Left Ventricular End-Diastolic Pressure Versus Urine Flow Rate-Guided Hydration in Preventing Contrast-Associated Acute Kidney Injury.

OBJECTIVES: This study compared left ventricular end-diastolic pressure (LVEDP)-guided and urine flow rate (UFR)-guided hydration. BACKGROUND: Tailored hydration regimens improve the prevention of contrast-associated acute kidney injury (CA-AKI). METHODS: Between July 15, 2015, and June 6, 2019, patients at high risk for CA-AKI scheduled for coronary and peripheral procedures were randomized to 2 groups: 1) normal saline infusion rate adjusted according to the LVEDP (LVEDP-guided group); and 2) hydration controlled by the RenalGuard System in order to reach UFR ≥300 ml/h (UFR-guided group). The primary endpoint was the composite of CA-AKI (i.e., serum creatinine increase ≥25% or ≥0.5 mg/dl at 48 h) and acute pulmonary edema (PE). Major adverse events (all-cause death, renal failure requiring dialysis, PE, and sustained kidney injury) at 1 month were assessed. RESULTS: The primary endpoint occurred in 20 of 351 (5.7%) patients in the UFR-guided group and in 36 of 351 (10.3%) patients in the LVEDP-guided group (relative risk [RR]: 0.560; 95% confidence interval [CI]: 0.390 to 0.790; p = 0.036). CA-AKI and PE rates in the UFR-guided group and LVEDP-guided group were 5.7% and 10.0% (RR: 0.570; 95% CI: 0.300 to 0.960; p = 0.048), and, respectively, 0.3% and 2.0% (RR: 0.070; 95% CI: 0.020 to 1.160; p = 0.069). Three patients in the UFR-guided group experienced complications related to the Foley catheter. Hypokalemia rate was 6.2% in the UFR-guided group and 2.3% in the LVEDP-guided group (p = 0.013). The 1-month major adverse events rate was 7.1% in the UFR-guided group and 12.0% in the LVEDP-guided group (p = 0.030). CONCLUSIONS: The study demonstrates that UFR-guided hydration is superior to LVEDP-guided hydration to prevent the composite of CA-AKI and PE.

Sympathetic Overactivation in Patients With Essential Hypertension and Hepatic Iron Overload.

Iron overload has been recently shown to be associated with a hyperadrenergic state in genetic hemochromatosis. Whether this is also the case in essential hypertension, characterized by sympathetic activation and frequently by body iron overload, is unknown. In 17 healthy normotensive controls (age 52.3±3.2 years, mean±SE), in 21 age-matched patients with hypertension with iron overload (HT+), defined by serum ferritin levels, and in 28 hypertensives without this condition, we measured efferent postganglionic muscle sympathetic nerve traffic (microneurography), heart rate and blood pressure variability (power spectral analysis), serum ferritin, and metabolic variables. Muscle sympathetic nerve traffic was significantly (P<0.02 at least) greater in HT+ than in patients with hypertension without iron overload and normotensive subjects both when expressed as bursts incidence over time (41.8±1.4 versus 31.5±1.4 and 23.6±0.9 bursts/min) and as bursts corrected for heart rate (55.3±1.8 versus 42.3±1.2 and 31.7±1.2 bursts/100 heartbeats). In HT+, low-frequency systolic blood pressure variability was significantly reduced. In HT+, but not in the other 2 groups, muscle sympathetic nerve traffic was significantly related to serum ferritin (r=0.51, P<0.03), transferrin saturation (r=0.47, P<0.03), and hepatic iron load (r=0.76, P<0.0001, magnetic resonance imaging), as well as to homeostatic model assessment index values (r=0.46, P<0.05). These data provide the first evidence that in HT+ elevated serum ferritin is associated with a hyperadrenergic state of greater magnitude than the one seen in patients with hypertension without iron overload. They also show that the potentiation of the sympathetic activation detected in HT+ is related to elevated serum ferritin and to the associated metabolic alterations, possibly participating in the increased cardiovascular risk characterizing iron overload.

