The multifactorial aetiology and management of premenstrual dysphoric disorder with leuprorelin acetate.

Up to 18% of women of reproductive age may experience symptoms during the luteal phase of the menstrual cycle known as premenstrual syndrome (PMS) or its more severe form, premenstrual dysphoric disorder (PMDD). A plethora of symptoms have been described, but both are commonly associated with other mood-related disorders such as major depression causing significant life impairment. Originally known as late luteal phase dysphoric disorder in the DSM-III-R (American Psychiatric Association 1987), the syndrome was renamed PMDD in the DSM-IV (American Psychiatric Association 1994). Between 3% and 8% of women meet the diagnostic criteria for PMDD. Currently, there is no consensus on its aetiology although it is thought to be multifactorial. Biological, genetic, psychological, environmental and social factors have all been suggested. However, an altered sensitivity to the normal hormonal fluctuations that influence functioning of the central nervous system is thought most likely. PMDD is identified in the DSM-5 by the presence of at least five symptoms accompanied by significant psychosocial or functional impairment. During evaluation, it is recommended that clinicians confirm symptoms by prospective patient mood charting for at least two menstrual cycles. Management options include psychotropic agents, ovulation suppression and dietary modification. Selective serotonin reuptake inhibitors (SSRIs) are considered primary therapy for psychological symptoms. Ovulation suppression is another option with the combined oral contraceptive pill (COCP) or GnRH (gonadotropin-releasing hormone) agonists. Rarely symptoms warrant a bilateral oophorectomy and a 6-month trial of GnRH agonists prior to surgery may be prudent to determine its potential efficacy. The authors present the case of a multiparous woman in her mid-30s experiencing severe symptoms during the luteal phase of her menstrual cycle. A trial of the contraceptive pill and SSRIs were unsuccessful. Treatment with leuprorelin acetate (Prostap) improved her symptoms. She therefore elected to undergo a bilateral oophorectomy with resolution of her symptoms. She started hormone replacement therapy (HRT). This case demonstrates the multifactorial aetiology of PMDD and the challenges in its management. Women with PMDD suffer functional impairments comparable with other depressive disorders and yet PMDD and its impact remain under-recognised. As the psychological nature and consequences of PMDD often seem indistinguishable from symptoms of other mental health difficulties, this condition presents distinct diagnostic challenges for healthcare professionals. It is crucial to establish the correct diagnosis using clearly defined criteria because if it is left untreated, it can cause considerable impairment to the woman's quality of life.

Restrictive or Liberal Transfusion Strategy in Myocardial Infarction and Anemia.

BACKGROUND: A strategy of administering a transfusion only when the hemoglobin level falls below 7 or 8 g per deciliter has been widely adopted. However, patients with acute myocardial infarction may benefit from a higher hemoglobin level. METHODS: In this phase 3, interventional trial, we randomly assigned patients with myocardial infarction and a hemoglobin level of less than 10 g per deciliter to a restrictive transfusion strategy (hemoglobin cutoff for transfusion, 7 or 8 g per deciliter) or a liberal transfusion strategy (hemoglobin cutoff, <10 g per deciliter). The primary outcome was a composite of myocardial infarction or death at 30 days. RESULTS: A total of 3504 patients were included in the primary analysis. The mean (±SD) number of red-cell units that were transfused was 0.7±1.6 in the restrictive-strategy group and 2.5±2.3 in the liberal-strategy group. The mean hemoglobin level was 1.3 to 1.6 g per deciliter lower in the restrictive-strategy group than in the liberal-strategy group on days 1 to 3 after randomization. A primary-outcome event occurred in 295 of 1749 patients (16.9%) in the restrictive-strategy group and in 255 of 1755 patients (14.5%) in the liberal-strategy group (risk ratio modeled with multiple imputation for incomplete follow-up, 1.15; 95% confidence interval [CI], 0.99 to 1.34; P = 0.07). Death occurred in 9.9% of the patients with the restrictive strategy and in 8.3% of the patients with the liberal strategy (risk ratio, 1.19; 95% CI, 0.96 to 1.47); myocardial infarction occurred in 8.5% and 7.2% of the patients, respectively (risk ratio, 1.19; 95% CI, 0.94 to 1.49). CONCLUSIONS: In patients with acute myocardial infarction and anemia, a liberal transfusion strategy did not significantly reduce the risk of recurrent myocardial infarction or death at 30 days. However, potential harms of a restrictive transfusion strategy cannot be excluded. (Funded by the National Heart, Lung, and Blood Institute and others; MINT ClinicalTrials.gov number, NCT02981407.).

