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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 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.

BACKGROUND: In patients with an indication for oral anticoagulation (OAC) with warfarin, the management of OAC peri-procedure of percutaneous coronary intervention (PCI) is still not fully defined. To investigate clinical practice and outcomes associated with continuation vs interruption of OAC, with or without bridging with low-molecular-weight heparin (LMWH), we examined the database of the observational, prospective, multicenter Italian WAR-STENT registry. METHODS: The WAR-STENT registry was conducted in 2008-2010 in 37 Italian centers and included 411 consecutive patients in 157 of whom the peri-procedural international normalized ratio (INR) value was available. In relation to the continuation vs interruption of OAC, patients were divided into group 1 (n = 106) and group 2 (n = 51) respectively, and compared. RESULTS: The basal characteristics of the two groups were similar. The most frequent indication for OAC was atrial fibrillation and for PCI acute coronary syndromes, respectively. The pre-procedural mean value of INR was significantly different in group 1 vs group 2 (2.3 ± 0.4 vs 1.5 ± 0.2; p

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.

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.

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.

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.

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.

Patients with diabetes mellitus (DM) have worse outcomes after percutaneous coronary intervention (PCI). Recent evidences suggest a differential impact of insulin-treated and noninsulin-treated DM on prognosis. We evaluated the clinical outcome of diabetic patients after PCI with polymer-free biolimus-eluting stent from the RUDI-FREE Registry, investigating a possible different prognostic impact of insulin-treated and noninsulin-treated DM. A total of 1,104 consecutive patients who underwent PCI with polymer-free biolimus-eluting stent, enrolled in the RUDI-FREE observational, multicenter, single-arm registry, were stratified by diabetic status; diabetic population was further divided on the basis of insulin treatment. Primary end points of the study were target lesion failure (TLF; composite of cardiac death, target vessel myocardial infarction, target lesion revascularization) and major adverse cardiac and cerebrovascular events (composite of cardiac death, stroke, and myocardial infarction). Multiple ischemic adverse events were also single-handedly considered as secondary end points. At 1 year, TLF was significantly higher in the diabetic cohort, as compared with nondiabetic patients (6.0% vs 3.1%, p 0.022). None of the end points resulted significantly different between nondiabetics and noninsulin-treated diabetic patients. Divergently, compared with nondiabetic, insulin-treated diabetic patients faced significant higher rates of TLF (10.8% vs 3.1%, p 0.003), major adverse cardiac and cerebrovascular events (10.8% vs 3.4%, p 0.004), and of most of the analyzed adverse events. In conclusion, patients with DM had a higher risk of TLF compared with nondiabetics; nonetheless, the worse outcome of the diabetic population seems to be driven by the insulin-treated diabetic subpopulation. This finding suggests a different risk profile of insulin-treated and noninsulin-treated diabetic patients in the modern era of PCI.

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

Aims Polymer-free biolimus-eluting stents (PF-BES) have been shown to be superior to bare metal stents in high bleeding risk (HBR) patients treated with one-month dual antiplatelet therapy (DAPT). However, limited evidence is available on PF-BES in non-HBR patients. We aimed to evaluate the safety and efficacy of PF-BES in all-comer patients undergoing percutaneous coronary intervention (PCI). Methods and results Patients with stable coronary artery disease or acute coronary syndromes (ACS) undergoing PCI with PF-BES in routine clinical practice were included in a multicentre, prospective registry. DAPT duration was left to the discretion of the operator. The primary endpoint was the composite of cardiovascular death, myocardial infarction (MI), and definite/probable stent thrombosis (ST) at one year. Overall, 1,104 consecutive patients treated with PF-BES were included at 16 Italian centres. Mean age was 68.7±11.2 years, 77.2% of patients were male, 30% had diabetes, 15.1% had chronic kidney disease, and 40.5% had ACS at baseline. Mean CRUSADE score was 24.1±13.1, and 83.7% of patients did not have high bleeding risk features. At one year, the primary endpoint occurred in 4.1% of patients, cardiovascular death in 2.4%, MI in 1.8%, and definite/probable ST in 1.1%. With respect to efficacy, target lesion revascularisation occurred in 1.2% of patients. Conclusions This is the first study providing clinical evidence on the use of PF-BES in all-comer patients irrespective of HBR status. Our findings suggest that PF-BES has a favourable safety and efficacy profile in a real-world clinical setting. Further investigation in randomised clinical trials against new-generation DES is warranted.

