Successful interdisciplinary treatment of a rare cause of acute myocardial ischaemia from intermittent tumour-associated obstruction of the left main coronary artery: a case report.

BACKGROUND: A papillary fibroelastoma of the aortic valve has been reported as a rare cause of myocardial ischaemia. An advanced combined interventional and surgical approach leading to sufficient therapy for the patient is presented in this case report. CASE SUMMARY: A 56-year-old female patient presented in an emergency room of a hospital with an acute coronary syndrome. Over 1.5 years, recurrent stable angina had been known in the patient and significant coronary artery disease has already been ruled out in a previous coronary angiogram. The patient was immediately transferred to the catheter laboratory due to cardiogenic shock where a drug-eluting stent was implanted to, firstly, recanalize the left main coronary artery (LMCA) and, secondly, to protect the left main ostium from obstruction by an echocardiographic-proven mass. During subsequent deterioration of haemodynamics caused by decreasing left ventricular function and acute severe mitral insufficiency, firstly an intra-aortic balloon pump and secondly a veno-arterial extracorporeal membrane oxygenation was established through the femoral vessels. The patient was transferred to our cardiac surgery unit and was successfully operated utilizing a valve-sparing technique by extracting the tumour mass from the left coronary cusp and extracting the stent carefully from the LMCA. Histology revealed a papillary fibroelastoma. CONCLUSION: A papillary fibroelastoma of the aortic valve with intermittent obstruction of the coronary arteries requires surgical therapy. Interventional recanalization and extracorporeal support might be useful strategies to ensure the patient's safety as a bridge to surgery.

A prospective cohort study to assess the relevance of vedolizumab drug level monitoring in IBD patients.

BACKGROUND: Vedolizumab (VDZ) drug monitoring strategies in inflammatory bowel disease (IBD) patients have not been systematically investigated so far. We evaluated the correlation between VDZ trough levels (VTL) and the treatment response in IBD. METHODS: Fifty-one patients with active IBD on or starting a therapy with VDZ were enrolled in this prospective and observational single centre study. Disease activity indices, blood tests, and anthropometric parameters were assessed over a time period of 6 months. One hundred and fifty-five VDZ serum trough levels were measured directly before the next scheduled application using liquid chromatography mass spectrometry (LC-MS/MS). RESULTS: VDZ treatment was found to be clinically effective (Harvey Bradshaw Index (HBI) dropping from 10 to 5.5 points (p < .0005) in Crohn's disease (CD) patients; partial Mayo score (pMS) from 4.4 to 2.1 points (p < .0005) in ulcerative colitis patients (UC). CRP levels tended to decrease and haemoglobin levels to increase under VDZ therapy. CD patients with a serum CRP level lower than 5 mg/l exhibited significantly higher VTL than those with elevated CRP levels (34.9 versus 21.7 µg/ml, p = .00153). UC patients with haemoglobin levels higher 12 g/dl at the time of VTL measurement had significantly higher VTL compared to patients with lower haemoglobin levels (35.4 versus 15.6 µg/ml, p < .0005). CONCLUSIONS: Our data suggest a significant correlation between VTL and response to therapy in IBD patients (higher VTL associated with better response).

White-Light or Narrow-Band Imaging Colonoscopy in Surveillance of Ulcerative Colitis: A Prospective Multicenter Study.

