One-year outcomes of consecutive patients treated by Endeavor zotarolimus and Resolute zotarolimus stents: the impact of polymer coating in drug-eluting stent technology.

BACKGROUND: Polymer-coating represents a key component of drug-eluting stent (DES) technology and its possible impact on vessel-wall healing is a matter of debate. The clinical impact of different polymer-coating may be assessed by comparing the outcome of patients treated by DES having the same stent platform and drug, and differing in the polymer. Thus, we compared the clinical outcome of patients treated by Endeavor Zotarolimus-eluting stent (E-ZES) and Resolute Zotarolimus-eluting stent (R-ZES) as they differ in the polymer-coating only. METHODS: At our Institution, E-ZES was available during a first period and then it was substituted by the R-ZES during a second period. Clinical, angiographic, and procedural data were prospectively collected. Clinical follow-up was prospectively obtained up to 1-year. Primary endpoint was the occurrence of major adverse cardiac events (MACE) at 12-month. RESULTS: A total of 467 patients undergoing percutaneous coronary intervention were enrolled: 233 patients treated with E-ZES and 234 with R-ZES. Patients treated by R-ZES had similar clinical characteristics and worse angiographic characteristics compared with those treated by E-ZES. At 12-month follow-up, MACE rate was significantly lower in the R-ZES group compared with E-ZES group (4.2% vs. 14.6%; P < 0.01). This difference was due to nonsignificantly lower rates of death and myocardial infarction and to significant lower rate of target-lesion-revascularization (R-ZES 3.4% vs. E-ZES 10.3%, P < 0.01). CONCLUSIONS: The results of this study suggest that the clinical outcome of patients treated by DES differing for the polymer coating only may be different. Polymer coating is a pivotal, probably underrated, component of DES technology which may influence the clinical performance of DES.

Vascular complications and access crossover in 10,676 transradial percutaneous coronary procedures.

BACKGROUND: Randomized trials have shown that transradial approach, compared with transfemoral, reduces vascular complications (VCs) of coronary procedures in selected patients. Yet, radial approach is associated to a variety of access-site VC as well as to a higher failure rate compared with femoral access. METHODS: At our institution, from May 2005 to May 2010, we prospectively assessed the occurrence and outcome of VC in consecutive patients undergoing transradial percutaneous coronary procedures performed by trained radial operators. The need of access crossover to complete the procedure was also prospectively investigated. Vascular complications were classified as "radial related" or "nonradial related" (in the case of access crossover). Vascular complications were also classified "major" if requiring surgery and/or blood transfusions or causing hemoglobin drop >3 g/dL. RESULTS: Ten thousand six hundred seventy-six procedures were performed using a right radial (87.5%), left radial (12.4%), or ulnar (0.1%) artery as primary access. A total of 53 VCs (0.5%) were observed: 44 (83%) radial related and 9 (17%) nonradial related. Major VCs occurred in 16 patients only (0.2%) and were radial related in 10 (62.5%) and nonradial related in 6 (37.5%) patients. Vascular complications rate was stable during the study and independent of operator's experience. Access crossover rate was 4.9%, differed according to the operator radial experience and significantly decreased over time. CONCLUSIONS: The present study, conducted in a center with high volume of radial procedures, shows that transradial approach is associated with a very low rate of VC, which is stable over time. On the contrary, access crossover rate decreased over time and differed according to operator (radial) experience.

Transradial approach (left vs right) and procedural times during percutaneous coronary procedures: TALENT study.