Levator Ani Syndrome Presenting with Vaginal Pain.

Levator ani syndrome (LAS), also known as levator ani spasm, puborectalis syndrome, chronic proctalgia, pyriformis syndrome and pelvic tension myalgia, produces chronic anal pain. The levator ani muscle is susceptible to the development of myofascial pain syndrome, and trigger points may be elicited on physical examination. The pathophysiology remains to be fully delineated. The diagnosis of LAS is suggested primarily by the clinical history, physical examination and the exclusion of organic disease that can produce recurrent or chronic proctalgia. Digital massage, sitz bath, electrogalvanic stimulation and biofeedback are the treatment modalities most frequently described in the literature. Pharmacological management includes non-steroidal anti-inflammatory medications, diazepam, amitriptyline, gabapentin and botulinum toxin. The evaluation of these patients can be challenging due to a diversity of causative factors. The authors present the case of a nulliparous woman in her mid-30s presenting with acute onset of lower abdominal and rectal pain radiating to her vagina. There was no history of trauma, inflammatory bowel disease, anal fissure or altered bowel habit. Each pain episode lasted longer than 20 min and was exacerbated by sitting. Neurological examination showed no evidence of neurological dysfunction. Rectal examination was unremarkable. During vaginal examination, palpation of the levator ani muscles elicited pain indicating pelvic floor dysfunction. Laboratory investigations including a full blood count and C reactive protein were within normal range. Further investigation with a transabdominal ultrasound scan, CT of the abdomen and pelvis and MRI of the lumbar spine were unremarkable. She commenced treatment with amitriptyline 20 mg once daily. She was referred for pelvic floor physiotherapy. Functional pain syndromes, such as LAS, should be regarded as diagnoses of exclusion and considered only after a thorough evaluation has been performed to rule out structural causes of pain. Knowledge of the pelvic floor and pelvic wall muscles may enable the physician to identify LAS, a possible cause of chronic pelvic pain.

Ruptured ovarian ectopic pregnancy presenting with an acute abdomen.

An ectopic pregnancy occurs in 2% of all pregnancies. A primary ovarian ectopic (OP) is a rare entity and occurs in <2% of all ectopic gestations. It may present in those individuals who take ovulatory drugs, use an intrauterine device or have undergone in vitro fertilisation or embryo transfer. Multiparity and a younger age are other recognised risk factors. Diagnosing an OP pregnancy remains a challenge and it may be misdiagnosed as a bleeding luteal cyst, a haemorrhagic ovarian cyst or a tubal pregnancy by ultrasound scan. The diagnosis is often only established at laparoscopy following histopathological examination. A ruptured OP is a potentially life-threatening condition due to its potential for haemorrhage and hemodynamic collapse. Hence, early diagnosis is crucial to prevent serious morbidity and mortality. The authors present the case of a multiparous woman in her late 30s presenting with a seizure and lower abdominal pain at 6 weeks gestation. Her beta human chorionic gonadotropin was >9000 Miu/mL. A transvaginal ultrasound scan showed no evidence of an intrauterine pregnancy. There was free fluid in the pelvis. She was hemodynamically stable. She underwent a diagnostic laparoscopy, which showed hemoperitoneum and a ruptured left OP pregnancy. She underwent a left oophorectomy. Histology confirmed chorionic villi within the ovarian stroma. This case demonstrates the challenges in preoperative diagnosis of a ruptured OP pregnancy and acts as a cautionary reminder that individuals can present with hemodynamic stability. Rarely, as in this case, an OP pregnancy can occur without the presence of risk factors. Despite its rarity, a ruptured OP pregnancy should be considered in the differential diagnosis of women of reproductive age presenting to the emergency department with acute abdominal pain and a positive pregnancy test.

Why Do I Get Side Effects? Personalized (N-of-1) Trials for Statin Intolerance and the Nocebo Effect.

