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Background: Oral activated factor XI (FXIa) inhibitors may modulate coagulation to prevent thromboembolic events without substantially increasing bleeding. We explored the pharmacodynamics, safety, and efficacy of the oral FXIa inhibitor asundexian for secondary prevention after acute myocardial infarction (MI). Methods: We randomized 1601 patients with recent acute MI to oral asundexian 10, 20, or 50 mg or placebo once daily for 6 to 12 months in a double-blind, placebo-controlled, phase 2, dose-ranging trial. Patients were randomized within 5 days of their qualifying MI and received dual antiplatelet therapy with aspirin plus a P2Y12 inhibitor. The effect of asundexian on FXIa inhibition was assessed at 4 weeks. The prespecified main safety outcome was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding comparing all pooled asundexian doses with placebo. The prespecified efficacy outcome was a composite of cardiovascular death, MI, stroke, or stent thrombosis comparing pooled asundexian 20 and 50 mg doses with placebo. Results: The median age was 68 years, 23% of participants were women, 51% had ST-segment–elevation MI, 80% were treated with aspirin plus ticagrelor or prasugrel, and 99% underwent percutaneous coronary intervention before randomization. Asundexian caused dose-related inhibition of FXIa activity, with 50 mg resulting in >90% inhibition. Over a median follow-up of 368 days, the main safety outcome occurred in 30 (7.6%), 32 (8.1%), 42 (10.5%), and 36 (9.0%) patients receiving asundexian 10 mg, 20 mg, or 50 mg, or placebo, respectively (pooled asundexian versus placebo: hazard ratio, 0.98 [90% CI, 0.71–1.35]). The efficacy outcome occurred in 27 (6.8%), 24 (6.0%), 22 (5.5%), and 22 (5.5%) patients assigned asundexian 10 mg, 20 mg, or 50 mg, or placebo, respectively (pooled asundexian 20 and 50 mg versus placebo: hazard ratio, 1.05 [90% CI, 0.69–1.61]). Conclusions: In patients with recent acute MI, 3 doses of asundexian, when added to aspirin plus a P2Y12 inhibitor, resulted in dose-dependent, near-complete inhibition of FXIa activity without a significant increase in bleeding and a low rate of ischemic events. These data support the investigation of asundexian at a dose of 50 mg daily in an adequately powered clinical trial of patients who experienced acute MI. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04304534; URL: https://www.clinicaltrialsregister.eu/ctr-search/search ; Unique identifier: 2019-003244-79.

Aim Percutaneous coronary intervention with stent implantation (PCI-S) in patients requiring chronic oral anticoagulant therapy (OAC) is associated with an increased risk of bleeding and ischemic complications. Different randomized studies showed a significant advantage of a double antithrombotic therapy and superiority of direct oral anticoagulant (DOAC) compared with warfarin, but real-world data are limited. Aim is to evaluate the antithrombotic management and clinical outcome of patients with an indication for OAC who undergo PCI-S in a 'real-world' setting. Methods The multicentre prospective observational PERSEO (PERcutaneouS coronary intErventions in patients treated with Oral anticoagulant therapy) Registry (ClinicalTrials.gov Identifier: NCT03392948) has been designed to enrol patients requiring OAC treated by PCI-S in 25 Italian centres. A target of at least 1080 patients will be followed for 1 year and data on thromboembolic and bleeding events and changes in antithrombotic therapy will be registered. The primary end point is a combined measure of efficacy and safety outcome (NACE), including major bleeding events and major adverse cardiac and cerebral events at 1-year follow-up in patients treated with DOAC (and dual or triple antiplatelet therapy) compared with the corresponding strategies with vitamin K antagonists. A secondary prespecified analysis has been defined to evaluate NACE in dual versus triple antithrombotic therapy after hospital discharge at 1-year follow-up. Conclusion The PERSEO Registry will investigate in a 'real world' setting the safety and efficacy of DOAC versus warfarin and dual versus triple antithrombotic therapy in patients with indication for oral anticoagulant therapy who undergo PCI-S.

BACKGROUND: On March 9, 2020, the Italian government imposed a national lockdown to tackle the COronaVIrus Disease 19 (COVID-19) pandemic, including stay at home recommendations. The precise impact of COVID-19 scare and lockdown on emergency access for acute myocardial infarction (MI) is still subject to debate. METHODS: Data on all patients undergoing invasive coronary angiography at 9 hospitals in the greater area of Rome, Italy, between February 19, 2020 and March 29, 2020, 9, 2020, were retrospectively collected. Incidence of ST-elevation MI (STEMI), and non-ST-elevation MI (NSTEMI), as well as corresponding percutaneous coronary intervention (PCI), was compared distinguishing two different 20-day time periods (before vs on or after March 10, 2020). RESULTS: During the study period, 1,068 patients underwent coronary angiography, 142 (13%) with STEMI and 169 (16%) with NSTEMI. The average daily number of STEMI decreased from 4.3 before the lockdown to 2.9 after the lockdown (p=0.021). Similarly, the average daily number of NSTEMI changed from 5.0 to 3.5 (p=0.028). The average daily number of primary PCI changed from 4.2 to 2.9 (p=0.030), while the average daily number of PCI for NSTEMI changed from 3.5 to 2.5 (p=0.087). For STEMI patients, the time from symptom onset to hospital arrival (onset-to-door time less than three hours) showed a significant increase after the lockdown (p=0.018), whereas door-to-balloon time did not change significantly from before to after the lockdown (p=0.609). CONCLUSIONS: The present study, originally reporting on the trends in STEMI and NSTEMI in the Rome area, highlights that significant decreases in the incidence of both acute coronary syndromes occurred between February 19, 2020 and March 29, 2020, together with increases in time from symptom onset to hospital arrival, luckily without changes in door-to-balloon time.

Patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) with or without acute coronary syndromes (ACS) represent a subgroup with a challenging pharmacological management. Indeed, if on the one hand, antithrombotic therapy should reduce the risk related to recurrent ischaemic events and/or stent thrombosis; on the other hand, care must be taken to avoid major bleeding events. In recent years, several trials, which overall included more than 12 000 patients, have been conducted demonstrating the safety of different therapeutic combinations of oral antiplatelet and anticoagulant agents. In the present ANMCO position paper, we propose a decision-making algorithm on antithrombotic strategies based on scientific evidence and expert consensus to be adopted in the periprocedural phase, at the time of hospital discharge, and in the long-term follow-up of patients with AF undergoing PCI with/without ACS.

Patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) with or without acute coronary syndromes (ACS) represent a subgroup with a challenging pharmacological management. Indeed, if on the one hand antithrombotic therapy should reduce the risk related to recurrent ischemic events and/or stent thrombosis, on the other hand care should be taken to avoid major bleeding events. In recent years, several trials, which overall included more than 12 000 patients, have been conducted demonstrating the safety of different therapeutic combinations of oral antiplatelet and anticoagulant agents. In the present ANMCO position paper we propose a decision-making algorithm on antithrombotic strategies based on scientific evidence and expert consensus to be adopted in the periprocedural phase, at the time of hospital discharge and in the long-term follow-up of patients with AF undergoing PCI with/without ACS.

Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is a widely adopted strategy for the treatment of de novo coronary artery disease. DES implantation conveys an inherent risk for short- and long-term complications, including in-stent restenosis and stent thrombosis. Drug-coated balloons are emerging as an alternative approach to fulfill the "leaving nothing behind" principle and avoid long-term DES-related complications.TRANSFORM II is an investigator-initiated, multicenter, noninferiority, randomized clinical trial, testing a sirolimus-coated balloon (SCB) versus the standard of care for native coronary vessels with a 2-3 mm diameter, in terms of 12-month target lesion failure (TLF; primary endpoint) and net adverse cardiovascular events (coprimary endpoint). Patients undergoing PCI will be randomized to be treated with either SCB or new-generation everolimus-eluting stent and will be followed up clinically for up to 60 months. Assuming a TLF rate of 8% at 12 months with DES, a sample size of 1325 patients was chosen to ensure an 80% power to detect a 1.5% lower incidence in the SCB group with a type I error rate of 0.05. The TRANSFORM II trial is registered on clinicaltrials.gov (identification number NCT04893291). Several substudies, including an optical coherence tomography assessment at 9 months (intracoronary imaging substudy), will investigate the study device in different clinical and lesion settings.The randomized TRANSFORM II trial will determine whether a novel SCB is noninferior to a current everolimus-eluting stent when adopted for the treatment of de novo lesions in coronary vessels with a diameter between 2 and 3 mm.

In the patients on warfarin undergoing percutaneous coronary intervention included in the prospective, multicentre, observational WAR-STENT registry, age ≥75 years was associated with a significant increase in in-hospital major bleeding, length of hospitalization, and use of bare-metal stents, with no differences in the peri-procedural management and antithrombotic therapy.

In the cardiology community, the use of transradial access for percutaneous coronary procedures is progressively increasing all around the world overtaking the use of transfemoral access. The advantages of the transradial access are based on a significant reduction in bleeding and vascular events compared to the femoral access and on a reduction in mortality in the setting of acute coronary syndromes. However, in recent years a slight but significant increase in radiation exposure for patients and operators associated with the radial approach has been detected, increasing concerns about possible long term increased stochastic risk. In particular interventional cardiologists are among physicians performing interventional procedures using X-rays, those exposed to the highest radiation dose during their activity and this exposure is not without possible long-term clinical consequences in term of deterministic and stochastic effects. All the operators should be aware of these risks and manage to reduce their radiation exposure. In this review we analysed the differences in term of radiation exposure comparing the radial and the femoral access for percutaneous coronary procedures. Then, we discussed the possible clinical consequences of these differences and finally we showed the available tools aimed to reduce the operator radiation exposure. In particular the use of adjunctive protective drapes placed on the patient might reduce operator radiation exposure in up to 81% of the dose.

Purpose To evaluate the outcome of patients with an established indication for oral anticoagulation (OAC) undergoing coronary stent implantation (PCI-S) and stratified by the baseline risk of bleeding. Material and methods The database of the prospective, multicentre, observational WAR-STENT registry ( ClinicalTrials.gov identifier NCT00722319 ) was analyzed and patients with atrial fibrillation and CHA 2 DS 2 -VASc score ≥2, mechanical heart valve, prior cardiac embolism, intra-cardiac thrombus and recent venous thromboembolism who were treated with either triple (warfarin, aspirin and clopidogrel) or dual (warfarin and clopidogrel) or dual antiplatelet (aspirin and clopidogrel) therapy, identified. Patients were then sorted into two groups at non-low and low risk of bleeding, as defined by an ATRIA score >3 and ≤3 respectively, and compared regarding major adverse cardiac and vascular events (MACVE) and bleeding. Results At 12-month follow up, MACVE were comparable in the two groups, whereas total, major and minor bleeding, as well as combined MACVE and total bleeding, were significantly more frequent in the non-low bleeding risk group. Upon Cox univariate and multivariable analysis, non-low bleeding risk category confirmed as an independent predictor of major bleeding. The choice of antithrombotic therapy however, appeared not to be influenced by the bleeding risk category at baseline. Conclusions In patients with an established indication for OAC undergoing PCI-S, non-low bleeding risk category is the most potent independent predictor of major bleeding. Stratification of the bleeding risk at baseline should therefore be regarded as an indispensable process to be carried out before selection of the antithrombotic therapy.

Summary Background A routine invasive strategy is recommended for patients with non-ST-elevation acute coronary syndromes (NSTE-ACS). However, optimal timing of invasive strategy is less clearly defined. Individual clinical trials were underpowered to detect a mortality benefit; we therefore did a meta-analysis to assess the effect of timing on mortality. Methods We identified randomised controlled trials comparing an early versus a delayed invasive strategy in patients presenting with NSTE-ACS by searching MEDLINE, Cochrane Central Register of Controlled Trials, and Embase. We included trials that reported all-cause mortality at least 30 days after in-hospital randomisation and for which the trial investigators agreed to collaborate (ie, providing individual patient data or standardised tabulated data). We pooled hazard ratios (HRs) using random-effects models. This meta-analysis is registered at PROSPERO (CRD42015018988). Findings We included eight trials (n=5324 patients) with a median follow-up of 180 days (IQR 180–360). Overall, there was no significant mortality reduction in the early invasive group compared with the delayed invasive group HR 0·81, 95% CI 0·64–1·03; p=0·0879). In pre-specified analyses of high-risk patients, we found lower mortality with an early invasive strategy in patients with elevated cardiac biomarkers at baseline (HR 0·761, 95% CI 0·581–0·996), diabetes (0·67, 0·45–0·99), a GRACE risk score more than 140 (0·70, 0·52–0·95), and aged 75 years older (0·65, 0·46–0·93), although tests for interaction were inconclusive. Interpretation An early invasive strategy does not reduce mortality compared with a delayed invasive strategy in all patients with NSTE-ACS. However, an early invasive strategy might reduce mortality in high-risk patients. Funding None.

Intravenous (IV) infusion of adenosine represents the gold standard for measuring fractional flow reserve (FFR). However, IV adenosine is more expensive and time-consuming compared with intracoronary (IC) boluses of adenosine. We conducted a meta-analysis of studies comparing IC with IV adenosine for FFR assessment in the same coronary lesions. We searched for studies comparing IC with IV adenosine and reporting absolute FFR values or rate of abnormal FFR for both routes. Prespecified subgroup analysis was performed to appraise studies using low-dose (100 μg) or high-dose IC adenosine (≥100 μg). We retrieved 11 studies amounting to 587 patients and 621 lesions. Six studies evaluated low-dose IC boluses (15 to 80 μg) and 5 studies high-dose boluses (120 to 600 μg). Absolute FFR values were slightly, yet significantly lower with IV adenosine compared with IC adenosine (mean difference 0.02, 95% confidence interval [CI] 0.00 to 0.03, p = 0.02). This difference, however, did not translate into a significant difference in the rate of abnormal FFR between IC and IV adenosine (hazard ratio 0.93, 95% CI 0.76 to 1.13, p = 0.57); moreover, no statistically significant difference was observed between low-dose and high-dose IC adenosine subgroups. Adverse events were less frequent with IC adenosine compared with IV adenosine (risk ratio 0.17, 95% CI 0.07 to 0.43, p0.001). In conclusion, IC administration of adenosine, although inducing a slightly lower amount of hyperemia compared with IV infusion of adenosine, yields a similar diagnostic accuracy in identifying hemodynamically significant coronary stenosis and is better tolerated by the patients.