BACKGROUND: most of the studies assessing transradial approach for coronary angiography (CA) have been performed through right radial approach (RRA). Our aim was to evaluate the safety and efficacy of left radial approach (LRA) compared with RRA for coronary procedures. METHODS: from January 2009 to December 2009, in 2 hospitals, 1,540 patients were randomized to RRA (770 patients) or LRA (770 patients) for percutaneous coronary procedures. The primary end point was fluoroscopy time for CA and for percutaneous coronary intervention (PCI) evaluated independently. Prespecified subgroup analyses according to patient age and operator experience were planned. RESULTS: in 1,467 patients (732 RRA and 735 LRA), a CA (diagnostic group) was performed, and in 688 (344 each for RRA and LRA), a PCI. In the diagnostic group, LRA was associated with significantly lower fluoroscopy time (149 seconds, interquartile range [IQR] 95-270 seconds) and dose area product fluoroscopy (10.7 Gy cm(2), IQR 6-20.5 Gy cm(2)) compared with the RRA (168 seconds, IQR 110-277 seconds, P = .0025 and 12.1 Gy cm(2), IQR 7-23.8 Gy cm(2), P = .004, respectively). In the PCI group, there were no significant differences in fluoroscopy time (614 seconds, IQR 367-1,087 seconds for LRA and 695 seconds, IQR 415-1,235 seconds, P = .087 for RRA) and dose area product fluoroscopy (53.7 Gy cm(2), IQR 29-101 Gy cm(2) for LRA and 63.1 Gy cm(2), IQR 31-119 Gy cm(2), P = .17 for RRA). According to subgroup analyses, the differences between LRA and RRA were confined to older patients (≥ 70 years old) and to operators in training. CONCLUSIONS: left radial approach for coronary diagnostic procedures is associated with lower fluoroscopy time and radiation dose adsorbed by patients compared with the RRA, particularly in older patients and for operators in training.

Comparative assessment of mammalian target of rapamycin inhibitor-eluting stents in the treatment of coronary artery bifurcation lesions: the CASTOR-Bifurcation registry.

Drug-eluting stents (DES) have revolutionized the treatment of coronary bifurcation lesions. Among different DES types, sirolimus-eluting stents (SES) showed better outcomes than paclitaxel-eluting stents. Because novel sirolimus analogues have been implemented in DES, a prospective observational comparison was undertaken to compare major mammalian target of rapamycin inhibitor-eluting stents in the treatment of bifurcation lesions according to the provisional T-stenting and small protrusion (TAP) technique. Overall, 187 patients (165 men, 65 ± 10 years) were enrolled in the study: 80 patients received a SES, whereas zotarolimus-eluting stents (ZES) were implanted in 53 patients and everolimus-eluting stents (EvES) in 62 patients. Primary end-point of the study was the 12-month incidence of target bifurcation failure (TBF) defined as occurrence of cardiovascular death, nonfatal myocardial infarction (MI), and target vessel revascularization (TVR) or angiographic documentation of > 50% restenosis on the main vessel or TIMI flow < 3 on the side branch. Groups were homogeneous according to main clinical and angiographic characteristics. Overall, 17 (9.1%) patients had TBF: 4 (2.1%) patients had nonfatal non-ST-segment elevation MI, 9 (4.8%) patients underwent TVR, and 6 (3.2%) patients had an angiographic restenosis. The rate of TBF was statistically different among the three groups (7.9% in SES group, 18% in ZES group, and 3.3% in EvES group, P = 0.024). Previous MI was associated with a worse outcome (P = 0.025), whereas final kissing balloon was associated with a better outcome (P = 0.045). In conclusion, in this prospective registry, significant differences between DES were found in the outcome of patients treated for coronary bifurcation lesions according to provisional TAP technique. Thus, prospective randomized trials in this field are needed.

Renal artery stenting in patients with chronic ischemic heart disease.

