has been associated with a low rate of major peripheral neurovascular complications. The majority (83.3%) of complications were successfully treated with a nonoperative management algorithm.

The prognostic value of the relationship between right atrial and pulmonary capillary wedge pressure in diverse cardiovascular conditions.

BACKGROUND: Physical examination of jugular venous pressure is used to estimate right atrial (RA) pressure and infer left-sided filling pressure to assist volume management. Previous studies in advanced heart failure patients showed about 75% concordance between RA and pulmonary capillary wedge (PCW) pressures. We sought to determine the relationship between mean RA and mean PCW pressure and assess the clinical significance in a broad population of patients undergoing invasive right heart catheterization (RHC). METHODS: We examined 4135 RHC cases at a single academic medical center from February 2007 to December 2014, analyzing baseline variables, hemodynamic data, and in-hospital mortality. RESULTS: The overall Pearson correlation for mean RA and PCW pressures was 0.68 with 70% concordance between dichotomized pressures (RA ≥10 and PCW ≥22 mmHg). Results were similar in subgroups with heart failure (r=0.67, 72%), STEMI/NSTEMI (r=0.60, 69%), unstable angina (r=0.78, 69%), stable/no angina (r=0.72, 67%), and valvular disease (r=0.61, 72%; Chi-square P=.15). Mean RA pressure was independently associated with in-hospital mortality in multivariate analysis (OR 1.12 [95% CI 1.081-1.157] per 1 mmHg increase, P<.001). The RA/PCW ratio was not independently associated with in-hospital mortality. Mean RA pressure was also weakly associated with worse renal function (rho=-0.16, P<.001). CONCLUSION: In patients undergoing right catheterization for diverse indications, the mean RA and PCW pressures correlated moderately well, but there was discordance in a sizable minority, in whom assessment of left-sided filling pressures using estimated jugular venous pressure may be misleading. Elevated right atrial pressure is a marker for in-hospital mortality.

Time-Course of Cause-Specific Hospital Admissions During Snowstorms: An Analysis of Electronic Medical Records From Major Hospitals in Boston, Massachusetts.

With global climate change, more frequent severe snowstorms are expected; however, evidence regarding their health effects is very limited. We gathered detailed medical records on hospital admissions (n = 433,037 admissions) from the 4 largest hospitals in Boston, Massachusetts, during the winters of 2010-2015. We estimated the percentage increase in hospitalizations for cardiovascular and cold-related diseases, falls, and injuries on the day of and for 6 days after a day with low (0.05-5.0 inches), moderate (5.1-10.0 inches), or high (>10.0 inches) snowfall using distributed lag regression models. We found that cardiovascular disease admissions decreased by 32% on high snowfall days (relative risk (RR) = 0.68, 95% confidence interval (CI): 0.54, 0.85) but increased by 23% 2 days after (RR = 1.23, 95% CI: 1.01, 1.49); cold-related admissions increased by 3.7% on high snowfall days (RR = 3.7, 95% CI: 1.6, 8.6) and remained high for 5 days after; and admissions for falls increased by 18% on average in the 6 days after a moderate snowfall day (RR = 1.18, 95% CI: 1.09, 1.27). We did not find a higher risk of hospitalizations for injuries. To our knowledge, this is the first study in which the time course of hospitalizations during and immediately after snowfall days has been examined. These findings can be translated into interventions that prevent hospitalizations and protect public health during harsh winter conditions.

Utility of a real-time appropriate use criteria decision support application for percutaneous coronary interventions in non-acute coronary syndrome.

OBJECTIVES: The aim of this study was to test the feasibility and value of a real-time online appropriate use criteria (AUC) application for percutaneous coronary intervention (PCI) in patients without acute coronary syndrome. BACKGROUND: High rates of non-appropriate elective PCI in the National Cardiovascular Data Registry (NCDR) CathPCI Registry have created interest in integrating decision support tools into routine clinical care to improve the frequency of appropriate PCIs. METHODS: Patients undergoing diagnostic coronary angiography and subsequent PCI for non-ACS indications at a single center were scored using a real-time AUC application pre-procedure. Blinded angiographic review was performed subsequently for each case. Rates of appropriate, inappropriate, uncertain and not rated PCIs were tabulated according to specific clinical scenarios using information available both before and after the angiographic audit. RESULTS: Of 308 PCIs in 272 patients, 196 (63.6%) were deemed appropriate, 79 (25.6%) uncertain, and two (0.6%) inappropriate; 31 (10.1%) scenarios could not be rated. With angiographic audit, inappropriate PCIs increased to 9.7%. There was a significant improvement in the rate of appropriate PCI using the real-time AUC application compared with retrospective data collection for NCDR reporting (64% vs. 53%, P = 0.01). CONCLUSIONS: Use of a real-time AUC application together with angiographic audit may improve the accuracy of reporting PCI appropriateness. © 2015 Wiley Periodicals, Inc.

