Cost-Comparison of Mechanical Thrombectomy and Catheter-Directed Thrombolysis in Intermediate-Risk Pulmonary Embolism.

Background: Catheter-directed thrombolysis (CDT) and large-bore mechanical thrombectomy (MT) are the leading percutaneous-based therapies for the management of intermediate-risk pulmonary embolism (PE). While previous studies have demonstrated their procedural safety and efficacy, the cost implications of these interventions remain unclear. This study aims to conduct a cost-benefit analysis to evaluate the economic advantages associated with CDT and MT from the perspective of the treating hospital. Methods: A total of 372 consecutive patients with intermediate-risk acute PE who underwent either MT or CDT at 3 academic centers between 2013 and 2021 were included in this analysis. The costs of care incurred during the index hospitalization for the 2 treatment groups were collected and compared using an adjusted cost model. Results: This study compared the hospital costs of 226 patients who underwent CDT and 146 patients who underwent MT. In the unadjusted overall cohort, the use of CDT was associated with a numerical but nonsignificant increase in costs amounting to $5120 relative to MT (P = .062). This cost difference was primarily driven by the longer length of stay in the intensive care unit and hospital for CDT patients, particularly earlier in the studied timeframe. However, when accounting for confounders including variations between the treating institutions and the timing of treatment during the study period, the adjusted cost differential between CDT and MT narrowed to $1351 (P = .71). Conclusions: This multicenter cost analysis does not reveal a clear cost advantage of 1 treatment over the other for intermediate-risk PE. The observed cost differences were influenced by variations in practice patterns across the study period and among the 3 participating institutions. Future efforts should also focus on strategies to reduce the length of stay, improve efficiency, and minimize the overall cost of care for intermediate-risk PE patients.

A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (ENGULF).

Background: Despite advances in therapy options, pulmonary embolism (PE) continues to carry a high risk of mortality and morbidity. Currently, therapeutic options are limited with only 2 US Food and Drug Administration-cleared catheter-based embolectomy devices approved for the treatment of intermediate-risk PE. The novel Helo PE thrombectomy catheter (Endovascular Engineering, Inc) has a flexible and collapsible funnel with an internal agitator for a dual mechanism of treatment for acute PE. We sought to investigate the safety and feasibility of the novel Helo PE thrombectomy catheter in intermediate-risk PE. Methods: A prospective, single-arm feasibility study evaluating the Helo PE catheter was performed in patients presenting with intermediate-risk PE. Patients underwent preprocedural and postprocedural computed tomography angiography. Primary efficacy was the difference in preprocedural to postprocedural right ventricle/left ventricle (RV/LV) ratio. Primary and secondary safety outcomes were all-cause mortality, major life-threatening bleeding, device-related serious adverse events, pulmonary or cardiac injury, and clinical decompensation at 48 hours postprocedure and at 30 days. Results: A total of 25 patients from 8 centers were consented and included in the analysis. Preprocedural computed tomography angiography revealed an RV/LV ratio of 1.53 ± 0.27. All patients underwent a successful thrombectomy procedure. Postprocedure, the RV/LV ratio was reduced to 1.15 ± 0.18, translating into a 23.2 ± 12.81% decrease from baseline. No patients underwent adjunctive thrombolysis. Two patients had adjunctive catheter-directed embolectomy with an alternative device. Two patients had postprocedural anemia requiring transfusion but did not meet criteria for major life-threatening bleeding by VARC-2 criteria. There were no major adverse events including no deaths, major bleeding, pulmonary injury, or vascular complications at 48 hours or 30 days post procedure. Conclusions: In this multicenter first-in-human study, use of the Helo PE thrombectomy catheter was feasible and safe for the treatment of acute PE.

Mechanical thrombectomy versus catheter directed thrombolysis in patients with pulmonary embolism: A multicenter experience.

