Peter Den Heijer - Academia.edu (original) (raw)
Papers by Peter Den Heijer
The Lancet, 2019
BACKGROUND The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferi... more BACKGROUND The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferiority trial that compared percutaneous coronary intervention (PCI) using first-generation paclitaxel-eluting stents with coronary artery bypass grafting (CABG) in patients with de-novo three-vessel and left main coronary artery disease, and reported results up to 5 years. We now report 10-year all-cause death results. METHODS The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension of follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to the PCI group or CABG group. Patients with a history of PCI or CABG, acute myocardial infarction, or an indication for concomitant cardiac surgery were excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause death, which was assessed acc...
atrick W. Serruys, MD, PHD, FACC,* Georgios Sianos, MD, PHD,* Alexandre Abizaid, MD,† iro Aoki, M... more atrick W. Serruys, MD, PHD, FACC,* Georgios Sianos, MD, PHD,* Alexandre Abizaid, MD,† iro Aoki, MD,* Peter den Heijer, MD, PHD,‡ Hans Bonnier, MD, PHD,§ Pieter Smits, MD, PHD, ougal McClean, MD,¶ Stefan Verheye, MD, PHD,# Jorge Belardi, MD,** Jose Condado, MD,†† ichel Pieper, MD,‡‡ Louise Gambone, BA,§§ Marco Bressers, MSC, Janette Symons, duardo Sousa, MD,† Frank Litvack, MD, FACC§§ otterdam, Breda, and Eindhoven, the Netherlands; Sao Paulo, Brazil; Christchurch, New Zealand; Antwerp, elgium; Buenos Aires, Argentina; Caracas, Venezuela; Kreuzlingen, Switzerland; and Menlo Park, California
Heart
ObjectivesThe balloon-expandable Sapien-3 valve demonstrated superior results in terms of residua... more ObjectivesThe balloon-expandable Sapien-3 valve demonstrated superior results in terms of residual aortic regurgitation when compared with self-expandable devices. We aimed to compare for the first-time early outcomes of Sapien-3 transcatheter heart valve (THV) with the balloon-expandable Myval device.MethodsConsecutive real-world patients from nine European institutions with symptomatic severe aortic stenosis treated either with Sapien-3 or Myval THV devices after June 2018 were compared. Early clinical outcomes were prospectively gathered and blinded analysis of 30-day echocardiography was conducted. Matching for the following variables was performed: age, body surface area, Society of Thoracic Surgeons risk score, left ventricular function, mean gradient, transfemoral approach, aortic valvular calcium, aortic annulus mean diameter, area and eccentricity index.ResultsA total of 416 patients treated either with the Sapien-3 (n=286, 68.7%) or with Myval THV (n=130, 31.3%) were inclu...
The American Journal of Cardiology
Older patients who undergo coronary interventions are at greater risk of ischemic events and less... more 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.
International Journal of Cardiology
BACKGROUND The COMBO drug-eluting stent combines sirolimus-elution from a biodegradable polymer w... more 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).
Journal of the American College of Cardiology
Analyses of thrombi of patients with ST-segment elevation myocardial infarction (STEMI) showed, i... more Analyses of thrombi of patients with ST-segment elevation myocardial infarction (STEMI) showed, in addition to fresh thrombi, also a prevalence of relatively old thrombi. Old thrombi were present in up to 50% of patients with STEMI and associated with a worse prognosis. No data are available
![Research paper thumbnail of Corrigendum to “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. 283 (2019) 67–72]](https://attachments.academia-assets.com/76778356/thumbnails/1.jpg)
](International Journal of Cardiology
The American journal of cardiology, 2018
In patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutan... more In patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI), lack of ST-segment resolution (STR) is associated with poor prognosis at short- and long-term follow-up. The aim of this study was to evaluate the role of STR on very long-term outcomes in patients with STEMI treated with pPCI included in the EXAMINATION (Evaluation of the Xience-V Stent in Acute Myocardial Infarction) trial. Patients were stratified according to the presence of STR < 50% and STR < 70% at the 30-minute post-pPCI electrocardiogram. Primary end point was the patient-oriented composite endpoint (POCE) of all-cause death, any myocardial infarction, or any revascularization at 5-year follow-up. Both baseline and post-PCI 30-minute electrocardiograms were available for STR assessment in 1,351 patients. Of these patients, 228 (16.9%) and 500 (37.0%) exhibited STR < 50% and STR < 70%, respectively. At 5-year follow-up, the POCE was ...