Cardiac biomarker measurement after elective percutaneous coronary interventions in older patients: insights from the National Cardiovascular Data Registry.

BACKGROUND: Guidelines recommend consideration of cardiac biomarker measurement after elective percutaneous coronary intervention (PCI), especially with complex cases or complicated procedures. However, the long-term prognostic implications of biomarker measurement after elective PCI have not been well characterized in older patients. METHODS: We examined 157,825 Medicare patients undergoing elective PCI in the United States from 2004 to 2008 at 711 hospitals in the CathPCI Registry. Clinical characteristics and 1-year mortality risk were studied, stratified by creatine kinase-muscle band measurement. RESULTS: Overall, 26% of patients on elective PCI had postprocedure biomarkers measured. These patients had more complex coronary anatomy and procedures but had similar rates of PCI success and inhospital mortality when compared with patients without biomarker measurement. The treating hospital was a significant factor associated with the likelihood of postprocedure biomarker surveillance. Hospitals that measured creatine kinase-muscle band in ≥ 90% of patients on elective PCI had lower associated 1-year mortality rates (adjusted hazard ratio 0.84, 95% CI 0.75-0.94) compared with hospitals that measured in < 10% of patients. CONCLUSIONS: Among older patients undergoing elective PCI, postprocedure cardiac biomarker measurement occurred infrequently and was concentrated at certain hospitals. Hospitals that routinely measured post-PCI biomarkers were associated with lower long-term mortality compared with hospitals without routine measurement.

Risk factors for nosocomial gastrointestinal bleeding and use of acid-suppressive medication in non-critically ill patients.

BACKGROUND: It is unknown whether there exist certain subsets of patients outside of the intensive care unit in whom the risk of nosocomial gastrointestinal bleeding is high enough that prophylactic use of acid-suppressive medication may be warranted. OBJECTIVE: To identify risk factors for nosocomial gastrointestinal bleeding in a cohort of non-critically ill hospitalized patients, develop a risk scoring system, and use this system to identify patients most likely to benefit from acid suppression. DESIGN: Cohort study. PATIENTS: Adult patients admitted to an academic medical center from 2004 through 2007. Admissions with a principal diagnosis of gastrointestinal bleeding or a principal procedure code for cardiac catheterization were excluded. MAIN MEASURES: Medication, laboratory, and other clinical data were obtained through electronic data repositories maintained at the medical center. The main outcome measure-nosocomial gastrointestinal bleeding occurring outside of the intensive care unit-was ascertained via ICD-9-CM coding and confirmed by chart review. KEY RESULTS: Of 75,723 admissions (median age = 56 years; 40 % men), nosocomial gastrointestinal bleeding occurred in 203 (0.27 %). Independent risk factors for bleeding included age > 60 years, male sex, liver disease, acute renal failure, sepsis, being on a medicine service, prophylactic anticoagulants, and coagulopathy. Risk of bleeding increased as clinical risk score derived from these factors increased. Acid-suppressive medication was utilized in > 50 % of patients in each risk stratum. Our risk scoring system identified a high risk group in whom the number-needed-to-treat with acid-suppressive medication to prevent one bleeding event was < 100. CONCLUSIONS: In this large cohort of non-critically ill hospitalized patients, we identified several independent risk factors for nosocomial gastrointestinal bleeding. With further validation at other medical centers, the risk model derived from these factors may help clinicians to direct acid-suppressive medication to those most likely to benefit.

Predicting the restenosis benefit of drug-eluting versus bare metal stents in percutaneous coronary intervention.

