Kidney Injury After Minimal Radiographic Contrast Administration in Patients With Acute Coronary Syndromes.

BACKGROUND: Acute kidney injury (AKI) is common in patients with acute coronary syndromes (ACS) treated by percutaneous coronary intervention. OBJECTIVES: Contrast media (CM) volume minimization has been advocated for prevention of AKI. The DyeVert CM diversion system (Osprey Medical, Inc) is designed to reduce CM volume during coronary procedures. METHODS: In this randomized, single-blind, investigator-driven clinical trial conducted in 4 Italian centers from February 4, 2020 to September 13, 2022, 550 participants with ACS were randomly assigned in a 1:1 ratio to the following: 1) the contrast volume reduction (CVR) group (n = 276), in which CM injection was handled by the CM diversion system; and 2) the control group (n = 274), in which a conventional manual or automatic injection syringe was used. The primary endpoint was the rate of AKI, defined as a serum creatinine (sCr) increase ≥0.3 mg/dL within 48 hours after CM exposure. RESULTS: There were 412 of 550 (74.5%) participants with ST-segment elevation myocardial infarction (211 of 276 [76.4%] in the CVR group and 201 of 274 [73.3%] in the control group). The CM volume was lower in the CVR group (95 ± 30 mL vs 160 ± 23 mL; P < 0.001). Seven participants (1 in the CVR group and 6 in the control group) did not have postprocedural sCr values. AKI occurred in 44 of 275 (16%) participants in the CVR group and in 65 of 268 (24.3%) participants in the control group (relative risk: 0.66; 95% CI: 0.47-0.93; P = 0.018). CONCLUSIONS: CM volume reduction obtained using the CM diversion system is effective for prevention of AKI in patients with ACS undergoing invasive procedures. (REnal Insufficiency Following Contrast MEDIA Administration TriaL IV [REMEDIALIV]: NCT04714736).

Intravenous volume expansion to prevent contrast-associated acute kidney injury.

OBJECTIVES: Several volume expansion protocols have been proposed to prevent contrast-associated acute kidney injury (CA-AKI). The aim of our study was to seek the ideal intravenous volume expansion to prevent CA-AKI in patients with chronic kidney disease (CKD) undergoing invasive cardiovascular procedures. METHODS: We analyzed 1927 CKD patients enrolled in 6 studies that took place from September 15, 2000 to June 6, 2019. Four volume expansion regiments were included: (1) conventional group (n=625); (2) bicarbonate group (n=255); (3) left ventricular end-diastolic pressure-guided group (n=355); and (4) urine flow rate-guided group (n=500). RESULTS: CA-AKI (serum creatinine increase ≥0.3 mg/dL at 48 hours) occurred in 224 (11%) patients. In patients with CA-AKI, volume expansion was lower (2090 ± 1382 mL vs 2551 ± 1716 mL; P less than .001) and acute pulmonary edema occurred more often (3.5% vs 0.29%; P less than .001). By ROC curve analysis, an absolute volume expansion greater than or equal to 1430 mL (AUC = 0.70) and a volume expansion to contrast media volume ratio greater than or equal to 17 (AUC = 0.57) were the best thresholds for freedom from CA-AKI. CONCLUSIONS: In our comprehensive pooled analysis, an absolute volume expansion greater than or equal to 1430 mL and a volume expansion to contrast media volume ratio greater than or equal to 17 are the best dichotomous thresholds for CA-AKI prevention. These cutoffs should be formally tested in a dedicated trial as a pragmatic means to prevent CA-AKI.

Contrast media volume reduction with the DyeVertTM system to prevent acute kidney injury in stable patients undergoing coronary procedures.

