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

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.

Summary Objective In the SMILE-4 study, zofenopril + acetyl salicylic acid (ASA) was more effective than ramipril + ASA on 1-year prevention of major cardiovascular events (MACE) in patients with acute myocardial infarction complicated by left ventricular dysfunction. In this retrospective analysis, we evaluated drug efficacy in subgroups of patients, according to a history of diabetes mellitus. Methods The primary study endpoint was 1-year combined occurrence of death or hospitalization for cardiovascular causes. Diabetes was defined according to medical history (previous known diagnosis). Results A total of 562 of 693 (81.0%) patients were classified as nondiabetics and 131 (18.9%) as diabetics. The adjusted rate of MACE was lower under zofenopril than under ramipril in both nondiabetics [27.9% vs. 34.9% ramipril; odds ratio, OR and 95% confidence interval: 0.55 (0.35, 0.86)] and diabetics [30.9% vs. 41.3%; 0.56 (0.18, 1.73)], although the difference was statistically significant only for the nondiabetic group (P = 0.013). Zofenopril was superior to ramipril as regards to the primary study endpoint in the subgroup of 157 patients with uncontrolled blood glucose (≥126 mg/dL), regardless of a previous diagnosis of diabetes [0.31 (0.10, 0.90), P = 0.030]. Zofenopril significantly reduced the risk of hospitalization for cardiovascular causes in both nondiabetics [0.64 (0.43, 0.96), P = 0.030] and diabetics [0.38 (0.15, 0.95), P = 0.038], whereas it was not better than ramipril in terms of prevention of cardiovascular deaths. Conclusions This retrospective analysis of the SMILE-4 study confirmed the good efficacy of zofenopril plus ASA in the prevention of long-term MACE also in the subgroup of patients with diabetes mellitus.

We present the case of a 28-year-old woman who was admitted to our cardiology unit for acute coronary syndrome. Her history was notable for cardiovascular disease familiarity, active smoking, and oral contraceptive use. On further analysis, she was noted to have thrombophilic polymorphisms involving the plasminogen activator inhibitor (PAI), angiotensin-converting enzyme (ACE), and methylenetetrahydrofolate reductase (MTHFR) genes. We discuss the implications that these cofactors may have had in the genesis of the disease.

Cardiac resynchronization therapy improves symptoms and survival of patients with congestive heart failure. Usually, the transvenous placement of the left ventricular lead is feasible, but in case of anatomic abnormalities of the coronary sinus, an unintended left phrenic nerve stimulation, a dislodgement of the percutaneous electrode, or a loss of capture of the electrode, surgical treatment should be considered. From January 2010 to September 2011, 15 patients underwent surgical implantation of the left ventricular lead after failure of transvenous placement. The MyoPore sutureless myocardial pacing lead (MSMPL) was implanted through a left minithoracotomy (~5 cm) under selective right lung ventilation. Time of surgery was 38.5 ± 3.0 minutes, and no surgical complications or early deaths are reported so far. After 10.7 ± 8.3 months of follow-up, no cases of late mortality, dislodgement, or loss of capture of the electrode are described. The use of the MSMPL is not novel, although the association with a minimally invasive approach may represent an alternative for a high-risk population. The screw-in of the lead ensures low impedance and threshold of stimulation (1.1 ± 0.6 V at 0.5 milliseconds) both in early and medium terms. In conclusion, in case of failure of the transvenous approach, the MSMPL may be easily implanted through a left minithoracotomy, and the results are noteworthy.

Aims Recently, a mechanical single-sheath technique with a multiple venous entry-site approach for the removal of pacemaker and implantable defibrillator leads was reported to have a high success rate and few complications. In our institution, this technique of lead removal has been used since 2002. In this paper, we report our experience, with the aim of evaluating the effectiveness and safety of the proposed procedure. Methods and results This study is a retrospective analysis of the case records of all patients referred to our institution for transvenous lead extraction, according to class I or II Heart Rhythm Society indications. Over 7 years, 300 consecutive patients underwent procedures for transvenous removal of 518 leads. The most frequent indication for extraction was infection (74%). Complete removal of 502 (96.9%) leads and partial removal of 10 leads (1.9%) were achieved. Six leads (1.2%) could not be removed. All defibrillation coils and coronary sinus leads were successfully removed. There were no procedure-related deaths but only one major complication (0.3%). Conclusion Our experience shows that the proposed mechanical technique is very effective and associated with few serious complications, thus confirming previous findings. This approach may be reproduced in other settings with very satisfactory results.