Comparison of SFA lesion treatment with Zilver PTX in diabetics vs. non-diabetics: 2-year clinical and functional results.

BACKGROUND: Prospective single-arm study, aimed at evaluating safety and effectiveness at 12 and 24 months of the paclitaxel-eluting nitinol stent (Zilver PTX), and focused in particular on the treatment of complex lesions and/or diabetic patients. METHODS: Between May 2010 and March 2012, 67 patients (78% males) were treated by Zilver PTX, because of stenosis or occlusions of the superficial femoral artery in one of two centers. The mean age of patients was 70.1±8 years. Thirty-two of 67 (48%) were diabetics, 14 (21%) active smokers and 11 (14.6%) had chronic renal failure (end stage renal disease). The average length of lesions was 104±60 mm. Occlusion was complete in 46.3% of cases, whereas severely calcified lesions were present in 30% of patients (18.8% in diabetics and 31.4% in non-diabetics). Twenty-six patients (39%) had type C or D lesions according to TASC 2. RESULTS: One hundred-two stents were used (1.7±0.9 per patients); median 1 (range 1-4). All patients had successful stent placement. Primary patency, evaluated by Kaplan-Meier method was 88±0.06% at 12 months, and 68±0.1% at 24 months. In particular, the difference between diabetics (D) and non-diabetics (non-D) was not significant (P=0.07, Log-Rank). Patients turned from 4.2±1.3 to 1.6±1.3 Rutherford class. There were 5 deaths due to systemic comorbidities. There also were 3 major amputations, all of them also in the D group. Among the other patients, differences between D and non-D patients were not significant in terms of wound healing, bipedal stay and spontaneous ambulation. The mean follow-up length was 28±5 months (range 24-36 months). There was only one patient who had fracture and stent migration (1.5%). In 13 diabetic patients, tibial PTA was also associated. Additional treatment was required in 6 D and 1 non-D. CONCLUSIONS: The use of Zilver PTX is safe and effective in the treatment of SFA lesions. In particular, both stent patency and functional results on the basis of both clinical and instrumental tools were similar in D and non-D, suggesting a particularly favorable activity of PTX in a subpopulation of diabetics. Further studies are required to confirm these results, which seem to be particularly promising in diabetic patients.

Transcatheter CoreValve implantation for aortic regurgitation in a Jehovah's witness with prior aortic dissection.

Indications for transcatheter valve implantation have been extended to treat native valve aortic regurgitation in case of disproportionate risk for open surgery. Transcatheter aortic valves are also an attractive alternative in patients who refuse blood transfusions. We report the successful off-label implantation of a self-expandable transcatheter valve in a Jehovah's Witness with prior replacement of the ascending aorta for Type A dissection, residual severe aortic regurgitation and refractory heart failure.

Bilateral ureteroarterial fistula: a case report and review of literature.

Ureteral arterial fistula (UAF) is an uncommon condition characterized by a direct fistulous communication between a ureter and an iliac artery resulting in bleeding into the ureter, which can be massive and life-threatening because of hemodynamic instability, as confirmed by the high mortality rate (7-23% overall).This condition is actually increasing in frequency because of its relation to predisposing factors such as vascular pathology, previous radiation therapy, previous surgery, and necessity of ureteral stenting. Diagnosis is often challenging, as in most patients, the only symptom is hematuria and the treatment may require a multidisciplinary approach, including the expertise of the urologist, vascular surgeon, and interventional radiologist. Endovascular approach offers advantages over open surgery decreasing morbidity (reduced risk of injury to adjacent structure) and shortening hospital staying. There is no consensus regarding the safety of intentional occlusion of the hypogastric artery: proximal occlusion of a hypogastric artery typically produces little or no clinical symptoms due to well-collateralized pelvic arterial networks. On the contrary, significant complications, such as colonic ischemia, spinal cord paralysis, buttock claudication, or erectile dysfunction, are well-recognized adverse events after hypogastric artery embolization, especially in bilateral cases. We describe our experience of a bilateral UAF treated with bilateral endvascular approach.