Radiation exposure is an important issue for interventional cardiologists that is often underevaluated. Our aim was to evaluate determinants of operator radiation exposure during percutaneous coronary procedures.The RADIANT (NCT01974453) is a prospective, single-center observational study involving 4 expert operators and 2 fellows performing percutaneous coronary procedures. The operator radiation dose was evaluated using dedicated electronic dosimeters in 2,028 procedures: 1,897 transradial access (TRA; 1,120 right and 777 left TRA) and 131 transfemoral access (TFA).In the whole population, operator radiation dose at the thorax did not differ between TFA (9μSv [interquartile range 5-18μSv]) and TRA (9μSv [4-21μSv]), but after propensity score matching analysis, TFA showed lower dose (9μSv [5-18μSv]) compared with TRA (17μSv [9-28μSv], P.001). In the whole transradial group, left TRA (5μSv [2-12μSv]) was associated with significant lower operator dose compared with right TRA (13μSv [6-26μSv], P.001).The use of adjunctive protective pelvic drapes was significantly associated with lower radiation doses compared with procedures performed without drapes (P.001). Among the operators, an inverse relation between height and dose was observed. Finally, left projections and the use of angiographic systems not dedicated for coronary and high frame rates were all associated with a significant higher operator radiation exposure.In a high-volume center for transradial procedures, TFA is associated with lower operator radiation dose compared with TRA. The use of adjunctive anti-rx drapes seems a valuable tool to reduce the higher operator radiation exposure associated with TRA.

Background It remains unclear whether radial access increases the risk of operator or patient radiation exposure compared to transfemoral access when performed by expert operators. Objectives This study sought to determine whether radial access increases radiation exposure. Methods A total of 8,404 patients, with or without ST-segment elevation acute coronary syndrome, were randomly assigned to radial or femoral access for coronary angiography and percutaneous intervention, and collected fluoroscopy time and dose-area product (DAP). RAD-MATRIX is a radiation sub-study of the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX) trial. We anticipated that 13 or more operators, each wearing a thorax (primary endpoint), wrist, and head (secondary endpoints) lithium fluoride thermoluminescent dosimeter, and randomizing at least 13 patients per access site, were needed to establish noninferiority of radial versus femoral access. Results Among 18 operators, performing 777 procedures in 767 patients, the noninferiority primary endpoint was not achieved (p value for noninferiority = 0.843). Operator equivalent dose at the thorax (77 μSv) was significantly higher with radial than femoral access (41 μSv; p = 0.02). After normalization of operator radiation dose by fluoroscopy time or DAP, the difference remained significant. Radiation dose at wrist or head did not differ between radial and femoral access. Thorax operator dose did not differ for right radial (84 μSv) compared to left radial access (52 μSv; p = 0.15). In the overall MATRIX population, fluoroscopy time and DAP were higher with radial compared to femoral access: 10 min versus 9 min (p Conclusions Compared to femoral access, radial access is associated with greater operator and patient radiation exposure when performed by expert operators in current practice. Radial operators and institutions should be sensitized towards radiation risks and adopt adjunctive radioprotective measures. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX; NCT101433627)

Background It remains unclear whether radial access (RA), compared with femoral access (FA), mitigates the risk of acute kidney injury (AKI). Objectives The authors assessed the incidence of AKI in patients with acute coronary syndrome (ACS) enrolled in the MATRIX-Access (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) trial. Methods Among 8,404 patients, 194 (2.3%) were excluded due to missing creatinine values, no or an incomplete coronary angiogram, or previous dialysis. The primary AKI-MATRIX endpoint was AKI, defined as an absolute (>0.5 mg/dl) or a relative (>25%) increase in serum creatinine (sCr). Results AKI occurred in 634 patients (15.4%) with RA and 712 patients (17.4%) with FA (odds ratio [OR]: 0.87; 95% confidence interval [CI]: 0.77 to 0.98; p = 0.0181). A >25% sCr increase was noted in 633 patients (15.4%) with RA and 710 patients (17.3%) with FA (OR: 0.87; 95% CI: 0.77 to 0.98; p = 0.0195), whereas a >0.5 mg/dl absolute sCr increase occurred in 175 patients (4.3%) with RA versus 223 patients (5.4%) with FA (OR: 0.77; 95% CI: 0.63 to 0.95; p = 0.0131). By implementing the Kidney Disease Improving Global Outcomes criteria, AKI was 3-fold less prevalent and trended lower with RA (OR: 0.85; 95% CI: 0.70 to 1.03; p = 0.090), with stage 3 AKI occurring in 28 patients (0.68%) with RA versus 46 patients (1.12%) with FA (p = 0.0367). Post-intervention dialysis was needed in 6 patients (0.15%) with RA and 14 patients (0.34%) with FA (p = 0.0814). Stratified analyses suggested greater benefit with RA than FA in patients at greater risk for AKI. Conclusions In ACS patients who underwent invasive management, RA was associated with a reduced risk of AKI compared with FA. (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX [MATRIX]; NCT01433627 )

The radiation dose received by interventional cardiologists during their activity in the catheterization laboratory is a matter of concern in terms of possible deterministic and stochastic risk. At the same time, very often, the knowledge of the effect and consequences of radiation exposure in the interventional cardiology community is limited. This document endorsed by the Italian Society of Interventional Cardiology (SICI-GISE) provides recommendations for cardiologists' radiation protection. Radiation safety considerations dedicated to women and other staff personnel working in the catheterization laboratory are also discussed.

Different tools and devices are effective to reduce operator radiation exposure at thorax level during percutaneous coronary procedures, but the operator radiation dose received at pelvic region still remains high. Our aim was to evaluate the efficacy of under-the-table adjunctive shields to reduce operator radiation exposure during percutaneous coronary procedures Methods and Results: The EXTRA-RAD study (Extended Protective Shield Under Table to Reduce Operator Radiation Dose in Percutaneous Coronary Procedures) is a prospective, single-center, randomized study. Patients who underwent transradial coronary procedures were randomized into 2 groups: group 1 (standard arrangement) and group 2 (adjunctive anti-rx shield under the angiographic table). In group 2, a further randomization was performed to compare 2 different under-the-table shields (a small curtain and a drape). A total of 205 procedures (122 diagnostic coronary angiographies and 83 percutaneous coronary interventions) performed in 157 patients by 4 different operators were included without significant differences in clinical and procedural characteristics between groups. The use of adjunctive shields was associated with lower radiation dose compared with no shield at pelvic region (42 µSv [14-98] in group 1, 13 µSv [5-27] in group 2; P0.0001) and also at thorax level (4 µSv [1-13] in group 1, 2 µSv [1-4] in group 2; P=0.001). The reduction in dose was observed in all the operators. No significant differences were observed in pelvic dose using the 2 different shields ( P=0.183).The use of adjunctive anti-rx shields under the angiographic table during transradial coronary procedures is associated with a significant lower radiation dose to operators at pelvic and thorax level.URL: https://www.clinicaltrials.gov . Unique identifier: NCT03259126.

