Antonio Zingarelli

Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial

BACKGROUND It is unclear whether radial compared with femoral access improves outcomes in unselected patients with acute coronary syndromes undergoing invasive management. METHODS We did a randomised, multicentre, superiority trial comparing transradial against transfemoral access in patients with acute coronary syndrome with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention. Patients were randomly allocated (1:1) to radial or femoral access with a web-based system. The randomisation sequence was computer generated, blocked, and stratified by use of ticagrelor or prasugrel, type of acute coronary syndrome (ST-segment elevation myocardial infarction, troponin positive or negative, non-ST-segment elevation acute coronary syndrome), and anticipated use of immediate percutaneous coronary intervention. Outcome assessors were masked to treatment allocation. The 30-day coprimary outcomes were major adverse cardiovascular events, defined as death, myocardial infarction, or stroke, and net adverse clinical events, defined as major adverse cardiovascular events or Bleeding Academic Research Consortium (BARC) major bleeding unrelated to coronary artery bypass graft surgery. The analysis was by intention to treat. The two-sided α was prespecified at 0·025. The trial is registered at ClinicalTrials.gov, number NCT01433627. FINDINGS We randomly assigned 8404 patients with acute coronary syndrome, with or without ST-segment elevation, to radial (4197) or femoral (4207) access for coronary angiography and percutaneous coronary intervention. 369 (8·8%) patients with radial access had major adverse cardiovascular events, compared with 429 (10·3%) patients with femoral access (rate ratio [RR] 0·85, 95% CI 0·74-0·99; p=0·0307), non-significant at α of 0·025. 410 (9·8%) patients with radial access had net adverse clinical events compared with 486 (11·7%) patients with femoral access (0·83, 95% CI 0·73-0·96; p=0·0092). The difference was driven by BARC major bleeding unrelated to coronary artery bypass graft surgery (1·6% vs 2·3%, RR 0·67, 95% CI 0·49-0·92; p=0·013) and all-cause mortality (1·6% vs 2·2%, RR 0·72, 95% CI 0·53-0·99; p=0·045). INTERPRETATION In patients with acute coronary syndrome undergoing invasive management, radial as compared with femoral access reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality. FUNDING The Medicines Company and Terumo.

Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes

BACKGROUND Conflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome. METHODS We randomly assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin. Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion. Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events (a composite of death, myocardial infarction, or stroke) and net adverse clinical events (a composite of major bleeding or a major adverse cardiovascular event). The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events. RESULTS The rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin (10.3% and 10.9%, respectively; relative risk, 0.94; 95% confidence interval [CI], 0.81 to 1.09; P=0.44), nor was the rate of net adverse clinical events (11.2% and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P=0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74 to 1.11; P=0.34). CONCLUSIONS In patients with an acute coronary syndrome, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin. The rate of the composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion. (Funded by the Medicines Company and Terumo Medical; MATRIX ClinicalTrials.gov number, NCT01433627.).

Long-term follow-up of Tako-Tsubo-like syndrome: a retrospective study of 22 cases.

Objectives To assess the late outcome of the Tako-Tsubo like syndrome in a community hospital in northern Italy. Methods and results We reviewed 2233 patients who were admitted from 2001 to 2006 with diagnosis of acute coronary syndrome. Twenty-two patients (1%) presenting clinical and instrumental characteristics of Tako-Tsubo like syndrome were included in the study and prospectively underwent clinical and echocardiographic follow-up. All patients were women; aged 76 ± 7 years; 82% experienced a stress before the acute episode; 50% reported chest pain and dyspnoea also days before. Mean troponin peak value was 3.6 ± 3.3 μg/l. Mean acute echocardiographic ejection fraction was 40 ± 7%. Eighteen percent of them presented major in-hospital complications. At a mean follow-up time of 27 ± 19 months, 2 patients (9%) died because of ischemic stroke and renal failure, respectively, 14 (63%) were asymptomatic, 1 (5%) declared a paroxysmal episode of atrial fibrillation, and 5 (23%) still lamented dyspnoea or atypical chest pain. In all patients, typical apical ballooning disappeared and an increase in mean ejection fraction to 60 ± 4% was observed. Conclusion After complications are promptly recognized and treated in the acute phase, prognosis of Tako-Tsubo like syndrome appears to be good at long-term follow-up, with a complete recovery of normal left ventricular function.