Incidence and predictors of coronary stent thrombosis: evidence from an international collaborative meta-analysis including 30 studies, 221,066 patients, and 4276 thromboses.

BACKGROUND: Stent thrombosis remains among the most feared complications of percutaneous coronary intervention (PCI) with stenting. However, data on its incidence and predictors are sparse and conflicting. We thus aimed to perform a collaborative systematic review on incidence and predictors of stent thrombosis. METHODS: PubMed was systematically searched for eligible studies from the drug-eluting stent (DES) era (1/2002-12/2010). Studies were selected if including ≥ 2000 patients undergoing stenting or reporting on ≥ 25 thromboses. Study features, patient characteristics, and incidence of stent thrombosis were abstracted and pooled, when appropriate, with random-effect methods (point estimate [95% confidence intervals]), and consistency of predictors was formally appraised. RESULTS: A total of 30 studies were identified (221,066 patients, 4276 thromboses), with DES used in 87%. After a median of 22 months, definite, probable, or possible stent thrombosis had occurred in 2.4% (2.0%; 2.9%), with acute in 0.4% (0.2%; 0.6%), subacute in 1.1% (1.0%; 1.3%), late in 0.5% (0.4%; 0.6%), and very late in 0.6% (0.4%; 0.8%). Similar figures were computed for studies reporting only on DES. From a total of 47 candidate variables, definite/probable stent thrombosis was more commonly and consistently predicted by early antiplatelet therapy discontinuation, extent of coronary disease, and stent number/length, with acute coronary syndrome at admission, diabetes, smoking status, and bifurcation/ostial disease also proving frequent predictors, but less consistently. CONCLUSIONS: Despite numerous possible risk factors, the most common and consistent predictors of stent thrombosis are early antiplatelet therapy discontinuation, extent of coronary disease, and stent number/length.

Limb revascularization feasibility in diabetic patients with critical limb ischemia: results from a cohort of 344 consecutive unselected diabetic patients evaluated in 2009.

AIMS: To evaluate the feasibility of peripheral revascularization by angioplasty (PTA) or bypass grafting (BPG) in diabetic patients with critical limb ischemia (CLI). METHODS: All diabetic patients referred to our Diabetic Foot Centre for foot lesion or rest pain were assessed for the presence of CLI as assessed by the TASC criteria. All patients underwent angiography that was evaluated jointly by an interventional radiologist, a vascular surgeon and a diabetologist of the diabetic foot care team. RESULTS: During 2009, 344 diabetics were admitted because of CLI in a total of 360 limbs. PTA was performed in 308 (85.6%) limbs, and BPG was performed in 40 (11.1%) limbs in which PTA was not feasible. Revascularization could not be carried out in 12 (3.3%) limbs due to the lack of target vessel (9 limbs) or high surgical risk (3 limbs). According to the judgement of the vascular surgeon, BPG was anatomically feasible in 180 (58.4%) of the 308 limbs that underwent PTA. Therefore, considering also the 40 limbs that underwent BPG, surgical revascularization was judged anatomically possible in a total of 220 (61.1%) limbs. At 30 days, 19 (5.3%) above-the-ankle amputations were performed: 8 (66.7%) amputations were performed in the 12 non-revascularized limbs, 8 (2.6%) amputations were performed in the 308 limbs treated with PTA and 3 (7.5%) amputations were performed in the 40 limbs treated with BPG. CONCLUSIONS: Revascularization by PTA is highly feasible in diabetics with CLI. The feasibility of revascularization by BPG is lower but nonetheless consistent. In centres where both revascularization procedures are available, it is possible to revascularize more than 96% of diabetics with CLI.

Renal Insufficiency After Contrast Media Administration Trial II (REMEDIAL II): RenalGuard System in high-risk patients for contrast-induced acute kidney injury.