Journal of the American College of Cardiology
TCT-470 Two Year Clinical Results after Deployment of the Abluminal Sirolimus Coated Bio-Engineer... more TCT-470 Two Year Clinical Results after Deployment of the Abluminal Sirolimus Coated Bio-Engineered (COMBO) Stent in a Thousand Patient All-Comers Registry Deborah Kalkman, Pier Woudstra, Peter Den Heijer, Ian Brian Alexander Menown, Andrejs Erglis, Harry Suryapranata, Karin Arkenbout, Andres Iñiguez, Arnoud van’t Hof, Philippe Muller, Jan Tijssen, Robbert de Winter Academic Medical Center, Amsterdam, Netherlands; CVPath, Gaithersburg, Netherlands; Amphia Hospital Breda, Breda, Netherlands; Craigavon Cardiac Centre, Craigavon, Northern Ireland, United Kingdom; P. Stradins Clinical University Hospital, Riga, Latvia; Zwolle, Netherlands; Ter Gooi Hospitals, Ouderkerk Amstel, Netherlands; Hosp. Álvaro Cunqueiro, Vigo, Spain; Isala, Zwolle, Zwolle, Netherlands; INCCI, Luxembourg, Luxembourg; AMC-UVA, Naarden, Netherlands; Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2017
Patients presenting with acute coronary syndrome (ACS) are at increased risk of complications aft... more Patients presenting with acute coronary syndrome (ACS) are at increased risk of complications after percutaneous coronary intervention with stent placement compared to patients with stable angina (SA) treated in an elective setting. The novel pro-healing COMBO stent is a bio-engineered drug eluting stent designed to promote vessel healing. Therefore, the stent may reduce this difference in clinical outcomes between elective and ACS-patients and prevent late stent thrombosis. The European, prospective, multicenter, 1000 all-comers patient REMEDEE registry evaluates clinical outcomes after COMBO stent placement in ACS- and elective patients. The primary endpoint at 12 months is target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction and target lesion revascularization. A total of 49.9% (n = 498) of patients presented with acute coronary syndrome. TLF was 7.1% in ACS patients, definite and probable stent thrombosis was observed in 0.5% of ACS pati...
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Jan 10, 2016
Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve... more Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System (DFM-TAVS), when used in routine clinical practice. This is a prospective, open-label, multicentre, post-market registry of patients treated with DFM-TAVS according to approved commercial indications. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events were adjudicated and classified according to VARC-2 criteria by an independent clinical events committee. The primary endpoint was freedom from all-cause mortality at 30 days post procedure. Secondary endpoints included procedural, early safety and efficacy endpoints at 30 days. Two hundred and fifty patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) with the DFM-TAVS were enrolled in 21 European centres. The primary endpoint, freedom from all-cause mortality at 30 days, was met in 98% (245/250) of patients. Device success was 83.8%....