Summary Background The Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox (MATRIX) programme was designed to assess the comparative safety and effectiveness of radial versus femoral access and of bivalirudin versus unfractionated heparin with optional glycoprotein IIb/IIIa inhibitors in patients with the whole spectrum of acute coronary syndrome undergoing invasive management. Here we describe the prespecified final 1-year outcomes of the entire programme. Methods MATRIX was a programme of three nested, randomised, multicentre, open-label, superiority trials in patients with acute coronary syndrome in 78 hospitals in Italy, the Netherlands, Spain, and Sweden. Patients with ST-elevation myocardial infarction were simultaneously randomly assigned (1:1) before coronary angiography to radial or femoral access and to bivalirudin, with or without post-percutaneous coronary intervention infusion or unfractionated heparin (one-step inclusion). Patients with non-ST-elevation acute coronary syndrome were randomly assigned (1:1) before coronary angiography to radial or femoral access and, only if deemed eligible to percutaneous coronary intervention after angiography (two-step inclusion), entered the antithrombin type and treatment duration programmes. Randomisation sequences were computer generated, blocked, and stratified by intended new or current use of P2Y12 inhibitor (clopidogrel vs ticagrelor or prasugrel), and acute coronary syndrome type (ST-elevation myocardial infarction, troponin-positive, or troponin-negative non-ST-elevation acute coronary syndrome). Bivalirudin was given as a bolus of 0·75 mg/kg, followed immediately by an infusion of 1·75 mg/kg per h until completion of percutaneous coronary intervention. Heparin was given at 70–100 units per kg in patients not receiving glycoprotein IIb/IIIa inhibitors, and at 50–70 units per kg in patients receiving glycoprotein IIb/IIIa inhibitors. Clinical follow-up was done at 30 days and 1 year. Co-primary outcomes for MATRIX access and MATRIX antithrombin type were major adverse cardiovascular events, defined as the composite of all-cause mortality, myocardial infarction, or stroke up to 30 days; and net adverse clinical events, defined as the composite of non-coronary artery bypass graft-related major bleeding, or major adverse cardiovascular events up to 30 days. The primary outcome for MATRIX treatment duration was the composite of urgent target vessel revascularisation, definite stent thrombosis, or net adverse clinical events up to 30 days. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01433627. Findings Between Oct 11, 2011, and Nov 7, 2014, we randomly assigned 8404 patients to receive radial (4197 patients) or femoral (4207 patients) access. Of these 8404 patients, 7213 were included in the MATRIX antithrombin type study and were randomly assigned to bivalirudin (3610 patients) or heparin (3603 patients). Patients assigned to bivalirudin were included in the MATRIX treatment duration study, and were randomly assigned to post-procedure infusion (1799 patients) or no post-procedure infusion (1811 patients). At 1 year, major adverse cardiovascular events did not differ between patients assigned to radial access compared with those assigned to femoral access (14·2% vs 15·7%; rate ratio 0·89, 95% CI 0·80–1·00; p=0·0526), but net adverse clinical events were fewer with radial than with femoral access (15·2% vs 17·2%; 0·87, 0·78–0·97; p=0·0128). Compared with heparin, bivalirudin was not associated with fewer major adverse cardiovascular (15·8% vs 16·8%; 0·94, 0·83–1·05; p=0·28) or net adverse clinical events (17·0% vs 18·4%; 0·91, 0·81–1·02; p=0·10). The composite of urgent target vessel revascularisation, stent thrombosis, or net adverse clinical events did not differ with or without post-procedure bivalirudin infusion (17·4% vs 17·4%; 0·99, 0·84–1·16; p=0·90). Interpretation In patients with acute coronary syndrome, radial access was associated with lower rates of net adverse clinical events compared with femoral access, but not major adverse cardiovascular events at 1 year. Bivalirudin with or without post-procedure infusion was not associated with lower rates of major adverse cardiovascular events or net adverse clinical events. Radial access should become the default approach in acute coronary syndrome patients undergoing invasive management. Funding Italian Society of Invasive Cardiology, The Medicines Company, Terumo, amd Canada Research Chairs Programme.

