Publications by authors named "Clemens von Birgelen"

217 Publications

Similar long-term outcome of dissimilar drug-eluting stents: is it time to change the assessment?

EuroIntervention 2021 Apr 2;16(18):e1468-e1469. Epub 2021 Apr 2.

Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.

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http://dx.doi.org/10.4244/EIJV16I18A266DOI Listing
April 2021

Impact of renin-angiotensin system inhibitors on mortality during the COVID Pandemic among STEMI patients undergoing mechanical reperfusion: Insight from an international STEMI registry.

Biomed Pharmacother 2021 Mar 16;138:111469. Epub 2021 Mar 16.

Division of Cardiology, Ospedale degli Infermi, ASL Biella, Italy.

Background: Concerns have been raised on a potential interaction between renin-angiotensin system inhibitors (RASI) and the susceptibility to coronavirus disease 2019 (COVID-19). No data have been so far reported on the prognostic impact of RASI in patients suffering from ST-elevation myocardial infarction (STEMI) during COVID-19 pandemic, which was the aim of the present study.

Methods: STEMI patients treated with primary percutaneous coronary intervention (PPCI) and enrolled in the ISACS-STEMI COVID-19 registry were included in the present sub-analysis and divided according to RASI therapy at admission.

Results: Our population is represented by 6095 patients, of whom 3654 admitted in 2019 and 2441 in 2020. No difference in the prevalence of SARSCoV2 infection was observed according to RASI therapy at admission (2.5% vs 2.1%, p = 0.5), which was associated with a significantly lower mortality (adjusted OR [95% CI]=0.68 [0.51-0.90], P = 0.006), confirmed in the analysis restricted to 2020 (adjusted OR [95% CI]=0.5[0.33-0.74], P = 0.001). Among the 5388 patients in whom data on in-hospital medication were available, in-hospital RASI therapy was associated with a significantly lower mortality (2.1% vs 16.7%, OR [95% CI]=0.11 [0.084-0.14], p < 0.0001), confirmed after adjustment in both periods. Among the 62 SARSCoV-2 positive patients, RASI therapy, both at admission or in-hospital, showed no prognostic effect.

Conclusions: This is the first study to investigate the impact of RASI therapy on the prognosis and SARSCoV2 infection of STEMI patients undergoing PPCI during the COVID-19 pandemic. Both pre-admission and in-hospital RASI were associated with lower mortality. Among SARSCoV2-positive patients, both chronic and in-hospital RASI therapy showed no impact on survival.
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http://dx.doi.org/10.1016/j.biopha.2021.111469DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7962982PMC
March 2021

Acute myocardial infarction treated with novel Resolute Onyx and Orsiro stents in the randomized BIONYX trial.

Catheter Cardiovasc Interv 2021 Mar 10. Epub 2021 Mar 10.

Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.

Objectives: To compare 2-year outcome following treatment with drug-eluting stents (DES) for acute myocardial infarction (MI) versus non-MI clinical syndromes. In acute MI patients, a stent-level comparison was performed, comparing Resolute Onyx versus Orsiro stents.

Background: In patients presenting with acute MI, higher adverse event rates have been reported. So far, no clinical results >1 year have been published of acute MI patients treated with Resolute Onyx.

Methods: This post-hoc analysis of the randomized BIONYX trial(NCT02508714) assessed the main outcome target vessel failure (TVF: cardiac death, target vessel MI, or target vessel revascularization) with Kaplan-Meier methods.

Results: Of all 2,488 trial participants, acute MI patients (n = 1,275[51.2%]) were significantly younger and had less comorbidities than non-MI patients (n = 1,213[48.8%]). TVF rates were lower in acute MI patients (77/1,275[6.1%] vs. 103/1,213[8.6%], HR:0.70, 95%-CI 0.52-0.94; p = 0.02), mainly driven by target vessel revascularization (4.1 vs. 6.1%, p = 0.03). Multivariate analysis showed no independent association of clinical syndrome with TVF (adjusted-HR: 0.81, 95%-CI 0.60-1.10; p = .17). In MI patients treated with Resolute Onyx (n = 626) versus Orsiro (n = 649), there was no difference in TVF (6.2 vs. 6.1%; p = 0.97) and its components. There was only 1(0.2%) definite-or-probable stent thrombosis in RO-ZES and 8(1.2%) in O-SES (p = .053).