Background: Different tools and devices are effective to reduce operator radiation exposure at thorax level during percutaneous coronary procedures, but the operator radiation dose received at pelvic region still remains high. Our aim was to evaluate the efficacy of under-the-table adjunctive shields to reduce operator radiation exposure during percutaneous coronary procedures Methods and Results: The EXTRA-RAD study (Extended Protective Shield Under Table to Reduce Operator Radiation Dose in Percutaneous Coronary Procedures) is a prospective, single-center, randomized study. Patients who underwent transradial coronary procedures were randomized into 2 groups: group 1 (standard arrangement) and group 2 (adjunctive anti-rx shield under the angiographic table). In group 2, a further randomization was performed to compare 2 different under-the-table shields (a small curtain and a drape). A total of 205 procedures (122 diagnostic coronary angiographies and 83 percutaneous coronary interventions) performed in 157 patients by 4 different operators were included without significant differences in clinical and procedural characteristics between groups. The use of adjunctive shields was associated with lower radiation dose compared with no shield at pelvic region (42 µSv [14–98] in group 1, 13 µSv [5–27] in group 2; P P =0.001). The reduction in dose was observed in all the operators. No significant differences were observed in pelvic dose using the 2 different shields ( P =0.183). Conclusions: The use of adjunctive anti-rx shields under the angiographic table during transradial coronary procedures is associated with a significant lower radiation dose to operators at pelvic and thorax level. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03259126.

AIMS Bindarit (BND) is a selective inhibitor of monocyte chemotactic protein-1 (MCP-1/CCL2), which plays an important role in generating intimal hyperplasia. Our aim was to explore the efficacy and safety of bindarit in preventing restenosis following percutaneous coronary intervention. METHODS AND RESULTS A phase II, double-blind, multicentre randomised trial included 148 patients randomised into three arms (BND 600 mg, n=48; BND 1,200 mg, n=49; PLB, n=51). Bindarit was given following PCI and continued for 180 days. Monthly clinical follow-up and six-month coronary angiography were conducted. The primary endpoint was in-segment late loss; the main secondary endpoints were in-stent late loss and major adverse cardiovascular events. Efficacy analysis was carried out on two populations, ITT and PP. There were no significant differences in the baseline characteristics among the three treatment groups. In-segment and in-stent late loss at six months in BND 600, BND 1,200 and PLB were: (ITT 0.54 vs. 0.52 vs. 0.72; p=0.21), (PP 0.46 vs. 0.53 vs. 0.72; p=0.12) and (ITT 0.74 vs. 0.74 vs. 1.05; p=0.01), (PP 0.66 vs. 0.73 vs. 1.06; p=0.003), respectively. The MACE rates at nine months among treatment groups were 20.8% vs. 28.6% vs. 25.5% (p=0.54), respectively. CONCLUSIONS This was a negative study with the primary endpoint not being met. However, significant reduction in the in-stent late loss suggests that bindarit probably exerts a favourable action on the vessel wall following angioplasty. Bindarit was well tolerated with a compliance rate of over 90%. A larger study utilising a loading dose and targeting a specific patient cohort may demonstrate more significant results.

Transradial approach currently represents the preferred arterial access approach for percutaneous coronary procedures primarily due to the reduced access-site complications compared with femoral access (1). However, because of its thinner caliber and higher sensitivity to mechanical and humoral stresses than other somatic vessels, radial artery is prone to spasm (2). In general, spasm is a benign complication that can be resolved with nitrates or Ca2+-channel blockers, but in some rare cases, the spasm is so severe and prolonged that it may lead to radial sheath entrapment, with documented rare cases of radial avulsion (3).

BACKGROUND The use of adjunctive protective drapes placed on the patient protects the operating physician from scatter radiation during percutaneous coronary procedures (PCP). No data are available on the effect of these drapes for staff members' radio-protection. PURPOSE To evaluate staff radiation exposure during PCP and the effect of adjunctive protective drapes on dose reduction. METHODS The RADIANT study (NCT01974453) is a prospective, observational study evaluating operator radiation exposure during PCP using electronic dosimeter. In a sub-group of procedures all the staff members (II operator, nurse circulator and technologist) were also equipped with a dedicated electronic dosimeter. RESULTS From a total of 2028 procedures included in the RADIANT study, staff members' doses were available for 122 procedures (67 coronarography and 55 percutaneous coronary interventions). Median fluoroscopy time was 306 s (Interquartile range 155-526 s) and the dose area product (DAP) was 18.0 Gy*cm2 (10-35.5 Gy*cm2). The radiation exposure was highest for the operating physician (6.7 μSv) and progressively lower for the nurse circulator (1.8 μSv), the II operator (1 μSv) and the technologist (0.7 μSv, p

Objectives: The aim of this prospective study was to evaluate muscle force of the hand, thumb, and forefinger in patients with prolonged radial occlusion after transradial percutaneous coronary procedures. Background: There are no data on hand strength and function in patients with prolonged radial occlusion after percutaneous coronary procedures. Methods: Elective patients with chronic stable angina undergoing percutaneous coronary procedures were evaluated the day before the procedure for radial artery patency, Allen test, hand grip, and thumb and forefinger pinch tests. The same measures were performed the day after the procedure and at follow-up. At follow-up, patients were divided in two groups according to the radial patency (group 1) or occlusion (group 2). Results: Of the 99 patients included in the study, 90 patients had a patent radial artery (group 1), and nine (9.1%) patients had an occluded artery (group 2). At baseline, there were no significant differences in hand grip test between the two groups (42 ± 11 kg in group 1 and 41 ± 17 kg in group 2, P = 0.74). In both groups, after the procedure, the hand grip test values was significantly reduced compared with baseline values (40 ± 11 kg in group 1, P

Objectives To compare the incidence of major adverse cardiac and cerebrovascular events (MACCE) and thrombolysis in myocardial infarction (TIMI) bleedings in primary percutaneous coronary intervention (pPCI) performed through transradial approach (TRA) or transfemoral approach (TFA) with systematic closure by FemoSeal™. Background Although the risk of bleeding can be reduced using vascular closure devices (VCD), there are few data comparing TRA and TFA with VCD, particularly in the setting of pPCI. Methods we included in this retrospective registry 777 patients who underwent pPCI at two centers from years 2010 to 2013. Exclusion criteria were implantation of intra-aortic balloon pump and achievement of femoral hemostasis by other means than FemoSeal™. We performed propensity-score matching and multivariate analysis to adjust for clinical and procedural confounders. Results We enrolled 511 patients in TRA group and 266 in TFA group. Both in the general population and in the propensity-matched population, the incidence of MACCE was comparable in TRA vs. TFA patients (3.5 vs. 3.4% and 4.4 vs. 2.6%, respectively; P = ns). On the contrary, we observed a higher incidence of TIMI bleedings in TFA vs. TRA patients (5.6 vs. 2.2% in the general population and 6.6 vs. 1.3% in the propensity-matched population; P