BACKGROUND & AIMS: Early detection of neoplastic lesions is essential in patients with long-standing ulcerative colitis but the best technique of colonoscopy still is controversial. METHODS: We performed a prospective multicenter study in patients with long-standing ulcerative colitis. Two colonoscopies were performed in each patient within 3 weeks to 3 months. In white-light (WL) colonoscopy, stepwise random biopsy specimens (4 biopsy specimens every 10 cm), segmental random biopsies (2 biopsy specimens in 5 segments), and targeted biopsy specimens were taken. In NBI colonoscopy, segmental and targeted biopsy specimens were taken. The sequence of WL and NBI colonoscopy was randomized. RESULTS: In 36 of 159 patients enrolled (22.6%), 54 lesions with intraepithelial neoplasia (IN) were found (51 low-grade, 3 high-grade). In WL colonoscopy we found 11 IN in stepwise biopsy specimens, 4 in segmental biopsy specimens, and 15 in targeted biopsy specimens. In NBI colonoscopy 7 IN were detected in segmental biopsy specimens and 24 IN were detected in targeted biopsy specimens. Almost all IN were found with one technique alone (κ value of WL vs NBI, -0.86; P < .001). Statistically equivalent numbers of IN were found in NBI colonoscopy with targeted and segmental biopsy specimens as in WL colonoscopy with targeted and stepwise biopsy specimens, but with fewer biopsy specimens (11.9 vs 38.6 biopsy specimens, respectively; P < .001), and less withdrawal time was necessary (23 vs 13 min, respectively; P < .001). CONCLUSIONS: Stepwise biopsy specimens are indispensable in WL colonoscopy. The combination of targeted and segmental biopsy specimens in the NBI technique is as sensitive as targeted together with stepwise biopsy specimens in WL colonoscopy, but requires fewer biopsy specimens and less time. The highest sensitivity should be reached by combining the WL and NBI techniques by switching between the modes.

An unusual complication in ulcerative colitis during treatment with azathioprine and infliximab: Isospora belli as 'Casus belli'.

The treatment of ulcerative colitis is based on systemic corticosteroids, immunomodulators such as cyclosporine and azathioprine and TNF-α antagonists. Patients undergoing such immunosuppressive treatment are more susceptible for infectious pathogens. Here, we report the case of a patient with a 13-year history of ulcerative colitis, treated initially with systemic corticosteroids in combination with immunomodulators, and subsequently with infliximab. The patient presented with severe watery diarrhoea, abdominal cramps, weight loss and low-grade fever. Stool examinations for cytomegalovirus, bacteria and parasites were negative. Following detection of numerous oocytes of Isospora belli (IB) in direct smear preparations of the diarrhoeic stool samples, the patient was successfully treated with trimethoprim-sulfamethoxazole (co-trimoxazole).

Impact of infarct-related artery patency before primary PCI on outcome in patients with ST-segment elevation myocardial infarction: the HORIZONS-AMI trial.

AIMS: We assessed the impact of early infarct-related artery (IRA) recanalisation on the outcomes of patients in the recently conducted, large-scale, multicentre HORIZONS-AMI trial. METHODS AND RESULTS: Of the 3,602 patients enrolled in the HORIZONS-AMI trial, 3,093 patients (85.9%) were treated with percutaneous coronary intervention (PCI) to a single artery. We analysed one-year outcomes in these patients according to the presence or absence of early IRA patency, defined as Thrombolysis in Myocardial Infarction (TIMI) 2 or 3 flow in the IRA. Baseline coronary angiography showed early IRA patency in 1,121 patients (36.2%), while 1,972 patients (63.8%) had TIMI 0 or 1 flow. The presence compared with the absence of early IRA patency was associated with better angiographic results after primary PCI with more TIMI 3 flow after PCI (93.2% vs. 82.9%, p<0.0001) and myocardial blush grade 2 or 3 (84.4% vs. 71.1%, p<0.0001). Early IRA patency was associated with lower rates of one-year mortality (2.5% vs. 3.9%, p=0.04) and definite or probable stent thrombosis (2.0% vs. 4.0%, p=0.002). In multivariable analysis, early IRA patency at baseline angiography was an independent predictor of reduced mortality at one year (HR 0.58, 95% CI: 0.36-0.98, p=0.02). CONCLUSIONS: Early IRA patency in patients with STEMI undergoing primary PCI is associated with better TIMI flow and myocardial blush post PCI and is an independent predictor of lower one-year mortality. ClinicalTrials.gov identifier NCT00433966.

A glycerin hydrogel-based wound dressing prevents peristomal infections after percutaneous endoscopic gastrostomy (PEG): a prospective, randomized study.