BACKGROUND: The RenalGuard System, which creates high urine output and fluid balancing, may be beneficial in preventing contrast-induced acute kidney injury. METHODS AND RESULTS: The Renal Insufficiency After Contrast Media Administration Trial II (REMEDIAL II) trial is a randomized, multicenter, investigator-driven trial addressing the prevention of contrast-induced acute kidney injury in high-risk patients. Patients with an estimated glomerular filtration rate ≤30 mL · min(-1) · 1.73 m(-2) and/or a risk score ≥11 were randomly assigned to sodium bicarbonate solution and N-acetylcysteine (control group) or hydration with saline and N-acetylcysteine controlled by the RenalGuard System and furosemide (RenalGuard group). The primary end point was an increase of ≥0.3 mg/dL in the serum creatinine concentration at 48 hours after the procedure. The secondary end points included serum cystatin C kinetics and rate of in-hospital dialysis. Contrast-induced acute kidney injury occurred in 16 of 146 patients in the RenalGuard group (11%) and in 30 of 146 patients in the control group (20.5%; odds ratio, 0.47; 95% confidence interval, 0.24 to 0.92). There were 142 patients (48.5%) with an estimated glomerular filtration rate ≤30 mL · min(-1) · 1.73 and 149 patients (51.5%) with only a risk score ≥11. Subgroup analysis according to inclusion criteria showed a similarly lower risk of adverse events (estimated glomerular filtration rate ≤30 mL · min(-1) · 1.73 m(-2): odds ratio, 0.44; risk score ≥11: odds ratio, 0.45; P for interaction=0.97). Changes in cystatin C at 24 hours (0.02±0.32 versus -0.08±0.26; P=0.002) and 48 hours (0.12±0.42 versus 0.03±0.31; P=0.001) and the rate of in-hospital dialysis (4.1% versus 0.7%; P=0.056) were higher in the control group. CONCLUSION: RenalGuard therapy is superior to sodium bicarbonate and N-acetylcysteine in preventing contrast-induced acute kidney injury in high-risk patients. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrial.gov. Unique identifier: NCT01098032.

[Cardiac stem cell therapy for the treatment of chronic stable angina refractory to conventional therapy. State of the art and current clinical experience of the San Raffaele Hospital of Milan, Italy]. / La terapia cellulare cardiaca nel trattamento dei pazienti con angina cronica refrattaria alle terapie convenzionali. Excursus sullo stato dell'arte e descrizione dell'esperienza clinica in corso all'Ospedale San Raffaele di Milano.

BACKGROUND: Cardiac stem cell therapy is a field of scientific research with the goal to translate into clinical benefit the initial findings obtained in basic research laboratories. We have moved into clinical trials in different disease categories: acute myocardial infarction, chronic stable angina refractory to conventional therapy and heart failure. So far we have faced with contradictory results. Some previous studies suggested that bone marrow cell injection may improve myocardial perfusion and left ventricular function in patients with chronic myocardial ischemia. METHODS: In this paper we present a brief review about stem cell use in clinical cardiology and describe our research protocol evaluating the effects of direct intramyocardial injection of autologous bone marrow cells (CD34+ selected cells versus all mononuclear cells) in patients with chronic myocardial ischemia. RESULTS: Preliminary results show that this procedure seems to be safe and generally well tolerated by patients. An improvement in symptoms, in the first 6 months, appears to be achieved in approximately 50% of patients, with concomitant improvement of quantitative scintigraphic stress test imaging. CONCLUSIONS: Before drawing any definitive conclusions, we need to wait for the end of enrollment and unblinding of study randomization.

The CID Chrono cobalt-chromium alloy carbofilm-coated coronary stent system.