OBJECTIVES: To investigate the role of renal stenting in selected patients with chronic ischemic heart disease and renal artery stenosis. METHODS: Consecutive patients, with chronic ischemic heart disease and severe hypertension and/or impaired renal function undergoing renal stenting, were prospectively enrolled. Mid-term (at least 2 years) follow-up was performed to assess both changes in renal function [serum creatinine and estimated glomerular filtrate rate (eGFR)] and blood pressure (BP) control (number of required drugs) and to record the incidence of clinical major adverse events. Moreover, in the first consecutive 24 patients, out-of-range pressure values at 24-hr BP monitoring and GFR at renal scintigraphy were measured at baseline and 1 month after stenting. RESULTS: Seventy patients treated by stenting on 86 renal arteries entered the study. Procedural success rate was 99% and no major complication occurred. At 2-year follow-up, both mean serum creatinine (-0.1 +/- 0.7 mg/dl at follow-up compared to baseline, P = 0.6) and eGFR (+3.7 +/- 23.5 ml/min/1.73m(2) at follow-up compared to baseline, P = 0.2) did not significantly change while the number of drugs required to control BP significantly decreased (2.7 +/- 0.8 to 2.2 +/- 0.7, P < 0.0001). In the subset of 24 patients evaluated at 1 month, GFR significantly increased (62 +/- 20 ml/min to 67 +/- 21 ml/min; P = 0.008) and the rate of the out-of-range systolic pressure values at 24-hr monitoring significantly decreased (51-33%, P = 0.005). Elevated baseline creatinine values and the presence of global renal ischemia were identified as predictors of poor outcome at the multivariate analysis. CONCLUSIONS: In selected patients with chronic ischemic heart disease and hypertension and/or renal insufficiency, renal stenting may be performed with very low periprocedural complications and results in unchanged renal function and improved BP control.

Outcome of patients treated by a novel thin-strut cobalt-chromium stent in the drug-eluting stent era: Results of the SKICE (Skylor in real world practice) registry.

OBJECTIVES: To investigate the outcome of patients undergoing percutaneous coronary interventions (PCI) with implantation of a new thin-strut cobalt-chromium bare-metal-stent (BMS) in the drug-eluting-stent (DES) era. BACKGROUND: Despite the contemporary penetration of DES in the clinical practice, a relevant percentage of patients are still treated by BMS. Data on clinical outcome of novel BMSs are lacking. METHODS: This is a single-centre-registry enrolling patients treated by Skylor stent implantation. During the study, the criteria for BMS selection adopted at our institution ("internal" criteria) were as follows: (1) limited compliance to prolonged double antiplatelet therapy, (2) ST-elevation myocardial infarction (STEMI) or saphenous vein grafts (SVG) interventions, and (3) in the absence of these conditions, noncomplex (no bifurcations, no chronic total occlusions) lesions considered at low restenosis risk on the basis of arbitrary angiographic criteria (short lesions, large vessels). Primary and secondary end-points were respectively major adverse cardiovascular events (MACE) and target vessel failure (TVF) up to 9-month. RESULTS: A total of 150 patients were treated with Skylor stent on 169 lesions. At 9-month follow-up, MACE occurred in 12 patients (8.0%) and TVF in 21 lesions (12.4%). By multivariable analysis, the predictors of MACE were Euroscore>or=9 and ejection fraction < 30% while the predictors of TVF were the absence of the angiographic criteria of low restenosis risk and ejection fraction < 30%. CONCLUSIONS: In the DES era, the use of a last-generation BMS in patients with limited compliance to double antiplatelet therapy, STEMI or SVG interventions, and noncomplex angiographic lesions may be associated with acceptable clinical outcome.

Outcome of overlapping heterogenous drug-eluting stents and of overlapping drug-eluting and bare metal stents.