BACKGROUND: Despite the use of prophylactic antibiotics, peristomal infection is the most common complication of percutaneous endoscopic gastrostomy (PEG). A new glycerin hydrogel (GHG) wound dressing has been proposed to possess more effective antimicrobial properties but has not been tested in a larger trial. The aim of the study was therefore to assess the superiority of GHG regarding the incidence of peristomal wound infections during a 30-day postprocedure follow-up. METHODS: Sixty-eight patients with cancer undergoing PEG were recruited from 1 university and 2 general hospitals between January 2007 and December 2008. Patients were randomized to group 1 (34 patients), which received GHG, or group 2 (34 patients), which received a traditional wound dressing. Dressing changes were done at day 1 and weeks 1, 2, and 4 (group 1) vs daily changes during week 1 and at weeks 2 and 4 (group 2). The PEG site was assessed by using 2 different infection scores. RESULTS: At the end of the first and second weeks, a statistically significant reduction of the mean infection scores was seen in patients with GHG wound dressings (first week: 1.64 ± 1.6 vs 3.12 ± 2.69, P < .008; second week: 1.37 ± 1.11 vs 2.53 ± 2.37, P < .02). After 7 days, wound reactions occurred in 14.7% in the GHG group vs 47.05% in the traditional group (p <0.005). The GHG wound dressing required 5 times less frequent dressing changes. CONCLUSION: The GHG wound dressing significantly reduces peristomal wound infections and is a convenient, cost-effective alternative for wound management following PEG.

Five-year results of the Multicenter Randomized Controlled Open-Label Study of the CYPHER Sirolimus-Eluting Stent in the Treatment of Diabetic Patients with De Novo Native Coronary Artery Lesions (SCORPIUS) study: a German multicenter investigation on the effectiveness of sirolimus-eluting stents in diabetic patients.

BACKGROUND: Because a delayed arterial healing response after drug-eluting stent implantation has raised concerns about safety in diabetic patients, long-term effects of treatment with sirolimus-eluting stent (SES), as compared with bare-metal stent (BMS), have to be established. The aim of the 5-year follow-up of the randomized, controlled, open-label multicenter SCORPIUS study was to assess long-term safety and efficacy of the CYPHER (Cordis, Johnson & Johnson, Bridgewater, NJ) SES in percutaneous coronary intervention of diabetic patients. METHODS: A total of 190 patients with type 2 diabetes mellitus were randomized to receive either a SES (n = 95) or a BMS (n = 95). Dual-antiplatelet therapy (aspirin plus clopidogrel) was prescribed for at least 6 months. Clinical follow-up data were scheduled at 1, 8, and 12 months and 5 years. RESULTS: Treatment with SES resulted in a 16% decrease in the rate of major adverse cardiac events (36% vs 52%; hazard ratio 0.6, 95% CI 0.4-0.9; P = .02). This reduction in major adverse cardiac events with SES at 5 years was mostly attributable to a lower number of repeat target lesion revascularization (13% vs 29%; hazard ratio 0.4, 95% CI 0.2-0.7; P = .003). No differences between groups were observed for safety end points (all-cause mortality 21% vs 21%, cardiac death 15% vs 13%, repeat myocardial infarction 8% vs 9%, and stent thrombosis 5% vs 6%) at 5 years. CONCLUSIONS: The 5-year follow-up of the SCORPIUS trial demonstrates the long-term antirestenotic efficacy of SES in diabetic patients with significantly reduced target lesion revascularization and comparable rates of mortality, myocardial infarction, and stent thrombosis compared with BMS.

Heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZONS-AMI): final 3-year results from a multicentre, randomised controlled trial.