Journal of the American College of Cardiology, 2016
TCT-263 Impact of Diabetes on Clinical Outcomes in Patients Undergoing Unprotected Left Main Perc... more TCT-263 Impact of Diabetes on Clinical Outcomes in Patients Undergoing Unprotected Left Main Percutaneous Coronary Intervention with Drug-Eluting Stents Bo Xu, Jonathan Murphy, Yuejin Yang, Shubin Qiao, Changdong Guan, Runlin Gao, Ajay Kirtane Fu Wai Hospital, Beijing, Beijing, China; department of medicine, Herning hospital, denmark, new york, New York, United States; Cardiovascular Institute and Fu Wai Hospital, Beijing, Beijing, China; Beijing Fuwai Hospital, Beijing, Beijing, China; Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, Beijing, China; Fu Wai Hospital, Beijing, Beijing, China; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States
Journal of the American College of Cardiology, 2016
Drug eluting stents with biodegradable polymer have been developed to address the risk of very la... more Drug eluting stents with biodegradable polymer have been developed to address the risk of very late adverse events. COMPARE II is one of the largest randomized studies comparing the biodegradable polymer-coated biolimus-eluting stent (BES; Nobori®) with second-generation durable polymer-coated
Journal of the American College of Cardiology, 2016
TCT-470 Two Year Clinical Results after Deployment of the Abluminal Sirolimus Coated Bio-Engineer... more TCT-470 Two Year Clinical Results after Deployment of the Abluminal Sirolimus Coated Bio-Engineered (COMBO) Stent in a Thousand Patient All-Comers Registry Deborah Kalkman, Pier Woudstra, Peter Den Heijer, Ian Brian Alexander Menown, Andrejs Erglis, Harry Suryapranata, Karin Arkenbout, Andres Iñiguez, Arnoud van’t Hof, Philippe Muller, Jan Tijssen, Robbert de Winter Academic Medical Center, Amsterdam, Netherlands; CVPath, Gaithersburg, Netherlands; Amphia Hospital Breda, Breda, Netherlands; Craigavon Cardiac Centre, Craigavon, Northern Ireland, United Kingdom; P. Stradins Clinical University Hospital, Riga, Latvia; Zwolle, Netherlands; Ter Gooi Hospitals, Ouderkerk Amstel, Netherlands; Hosp. Álvaro Cunqueiro, Vigo, Spain; Isala, Zwolle, Zwolle, Netherlands; INCCI, Luxembourg, Luxembourg; AMC-UVA, Naarden, Netherlands; Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark
Journal of the American College of Cardiology, 2016
RESULTS A total of 1119 confirmed STEMI patients (51.7%) were admitted during OFF-hours and 1048 ... more RESULTS A total of 1119 confirmed STEMI patients (51.7%) were admitted during OFF-hours and 1048 (48.3%) patients during ONhours. Baseline characteristics were well balanced between the two groups including features of high risk STEMI such as cardiac arrest (8.9% vs. 7.9% p 1⁄40.55) and shock (14.7% vs. 12.3 % p1⁄4 0.30). Time from symptom onset to First Medical Contact (FMC) and from FMC to angiography were similar during OFF-hours and ON-hours (120 min p1⁄40.67 and 94 min p1⁄40.2). The use of radial access was high and not different (87.5 % and 88.4 %, p1⁄40.27) in OFFvs. ON-hours. In-Hospital mortality during OFFvs. ON-hours was 1.6 % vs. 2.8% in patients without cardiac arrest or shock (p1⁄40.14) and 45.1 % vs. 50.4% (p1⁄40.39) in those with cardiac arrest or shock. At one-year follow-up, there was no impact of admission time on all-cause mortality (12% vs. 13.4%, p1⁄40.40).
Circulation, Nov 22, 2011
Introduction: Transcatheter aortic valve implantation (TAVI) is a valuable therapy in selected pa... more Introduction: Transcatheter aortic valve implantation (TAVI) is a valuable therapy in selected patients with severe aortic stenosis. However, ∼30% of patients develop a new left bundle branch block...
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Jan 28, 2015
Our aim was to evaluate the long-term device performance and clinical outcomes of patients with s... more Our aim was to evaluate the long-term device performance and clinical outcomes of patients with symptomatic, severe aortic valve stenosis (AS) who underwent transcatheter aortic valve implantation (TAVI) with the CoreValve bioprosthesis. The CoreValve CE Pivotal Study was a prospective, multicentre, single-arm TAVI trial using the CoreValve system. Valve performance, patient quality of life (QoL), New York Heart Association (NYHA) class, and mortality at four years were analysed in 126 patients (mean age 82.4 years, 42.9% male, mean logistic EuroSCORE 23.4%) with severe AS. Mean aortic valve gradient decreased from 46.9±16.1 mmHg at baseline to 9.8±4.1 mmHg at discharge and to 7.8±2.7 mmHg at four years. Mean effective orifice area increased from 0.7±0.2 cm2 to 1.8±0.4 cm2 after TAVI and was 1.6±0.5 cm2 at four years. There were no reports of structural valve deterioration or valve migration. There was sustained improvement in QoL and NYHA class in surviving patients. All-cause and ...
