1022-107 Outcome of Different Reperfusion Strategies in Thrombolytic “Eligible” versus “Ineligible” Patients with Acute Myocardial Infarction

Pts considered “not eligible” for inclusion in most early U.S. thrombolytic trials because of advanced age, late presentation, prior CABG or shock have avery poor prognosis; thus, some have suggested broadening the criteria for lyric eligibility. To examine the role of different reperfusion strategies in pts traditionally considered lytic “eligible” vs. “ineligible” (age>70, MI onset>4 hours, or prior CABG), we examined the PAMI database in which 395 pts of any age within 12 hours onset of MI were randomized to t-PA or primary PTCA (pts with shock were excluded). Compared to lyric eligible pts, ineligible pts were o1der(67 vs. 56 yrs, p<0.0001). more frequently female (38% vs. 20%, P<0.0001), diabetic (17% vs. 10%, P=0.03), had prior CABG (8% vs. 0%, P<0.0001), presented later (4.4 vs. 2.2 hours, p<0.0001), and were more likely to present in CI-1F (20% vs. 11%, P=0.01). Endpoints included death (D), reinfarction (R), recurrent ischemic events (RIE) and stroke:Thrombolytic eligibleThrombolytic ineligiblePTCA (n=127)t-PA (n=117)PPTCA (n=68)t-PA (n=83)Pin-hosp. D2.4%1.7%NS2.9%13.3%0.025in-hosp. D or R5.5%9.4%NS4.4%15.7%0.026in-hosp. RIE11.8%29.1%0.00087.4%26.6%0.002in-hasp. stroke0%1.7%NS0%6.0%0.046 month D3.9%1.7%NS2.9%15.7%0.0096 month D or R8.7%12.8%NS7.4%22.9%0.009In conclusion: Pts traditionally considered thrombolytic eligible comprise a low risk cohort, and have a favorable prognosis whether treated with primary PTCA or t-PA. In contrast, pts historically excluded from most early lytic trials because of advanced age, late presentation or prior CABG are at increased risk, and may have improved survival with primary PTCA rather than thrompresented laterbolysis

One-year outcomes of coronary artery bypass graft surgery versus percutaneous coronary intervention with multiple stenting for multisystem disease: A meta-analysis of individual patient data from randomized clinical trials

BackgroundWe aimed to provide a quantitative analysis of the 1-year clinical outcomes of patients with multisystem coronary artery disease who were included in recent randomized trials of percutaneous coronary intervention with multiple stenting versus coronary artery bypass graft surgery.MethodsAn individual patient database was composed of 4 trials (Arterial Revascularization Therapies Study, Stent or Surgery Trial, Argentine Randomized Trial of Percutaneous Transluminal Coronary Angioplasty Versus Coronary Artery Bypass Surgery in Multivessel Disease 2, and Medicine, Angioplasty, or Surgery Study 2) that compared percutaneous coronary intervention with multiple stenting (N = 1518) versus coronary artery bypass graft surgery (N = 1533). The primary clinical end point of this study was the combined incidence of death, myocardial infarction, and stroke at 1 year after randomization. Secondary combined end points included the incidence of repeat revascularization at 1 year. All analyses were based on the intention-to-treat principle.ResultsAfter 1 year of follow-up, 8.7% of patients randomized to percutaneous coronary intervention with multiple stenting versus 9.1% of patients randomized to coronary artery bypass graft surgery reached the primary clinical end point (hazard ratio 0.95 and 95% confidence interval 0.74’1.2). Repeat revascularization procedures occurred more frequently in patients allocated to percutaneous coronary intervention with multiple stenting compared with coronary artery bypass graft surgery (18% vs 4.4%; hazard ratio 4.4 and 95% confidence interval 3.3’5.9). The percentage of patients who were free from angina was slightly lower after percutaneous coronary intervention with multiple stenting than after coronary artery bypass graft surgery (77% vs 82%; P = .002).ConclusionsOne year after the initial procedure, percutaneous coronary intervention with multiple stenting and coronary artery bypass graft surgery provided a similar degree of protection against death, myocardial infarction, or stroke for patients with multisystem disease. Repeat revascularization procedures remain high after percutaneous coronary intervention, but the difference with coronary artery bypass graft surgery has narrowed in the era of stenting

1022-103 Does Primary Angioplasty Improve the Prognosis of Patients with Diabetes and Acute Myocardial Infarction?