Overlapping homogenous drug-eluting stents (DESs) may be used instead of overlapping bare metal stents (BMSs) to treat coronary lesions longer than available stents. Yet, no data are available on patients treated with overlapping heterogenous DESs or DESs and BMSs. We prospectively assessed 9-month clinical outcome and 6-month angiographic late loss (evaluated at 5 different lesion segments) in a consecutive series of 40 patients who received overlapping homogenous DESs (sirolimus-eluting stent [SES] or paclitaxel-eluting stent [PES]), heterogenous DESs (SES + PES), or overlapping DESs and BMSs. In 8 patients (7 with angiographic follow-up) with overlapping heterogenous DESs, no angiographic or clinical adverse event was observed. Moreover, in-segment late loss was similar to that of patients who received homogenous DESs. In 8 patients (7 with angiographic follow-up) with overlapping DESs and BMSs, there was a higher incidence of major adverse events (3 repeat percutaneous coronary interventions and 1 death, 50% adverse event rate) and worse in-segment binary restenosis rate compared with patients treated with homogenous or heterogenous DESs (p = 0.02 and 0.012, respectively). Late lumen loss at the site of stent overlap showed significant differences according to type of overlapped stent (1.00 +/- 0.76 mm in DES-BMS overlap, 0.32 +/- 0.55 mm in PES-PES overlap, 0.13 +/- 0.11 in SES-PES overlap, and 0.08 +/- 0.10 mm in SES-SES overlap, p = 0.005). In conclusion, the present study suggests that overlap of DESs and BMSs should be avoided because the antirestenotic effect of DESs is skewed by contiguous BMS implantation. Overlap between SESs and PESs in this very preliminary report was associated with no specific adverse event.

Predictive value of preintervention C-reactive protein on clinical outcome after directional coronary atherectomy followed by stent implantation.

BACKGROUND: Preprocedural C-reactive protein (CRP) serum levels have been shown to predict the recurrence of angina or major adverse cardiac events after percutaneous coronary intervention. Directional coronary atherectomy (DCA), by reducing residual plaque burden and restenosis, has been shown to improve clinical outcome after coronary stenting. Thus, we assessed the influence of preprocedural CRP serum levels on the recurrence of cardiac events after DCA followed by bare metal stent implantation. METHODS: We enrolled 40 consecutive patients (34 males; 61+/-10 years old) with single-vessel disease who were undergoing DCA. In all patients, preprocedural CRP serum levels were measured by an ultrasensitive nephelometric method. The endpoint of the study was defined as the composite incidence of death, myocardial infarction, and recurrence of angina requiring repeat revascularization at 6-month follow-up. RESULTS: CRP serum levels were a significant independent predictor of the composite endpoint at multiple regression analysis [odds ratio=1.69; 95% confidence interval (95% CI)=1.04-2.75; P=.033]. Patients with recurrence of cardiac events had CRP serum levels higher than those of patients not having events on follow-up [3.95 (2.2-5.7) vs. 2 (1.3-3.3); P=.05]. CONCLUSION: In conclusion, our study shows that baseline CRP serum levels predict cardiac events after coronary bare metal stenting despite plaque debulking with directional atherectomy.

Manual thrombus-aspiration improves myocardial reperfusion: the randomized evaluation of the effect of mechanical reduction of distal embolization by thrombus-aspiration in primary and rescue angioplasty (REMEDIA) trial.

OBJECTIVES: The aim of this study was to evaluate the use of a new manual thrombus-aspirating device in unselected patients with ST-segment elevation acute myocardial infarction (STEMI) undergoing urgent percutaneous coronary intervention (PCI). BACKGROUND: Failure to achieve myocardial reperfusion often occurs during PCI in patients with STEMI. The use of thrombus-aspirating devices might improve myocardial reperfusion by reducing distal embolization. METHODS: We prospectively randomized before coronary angiography 100 consecutive patients with STEMI to either standard PCI or PCI with manual thrombus-aspiration. Primary end points of the study were post-procedural rates of myocardial blush grade (MBG) > or =2 and ST-segment resolution (STR) > or =70%. Analyses were planned by intention to treat. RESULTS: Ninety-nine patients entered the analyses. The rates of post-procedural MBG > or =2 and STR > or =70% were, respectively, 68.0% and 44.9% in the thrombus-aspiration group compared with 58.0% and 36.7% in the standard PCI group: odds ratio (OR) 2.6 (95% confidence interval [CI] 1.2 to 5.9), p = 0.020, and 2.4 (95% CI 1.1 to 5.3), p = 0.034, respectively. Moreover, the rate of patients achieving both the angiographic and electrocardiographic (ECG) criteria of optimal reperfusion was significantly higher in the thrombus-aspiration group compared with standard PCI: 46.0% versus 24.5%, OR 2.6 (95% CI 1.1 to 6.2), p = 0.025. In multivariate analysis, randomization to thrombus-aspiration was a significant independent predictor of achievement of MBG > or =2 and STR > or =70% (p = 0.013). CONCLUSIONS: This prospective randomized study shows that manual thrombus-aspiration in unselected patients with STEMI undergoing primary or rescue PCI is clinically feasible and results in better angiographic and ECG myocardial reperfusion rates compared with those achieved by standard PCI.