The ability of statins to reduce the morbidity and mortality of cardiovascular disease has ensured that they are among the most prescribed drugs in modern medicine. Unfortunately, most patients who start taking statins will end up stopping them, most commonly due to side effects. Confusingly, however, in blinded placebo-controlled trials, side effects appear no more common in those taking statins than those taking placebo. One possible explanation is that ever-present background symptoms are being falsely attributed to statins. However, another explanation is the nocebo effect, where the act of just taking a tablet (even a placebo) causes genuine side effects in patients. Two recent randomized placebo-controlled personalized (N-of-1) trials have been reported: StatinWise and SAMSON. In these trials, each participant was randomized to multiple periods of statin and placebo, with regular symptom burden assessments. Together, these trials support the existence of a significant nocebo effect from taking statins. Possibly even more importantly, they demonstrate the ability of personalized trials to inform and empower patients: up to half of the patients in these trials were able to successfully restart statins after taking part, despite previously having been statin intolerant. StatinWise and SAMSON have raised public awareness of the nocebo effect in statin intolerance. However, they also demonstrate a potential role for the personalized design outside of clinical trials. If taking part in these personalized experiments allows half of our patients to successfully restart life-saving medications, maybe we should be able to prescribe personalized experiments to our patients in the clinical setting?

Side Effect Patterns in a Crossover Trial of Statin, Placebo, and No Treatment.

BACKGROUND: Most people who begin statins abandon them, most commonly because of side effects. OBJECTIVES: The purpose of this study was to assess daily symptom scores on statin, placebo, and no treatment in participants who had abandoned statins. METHODS: Participants received 12 1-month medication bottles, 4 containing atorvastatin 20 mg, 4 placebo, and 4 empty. We measured daily symptom intensity for each using an app (scale 1-100). We also measured the "nocebo" ratio: the ratio of symptoms induced by taking statin that was also induced by taking placebo. RESULTS: A total of 60 participants were randomized and 49 completed the 12-month protocol. Mean symptom score was 8.0 (95% CI: 4.7-11.3) in no-tablet months. It was higher in statin months (16.3; 95% CI: 13.0-19.6; P < 0.001), but also in placebo months (15.4; 95% CI: 12.1-18.7; P < 0.001), with no difference between the 2 (P = 0.388). The corresponding nocebo ratio was 0.90. In the individual-patient daily data, neither symptom intensity on starting (OR: 1.02; 95% CI: 0.98-1.06; P = 0.28) nor extent of symptom relief on stopping (OR: 1.01; 95% CI: 0.98-1.05; P = 0.48) distinguished between statin and placebo. Stopping was no more frequent for statin than placebo (P = 0.173), and subsequent symptom relief was similar between statin and placebo. At 6 months after the trial, 30 of 60 (50%) participants were back taking statins. CONCLUSIONS: The majority of symptoms caused by statin tablets were nocebo. Clinicians should not interpret symptom intensity or timing of symptom onset or offset (on starting or stopping statin tablets) as indicating pharmacological causation, because the pattern is identical for placebo. (Self-Assessment Method for Statin Side-effects Or Nocebo [SAMSON]; NCT02668016).

Preparing nurses for fieldwork in tropical nursing.

Due to factors related to increasing globalization, geopolitical conflicts, and climate change, tropical nursing is increasingly important. This article offers an overview of the Diploma in Tropical Nursing program and explores the challenges facing nurses who serve patients in tropical settings with limited resources.

Could congressionally mandated incentives lead to deployment of large-scale CO2 capture, facilities for enhanced oil recovery CO2 markets and geologic CO2 storage?

In passing the Bipartisan Budget Act of 2018, Congress reformed and strengthened a section of the tax code, 45Q, which provides tax credits of up to $35/ton CO2 for the capture and utilization of CO2 in qualifying applications such as enhanced oil recovery (EOR) and up to $50/ton CO2 for CO2 that is captured and permanently stored in a geologic repository. Earlier versions of the tax credit with lower credit values generated limited interest. This change to the tax code could potentially alter U.S. energy systems. This paper examines the effect of the increased 45Q credits on CO2 capture, utilization and storage (CCUS) deployment in the United States and on petroleum and power production. A range of potential outcomes is explored using five modeling tools. The paper goes on to explore the potential impact of possible modifications of the current tax credit including extension of its availability in time, the period over which 45Q tax credits can be utilized for any given asset and increases in the value of the credit as well as interactions with technology availability and carbon taxation. The paper concludes that 45Q tax credits could stimulate additional CCUS beyond that which is already underway.

Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC-HOT study.