BACKGROUND: Contrast associated acute kidney injury (CA-AKI) can lead to an increased risk of adverse events. Contrast media (CM) volume reduction has been advocated as a pivotal strategy to prevent CA-AKI in stable patients undergoing percutaneous coronary procedures. AIMS: To compare the effectiveness of CM volume reduction with the DyeVertTM system versus conventional strategy in reducing the risk of CA-AKI. METHODS: We prospectively collected data from 136 patients with stable coronary artery disease at high risk of CA-AKI treated with left ventricular end diastolic pressure (LVEDP)- guided hydration and undergoing interventions with the use of the DyeVertTM (Osprey Medical Inc.) system. Patients previously enrolled in the LVEDP-guided hydration arm of the "Renal Insufficiency Following Contrast MEDIA Administration triaL III" (REMEDIAL III) were considered as controls. Propensity score was used to perform 1:1 matching to adjust for major confounders. The primary outcome was the occurrence of CA-AKI, as defined by an absolute increase of creatinine values ≥0.3 mg/dL at 48 h. RESULTS: Patients in the DyeVert group were treated with a significant lower CM volume (median: 47.5 vs. 84.0 mL, p < 0.001). The trend in creatinine increase was lower (p = 0.004) and the Δ of creatinine (0-48 h) showed a higher drop (-0.18 vs. -0.10 mg/dL, p = 0.036) in the DyeVert group. The risk of CA-AKI was significantly lower in DyeVert group compared to control group (5.1% vs. 16.8%; odds ratio 0.27, 95% confidence interval [0.12-0.61]). CONCLUSIONS: CM volume reduction with the DyeVertTM system seems to be superior to conventional strategies in reducing the occurrence of CA-AKI.

Paclitexel versus sirolimus-coated balloon in the treatment of coronary instent restenosis.

BACKGROUND: Few studies compared paclitaxel-coated balloon (PCB) versus sirolimus-coated balloon (SCB) in the treatment of drug-eluting stent (DES) instent restenosis (ISR). METHODS: Between November 5, 2009, and October 14, 2020, in our center 212 patients with first DES-ISR were treated with PCB (Restore®; Cardionovum GmbH, Bonn, Germany), whereas 230 patients were treated with SCB (Devoir®; MINVASYS SAS, Gennevilliers, France). Following a propensity matching, 186 patients were included into PCB group (PCB group), and in the SCB group (SCB group). The primary purpose of the study was the 1-year target lesion failure (TLF) rate, including cardiac death, target vessel-related myocardial infarction, and repeated target lesion or target vessel revascularization. RESULTS: Procedural success occurred in all cases. Fully optimal predilation (that is, balloon-to-stent ratio >0.91, time of DCB inflation >60 sec, and residual percent diameter stenosis after lesion preparation <20%) was observed more often in the SCB group (126 [68%] patients versus 106 [57%] patients; P=0.042). One-year TLF occurred in 29 (15.5%) patients in the SCB group and in 32 (17%) patients in the PCB group (OR=1.12 [0.65-1.95]; P=0.78). By logistic Cox regression analysis fully optimal predilation (OR=0.06; 95% CI: 0.01-0.21; P<0.001) but not DCB type (OR=0.74; 95% CI: 0.41-1.31; P=0.29) was independent predictor of 1-year TLF. CONCLUSIONS: The current study suggests that 1-year TLF is not statistically and clinically different in patients with DES ISR treated with a PCB and a SCB.

Impact of a contrast media volume control device on acute kidney injury rate in patients with acute coronary syndrome.

BACKGROUND: The DyeVert™ system (Osprey Medical Inc., Minnesota, MN) may reduce contrast media (CM) volume during coronary procedures while maintaining fluoroscopic image quality. Here, we assessed whether the use of the DyeVert system reduces acute kidney injury (AKI) rate in patients with acute coronary syndrome (ACS) undergoing invasive coronary procedures. METHODS: ACS patients scheduled for coronary procedure from January 2017 to December 2019 were included. Two groups were identified: (a) Control group (n = 339), including patients in which a conventional manual injection syringe was used; and (b) DyeVert group (n = 112), in which CM injection was handled by the DyeVert™ system. A propensity score matching was performed to reduce the effect of treatment selection bias and potential confounders. In all cases, a low-osmolar, nonionic CM was administered. The primary objective was the rate of AKI, defined as a serum creatinine increase ≥0.3 mg/dl within 72 hr after CM exposure. RESULTS: CM volume was higher in the Control group than in the DyeVert group (130 [120-188] ml vs. 99 [69-136] ml; p <.001). In the DyeVert group the mean percent CM volume saved was 38 ± 13%. AKI occurred in 7/90 patients (8%) in the DyeVert group and in 17/90 (19%) patients in the Control group (odds ratio = 0.37; 95% confidence interval 0.14-0.95; p =.047). CONCLUSIONS: This preliminary result suggests that CM volume reduction obtained by the DyeVert™ system is an effective strategy to prevent AKI in ACS patients undergoing invasive procedure.

