Publications by authors named "Martin Hudec"

15 Publications

  • Page 1 of 1

One-Year COMBO Stent Outcomes in Acute Coronary Syndrome: from the COMBO Collaboration.

Cardiovasc Drugs Ther 2021 Apr 30;35(2):309-320. Epub 2021 Jan 30.

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital, New York, USA.

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.
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http://dx.doi.org/10.1007/s10557-020-07087-6DOI Listing
April 2021

Myocardial infarction or broken heart syndrome?

Vnitr Lek 2020 ;66(6):378-380

Takotsubo or broken heart syndrome represents a rare type of cardiomyopathy, often imitating acute myocardial infarction. It is a sudden transient cardiac syndrome that typically involves left ventricular apical akinesis with preserved motility of basal heart segments. In contrast to acute myocardial infarction, the pathology is fully reversible in the majority of patients. In the present casereport, we discuss 78yearsold female referred to our department for typical symptomatology of acute myocardial infarction. Coronary angiography revealed significant stenosis on the left anterior descending coronary artery, but ventriculography disclosed apical dysfunction and clinical course of the disease result in the diagnosis of Takotsubo cardiomyopathy. Until recently, normal or nonobstructive coronary angiography represented one of the mean diagnostic features of Takotsubo cardiomyopathy. In 2018, new diagnostic criteria were introduced, importantly modifying our approach to the Takotsubo diagnostics with omitting a coronary lesion as an exclusion criterium of the Takotsubo cardiomyopathy.
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January 2021

1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry.

Int J Cardiol Heart Vasc 2020 Dec 6;31:100605. Epub 2020 Sep 6.

Icahn School of Medicine at Mount Sinai Hospital, New York, United States.

Background: The COMBO stent is a biodegradable-polymer sirolimus-eluting stent with endothelial progenitor cell capture technology for faster endothelialization.

Objective: We analyzed COMBO stent outcomes in relation to bleeding risk using the PARIS bleeding score.

Methods: MASCOT 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 < 0.01), driven by physician-guided discontinuation.

Conclusions: 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.
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http://dx.doi.org/10.1016/j.ijcha.2020.100605DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7486438PMC
December 2020

1-Year Outcomes with COMBO Stents in Small-Vessel Coronary Disease: Subgroup Analysis From the COMBO Collaboration.

Cardiovasc Revasc Med 2020 12 7;21(12):1542-1547. Epub 2020 May 7.

Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.

Background: Small vessel diameter is associated with higher risk of target lesion revascularization (TLR) after percutaneous coronary intervention (PCI). The COMBO sirolimus-eluting biodegradable-polymer stent has a proprietary anti-CD34 antibody layer to enhance homogeneous endothelialization, which may be advantageous in treating small vessels.

Objective: We examined for differences in 1-year clinical outcomes after PCI by maximum implanted stent diameter from the COMBO collaboration.

Methods: The COMBO collaboration (n = 3614) is a patient-level pooled dataset of patients undergoing PCI with COMBO stents in the MASCOT and REMEDEE multicenter registries. Stent diameter was available in 3590 (99.3%) patients. We compared patients receiving COMBO stents <3 mm versus ≥3 mm. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI) or clinically driven TLR. Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods.

Results: The study included 792 (22%) patients with small stents <3 mm and 2798 (78%) patients with large stents ≥3 mm. Small stent patients included more women with lower body mass index and higher prevalence of diabetes but similar prevalence of acute coronary syndrome. Risk of 1-year TLF was similar in small and large stent groups (4.4% vs. 3.8%, HR 1.12, 95% CI 0.74-1.72, p = 0.58). There were no differences in the rates of cardiac death (1.7% vs. 1.5%, p = 0.74), TV-MI (1.4% vs. 1.2%, p = 0.58) or TLR (2.7% vs. 2.1%, p = 0.31). Definite or probable ST occurred in 1.3% of the small stent and 0.7% of the large stent PCI patients, p = 0.14, HR 2.13, 95% CI 0.93-5.00, p = 0.07.

Conclusions: One-year ischemic outcomes after COMBO PCI were similar irrespective of stent diameter in this all-comers international cohort.
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http://dx.doi.org/10.1016/j.carrev.2020.05.002DOI Listing
December 2020

Comparison of One-Year Outcomes in Patients >75 Versus ≤75 Years With Coronary Artery Disease Treated With COMBO Stents (From The MASCOT Registry).

