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Purpose: The COMBO biodegradable polymer sirolimus-eluting stent includes endothelial progenitor cell capture (EPC) technology for rapid endothelialization, which may offer advantage in acute coronary syndromes (ACS). We sought to analyze the performance of the COMBO stent by ACS status and ACS subtype. Methods: The COMBO collaboration (n = 3614) is a patient-level pooled dataset from the MASCOT and REMEDEE registries. We evaluated outcomes by ACS status, and ACS subtype in patients with ST segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) versus unstable angina (UA). The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Secondary outcomes included stent thrombosis (ST). Results: We compared 1965 (54%) ACS and 1649 (46.0%) non-ACS patients. ACS presentations included 40% (n = 789) STEMI, 31% (n = 600) NSTEMI, and 29% (n = 576) UA patients. Risk of 1-year TLF was greater in ACS patients (4.5% vs. 3.3%, HR 1.51 95% CI 1.01–2.25, p = 0.045) without significant differences in definite/probable ST (1.1% vs 0.5%, HR 2.40, 95% CI 0.91–6.31, p = 0.08). One-year TLF was similar in STEMI, NSTEMI, and UA (4.8% vs 4.8% vs. 3.7%, p = 0.60), but definite/probable ST was higher in STEMI patients (1.9% vs 0.5% vs 0.7%, p = 0.03). Adjusted outcomes were not different in MI versus UA patients. Conclusions: Despite the novel EPC capture technology, COMBO stent PCI was associated with somewhat greater risk of 1-year TLF in ACS than in non-ACS patients, without significant differences in stent thrombosis. No differences were observed in 1-year TLF among ACS subtypes.

Clinic blood pressure (BP) measurement remains a crucial step in managing hypertension. While the number of measures recorded in different settings varies, with typically 1‐3 measures, there has been no prior justification for the actual number of measures required. We investigated the pattern of BP variability over 5 consecutive automated readings (R1‐R5) and the influence of patient characteristics on this pattern to identify the phenotype of hypertension in a Middle Eastern population. There were 1389 outpatients (51% men, 49% women), age range (18‐87 y) who had 5 unattended automated consecutive BP measurements with one‐minute intervals using the validated Datascope Mindray Passport V Monitor with the patient blinded from the results. Mean (±SEM) SBP for R1 (136.0 ± 2 mm Hg) was similar to R2 (136.2 ± 2 mm Hg). Thereafter SBP progressively declined till R5 by total of 5.5 mm Hg. The SBP decline was less (4.2 mm Hg) in older (>50 years) vs younger participants (8.1 mm Hg; P R1, and 24% additionally had R5 > R1. Age was a strong independent predictor of having both R2 > R1 and R5 > R1, as well as diabetes. Diastolic blood pressure (DBP) decreased by average 2.8 mm Hg from R1 to R5. Females had a 5‐fold greater total decline in DBP vs males (P

Older patients who undergo coronary interventions are at greater risk of ischemic events and less likely to tolerate prolonged dual antiplatelet therapy (DAPT) due to bleeding risk. The COMBO biodegradable polymer sirolimus-eluting stent promotes rapid endothelialization through endothelial progenitor cell capture technology which may be advantageous in elderly patients. We compared 1-year clinical outcomes and DAPT cessation events in patients >75 versus ≤75 years from the MASCOT registry. MASCOT was a prospective, multicenter cohort study of all-comers undergoing attempted COMBO stenting. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a nontarget vessel or clinically driven target lesion revascularization. Bleeding was adjudicated using the Bleeding Academic Research Consortium criteria. Adjusted outcomes were analyzed using Cox regression methods. The study included 18% (n = 479) patients >75 years and 72% (n = 2,135) patients ≤75 years. One-year TLF occurred in 4.6% patients >75 years versus 3.1% patients ≤75years of age, p = 0.10; adj hazard ratio 1.36, 95% confidence intervals 0.77 to 2.38, p = 0.29. There were no significant differences in cardiac death (1.7% vs 1.3%, p = 0.55), MI (2.1% vs 1.2%, p = 0.14), target lesion revascularization (1.7% vs 1.4%, p = 0.60) and definite stent thrombosis (0.8% vs 0.4%, p = 0.19). Major Bleeding Academic Research Consortium 3,5 bleeding (3.1% vs 1.5%, p = 0.01) and DAPT cessation rates (32.4% vs 23.0%, p 75 years treated with COMBO stents had similar TLF but significantly greater incidence of bleeding than younger patients and DAPT cessation in one-third of patients over 1 year.