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.

Renal insufficiency following contrast media administration trial III: Urine flow rate-guided versus left-ventricular end-diastolic pressure-guided hydration in high-risk patients for contrast-induced acute kidney injury. Rationale and design.

BACKGROUND: Urine flow rate (UFR)-guided and left-ventricular end-diastolic pressure (LVEDP)-guided hydration regimens have been proposed to prevent contrast-induced acute kidney injury (CIAKI). The REnal Insufficiency Following Contrast MEDIA Administration triaL III (REMEDIAL III) is a randomized, multicenter, investigator-sponsored trial aiming to compare these two hydration strategies. METHODS: Patients at high risk for CIAKI (that is, those with estimated glomerular filtration rate ≤ 45 mL/min/1.73 m2 and/or with Mehran's score ≥11 and/or Gurm's score >7) will be enrolled. Patients will be randomly assigned to (a) LVEDP-guided hydration with normal saline (LVEDP-guided group) and (b) UFR-guided hydration carried out by the RenalGuard system (RenalGuard group). Seven-hundred patients (350 in each arm) will be enrolled. In the LVEDP-guided group the fluid infusion rate will be adjusted according to the LVEDP as follows: 5 mL kg-1 hr-1 for LVEDP ≤12 mmHg, 3 mL kg-1 hr-1 for LVEDP 13-18 mmHg, and 1.5 mL kg-1 hr-1 for LVEDP >18 mmHg. In the RenalGuard group hydration with normal saline plus low-dose of furosemide is controlled by the RenalGuard system, in order to reach and maintain a high (>300 mL/hr) UFR. In all cases, iobitridol (a low-osmolar, nonionic contrast agent) will be administered. RESULTS: The primary endpoint is the composite of CIAKI (i.e., serum creatinine increase ≥25% and/or ≥0.5 mg/dL from the baseline to 48 hr after contrast media exposure) and/or acute pulmonary edema. CONCLUSION: The REMEDIAL III will test the hypothesis that the UFR-guided hydration is superior to the LVEDP-guided hydration to prevent the composite of CIAKI and/or acute pulmonary edema.

Elective Mechanical Circulatory Support in the Percutaneous Treatment of Patients With Combined Complex Coronary Artery Disease and Severe Aortic Valve Stenosis.

OBJECTIVES: One of the procedural concerns during percutaneous treatment of patients with concomitant coronary artery disease (CAD) and aortic valve stenosis (AS) is the risk of hemodynamic instability. In the present study, we assessed the safety and effectiveness of elective hemodynamic support with the Impella 2.5 system (Abiomed, Inc) in patients undergoing combined high-risk percutaneous coronary intervention (PCI) and balloon aortic valvuloplasty (BAV), as a bridge to transcatheter aortic valve replacement. METHODS: Ten patients suffering from acute coronary syndrome (ACS) and severe AS were included. In all patients, we first performed PCI with the hemodynamic support of the Impella 2.5 system, and then BAV. RESULTS: The Impella catheter was successfully positioned in the left ventricle in all instances. All cases were successful, without any intraprocedural complications. All patients were discharged without any major clinical events. CONCLUSIONS: These preliminary results suggest that elective use of the Impella 2.5 system is safe and effective when performing PCI and BAV in high-risk ACS patients suffering from concomitant severe CAD and AS.

Sirolimus-eluting BiOSS LIM dedicated bifurcation stent in the treatment of unprotected distal left main stenosis.