BACKGROUND: Drug-eluting stents (DES) for percutaneous coronary intervention decrease the risk of restenosis compared with bare metal stents. However, they are costlier, require prolonged dual antiplatelet therapy, and provide the most benefit in patients at highest risk for restenosis. To assist physicians in targeting DES use in patients at the highest risk for target vessel revascularization (TVR), we developed and validated a model to predict TVR. METHODS AND RESULTS: Preprocedural clinical and angiographic data from 27 107 percutaneous coronary intervention hospitalizations between October 1, 2004, and September 30, 2007, in Massachusetts were used to develop prediction models for TVR at 1 year. Models were developed from a two-thirds random sample and validated in the remaining third. The overall rate of TVR was 7.6% (6.7% with DES, 11% with bare metal stents). Significant predictors of TVR included prior percutaneous coronary intervention, emergency or salvage percutaneous coronary intervention, prior coronary bypass surgery, peripheral vascular disease, diabetes mellitus, and angiographic characteristics. The model was superior to a 3-variable model of diabetes mellitus, stent diameter, and stent length (c statistic, 0.66 versus 0.60; P<0.001) and was well calibrated. The predicted number needed to treat with DES to prevent 1 TVR compared with bare metal stents ranged from 6 (95% confidence interval, 5.4-7.6) to 80 (95% confidence interval, 62.7-116.3), depending on patients' clinical and angiographic factors. CONCLUSIONS: A predictive model using commonly collected variables can identify patients who may derive the greatest benefit in TVR reduction from DES. Whether use of the model improves the safety and cost-effectiveness of DES use should be tested prospectively.

Incidence of Myopericarditis and Myocardial Injury in Coronavirus Disease 2019 Vaccinated Subjects.

Several recent publications have described myopericarditis cases after the coronavirus disease 2019 (COVID-19) vaccination. However, it is uncertain if these cases occurred secondary to the vaccination or more common etiologies of myopericarditis. To help determine whether a correlation exists between COVID-19 vaccination and myopericarditis, the present study compared the gender-specific cumulative incidence of myopericarditis and myocardial injury in a cohort of COVID-19 vaccinated patients at a tertiary care center in 2021 with the cumulative incidence of these conditions in the same subjects exactly 2 years earlier. We found that the age-adjusted incidence rate of myopericarditis in men was higher in the vaccinated than the control population, rate ratio 9.7 (p = 0.04). However, the age-adjusted incidence rate of myopericarditis in women was no different between the vaccinated and control populations, rate ratio 1.28 (p = 0.71). We further found that the rate of myocardial injury was higher in both men and women in 2021 than in 2019 both before and after vaccination, suggesting that some of the apparent increase in the diagnosis of myopericarditis after vaccination may be attributable to factors unrelated to the COVID-19 vaccinations. In conclusion, our study reaffirms the apparent increase in the diagnosis of myopericarditis after COVID-19 vaccination in men but not in women, although this finding may be confounded by increased rates of myocardial injury in 2021. The benefits of COVID-19 vaccination to individual and public health clearly outweigh the small potential increased risk of myopericarditis after vaccination.

Prevalence and Risk Factors for Preprocedural Medication Errors in Patients With Atrial Fibrillation and Atrial Flutter.

Perfect adherence to anticoagulant medications is an important aspect of care for patients with atrial fibrillation undergoing cardiac electrophysiology procedures to minimize the risk of stroke. Despite this, adherence remains imperfect as is associated with added cost of additional procedures (e.g., transesophageal echocardiography) and administrative burden. We sought to identify characteristics of such patients and predictors of medication errors at Beth Israel Deaconess Medical Center.

Lessons for Treating Structural Heart Patients during the COVID-19 Pandemic and Beyond.

Background: We sought to compare characteristics and outcomes of structural heart disease (SHD) patients treated during the regional peak of the Coronavirus Disease 2019 (COVID-19) pandemic ("COVID era") compared with historical controls. During the COVID era, elective SHD procedures at Beth Israel Deaconess Medical Center were canceled but urgent cases were still performed. We enacted several practice changes in an effort to minimize complications, prevent COVID transmission, and decrease hospital stay during the pandemic. Methods: Baseline characteristics and outcomes were collected on all patients who underwent SHD procedures during the COVID era and compared with patients treated during the same time period in 2019. Results: Compared with SHD patients treated during 2019 (N = 259), those treated during the COVID era (N = 26) had higher left ventricular end diastolic pressure (LVEDP; 28 vs. 21 mmHg, p = 0.001), and were more likely New York Heart Association class IV (26.9% vs. 10.0%, p = 0.019), but had a lower rate of bleeding/vascular complications (0% vs. 16.2%, p = 0.013), a lower rate of permanent pacemaker implantation (0% vs. 17.4%, p = 0.019), and a greater proportion of patients were discharged on post-operative day 1 (POD#1; 68.2% vs. 22.2%, p < 0.001). Conclusion: Practice changes employed for patients treated during the COVID era were associated with fewer vascular complications, a greater proportion of patients discharged on POD#1, and a lower rate of pacemaker implantation despite more severe illness. As a result, we plan to continue these practices in the post-COVID era.