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.

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 CHA2DS2-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.

An early invasive strategy (EIS) has been shown to yield a better clinical outcome than an early conservative strategy (ECS) in patients with non-ST-elevation acute coronary syndromes (NSTEACSs), particularly in those at higher risk according to the GRACE risk score. However, findings of the clinical trials have not been confirmed in registries.To investigate the outcome of patients with NSTEACS treated according to an EIS or a ECS in a real-world all-comers outcome research study.The primary hypothesis of the study was the non-inferiority of an ECS in comparison with an EIS as to a combined primary end-point of death, non-fatal myocardial infarction and hospital readmission for acute coronary syndromes at one year. Participating centres were divided into two groups: those with a pre-specified routine EIS and those with a pre-specified routine ECS. Two statistical analyses were performed: a) an 'intention to treat' analysis: all patients were considered to be treated according to the pre-specified routine strategy of that centre; b) a 'per protocol' analysis: patients were analysed according to the actual treatment applied. Cox model including propensity score correction was applied for all analyses.The intention to treat analysis showed an equivalence between EIS and ECS (11.4% vs. 11.1%) with regard to the primary end-point incidence at one year. In the three subgroups of patients according to the GRACE risk score (⩽ 108, 109-140,140), EIS and ECS confirmed their equivalence (5.3% vs. 3.9%, 8.4% vs. 7.6%, and 20.3% vs. 20.9%, respectively). When the per protocol analysis was applied, a reduction of the primary end-point at one year with EIS vs. ECS was demonstrated (6.2% vs. 15.3%, p=0.021); analysis of the subgroups according to the GRACE risk score numerically confirmed these data (3.1% vs. 6.5%, 5.1% vs. 10.0%, and 10.8% vs. 24.5%, respectively).In a real-life registry of all-comers NSTEACS patients, ECS was non-inferior to EIS; however, when EIS was applied according to clinical judgement, a reduction of clinical events at one year was demonstrated.

AIMS The aim of this study was to compare different radiation protection drapes in terms of radiation dose absorbed by operators during right or left transradial procedures. METHODS AND RESULTS Patients who underwent transradial coronary procedures were randomised initially into four groups: Group 1 (no drapes), Group 2 (drape on patient's arm), Group 3 (pelvic drape), Group 4 (combined arm and pelvic drapes). Subsequently, each group was further randomised to right or left radial access. The primary endpoint was the operator radiation dose at the thorax. A total of 452 procedures were included. The use of drapes was associated with a lower radiation dose compared to no drapes (8.6 µSv [4.1-17.9] Group 1, 5.8 µSv [3.4-13] Group 2, 3.6 µSv [2.1-6.9] Group 3, 3.7 µSv [1.9-10.3] Group 4, p

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.

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 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.

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.

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.

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.