BACKGROUND: Proximal optimization technique (POT) has been proposed to adapt the conventional drug-eluting stent (DES) with the fractal anatomy of the bifurcation. However, only few DES are labeled for post-expansion beyond 5.0 mm. Furthermore, recrossing in the side branch (SB) through the main vessel (MV) stent cells may be challenging. OBJECTIVES: To compare the sirolimus-eluting, balloon-expandable dedicated bifurcation stent BiOSS LIM DES versus the second generation DES in the treatment of distal unprotected left main coronary arteries (ULMCAs) lesions. METHODS: Forty-two consecutive patients with distal ULMCA lesions were treated with the BiOSS LIM (BiOSS LIM group) in our center. A matched-group of patients treated with second-generation DES was selected from our database (Control group). The primary endpoint was the procedural complication rate, including (a) SB occlusion, defined as intraprocedural TIMI flow grade <3 immediately after MV stenting; and/or (b) trouble in SB access, defined as the need of ≥2 guidewires or a failure to recross in the SB trough the MV stent cells. The need of POT in the two groups was also analyzed. RESULTS: The primary endpoint occurred in four (9.5%) patients in the BiOSS LIM group and in 13 (31%) in the Control group (p = 0.028; OR = 4.25; 95% confidence interval: 1.25-14.43). POT was performed more often in the Control group (71% vs. 35%; p = 0.004). CONCLUSIONS: Compared to conventional DES, the BiOSS LIM stent (1) facilitates SB recrossing and (2) fits well with the fractal anatomy of the left main bifurcation.

Left ventricular support during complex transradial percutaneous coronary intervention for complete revascularization.

Although there is not uniform definition of high-risk percutaneous coronary intervention (PCI), patients with severe three-vessel disease, left main disease, single remaining patent vessel and/or depressed left ventricular ejection fraction are considered a high-risk population. In this setting, periprocedural hemodynamic instability represents a serious issue. Percutaneous mechanical circulatory support (MCS) devices may improve both safety and efficacy of high-risk PCI. Indeed, MCS help to maintain coronary perfusion pressure and reduce myocardial workload, providing the operator sufficient time to reach the target of complete revascularization. The most used MCS are intra-aortic balloon pump and Impella. There are a plenty of data in literature about the efficacy and safety of the use of MCS in high-risk PCI performed through the femoral access. However, there is a paucity of data about the use of MCS in transradial high-risk PCI. Radial over femoral access has been showed to reduce bleeding complications and therefore may further improve the outcome of high-risk PCI. Herein we report a case of transradial high-risk PCI supported by the Impella 2.5 L and review the available data on this topic.

Persistent serum creatinine increase following contrast-induced acute kidney injury.

BACKGROUND: Contrast-induced acute kidney injury (CI-AKI) may led to both a transient and a persistent serum creatinine (sCr) increase. OBJECTIVES: To assess whether serum cystatin C (sCyC) and urine and serum neutrophil gelatinase-associated lipocalin (uNGAL, sNGAL) are useful in the early identification of persistent sCr increase following CI-AKI. METHODS: One hundred and eighteen patients who developed CI-AKI were included into the study. Persistent sCr elevation was defined as a persistent increase ≥0.3 mg dL-1 at 1 month after contrast media (CM) administration. RESULTS: sCr levels recovered in 87 patients (74%; Transient group), whereas a persistent elevation of sCr was observed in the remaining 31 patients (26%; Persistent group). By multivariable logistic regression analysis, independent predictors of persistent sCr increase were insulin therapy, uNGAL at 48 hr and absolute sCr difference between 48 and 72 hr. On the contrary, sCyC assessment did not help in the early identification of this subset of patients. By receiver operating curve analysis, the best cutoff values for predicting persistent sCr increase were uNGAL ≥0.50 ng dL-1 at 48 hr, and the absolute sCr increase ≥0.20 mg dL-1 between 48 and 72 hr. CONCLUSIONS: uNGAL ≥0.50 ng dL-1 at 48 hr and absolute sCr increase ≥0.20 mg dL-1 between 48 and 72 hr but not sCyC are useful in the early identification of patients developing persistent sCr increase after CM administration.