Stent thrombosis in randomized clinical trials of drug-eluting stents.

BACKGROUND: Definitions of stent thrombosis that have been used in clinical trials of drug-eluting stents have been restrictive and have not been used in a uniform manner. METHODS: We applied a hierarchical classification of stent thrombosis set by the Academic Research Consortium (ARC) across randomized trials involving 878 patients treated with sirolimus-eluting stents, 1400 treated with paclitaxel-eluting stents, and 2267 treated with bare-metal stents. We then pooled 4 years of follow-up data. All events were adjudicated by an independent clinical-events committee. RESULTS: The cumulative incidence of stent thrombosis according to the original protocol definitions was 1.2% in the sirolimus-stent group versus 0.6% in the bare-metal-stent group (P=0.20; 95% confidence interval [CI], -0.4 to 1.5) and 1.3% in the paclitaxel-stent group versus 0.8% in the bare-metal-stent group (P=0.24; 95% CI, -0.3 to 1.4). The incidence of definite or probable stent thrombosis as defined by the ARC was 1.5% in the sirolimus-stent group versus 1.7% in the bare-metal-stent group (P=0.70; 95% CI, -1.5 to 1.0) and 1.8% in the paclitaxel-stent group versus 1.4% in the bare-metal-stent group (P=0.52; 95% CI, -0.7 to 1.4). The incidence of definite or probable events occurring 1 to 4 years after implantation was 0.9% in the sirolimus-stent group versus 0.4% in the bare-metal-stent group and 0.9% in the paclitaxel-stent group versus 0.6% in the bare-metal-stent group. CONCLUSIONS: The incidence of stent thrombosis did not differ significantly between patients with drug-eluting stents and those with bare-metal stents in randomized clinical trials, although the power to detect small differences in rates was limited.

Clinical features and outcomes of carotid artery stenting by clinical expert consensus criteria: a report from the CARE registry.

BACKGROUND: In 2007, a multispecialty society task force published a clinical expert consensus document (CECD) on carotid stenting (CAS), containing recommendations for appropriate patient selection and quality of care. The CECD also inspired creation of a large, national registry of carotid revascularization, the Carotid Artery Revascularization and Endarterectomy (CARE) registry. Our goal here was to investigate whether initial CAS procedures submitted to CARE conformed to CECD recommendations, and examine their clinical outcomes. METHODS: We analyzed CAS procedures for the period January 1, 2005 through December 31, 2008. These were grouped into those that conformed to CECD recommendations [CECD(+), n = 4,636, 79.8%] and those that did not [CECD(-), n = 1,168, 20.2%]. RESULTS: The CECD(+) patients were older than CECD(-) patients (71.5 +/- 10.3 vs. 67.6 +/- 10.3 years, P = 0.001, respectively), and more frequently had chronic kidney disease (46.9% vs. 17.8%, P = 0.001), chronic lung disease (33.0% vs. 12.4%, P = 0.001), ejection fraction

Neuregulin-1 attenuated doxorubicin-induced decrease in cardiac troponins.