OBJECTIVES: Compare in-hospital outcomes of patients treated with either mechanical thrombectomy (MT) or catheter directed lysis (CDL) in treatment of acute pulmonary embolism (PE). METHODS: This is a multicenter, retrospective cohort study of patients undergoing MT or CDL for acute PE between 2014 and 2021. The primary outcome was the composite of in-hospital death, significant bleed, vascular complication, or need for mechanical support post-procedure. Secondary outcomes included the individual components of the composite outcome in addition to blood transfusions, invasive hemodynamics, echocardiographic data, and intensive care unit (ICU) utilization. RESULTS: 458 patients were treated for PE with 266 patients in the CDL arm and 192 patients in the MT arm. The primary composite endpoint was not significantly different between the two groups with CDL 12% versus MT 11% (p = 0.5). There was a significant difference in total length of ICU time required with more in the CDL group versus MT (3.8 ± 2.0 vs. 2.8 ± 3.0 days, p = 0.009). All other secondary end points showed no significant difference between the groups. CONCLUSIONS: In patients undergoing catheter directed treatment of PE, there was no difference between MT and CDL in terms of in-hospital mortality, bleeds, catheter-related complications, and hemodynamics.

Attitudes toward pharmacogenetics in patients undergoing CYP2C19 testing following percutaneous coronary intervention.

Aim: Patient knowledge and attitudes toward pharmacogenetic (PGx) testing may impact adoption of clinical testing. Methods: Questionnaires regarding knowledge, attitudes and ethics of PGx testing were distributed to 504 patients enrolled in the ADAPT study conducted at two urban hospitals in Philadelphia, Pennsylvania, USA. Responses were assessed using multivariable logistic regression. Results: 311 completed the survey (62% response rate). 74% were unaware of PGx testing, but 79% indicated using PGx results to predict medication efficacy was important. In a multivariable model, higher education level (p = 0.031) and greater genetics knowledge (p < 0.001) were associated with more positive attitudes toward PGx testing. Conclusion: Greater patient knowledge of genetics was associated with a more positive attitude toward PGx testing, indicating that educational strategies aimed at increasing genetics knowledge may enhance adoption of PGx testing in the clinic.

Pharmacogenetic (PGx) testing looks for genetic variations that may impact one's ability to respond to certain medications. This has the potential to improve patient care and minimize side effects from medications but is not currently used as standard of care for several reasons including a limited understanding of patient perceptions toward PGx testing. This study aimed to assess patient knowledge, attitudes and ethics of PGx testing. Questionnaires were given to patients enrolled in a clinical trial at two urban hospitals in Philadelphia, Pennsylvania, USA. In the study, patients underwent a nonsurgical procedure to open narrowed blood vessels supplying the heart muscles and were prescribed antiplatelet medications afterward. As part of study participation, some patients had undergone PGx testing to guide antiplatelet therapy following while others received standard of care (no PGx testing). We found that patients were generally not aware of PGx testing but felt it would be important information to have to guide their treatment options. Higher education levels and greater genetics knowledge were factors associated with more positive attitudes toward PGx testing. An understanding of patient perceptions, knowledge and misconceptions of PGx testing can allow healthcare professionals to better address knowledge gaps and increase the use of PGx testing in clinical settings.

Interventional cardiologists' attitudes towards pharmacogenetic testing and impact on antiplatelet prescribing decisions.

Aim: To determine if interventional cardiologists' knowledge and attitudes toward pharmacogenetic (PGx) testing influenced their antiplatelet prescribing decisions in response to CYP2C19 results. Materials & methods: Surveys were administered prior to participating in a randomized trial of CYP2C19 testing. Associations between baseline knowledge/attitudes and agreement with the genotype-guided antiplatelet recommendations were determined using multivariable logistic regression. Results: 50% believed that PGx testing would be valuable to predict medication toxicity or efficacy. 64% felt well informed about PGx testing and its therapeutic application. However, PGx experience, knowledge, nor attitudes were significantly associated with agreement to genotype-guided antiplatelet recommendations. Conclusion: Cardiologists' knowledge and attitudes were not associated with CYP2C19-guided antiplatelet prescribing, but larger studies should be done to confirm this finding.

Lay abstract Our study aimed to determine if interventional cardiologists' knowledge and attitudes toward pharmacogenetic (PGx) testing influenced their medication prescribing decisions in response to variations in patients' genes. Surveys were given to the cardiologist prior to their participation in a PGx study. Associations between initial knowledge/attitudes and agreement with the PGx-guided medication recommendations were determined. 50% believed that PGx testing would be valuable to predict medication toxicity or efficacy. A total of 64% felt well informed about PGx testing and its therapeutic application. However, PGx experience, knowledge, or attitudes did not align with antiplatelet prescribing decisions. Cardiologists' knowledge and attitudes were not associated with PGx-guided medication prescribing, but larger studies should be done to confirm this finding.