Impact of statin therapy intensity on endothelial progenitor cells after percutaneous coronary intervention in diabetic patients. The REMEDY-EPC late study.

BACKGROUND: A low number (that is, ≤0.0038 per 100 peripheral mononuclear cells) of circulating endothelial progenitor cells (EPC) is common in diabetic patients. Statins increase EPC levels. It is unclear whether intensity of statin therapy has a different impact on EPC levels. METHODS: Diabetic patients undergoing drug-eluting stent (DES) implantation were randomized to 1) High intensity statin therapy (atorvastatin 80mg/day; n=66) or 2) Moderate intensity statin therapy (atorvastatin 20mg/day; n=64). EPC levels were assessed at baseline, 24h and 3months. Endpoints assessed at 3months were 1) changes in the proportion of patients with low EPC levels, and 2) uncovered struts rate and neointima growth evaluated by optical coherence tomography. RESULTS: Low EPC levels rate significantly decreased in the High intensity statin therapy group (from 31.7% to 12.7%; p=0.017) but not in the Moderate intensity statin therapy group (from 25.5% to 21.8%; p=0.81). Uncovered struts rate was similar in the 2 groups (2.4±2.6% vs 2.3±2.2%; p=0.82), whereas mean neointima area and volume were lower in the High intensity statin therapy group (0.68±0.69 vs 1.22±1.29mm2; p=0.001; and, respectively, 13.10±5.77 vs 20.19±24.08mm3; p=0.042). CONCLUSIONS: In diabetic patients, a high intensity statin therapy 1) significantly increases EPC levels and decreases in-stent neointima area and volume, and 2) does not have an impact on the degree of stent re-endothelialization at 3months after DES implantation.

Coronary artery bifurcation narrowing treated by Axxess stent implantation: The CARINAX registry.

OBJECTIVES: To compare the safety and efficacy of the Axxess™ biolimus-eluting stent with the second-generation drug-eluting stent (DES) in the treatment of bifurcation lesions. BACKGROUND: The Axxess™ is a dedicated bifurcation stent, designed to cover the lesion at the carina level. METHODS: Between April 2012 and August 2014, 165 patients with de novo bifurcation lesions were treated with the Axxess™ stent (Axxess group). A propensity-score matched group of 165 patients treated with DES in the same period was selected (Control group). The primary objectives were (1) the procedural complication rate, including side branch (SB) occlusion and trouble in SB access after main vessel stenting; and (2) the device, the angiographic, and the procedural success rate. RESULTS: Procedural complications occurred in 1 patient (0.6%) in the Axxess group and in 20 patients (12%) in the Control group (OR = 0.03; 95% confidence interval 0.005-0.27; P < 0.001). Device success was obtained in 164 (99.5%) patients in the Axxess group and in all in the Control group (P = 1.00). Angiographic success was obtained in all patients. Inaccurate Axxess™ stent position occurred in 21 (13%) patients, and was more often associated with moderate-to-severe calcifications and distal lesion site. Procedural success was obtained in 91.5% patients in the Axxess group and in 90% patients in the Control group (P = 0.72). CONCLUSIONS: The present registry suggests that the Axxess™ stent (1) may represent a valid alternative approach for the treatment of bifurcation lesions and (2) should be avoided in moderate-to-severe calcifications and/or in distal lesions. © 2016 Wiley Periodicals, Inc.

Performance of the XLIMUS Sirolimus-Eluting Coronary Stent in Very Complex Lesions.