BACKGROUND: Primary results of the HORIZONS-AMI trial have been previously reported. In this final report, we aimed to assess 3-year outcomes. METHODS: HORIZONS-AMI was a prospective, open-label, randomised trial undertaken at 123 institutions in 11 countries. Patients aged 18 years or older were eligible for enrolment if they had ST-segment elevation myocardial infarction (STEMI), presented within 12 h after onset of symptoms, and were undergoing primary percutaneous coronary intervention. By use of a computerised interactive voice response system, we randomly allocated patients 1:1 to receive bivalirudin or heparin plus a glycoprotein IIb/IIIa inhibitor (GPI; pharmacological randomisation; stratified by previous and expected drug use and study site) and, if eligible, randomly allocated 3:1 to receive a paclitaxel-eluting stent or a bare metal stent (stent randomisation; stratified by pharmacological group assignment, diabetes mellitus status, lesion length, and study site). We produced Kaplan-Meier estimates of major adverse cardiovascular events at 3 years by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00433966. FINDINGS: Compared with 1802 patients allocated to receive heparin plus a GPI, 1800 patients allocated to bivalirudin monotherapy had lower rates of all-cause mortality (5·9%vs 7·7%, difference -1·9% [-3·5 to -0·2], HR 0·75 [0·58-0·97]; p=0·03), cardiac mortality (2·9%vs 5·1%, -2·2% [-3·5 to -0·9], 0·56 [0·40-0·80]; p=0·001), reinfarction (6·2%vs 8·2%, -1·9% [-3·7 to -0·2], 0·76 [0·59-0·99]; p=0·04), and major bleeding not related to bypass graft surgery (6·9%vs 10·5%, -3·6% [-5·5 to -1·7], 0·64 [0·51-0·80]; p=0·0001) at 3 years, with no significant differences in ischaemia-driven target vessel revascularisation, stent thrombosis, or composite adverse events. Compared with 749 patients who received a bare-metal stent, 2257 patients who received a paclitaxel-eluting stent had lower rates of ischaemia-driven target lesion revascularisation (9·4%vs 15·1%, -5·7% [-8·6 to -2·7], 0·60 [0·48-0·76]; p<0·0001) after 3 years, with no significant differences in the rates of death, reinfarction, stroke or stent thrombosis. Stent thrombosis was high (≥4·5%) in both groups. INTERPRETATION: The effectiveness and safety of bivalirudin monotherapy and paclitaxel-eluting stenting are sustained at 3 years for patients with STEMI undergoing primary percutaneous coronary intervention. FUNDING: Boston Scientific and The Medicines Company.

Paclitaxel-eluting stents compared with bare metal stents in diabetic patients with acute myocardial infarction: the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial.

BACKGROUND: In the prospective, randomized Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, implantation of paclitaxel-eluting stents (PES) safely reduced the rates of ischemic target lesion revascularization (TLR) compared with bare metal stents (BMS) in patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary percutaneous intervention. Diabetes mellitus is a known predictor of adverse outcomes after percutaneous intervention in STEMI. We therefore sought to assess the impact of PES in diabetic patients with STEMI from the HORIZONS-AMI trial. METHODS AND RESULTS: A total of 478 patients with diabetes and 2527 without diabetes were randomly assigned to receive PES versus BMS. The 12-month rates of ischemic TLR were significantly reduced by PES compared with BMS in both diabetic (11.2% versus 5.2%; hazard ratio [95% confidence interval]=0.45 [0.21 to 0.93]; P=0.03) and nondiabetic (6.8% versus 4.3%, hazard ratio [95% confidence interval]=0.63 [0.44 to 0.92]; P=0.02) patients. In patients with insulin-treated diabetes, PES compared with BMS reduced the 12-month TLR rate from 21.4% to 7.3% (hazard ratio [95% confidence interval]=0.35 [0.12 to 1.03]; P=0.046). Angiographic late loss and binary restenosis at 13 months were also significantly reduced in PES-treated diabetic patients. There were no significant differences between the BMS and PES groups in the 12-month rates of death, reinfarction, stroke, or stent thrombosis in either diabetic or nondiabetic patients. CONCLUSIONS: In the large-scale, prospective, randomized HORIZONS-AMI trial, implantation of PES compared with BMS in patients with STEMI and diabetes mellitus resulted in significant reductions in ischemia-driven TLR and angiographic restenosis at 1 year, with comparable safety outcomes, including stent thrombosis. These results suggest that PES can safely be used to reduce restenosis in high-risk diabetic patients presenting with STEMI. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00433966.