BACKGROUND: In the randomized AMIHOT-II trial, supersaturated oxygen [SSO2 ] delivered into the left anterior descending (LAD) artery via an indwelling intracoronary infusion catheter following primary percutaneous coronary intervention (PCI) significantly reduced infarct size in patients with anterior ST-segment elevation myocardial infarction (STEMI) but resulted in a numerically higher incidence of safety events. OBJECTIVES: The IC-HOT study evaluated the safety of SSO2 therapy selectively delivered to the left main coronary artery (LMCA) for 60 minutes after PCI in patients with anterior STEMI. METHODS: SSO2 therapy was administered to the LMCA after stent implantation in 100 patients with anterior STEMI and proximal or mid-LAD occlusion presenting within 6 hours of symptom onset. The primary endpoint was the 30-day composite rate of net adverse clinical events (NACE) (death, reinfarction, clinically driven target vessel revascularization, stent thrombosis, severe heart failure, or TIMI major/minor bleeding) compared against an objective performance goal of 10.7%. Cardiac magnetic resonance imaging was performed at 4 and 30 days to assess infarct size. RESULTS: SSO2 delivery was successful in 98% of patients. NACE at 30 days occurred 7.1% of patients (meeting the primary safety endpoint of the study); there were no deaths, only one stent thrombosis and one case of severe heart failure. Median [interquartile range] infarct size was 24.1% [14.4%, 31.6%] at 4 days and 19.4% [8.8%, 28.9%] at 30 days. CONCLUSION: Following primary PCI in acute anterior STEMI, infusion of SSO2 via the LMCA was feasible and was associated with a favorable early safety profile.

Process evaluation of the impact and acceptability of a polypill for prevention of cardiovascular disease.

IMPORTANCE: The Use of a Multidrug Pill In Reducing cardiovascular Events (UMPIRE) trial has shown improved adherence with the use of a polypill strategy when compared with usual medications for cardiovascular disease (CVD) prevention. To advance from efficacy to impact, we need a better understanding of why and how such a strategy might be deployed in complex health systems. OBJECTIVE: To understand, from the perspective of UMPIRE trial participants and professionals, how and why a polypill strategy improves adherence compared with usual care, why improvement is greater in some subgroups, and to explore the acceptability of a polypill strategy among trial participants and healthcare professionals. DESIGN, SETTING AND PARTICIPANTS: A preplanned process evaluation, based on qualitative interviews, was conducted with a subsample of 102 trial participants and 41 healthcare professionals at the end of the UMPIRE trial in India and Europe. RESULTS: Most patients contrasted the simplicity of the polypill with usual medications that they found complex and, for many in India, expensive. Patients with low baseline adherence struggled most with complex medication lists, and those without established disease described less motivation to adhere when compared with people who had already been diagnosed with CVD; people in the latter group had already undertaken self-directed measures to adhere to CVD preventive medicines prior to entering the trial. Taking medication was one of many adaptations described by patients; these included dietary changes, stopping smoking and maintaining exercise. Most patients liked the polypill strategy, although some participants and health professionals were concerned that it would provide less tailored therapy for individual needs. CONCLUSIONS: Adherence to treatment lists with multiple medications is complex and influenced by several factors. Simplifying medication by using a once-daily polypill is one approach to CVD prevention that may enhance adherence. Prescribers should also consider the wide variety of adjustments that individuals need to make to cope with daily medication.

Coronary artery aneurysms: case report and review of transcatheter management strategies.

There is no consensus on the best management of coronary artery aneurysms (CAA) in adults. We describe two patients with CAA and review transcatheter approaches to exclude them from the circulation.

Mortality in patients with ST-segment elevation myocardial infarction who do not undergo reperfusion.

Reperfusion therapy reduces mortality in patients presenting with ST-segment elevation myocardial infarctions (STEMI). However, some patients may not receive thrombolytic therapy or undergo primary percutaneous coronary intervention. The decision making and clinical outcomes of these patients have not been well described. In this study, 139 patients were identified from a total of 1,126 patients with STEMI who did not undergo reperfusion therapy at a high-volume percutaneous coronary intervention center from October 2006 to March 2011. Clinical data, reasons for no reperfusion, management, and mortality were obtained by chart review. The mean age was 80 ± 13 years (61% women, 31% diabetic, and 37% known coronary artery disease). Of the 139 patients, 72 (52%) presented with primary diagnoses other than STEMI, and 39 (28%) developed STEMI >24 hours after admission. The most common reasons for no reperfusion were advanced age, co-morbid conditions, acute or chronic kidney injury, delayed presentation, advance directives precluding reperfusion, patient preference, and dementia. Eighty-four patients (60%) had ≥ 3 reasons for no reperfusion. Factors associated with hospital mortality were cardiogenic shock, intubation, and advance directives prohibiting reperfusion after physician consultation. In hospital and 1-year mortality were 53% and 69%, respectively. In conclusion, at a high-volume percutaneous coronary intervention center, most patients presenting with STEMI underwent immediate catheterization. The decision for no reperfusion was multifactorial, with advanced age reported as the most common factor. Outcomes were poor in this population, and fewer than half of these patients survived to hospital discharge.