The aim of this study was to compare radiation exposure, assessed by dose-area product (DAP), in right trans-radial approach (RR) versus left trans-radial approach (LR) for coronary procedures.In LR the catheter course is more similar to trans-femoral approach, thus allowing an easier negotiation of coronary ostia which, in turn, might translate into reduced fluoroscopy time (FT) and radiation exposure as compared to RR.We retrospectively selected diagnostic and interventional procedures (PCI) performed by RR or LR at our center from May 2009 to May 2014. We only included in the analysis the procedures in which DAP values were available.We analyzed 1464 procedures, 1175 of which performed by RR (80.3%) and 289 by LR (19.7%). Median DAP values were significantly higher in RR as compared to LR for diagnostic and interventional procedures (4482 vs. 3540 cGy.cm(2) and 11523 vs. 10086 cGy.cm(2), respectively; p0.05). No significant differences were observed in FT and in contrast volume (CV). In the propensity-matched cohort, consisting of 269 procedures for each group, no significant differences between LR and RR were observed in median DAP values for both diagnostic and interventional procedures (3990 vs. 3542 cGy.cm(2) and 9964 vs. 10216 cGy.cm(2), respectively; p = ns); FT and CV were also similar. At multiple linear regression analysis laterality of trans-radial approach was not associated with DAP.In an experienced trans-radial center LR is not associated with a reduction in radiation exposure, FT or CV as compared to RR.

To evaluate operator pelvic radiation exposure during percutaneous coronary procedures.During percutaneous coronary procedures, the operator's pelvic region is close to the x-ray source and is probably exposed to more radiation than the operator's thorax. However, no data are available on the pelvic radiation exposure of interventional cardiologists.The RADIANT study (NCT01974453) is a prospective, single-center, observational study evaluating operator radiation exposure during percutaneous coronary procedures using electronic dosimeters placed at thorax level. In the last period of the study enrollment, a single operator was also equipped with an adjunctive electronic dedicated dosimeter to evaluate pelvic radiation exposure.From a total of 2028 procedures included in the RADIANT study, operator pelvic doses were available for 138 procedures (68 right radial, 55 left radial, and 15 transfemoral). Median fluoroscopy time was 226 sec (interquartile range [IQR], 117-407 sec) and the dose-area product (DAP) was 15.3 Gy•cm² (IQR, 9.3-27.8 Gy•cm²). Radiation dose at pelvic region was significantly higher (40.1 μSv; IQR, 22.7-76.3 μSv) compared to thorax dose (5.6 μSv; IQR, 1.5-12 μSv; P.001) even after normalization by DAP (2.98 μSv/Gy•cm² [IQR, 1.6-4.6 μSv/Gy•cm²] at pelvic vs 0.33 μSv/Gy•cm² [IQR, 0.11-0.81 μSv/Gy•cm²] at thorax level; P.001). No significant differences were observed comparing pelvic dose in right radial (42 μSv), left radial (39 μSv), or femoral access (40 μSv; P=.43).Operator radiation exposure to the pelvic region during percutaneous coronary procedures is significantly higher compared to thorax radiation dose independently of the vascular access site employed.

Background The RAD-MATRIX trial reported a large operator radiation exposure variability in right radial percutaneous coronary procedures. The reasons of these differences are not well understood. Our aim was to appraise the determinants of operator radiation exposure during coronary right transradial procedures. Methods Patient arrangement during transradial intervention was investigated across operators involved in the RAD-MATRIX trial. Operator radiation exposure was analyzed according to the position of the patient right arm (close or far from the body) and in relation to the size of the upper leaded glass. Results Among the 14 operators who agreed to participate, there was a greater than 10-fold difference in radiation dose at thorax level (from 21.5 to 267 μSv) that persisted after normalization by dose-area product (from 0.35 to 3.5 μSv/Gy*cm 2 ). Among the operators who positioned the instrumented right arm far from the body (110.4 μSv, interquartile range 71.5-146.5 μSv), thorax dose was greater than that in those who placed the instrumented arm close to the right leg (46.1 μSv, 31.3-56.8 μSv, P = .02). This difference persisted after normalization by dose-area product ( P = .028). The use of a smaller full glass shield was also associated with a higher radiation exposure compared with a larger composite shield (147.5 and 60 μSv, respectively, P = .016). Conclusions In the context of the biggest radiation study conducted in patients undergoing transradial catheterization, the instrumented right arm arrangement close to the leg and greater upper leaded shield dimensions were associated with a lower operator radiation exposure. Our findings emphasize the importance of implementing simple preventive measures to mitigate the extra risks of radiation exposure with right radial as compared with femoral access.

It remains unclear whether radial access increases the risk of operator or patient radiation exposure compared to transfemoral access when performed by expert operators.This study sought to determine whether radial access increases radiation exposure.A total of 8,404 patients, with or without ST-segment elevation acute coronary syndrome, were randomly assigned to radial or femoral access for coronary angiography and percutaneous intervention, and collected fluoroscopy time and dose-area product (DAP). RAD-MATRIX is a radiation sub-study of the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX) trial. We anticipated that 13 or more operators, each wearing a thorax (primary endpoint), wrist, and head (secondary endpoints) lithium fluoride thermoluminescent dosimeter, and randomizing at least 13 patients per access site, were needed to establish noninferiority of radial versus femoral access.Among 18 operators, performing 777 procedures in 767 patients, the noninferiority primary endpoint was not achieved (p value for noninferiority = 0.843). Operator equivalent dose at the thorax (77 μSv) was significantly higher with radial than femoral access (41 μSv; p = 0.02). After normalization of operator radiation dose by fluoroscopy time or DAP, the difference remained significant. Radiation dose at wrist or head did not differ between radial and femoral access. Thorax operator dose did not differ for right radial (84 μSv) compared to left radial access (52 μSv; p = 0.15). In the overall MATRIX population, fluoroscopy time and DAP were higher with radial compared to femoral access: 10 min versus 9 min (p 0.0001) and 65 Gy·cmCompared to femoral access, radial access is associated with greater operator and patient radiation exposure when performed by expert operators in current practice. Radial operators and institutions should be sensitized towards radiation risks and adopt adjunctive radioprotective measures. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX; NCT101433627).

Background Interventional radiology and cardiology procedures contribute significantly to the collective dose of radiation exposure from medical interventions. Recent and dedicated studies comparing directly these procedures in term of patient radiation exposure are lacking. Our aim was to compare radiation exposure among different interventional procedures performed under fluoroscopic guidance. Methods The RODEO study (NCT: 02972736) is an international observational retrospective multicenter study enrolling all patients undergoing diagnostic or interventional procedures performed by different interventional operators (i.e. radiologists, interventional cardiologists or electrophysiologists) in 6 centers, without exclusion criteria. The primary end-point of the study was the comparison of dose area product (DAP) among interventional cardiology, electrophysiology or interventional radiology procedures. Results A total of 17,711 procedures were included in the study: 13,522 interventional cardiology, 2352 electrophysiology and 1864 interventional radiology procedures. The highest DAP values were observed for interventional radiology procedures (74Gy∗cm 2 [Interquartile range 27–178Gy∗cm 2 ]), followed by interventional cardiology (40Gy∗cm 2 [22–78Gy∗cm 2 ]) and electrophysiology procedures (13Gy∗cm 2 [4–44Gy∗cm 2 ], p 2 [51–260Gy∗cm 2 ]) whereas the lowest DAP values in pacemaker insertion (11Gy∗cm 2 [4–28Gy∗cm 2 ]). Conclusion In this large multicenter study, the highest radiation exposure was observed in procedures performed by interventional radiologists. However, among specific procedures, structural or valvular cardiac procedures were associated with the highest radiation exposure.

