Gender differences with short-term vs 12 months dual antiplatelet therapy in patients with acute coronary syndrome treated with the COMBO dual therapy stent: 2-years follow-up results of the REDUCE trial.

BACKGROUND: Gender differences in the thrombotic and bleeding risk have been suggested to condition the benefits of antithrombotic therapies in Acute Coronary Syndrome (ACS) patients, and mainly among those undergoing percutaneous coronary interventions with drug eluting stents (DES). The impact of gender on the optimal duration of dual antiplatelet therapy (DAPT) in ACS patients is still unexplored and was, therefore, the aim of the present sub-study. METHODS: REDUCE was a prospective, multicenter, randomized investigator-initiated study designed to enroll 1500 ACS patients after treatment with the COMBO Dual Stent Therapy, based on a noninferiority design. Patients were randomized in a 1:1 fashion to either 3 or 12 months of DAPT. Primary study endpoint was a composite of all-cause mortality, myocardial infarction, definite/probable stent thrombosis (ST), stroke, target-vessel revascularization (TVR) and bleedings (BARC II, III, V) at 12 months. Secondary endpoints were cardiovascular mortality and the individual components of the primary endpoint within 24 months. RESULTS: From June 2014 to May 2016 300 women and 1196 men were included in the study. Among them, 43.7% of females and 51.9% of males were assigned to the 3 months DAPT treatment. Baseline characteristics were well matched between the two arms, with the exception of a lower rate of TIMI flow < 3 (p = 0.04), lower systolic blood pressure (p = 0.05) and use of spironolactone (p = 0.006) among women and a more advanced age (p = 0.05) among men receiving a short-term DAPT. At a mean follow-up of 525 (± 198) days, no difference in the primary endpoint was observed according to DAPT duration in both females [6.9% vs 5.9%, HR (95% CI) = 1.19 (0.48-2.9), p = 0.71] and males [8.2% vs 9%, HR (95% CI) = 0.92 (0.63-1.35), p = 0.67; p INT = 0.20]. Results were confirmed after correction for baseline differences [females: adjusted HR (95% CI) = 1.12 (0.45-2.78), p = 0.81; males: adjusted HR (95% CI) = 0.90 (0.61-1.32), p = 0.60]. Comparable rates of survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events were observed with the two DAPT strategies, with no impact of gender. CONCLUSIONS: The present study shows that among ACS patients randomized in the REDUCE trial, a 3 months DAPT strategy offers comparable results as compared to a standard 12 months DAPT at 2-years follow-up in both male and female gender.

Everolimus-eluting bioresorbable scaffolds for treatment of coronary artery disease in patients with diabetes mellitus: the midterm follow-up of the prospective ABSORB DM Benelux study.

BACKGROUND: Percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains challenging even with modern drug-eluting stents (DES) due to high rates of repeat revascularization. Everolimus-eluting bioresorbable scaffolds (EE-BRS) might allow for repeat intervention prolonging the time interval of percutaneous treatment options. METHODS: The ABSORB DM Benelux Study is a dedicated prospective, international study to evaluate the midterm safety and efficacy of EE-BRS in DM patients. All DM patients that received ≥ 1 EE-BRS for any indication were enrolled and prospectively followed. Study endpoints were major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction (MI) and ischemic-driven target vessel revascularization (TVR); target lesion failure (TLF): a composite of cardiac death (CD), target vessel MI, and ischemic-driven target lesion revascularization (TLR), as well as definite or probable scaffold thrombosis (ScT). RESULTS: Between April 2015 till March 2017, 150 DM patients and 188 lesions were treated and followed up to 3 years. Device implantation success was 100%. MACE occurred in 15.2% (event rate of 8.8 per 100 PY). TLF was reported in 11.7% (7.0 events per 100 PY). CD, target vessel MI, ischemic-driven TLR occurred in 3.4%, 3.6% and 5.5% respectively, while ScT was observed in 1.4%. There were no occurrences of late or very late ScT. CONCLUSION: EE-BRS treatment in DM patients shows comparable midterm safety and efficacy outcomes when historically compared with modern DES. New-generation EE-BRS might offer an attractive alternative to metallic DES in treatment of fast progressing atherosclerosis population as in DM patients. Trial registration NTR5447. Registered 05 October 2015, retrospectively registered.