The Lancet, 2019
BACKGROUND The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferi... more BACKGROUND The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferiority trial that compared percutaneous coronary intervention (PCI) using first-generation paclitaxel-eluting stents with coronary artery bypass grafting (CABG) in patients with de-novo three-vessel and left main coronary artery disease, and reported results up to 5 years. We now report 10-year all-cause death results. METHODS The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension of follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to the PCI group or CABG group. Patients with a history of PCI or CABG, acute myocardial infarction, or an indication for concomitant cardiac surgery were excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause death, which was assessed acc...
atrick W. Serruys, MD, PHD, FACC,* Georgios Sianos, MD, PHD,* Alexandre Abizaid, MD,† iro Aoki, M... more atrick W. Serruys, MD, PHD, FACC,* Georgios Sianos, MD, PHD,* Alexandre Abizaid, MD,† iro Aoki, MD,* Peter den Heijer, MD, PHD,‡ Hans Bonnier, MD, PHD,§ Pieter Smits, MD, PHD, ougal McClean, MD,¶ Stefan Verheye, MD, PHD,# Jorge Belardi, MD,** Jose Condado, MD,†† ichel Pieper, MD,‡‡ Louise Gambone, BA,§§ Marco Bressers, MSC, Janette Symons, duardo Sousa, MD,† Frank Litvack, MD, FACC§§ otterdam, Breda, and Eindhoven, the Netherlands; Sao Paulo, Brazil; Christchurch, New Zealand; Antwerp, elgium; Buenos Aires, Argentina; Caracas, Venezuela; Kreuzlingen, Switzerland; and Menlo Park, California
Heart
ObjectivesThe balloon-expandable Sapien-3 valve demonstrated superior results in terms of residua... more ObjectivesThe balloon-expandable Sapien-3 valve demonstrated superior results in terms of residual aortic regurgitation when compared with self-expandable devices. We aimed to compare for the first-time early outcomes of Sapien-3 transcatheter heart valve (THV) with the balloon-expandable Myval device.MethodsConsecutive real-world patients from nine European institutions with symptomatic severe aortic stenosis treated either with Sapien-3 or Myval THV devices after June 2018 were compared. Early clinical outcomes were prospectively gathered and blinded analysis of 30-day echocardiography was conducted. Matching for the following variables was performed: age, body surface area, Society of Thoracic Surgeons risk score, left ventricular function, mean gradient, transfemoral approach, aortic valvular calcium, aortic annulus mean diameter, area and eccentricity index.ResultsA total of 416 patients treated either with the Sapien-3 (n=286, 68.7%) or with Myval THV (n=130, 31.3%) were inclu...
The American Journal of Cardiology
Older patients who undergo coronary interventions are at greater risk of ischemic events and less... more 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.
International Journal of Cardiology
BACKGROUND The COMBO drug-eluting stent combines sirolimus-elution from a biodegradable polymer w... more 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).
Journal of the American College of Cardiology
Analyses of thrombi of patients with ST-segment elevation myocardial infarction (STEMI) showed, i... more Analyses of thrombi of patients with ST-segment elevation myocardial infarction (STEMI) showed, in addition to fresh thrombi, also a prevalence of relatively old thrombi. Old thrombi were present in up to 50% of patients with STEMI and associated with a worse prognosis. No data are available
International Journal of Cardiology
The American journal of cardiology, 2018
In patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutan... more In patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI), lack of ST-segment resolution (STR) is associated with poor prognosis at short- and long-term follow-up. The aim of this study was to evaluate the role of STR on very long-term outcomes in patients with STEMI treated with pPCI included in the EXAMINATION (Evaluation of the Xience-V Stent in Acute Myocardial Infarction) trial. Patients were stratified according to the presence of STR < 50% and STR < 70% at the 30-minute post-pPCI electrocardiogram. Primary end point was the patient-oriented composite endpoint (POCE) of all-cause death, any myocardial infarction, or any revascularization at 5-year follow-up. Both baseline and post-PCI 30-minute electrocardiograms were available for STR assessment in 1,351 patients. Of these patients, 228 (16.9%) and 500 (37.0%) exhibited STR < 50% and STR < 70%, respectively. At 5-year follow-up, the POCE was ...