Reproducibility of near-infrared spectroscopy for the detection of lipid core coronary plaques and observed changes after coronary stent implantation.

OBJECTIVES: To evaluate the reproducibility of catheter-based intracoronary near-infrared spectroscopy (NIRS) for the detection of lipid core coronary plaques (LCPs) and to examine stenting-induced changes in NIRS findings. BACKGROUND: The in-vivo reproducibility of coronary NIRS findings and their changes after stenting have not previously been characterized. METHODS: NIRS assessment using an automated pullback catheter was performed in duplicate in 36 vessels in 31 patients. The reproducibility of the Lipid Core Burden Index (LCBI) and the presence and number of LCPs was assessed. The changes in LCBI after stenting were also assessed in 25 vessels in 22 patients. RESULTS: LCBI of the first and second pullback was 64 ± 43 and 70 ± 62, respectively, with excellent correlation (Spearman's rho 0.927, intraclass correlation coefficient 0.925). Depending on LCP definition, mean LCP length, and median LCP number ranged from 2.44 to 17.25 mm, and from 0 to 2, respectively per artery studied. High correlation was observed between the two pullbacks for total LCP length (depending on the LCP definition used, the Spearman's rho and the intraclass correlation coefficient ranged from 0.72 to 0.89, and from 0.76 to 0.91, respectively) and for LCP number (depending on the LCP definition used, the Spearman's rho and the intraclass correlation coefficient ranged from 0.70 to 0.87, and from 0.67 to 0.88, respectively). The mean LCBI decreased by 40% from 78 ± 47 to 48 ± 38 after stenting (P < 0.001). CONCLUSION: The LCBI and LCP length NIRS measurements have high reproducibility. LCBI significantly decreases after coronary stenting.

Analysis of saphenous vein graft lesion composition using near-infrared spectroscopy and intravascular ultrasonography with virtual histology.

OBJECTIVE: To examine the composition of saphenous vein graft (SVG) lesions using two novel modalities, near-infrared spectroscopy (NIRS) and intravascular ultrasonography with virtual histology (IVUS-VH). METHODS: We performed NIRS and IVUS-VH imaging of 23 SVGs in 21 patients undergoing clinically-indicated angiography. RESULTS: Mean patient and SVG age was 66±7 and 10±7 years, respectively. SVG lesion location was aorto-ostial in 8 (35%), body in 13 (57%) and distal anastomotic in 2 (9%). Compared to anastomotic lesions, body lesions had larger mean lumen area (6.4±1.8 mm2 vs. 4.2±6.4 mm2, P=0.02) but similar mean plaque burden (73±5% vs. 70±10%, P=0.66). A NIRS lipid core plaque was identified in 9 of 13 body lesions vs. 1 of 10 anastomotic lesions (69% vs. 10%, P=0.005). SVG body lesions had higher lipid core burden index (LCBI) compared to anastomotic lesions (184±76 vs. 49±54, P<0.001). By IVUS-VH, SVG lesions had high % necrotic core (28±10%) and % dense calcium (13±10%), without any significant difference between body and anastomotic sites. Older SVG age was associated with higher lesion and vessel LCBI (r=0.76 and r=0.64, respectively, P<0.001), but was not associated with IVUS-VH determined plaque composition. Higher HDL-cholesterol was associated with lower lesion LCBI (r=-0.43, P=0.04). CONCLUSIONS: NIRS-measured lipid core plaque in SVGs increases with increasing SVG age and is infrequent in anastomotic lesions. No association was found between IVUS-VH plaque composition measurements and SVG lesion location or age.

Peroxisome proliferator-activated receptor ligands reduce aortic dilatation in a mouse model of aortic aneurysm.