Background The COMBO drug-eluting stent combines sirolimus-elution from a biodegradable polymer with an anti-CD34+ antibody coating for early endothelialization. Objective We investigated for geographical differences in outcomes after percutaneous coronary intervention (PCI) with the COMBO stent among Asians and Europeans. Methods The COMBO Collaboration is a pooled patient-level analysis of the MASCOT and REMEDEE registries of all-comers undergoing attempted COMBO stent PCI. The primary outcome was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR). Results This study included 604 Asians (17.9%) and 2775 Europeans (82.1%). Asians were younger and included fewer females, with a higher prevalence of diabetes mellitus but lower prevalence of other comorbidities than Europeans. Asians had a higher prevalence of ACC/AHA C type lesions and received longer stent lengths. More Asians than Europeans were discharged on clopidogrel (86.5% vs 62.8%) rather than potent P2Y12 inhibitors. One-year TLF occurred in 4.0% Asians and 4.1% of Europeans, p = 0.93. The incidence of cardiac death was higher in Asians (2.8% vs. 1.3%, p = 0.007) with similar rates of TV-MI (1.5% vs. 1.2%, p = 0.54) and definite stent thrombosis (0.3% vs. 0.5%, p = 0.84) and lower incidence of TLR than Europeans (1.0% vs. 2.5%, p = 0.025). After adjustment, differences for cardiac death and TLR were no longer significant. Conclusions In the COMBO collaboration, although 1-year TLF was similar regardless of geography, Asians experienced higher rates of cardiac death and lower TLR than Europeans, while incidence of TV-MI and ST was similar in both regions. Adjusted differences did not reach statistical significance. Clinicaltrial.gov identifier-numbers NCT01874002 (REMEDEE Registry), NCT02183454 (MASCOT registry).

BACKGROUND The COMBO drug eluting stent is a novel device with luminal endothelial progenitor cell capture technology for rapid homogeneous endothelialization. METHODS AND RESULTS We examined for sex differences in 1-year outcomes after COMBO stenting from the COMBO collaboration, a pooled patient-level dataset from the MASCOT and REMEDEE multicenter registries. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR). Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods. The study included 861 (23.8%) women and 2,753 (76.2%) men. Women were older with higher prevalence of several comorbidities including diabetes mellitus. Risk of 1-year TLF was similar in both sexes (3.8% vs. 3.9%, HR 0.92, 95% CI 0.59-1.42, p = .70), without sex differences in the incidence of cardiac death (1.6% vs. 1.5%, p = .78), TV-MI (1.5% vs. 1.1%, p = .32), or CD-TLR (2.0% vs. 2.2%, p = .67). Definite or probable ST occurred in 0.4% women and 1.0% men (HR 0.26, 95% CI 0.06-1.11, p = .069). CONCLUSIONS Despite greater clinical risks at baseline, women treated with COMBO stents had similarly low 1-year TLF and other ischemic outcomes compared to men.

The COMBO biodegradable polymer sirolimus-eluting stent includes endothelial progenitor cell capture (EPC) technology for rapid endothelialization, which may offer advantage in acute coronary syndromes (ACS). We sought to analyze the performance of the COMBO stent by ACS status and ACS subtype.The COMBO collaboration (n = 3614) is a patient-level pooled dataset from the MASCOT and REMEDEE registries. We evaluated outcomes by ACS status, and ACS subtype in patients with ST segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) versus unstable angina (UA). The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Secondary outcomes included stent thrombosis (ST).We compared 1965 (54%) ACS and 1649 (46.0%) non-ACS patients. ACS presentations included 40% (n = 789) STEMI, 31% (n = 600) NSTEMI, and 29% (n = 576) UA patients. Risk of 1-year TLF was greater in ACS patients (4.5% vs. 3.3%, HR 1.51 95% CI 1.01-2.25, p = 0.045) without significant differences in definite/probable ST (1.1% vs 0.5%, HR 2.40, 95% CI 0.91-6.31, p = 0.08). One-year TLF was similar in STEMI, NSTEMI, and UA (4.8% vs 4.8% vs. 3.7%, p = 0.60), but definite/probable ST was higher in STEMI patients (1.9% vs 0.5% vs 0.7%, p = 0.03). Adjusted outcomes were not different in MI versus UA patients.Despite the novel EPC capture technology, COMBO stent PCI was associated with somewhat greater risk of 1-year TLF in ACS than in non-ACS patients, without significant differences in stent thrombosis. No differences were observed in 1-year TLF among ACS subtypes.