Magnetic susceptibility and R2* of myocardial reperfusion injury at 3T and 7T.

PURPOSE: Magnetic susceptibility (Δχ) alterations have shown association with myocardial infarction (MI) iron deposition, yet there remains limited understanding of the relationship between relaxation rates and susceptibility or the effect of magnetic field strength. Hence, Δχ and R2∗ in MI were compared at 3T and 7T. METHODS: Subacute MI was induced by coronary artery ligation in male Yorkshire swine. 3D multiecho gradient echo imaging was performed at 1-week postinfarction at 3T and 7T. Quantitative susceptibility mapping images were reconstructed using a morphology-enabled dipole inversion. R2∗ maps and quantitative susceptibility mapping were generated to assess the relationship between R2∗ , Δχ, and field strength. Infarct histopathology was investigated. RESULTS: Magnetic susceptibility was not significantly different across field strengths (7T: 126.8 ± 41.7 ppb; 3T: 110.2 ± 21.0 ppb, P = NS), unlike R2∗ (7T: 247.0 ± 14.8 Hz; 3T: 106.1 ± 6.5 Hz, P < .001). Additionally, infarct Δχ and R2∗ were significantly higher than remote myocardium. Magnetic susceptibility at 7T versus 3T had a significant association (ß = 1.02, R2 = 0.82, P < .001), as did R2∗ (ß = 2.35, R2 = 0.98, P < .001). Infarct pathophysiology and iron deposition were detected through histology and compared with imaging findings. CONCLUSION: R2∗ showed dependence and Δχ showed independence of field strength. Histology validated the presence of iron and supported imaging findings.

Intermediate-Term Outcomes for Patients with Submassive Pulmonary Embolism Treated With Catheter-Directed Thrombolysis.

OBJECTIVE: We aimed to assess the intermediate-term outcomes for patients receiving catheter-directed thrombolysis (CDT) for submassive pulmonary embolism (PE). BACKGROUND: Previous research has shown improvements in right ventricular (RV) function and dilation at 24 hours when CDT was used to treat submassive PE. METHODS: Consecutive patients presenting with submassive PE treated with directed t-PA infusion at a single center were identified and included in this study. Outcomes included cardiovascular mortality, RV function by echocardiogram, 30-day readmission, and major bleeding. RESULTS: The study population was 79 patients with submassive PE; 46% were men, with an average age of 58 years and an average pulmonary embolism severity index (PESI) score of 108. One patient died of cardiovascular causes during the index hospitalization. There were no additional deaths within 30 days of admission. The observed 30-day mortality rate was low compared with that predicted by PESI (1.3% vs 4.0%-11.4%). Fifty-two patients had follow-up echocardiography available for evaluation after CDT. Of these, 62% showed return to normal RV function and size, and 19% demonstrated mild residual RV dysfunction or dilation. Eight patients (10%) had a hospital readmission within 30 days of discharge, including 6 admissions due to cardiopulmonary complications or minor bleeding and 2 for non-cardiopulmonary or bleeding-related reasons. The observed readmission rate of 10% was similar to historic rates of 12.8%. CONCLUSIONS: Intermediate-term follow-up for CDT demonstrates high success rates with low adverse event rates. Further randomized data are needed to study the long-term benefits of CDT.

Iron imaging in myocardial infarction reperfusion injury.

Restoration of coronary blood flow after a heart attack can cause reperfusion injury potentially leading to impaired cardiac function, adverse tissue remodeling and heart failure. Iron is an essential biometal that may have a pathologic role in this process. There is a clinical need for a precise noninvasive method to detect iron for risk stratification of patients and therapy evaluation. Here, we report that magnetic susceptibility imaging in a large animal model shows an infarct paramagnetic shift associated with duration of coronary artery occlusion and the presence of iron. Iron validation techniques used include histology, immunohistochemistry, spectrometry and spectroscopy. Further mRNA analysis shows upregulation of ferritin and heme oxygenase. While conventional imaging corroborates the findings of iron deposition, magnetic susceptibility imaging has improved sensitivity to iron and mitigates confounding factors such as edema and fibrosis. Myocardial infarction patients receiving reperfusion therapy show magnetic susceptibility changes associated with hypokinetic myocardial wall motion and microvascular obstruction, demonstrating potential for clinical translation.