To examine the effect of different reperfusion modalities in pts with DM, the multicenter PAMI database was analyzed, in which 395 pts within 12 hours onset of acute MI were prospectively randomized to treatment with t-PA (n=200) vs. primary PTCA (n=195). DM was present in 50 (13%) pts. Compared to pts without DM, pts with DM were older (65 vs. 59 yrs, p=0.002), more often female (40% vs. 25%, p=0.03), more frequently had HTN (68% vs. 39%, P=0.0001), prior CHF (8% vs. 1%, P=0.0001). multivessel disease (76% vs. 51%, P=0.01) and presented later (3.8 vs. 3.0hours, p=0.03).In-hospital mortality was 10.0% in pts with DM vs. 3.8% in pts without DM (p<0.05). By multivariate analysis of 16 variables, however, advanced age and treatment by PTCA rather than t-PA, but not DM correlated with in-hospital mortality.Mortality stratified by treatment appears in the graph. Despite the apparently improved prognosis of pts with DM treated with PTCA vs. t-PA, the p value forthe x2 test for interaction effect between DM and treatment modality was 0.86; most of the benefit of PTCA was present in the elderly population.In conclusionPts with DM and acute MI have increased mortality, primarily because of advanced age. The outcome after PTCA compared to t-PA is improved in DM largely because of PTCA's beneficial effect in the elderly

Time course analysis of gene expression identifies multiple genes with differential expression in patients with in-stent restenosis

Abstract Background The vascular disease in-stent restenosis (ISR) is characterized by formation of neointima and adverse inward remodeling of the artery after injury by coronary stent implantation. We hypothesized that the analysis of gene expression in peripheral blood mononuclear cells (PBMCs) would demonstrate differences in transcript expression between individuals who develop ISR and those who do not. Methods and Results We determined and investigated PBMC gene expression of 358 patients undergoing an index procedure to treat in de novo coronary artery lesions with bare metallic stents, using a novel time-varying intercept model to optimally assess the time course of gene expression across a time course of blood samples. Validation analyses were conducted in an independent sample of 97 patients with similar time-course blood sampling and gene expression data. We identified 47 probesets with differential expression, of which 36 were validated upon independent replication testing. The genes identified have varied functions, including some related to cellular growth and metabolism, such as the NAB2 and LAMP genes. Conclusions In a study of patients undergoing bare metallic stent implantation, we have identified and replicated differential gene expression in peripheral blood mononuclear cells, studied across a time series of blood samples. The genes identified suggest alterations in cellular growth and metabolism pathways, and these results provide the basis for further specific functional hypothesis generation and testing of the mechanisms of ISR.http://deepblue.lib.umich.edu/bitstream/2027.42/112500/1/12920_2010_Article_214.pd

Sex‐related difference in the use of percutaneous left ventricular assist device in patients undergoing complex high‐risk percutaneous coronary intervention: Insight from the cVAD registry