Background Current surgical technique to fix the tricuspid valve regurgitation carry a high percentage (up to 37%) of recurrence of severe tricuspid valve regurgitation in mid-term follow up. There is a need for anatomically and physiologically correct Tricuspid annulus device. Our ring is developed in the way that mimics the normal anatomy & physiology of Tricuspid annulus. The aim of this study is to test three prototypes and choose the proper prototype that is tested and suitable to conform well to the normal shape of the tricuspid annulus with no distortion of the movement during the different phases of the cardiac cycle. Methods We used an acute open heart model in sheep as an animal model to test three prototypes. We used adult sheep (6 males and 6 females), body weight 60–70 Kg, age: 1–3 years old. We followed the protocol of open heart model in animals. Results Post Prototype implantation, Tricuspid valve leaflet coaptation was verified with no induced tricuspid regurgitation. On the other hand, there was no ring distortion or ring material fracture. All the three prototypes conformed well to the normal shape of the tricuspid annulus with no distortion of the movement during the different phases of the cardiac cycle (both in systole and diastole). Conclusions All the three tested prototypes seemed to be effective and reproducible.

BackgroundThe COMBO stent is a biodegradable-polymer sirolimus-eluting stent with endothelial progenitor cell capture technology for faster endothelialization. ObjectiveWe analyzed COMBO stent outcomes in relation to bleeding risk using the PARIS bleeding score. MethodsMASCOT was an international registry of all-comers undergoing attempted COMBO stent implantation. We stratified patients as low bleeding-risk (LBR) for PARIS score≤3 and intermediate-to-high (IHBR) for score>3 based on baseline age, body mass index, anemia, current smoking, chronic kidney disease and need for triple therapy. Primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a non-target vessel or clinically-driven target lesion revascularization (TLR). Bleeding was adjudicated using the Bleeding Academic Research Consortium (BARC) definition. Dual antiplatelet therapy (DAPT) cessation was independently adjudicated. Results The study included 56% (n=1270) LBR and 44% (n=1009) IHBR patients. Incidence of 1-year TLF was higher in IHBR patients (4.1% vs. 2.6%, p=0.047) driven by cardiac death (1.7% vs. 0.7%, p=0.029) with similar rates of MI (1.8% vs. 1.1%, p=0.17), TLR (1.5% vs. 1.6%, p=0.89) and definite/ probable stent thrombosis (1.2% vs. 0.6%, p=0.16). Incidence of 1-year major BARC 3 or 5 bleeding was significantly higher in IHBR patients (2.3% vs. 0.9%, p=0.0094), as was the incidence of DAPT cessation (29.3% vs. 22.8%, p Conclusion Patients with intermediate-to-high PARIS bleeding risk in the MASCOT registry experienced greater incidence of 1-year TLF, major bleeding and DAPT cessation than LBR patients, without significant differences in stent thrombosis.

The authors regret for H.M. Warda the affiliation ‘Tanta University Hospital, Tanta, Egypt' was not included in the original article and it has now been included. The authors would like to apologise for any inconvenience caused. © 2019 Elsevier B.V.

The Combo stent is a drug eluting stent with abluminal sirolimus in a bioabsorbable polymer and luminal anti-CD34 for endothelial progenitor capture and rapid endothelialization. This property may permit shorter period of dual antiplatelet therapy (DAPT) in patients at high bleeding risk (HBR). We

In-stent restenosis is the major drawback of percutaneous coronary interventions, occurring in 10-40% of the patients. Recently, new stents have emerged which are loaded with anti-inflammatory, anti-migratory, anti-proliferative or pro-healing drugs. These drugs are supposed to inhibit inflammation and neointimal growth and subsequently in-stent restenosis. In this review article the results of human clinical studies investigating drug-eluting stents are discussed from a clinical point of view, focussing on the efficacy in the prevention of restenosis and their potential side effects. Both success and failure in the field of drug-eluting stents have been described. Successful devices are the sirolimus-eluting and the polymer-based paclitaxel-eluting stents. Potentially dangerous side effects of drug-eluting stents are adverse drug interactions, incomplete stent apposition and increased in-stent thrombosis rates. Demonstration of long-term efficacy is mandatory since in some animal studies a delayed healing has been observed. Currently, the successful drug-eluting stents are under investigation in all types of lesions. We conclude that the results with some drug-eluting stents are promising, but further evidence on long-term efficacy and safety, also in high-risk subgroups, is needed.