Left main and saphenous vein graft spasm: an unusual association.

We present a case of left main spasm which was associated with spasm of a saphenous vein graft. This case emphasizes the importance of excluding an excessive vasoconstrictory response in patients treated with percutaneous coronary interventions.

Catheter-induced straightening of external iliac tortuosity: a cause of pseudostenosis to be borne in mind.

Reversible vascular obstructive lesions, i.e. pseudostenoses, may pose significant threats to interventional cardiologists as they can be mistaken for obstructive lesions and prompt inappropriate revascularization procedures. We hereby report for the first time in the literature a case of external iliac artery pseudostenosis due to catheter straightening of significant underlying vessel tortuosities. Despite the initial angiographic image obtained from retrograde catheterization of the right external iliac artery which was strongly suggestive for significant stenosis, a thorough review of clinical history, physical examination and a second-look angiography by means of contralateral catheterization and contrast injection showed the absence of any significant lesion in the tortuous left external iliac artery, thus avoiding an unnecessary and potentially harmful vascular intervention. This clinical vignette emphasizes the importance of a thorough clinical examination and angiographic assessment for the appropriate diagnosis and management of reversible stenoses.

Angiographic evaluation of the effect of intracoronary abciximab administration in patients undergoing urgent PCI.

BACKGROUND: Recent data suggest that the intracoronary (i.c.) administration of a systemic bolus dose of abciximab during PCI may increase the efficacy of this antiplatelet drug. However, the effect of i.c. abciximab on coronary angiographic flow has been not clarified. METHODS: We studied 37 consecutive patients with acute coronary syndromes (ACS) who underwent successful urgent PCI on the target vessel and were treated by an i.c. abciximab bolus (0.25 mg/kg) prior to the first balloon inflation (Group IC), and 37 matched controls who were treated by intravenous (i.v.) abciximab bolus at the same dose (Group IV). Corrected TIMI frame count (CTFC) in the culprit and in a non-culprit coronary artery branch was assessed before treatment, immediately after intracoronary administration of abciximab bolus and at the end of the procedure. RESULTS: After administration of abciximab, CTFC significantly decreased from 48+37 to 33+30 (P=0.001) in the culprit vessel while in the non-culprit vessel it remained unchanged (16+7 pre-treatment and 16+7 post-treatment, P=0.68). Final CTFC was 12+4 in Group IC and 14+5 in Group IV (P=0.069). Post-treatment mean peak of the cardiac enzymes showed a trend toward reduction in Group IC compared with Group IV. CONCLUSIONS: The i.c. administration of abciximab bolus acutely decreases CTFC through culprit vessels of patients with ACS undergoing urgent PCI. Further studies evaluating the potential clinical benefits associated with i.c. abciximab administration are warranted.

Use of a novel high-osmolar gadolinium chelate, gadobutrol, for percutaneous renal artery stenting in two patients with chronic renal failure.

Gadolinium chelates have been recently proposed and preliminarily tested as contrast agents for diagnostic and interventional angiography in alternative to iodinated media. However, in most studies low-osmolarity agents were employed and digital subtraction was required for satisfactory images. In this article, we report for the first time in the literature two cases of successful percutaneous renal artery stenting in which gadobutrol, a high-osmolar (1 mmol/ml) gadolinium chelate, was employed as contrast agent because of chronic renal failure and substantial risk for iodinated contrast-associated nephrotoxicity. In both patients gadobutrol yielded high-quality images without digital subtraction and was well tolerated with no ensuing renal dysfunction.