BACKGROUND: In an attempt to improve the stent's safety, development of bare metal stents (BMS) continues, with new materials and geometry. Chrono (CID, Italy) is a thin strut cobalt-chromium (Co-Cr) stent combining the clinical benefits of the bio- and haemo-compatible Carbofilm coating. METHODS: We assessed the safety and efficacy of percutaneous coronary interventions (PCI) using the new Co-Cr Chrono stent in patients undergoing elective PCI for de novo lesions in native coronary vessels. The patients were followed for 12 months for the occurrence of major cardiac events (MACE, defined as death, myocardial infarction, repeat PCI and bypass surgery). Patients with complex (B2/C) lesions were compared to those with non-complex lesions (A/B1). RESULTS: A total of 340 consecutive patients were analysed: 155 patients with complex lesions (Complex group) and 185 patients with non-complex lesions (Non-complex group). Dual antiplatelet therapy was maintained >1 month in 21% of patients in both Complex and Non-complex group. Stent length was longer in the Complex group (25 ± 10 mm versus 17 ± 6 mm; p<0.001). Stent diameter <3.0 mm was most frequent in the Complex group (35.5% versus 27.5%; p<0.05). During the 12-month follow-up period MACE occurred in 10.6% of the global population (12.3% in the Complex group and 9.2% in the Non-complex group; p=0.43). Repeat PCI was most frequent in the Complex group (9.7% versus 3.8%; p=0.044). The incidence of definite and probable stent thrombosis (ARC criteria) was 1.29% in the Complex group and 1.08% in the Non-complex group (p=1.0). CONCLUSIONS: Implantation of the Co-Cr Chrono stent results in a good safety and efficacy for both complex and non-complex de-novo coronary artery lesions.

A novel device for true lumen re-entry after subintimal recanalization of superficial femoral arteries: first-in-man experience and technical description.

Subintimal angioplasty (SAP) is frequently performed for the treatment of critical limb ischemia (CLI) and has been recognized as an effective technique for these patients. Nevertheless, this approach is limited by the lack of controlled re-entry into the true lumen of the target vessel. We describe a novel device for true lumen re-entry after subintimal recanalization of superficial femoral arteries (SFA). We report our experience with six patients treated between April 2009 and January 2010 with a novel system designed to facilitate true lumen re-entry. The device was advanced by ipsilateral antegrade approach through a 6-French sheath. Successful reaccess into the true lumen was obtained in five of six patients without complications. The patient in whom the reaccess to the true lumen was not possible underwent successful bypass surgery. At 30 days follow-up, the SFA was patent in all patients according to echo-Doppler examination. Our preliminary experience indicates that this novel re-entry device increases the success rate of percutaneous revascularization of chronically occluded SFA.

Circulating CD4+CD25hiCD127lo regulatory T-Cell levels do not reflect the extent or severity of carotid and coronary atherosclerosis.

OBJECTIVE: Regulatory T (Treg) cells play a protective role in experimental atherosclerosis. In the present study, we investigated whether the levels of circulating Treg cells relate to the degree of atherosclerosis in carotid and coronary arteries. METHODS AND RESULTS: We studied 2 distinct populations: (1) 113 subjects, selected from a free-living population (carotid study), in which we measured the intima-media thickness of the common carotid artery, as a surrogate marker of initial atherosclerosis; and (2) 75 controls and 125 patients with coronary artery disease (coronary study): 36 with chronic stable angina, 50 with non-ST-elevation acute coronary syndrome, 39 with ST-elevation acute myocardial infarction. Treg-cell levels were evaluated by flow cytometry (Treg cells identified as CD3(+)CD4(+)CD25(high)CD127(low)) and by mRNA expression of forkhead box P3 or of Treg-associated cytokine interleukin 10. In the carotid study, no correlation was observed between Treg-cell levels and intima-media thickness. No differences in Treg-cell levels were observed comparing rapid versus slow intima-media thickness progressors from a subgroup of patients (n=65), in which prospective data on 6-year intima-media thickness progression were available. In the coronary group, Treg-cell levels were not altered in chronic stable angina patients. In contrast, nonunivocal variations were observed in patients suffering an acute coronary syndrome (with a Treg-cell increase in ST-elevation acute myocardial infarction and a Treg-cell decrease in non-ST-elevation acute coronary syndrome patients). CONCLUSIONS: The results suggest that determination of circulating Treg-cell levels based on flow cytometry or mRNA assessment is not a useful indicator of the extent or severity of atherosclerosis.

Stent choice in primary percutaneous coronary intervention: drug-eluting stents or bare metal stents?