INTRODUCTION: Stent delivery failure may occur especially when treating complex coronary artery stenosis. XLIMUS (CARDIONOVUM GmbH, Bonn, Germany) is a new sirolimus-eluting stent (SES) with the following features: 1) cobalt chromium stent platform, with low (73 µm) strut thickness, (2) biodegradable polymer, and 3) potent antiproliferative drug (Sirolimus). Preliminary data suggest that XLIMUS SES may be ideal for the treatment of complex lesions. METHODS: In this registry, we assessed the deliverability, safety, and efficacy of percutaneous coronary interventions (PCI) using the XLIMUS SES in patients undergoing elective PCI in native coronary vessels for complex de novo lesions, including severe calcification, severe tortuosity, and chronic total occlusion. The primary objective of the study is the delivery success of the XLIMUS SES. The secondary objective is the 1-year rate of major adverse cardiac events (MACE; including all-cause death, nonfatal myocardial infarction, and repeat revascularization). RESULTS: A total of 200 consecutive patients with 255 lesions were included. Delivery success was obtained in 196 (98%) patients and in 251 (98.4%) lesions. The XLIMUS SES was successfully implanted on the first attempt with a single guidewire in 176 (88%) patients and in 208 (81.6%) lesions. Additional techniques to facilitate stent delivery (i.e., buddy wire, anchoring-balloon, or GuideLiner catheter) were necessary in 47 (18.4%) lesions. Failure in XLIMUS SES implantation occurred in 4 (1.6%) lesions. MACE rate at 1 year was 9%. CONCLUSIONS: This registry supports the positive performance of the XLIMUS SES in the treatment of complex coronary artery lesions.

RenalGuard System for the prevention of acute kidney injury in patients undergoing transcatheter aortic valve implantation.

AIMS: We aimed to assess whether the RenalGuard™ System is effective in preventing acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: Forty-eight consecutive patients with chronic kidney disease (CKD) scheduled for TAVI were assigned to: 1) hydration with sodium bicarbonate solution (Control group), or 2) hydration with RenalGuard Therapy (RenalGuard group). Hypotension was defined as periprocedural mean blood pressure <55 mmHg. The primary endpoint was the occurrence of AKI (i.e., an increase of ≥0.3 mg/dL in the serum creatinine concentration at seven days). AKI occurred in 10/26 (38.5%) patients in the Control group and in 1/22 (4.5%) patients in the RenalGuard group (p=0.005, odds ratio [OR] 0.076, 95% confidence interval [CI]: 0.009-0.66). RenalGuard Therapy protected against AKI (OR 0.71, 95% CI: 0.07-0.775, p=0.026), whereas post-procedural hypotension (OR 3.88, 95% CI: 1.06-14.24, p=0.040), and contrast media volume (OR 3.65, 95% CI: 1.15-5.75, p=0.043) increased the risk of AKI. CONCLUSIONS: This non-randomised pilot study suggests that RenalGuard Therapy may be effective in preventing AKI in CKD patients undergoing TAVI.

RenalGuard system in high-risk patients for contrast-induced acute kidney injury.

BACKGROUND: High urine flow rate (UFR) has been suggested as a target for effective prevention of contrast-induced acute kidney injury (CI-AKI). The RenalGuard therapy (saline infusion plus furosemide controlled by the RenalGuard system) facilitates the achievement of this target. METHODS: Four hundred consecutive patients with an estimated glomerular filtration rate ≤30 mL/min per 1.73 m(2) and/or a high predicted risk (according to the Mehran score ≥11 and/or the Gurm score >7%) treated by the RenalGuard therapy were analyzed. The primary end points were (1) the relationship between CI-AKI and UFR during preprocedural, intraprocedural, and postprocedural phases of the RenalGuard therapy and (2) the rate of acute pulmonary edema and impairment in electrolytes balance. RESULTS: Urine flow rate was significantly lower in the patients with CI-AKI in the preprocedural phase (208 ± 117 vs 283 ± 160 mL/h, P < .001) and in the intraprocedural phase (389 ± 198 vs 483 ± 225 mL/h, P = .009). The best threshold for CI-AKI prevention was a mean intraprocedural phase UFR ≥450 mL/h (area under curve 0.62, P = .009, sensitivity 80%, specificity 46%). Performance of percutaneous coronary intervention (hazard ratio [HR] 4.13, 95% CI 1.81-9.10, P < .001), the intraprocedural phase UFR <450 mL/h (HR 2.27, 95% CI 1.05-2.01, P = .012), and total furosemide dose >0.32 mg/kg (HR 5.03, 95% CI 2.33-10.87, P < .001) were independent predictors of CI-AKI. Pulmonary edema occurred in 4 patients (1%). Potassium replacement was required in 16 patients (4%). No patients developed severe hypomagnesemia, hyponatremia, or hypernatremia. CONCLUSIONS: RenalGuard therapy is safe and effective in reaching high UFR. Mean intraprocedural UFR ≥450 mL/h should be the target for optimal CI-AKI prevention.