We describe the case of a man with an implantable defibrillator and a dual-coil lead introduced via the right internal jugular vein. Due to pocket infection and lead erosion at the jugular vein, transvenous lead extraction was attempted with a mechanical single-sheath technique. The lead was completely removed without complications with culture and sensitivity results guiding an effective antibiotic therapy.

Revelation of a myocardial bridge has been described at coronary angiography. The pathophysiology of myocardial bridging is incompletely understood. It is sometimes associated with overt pathology, as well as it can just be an incidental finding without any significance. It has been also reported an acute myocardial infarction with normal coronary arteries associated with iatrogenic hyperthyroidism. We present a case of acute myocardial infarction in a 28-year-old Italian man with normal coronary arteries, iatrogenic elevated levels of free triiodothyronine and myocardial bridge.

BACKGROUND: Antecedent hypertension represents a risk factor for adverse outcomes in survivors of acute myocardial infarction (AMI). Prognosis of such patients might be greatly improved by drugs enhancing blood pressure control. In the present retrospective analysis of the randomized, double-blind, parallel-group, SMILE-4 study we compared the efficacy of zofenopril 60 mg and acetylsalicylic acid (ASA) 100 mg versus ramipril 10 mg and ASA in patients with AMI complicated by left ventricular dysfunction, classified according to a history of hypertension. METHODS: The primary study end-point was 1-year combined occurrence of death or hospitalization for cardiovascular causes. Hypertension was defined according to medical history and current blood pressure values at entry and could be determined in 682 of 716 patients of the intention-to-treat analysis. RESULTS: One hundred and fifty-seven patients (23%) were normotensives and 525 (77%) hypertensives. In the normotensive population the primary end-point occurred in 19 of 76 zofenopril-treated patients (25%) and in 23 of 81 ramipril-treated patients (28%) [odds ratio (95% confidence interval): 0.84 (0.41-1.71), P = 0.631]. In the hypertensive population, major cardiovascular outcomes were reported in 84 of 273 zofenopril-treated patients (31%) and in 99 of 252 ramipril-treated patients (39%), with a 31% significantly (P = 0.041) lower risk with zofenopril [0.69 (0.48-0.99)]. The superiority of zofenopril versus ramipril was particularly evident in patients with isolated systolic hypertension [n = 131, 0.48 (0.23-0.99), P = 0.045]. CONCLUSION: This retrospective analysis of the SMILE-4 study confirmed the good efficacy of zofenopril and ASA in the prevention of long-term cardiovascular outcomes also in the subgroup of patients with hypertension.

Previous data showed that recanalization of chronic total occlusions (CTO) with the subintimal tracking and reentry (STAR) technique is feasible. However, this technique is challenging and requires skilled operators to be performed. The aim of this study was to evaluate procedural and clinical outcomes of patients undergoing a contrast-guided STAR procedure.All consecutive patients (n=121) with coronary CTO treated with the contrast-guided STAR technique in three Italian centers were included in this study, after failure of conventional CTO approaches.The right coronary artery was involved in 76.8%, with blunt morphology in 62.8%. Angiographic and procedural success rates were 82.6% and 64.4%, respectively, with a 69.4% rate of complete recanalization. Stent implantation was performed in 81.8% of cases, using drug-eluting stents in 94.4%. Procedural complications occurred in 7.4% of cases. During follow-up no episodes of myocardial infarction were observed, but one cardiac death (0.8%). No definite or probable stent thrombosis was reported. The overall rate of target lesion revascularization was 21.4%.This study demonstrated that the contrast-guided STAR technique appears to be a feasible and relatively safe procedure when performed as rescue technique after failure of conventional CTO approaches. However, this procedure is limited by a high rate of target lesion revascularization and a second procedure may be necessary to obtain a definitive result.

A 79-year-old man was referred to our institution for pacemaker-pocket infection, following failed antibiotic treatment. System removal was attempted with mechanical single-sheath lead extraction technique. During removal, the ventricular lead fractured, a distal 3 mm fragment was retained in the intravascular path and migrated to …