The 1­year safety and efficacy outcomes of Absorb bioresorbable vascular scaffolds for coronary artery disease treatment in diabetes mellitus patients: the ABSORB DM Benelux study.

BACKGROUND: Diabetes mellitus (DM) patients show higher rates of repeat revascularisation even in the era of modern drug-eluting stents (DES). The concept of bioresorbable scaffolds is becoming captivating, as it might allow for repeat interventions, prolonging the time span during which patients can be treated by percutaneous coronary intervention (PCI). AIMS: We intend to evaluate the short- and long-term safety and efficacy of Absorb bioresorbable vascular scaffolds (Absorb BVS) in the treatment of coronary artery disease (CAD) in DM patients for any indication. METHODS: The ABSORB DM Benelux is an international prospective study in DM patients who have undergone PCI with ≥1 Absorb BVS. Major adverse cardiac events (MACE) at 1 year was the primary endpoint, defined as a composite of all-cause death, any myocardial infarction (MI) and ischaemia-driven target vessel revascularisation (TVR). Secondary endpoints were target lesion failure (TLF) and definite or probable scaffold thrombosis (ScT). RESULTS: Between April 2015 and March 2017, 150 DM patients and 188 non-complex lesions were treated. Device implantation was successful in 100%. MACE occurred in 14 (9.5%) patients, with all-cause death occurring in 4 (2.7%), any MI in 6 (4.1%) and ischaemia-driven TVR in 7 (4.8%) respectively. TLF was reported in 11 (7.5%). Definite and probable ScT was observed in 2 (1.4%). CONCLUSION: Absorb BVS for treatment of anatomically low-risk patients with DM show acceptable safety and efficacy outcomes at 1 year. If these promising results are confirmed after a longer follow-up period, new-generation bioresorbable scaffolds combined with refinement of implantation techniques might open new horizons for CAD treatment in DM patients.

Cardiac tamponade early after thrombolysis for acute myocardial infarction: a rare but not reported hemorrhagic complication.

Among 392 consecutive patients admitted for acute myocardial infarction and treated with thrombolytic drugs, 4 patients (1%) developed an early hemorrhagic pericardial effusion (without ventricular wall rupture) evolving within 24 h to cardiogenic shock consequent to cardiac tamponade. They all suffered from a large anterior myocardial infarction treated within 4 h after onset of symptoms with intravenous anisoylated plasminogen streptokinase activator complex (one case), recombinant tissue-type plasminogen activator (rt-PA) (two cases) or streptokinase (one case), anticoagulation with heparin (all cases) and aspirin (three cases). As soon as pericardial effusion was established by echocardiography, emergency percutaneous pericardiocentesis was performed at the bedside 20 +/- 6 h after thrombolytic therapy was started. This corrected immediately the clinical and hemodynamic status of each patient and a catheter was left in the pericardial space for 34 +/- 18 h. Thus, in the presence of unexplained clinical and hemodynamic deterioration occurring during the first 24 h after thrombolytic treatment of a large myocardial infarction, cardiac tamponade should be suspected. Immediate percutaneous pericardiocentesis followed by continuous drainage is a simple and definitive treatment for this complication.

Multicenter registry to evaluate the efficacy of the NIROYAL stent in de novo or restenotic coronary stenosis.

The purpose of this registry was to document the safety and efficacy of elective deployment of the NIROYAL stent (Boston Scientific SCIMED, Maple Grove, Minnesota) in coronary arteries. This was a prospective, multi-center international registry. NIROYAL stents (9, 16, 25 and 32 mm-long) were manually crimped onto coronary balloons and deployed in de novo or restenotic lesions in 165 male and female patients with angina pectoris and a reference vessel diameter of 2.0-4.5 mm. Stent deployment was successful in 98.8% of the lesions. Mean percent diameter stenosis decreased from 83.5+/-10.8% to 2.7+/- 6.2% after intervention. The interventional procedure of the treatment site was successful in 97.6% of patients. At six-month clinical follow-up, 88.5% had event-free survival [i.e., did not experience a major adverse cardiac event (MACE)] and 95.2% had no anginal symptoms. Furthermore, 87.3% of the patients were free of target vessel failure (defined as a composite of acute procedural failure, target vessel revascularization, myocardial infarction or death at six months). Only three MACE were observed within the first 30 days after stent implantation. A low left ventricular ejection fraction and the percentage stenosis pre-procedure were identified as statistically significant (p<0.05) predictive factors for MACE. The incidences of MACE and target vessel failure after six months follow-up were lower than that seen in other studies, and target lesion revascularization rates were low.