The controversial choice between bare metal stents and drug-eluting stents (DES) in primary percutaneous coronary intervention (PCI) seems to be driven by a growing body of evidence. Although evidence supporting the use of DES in the setting of ST-segment elevation myocardial infarction (STEMI) has been demonstrated, including a lower target vessel revascularization (TVR) rate without increased mortality, at present the proportion of DES implants in STEMI patients is low. This may be due to higher costs of DES, cultural issues, lack of concerns about restenosis in STEMI, lack of information on patient bleeding risk and the need for surgery within a limited time. In addition, initial enthusiasm about the efficacy of DES in reducing restenosis is now decreasing as a result of the safety concerns regarding in-stent thrombosis. Moreover, DES requires long-term dual antiplatelet therapy (DAT), which may pose problems in patients prone to bleeding or in candidates for elective surgery. Nevertheless, benefits associated with use of DES include significantly lower TVR rates without remarkable adverse effects in terms of death and myocardial infarction. Data about the efficacy of DES are still limited to 1-year follow-up in most trials. Uncoated stents permit early arterial wall healing, requiring a shorter duration of DAT and are potentially associated with a reduced risk of thrombus formation at long-term follow-up. Importantly, however, this potential late threat has not been confirmed in recent data from the limited number of studies with longer than 2-years follow-up. Anatomical features and individual risk profiles can sometimes help in the choice of the most suitable type of stent. In conclusion, stent choice in primary PCI cannot be standardized for all patients and appears to be influenced by various factors that need to be considered to provide better revascularization in terms of both efficacy and safety.

Rotational atherectomy followed by drug-eluting stent implantation in calcified coronary lesions.

AIMS: Little information is available on the outcome after rotational atherectomy (RA) followed by drug-eluting stent (DES) implantation in calcified coronary lesions. The aim of this study was to evaluate the outcome of patients with severe lesion calcification undergoing RA followed by implantation of DES. METHODS AND RESULTS: Ninety-five patients with 96 de novo severely calcified lesions were included. Twenty-nine patients (30.5%) had diabetes mellitus and seven patients (7.4%) had chronic renal failure. The total stent length per lesion was 48.4+/-24.9 mm. Procedural success rate was 95.8%. The incidence of cumulative major adverse cardiac events, defined as death, myocardial infarction (MI) and target vessel revascularisation (TVR), was 15.8% at the mean follow-up period of 14.7 months (range 6.0-57.7). Death occurred in four patients (4.2%). Non Q-wave MI occurred in 3 patients (3.2%) and Q-wave MI occurred in two patients (2.1%). The rate of target lesion revascularisation (TLR) was 9.5%. The rate of TVR was 11.6%. Two definite (2.1%) and 2 possible (2.1%) stent thromboses were observed. CONCLUSIONS: RA followed by DES implantation in severely calcified coronary lesions appears to be feasible including high rate of procedural success and low-incidence of TLR considering this complex lesion subset.

Clinical outcomes after unrestricted implantation of everolimus-eluting stents.

OBJECTIVES: The aim of this study was to evaluate the efficacy and safety of unrestricted everolimus-eluting stent (EES) implantation in a contemporary cohort of real-world patients. BACKGROUND: The randomized SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) trials have evaluated the performance of EES, resulting in their approval by the Food and Drug Administration, but data regarding unselected usage, including off-label indications are lacking. METHODS: Consecutive patients treated with EES (either PROMUS, Boston Scientific Corp., Natick, Massachusetts, or XIENCE-V, Abbott Vascular Devices, Santa Clara, California) between October 2006 and February 2008 were analyzed. End points were cardiac death, myocardial infarction (MI), ischemic-driven target lesion revascularization (TLR), stent thrombosis (ST), and major adverse cardiac events (MACE) (a composite of cardiac death, MI, TLR) during follow-up. RESULTS: We identified 345 patients (573 lesions) treated with EES. The majority of patients (71.9%) were treated for > or =1 off-label or untested indication. Clinical follow-up was completed in 99%. At a median follow-up of 378 days (interquartile range 334 to 473), MACE occurred in 36 (10.6%) patients, TLR in 27 (7.9%), MI in 7 (2.1%), and cardiac death in 7 (2.1%). Definite and probable ST was observed in 3 (0.9%) cases. Off-label EES implantation was not associated with a statistically significant increased risk of MACE (12.2% vs. 6.3%, p = 0.17), TLR (9.3% vs. 4.2%, p = 0.18), or ST (0.8% vs. 1.1%, p = 1.0). On multivariable analysis, previous bypass surgery (p = 0.002) and diabetes (p = 0.03) were associated with MACE. CONCLUSIONS: In unrestricted daily practice, EES were implanted predominantly for off-label indications and associated with a relative low rate of MACE and TLR.

