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.

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.

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.

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.

Intracoronary beta-radiation to reduce restenosis after balloon angioplasty and stenting; the Beta Radiation In Europe (BRIE) study.

AIMS: The BRIE trial is a registry evaluating the safety and performance of (90)Sr delivered locally (Beta-Cath TM system of Novoste) to de-novo and restenotic lesions in patients with up to two discrete lesions in different vessels. METHODS AND RESULTS: In total, 149 patients (175 lesions) were enrolled; 62 treated with balloons and 113 with stents. The restenosis rate, the minimal luminal diameter and the late loss were determined in three regions of interest: (a) in a subsegment of 5mm containing the original minimal luminal diameter pre-intervention termed target segment; (b) the irradiated segment, 28 mm in length, and (c) the entire analysed segment, 42 mm in length, termed the vessel segment. Binary restenosis was 9.9% for the target segment, 28.9% for the irradiated segment, and 33.6% for the vessel segment. These angiographic results include 5.3% total occlusions. Excluding total occlusions binary restenosis was 4.9%, 25% and 29.9%, respectively. At 1 year the incidence of major adverse cardiac events placed in a hierarchical ranking were: death 2%, myocardial infarction 10.1%, CABG 2%, and target vessel revascularization 20.1%. The event-free survival rate was 65.8%. Non-appropriate coverage of the injured segment by the radioactive source termed geographical miss affected 67.9% of the vessels, and increased edge restenosis significantly (16.3% vs 4.3%, P=0.004). It accounted for 40% of the treatment failures. CONCLUSION: The results of this registry reflect the learning process of the practitioner. The full therapeutic potential of this new technology is reflected by the restenosis rate at the site of the target segment. It can only be unravelled once the incidence of late vessel occlusion and geographical miss has been eliminated by the prolonged use of thienopyridine, the appropriate training of the operator applying this new treatment for restenosis prevention, and the use of longer sources.

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.

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.

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.

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.

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.

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.

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.

Brachial, radial, or femoral approach for elective Palmaz-Schatz stent implantation: a randomized comparison.

UNLABELLED: From October 1994 to November 1995, 150 male eligible patients were randomly assigned to Palmaz-Schatz stent implantation through 6 French catheters using the femoral (puncture) (n = 56), radial (puncture) (n = 56), or brachial (cutdown) (n = 38) approach at 6 participating Belgian centers. Acenocoumarol was given for 1 month after stenting. END POINTS: Primary-entry site complications (bleeding, haematoma, transfusion, occlusion, surgery) poststent implantation. Secondary-success rate, stent thrombosis, Q or non Q wave MI, repeat PTCA, CABG, CVA, haemorrage, death. There were no statistically significant differences between the three groups for base line and angiographic patient characteristics, procedural characteristics, in hospital outcome, average hospitalisation time after stenting, events during the month after stenting, or local complications at 1 month follow-up. The only statistically significant difference was the arterial time of the procedure: mean +/- SD (minutes) brachial 31.0 +/- 10.02 *P < 0.001, femoral 42.2 +/- 21.8, radial 55.8 +/- 31.3 **P < 0.0001 (*brachial vs. femoral, **brachial vs. radial). There was a clear trend toward more technical difficulties and more problems with the radial approach. In each group: vascular surgery at entry site: 0%, blood transfusion: 0%. In our study, local complications and length of hospital stay were similar with the three possible approaches, and brachial approach was associated with a shorter arterial time.

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.

A randomized trial of recombinant staphylokinase versus alteplase for coronary artery patency in acute myocardial infarction. The STAR Trial Group.

BACKGROUND: Recombinant staphylokinase (STAR) was shown recently to offer promise for coronary arterial thrombolysis in patients with evolving myocardial infarction. The present multicenter randomized open trial was designed to assess the thrombolytic efficacy, safety, and fibrin specificity of STAR relative to accelerated alteplase (recombinant tissue-type plasminogen activator [RTPA]). METHODS AND RESULTS: One hundred patients with evolving myocardial infarction of < 6 hours' duration and with ST-segment elevation were allocated to accelerated and weight-adjusted RTPA over 90 minutes (52 patients) or to STAR (the first 25 patients to 10 mg and the next 23 patients to 20 mg given intravenously over 30 minutes). All patients received aspirin and intravenous heparin. The main end points were coronary artery patency and plasma fibrinogen levels at 90 minutes. Thrombolysis in Myocardial Infarction (TIMI) perfusion grade 3 at 90 minutes was achieved in 62% of STAR patients versus 58% of RTPA patients (risk ratio, 1.1; 95% CI, 0.76 to 1.5). With 10 mg STAR, TIMI grade 3 patency was 50% (risk ratio, 0.86; 95% CI, 0.54 to 1.4 versus RTPA); with 20 mg STAR, it was 74% (risk ratio, 1.3; 95% CI, 0.90 to 1.8 versus RTPA). Residual fibrinogen levels at 90 minutes were 118 +/- 47% (mean +/- SD) of baseline with STAR and 68 +/- 42% with RTPA (P < .0005). STAR therapy was not associated with an excess mortality or electric, hemorrhagic, mechanical, or allergic complications. However, patients developed antibody-mediated STAR-neutralizing activity from the second week after STAR treatment. As an addendum to the randomized study, 5 patients were given 40 mg STAR over 30 minutes, resulting in TIMI perfusion grade 3 at 90 minutes in 4 patients without fibrinogen breakdown (residual levels at 90 minutes of 105 +/- 8% of baseline). CONCLUSIONS: STAR appears to be at least as effective for early coronary recanalization as and significantly more fibrin-specific than accelerated RTPA in patients with evolving myocardial infarction.