Coronary aneurysm five months after intracoronary beta-irradiation.

Intracoronary beta-irradiation is believed to be useful in preventing restenosis after coronary angioplasty or as adjunct therapy of an in-stent restenosis. Intracoronary aneurysms after gamma-irradiation were reported by Condado et al. in 1995, especially after doses higher than 25 Gy and without a centering device. In repeated small trials using intracoronary beta-irradiation no aneurysms were reported at 6 months follow-up. We report the development of a coronary aneurysm at 5 months after intracoronary beta-irradiation and stenting. Intracoronary brachytherapy is a new promising technique although one should be cautious about its possible unknown long-term complications.

Prinzmetal's variant angina: three case reports and a review of the literature.

Prinzmetal's variant angina is a rare entity. When angina-like symptoms occur at rest, mostly at a specific hour in the early morning, together with transient ST segment elevations and angiographically normal arteries, provocative tests with ergonovine or acetylcholine should be performed. Endothelial dysfunction, a strong thrombotic tendency, an increased platelet aggregation together with changes in autonomic tone can trigger coronary vasospasms. Once treated with calcium antagonists and nitrates the prognosis is excellent and severe complications such as arrhythmias, myocardial infarction or sudden death are extremely rare. Coronary stenting can be useful for refractory coronary spasm, CABG can be used for important coronary atherosclerosis. This review is illustrated with three typical presentations of variant angina: a myocardial infarction without significant organic coronary atherosclerosis, an ergonovine-induced coronary spasm with a non-significant coronary lesion and a multivessel spasm complicated by ventricular arrhythmia. All these three patients became asymptomatic after a treatment with calcium antagonists and nitrates.

Six months clinical, angiographic, and IVUS follow-up after PTFE graft stent implantation in native coronary arteries.

INTRODUCTION: Restenosis remains a problem even after stent implantation. An important breakthrough could be the use of graft stents, functioning as a mechanical barrier between the blood flow and the vessel wall, and possibly inducing less restenosis by more limited hyperplasia and minimal transgraft tissue penetration. OBJECTIVE: To assess the acute and 6 months clinical, angiographic and IVUS results of a new balloon expandable coronary polytetrafluoroethylene (PTFE) graft stent (Jomed). METHOD: Ten patients with a short (< or = 15 mm length) de novo proximal stenosis in a large (> or = 3 mm diameter) coronary artery were treated by elective implantation of a graft stent (19 mm stent, 15 mm graft). Clinical assessment, quantitative coronary angiography (QCA) and intracoronary ultrasound (IVUS) were performed before, immediately after and 6 months after implantation. A stress test was also done at 6 months. RESULTS: The coronary arteries treated were: RCA in 7 patients, LCX in 2 patients, LAD in 1 patient. Mean balloon size was 3.7 mm diameter, and mean inflation pressure was 18 atm (min. 12, max. 23). Additional stenting was needed in 3 patients. Two patients showed a minimal rise in CK (< 250 IU/l) and 1 patient needed a transfusion. No patient experienced a (sub)acute nor late thrombosis. As shown in the table, no restenosis was seen in the body of the graft stent. In 2 patients a restenosis was detected in the proximal and/or distal parts of the stent which are not covered by the graft. In 1 patient a restenosis was found outside the stent. All patients remained asymptomatic with a negative stress test at 6 months follow-up (FU). [table in text] CONCLUSIONS: A graft stent could indeed reduce the restenosis rate after stenting, in the part of the stent covered by the graft, but the uncovered distal and proximal parts are the weak points in this type of stent. For this reason, technical ameliorations in the construction of this graft stent are needed, e.g. a complete coverage of the stent by the PTFE graft and less rigidity of the stent causing reduced vessel trauma at the edges of the stent during implantation.