We investigated whether insulin-like growth factor-1 (IGF-1) is reduced in the early phase of acute myocardial infarction (AMI) and whether such a decrease might influence prognosis.Insulin-like growth factor-1 protects against insulin resistance and apoptosis. Although insulin resistance has been reported in AMI, IGF-1 levels have not been investigated.We measured serum IGF-1 in 23 patients with AMI within 24 h of symptom onset and in 11 matched controls. In the first 12 patients and controls, we also measured fasting insulin, diurnal growth hormone (GH) and insulin sensitivity (assessed as glucose disappearance or T/2 after an insulin bolus), and repeated IGF-1, insulin and GH after one year. In all patients, 90-day cardiovascular death, recurrent ischemia, reinfarction, revascularization and late malignant arrhythmias were assessed.The AMI patients versus controls showed markedly reduced IGF-1 (115 +/- 112 vs. 615 +/- 300 ng/ml, p0.0001) and slower T/2 (-0.98 +/- 1.5 vs. -2.57 +/- 1.0 mg/dl/min, p = 0.01). Low IGF-1 often preceded the rise of myocardial necrosis markers. Patients with 90-day events (n = 12) versus those without had lower IGF-1 (47 +/- 54 vs. 189 +/- 110 ng/ml, p0.0001). Acute phase GH and insulin concentrations did not differ significantly from controls. After one year, the patients' IGF-1 values had risen to 460 +/- 242 ng/ml (p = 0.1 vs. controls, p0.0005 vs. acute phase), whereas GH levels were lower (0.2 +/- 0.2 vs. 2.5 +/- 2.3 ng/ml, p = 0.01) and insulin levels higher (12.5 +/- 0.2 vs. 3.9 +/- 2.6 microU/ml, p0.0001) compared with controls.In the early phase of AMI, serum IGF-1 levels are markedly reduced and may contribute to adverse outcomes. Reduced IGF-1 preceding the rise of myocardial necrosis markers suggests a possible pathogenetic role. A compensatory increase in IGF-1 appears to occur by one year.

SummaryPreinfarction angina and early reperfusion of the infarct-related artery are major determinants of reduced infarct-size in patients with acute myocardial infarction. The beneficial effects of preinfarction angina on infarct size have been attributed to the development of collateral vessels and/or to post-ischemic myocardial protection. However, recently, a relation has been found between prodromal angina, faster coronary recanalization, and smaller infarcts in patients treated with rt-PA: those with preinfarction angina showed earlier reperfusion (p = 0.006) and a 50% reduction of CKMB-estimated infarct-size (p = 0.009) compared to patients without preinfarction angina. This intriguing observation is consistent with a subsequent observation of higher coronary recanalization rates following thrombolysis in patients with prodromal preinfarction angina compared to patients without antecedent angina. Recent findings in dogs show an enhanced spontaneous lysis of plateletrich coronary thrombi with ischemic preconditioning, which is prevented by adenosine blockade, suggesting an antithrom-botic effect of ischemic metabolites. Understanding the mechanisms responsible for earlier and enhanced coronary recanalization in patients with preinfarction angina may open the way to new reperfusion strategies.A vast number of studies, globally involving ≈17,000 patients with acute myocardial infarction, have unequivocally shown that an infarction preceded by angina evolves into a smaller area of necrosis compared to an infarct not preceded by angina (Table 1) (1). So far, preinfarction angina has been thought to have cardioprotective effects mainly through two mechanisms: collateral perfusion of the infarctzone (2-4), and ischemic preconditioning of the myocardium (5-7). Here we discuss a further mechanism of protection represented by improved reperfusion of the infarct-related artery.

BACKGROUND Data on the effect of bivalirudin therapy in primary percutaneous coronary interventions (PCI) performed through the transradial approach are limited. The aim of our study was to evaluate bleeding complications and clinical outcomes in primary PCI performed through the transradial approach with bivalirudin therapy. METHODS We retrospectively evaluated primary PCI performed through the transradial approach from January 2008 to June 2013. Patients were divided in two groups according to the use (group 1) or not (group 2) of bivalirudin. The primary end points were major bleedings and major adverse cardiac events (MACE) within 30 days. RESULTS During the 5 years analysed, 1009 patients underwent primary PCI through the transradial approach: 154 patients were treated with bivalirudin (males 79%, age 65 ± 14 years) and 855 with heparin (males 82%, 63 ± 12 years). In group 1, the use of glycoprotein IIb/IIIa inhibitors was only 4%, compared to 55% (p