Neuregulin-1 (NRG1) is a potential therapeutic agent for the treatment of doxorubicin (Dox)-induced heart failure. NRG1, however, activates the erbB2 receptor, which is frequently overexpressed in breast cancers. It is, therefore, important to understand how NRG1, via erbB2, protects the heart against Dox cardiotoxicity. Here, we studied NRG1-erbB2 signaling in Dox-treated mice hearts and in isolated neonatal rat ventricular myocytes (NRVM). Male C57BL/6 mice were treated with recombinant NRG1 before and daily after a single dose of Dox. Cardiac function was determined by catheterization. Two-week survival was analyzed by the Kaplan-Meier method. Cardiac troponins [cardiac troponin I (cTnI) and cardiac troponin T (cTnT)] and phosphorylated Akt protein levels were determined in mice hearts and in NRVM by Western blot analysis. Activation of caspases and ubiquitinylation of troponins were determined in NRVM by caspase assay and immunoprecipitation. NRG1 significantly improved survival and cardiac function in Dox-treated mice. NRG1 reduced the decrease in cTnI, cTnT, and cardiac troponin C (cTnC) and maintained Akt phosphorylation in Dox-treated mice hearts. NRG1 reduced the decrease in cTnI and cTnT mRNA and proteins in Dox-treated NRVM. Inhibition of erbB2, phosphoinositide 3-kinase (PI3K), Akt, and mTOR blocked the protective effects of NRG1 on cTnI and cTnT in NRVM. NRG1 significantly reduced Dox-induced caspase activation, which degraded troponins, in NRVM. NRG1 reduced Dox-induced proteasome degradation of cTnI. NRG1 attenuates Dox-induced decrease in cardiac troponins by increasing transcription and translation and by inhibiting caspase activation and proteasome degradation of troponin proteins. NRG1 maintains cardiac troponins by the erbB2-PI3K pathway, which may lessen Dox-induced cardiac dysfunction.

Expedited Removal of a Radial Hemostatic Compression Device Following Cardiac Catheterization Is Safe and Associated With Reduced Time to Discharge.

BACKGROUND: Radial access for cardiac catheterization has become increasingly adopted, owing much of its popularity to decreased bleeding complications compared with the femoral approach. Hemostatic compression devices (HCDs) for radial catheterization play a key role in this advantage, but the optimal duration of compression is unknown. A shorter duration of compression is encouraged by guidelines, but removing an HCD too quickly could result in serious bleeding. We aimed to evaluate the safety and effectiveness of expedited removal of a radial HCD after cardiac catheterization. METHODS: We conducted a prospective study of patients undergoing radial cardiac catheterization and/or percutaneous coronary intervention at a tertiary care academic medical center. Patients underwent HCD application using a TR Band® (Terumo Interventional Systems) which was removed after a prespecified amount of time in each of three sequential temporal cohorts: 2-h, 1-h, or 0.5-h. Each patient was monitored for development of bleeding or hematoma and for serious complications. RESULTS: A total of 354 patients participated in our study, with similar numbers in each group. There was a greater rate of minor bleeding in the 0.5-h (12%) and 1-h (19%) groups compared with the 2-h group (8%), but there were no serious complications (need for surgical consultation, transfusion, or unplanned admission) in any group. The average time to discharge was shorter in the 0.5-h and 1-h groups compared with the 2-h group. CONCLUSIONS: Deflating the radial HCD at 0.5 h is safe with no increase in the observed rate of major complications and is associated with reduced time to discharge after coronary angiography or percutaneous coronary intervention using the radial arterial approach.

Clinical, procedural, and pharmacologic correlates of acute and subacute stent thrombosis: results of a multicenter case-control study with 145 thrombosis events.

OBJECTIVES: The aim of this study was to determine correlates of acute/subacute coronary stent thrombosis among unselected patients treated in the era of routine dual antiplatelet therapy and specifically to investigate the influence of prophylactic administration of glycoprotein IIb/IIIa (GpIIb-IIIa) inhibitors and use of clopidogrel versus ticlopidine on the development of coronary stent thrombosis (ST). BACKGROUND: Because of a relative infrequency of ST events and relatively uniform practice patterns within randomized trials, previous studies have had a limited ability to address whether the use of different antiplatelet regimens at the time of coronary stenting is associated with differences in ST. METHODS: We performed a multicenter, case-control study to evaluate clinical, angiographic, and pharmacologic/procedural correlates of ST. Between 1996 and 2000, all cases of angiographically-confirmed ST (n = 145) among patients receiving dual antiplatelet therapy were identified from 10 participating clinical sites and were matched with a control without ST randomly selected from the same institution. RESULTS: Multivariable conditional logistic regression identified higher pre-procedure platelet count, stenting for acute myocardial infarction, use of a coil or self-expanding stent, and overt angiographic thrombus prior to the procedure, as independent predictors of ST (all P < .05). After adjusting for these factors, the use of clopidogrel (vs ticlopidine) was independently associated with an increased risk of ST (OR 2.1, 95% CI 1.0-4.1, P = .04). The use of prophylactic glycoprotein IIb/IIIa inhibitors was not associated with reduced ST in the overall analysis, but appeared to confer some protection against ST within the first 24 hours post procedure (OR 0.5 [95% CI 0.2-1.1] for ST during first day, OR 1.7 [95% CI 0.7-4.3] for ST on subsequent days). CONCLUSION: Both biologic and pharmacologic factors are independently associated with acute/subacute ST. The association between clopidogrel use (vs ticlopidine) and increased ST in this analysis requires confirmation in adequately powered clinical trials and suggests a potential role for newer and more potent antiplatelet agents.