Am J Cardiol 2020 07 24;127:1-8. Epub 2020 Apr 24.

Icahn School of Medicine at Mount Sinai Hospital, New York, New York, USA. Electronic address:

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 <0.001) were significantly higher in elderly patients. In conclusion, elderly patients >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.
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http://dx.doi.org/10.1016/j.amjcard.2020.04.014DOI Listing
July 2020

Real-World Dual Antiplatelet Therapy Following Polymer-Free Sirolimus-Eluting Stent Implantations to Treat Coronary Artery Disease.

Cardiovasc Drugs Ther 2020 06;34(3):335-344

Centre Hospitalier d'Avignon, Avignon, France.

Objectives: The objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population.

Methods: Patient-level data from two all-comers observational studies (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification process, we observed substantial deviations from DAPT guideline recommendations. To illuminate this gap between clinical practice and guideline recommendations, we conducted a post hoc analysis of DAPT regimens and clinical event rates for which we defined the net adverse event rate (NACE) consisting of target lesion revascularization (TLR, primary endpoint of all-comers observational studies) all-cause death, myocardial infarction (MI), stent thrombosis (ST), and bleeding events. A logistic regression was utilized to determine predictors why ticagrelor was used in stable coronary artery disease (CAD) patients instead of the guideline-recommended clopidogrel.

Results: For stable CAD, the composite endpoint of clinical, bleeding, and stent thrombosis, i.e., NACE, between the clopidogrel and ticagrelor treatment groups was not different (5.4% vs. 5.1%, p = 0.745). Likewise, in the acute coronary syndrome (ACS) cohort, the NACE rates were not different between both DAPT strategies (9.2% vs. 9.3%, p = 0.927). There were also no differences in the accumulated rates for TLR, myocardial infarction ([MI], mortality, bleeding events, and stent thrombosis in elective and ACS patients. The main predictors for ticagrelor use in stable CAD patients were age < 65 years, smaller vessels, treatment of ostial and calcified lesions, and in-stent restenosis.

Conclusion: Within the framework of a post hoc analysis based on a real-world, large cohort study, there were no differences in the combined endpoint of major adverse cardiac events (MACE), bleeding and thrombotic events for clopidogrel and ticagrelor in stable CAD or ACS patients. Despite the recommendation for clopidogrel by the European Society of Cardiology (ESC), real-world ticagrelor use was observed in subgroups of stable CAD patients that ought to be explored in future trials.
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http://dx.doi.org/10.1007/s10557-020-06963-5DOI Listing
June 2020

Sex differences in 1-year clinical outcomes after percutaneous coronary intervention with COMBO stents: From the COMBO collaboration.

Catheter Cardiovasc Interv 2021 Apr 21;97(5):797-804. Epub 2020 Mar 21.

Icahn School of Medicine at Mount Sinai Hospital, New York, USA.

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.
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http://dx.doi.org/10.1002/ccd.28853DOI Listing
April 2021

1-year results after PCI with the COMBO stent in all-comers in Asia versus Europe: Geographical insights from the COMBO collaboration.

Int J Cardiol 2020 05 24;307:17-23. Epub 2020 Jan 24.

Icahn School of Medicine at Mount Sinai Hospital, New York, United States of America. Electronic address:

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 P2Y 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).
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http://dx.doi.org/10.1016/j.ijcard.2020.01.045DOI Listing
May 2020

Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk.

N Engl J Med 2020 03 12;382(13):1208-1218. Epub 2020 Feb 12.

From Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (S.W.); Montefiore Medical Center (A.L.), Columbia University Irving Medical Center-New York-Presbyterian Hospital (A.J.K., S.O.M.), the Cardiovascular Research Foundation (A.J.K., S.O.M., I.J., G.W.S.), Mount Sinai Medical Center (R. Mehran), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S.) - all in New York; Isala Zwolle, Zwolle, the Netherlands (E.K.); Medical University of Silesia, Katowice (E.K.), and Poland Miedziowe Centrum Zdrowia, Lubin (A.W.) - both in Poland; Piedmont Heart Institute, Atlanta (D.E.K.); the Division of Cardiovascular Diseases, Scripps Clinic, La Jolla (M.J.P.), and Medtronic, Santa Rosa (S.B., L.B., M.L.) - both in California; Instituto Dante Pazzanese de Cardiologia, São Paulo (A. Abizaid); University Hospitals Cleveland Medical Center, Cleveland (D.I.S.); GenesisCare Cardiology, Alexandria, NSW (S.G.W.), and St. Andrew's Hospital, Adelaide, SA (C.T.) - both in Australia; Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom (A.Z.); Stredoslovensky Ustav Srdcovych a Cievnych Chorob, Banska Bystrica, Slovakia (M.H., P.P.); Hospital Serdang, Kajang, Malaysia (A.K.A.G., K.S.); Acibadem City Clinic, Sofia, Bulgaria (I.P.); Galway University Hospitals-University Hospital Galway, Galway, Ireland (D.M.); Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar (E.P.), and Hospital Universitario La Paz and Hospital La Paz Institute for Health Research, Madrid (R. Moreno) - all in Spain; Centro Cardiologico Monzino IRCCS, Milan (F.F.); Waikato Hospital, Hamilton, New Zealand (S.P.); Seoul National University Hospital, Seoul (H.-S.K.), and Keimyung University Dongsan Medical Center, Daegu (S.-H.H.) - both in South Korea; and Centre Hospitalier Universitaire Charleroi, Charleroi, Belgium (A. Aminian).

Background: Polymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited.

Methods: In an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus-coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority.

Results: A total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P = 0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P = 0.007 for noninferiority).

Conclusions: Among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.).
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http://dx.doi.org/10.1056/NEJMoa1910021DOI Listing
March 2020

High-pressure jet-induced hydrodynamic cavitation as a pre-treatment step for avoiding cyanobacterial contamination during water purification.

J Environ Manage 2020 Feb 25;255:109862. Epub 2019 Nov 25.

Department of Experimental Phycology and Ecotoxicology, Institute of Botany, Czech Academy of Sciences, Lidická 25/27, 60200, Brno, Czech Republic.

Due to specific physical properties, hydrodynamic cavitation (HC) is assigned to the powerful technologies for treating the biotic contamination in water including cyanobacteria. Contaminated water stream (CWS) can be cavitated directly by passing through some HC device, or indirectly when high-pressure jet stream (HPJS) is directed against its flow. Relatively small HPJS stream can thus treat a big volume of CWS in a short time or even work in continuous mode. Cyanobacteria floating in the CWS are forced to flow through the mixing cavitation zone. Within 2 h after single HC treatment, cyanobacterial cell suspensions showed disintegration of larger colonies and enhanced biomass sedimentation. Additional pre-treatment of CWS with low amounts of hydrogen peroxide (HO; 33, 66 and 99 μmol/L) enhanced the effect of HC and led to further inhibition of cyanobacterial photosynthesis (maximum quantum yield of photosystem II decreased by up to 60%). The number of cyanobacterial cells in the treated CWS decreased continuously over 48 and 72 h, though some cells remained alive and were able to recover photosynthetic activity. The technique proposed (direction of a HPJS against a CWS and pre-treatment with low HO concentrations) provides (i) effective removal of cells from the water column, and (ii) reduced contamination by organic compounds released from the cells (especially cyanotoxins) as the cell membranes are not destroyed and the cells remain alive. This process shows potential as an effective pre-treatment step in water purification processes related to cyanobacterial contamination.
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http://dx.doi.org/10.1016/j.jenvman.2019.109862DOI Listing
February 2020

Safety and efficacy of the COMBO bio-engineered stent in an all-comer PCI cohort: 1-Year final clinical outcomes from the MASCOT post-marketing registry.

Int J Cardiol 2019 05 21;283:67-72. Epub 2019 Jan 21.

Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address:

Background: The COMBO stent (OrbusNeich Medical, Ft. Lauderdale, Florida) is a new-generation bio-engineered drug eluting stent, combining an abluminal coating of a bioabsorbable polymer matrix for sustained release of sirolimus and luminal anti-CD34 coating for endothelial progenitor cell capture and rapid endothelialization.

Methods: The Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) registry was a prospective post-marketing study conducted from June 2014-May 2017 across 60 centers globally. Patients were eligible if COMBO stent implantation was attempted, and they received dual antiplatelet therapy (DAPT) per local guidelines. Follow-up was conducted by trained research staff at 1, 6 and 12 months by phone or clinic visit to capture clinical events and DAPT cessation events. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, non-fatal myocardial infarction not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization.