Rescue percutaneous coronary intervention for failed thrombolysis in a patient with anomalous coronary arteries.

Coronary artery anomalies (CAA) often render technically difficult the completion of coronary angiography and intervention. Their presence in patients undergoing emergency angiography for acute myocardial infarction (AMI) is particularly challenging for interventional cardiologists. In this article, we report, for the first time in the literature, a case of rescue percutaneous coronary intervention for failed thrombolysis in a patient with AMI due to occlusion of a left circumflex coronary artery with anomalous origin from right sinus of Valsalva (in an anomalous left coronary system also including an anomalous origin of the left anterior descending artery from the right sinus). In particular, the present clinical vignette emphasizes the importance of a thorough search for the culprit vessel during cardiac catheterization. Especially in the emergency setting, non-invasive methods of ischemia localization, such as ST-segment elevation at the ECG and wall motion abnormalities at echocardiography, are of pivotal usefulness to guide the interventional cardiologist in identifying and treating the diseased coronary vessel in a timely and effective fashion.

Use of a second buddy wire during percutaneous coronary interventions: a simple solution for some challenging situations.

The buddy wire technique, i.e. the use of a second 0.014 inch guide wire placed alongside the one employed to advance balloons and stents inside the coronary artery during percutaneous coronary intervention (PCI), may help in a series of procedural challenges during PCI. Indeed, by improving both the stability of the guiding catheter and the support for balloon and stent, a buddy wire use is sometimes the simplest way to accomplish a successful procedure. In this paper, we discuss technical aspects of some specific circumstances frequently encountered during PCI, in which a buddy wire may be helpful. These include: 1) The reduction of balloon slippage during angioplasty for in-stent restenosis; 2) insufficient back-up of the guiding catheter; 3) stenting of lesions located in vessels with proximal tortuosities/angulations; 4) stenting of lesions distally located in the vessel; 5) facilitation in the positioning of distal protection devices; 6) stenting of a lesion distally located from a previously implanted stent or from a coronary segment with both calcification and sharp bend; 7) PCI on coronary arteries with anomalous origin. Because of its simplicity, low cost, and availability, the use of a buddy wire should be considered when dealing with the aforementioned conditions during PCI procedures.

Comparison of outcomes (early and six- month) of direct stenting with conventional stenting (a meta-analysis of ten randomized trials).

Although direct stenting (DS) is increasingly used in clinical practice instead of stent implantation after predilatation (conventional stenting [CS]), its impact has not been scientifically proved. We therefore performed, using Mantel-Haenszel analysis, a meta-analysis of the published randomized studies comparing DS with CS. Furthermore, all the key procedural data were systematically sought out and pooled. Ten trials (2,650 coronary lesions, 2,576 patients) were identified and entered into the analysis. Adopted angiographic exclusion criteria were homogeneous. DS, compared with CS, was found to have a similar success rate (98.7% vs 98.9%) and no specific complications. Across the studies, the mean rate of crossover to predilatation in the DS arm was 5.9%. Overall, DS was associated with a 17% procedural time (95% confidence interval [CI] 14% to 20%), a 18% fluoroscopic time (95% CI 15% to 21%), a 11% contrast volume (95% CI 9% to 14%), and a 22% cost reduction (95% CI 16% to 28%). In the early postintervention period, DS was associated with a trend toward reduction of each of the major adverse events (MACEs) and with a significant reduction of myocardial infarction (MI) + death (odds ratio [OR] 0.57, 95% CI 0.35 to 0.95). However, at 6 months, the OR (95% CI) for death, MI, target lesion revascularization, and MACEs were 0.47 (0.19 to 1.27), 0.72 (0.45 to 1.25), 1.07 (0.77 to 1.46), and 0.82 (0.63 to 1.08), respectively. In the subgroup of studies providing quantitative angiographic data, all the parameters were found to be similar between the CS and DS groups. In conclusion, the present meta-analysis shows that DS compared with CS, in selected coronary lesions, is safe, optimizes equipment use, and may enhance the early results of coronary interventions while warranting similar late clinical outcomes.