One-Year Outcomes of Percutaneous Coronary Intervention in Patients with End-Stage Liver Disease.

BACKGROUND: Patients with cirrhosis and coronary artery disease (CAD) are at high risk for morbidity during surgical revascularization so they are often referred for complex percutaneous coronary intervention (PCI). Percutaneous coronary intervention in the cirrhotic population also has inherent risks; however, quantifiable data on long-term outcomes are lacking. METHODS: Patients with angiographically significant CAD and cirrhosis were identified from the catheterization lab databases of the University of Pennsylvania Health System between 2007 and 2015. Outcomes were obtained from the medical record and telephonic contact with patients/families. RESULTS: Percutaneous coronary intervention was successfully performed in 42 patients (51 PCIs). Twenty-nine patients with significant CAD were managed medically (36 angiograms). The primary outcome (a composite of mortality, subsequent revascularization, and myocardial infarction) was not significantly different between the 2 groups during a follow-up period at 1 year (PCI: 50%, Control: 40%, P = .383). In the PCI group, a composite adverse outcome rate that included acute kidney injury (AKI), severe bleed, and peri-procedural stroke was elevated (40%), with severe bleeding occurring after 23% of PCI events and post-procedural AKI occurring after 26% of events. The medical management group had significantly fewer total matched adverse outcomes (17% vs 40% in the PCI group, P = .03), with severe bleeding occurring after 11% of events and AKI occurring after 6% of events. Increased risk of adverse events following PCI was associated with severity of liver disease by Child-Pugh class. CONCLUSIONS: Percutaneous coronary intervention in patients with cirrhosis is associated with an elevated risk of adverse events, including severe bleeding and AKI.

Prospective CYP2C19 Genotyping to Guide Antiplatelet Therapy Following Percutaneous Coronary Intervention: A Pragmatic Randomized Clinical Trial.

BACKGROUND: CYP2C19 loss-of-function alleles impair clopidogrel effectiveness after percutaneous coronary intervention, but the clinical impact of implementing CYP2C19 genotyping in a real-world setting is unknown. The purpose of the study was to determine whether returning CYP2C19 genotype results along with genotype-guided pharmacotherapy recommendations using a rapid turnaround test would change antiplatelet prescribing following percutaneous coronary intervention.The primary outcome was the rate of prasugrel or ticagrelor prescribing in each arm. Secondary outcomes included agreement to the genotype-guided recommendations. METHODS: At the time of percutaneous coronary intervention, participants were randomly assigned to prospective rapid point-of-care genotyping of CYP2C19 major alleles (*2, *3, *17) via salivary swab (genotyped group) or no genotyping (usual care) to guide antiplatelet drug selection. Interventional cardiologists at 2 cardiac catheterization laboratories within the same health system were provided genotype information along with genotype-guided pharmacotherapy recommendations. RESULTS: A total of 504 participants were randomized, 249 to the genotyped and 255 to the usual care group. The participants were primarily men (73%); age, 63±10 years; and 50% had acute coronary syndromes. In the genotyped group, 28% were carriers of loss-of-function alleles (*2, *3). The use of prasugrel or ticagrelor was significantly higher in the genotyped group compared with the usual care group (30% versus 21%; odds ratio, 1.60 [95% CI, 1.07-2.42]; P=0.03). Within the genotyped group, 53% of loss-of-function allele carriers were started on prasugrel/ticagrelor, while 47% were started on clopidogrel. CONCLUSIONS: In a randomized controlled trial of clinical CYP2C19 genotyping implementation, pharmacogenetic test results significantly influenced antiplatelet drug prescribing; however, almost half of CYP2C19 loss-of-function carriers continued to receive clopidogrel. Interventional cardiologists consider both clinical and genetic factors when selecting antiplatelet therapy following percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique Identifier: NCT02508116.

Invasive hemodynamic assessment of patients with submassive pulmonary embolism.