OBJECTIVE: Osteopontin (OPN) is associated with human abdominal aortic aneurysms (AAA) and in vitro studies suggest that this cytokine is downregulated by peroxisome proliferator-activated receptor (PPAR) ligation. We examined the effect of two PPAR ligands within a mouse model of aortic aneurysm. METHODS: At 11 weeks of age apolipoprotein E deficient (ApoE(-/-)) mice were given pioglitazone (n=27), fenofibrate (n=27) or vehicle (n=27) in their drinking water. From 13 weeks of age mice received angiotensin II (1 microg/kg/min) infusion via subcutaneous pumps until death or 17 weeks when the aortas were harvested and maximum aortic diameters were recorded. Suprarenal aortic segments were assessed for OPN concentration and macrophage accumulation. Saline infused mice served as negative controls (n=22). RESULTS: Angiotensin II induced marked dilatation in the suprarenal aorta (>2-fold increase compared to controls) associated with upregulation of the cytokines OPN and macrophage infiltration. Suprarenal aortic expansion was significantly reduced by administration of pioglitazone (mean diameter 1.61+/-0.11 mm, p=0.011) and fenofibrate (mean diameter 1.51+/-0.13 mm, p=0.001) compared to the vehicle control group (mean diameter 2.10+/-0.14 mm). Immunostaining for macrophages was reduced in mice treated with pioglitazone (median staining area 6.2%, interquartile range 4.1-7.2, p<0.001) and fenofibrate (median staining area 4.0%, interquartile range 2.2-6.1, p<0.001) compared to mice receiving vehicle control (median staining area 13.2%, interquartile range 8.4-20.0). CONCLUSION: These findings suggest the potential value of peroxisome proliferator-activated receptor ligation as a therapy for human AAAs.

Sorting through new biomarkers.

Early diagnosis of acute coronary syndromes (ACS) allows for efficient risk stratification, appropriate targeted therapies, and faster patient disposition within crowded emergency departments. Although only troponin testing is recommended for routine use in the 2007 American College of Cardiology/American Heart Association guidelines for non-ST-elevation ACS, emerging data support selected use of other biomarkers, including B-type natriuretic peptides (BNPs) and C-reactive protein. There remains a need to identify additional biomarkers in ACS to enhance risk stratification and to help guide therapeutic decisions in this increasingly complex area of cardiovascular medicine. Cardiac biomarkers may help to diagnosis ACS before cardiomyocyte necrosis, to influence the decision for early invasive treatment, and to provide a means of monitoring response to therapy. In this review, we assess new data in ACS with respect to troponins, BNPs, myeloperoxidase, fatty acid-binding protein, and monocyte chemoattractant protein-1. We also discuss novel biomarkers including growth deficient factor-15 and neopterin.

Unprotected left main disease managed with drug-eluting stents: long-term outcome of 100 patients with increased surgical risk.

OBJECTIVES: The purpose of this study was to determine long-term clinical outcomes in high surgical risk patients (pts) with unprotected left main (ULM) disease who were managed with drug-eluting stents (DES). BACKGROUND: The long-term efficacy of unprotected left main (ULM) stenting with DES remains uncertain. METHODS: From June 2003 to December 2005, 100 pts with increased surgical risk underwent ULM stenting with DES. Patient risk was estimated by EuroSCORE. Disease was confined to the ostium/main stem in Group A (31 pts) and involved the bifurcation in Group B (69 pts). Study endpoints were MI, TVR, and death. RESULTS: Mean age was 68 +/- 1 years, EF 52 +/- 1%. Mean EuroSCORE was 5.2 +/- 0.4, and 41% pts had a EuroSCORE of >6. In Group A, 87% of lesions were directly stented. In Group B, 61% of pts received one stent and 39% received two stents. Primary success was 95%. Follow-up data (mean 28 +/- 1 months) were obtained in all patients. Restenosis occurred at the proximal stent margin in 5/9 pts. There were 12 cardiac deaths (88% cardiac survival) and 9 noncardiac deaths (79% total survival). In Group B, 5 pts died suddenly: 3 within the first week and 2 additional pts after 1 year. Sudden death did not occur in Group A. All cause event-free survival was 65% in Group A and 67% in Group B. CONCLUSION: A substantial number of late adverse events occurred in both ostial and bifurcation groups with equal frequency. Until definitive data from randomized trials are available, ULM stenting should be performed only in patients with prohibitive surgical risk.