Journal of the American College of Cardiology
TCT-470 Two Year Clinical Results after Deployment of the Abluminal Sirolimus Coated Bio-Engineer... more TCT-470 Two Year Clinical Results after Deployment of the Abluminal Sirolimus Coated Bio-Engineered (COMBO) Stent in a Thousand Patient All-Comers Registry Deborah Kalkman, Pier Woudstra, Peter Den Heijer, Ian Brian Alexander Menown, Andrejs Erglis, Harry Suryapranata, Karin Arkenbout, Andres Iñiguez, Arnoud van’t Hof, Philippe Muller, Jan Tijssen, Robbert de Winter Academic Medical Center, Amsterdam, Netherlands; CVPath, Gaithersburg, Netherlands; Amphia Hospital Breda, Breda, Netherlands; Craigavon Cardiac Centre, Craigavon, Northern Ireland, United Kingdom; P. Stradins Clinical University Hospital, Riga, Latvia; Zwolle, Netherlands; Ter Gooi Hospitals, Ouderkerk Amstel, Netherlands; Hosp. Álvaro Cunqueiro, Vigo, Spain; Isala, Zwolle, Zwolle, Netherlands; INCCI, Luxembourg, Luxembourg; AMC-UVA, Naarden, Netherlands; Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2017
Patients presenting with acute coronary syndrome (ACS) are at increased risk of complications aft... more Patients presenting with acute coronary syndrome (ACS) are at increased risk of complications after percutaneous coronary intervention with stent placement compared to patients with stable angina (SA) treated in an elective setting. The novel pro-healing COMBO stent is a bio-engineered drug eluting stent designed to promote vessel healing. Therefore, the stent may reduce this difference in clinical outcomes between elective and ACS-patients and prevent late stent thrombosis. The European, prospective, multicenter, 1000 all-comers patient REMEDEE registry evaluates clinical outcomes after COMBO stent placement in ACS- and elective patients. The primary endpoint at 12 months is target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction and target lesion revascularization. A total of 49.9% (n = 498) of patients presented with acute coronary syndrome. TLF was 7.1% in ACS patients, definite and probable stent thrombosis was observed in 0.5% of ACS pati...
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Jan 10, 2016
Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve... more Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System (DFM-TAVS), when used in routine clinical practice. This is a prospective, open-label, multicentre, post-market registry of patients treated with DFM-TAVS according to approved commercial indications. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events were adjudicated and classified according to VARC-2 criteria by an independent clinical events committee. The primary endpoint was freedom from all-cause mortality at 30 days post procedure. Secondary endpoints included procedural, early safety and efficacy endpoints at 30 days. Two hundred and fifty patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) with the DFM-TAVS were enrolled in 21 European centres. The primary endpoint, freedom from all-cause mortality at 30 days, was met in 98% (245/250) of patients. Device success was 83.8%....