Background Radiation absorbed by interventional cardiologists is a frequently under-evaluated important issue. Aim is to compare radiation dose absorbed by interventional cardiologists during percutaneous coronary procedures for acute coronary syndromes comparing transradial and transfemoral access. Methods The randomized multicentre MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) trial has been designed to compare the clinical outcome of patients with acute coronary syndromes treated invasively according to the access site (transfemoral vs. transradial) and to the anticoagulant therapy (bivalirudin vs. heparin). Selected experienced interventional cardiologists involved in this study have been equipped with dedicated thermoluminescent dosimeters to evaluate the radiation dose absorbed during transfemoral or right transradial or left transradial access. For each access we evaluate the radiation dose absorbed at wrist, at thorax and at eye level. Consequently the operator is equipped with three sets (transfemoral, right transradial or left transradial access) of three different dosimeters (wrist, thorax and eye dosimeter). Primary end-point of the study is the procedural radiation dose absorbed by operators at thorax. An important secondary end-point is the procedural radiation dose absorbed by operators comparing the right or left radial approach. Patient randomization is performed according to the MATRIX protocol for the femoral or radial approach. A further randomization for the radial approach is performed to compare right and left transradial access. Conclusions The RAD-MATRIX study will probably consent to clarify the radiation issue for interventional cardiologist comparing transradial and transfemoral access in the setting of acute coronary syndromes.

Little is known about the efficacy and medium-term outcomes of primary percutaneous coronary intervention (PCI) in very old patients. We evaluated in-hospital and 6-month outcomes in a retrospective cohort of nonagenarian patients presenting at our hospital with ST-segment elevation myocardial infarction (STEMI) and treated by primary PCI from January 2003 to May 2012. During this period, primary PCI was performed in 1598 consecutive patients; twenty-seven patients (age, 92.5 ± 2.5 years) were enrolled in the study. Four patients (15%) were in advanced Killip class at presentation. STEMI location was anterior in 44%. Patients received aspirin, 300 mg clopidogrel loading dose, and heparin. Abciximab was given to 41% of patients. Coronary angiography showed multivessel disease in 52% of patients. Pain-to-balloon and door-to-balloon times were 375.0 ± 410.2 minutes and 107.3 ± 47.6 minutes, respectively. Intra-aortic balloon pump was implanted in 1 patient. An average of 1.3 ± 0.7 stents (95% bare-metal stents) were implanted per patient. Procedural success rate, defined as Thrombolysis in Myocardial Infarction (TIMI) flow grade ≥ 2 and residual stenosis20%, was 89%. Hospital mortality was 18.5%. TIMI major bleeding and acute renal failure, defined as an absolute increase of 0.5 mg/dL serum creatinine, occurred in 7% and 22% of patients, respectively. Overall 6-month survival rate was 67%. Our data suggest that primary PCI can be performed in nonagenarian patients with high success rate and with an acceptable bleeding risk, even when aggressive antithrombotic drugs, such as glycoprotein IIb/IIIa inhibitors, are given.

Longitudinal deformation of coronary stents has been recently described and seems to be more frequent with certain contemporary stent platforms. Indeed, in order to increase flexibility and deliverability, stent manufacturers have reduced strut thickness and the number of connectors within cells; this could negatively affect other mechanical properties of the device, such as the resistance to longitudinal stress. Moreover, longitudinal deformation has been associated to adverse events, such as stent thrombosis.We report 3 cases of longitudinal stent deformation observed at our institution.The first case was a consequence of postdilatation of the stent with a non-compliant balloon, whereas the other 2 cases involved the treatment of bifurcation lesions. One case was complicated by acute, intraprocedural stent thrombosis; such a dreadful complication, to the best of our knowledge, has not been previously reported.Although longitudinal stent deformation is an infrequent finding, usually not associated with adverse events, at least in the short term, it can sometimes turn into a catastrophic, life-threatening complication. The growing number of reports about this issue in recent years should prompt the operators to carefully select coronary stents, especially when dealing with certain lesion subsets, such as ostial lesions, bifurcations, and long lesions.