The risk of acute kidney injury (AKI) is a major issue after percutaneous coronary interventions (PCIs), especially in the setting of ST-elevation myocardial infarction. Preliminary data from large retrospective registries seem to show a reduction of AKI when a transradial (TR) approach for PCI is adopted. Little is known about the relation between vascular access and AKI after emergent PCI. We here report the results of the Primary PCI from Tevere to Navigli (PRIPITENA), a retrospective database of primary PCI performed at high-volume centers in the urban areas of Rome and Milan. Primary end point of this study was the occurrence of AKI in the TR and transfemoral (TF) access site groups. Secondary end points were major adverse cardiovascular events, stent thrombosis, and Thrombolysis in Myocardial Infarction major and minor bleedings. The database included 1,330 patients, 836 treated with a TR and 494 with a TF approach. After a propensity-matched analysis performed to exclude possible confounders, we identified 450 matched patients (225 TR and 225 TF). The incidence of AKI in the 2 matched groups was lower in patients treated with TR primary PCI (8.4% vs 16.9%, p = 0.007). Major adverse cardiovascular events and stent thrombosis were not different among study groups, whereas major bleedings were more often seen in the TF group. At multivariate analysis, femoral access was an independent predictor of AKI (odds ratio 1.654, 95% confidence interval 1.084 to 2.524, p = 0.042). In conclusion, in this database of primary PCI, the risk of AKI was lower with a TR approach, and the TF approach was an independent predictor for the occurrence of this complication.

Background Stent deployment may be associated with distal embolization and slow flow in coronary thrombotic lesions. There are no data on the risk of distal thrombus embolization according to the stent design. The aim was to evaluate coronary flow after percutaneous coronary interventions (PCI) in acute myocardial infarction according to the employed stent (closed versus open cell design). Methods From March 2010 to December 2011, 223 consecutive patients with acute ST-elevation myocardial infarction were randomized to primary PCI either with an open cell (112 patients, 88 men) or with a closed cell stent design (111 patients, 92 men). The primary endpoint was the corrected TIMI frame count (cTFC) after the procedure. Results There were no significant differences in procedural success nor in-stent deployment in the 2 groups. At baseline, there were no significant differences in cTFC between the 2 groups (70 ± 37 and 67 ± 39, P = .65, respectively). After the procedure, the open cell group showed significantly higher cTFC compared to the closed cell group (18 ± 11 and 15 ± 5, P = .003 respectively). This difference was associated with a significant lower rate of TIMI 3 flow (87% and 95%, P = .037) and myocardial blush grade 3 (65% and 87%, P = .001) in the open compared to the closed cell group. There were 2 cases of death in the open cell and 1 case in the closed cell group. Conclusions The use of a closed cell stent design rather than an open cell during PCI for acute ST-elevation myocardial infarction is associated with better coronary angiographic flow after PCI.

In the last decade the radial access use in the catheterization laboratory has sensibly grown up worldwide. From an initial sporadic use as alternative but challenging vascular approach, radial artery is today utilized by default for percutaneous procedures in many centers. The tangible interest in the transradial approach is also testified by increasing presence of specific sessions in the main interventional meetings and by continuous development of dedicated catheters and ancillary devices by manufacturers. In this review we describe the anatomical characteristics and the technical aspects related to transradial procedure underlying its pros/cons in opposition to femoral access. We also point up practical instructions trying to resolve the main concerns related to an extensive use of radial approach in catheterization laboratory, such as increased operator's discomfort, higher radiation exposure, safety and feasibility for complex high-risk procedures.

Background Transradial approach (TRA) for percutaneous coronary procedures is associated with improved patient outcome and is being increasingly adopted worldwide. We surveyed Italian interventional cardiologists in order to take a snapshot of the current practice of TRA. Methods A web-based questionnaire was emailed to all members of the Italian Society of Interventional Cardiology. Results The survey was taken by 508 respondents. Cardiogenic shock and chronic total occlusions represented the principal limitations to TRA. Right TRA was the default approach for 81% of respondents. Both diagnostic and interventional procedures were routinely performed through 6 Fr sheaths (83% and 93%, respectively); dedicated TRA curves were used in 11% of diagnostic and in about 3% of interventional procedures. Almost 70% of the operators did not assess dual hand circulation. In case of crossover, the contralateral radial artery was the preferred site (57%). Radial artery hemostasis was mostly achieved by pneumatic bracelet (64%) and patency of the radial artery during hemostasis was ensured in 60% of cases. Pre-discharge patency of the radial artery was routinely assessed by almost 60% of respondents. For diagnostic procedures, adequate heparin anticoagulation (5000 IU) was only given by 45% of operators. Most respondents believed that TRA is associated with greater radiation exposure for both the patient (82%) and the operator (98%) as compared to transfemoral approach. Conclusions This survey provides contemporary data about the adoption of TRA in Italy and gives interesting insights about several technical and clinical issues related to the practice of this vascular approach for coronary procedures.

Periprocedural bleedings, often related to vascular access site, represent an important drawback of percutaneous coronary procedures and are associated with worse outcomes. Radial access (RA) and, potentially, femoral access (FA) with vascular closure device (VCD) are useful strategies in order to mitigate periprocedural bleedings; nevertheless, their relative efficacy is largely undetermined. We aimed to perform a systematic review and meta-analysis of available studies comparing the efficacy of RA and FA with hemostasis by VCD (FA + VCD) on the reduction of access-site complications and/or periprocedural bleedings.Published studies reporting outcomes on access-site complications and periprocedural bleedings were included in the analysis. Data were extracted by two independent reviewers; odds ratio (OR) and 95% confidence interval (CI) were calculated by random-effects model and were used as summary statistics.We included in the analysis 13 studies, of which 5 were randomized. Access-site complications were reported by 11 studies, amounting to 157,031 patients (77,713 in the RA group and 79,318 in the FA + VCD group), whereas periprocedural bleedings were reported by 12 studies, amounting to 600,196 patients (137,277 in the RA group and 462,919 in the FA + VCD group). RA was associated with a significant reduction in access-site complications (OR, 0.25; 95% CI ,0.21-0.31; P.001) and periprocedural bleedings (OR, 0.40; 95% CI, 0.34-0.48; P.001) as compared with FA + VCD; the results were consistent among randomized and observational studies.This meta-analysis shows that RA is superior to FA + VCD in the reduction of access-site complications and periprocedural bleedings.