ObjectiveTo assess the in‐hospital and short‐term outcome differences between males and females who underwent high‐risk PCI with mechanical circulatory support (MCS).BackgroundSex differences have been noted in several percutaneous coronary intervention (PCI) series with females less likely to be referred for PCI due increased risk of adverse events. However, data on sex differences in utilization and outcomes of high‐risk PCI with MCS is scarce.MethodsUsing the cVAD Registry, we identified 1,053 high‐risk patients who underwent PCI with MCS using Impella 2.5 or Impella CP. Patients with cardiogenic shock were excluded. A total of 792 (75.21%) males and 261 (24.79%) females were included in the analysis with median follow‐up of 81.5 days.ResultsFemales were more likely to be African American, older (72.05 ± 11.66 vs. 68.87 ± 11.17, p < .001), have a higher prevalence of diabetes (59.30 vs. 49.04%, p = .005), renal insufficiency (35.41 vs. 27.39%, p = .018), and peripheral vascular disease (31.89 vs. 25.39%, p of .05). Women had a higher mean STS score (8.21 ± 8.21 vs. 5.04 ± 5.97, p < .001) and lower cardiac output on presentation (3.64 ± 1.30 vs. 4.63 ± 1.49, p < .001). Although women had more comorbidities, there was no difference in in‐hospital mortality, stroke, MI or need for recurrent revascularization compared to males. Females were more likely to have multivessel revascularization than males. Ejection fraction improved in both males and females at the time of discharge (26.59 to 31.40% and 30.75 to 36.05%, respectively, p < .0001). However, females had higher rate of bleeding requiring transfusion compared with males (9.58 vs. 5.30%, p = .019).ConclusionFemale patients undergoing high PCI were older and had more comorbidities but had similar outcomes compared to males.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/162726/2/ccd28509_am.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/162726/1/ccd28509.pd

Photonic Sorting of Aligned, Crystalline Carbon Nanotube Textiles

Floating catalyst chemical vapor deposition uniquely generates aligned carbon nanotube (CNT) textiles with individual CNT lengths magnitudes longer than competing processes, though hindered by impurities and intrinsic/extrinsic defects. We present a photonic-based post-process, particularly suited for these textiles, that selectively removes defective CNTs and other carbons not forming a threshold thermal pathway. In this method, a large diameter laser beam rasters across the surface of a partly aligned CNT textile in air, suspended from its ends. This results in brilliant, localized oxidation, where remaining material is an optically transparent film comprised of few-walled CNTs with profound and unique improvement in microstructure alignment and crystallinity. Raman spectroscopy shows substantial D peak suppression while preserving radial breathing modes. This increases the undoped, specific electrical conductivity at least an order of magnitude to beyond that of single-crystal graphite. Cryogenic conductivity measurements indicate intrinsic transport enhancement, opposed to simply removing nonconductive carbons/residual catalyst

715-2 A Prospective, Randomized Trial Evaluating the Prophylactic Use of Balloon Pumping in High Risk Myocardial Infarction Patients: PAMI-2

Myocardial infarction (MI) patients with advanced age, multivessel disease or ventricular dysfunction continue to have a poor prognosis despite reperfusion therapy. Furthermore, the majority of deaths from MI occur within the first 48 hours, thus risk stratification and therapeutic interventions ideally should occur acutely. The PAMI-2 study has prospectively evaluated the hypotheses that 1) emergency catheterization with primary PTCA may allow acute risk stratification and 2) clinical outcome, ventricular function and infarct vessel patency will be improved by balloon pumping in patients identified to be high risk. MI patients who presented 0–12 hrs underwent emergency catheterization and PTCA and were stratified as high risk if one of the following was present: age&gt;70 yrs, vein graft occlusion, 3 vessel disease, ejection fraction &lt;45%, suboptimal PTCA result or if malignant arrhythmias persisted post PTCA. High risk patients were randomized to receive or not receive an intra aortic balloon pump (IABP) for 48 hrs. Catheterization was repeated at day 7 to determine infarct vessel patency and improvement in ventricular function. At 6 weeks a rest and exercise radionuclide ventriculogram was performed. To date, 320 patients have been enrolled, 175 of which have complete data available for analysis. The reasons for high risk status include: advanced age 38%, poor LV function 55%, 3 vessel disease 37%, vein graft occlusion 6%, suboptimal PTCA 9%, and arrhythmias 5%. Despite the high risk status, in-hospital outcomes have been favorable: death 2.9%, recurrent MI 5.8%, stroke 1.2%, angiographic reocclusion 5.8%, heart failure 19.1% and combined events 26.6%. Thus “high risk” patients treated with primary PTCA±balloon pumping appear to have a good prognosis. Whether the improved outcome is due to balloon pump support or simply due to aggressive mechanical revascularization will be determined in the entire cohort by March 1995