OBJECTIVES: To investigate the invasive hemodynamics in patients with intermediate-risk pulmonary embolism (PE) and the change that occurs with catheter-directed thrombolysis (CDT). BACKGROUND: Intermediate-risk PE is associated with right ventricular strain and worse outcomes yet the invasive hemodynamics have not been well described. METHODS: Ninety-two consecutive patients with intermediate-risk PE referred for CDT at two tertiary medical centers with Pulmonary Embolism Response Teams were included in this prospective cohort study. Hemodynamics at baseline and after CDT therapy was measured. Patients with cardiac index (CI) ≤1.8 L min-1 m-2 were compared to those without shock (CI > 1.8). Linear regression analysis was performed to study the relationship between clinical variables and low CI. RESULTS: Thirty-seven out of 92 (40%) had a CI less than 1.8 L min-1 m-2 . When comparing the low CI to the normal CI groups, most demographics, vital signs, biomarkers, and PE severity index (PESI) scores were similar. The low CI group had more females and slightly lower systolic blood pressures although still in the normal range (122 vs. 132 mmHg, p = .026). Treatment with CDT was associated with significant improvement in CI, heart rate, and pulmonary artery pressures in both groups. Linear regression analysis did not reveal a strong correlation between CI and noninvasive metrics such as heart rate, blood pressure, or PESI score. CONCLUSIONS: Forty percent of patients with submassive PE had a depressed CI and treatment with CDT lead to hemodynamic improvements. Invasive hemodynamics may help better identify higher risk patients and guide therapy.

Revascularization strategies and in-hospital management in acute coronary syndromes complicated by hemophilia A or hemophilia B.

: Among adult patients with hemophilia A and hemophilia B the emergent management of acute coronary syndromes (ACSs) is challenging, and exposure to antithrombotic agents and/or revascularization procedures may confer an enhanced risk of bleeding. We sought to identify clinical characteristics and in-hospital outcomes among ACS patients with hemophilia A/hemophilia B, compared with matched noncoagulopathic ACS controls. Case discharges from the Nationwide Inpatient Sample, Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality (1998-2011) had International Classification of Diseases, 9th Revision codes for hemophilia A/hemophilia B and ACS. Control discharges were matched to cases by year of discharge and hospital. Discharges in both groups were assessed for cardiovascular risk factors, type of ACS, use of coronary artery bypass grafting, percutaneous coronary intervention (PCI), bare-metal stent and/or drug-eluting stent, bleeding, and death. In total, 237 cases and 148 848 matched controls were identified. Among cases, HIV/Hepatitis C positivity was more common and obesity/hyperlipidemia less common. ST-elevation myocardial infarction (STEMI) occurred less frequently among hemophilia A cases than controls. hemophilia A and hemophilia B cases were more likely to be managed medically. Cases treated with coronary stent placement were more likely to receive a bare-metal stent than controls. Among PCI, bleeding was more common among hemophilia A cases. The death rates were comparable between groups. ACS-hemophilia A/hemophilia B cases were more often treated noninvasively compared with controls, suggesting an avoidance of PCI/coronary artery bypass grafting in this population, and bleeding (among hemophilia A) was more common. These findings support further study of the management of ACS and in-hospital outcomes among individuals with hemophilia.

Hybrid Coronary Revascularization for the Treatment of Multivessel Coronary Artery Disease: A Multicenter Observational Study.