Objectives The purpose of this study was to assess whether transradial access for ST-segment elevation acute coronary syndrome undergoing early invasive treatment is associated with better outcome compared with conventional transfemoral access. Background In patients with acute coronary syndrome, bleeding is a significant predictor of worse outcome. Access site complications represent a significant source of bleeding for those patients undergoing revascularization, especially when femoral access is used. Methods The RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) was a multicenter, randomized, parallel-group study. Between January 2009 and July 2011, 1,001 acute ST-segment elevation acute coronary syndrome patients undergoing primary/rescue percutaneous coronary intervention were randomized to the radial (500) or femoral (501) approach at 4 high-volume centers. The primary endpoint was the 30-day rate of net adverse clinical events (NACEs), defined as a composite of cardiac death, stroke, myocardial infarction, target lesion revascularization, and bleeding). Individual components of NACEs and length of hospital stay were secondary endpoints. Results The primary endpoint of 30-day NACEs occurred in 68 patients (13.6%) in the radial arm and 105 patients (21.0%) in the femoral arm (p = 0.003). In particular, compared with femoral, radial access was associated with significantly lower rates of cardiac mortality (5.2% vs. 9.2%, p = 0.020), bleeding (7.8% vs. 12.2%, p = 0.026), and shorter hospital stay (5 days first to third quartile range, 4 to 7 days] vs. 6 [range, 5 to 8 days]; p = 0.03). Conclusions Radial access in patients with ST-segment elevation acute coronary syndrome is associated with significant clinical benefits, in terms of both lower morbidity and cardiac mortality. Thus, it should become the recommended approach in these patients, provided adequate operator and center expertise is present. (Radial Versus Femoral Investigation in ST Elevation Acute Coronary Syndrome [RIFLE-STEACS]; NCT01420614 )

The cardioprotective role that statin and aspirin has appears to be reduced in patients with chronic kidney disease (CKD). This analysis aims to evaluate the impact of statin and aspirin on the outcome of patients with CKD and acute coronary syndrome (ACS).All patients who were enrolled in the IN-ACS Outcome registry, diagnosed with CKD, were included in our analysis. We divided patients into four groups, according to previous chronic therapy: neither aspirin nor statin therapy (Group 1), aspirin only therapy (Group 2), statin only therapy (Group 3) and aspirin plus statin therapy (Group 4).Of the 5483 patients enrolled that had data on glomerular filtration rate available, 1484 had CKD: These segregated into 589 patients in Group 1, 477 in Group 2, 89 in Group 3 and 329 in Group 4. Despite having a higher baseline risk profile, groups 3 and 4, as compared to the other two groups, exhibited a significantly lower in-hospital mortality (1% in Group 3, 2% in Group 4; but 8% in Group 1 and 7% in Group 2, p = 0.0007); while at 30 days it remained so, as it was 1% in Group 3, 4% in Group 4 (and 10% in Group 1 and 10% in Group 2 p = 0.0002); and at 1 year it was 11% in Group 3 and 13% in Group 4 (compared to 20% in Group 1 and 23% in Group 2, p = 0.0012).In a large cohort of patients with CKD and ACS, chronic treatment with statin or the combination of aspirin and statin is associated with short-term and long-term better outcomes for in-hospital mortality, as compared to those receiving no therapy or aspirin therapy alone.

Background: Transradial approach (TRA) for percutaneous coronary interventions (PCIs) is a common alternative to transfemoral approach associated with lower complications. However, a limitation of TRA is the use of large caliber guiding catheters due to the small size of the radial artery. The sheathless guiding catheter system that is in diameter 1–2 French (Fr) smaller than the corresponding introducer sheath may overcome these difficulties. Methods: From January 2010 through December 2010 in 5 Italian high-volume hospitals, 213 consecutive patients who underwent TRA-PCIs using the sheathless Eaucath guiding catheter system because of small radial artery caliber (Group 1) or undergoing bifurcation PCIs (Group 2) were enrolled in this registry. In patients of Group 1 (n = 79), a 6.5-Fr sheathless guiding catheter was employed, whereas in patients of Group 2 (n = 134) a 7.5 Fr was used. Results: Among the 213 patients enrolled, 270 vessels were treated for 316 lesions. No procedures required conversion to a conventional guiding catheter system. There were significantly more female patients in Group 1, and they were, older, shorter, and thinner than patients in Group 2. No cases of major vascular complications were observed in either groups. During procedures, adjunctive devices employed included intravascular ultrasound, thrombectomy catheters, and distal protection systems. Conclusions: The use of the sheathless guiding catheter system is feasible for TRA-PCIs in case of small radial artery caliber or intended coronary bifurcation intervention. (J Interven Cardiol 2011;24:407–412)

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.

Aims: To assess: the reasons behind an operator choosing to perform radial artery catheterisation (RAC) as against femoral arterial catheterisation, and to explore why RAC may fail in the real world. Methods and results: A pre-determined analysis of PREVAIL study database was performed. Relevant data were collected in a prospective, observational survey of 1,052 consecutive patients undergoing invasive cardiovascular procedures at nine Italian hospitals over a one month observation period. By multivariate analysis, the independent predictors of RAC choice were having the procedure performed: (1) at a high procedural volume centre; and (2) by an operator who performs a high volume of radial procedures; clinical variables played no statistically significant role. RAC failure was predicted independently by (1) a lower operator propensity to use RAC; and (2) the presence of obstructive peripheral artery disease. A 10-fold lower rate of RAC failure was observed among operators who perform RAC for > 85% of their personal caseload than among those who use RAC < 25% of the time (3.8% vs. 33.0%, respectively); by receiver operator characteristic (ROC) analysis, no threshold value for operator RAC volume predicted RAC failure. Conclusions: A routine RAC in all-comers is superior to a selective strategy in terms of feasibility and success rate.

Chronic use of aspirin and statins has been associated with reduced risk of subsequent myocardial infarction (MI). However, in patients with chronic kidney disease (CKD), the cardioprotective role of aspirin and statins seems to be reduced. To evaluate the impact of chronic aspirin and statin use on clinical presentation of acute MI according to renal function, the authors retrospectively analyzed 595 consecutive patients admitted to our hospital for acute MI. Renal function was normal in 404 patients and impaired in 191. Patients on therapy (113 patients) were less likely to have ST-segment elevation MI (STEMI) compared with patients not treated (36% vs 53%, respectively, P=.0002). These results have been confirmed in the population of patients with CKD (48% of STEMI in patients receiving chronic therapy and 67% in patients without therapy,P=.01). Multivariate analysis in the group of patients with CKD showed that use of aspirin or statins was an independent predictor of a decreased probability of STEMI (odds ratio, 0.5; 95% confidence interval, 0.2-1.0,P=.05). The authors' results suggest that in a community-based sample of patients with acute MI, chronic aspirin and statin therapy has a cardioprotective role that is evident also in patients with CKD.