Early and 3 months follow-up results in 22 adult patients undergoing percutaneous transvenous mitral valvuloplasty.

Between April 1988 and October 1989, 22 adult patients with isolated or predominant severe mitral stenosis underwent Percutaneous Transvenous Mitral Valvuloplasty (PTMV). In 20 patients, a transseptal double balloon technique was used; in the last 2 patients, dilatation was performed using the Inoué balloon. Immediately after the procedure, the mitral valve area (MVA) rose from 1.2 +/- 0.3 to 2.2 +/- 0.8 cm2 (p less than 0.0001) using the hemodynamic method and from 1.1 +/- 0.4 to 1.9 +/- 0.4 cm2 (p less than 0.0001) using a Doppler technique. The mean left atrial pressure decreased from 20.3 +/- 6.0 to 10.5 +/- 5.0 mm Hg (p less than 0.0001). After the procedure, severe mitral regurgitation or significant iatrogenic interatrial septum defect did not occur. Two cerebral accidents were observed. One patient had a severe stroke with aphasia and hemiplegia but recovered within 3 months. The other patient had a minor dysarthric event, which resolved completely after 24 hours. Three months follow-up data in 16 patients revealed that they all were in NYHA class I or II. Restenosis occurred in 1 case. In the whole group of patients the MVA calculated by Doppler examination was similar to immediately after PTMV (1.9 +/- 0.4 versus 1.9 +/- 0.7 cm2).

Coronary NIR stent implantation for refractory variant angina.

A 44-year-old woman with severe variant angina refractory to maximal medical therapy and at risk of sudden death was successfully treated by a NIR stent implantation on a moderate lesion of LAD. Six months later she was asymptomatic, without in-stent restenosis. This procedure represents an alternative treatment for patients with refractory vasospastic angina.

Successful non-surgical treatment of endocarditis caused by Staphylococcus haemolyticus following transcatheter aortic valve implantation (TAVI).

We describe a case of a 79-year-old male patient with severe aortic stenosis who underwent transcatheter aortic valve implantation (TAVI) at our institution. He presented at the emergency department with dyspnea and fatigue 7 months after implantation. The diagnosis of early prosthetic valve endocarditis (PVE) caused by Staphylococcus haemolyticus was made by transesophageal echocardiography (TEE) and multiple positive blood cultures. Since our patient was considered inoperable due to a history of coronary artery bypass graft (CABG) surgery with patent bypasses, high peri-operative mortality including renal failure and a poor general prognosis, surgical removal of the valve was not an option. The patient was successfully treated with antibiotic therapy.

Giant left main coronary artery aneurysm in association with severe atherosclerotic coronary disease.

Aneurysms of the coronary arteries occur in 1.5-4.9% of coronary angiograms. Only a few cases of a giant aneurysm of the left main coronary artery in conjunction with severe atherosclerotic coronary disease have been reported. This report details the exceptional case of a 72-year-old patient with a giant "true saccular" aneurysm branched on the left main coronary artery. The development of an aneurysmal dilatation in conjunction with progression of coronary arteriosclerosis, observed from two different angiographic studies at an interval of 25 years, is very illustrative for evolutive atherosclerotic heart disease. This finding may support the hypothesis that atherosclerosis may be the common etiology for coronary aneurysmal dilatation.

Successful mitral valvuloplasty using the Inoue balloon in a patient with mitral stenosis associated with subvalvular fibrosis and reduced left ventricular inflow cavity: a case report.

Percutaneous transvenous mitral valvuloplasty (PTMV) was performed with two cylindric pigtail balloon catheters in a 52-year-old woman with symptomatic mitral stenosis. The subvalvular apparatus was fibrous with welded chordae and the subvalvular left ventricular space was markedly reduced. As a result of this distorted anatomy, during the inflations, the two balloons constantly slipped back into the left atrium before full inflation was obtained. After the procedure, the mitral valve area (MVA), as estimated by echo-doppler (ED), increased from 1.00 to 1.34 cm2. After 2 months of mild clinical improvement, the patient again became symptomatic and ED examination showed a MVA of 1.25 cm2. A second PTMV was performed with an Inoue balloon, the entire procedure taking less than 1 hour. A stable position of the Inoue balloon and complete dilatation were achieved. ED examination showed a mitral valve area of 2.30 cm2. There was no mitral regurgitation nor atrial septal defect. After 3 months, she has only N.Y.H.A. class I symptoms and MVA, as estimated by ED, was 2.40 cm2.