Bivalirudin or unfractionated heparin in patients with acute coronary syndromes managed invasively with and without ST elevation (MATRIX): randomised controlled trial.

Objective To test the optimal antithrombotic regimen in patients with acute coronary syndrome. Design Randomised controlled trial. Setting Patients with acute coronary syndrome with and without ST segment elevation in 78 centres in Italy, the Netherlands, Spain, and Sweden. Participants 7213 patients with acute coronary syndrome and planned percutaneous coronary intervention: 4010 with ST segment elevation and 3203 without ST segment elevation. The primary study results in the overall population have been reported previously. Interventions Patients were randomly assigned, in an open label fashion, to one of two regimens: bivalirudin with glycoprotein IIb/IIIa inhibitors restricted to procedural complications or heparin with or without glycoprotein IIb/IIIa inhibitors. Main outcome measures Primary endpoints were the occurrence of major adverse cardiovascular events, defined as death, myocardial infarction or stroke; and net adverse clinical events, defined as major bleeding or major adverse cardiovascular events, both assessed at 30 days. Analyses were performed by the principle of intention to treat. Results Use of a glycoprotein IIb/IIIa inhibitor in patients assigned to heparin was planned at baseline in 30.7% of patients with ST segment elevation, in 10.9% without ST segment elevation, and in no patients assigned to bivalirudin. In patients with ST segment elevation, major adverse cardiovascular events occurred in 118 (5.9%) assigned to bivalirudin and 129 (6.5%) assigned to heparin (rate ratio 0.90, 95% confidence interval 0.70 to 1.16; P=0.43), whereas net adverse clinical events occurred in 139 (7.0%) patients assigned to bivalirudin and 163 (8.2%) assigned to heparin (0.84, 0.67 to 1.05; P=0.13). In patients without ST segment elevation, major adverse cardiovascular events occurred in 253 (15.9%) assigned to bivalirudin and 262 (16.4%) assigned to heparin (0.97, 0.80 to 1.17; P=0.74), whereas net adverse clinical events occurred in 262 (16.5%) patients assigned to bivalirudin and 281 (17.6%) assigned to heparin (0.93, 0.77 to 1.12; P=0.43). Conclusions A bivalirudin monotherapy strategy compared with heparin with or without glycoprotein IIb/IIIa inhibitors, did not result in reduced major adverse cardiovascular events or net adverse clinical events in patients with or without ST segment elevation. Trial Registration ClinicalTrials.gov NCT01433627.

Randomized comparison of operator radiation exposure comparing transradial and transfemoral approach for percutaneous coronary procedures: rationale and design of the minimizing adverse haemorrhagic events by TRansradial access site and systemic implementation of angioX - RAdiation Dose study (RAD-MATRIX).

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.

Aberrant Right Subclavian Artery (Arteria Lusoria) Challenging 4-French Homolateral Transradial Coronary Catheterisation in Adulthood

We report a case of an accidental finding of an aberrant right subclavian artery diagnosed in an adult man during a 4-French coronary angiography performed by right transradial access, then confirmed by multi-slice computed tomography. Tips and tricks have been suggested to complete the 4-French procedure avoiding changing the vascular access.

Determinants of radiation dose during right transradial access: Insights from the RAD-MATRIX study.

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 &mgr;Sv) that persisted after normalization by dose‐area product (from 0.35 to 3.5 &mgr;Sv/Gy*cm2). Among the operators who positioned the instrumented right arm far from the body (110.4 &mgr;Sv, interquartile range 71.5‐146.5 &mgr;Sv), thorax dose was greater than that in those who placed the instrumented arm close to the right leg (46.1 &mgr;Sv, 31.3‐56.8 &mgr;Sv, 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 &mgr;Sv, 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. Graphical abstract Figure. No caption available.

Anomalous single coronary artery (R-type) in the elderly: Description of benign and isolated variant

a Interventional Cardiology and Clinic of Cardiovascular Diseases, University of Genoa, San Martino University Hospital and Scientific Institute for Cancer Research, Genoa, Italy b Department of Radiology and Interventional Radiology, San Martino University Hospital and Scientific Institute for Cancer Research, Genoa, Italy c Division of Cardiology, San Martino University Hospital and Scientific Institute for Cancer Research, Genoa, Italy