Cardiac catheterization through the radial artery approach (RA) has been shown to significantly reduce access-site complications compared with the femoral artery approach (FA) in many clinical settings. However, in the subset of patients with previous coronary artery bypass grafting (CABG), optimal vascular access site for coronary angiography and intervention is still a matter of debate. We aimed to perform a systematic review and meta-analysis of available studies comparing RA with FA in patients with previous CABG. Data were extracted by two independent reviewers; weighted mean differences and 95% confidence interval (CI) were calculated for continuous outcomes, whereas odds ratio (OR) and 95% CI were calculated for dichotomous outcomes. Summary statistics were calculated by random-effects model using Review Manager 5.3 software. The meta-analysis included 1 randomized and 8 nonrandomized studies, with a total of 2,763 patients. Compared with FA, RA required similar procedural time (mean difference 3.24 minutes, 95% CI -1.76 to 8.25, p = 0.20), fluoroscopy time (mean difference 0.62 minutes, 95% CI -0.83 to 2.07, p = 0.40), and contrast volume (mean difference -2.58 ml, 95% CI -18.36 to 13.20, p = 0.75) and was associated with similar rate of procedural failure (OR 1.32, 95% CI 0.63 to 2.80, p = 0.46), higher rate of crossover to another vascular access (OR 7.0, 95% CI 2.74 to 17.87, p0.0001), and lower risk of access-site complications (OR 0.46, 95%CI 0.26 to 0.80, p = 0.006). In conclusion, the present meta-analysis suggests that in patients with previous CABG undergoing coronary procedures, RA, compared with FA, is associated with increased crossover rate but may reduce access-site complications.

The aim of this prospective study was to evaluate muscle force of the hand, thumb, and forefinger in patients with prolonged radial occlusion after transradial percutaneous coronary procedures.There are no data on hand strength and function in patients with prolonged radial occlusion after percutaneous coronary procedures.Elective patients with chronic stable angina undergoing percutaneous coronary procedures were evaluated the day before the procedure for radial artery patency, Allen test, hand grip, and thumb and forefinger pinch tests. The same measures were performed the day after the procedure and at follow-up. At follow-up, patients were divided in two groups according to the radial patency (group 1) or occlusion (group 2).Of the 99 patients included in the study, 90 patients had a patent radial artery (group 1), and nine (9.1%) patients had an occluded artery (group 2). At baseline, there were no significant differences in hand grip test between the two groups (42 ± 11 kg in group 1 and 41 ± 17 kg in group 2, P = 0.74). In both groups, after the procedure, the hand grip test values was significantly reduced compared with baseline values (40 ± 11 kg in group 1, P 0.0001 and 37 ± 17 kg in group 2, P = 0.007). Finally, at follow-up, in both groups, the hand grip test values returned to baseline values. Thumb and forefinger pinch tests did not show significant differences after the procedure and at follow-up, compared with baseline.Radial artery occlusion after percutaneous coronary procedures was not associated with a reduction in hand and finger strength.

Post procedural embolic events including transient ischemic attack (TIA) or stroke are remaining problems after carotid artery stenting (CAS). Recently, strut malappositin (SM) and plaque prolapse (PP) after the stenting have been suggested as the major causes. Now some mesh-covered stents are

To compare the incidence of major adverse cardiac and cerebrovascular events (MACCE) and thrombolysis in myocardial infarction (TIMI) bleedings in primary percutaneous coronary intervention (pPCI) performed through transradial approach (TRA) or transfemoral approach (TFA) with systematic closure by FemoSeal™.Although the risk of bleeding can be reduced using vascular closure devices (VCD), there are few data comparing TRA and TFA with VCD, particularly in the setting of pPCI.we included in this retrospective registry 777 patients who underwent pPCI at two centers from years 2010 to 2013. Exclusion criteria were implantation of intra-aortic balloon pump and achievement of femoral hemostasis by other means than FemoSeal™. We performed propensity-score matching and multivariate analysis to adjust for clinical and procedural confounders.We enrolled 511 patients in TRA group and 266 in TFA group. Both in the general population and in the propensity-matched population, the incidence of MACCE was comparable in TRA vs. TFA patients (3.5 vs. 3.4% and 4.4 vs. 2.6%, respectively; P = ns). On the contrary, we observed a higher incidence of TIMI bleedings in TFA vs. TRA patients (5.6 vs. 2.2% in the general population and 6.6 vs. 1.3% in the propensity-matched population; P 0.05); this difference was mainly driven by TIMI major bleedings. TFA was an independent predictor of bleeding at multivariate analysis.In pPCI the rate of TIMI major bleedings was higher in TFA with closure by FemoSeal™ as compared to TRA, whereas the rates of minor bleedings and of MACCE were similar.

Background: To better understand the mechanisms linking C reactive protein (CRP) to the risk of coronary thrombosis, we investigated the relation between inflammatory state and hemostatic response to coronary angioplasty in patients with either stable or unstable angina.

Aims Current guidelines give a class III recommendation to the intraprocedural use of unfractionated heparin (UFH) in patients pretreated with enoxaparin. The aim of our study was to evaluate bleeding complications in patients who underwent percutaneous coronary interventions (PCIs) performed using intraprocedural crossover of heparin therapy. Methods We retrospectively evaluated all PCIs performed at two Italian hospitals since January 2011 to December 2013. After a propensity-matched analysis, patients were divided into two groups (with a ratio 1 : 2) according to intraprocedural crossover of heparins (from enoxaparin to UFH) (Group 1) or intraprocedural UFH alone (Group 2). The primary end-point was a haemoglobin drop of at least 3 g/dl within 48 h after the procedure. Results During the 3 years analysed, 3224 patients underwent PCI, and after the propensity analysis, 309 patients were considered eligible for our study: 104 patients in Group 1 (69 ± 12 years, 78% men) and 205 patients in Group 2 (69 ± 13 years, 80% men, P = NS). There were no significant differences between the two groups for BMI, periprocedural use of antiplatelet therapy, baseline haemoglobin haematocrit or platelets levels. The primary end-point did not differ between the two groups (2.9% in Group 1 and 3.4% in Group 2, P = 0.550). Also, nadir of haematocrit or haemoglobin levels did not differ between the two groups. Finally, in hospital, major adverse cardio-cerebrovascular events did not differ between the two groups (1.9% in Group 1 and 3.9% in Group 2, P = 0.50). Conclusion In this retrospective analysis of a large PCI database, the ‘heparins crossover’ during PCI was not associated with increased bleeding risk.

Although transradial access (TRA) is being increasingly used in interventional cardiology, there are concerns about a possible increase in radiation exposure (RE) as compared to transfemoral access (TFA).In this retrospective study, we aimed to compare RE during coronary angiography and percutaneous coronary intervention (PCI) according to the vascular access route (TRA vs TFA). We included all procedures performed in our laboratory, in which RE data (dose area product, cGy•cm²) were available, from May 2009 to May 2013. Both multiple linear regression analysis and propensity score matching were performed in order to compare RE between TRA and TFA after adjusting for clinical and procedural confounders.DAP values were available for 1396 procedures; TRA rate was 82.6%. TRA patients were younger, less frequently female, and had higher body mass index as compared to TFA patients; the rates of PCI, ad hoc PCI, bypass angiography, thrombus aspiration, and primary angioplasty, as well as the number of stents implanted, fluoroscopy time, and contrast dose were significantly higher in TFA. Median DAP value was significantly higher in TFA than in TRA (9670 cGy•cm² vs 7635 cGy•cm²; P.01). After adjusting for clinical and procedural confounders, vascular access was not found to be an independent predictor of RE at multiple regression analysis; this was also confirmed by stratified comparison of DAP values by quintiles of propensity score.After adjusting for clinical and procedural confounders, TRA was not found to be associated with increased RE as compared to TFA in an experienced TRA center.