BACKGROUND: Hybrid coronary revascularization (HCR) combines minimally invasive surgical coronary artery bypass grafting of the left anterior descending artery with percutaneous coronary intervention (PCI) of non-left anterior descending vessels. HCR is increasingly used to treat multivessel coronary artery disease that includes stenoses in the proximal left anterior descending artery and at least 1 other vessel, but its effectiveness has not been rigorously evaluated. OBJECTIVES: This National Institutes of Health-funded, multicenter, observational study was conducted to explore the characteristics and outcomes of patients undergoing clinically indicated HCR and multivessel PCI for hybrid-eligible coronary artery disease, to inform the design of a confirmatory comparative effectiveness trial. METHODS: Over 18 months, 200 HCR and 98 multivessel PCI patients were enrolled at 11 sites. The primary outcome was major adverse cardiac and cerebrovascular events (MACCE) (i.e., death, stroke, myocardial infarction, repeat revascularization) within 12 months post-intervention. Cox proportional hazards models were used to model time to first MACCE event. Propensity scores were used to balance the groups. RESULTS: Mean age was 64.2 ± 11.5 years, 25.5% of patients were female, 38.6% were diabetic, and 4.7% had previous stroke. Thirty-eight percent had 3-vessel coronary artery disease, and the mean SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score was 19.7 ± 9.6. Adjusted for baseline risk, MACCE rates were similar between groups within 12 months post-intervention (hazard ratio [HR]: 1.063; p = 0.80) and during a median 17.6 months of follow-up (HR: 0.868; p = 0.53). CONCLUSIONS: These observational data from this first multicenter study of HCR suggest that there is no significant difference in MACCE rates over 12 months between patients treated with multivessel PCI or HCR, an emerging modality. A randomized trial with long-term outcomes is needed to definitively compare the effectiveness of these 2 revascularization strategies. (Hybrid Revascularization Observational Study; NCT01121263).

Novel anti-platelet agents in acute coronary syndrome: mechanisms of action and opportunities to tailor therapy.

Dual anti-platelet therapy, most commonly aspirin and clopidogrel, has been the standard of care for over a decade in patients who have experienced acute coronary syndrome, particularly when treated with coronary stenting. However, residual risk in patients receiving dual anti-platelet therapy post-acute coronary syndrome raises an unmet need for alternative therapy to clopidogrel. Consequently, novel anti-platelets agents including the P2Y12 receptor antagonists, such as prasugrel and ticagrelor, have emerged. Furthermore, using new methods to assess genetic polymorphisms and functional phenotypic assessments of platelet reactivity may become important in the development of personalized medicine and in developing tailored approaches to individual treatment. While robust large-scale evidence for genotypic- and phenotypic-guided therapy in improving outcomes is currently lacking, tremendous interest from various stakeholders including researchers, funding agencies, and industry continues to spur research endeavors in this arena. Further investigation is required in this emerging field to potentially offer improved platelet inhibition that may optimize cardioprotection and minimize bleeding risk in patients with acute coronary syndrome.

Effective management of acute coronary thrombosis in a young woman with lupus using aggressive medical therapy.

Systemic lupus erythematosus is a chronic inflammatory disorder that predisposes to acute coronary thrombosis. To demonstrate how the pathophysiology of lupus-mediated coronary events may be unique, we offer the case and management of a young woman with lupus who presented with acute myocardial infarction. She was initially managed with medical therapy including the standard regimen of aspirin, heparin, and clopidogrel. Despite a Thrombolysis in Myocardial Infarction risk score of only 2, she was also given eptifibatide infusion because of clinical concerns. Repeated cardiac catheterization showed marked regression of the thrombus, and coronary fractional flow reserve calculation demonstrated full recovery of coronary vasculature with this therapy. This case demonstrates effective management of life-threatening coronary thrombosis with medical therapy only in a young woman with lupus. We briefly review the pathophysiology of acute coronary thrombosis in lupus patients and distinguish this from the more common process of age-related atherosclerosis. Given the lack of evidence in this specific population, we discuss a pathophysiology-based clinical decision-making tool. Assessing clinical risk factors and using technologies such as intravascular ultrasound can help make the correct treatment decision.

Evaluation of thrombocytopenia in the acute coronary syndrome.

PURPOSE OF REVIEW: Thrombocytopenia is relatively common in patients with acute coronary syndromes and is associated with an increased risk of adverse outcomes, regardless of the etiology of the low platelet count. Treatment strategies, both medical and mechanical, may cause thrombocytopenia. This review will introduce a differential diagnosis, diagnostic strategies, and treatment options for patients with an acute coronary syndrome. RECENT FINDINGS: Recent data has strengthened the relationship between thrombocytopenia and adverse outcomes, particularly death and bleeding, in this population of cardiac patients. In addition, bleeding is recognized as a strong independent predictor of an adverse event. Thrombocytopenia may be a marker for acuity of illness and often may be only an association between a low platelet count and therapeutic interventions in this population. Nevertheless, thrombocytopenia due to glycoprotein 2b3a receptor inhibitors, heparins, thienopyridines, and intra-aortic balloon pumps must be recognized and managed appropriately. SUMMARY: Surveillance for and early recognition of thrombocytopenia, an appropriate differential diagnosis, and early institution of treatment are critically important in the management of patients with acute coronary syndromes.