Journal of the American College of Cardiology, 2016
TCT-263 Impact of Diabetes on Clinical Outcomes in Patients Undergoing Unprotected Left Main Perc... more TCT-263 Impact of Diabetes on Clinical Outcomes in Patients Undergoing Unprotected Left Main Percutaneous Coronary Intervention with Drug-Eluting Stents Bo Xu, Jonathan Murphy, Yuejin Yang, Shubin Qiao, Changdong Guan, Runlin Gao, Ajay Kirtane Fu Wai Hospital, Beijing, Beijing, China; department of medicine, Herning hospital, denmark, new york, New York, United States; Cardiovascular Institute and Fu Wai Hospital, Beijing, Beijing, China; Beijing Fuwai Hospital, Beijing, Beijing, China; Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, Beijing, China; Fu Wai Hospital, Beijing, Beijing, China; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States
Journal of the American College of Cardiology, 2016
Drug eluting stents with biodegradable polymer have been developed to address the risk of very la... more Drug eluting stents with biodegradable polymer have been developed to address the risk of very late adverse events. COMPARE II is one of the largest randomized studies comparing the biodegradable polymer-coated biolimus-eluting stent (BES; Nobori®) with second-generation durable polymer-coated
Journal of the American College of Cardiology, 2016
TCT-470 Two Year Clinical Results after Deployment of the Abluminal Sirolimus Coated Bio-Engineer... more TCT-470 Two Year Clinical Results after Deployment of the Abluminal Sirolimus Coated Bio-Engineered (COMBO) Stent in a Thousand Patient All-Comers Registry Deborah Kalkman, Pier Woudstra, Peter Den Heijer, Ian Brian Alexander Menown, Andrejs Erglis, Harry Suryapranata, Karin Arkenbout, Andres Iñiguez, Arnoud van’t Hof, Philippe Muller, Jan Tijssen, Robbert de Winter Academic Medical Center, Amsterdam, Netherlands; CVPath, Gaithersburg, Netherlands; Amphia Hospital Breda, Breda, Netherlands; Craigavon Cardiac Centre, Craigavon, Northern Ireland, United Kingdom; P. Stradins Clinical University Hospital, Riga, Latvia; Zwolle, Netherlands; Ter Gooi Hospitals, Ouderkerk Amstel, Netherlands; Hosp. Álvaro Cunqueiro, Vigo, Spain; Isala, Zwolle, Zwolle, Netherlands; INCCI, Luxembourg, Luxembourg; AMC-UVA, Naarden, Netherlands; Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark
Journal of the American College of Cardiology, 2016
RESULTS A total of 1119 confirmed STEMI patients (51.7%) were admitted during OFF-hours and 1048 ... more RESULTS A total of 1119 confirmed STEMI patients (51.7%) were admitted during OFF-hours and 1048 (48.3%) patients during ONhours. Baseline characteristics were well balanced between the two groups including features of high risk STEMI such as cardiac arrest (8.9% vs. 7.9% p 1⁄40.55) and shock (14.7% vs. 12.3 % p1⁄4 0.30). Time from symptom onset to First Medical Contact (FMC) and from FMC to angiography were similar during OFF-hours and ON-hours (120 min p1⁄40.67 and 94 min p1⁄40.2). The use of radial access was high and not different (87.5 % and 88.4 %, p1⁄40.27) in OFFvs. ON-hours. In-Hospital mortality during OFFvs. ON-hours was 1.6 % vs. 2.8% in patients without cardiac arrest or shock (p1⁄40.14) and 45.1 % vs. 50.4% (p1⁄40.39) in those with cardiac arrest or shock. At one-year follow-up, there was no impact of admission time on all-cause mortality (12% vs. 13.4%, p1⁄40.40).
Circulation, Nov 22, 2011
Introduction: Transcatheter aortic valve implantation (TAVI) is a valuable therapy in selected pa... more Introduction: Transcatheter aortic valve implantation (TAVI) is a valuable therapy in selected patients with severe aortic stenosis. However, ∼30% of patients develop a new left bundle branch block...
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Jan 28, 2015
Our aim was to evaluate the long-term device performance and clinical outcomes of patients with s... more Our aim was to evaluate the long-term device performance and clinical outcomes of patients with symptomatic, severe aortic valve stenosis (AS) who underwent transcatheter aortic valve implantation (TAVI) with the CoreValve bioprosthesis. The CoreValve CE Pivotal Study was a prospective, multicentre, single-arm TAVI trial using the CoreValve system. Valve performance, patient quality of life (QoL), New York Heart Association (NYHA) class, and mortality at four years were analysed in 126 patients (mean age 82.4 years, 42.9% male, mean logistic EuroSCORE 23.4%) with severe AS. Mean aortic valve gradient decreased from 46.9±16.1 mmHg at baseline to 9.8±4.1 mmHg at discharge and to 7.8±2.7 mmHg at four years. Mean effective orifice area increased from 0.7±0.2 cm2 to 1.8±0.4 cm2 after TAVI and was 1.6±0.5 cm2 at four years. There were no reports of structural valve deterioration or valve migration. There was sustained improvement in QoL and NYHA class in surviving patients. All-cause and ...