Diagnosis and management of iron deficiency anemia in patients with IBD.

Anemia is the most prevalent extraintestinal complication of IBD. It can affect quality of life and ability to work, and can also increase the hospitalization rate in patients with IBD. Although the causes of anemia in IBD are multifactorial, iron deficiency anemia (IDA) is the most common. Assessment of the iron status of patients who have a condition associated with inflammation, such as IBD, by using common biochemical values is insufficient. However, new indices of iron metabolism (for instance ferritin:transferrin receptor ratio, reticulocyte hemoglobin content or percentage of hypochromic red blood cells) may help to improve the assessment of iron status in patients with IBD. The treatment of IDA traditionally involves oral iron supplementation. However, because of extensive gastrointestinal adverse effects, and data showing that the use of oral iron in IBD may be associated with disease exacerbation, current guidelines suggest that iron supplementation in IBD should be administered intravenously. This Review provides an overview of iron homeostasis in health before discussing diagnostic and therapeutic strategies for IDA in patients with IBD.

Impact of bivalirudin therapy in high-risk patients with acute myocardial infarction: 1-year results from the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) trial.

OBJECTIVES: This study sought to assess the relationship between 1-year mortality and baseline patient risk in the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) trial. BACKGROUND: The HORIZONS-AMI trial showed that bivalirudin compared with unfractionated heparin (UFH) plus glycoprotein IIb/IIIa inhibitors (GPI) decreased major bleeding and 30-day and 1-year mortality in patients undergoing primary percutaneous intervention for acute myocardial infarction. METHODS: Patients in the HORIZONS-AMI trial were classified as low, intermediate, and high risk according to the CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) risk score based on 7 clinical variables. RESULTS: Among 2,530 CADILLAC-score evaluable HORIZONS-AMI trial patients, 1,522 (60%) were classified as low risk, 531 (21%) as intermediate risk, and 477 (19%) as high risk. The mortality rates in the bivalirudin and UFH plus GPI arms, respectively, were 0.4% and 1.2% (p = 0.09) in the low-risk group, 4.2% and 4.1% (p = 0.99) in the intermediate-risk group, and 8.4% and 15.9% (p = 0.01) in the high-risk group. Among high-risk patients, there was also a decreased rate of recurrent myocardial infarction in patients randomized to bivalirudin as compared to UFH plus GPI (3.6% vs. 7.9%, p = 0.04). CONCLUSIONS: In high-risk patients undergoing primary percutaneous coronary intervention for acute myocardial infarction, bivalirudin compared with UFH plus GPI reduces 1-year mortality and recurrent myocardial infarction. (HORIZONS-AMI trial; NCT00433966).

Management of inflammatory bowel diseases during pregnancy.

Inflammatory bowel diseases (IBD) have a high prevalence in younger patients with child-bearing potential. Usually, pregnancies in women with IBD will develop normally, if the patient is in remission or has minor disease activity at the time of conception. In contrast, the frequency of normal pregnancies is significantly reduced and the frequency of adverse outcomes like preterm birth or miscarriage is increased, when conception occurs in phases with active IBD. Therefore, it is generally recommended to women with IBD to conceive at a time with minor disease activity or in remission. IBD patients who plan to become pregnant or are pregnant should be treated adequately. Currently, it is widely accepted that the treatment of IBD with corticosteroids and 5-ASA derivatives does not increase the risk of malformations or adverse outcomes in pregnant IBD patients. However, a slight increase in the number of pre-term deliveries or reduced birth weight is observed. More recently, it has also been appreciated that azathioprine and 6-MP and presumably also infliximab and other TNF-alpha blockers can be safely used during pregnancy in IBD, as no significant increase of malformations, miscarriages or adverse pregnancy outcomes is observed. Information on cyclosporine and tacrolimus during pregnancy is scarcer, but it may be continued or started in some situations if clinically needed. Methotrexate is contraindicated, as this drug is known to significantly increase the risk of malformations and spontaneous abortion. Patients, who wish to nurse their babies, may be treated with steroids and 5-ASA derivatives without a significantly increased risk for the newborn.

Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial.

BACKGROUND: In the HORIZONS-AMI trial, patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) who were treated with the thrombin inhibitor bivalirudin had substantially lower 30-day rates of major haemorrhagic complications and net adverse clinical events than did patients assigned to heparin plus a glycoprotein IIb/IIIa inhibitor (GPI). Here, we assess whether these initial benefits were maintained at 1 year of follow-up. METHODS: Patients aged 18 years or older were eligible for enrolment in this multicentre, open-label, randomised controlled trial if they had STEMI, presented within 12 h after the onset of symptoms, and were undergoing primary PCI. 3602 eligible patients were randomly assigned by interactive voice response system in a 1:1 ratio to receive bivalirudin (0.75 mg/kg intravenous bolus followed by 1.75 mg/kg per h infusion; n=1800) or heparin plus a GPI (control; 60 IU/kg intravenous bolus followed by boluses with target activated clotting time 200-250 s; n=1802). The two primary trial endpoints were major bleeding and net adverse clinical events (NACE; consisting of major bleeding or composite major adverse cardiovascular events [MACE; death, reinfarction, target vessel revascularisation for ischaemia, or stroke]). This prespecified analysis reports data for the 1-year follow-up. Analysis was by intention to treat. Patients with missing data were censored at the time of withdrawal from the study or at last follow-up. This trial is registered with ClinicalTrials.gov, number NCT00433966. FINDINGS: 1-year data were available for 1696 patients in the bivalirudin group and 1702 patients in the control group. Reasons for participant dropout were loss to follow-up and withdrawal of consent. The rate of NACE was lower in the bivalirudin group than in the control group (15.6%vs 18.3%, hazard ratio [HR] 0.83, 95% CI 0.71-0.97, p=0.022), as a result of a lower rate of major bleeding in the bivalirudin group (5.8%vs 9.2%, HR 0.61, 0.48-0.78, p<0.0001). The rate of MACE was similar between groups (11.9%vs 11.9%, HR 1.00, 0.82-1.21, p=0.98). The 1-year rates of cardiac mortality (2.1%vs 3.8%, HR 0.57, 0.38-0.84, p=0.005) and all-cause mortality (3.5%vs 4.8%, HR 0.71, 0.51-0.98, p=0.037) were lower in the bivalirudin group than in the control group. INTERPRETATION: In patients with STEMI undergoing primary PCI, anticoagulation with bivalirudin reduced the rates of net adverse clinical events and major bleeding at 1 year compared with treatment with heparin plus a GPI. This finding has important clinical implications for the selection of optimum treatment strategies for patients with STEMI. FUNDING: Cardiovascular Research Foundation, with unrestricted grant support from Boston Scientific Corporation and The Medicines Company.

Bivalirudin during primary PCI in acute myocardial infarction.

BACKGROUND: Treatment with the direct thrombin inhibitor bivalirudin, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, results in similar suppression of ischemia while reducing hemorrhagic complications in patients with stable angina and non-ST-segment elevation acute coronary syndromes who are undergoing percutaneous coronary intervention (PCI). The safety and efficacy of bivalirudin in high-risk patients are unknown. METHODS: We randomly assigned 3602 patients with ST-segment elevation myocardial infarction who presented within 12 hours after the onset of symptoms and who were undergoing primary PCI to treatment with heparin plus a glycoprotein IIb/IIIa inhibitor or to treatment with bivalirudin alone. The two primary end points of the study were major bleeding and combined adverse clinical events, defined as the combination of major bleeding or major adverse cardiovascular events, including death, reinfarction, target-vessel revascularization for ischemia, and stroke (hereinafter referred to as net adverse clinical events) within 30 days. RESULTS: Anticoagulation with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, resulted in a reduced 30-day rate of net adverse clinical events (9.2% vs. 12.1%; relative risk, 0.76; 95% confidence interval [CI] 0.63 to 0.92; P=0.005), owing to a lower rate of major bleeding (4.9% vs. 8.3%; relative risk, 0.60; 95% CI, 0.46 to 0.77; P<0.001). There was an increased risk of acute stent thrombosis within 24 hours in the bivalirudin group, but no significant increase was present by 30 days. Treatment with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, resulted in significantly lower 30-day rates of death from cardiac causes (1.8% vs. 2.9%; relative risk, 0.62; 95% CI, 0.40 to 0.95; P=0.03) and death from all causes (2.1% vs. 3.1%; relative risk, 0.66; 95% CI, 0.44 to 1.00; P=0.047). CONCLUSIONS: In patients with ST-segment elevation myocardial infarction who are undergoing primary PCI, anticoagulation with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, results in significantly reduced 30-day rates of major bleeding and net adverse clinical events. (ClinicalTrials.gov number, NCT00433966 [ClinicalTrials.gov].).