Frequency of a positive modified Allen's test in 1,000 consecutive patients undergoing cardiac catheterization.

The modified Allen's test (A.T.) is used to prove the adequacy of the blood supply through the ulnar artery to the hand. The test is considered normal if, after compression of both the ulnar and radial arteries followed by repeated clenching of the fingers to squeeze out the blood, the normal or a slightly more pronounced red color of the palm of the hands returns within < 10 sec after release of only the ulnar artery. It is important to perform the test whenever intravascular access to the radial artery is planned. The objective of this study was to determine the percentage of patients presenting a clearly positive (< 5 sec), a moderately positive (between 5-9 sec), or a negative A.T. (10 sec and more), We performed an A.T. on 1,000 consecutive and different patients undergoing cardiac catheterization, on the right wrist, two times, each time by a different examinator trained in this test. An A.T. was performed on 1,000 patients:640 men, 360 women, mean age 62.3 yr (range 28-90 yr). In our population of patients, the relative percentages of a clearly positive (< 5 sec), moderately positive (between 5-9 sec), or negative modified Allen's test (10 sec and more) is 49%, 24%, and 27%, respectively.

Coronary embolization of the membrane fixing a "Multilink" stent to its delivery balloon.

We report on a case of coronary embolization of an elastic membrane fixing the ACS RX Multilink stent over its balloon, after a successful stent delivery. The membrane was dislodged from the balloon in the ostium of the right coronary artery as the delivery balloon was being pulled back into the guiding catheter. All attempts to retrieve the membrane, to cover it with another stent, or to push it into a terminal segment of the artery to limit the jeopardized myocardial mass were unsuccessful. No CABG was performed because the left coronary system was normal and the procedure occurred 2 months after an incomplete inferior myocardial infarction. There was no increase in cardiac enzymes nor electrocardiographic signs of a new myocardial infarction at discharge or at 1-mo follow-up. It seems preferable to avoid further use of stents tied to their balloons with an intermediary, and possibly detachable, element.

The role of percutaneous transvenous balloon mitral valvuloplasty in the treatment of patients with symptomatic mitral stenosis.

Since its introduction in 1984, percutaneous transvenous mitral balloon valvuloplasty (PTMV) has emerged as an effective technique in the treatment of selected patients with severe mitral stenosis. The most important factors determining the haemodynamic and clinical outcome after PTMV are the anatomic and pathological features of the mitral valve apparatus. In patients with pliable, non-calcified valves, immediate success rates of well over 90% are achieved. Short-term follow-up studies of such patients after PTMV demonstrate a low rate of valve restenosis, with the vast majority of patients remaining much improved clinically. Less favourable immediate and short-term results are observed in patients who have non-pliable, calcified valves. Major acute complications of PTMV include thromboembolic events and the production of severe mitral regurgitation. It appears that, as a result of increased operator experience, better patient selection and refinements in the technique of PTMV, the rates of these acute complications are now very low. Follow-up studies will be needed to assess the long-term efficacy of the procedure. The first publications on this field are encouraging.

Effects of an ionic versus a nonionic low osmolar contrast agent on the thrombotic complications of coronary angioplasty.

An increasing body of evidence suggests that the potential for thrombotic complications is greater with nonionic than with ionic contrast agents. This is a particularly important consideration in the highly thrombogenic setting of percutaneous transluminal coronary angioplasty (PTCA). To explore this issue further, 500 consecutive patients undergoing PTCA were prospectively randomized to receive the low osmolality ionic ioxaglate or the nonionic agent iohexol. The number of acute thrombotic in-laboratory events was significantly less in the ioxaglate than in the iohexol group (8 versus 18; P < 0.05), but there was no significant difference between the 2 groups as regards the number of out-of-laboratory acute rethrombotic events. With multivariate analysis, use of the nonionic agent rather than the ionic agent emerged as an independent predictor of acute in-laboratory rethrombosis. These data suggest that, in the performance of PTCA, an ionic, rather than a nonionic, should be the preferred contrast agent.