Adjunctive use of abciximab during percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) improves clinical outcome. This study addresses the outcome of patients with AMI treated with abciximab, initiated either before transport to a PCI center (early group) or immediately upon arrival at the catheterization laboratory (late group) for primary PCI. Of 446 consecutive patients with AMI, angiographic data and clinical complications were evaluated up to 6 months after primary PCI. Patients received abciximab before transport (early group; n = 138) or just before the intervention (late group; n = 308). Baseline data, including transport time (45 ± 15 min; range, 15–60 min), were comparable in both groups. Early reperfusion was more prevalent in the early group (35% vs. late 19%; P < 0.001). Furthermore, a better final TIMI 3 flow was noted in the early group (91% vs. late 83%; P = 0.05). Although mortality reduction attributable to early abciximab treatment could not be demonstrated, major adverse cardiac events (MACE) occurred in 27% in the early group and 36% in the late group (P = 0.05). Revascularization rates were similar, but repeat acute coronary syndromes were less frequent in the early group (11% vs. late group 20%; P = 0.04). In multivariate analysis, cardiogenic shock, out-of-hospital cardiac arrest, and previously known coronary artery disease were independent predictors of higher MACE rate, whereas early reperfusion and final TIMI 3 flow reduced 6-month MACE rate. Abciximab pretreatment of patients with AMI for primary PCI results in better initial and final TIMI flow and tends to improve 6-month clinical outcome. © 2005 Wiley-Liss, Inc.

Intracoronary stent implantation is a frequently performed procedure in the treatment of stenoses in coronary arteries, but in-stent restenosis occurs in approximately 10% to 15% of patients. A noninvasive diagnostic procedure to evaluate in-stent restenosis would therefore be of great benefit. We investigated the feasibility of assessing stent patency with 16-slice computed tomography. Multislice computed tomography (MSCT) was performed in 22 patients with previously implanted stents. For each stent, assessability was determined and related to stent type and diameter. Subsequently, the presence of significant restenosis was determined in the evaluable stents. In addition, peristent lumina (5 mm proximal and distal to the stent) were evaluated. Conventional angiography in combination with quantitative coronary angiography served as the standard of reference. MSCT was performed successfully in all but 1 patient. Of 65 stents, 50 (77%) were determined assessable. Uninterpretable stents tended to have a thicker strut and/or a smaller diameter. In the evaluable stents, 7 of 9 stenoses were detected and the absence of restenosis was correctly identified in all 41 patent stents, resulting in a sensitivity and specificity of 78% and 100%, respectively. Sensitivity and specificity for the detection of peristent stenosis were 75% and 96%, respectively. In conclusion, MSCT may be useful in the assessment of stent patency and may function as a gatekeeper before invasive diagnostic procedures.

The present report describes outcomes of randomized selective intracoronary aqueous oxygen versus standard care in patients who had acute anterior wall myocardial infarction within 6 hours of onset (n = 50). Left ventricular (LV) dimensions and function were assessed by contrast echocardiography at baseline and 1 month. It is demonstrated that aqueous oxygen prevents LV remodeling and preserves LV ejection fraction.

Objectives We investigated the incidence of radial anomalies (RA) in patients undergoing transradial (TR) coronary procedure and their impact on procedural outcome in the Egyptian population. Background Radial anomalies (RA) are considered an important factor for procedural failure. Information about anatomical variation is limited in our Egyptian population. Methods We performed a multicentre prospective study in Egypt. A total of 650 consecutive patients undergoing their first TR coronary procedure were recruited from January 2013 till January 2015. By retrograde radial arteriography we assessed the frequency of RA and their impact on procedural outcome. Results 650 consecutive patients were studied, 74% male, mean (SD) age 55 (10) years. The overall incidence of radial artery anomaly was 12.6% (n = 82). 40 (6.2%) patients had a high-bifurcating radial origin, 8 (1.2%) had a full radial loop, 14 (2.1%) had extreme radial artery tortuosity and 20 (3%) had other anomalies such as persistent left subclavian artery and extreme subclavian tortuosity. Overall transradial procedural success was 95%. Procedural failure was more common in patients with anomalous anatomy (39%) than in patients with normal anatomy (0.2%). Procedural failure was highest in patients with radial loop (87.5%), followed by those with subclavian tortuosity (45%), then high radial bifurcation (30%), and severe radial tortuosity (28.5%). 14 (2.1%) vascular complications occurred, all of which were treated conservatively. Conclusion There is a relatively significant presence of radial anomalies, with different degrees of impact on procedural failure rate, in our Egyptian population. Further collaborative studies are recommended to increase our success rates.