Differential outcomes after sirolimus-eluting stent implantation: comparing on-label versus off-label patients in the 'real world'.

BACKGROUND: Randomized controlled trials indicate that sirolimus-eluting stents (SES) reduce the rates of restenosis and need for subsequent revascularization procedures, but patients enrolled in randomized trials represent a highly selected population. This study examined the performance of SES in a 'real world' setting by comparing the outcomes of trial-eligible versus ineligible patients undergoing percutaneous coronary intervention. METHODS: From the US commercial introduction of SES in April 2003 until December 2003, all patients that received an SES at our institution were followed in a prospective registry (n=838). For the purpose of this analysis, the registry population was divided into two groups based on the inclusion and exclusion criteria of the stenosis in a native coronary artery (SIRIUS) trial. The primary endpoint of the study was the rate of target lesion revascularization (TLR) at follow-up. Secondary endpoints included major adverse cardiac events (MACE) such as cardiac death, myocardial infarction, and target vessel revascularization. Clinical follow-up was complete for 92% of patients with a median duration of 14.2 months. RESULTS: Overall, 296 patients (35.3%) met entry criteria for the SIRIUS trial and thus comprised the SIRIUS eligible group. Patients in the SIRIUS ineligible group (n=542) were more likely to have chronic kidney disease and earlier bypass surgery and had longer mean stent length. At 1 year, TLR occurred in 3.0% of the SIRIUS eligible population and in 9.2% of the SIRIUS ineligible group (P=0.001). The secondary endpoint of cumulative MACE occurred in 6.6% of the SIRIUS eligible versus in 17.7% of the SIRIUS ineligible population (P<0.001). Two patients (0.4%) in the SIRIUS ineligible group had a late stent thrombosis on days 39 and 99, respectively, versus none in the SIRIUS eligible group. CONCLUSION: Among 'real world' patients treated with SES, the incidence of TLR and MACE at 1 year was substantially greater among SIRIUS ineligible patients compared with SIRIUS eligible patients. These findings confirm that pivotal clinical trials of drug-eluting stents tend to enroll low-risk patients and that the estimated rates of TLR and MACE derived from such trials may not reflect subsequent outcomes with unrestricted clinical use.

Long-term trends in the incidence of and survival with heart failure.

BACKGROUND: Heart failure is a major public health problem. Long-term trends in the incidence of heart failure and survival after its onset in the community have not been characterized. METHODS: We used statistical models to assess temporal trends in the incidence of heart failure and Cox proportional-hazards regression to evaluate survival after the onset of heart failure among subjects in the Framingham Heart Study. Cases of heart failure were classified according to the date of onset: 1950 through 1969 (223 cases), 1970 through 1979 (222), 1980 through 1989 (307), and 1990 through 1999 (323). We also calculated 30-day, 1-year, and 5-year age-adjusted mortality rates for each period. RESULTS: Heart failure occurred in 1075 subjects (51 percent of whom were women). As compared with the rate for the period from 1950 through 1969, the incidence of heart failure remained virtually unchanged among men in the three subsequent periods but declined by 31 to 40 percent among women (rate ratio for the period from 1990 through 1999, 0.69; 95 percent confidence interval, 0.51 to 0.93). The 30-day, 1-year, and 5-year age-adjusted mortality rates among men declined from 12 percent, 30 percent, and 70 percent, respectively, in the period from 1950 through 1969 to 11 percent, 28 percent, and 59 percent, respectively, in the period from 1990 through 1999. The corresponding rates among women were 18 percent, 28 percent, and 57 percent for the period from 1950 through 1969 and 10 percent, 24 percent, and 45 percent for the period from 1990 through 1999. Overall, there was an improvement in the survival rate after the onset of heart failure of 12 percent per decade (P=0.01 for men and P=0.02 for women). CONCLUSIONS: Over the past 50 years, the incidence of heart failure has declined among women but not among men, whereas survival after the onset of heart failure has improved in both sexes. Factors contributing to these trends need further clarification.