Left ventricular thrombosis (LVT) is a possible complication of acute myocardial infarction. Aim of our study was to evaluate incidence and clinical characteristics of patients with LVT after ST elevation myocardial infarction (STEMI) using contrast- enhanced magnetic resonance (CMR).In a prospective cohort of 36 consecutive patients with STEMI acutely reperfused with primary percutaneous coronary intervention, CMR was performed within one week. LVT was found in 7 patients (19%), and was located in left ventricle apex or adherent to antero-septum. Compared to the rest of population patients with LVT have lower ejection fraction (38 ± 7% versus 51 ± 6%, P = 0.009), larger left ventricle end systolic volume (95.8 ± 19 ml versus 68.9 ± 19 ml, P = 0.02), higher time to reperfusion (9.3 ± 7.2 versus 5 ± 3.6, P = 0.03) and left anterior descending artery was constantly involved (100% versus 41 %, P = 0.06). In 5 cases the LVT was also detected by echocardiography, however, in 2 cases it was missed.The incidence of LVT after STEMI is not negligible and was accurately detected by CMR. Localization of myocardial infarction, time to reperfusion, ejection fraction and left ventricle end systolic volume are the most important predictors of left ventricle thrombus formation.

Despite aggressive control of modifiable risk factors, recurrent acute coronary syndromes are still common, and the underlying mechanisms largely elusive. Glycoprotein (Gp) Ia/IIa is one of several collagen receptors involved in platelet adhesion.1 A C807T gene variant of GpIa is related to Gp Ia/IIa receptor density on the platelet surface,2 with the density proportionate to the number of T alleles.2 Previous case-control studies in white subjects have associated this variant with acute ischaemic heart disease.3 As it is not known whether the 807T allele may also predict recurrent acute coronary syndromes, this was investigated in 117 survivors of a first acute coronary event; patients were followed for up to five years. Between 1996 and 1998 we enrolled 195 patients below the age of 65 years; these patients were discharged from our coronary care unit with a diagnosis of acute myocardial infarction (MI), according to World Health Organization criteria, (MI, n = 141) or severe Braunwald class IIIB unstable angina (UA, n = 54) at first presentation of disease. After informed consent for genetic analyses, a final number of 117 patients (79 MI, 38 UA) accepted follow up assessment which took place at six months, two years, and five years. Clinical evaluation was blinded to the results of genotyping. Major cardiovascular risk factors, angiographic extent of disease, and left ventricular ejection fraction (LVEF) were assessed at enrolment. Antiplatelet drugs during follow up consisted of aspirin or ticlopidine if aspirin was contraindicated. Following percutaneous coronary interventions, aspirin and ticlopidine were both prescribed for four weeks. Gp IIb/IIIa inhibitors were not administered. The primary end point was the composite of fatal and …

To investigate the safety and efficacy of Genous Bio-engineered R stent (GRS) with ≤ 15-day or15-day dual antiplatelet therapy (DAT), in patients undergoing percutaneous coronary intervention (PCI), with known or expected low compliance to long-term DAT (Antiplatelet theRapy after Genous EPC-capturing coroNary stenT implantatiOn--ARGENTO study).Consecutive patients without ≤ 12-month revascularization history, known statins allergy, known hypersensitivity reaction or previous or concomitant monoclonal and/or recombinant antibodies therapy, treated with single- or multivessel PCI plus GRS, were prospectively enrolled, at four PCI centers. Major adverse cardiac events (MACEs), the composite of cardiac death, any myocardial infarction (MI) and target vessel revascularization (TVR), and stent thrombosis (ST) cumulative incidences were evaluated.Between March 2008 and March 2010, 384 patients (70.3% male, 423 lesions) were enrolled. At follow-up (22.8 ± 13.6 months), 8.6% MACEs, 3.4% cardiac death, 3.4% any MI, 4.7% TVR and 2.3% overall ST (definite/probable ST 1.3%) rates were reported, without differences between ≤ 15-day and15-day DAT groups. At Cox multivariable-adjusted regression analysis (Hosmer-Lemeshow statistic, p=0.50) female sex, diabetes, previous PCI history,45% left ventricular ejection fraction at admission and lesion length were identified as independent MACE predictors. DAT time duration (hazard ratio 1.98; 95% confidence interval 0.57-6.80, p=0.27) was not independent risk factor for MACEs.In consecutive, prospectively enrolled patients with PCI indication and known or supposed low compliance to long-term DAT, GRS implantation might be a safe and effective option regardless of DAT duration after stenting (≤ 15 days or15 days).