Evaluation of the dedicated Frontier coronary bifurcation stent: A matched pair analysis with drug-eluting and bare metal stents.

Treatment of coronary bifurcation lesions (CBL) remains challenging. This study sought to evaluate a novel dedicated stent system (Frontier stent) by angiographic and clinical comparison with the provisional T-stenting technique using drug-eluting (DES) and bare metal stents (BMS). The study group comprised 105 CBL in 105 patients. 35 consecutive CBL were treated with the Frontier system. The control group of 70 CBL (35 DES, 35 BMS) was pair matched with the former group stratified by the type of CBL (Medina classification) and the reference diameter of the main branch (MB). Clinical, procedural, and quantitative angiographic data (QCA) were obtained in all patients. A follow-up angiography 6 +/- 2-month post-index intervention was performed in 84/105 (80%) patients, clinical 6-month follow-up was available in all patients (100%). All Frontier stent procedures were clinically and angiographically successful. Post-procedural QCA analysis of the MB and the side branches revealed comparable minimal lumen diameters (MLDs) between groups. Moreover, contrast use and radiation exposure were not different between groups. DES use, however, was associated with a significantly lower late lumen (LL) loss in the main and the side branch as compared to the Frontier stent and BMS group. Likewise, MACE rates were lowest in the DES group (6%, P < 0.05 vs. BMS) as compared to the Frontier stent (9%) and the BMS group (16%). The Frontier stent accomplishes treatment of CBL with excellent acute clinical, procedural, and angiographic results. Provisional T-stenting using DES provides superior clinical and angiographic long-term results as compared to BMS and Frontier stents. The results of next generation CBL systems combining a dedicated specific CBL design with DES surfaces are to be awaited.

One-year results of the SCORPIUS study: a German multicenter investigation on the effectiveness of sirolimus-eluting stents in diabetic patients.

OBJECTIVES: This study sought to analyze the effectiveness of drug-eluting stents in a high-risk group of diabetic patients. Previously, this had been analyzed only in substudies of larger trials or in clinical investigations enrolling a small number of patients. BACKGROUND: Drug-eluting stents are highly effective in reducing the rate of in-stent restenosis. METHODS: Two hundred patients with diabetes and de novo coronary artery lesions were enrolled in 16 centers: 98 were randomly assigned to sirolimus-eluting stents (SES) and 102 received bare-metal stents (BMS). The primary end point was in-segment late luminal loss. Major adverse cardiac events (MACE) rate was analyzed at 30 days and 8 and 12 months. RESULTS: The extent of in-segment late luminal loss in the SES group was 0.18 mm compared with 0.74 mm in the BMS group. In-segment restenosis was identified on follow-up angiography in 8.8% of the patients in SES and in 42.1% in BMS (p < 0.0001). Target lesion revascularization was performed in 5.3% of the patients in SES and in 21.1% of the patients in BMS (p = 0.002). The SES was effective in the treatment group with oral diabetic medication as well as in the insulin-dependent treatment group (3.6% SES vs. 38.8% BMS). There was no subacute stent thrombosis in the SES group up to 1 year. The MACE rate was not significantly different at 30 days. At 12 months, MACE rate was 14.7% in SES versus 35.8% in BMS. CONCLUSIONS: The SES is safe and highly effective in patients with diabetes mellitus and coronary artery disease and associated with a significant decrease in the extent of late luminal loss.