Neutrophil Gelatinase-Associated Lipocalin and Contrast-Induced Acute Kidney Injury.

BACKGROUND: Neutrophil gelatinase-associated lipocalin (NGAL) is an early marker of acute kidney injury (AKI). METHODS AND RESULTS: Urine NGAL and serum NGAL (sNGAL) were assessed at 2, 6, 24, and 48 hours after contrast media (CM) exposure in 458 high-risk patients (development set). Optimal thresholds in predicting contrast-induced AKI (serum creatinine [sCr] increase ≥0.3 mg/dL at 48 hours after CM administration) were identified. Major adverse events (MAE; death, dialysis, nonfatal myocardial infarction, sustained kidney injury, and myocardial revascularization) at 1 year were assessed. In the development set, optimal thresholds for contrast-induced AKI occurred at 6 hours for both urine NGAL (≥20 ng/mL; 97% negative predictive value and 27% positive predictive value) and sNGAL (≥179 ng/mL; 93% negative predictive value and 20% positive predictive value). Furthermore, sNGAL ≥179 ng/mL at 6 hours was an independent predictor of 1-year MAE. 1-year MAE occurred in 27/198 patients (13.5%) with sNGAL <179 ng/mL and sCr <0.3 mg/dL, in 57/193 (29.5%) patients with only sNGAL ≥179 ng/mL, and in 37/67 (55%) patients with sCr ≥0.3 mg/dL. In additional 253 patients (validation set), no patient with urine NGAL <20 ng/mL or sNGAL <179 ng/mL at 6 hours developed contrast-induced AKI. Furthermore, 6/68 (9%) patients with sNGAL <179 ng/mL and sCr increase <0.3 mg/dL had 1-year MAE versus 17/57 (30%) patients with sNGAL ≥179 ng/mL and sCr increase <0.3 mg/dL and 8/16 (50%) patients with sCr increase ≥0.3 mg/dL. CONCLUSIONS: Urine NGAL <20 ng/mL and sNGAL <179 ng/mL at 6 hours are reliable markers for ruling out contrast-induced AKI. sNGAL ≥179 ng/mL at 6 hours predicts 1-year MAE. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01098032.

Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Internal Carotid Artery Stent Implantation.

OBJECTIVES: This study sought to investigate acute kidney injury (AKI) following carotid artery stenting (CAS). BACKGROUND: Few data exist on AKI following CAS. METHODS: This study evaluated 126 chronic kidney disease (CKD) patients who underwent CAS. The risk for contrast-induced AKI was defined by the Mehran score. Hemodynamic depression (i.e., periprocedural systolic blood pressure <90 mm Hg or heart rate <60 beats/min), AKI (i.e., an increase of ≥0.3 mg/dl in the serum creatinine concentration at 48 h), and 30-day major adverse events (including death, stroke, and acute myocardial infarction) were assessed. RESULTS: AKI occurred in 26 patients (21%). Although baseline kidney function and contrast volume were similar in the AKI group and the non-AKI group, the risk score was higher (10 ± 3 vs. 8 ± 3; p = 0.032), and hemodynamic depression (mostly due to hypotension) (65.5% vs. 35%; p = 0.005) was more common in the AKI group. The threshold of hemodynamic depression duration for AKI development was 2.5 min (sensitivity 54%, specificity 82%). Independent predictors of AKI were hemodynamic depression (odds ratio [OR]: 4.01; 95% confidence interval [CI]: 1.07 to 15.03; p = 0.009), risk score (OR: 1.29; 95% CI: 1.03 to 1.60; p = 0.024), and male sex (OR: 6.07; 95% CI: 1.18 to 31.08; p = 0.021). Independent predictors of 30-day major adverse events that occurred more often in the AKI group (19.5% vs. 7%; p = 0.058) were AKI (HR: 4.83; 95% CI: 1.10 to 21.24; p = 0.037) and hemodynamic depression (HR: 5.58; 95% CI: 1.10 to 28.31; p = 0.038). CONCLUSIONS: AKI in CKD patients undergoing CAS is mostly due to hemodynamic depression and is associated with a higher 30-day major adverse events rate.