Double-Blind Phase III Trial of Adjuvant Chemotherapy With and Without Bevacizumab in Patients With Lymph Node-Positive and High-Risk Lymph Node-Negative Breast Cancer (E5103)

Purpose Bevacizumab improves progression-free survival but not overall survival in patients with metastatic breast cancer. E5103 tested the effect of bevacizumab in the adjuvant setting in patients with human epidermal growth factor receptor 2-negative disease. Patients and Methods Patients were assigned 1:2:2 to receive placebo with doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (arm A), bevacizumab only during AC and paclitaxel (arm B), or bevacizumab during AC and paclitaxel followed by bevacizumab monotherapy for 10 cycles (arm C). Random assignment was stratified and bevacizumab dose adjusted for choice of AC schedule. Radiation and hormonal therapy were administered concurrently with bevacizumab in arm C. The primary end point was invasive disease-free survival (IDFS). Results Four thousand nine hundred ninety-four patients were enrolled. Median age was 52 years; 64% of patients were estrogen receptor positive, 27% were lymph node negative, and 78% received dose-dense AC. Chemotherapy-associated adverse events including myelosuppression and neuropathy were similar across all arms. Grade ≥ 3 hypertension was more common in bevacizumab-treated patients, but thrombosis, proteinuria, and hemorrhage were not. The cumulative incidence of clinical congestive heart failure at 15 months was 1.0%, 1.9%, and 3.0% in arms A, B, and C, respectively. Bevacizumab exposure was less than anticipated, with approximately 24% of patients in arm B and approximately 55% of patients in arm C discontinuing bevacizumab before completing planned therapy. Five-year IDFS was 77% (95% CI, 71% to 81%) in arm A, 76% (95% CI, 72% to 80%) in arm B, and 80% (95% CI, 77% to 83%) in arm C. Conclusion Incorporation of bevacizumab into sequential anthracycline- and taxane-containing adjuvant therapy does not improve IDFS or overall survival in patients with high-risk human epidermal growth factor receptor 2-negative breast cancer. Longer duration bevacizumab therapy is unlikely to be feasible given the high rate of early discontinuation

Predictors of left ventricular ejection fraction in high-risk percutaneous coronary interventions

Revascularization completeness after percutaneous coronary intervention (PCI) is associated with improved long-term outcomes. Mechanical circulatory support [intra-aortic balloon pump (IABP) or Impella] is used during high-risk PCI (HR-PCI) to enhance peri-procedural safety and achieve more complete revascularization. The relationship between revascularization completeness [post-PCI residual SYNTAX Score (rSS)] and left ventricular ejection fraction (LVEF) in HR-PCI has not been established. We investigated LVEF predictors at 90 days post-PCI with Impella or IABP support. Individual patient data (IPD) were analyzed from PROTECT II (NCT00562016) in the base case. IPD from PROTECT II and RESTORE-EF (NCT04648306) were naïvely pooled in the sensitivity analysis. Using complete cases only, linear regression was used to explore the predictors of LVEF at 90 days post-PCI. Models were refined using stepwise selection based on Akaike Information Criterion and included: treatment group (Impella, IABP), baseline characteristics [age, gender, race, New York Heart Association Functional Classification, LVEF, SYNTAX Score (SS)], and rSS. Impella treatment and higher baseline LVEF were significant predictors of LVEF improvement at 90 days post-PCI (p ≤ 0.05), and a lower rSS contributed to the model (p = 0.082). In the sensitivity analysis, Impella treatment, higher baseline LVEF, and lower rSS were significant predictors of LVEF improvement at 90 days (p ≤ 0.05), and SS pre-PCI contributed to the model (p = 0.070). Higher baseline LVEF, higher SS pre-PCI, lower rSS (i.e. completeness of revascularization), and Impella treatment were predictors of post-PCI LVEF improvement. The findings suggest potential mechanisms of Impella include improving the extent and quality of revascularization, and intraprocedural ventricular unloading