Patient satisfaction is comparable to early discharge versus overnight observation after elective percutaneous coronary intervention.

BACKGROUND: Previous investigation has suggested that early discharge after percutaneous coronary intervention (PCI) is feasible and safe, but these studies have utilized largely radial approaches or been conducted in non-U.S. cohorts. We sought to assess patient satisfaction, safety and cost of a strategy of selective early discharge in U.S. patients undergoing PCI via a femoral approach with contemporary adjunctive pharmacologic and hemostasis agents. METHODS AND RESULTS: Patients with stable coronary artery disease undergoing elective PCI were prospectively recruited and randomized to either routine care, with an overnight hospital stay, versus early discharge 2 hours following successful PCI with adjunctive bivalirudin therapy and a femoral arterial closure device at the end of the procedure. The primary endpoints were safety and patient satisfaction as measured by a validated patient satisfaction survey during the index hospital stay and at 30 days. A total of 39 patients were randomized, with 20 to routine care and 19 to early discharge. There was no difference in major safety endpoints including death, non-fatal MI, urgent target lesion revascularization and thrombolysis in myocardial infarction (TIMI) major bleeding, with none in either group. Mean patient satisfaction scores were similar and high in both groups (89.6 for early discharge patients and 90.7 for routine care patients, p = 0.68). There was lower cost in the early discharge group, with a mean cost of 8,604 USD versus 10,565 USD in the routine care group (mean difference 1,961 USD, 95% confidence interval, -96 USD to 4,017 USD). CONCLUSION: Patients undergoing elective PCI for stable coronary artery disease may have similar safety and satisfaction with early discharge when using a careful strategy that incorporates optimal stent and hemostasis results and contemporary adjunctive anticoagulation therapy, with lower cost. This strategy may serve as a basis for a larger-scale randomized trial.

Lack of clinical long-term benefit with the use of a drug eluting stent compared to use of a bare metal stent in saphenous vein grafts.

BACKGROUND: Small randomized trials have shown short-term improved outcome with drug-eluting stents (DES) over bare metal stent (BMS) in saphenous vein graft (SVG) interventions by reducing in-stent restenosis and target vessel revascularization (TVR). It is not clear, however, if these benefits are maintained long term. The aim of this study is to compare the outcome in a larger cohort of patients undergoing SVG stent implantation with DES or BMS, at 2 years. METHODS: From among 250 patients who underwent SVG stenting, 225 patients with available follow-up were selected from data bases at the three participating institutions. One-hundred-six patients had DES (sirolimus, paclitaxel or tacrolimus eluting stent) and 119 patients had any available BMS from April 2002 to December 2006. The primary endpoint was MACE rate, a combination of cardiac death, S-T elevation myocardial infarction (STEMI) and target lesion revascularization. Secondary end points were the individual components of the primary endpoint. Follow-up was obtained by mailed interviews or telephone calls and review of the hospital chart. RESULTS: The DES and BMS groups had similar age (71 +/- 8 years vs. 70 +/- 7 years, P = 1.0), diabetes (45% vs. 36%, P = 0.3), history of MI (58% vs. 51%, P = 0.6), EF (44% vs. 47%, P = 0.2) and previous PCI (40% vs. 35%, P = 0.4). Reference vessel diameter (3.15 +/- 0.5 mm vs. 3.5 +/- 0.5 mm. P = 0.001) and stent size (3.3 +/- 0.4 mm vs. 3.9 +/- 0.5 mm, P = 0.001) were smaller in the DES group; however, the BMS were longer (24 +/- 10 mm vs. 21 +/- 6 mm, P = 0.05). At one year there was a trend (P = 0.1) for lower MACE rate in the DES group, but at two years there was no difference in MACE free survival between the DES and BMS groups (81 % vs. 82%, P = 0.9). The death rate was similar (6% each) with three patients having STEMI (two in the DES and one in the BMS). TVR was also similar (14% in each group). CONCLUSION: In patients undergoing treatment of SVG disease with a stent, the marginal benefit of DES seen at 1 year was lost at 2-year follow-up.