Case-control registry of excimer laser coronary angioplasty versus distal protection devices in patients with acute coronary syndromes due to saphenous vein graft disease.

Laser atherectomy might decrease procedural complications during percutaneous coronary intervention (PCI) of degenerated saphenous vein grafts (SVGs) in case of unstable or thrombotic lesions because of its ability to debulk and vaporize thrombus. We aimed at prospectively evaluating the safety and efficacy of excimer laser coronary angioplasty (ELCA) as a primary treatment strategy in consecutively unstable patients undergoing PCI of degenerated SVG lesions. Seventy-one consecutive patients with non-ST elevation acute coronary syndrome (mean age 69 ± 10 years, 66 men [89%]) undergoing PCI of degenerated SVG were enrolled in a prospective case-control registry, using 2 different distal protection devices (DPDs; FilterWire EZ [Boston Scientific, Natick, Massachusetts; n = 24] and SpiderRX [Ev3, Plymouth, Minnesota; n = 23]) or ELCA (n = 24). Primary end points of the study were incidence of angiographic microvascular obstruction (Thrombolysis In Myocardial Infarction flow grade of <3 or Thrombolysis In Myocardial Infraction flow grade of 3 with myocardial blush grade 1 to 2) and incidence of type IVa myocardial infarction. Angiographic microvascular obstruction incidence tended to be less in ELCA-treated patients compared with DPD-treated patients (3 [13%] vs 15 [32%], p = 0.09). Type IVa myocardial infarction incidence was more in DPD-treated patients compared with ELCA-treated patients (23 [49%] vs 5 [21%], p = 0.04). In conclusion, in patients with non-ST elevation acute coronary syndrome undergoing PCI of degenerated SVG, ELCA compared with DPD, is associated with a trend for better myocardial reperfusion and a lesser incidence of periprocedural necrosis. Controlled randomized trials are warranted to confirm these early observations.

Management and timing of access-site vascular complications occurring after trans-radial percutaneous coronary procedures.

BACKGROUND: Access-site vascular complications (ASVC) in patients undergoing trans-radial coronary procedures are rare but may have relevant clinical consequences. Data regarding the optimal management of radial-access-related ASVC are lacking. METHODS: During a period of 6 years we prospectively collected ASVC. ASVC were defined as any complication requiring ultrasound examination or upper limb angiography. ASVC were categorized according to the timing of diagnosis: "very early" (in the cath lab), "early" (after cath lab discharge, but during the hospital stay) and "late" (after hospital discharge). The need of surgery (primary end-point) and the development of neurological hand deficit (secondary end-point) were assessed. RESULTS: Fifty-seven radial-artery related ASVC were collected. ASVC diagnosis was obtained by upper limb angiography in 25 patients (44%) and by Doppler in 32 patients (56%). Surgery was required in 6 cases (11%), the remaining patients receiving successful conservative management (which included prolonged local compression). Three patients (who received surgery) exhibited a mild neurological hand deficit in the follow-up. Need for surgery differed significantly according to timing of diagnosis as it occurred in 1 of 26 patients (3.8%) with "very early" diagnosis, in 1 of 21 patients (4.8%) with "early" diagnosis, and in 4 of 10 patients (40%) with "late" diagnosis (p=0.026). CONCLUSIONS: ASVC are diagnosed with different timing after trans-radial procedures. Conservative management including local compression allows successful management in the majority of ASVC. Prompt recognition is pivotal as late diagnosis is associated to the need for surgery.

Influence of the amount of myocardium subtended by a stenosis on fractional flow reserve.