Favorable long-term outcome after drug-eluting stent implantation in nonbifurcation lesions that involve unprotected left main coronary artery: a multicenter registry.

BACKGROUND: The presence of a lumen narrowing at the ostium and the body of an unprotected left main coronary artery but does not require bifurcation treatment is a class I indication of surgical revascularization. METHODS AND RESULTS: A total of 147 consecutive patients who had a stenosis in the ostium and/or the midshaft of an unprotected left main coronary artery (treatment of the bifurcation not required) and were electively treated with percutaneous coronary intervention and sirolimus-eluting stents (n=107) or paclitaxel-eluting stents (n=40) in 5 centres were included in this registry. In 72 patients (almost 50%), intravascular ultrasound guidance was performed. Procedural success was achieved in 99% of the patients; in 1 patient with stenosis in the left main coronary artery ostium, a >30% residual stenosis persisted at the end of the procedure, and the patient was referred for coronary artery bypass graft surgery. During hospitalization, no patients experienced a Q-wave myocardial infarction or died. One patient died 19 days after the procedure because of pulmonary infection. At long-term clinical follow-up (886+/-308 days), 5 patients had died; 7 patients had target vessel revascularization (5 repeat percutaneous coronary interventions and 2 coronary artery bypass graft surgeries), and of these only 1 patient had a target lesion revascularization. Angiographic follow-up was performed in 106 patients (72%) with a late loss of -0.01 mm. Restenosis in the left main trunk occurred only in 1 patient (0.9%). CONCLUSIONS: Percutaneous coronary intervention with sirolimus-eluting stents or paclitaxel-eluting stents implantation in nonbifurcation left main coronary artery lesions appears safe with a long-term major adverse clinical event rate of 7.4% and a restenosis rate of 0.9%.

Comparable clinical outcomes with paclitaxel- and sirolimus-eluting stents in unrestricted contemporary practice.

OBJECTIVES: This study was designed to compare the outcomes of paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) in a contemporaneous cohort of real-world patients. BACKGROUND: A number of randomized comparisons of PES and SES have shown unequivocal advantages for SES in angiographic end points such as late loss. However, the data on clinical outcomes are less consistent. METHODS: All consecutive patients successfully treated with only SES or PES in de novo native vessel lesions between March 2003 and March 2005 were analyzed. Our end points were major adverse cardiac events (MACE), a composite of death, myocardial infarction (MI), target vessel revascularization (TVR), and target lesion revascularization (TLR). We also analyzed late loss and angiographic restenosis. RESULTS: There were 609 patients (1,064 lesions) treated with PES and 674 patients (1,205 lesions) treated with SES. Diabetes mellitus was present in 26.8% of patients and multivessel disease in 75% of patients. Bifurcations made up 16.3% of lesions, chronic occlusions 9.5%, left main 4.8%, and American Heart Association/American College of Cardiology type B2/C 75.4%. Despite a higher late loss in the PES group (p = 0.0001), there were no differences in angiographic restenosis (PES 18% vs. SES 17.8%, p = 0.95), TLR (PES 11.9% vs. SES 11%, p = 0.47), or MACE (PES 21.3% vs. SES 21.1%, p = 0.95). The relative risk of MACE for the PES group was 1.02 (95% confidence interval [CI] 0.78 to 1.33). Multivariable analysis confirmed the lack of association of stent type with MACE (odds ratio 1.03 [95% CI 0.77 to 1.38], p = 0.83) and TLR (odds ratio 1.08 [95% CI 0.81 to 1.44], p = 0.61). CONCLUSIONS: In this complex cohort, both stent platforms demonstrated similar clinical outcomes despite different late loss.