The STENTYS® paclitaxel-eluting stent in the treatment of unprotected distal left main.

BACKGROUND: Vessel tapering represents an important limitation of the balloon-expandable drug-eluting stent (DES) in the treatment of distal unprotected left main coronary artery (ULMCA) lesions. In this study, we assessed the suitability of the STENTYS DES((P)) , a self-apposing nitinol paclitaxel-eluting stent, for use in the treatment of distal ULMCA lesions. METHODS AND RESULTS: From February 2012 to September 2013, 75 consecutive patients with tapered (that is a >1 mm difference in the diameter from the proximal to the distal main vessel) distal ULMCA lesions were treated with the STENTYS DES((P)) (STENTYS-DES group) at the Clinica Mediterranea (Naples, Italy). A matched-group of 75 patients treated with second-generation DES in the same period (Control group) was selected from the database of New Tokyo Hospital (Chiba, Japan). The result was assessed by both quantitative coronary angiography and intravascular ultrasound (IVUS). Although the final balloon diameter was larger in the Control group (4.51 ± 0.51 vs. 3.62 ± 0.49 mm; P < 0.001), the IVUS analysis showed a larger final minimal lumen area in the STENTYS-DES group than in the Control group (left main: 17.45 ± 3.45 vs. 14.84 ± 3.45 mm(2) ; P < 0.001; polygon of confluence: 15.74 ± 3.28 vs. 12.55 ± 5.45 mm(2) ; P < 0.002; ostial left anterior descending artery: 11.73 ± 1.97 vs. 8.56 ± 1.80 mm(2) ; P < 0.001). At 12 ± 5 months, major adverse cardiac events (including death, myocardial infarction, and repeat revascularization) occurred in seven patients in both groups. CONCLUSIONS: This pilot study suggests that the self-apposing properties of the STENTYS DES((P)) offer a valid alternative for the treatment of the distal ULMCA lesions.

Novel approaches for preventing or limiting events (Naples) III trial: randomized comparison of bivalirudin versus unfractionated heparin in patients at increased risk of bleeding undergoing transfemoral elective coronary stenting.

OBJECTIVES: This study sought to assess the safety and the efficacy of bivalirudin compared with unfractionated heparin (UFH) alone in the subset of patients at increased risk of bleeding undergoing transfemoral elective percutaneous coronary intervention (PCI). BACKGROUND: Bivalirudin, a synthetic direct thrombin inhibitor, determines a significant decrease of in-hospital bleeding following PCI. METHODS: This is a single-center, investigator-initiated, randomized, double-blind, controlled trial. Consecutive biomarker-negative patients at increased bleeding risk undergoing PCI through the femoral approach were randomized to UFH (UFH group; n = 419) or bivalirudin (bivalirudin group; n = 418). The primary endpoint was the rate of in-hospital major bleeding. RESULTS: The primary endpoint occurred in 11 patients (2.6%) in the UFH group versus 14 patients (3.3%) in the bivalirudin group (odds ratio: 0.78; 95% confidence interval: 0.35 to 1.72; p = 0.54). Distribution of access-site and non-access-site bleeding was 18% and 82% in the UFH group versus 50% and 50% in the bivalirudin group (p = 0.10). CONCLUSIONS: The results of this randomized study, carried out at a single institution, suggest that there is no difference in major bleeding rate between bivalirudin and UFH in increased-risk patients undergoing transfemoral PCI. (Novel Approaches in Preventing and Limiting Events III Trial: Bivalirudin in High-Risk Bleeding Patients [NAPLES III]; NCT01465503).