Rational use of drug-eluting stents: a comparison of different policies.

Long-term results of recent landmark trials document both benefits and risks of drug-eluting stents (DES) for coronary revascularization. Interestingly, the conclusions drawn from these data vary widely since significant differences in DES penetration rates become obvious when the utilization of this technology is compared between hospitals or even countries. Based on the recommendations of the European Society of Cardiology, the FDA as well as data derived from the BASKET-LATE study, we propose that a maximum penetration rate of 50% for DES seems appropriate at present. Analysis of the length/diameter distribution combined with the use of validated restenosis reference charts allows identification of high-risk patients regarding restenosis risk and modeling the use of DES depending on financial resources and clinical indication. Such algorithm provides the rational for preprocedural risk stratification and efficient use of resources.

Surgical interventions after emergency endovascular stent-grafting for acute type B aortic dissections.

In this retrospective study we reviewed our results of secondary surgery for complications after emergency placement of aortic stents for acute type B dissection. From October 2000 to June 2006, endovascular stent-grafting (ESG) was performed in 13 patients as an emergency procedure for acute type B dissection. Self-expanding nitinol stents (mean diameter 39.8+/-4.7 mm) were placed into the descending aorta distal to the left subclavian artery. In-hospital mortality was 15.4% (2/13) and related to persistent visceral malperfusion. Three patients (23%) required consecutive open surgery of the thoracic aorta after emergency endovascular stent-grafting for acute type B dissection. Indications for surgery included acute development of retrograde type A aortic dissection and acute stent dislocation by fractured wires and secondary leakage. Elective surgery was necessary in one patient 6 months after stent-grafting for late formation of an aneurysm of the descending aorta. There were no deaths or major morbidity after surgery of the thoracic aorta early or during follow-up. Mean follow-up was 38.0+/-13.9 months (range 1-70 months) and complete. We conclude from our study that stent-grafting of the descending aorta is a feasible, relatively safe and effective approach even in the emergency treatment of patients with complicated acute type B dissection. However, in a relevant number of patients emergency stent-grafting for acute type B aortic dissection results in complications that require secondary surgical treatment.

Apical and midventricular transient left ventricular dysfunction syndrome (tako-tsubo cardiomyopathy): frequency, mechanisms, and prognosis.

BACKGROUND: The frequency and potential differences between patients with apical ("typical") and midventricular ("atypical") ballooning have not been described. METHODS: Consecutive patients with the diagnosis of a troponin-positive acute coronary syndrome (ACS) were prospectively included into a registry (n = 3,265). Of those, 2,944 patients underwent left-heart catheterization and form the study population. Demographic, clinical, and angiographic data including assessment of microvascular dysfunction (Thrombolysis in Myocardial Infarction [TIMI] blush grade, corrected TIMI frame count), as well as clinical outcome were assessed in all patients. RESULTS: In patients with troponin-positive ACS, the frequency of transient cardiomyopathy was 1.2% (35 of 2,944 patients). Typical apical wall motion abnormality was observed in 21 of 35 patients (60%), as compared to an atypical (midventricular) pattern in 14 of 35 patients (40%). Both groups did not differ regarding demographic, clinical, laboratory, or angiographic parameters. Scintigraphy and PET studies were performed in 17 of 35 patients (49%) with transient cardiomyopathy, and showed a strong correlation between location of wall motion abnormality and myocardial metabolism defects, with a significantly higher apical decrease in glucose uptake in patients with a typical pattern. CONCLUSIONS: Transient cardiomyopathy affects approximately 1% of patients with a troponin-positive ACS. A typical apical wall motion abnormality is seen in only 60% of patients. Transient cardiomyopathy, also termed Tako-Tsubo cardiomyopathy, therefore should no longer be regarded as an exclusively apical ballooning syndrome, but rather a transient left ventricular dysfunction syndrome with an apical or midventricular pattern of wall motion abnormality.