Results: A total of 2614 patients were enrolled over the study period with 96.7% completion of 1-year follow-up. The mean age of enrolled patients was 62.9 ± 11.2 years and 23.0% were female. Diabetes mellitus was present at baseline in 33.5%. A total of 56.1% patients underwent PCI for acute coronary syndrome (ACS). The 1-year primary endpoint of TLF occurred in 3.4% patients (n = 88). Definite stent thrombosis occurred in 0.5% patients (n = 12).

Conclusion: The MASCOT post marketing registry provides comprehensive safety and efficacy outcomes following contemporary PCI using the novel COMBO stent in an all-comer population. This platform is associated with low rates of 1-year TLF and ST. CLINICALTRIALS.

Gov Identifier: NCT02183454.
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http://dx.doi.org/10.1016/j.ijcard.2019.01.053DOI Listing
May 2019

Polymer-free sirolimus-eluting stents in a large-scale all-comers population.

Open Heart 2017;4(2):e000592. Epub 2017 Jun 6.

Klinik für Kardiologie, Angiologie, Pneumologie, Klinikum Esslingen, Esslingen, Baden-Württemberg, Germany.

Objective: The objective of this study was to assess the safety and efficacy of a polymer-free sirolimus coated, ultrathin strut drug-eluting stent (PF-SES) in an unselected patient population with a focus on acute coronary syndrome (ACS). Furthermore, stable coronary artery disease (CAD) with short (≤6 months) versus long (>6 months) dual antiplatelet therapy (DAPT) were also studied.

Methods: Patients who received PF-SES were investigated in an unselected large-scale international, single-armed, multicenter, 'all comers' observational study. The primary endpoint was the 9-month target lesion revascularisation (TLR) rate, whereas secondary endpoints included the 9-month major adverse cardiac events (MACE) and procedural success rates. A priori defined subgroups such as patients with ACS, diabetes, lesion subsets and procedural characteristics relative to DAPT were investigated.

Results: A total of 2877 patients of whom 1084 had ACS were treated with PF-SES (1.31±0.75 stents per patient). At 9 months, the accumulated overall TLR rate was 2.3% (58/2513). There was no significant difference between ACS and stable CAD (2.6% vs 2.1%, p=0.389). However, the overall MACE rate was 4.3% (108/2513) with a higher rate in patients with ACS when compared with the stable CAD subgroup (6.1%, 58/947 vs 3.2%, 50/1566, p<0.001).

Conclusions: PF-SES angioplasty is safe and effective in the daily clinical routine with low rates of TLR and MACE in an unselected patient population. Our data are in agreement with prior clinical findings that extended DAPT duration beyond 6 months do not improve clinical outcomes in patients with stable CAD (ClinicalTrials.gov Identifier NCT02629575).

Trial Registration Number: NCT02629575.
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http://dx.doi.org/10.1136/openhrt-2017-000592DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5515132PMC
June 2017

Case report of out-of-hospital heat dissipation of an implantable cardioverter-defibrillator.

Europace 2011 Jun 11;13(6):902-4. Epub 2010 Oct 11.

Middle-Slovak Institute of Cardiovascular Diseases, Banska Bystrica, Slovakia.

The implantable cardioverter-defibrillator (ICD) has revolutionized the treatment of patients at risk of sudden cardiac death due to ventricular arrhythmias. Repeated studies have shown them to increase overall survival rates in patients with congestive heart failure or previous myocardial infarction and left ventricular dysfunction. We present a rare case of out-of-hospital ICD heat dissipation due to rapid battery discharge preceded by an audible popping noise.
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http://dx.doi.org/10.1093/europace/euq338DOI Listing
June 2011

Secondary hypothyroidism in hereditary hemochromatosis: recovery after iron depletion.

Thyroid 2008 Feb;18(2):255-7

Department of Endocrinology, South Infirmary-Victoria University Hospital, Cork, Republic of Ireland.

We report the case of a 56 year old male with hereditary haemochromatosis complicated by hepatic cirrhosis, insulin treated diabetes mellitus, hypogonadism and secondary hypothyroidism, the latter which was corrected by iron depletion. This is only the second such case to be reported.
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http://dx.doi.org/10.1089/thy.2007.0140DOI Listing
February 2008