Comparison of coronary drug-eluting stents versus coronary artery bypass grafting in patients with diabetes mellitus.

We compared 1-year outcome after drug-eluting stent (DES) implantation with off-pump bypass grafing (OPCABG) in patients with type 2 diabetes mellitus and multivessel coronary artery disease involving the proximal segment of the left anterior descending coronary artery. All consecutive diabetic patients treated by DES (DES group) or OPCABG (CABG group) in our institution from April 2002 to December 2004 because of de novo coronary lesions were included. Patients in the CABG group (n = 149) were older and had a higher rate of 3-vessel disease than those in the DES group (n = 69). At 12 months, major adverse cardiac and cerebrovascular events occurred in 29% of the DES group and 20.5% of the CABG group (unadjusted analysis, odds ratio 1.20, 95% confidence interval [CI] 0.93 to 1.54, p = 0.17). After propensity score analysis, adjusting for baseline differences between the 2 cohorts, DESs increased the risk of 12-month major adverse cardiac and cerebrovascular events (hazard ratio 1.88, 95% CI 1.09 to 3.02, p = 0.020). This was due to the higher rate for repeat revascularization in the DES group (19% vs 5%, odds ratio 2.05, 95% CI 1.12 to 3.75, p = 0.001). In contrast, there was no difference in the rate of the composite end points of death, myocardial infarction, and stroke (DES group 13%, CABG group 12%; adjusted analysis, hazard ratio 0.80, 95% CI 0.80 to 1.35, p = 0.40). In conclusion, at 1 year in diabetic patients with multivessel coronary artery disease involving the proximal left anterior descending coronary artery, the advantage of OPCABG over DES implantation seems to be limited at a lower rate of repeat revascularization. No difference seems to exist in the rate of death, stroke, and myocardial infarction.

Renal Insufficiency Following Contrast Media Administration Trial (REMEDIAL): a randomized comparison of 3 preventive strategies.

BACKGROUND: Volume supplementation by saline infusion combined with N-acetylcysteine (NAC) represents an effective strategy to prevent contrast agent-induced nephrotoxicity (CIN). Preliminary data support the concept that sodium bicarbonate and ascorbic acid also may be effective in preventing CIN. METHODS AND RESULTS: Three hundred twenty-six consecutive patients with chronic kidney disease, referred to our institutions for coronary and/or peripheral procedures, were randomly assigned to prophylactic administration of 0.9% saline infusion plus NAC (n=111), sodium bicarbonate infusion plus NAC (n=108), and 0.9% saline plus ascorbic acid plus NAC (n=107). All enrolled patients had serum creatinine > or = 2.0 mg/dL and/or estimated glomerular filtration rate < 40 mL x min(-1) x 1.73 m(-2). Contrast nephropathy risk score was calculated in each patient. In all cases, iodixanol (an iso-osmolar, nonionic contrast agent) was administered. The primary end point was an increase of > or = 25% in the creatinine concentration 48 hours after the procedure (CIN). The amount of contrast media administered (179+/-102, 169+/-92, and 169+/-94 mL, respectively; P=0.69) and risk scores (9.1+/-3.4, 9.5+/-3.6, and 9.3+/-3.6; P=0.21) were similar in the 3 groups. CIN occurred in 11 of 111 patients (9.9%) in the saline plus NAC group, in 2 of 108 (1.9%) in the bicarbonate plus NAC group (P=0.019 by Fisher exact test versus saline plus NAC group), and in 11 of 107 (10.3%) in the saline plus ascorbic acid plus NAC group (P=1.00 versus saline plus NAC group). CONCLUSIONS: The strategy of volume supplementation by sodium bicarbonate plus NAC seems to be superior to the combination of normal saline with NAC alone or with the addition of ascorbic acid in preventing CIN in patients at medium to high risk.