BACKGROUND: Fractional flow reserve (FFR) specifically relates to the severity of a stenosis to the mass of tissue to be perfused. Accordingly, the larger the territory to be perfused, the greater the flow and the pressure gradient induced by maximal hyperemia. Although this notion may be considered intuitive, its unequivocal demonstration is still lacking. The aim of our study was to evaluate the influence of the amount of myocardium subtended to an intermediate stenosis on FFR, especially in relation to quantitative coronary angiography. METHODS AND RESULTS: The severity of each lesion was assessed by FFR and 2-dimensional quantitative coronary angiography. The amount of jeopardized myocardium was evaluated using 3 validated scores specifically adapted to this aim: the Duke Jeopardy Score (DJS), the Myocardial Jeopardy Index (MJI), and the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH) Lesion Score (ALS). The presence of a concomitant collateralized chronic total occlusion was also reported. A total of 213 intermediate coronary stenoses in 184 patients were enrolled. FFR values were correlated to minimal lumen diameter (r=0.34; P<0.0001) and diameter stenosis (r=-0.28; P<0.0001). FFR was inversely correlated with DJS, MJI, and ALS (r=-0.28, P<0.0001; r=-0.40, P<0.0001; and r=-0.34, P<0.0001). Lesions localized on proximal left anterior descending were related to significantly lower FFR values and to a higher rate of a positive FFR compared with those in distal left anterior descending, left circumflex, and right coronary arteries (0.80±0.09 versus 0.84±0.08 versus 0.88±0.09 versus 0.91±0.04; P<0.0001). The presence of a collateralized chronic total occlusion was associated with significantly lower FFR values (0.80±0.07 versus 0.85±0.09; P<0.005). At multivariate analysis MJI, minimal lumen diameter, and presence of a collateralized chronic total occlusion were confirmed as significant predictors of FFR. CONCLUSIONS: A larger amount of perfused myocardium subtended by a stenosis is associated with a higher probability that an angiographically intermediate coronary stenosis is functionally significant.

Sodium bicarbonate plus N-acetylcysteine to prevent contrast-induced nephropathy in primary and rescue percutaneous coronary interventions: the BINARIO (BIcarbonato e N-Acetil-cisteina nell'infaRto mIocardico acutO) study.

AIMS: Contrast-induced nephropathy (CIN) is a frequent and potentially harmful complication of percutaneous coronary interventions (PCI), especially in the setting of ST-elevation myocardial infarction (STEMI). We tested the efficacy of a sodium bicarbonate (SB)-based hydration in urgent PCI for STEMI. METHODS AND RESULTS: From June 2009 to September 2010, 262 consecutive STEMI patients undergoing urgent PCI were prospectively enrolled and treated by SB-based hydration (154 mEq/L at 3 ml Kg-1 for one hour followed by 1 ml Kg-1 for six hours) (group A). As controls, 262 consecutive STEMI patients receiving 0.9% saline hydration (1 ml Kg-1 for 24 hours) before June 2009 were retrospectively enrolled (group B). Both groups received high-dose N-acetylcysteine (NAC). The primary endpoint was the composite of in-hospital death, need for dialysis and CIN (≥25% increase in serum creatinine at 48 hours). The two groups were comparable for baseline clinical and procedural characteristics, for Mehran risk score and baseline estimated glomerular filtration rate. The primary combined endpoint was significantly reduced in group A as compared to group B (9.2 vs. 18.7%, p=0.023) with a number needed to treat (NNT) of 11. Specifically, a significant reduction of both in-hospital death (2.3 vs. 6.1%, p=0.049, NNT 27) and CIN (8.0 vs. 14.1%, p=0.03, NNT 17) was observed, with no difference in the need for dialysis. CONCLUSIONS: Our data indicate that hydration with sodium bicarbonate in addition to high-dose NAC in the setting of urgent PCI for STEMI is associated with a net clinical benefit.