Conclusions: Two years after treatment with thin-strut DES in this randomized trial, patients treated for acute MI had lower adverse event rates than non-MI patients. Yet, these findings were mainly attributable to between-group differences in patient and lesion characteristics. In patients who underwent PCI for acute MI, both Resolute Onyx and Orsiro showed favorable and similar 2-year outcomes.
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http://dx.doi.org/10.1002/ccd.29594DOI Listing
March 2021

Detection of Major Cardioembolic Sources in Real-World Patients with Ischemic Stroke or Transient Ischemic Attack of Undetermined Cause.

Cerebrovasc Dis Extra 2021 Feb 1;11(1):22-28. Epub 2021 Feb 1.

Department of Neurology, Isala Hospital, Zwolle, The Netherlands.

Background/aim: Current guidelines recommend transthoracic echocardiography (TTE) and ambulatory rhythm monitoring following ischemic stroke or transient ischemic attack (TIA) of undetermined cause for identifying cardioembolic sources (CES). Due to ongoing controversies about this routine strategy, we evaluated its yield in a real-world setting.

Methods: In a tertiary medical center, we retrospectively evaluated consecutive patients with ischemic stroke or TIA of undetermined cause, who (after standard work-up) underwent TTE, ambulatory rhythm monitoring, or both. CES were classified as major if probably related to ischemic events and warranting a change of therapy.

Results: Between January 2014 and December 2017, 674 patients had ischemic stroke or TIA of undetermined cause. Of all 484 patients (71.8%) who underwent TTE, 9 (1.9%) had a major CES. However, 7 of them had already been identified for cardiac evaluation due to new major electrocardiographic abnormalities or cardiac symptoms. Thus, only 2 patients (0.4%) truly benefitted from unselected TTE screening. Ambulatory rhythm monitoring was performed in 411 patients (61.0%) and revealed AF in 10 patients (2.4%).

Conclusion: Detecting a major CES is essential because appropriate treatment lowers the risk of recurrent stroke. Nonetheless, in this real-world study that aimed at routine use of TTE and ambulatory rhythm monitoring in patients with ischemic stroke or TIA of undetermined cause, the prevalence of major CES was low. Most patients with major CES on TTE already had an indication for referral to a cardiologist, suggesting that major CES might also have been identified with a much more selective use of TTE.
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http://dx.doi.org/10.1159/000512743DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7989814PMC
February 2021

Use of the left radial artery as vascular access for coronary angiography and as a bypass conduit: A clinical dilemma?

Cardiovasc Revasc Med 2021 Jan 16. Epub 2021 Jan 16.

Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, P.O. Box 217, 7500 AE Enschede, the Netherlands. Electronic address:

Purpose: International coronary revascularization guidelines recommend both, transradial vascular access for coronary angiography/intervention and use of the radial artery as a conduit for coronary artery bypass grafting (CABG). These recommendations may pose a clinical dilemma, as transradial access exposes these arteries to vascular trauma which makes them potentially unsuitable as future grafts. In this study, we investigated the awareness and views of cardiologists on these guideline recommendations.

Methods: We performed semi-structured interviews with 50 cardiologists from 19 centers, who regularly perform coronary angiographies or interventions, and outlined clinical scenarios to evaluate their preference of vascular access. In addition, we assessed whether preference was related to sub-specialization.

Results: The interviewed cardiologists had 16 ± 9.3 years of professional experience. There were 23 (46%) cardiologists from 7 centers without percutaneous coronary intervention facilities, and 27 (56%) cardiologists from 12 interventional centers. All 50 (100%) cardiologists indicated familiarity with the guidelines, yet 28 (56%) said not to be familiar with the aforementioned dilemma, and 9 (18%) stated there was no dilemma at all. Responses did not differ significantly between interventional (n = 28) and non-interventional (n = 22) cardiologists; however, if the right radial artery was unavailable (e.g., occluded), interventional cardiologists more often said to prefer access via the left radial artery (18/28 (64%) vs. 5/22 (23%), p = 0.001).

Conclusion: More than half of the interviewed cardiologists indicated that they had not realized that left transradial access preceding CABG may preclude later use of this artery as a conduit. Notably, in case of unavailability of the right radial artery, interventional cardiologists preferred left transradial access more often than non-interventional cardiologists.
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http://dx.doi.org/10.1016/j.carrev.2021.01.014DOI Listing
January 2021

Impact of COVID-19 pandemic and diabetes on mechanical reperfusion in patients with STEMI: insights from the ISACS STEMI COVID 19 Registry.

Cardiovasc Diabetol 2020 12 18;19(1):215. Epub 2020 Dec 18.

Division of Cardiology, Azienda Ospedaliero-Universitaria Maggiore della Carità, Università del Piemonte Orientale, Novara, Italy.

Background: It has been suggested the COVID pandemic may have indirectly affected the treatment and outcome of STEMI patients, by avoidance or significant delays in contacting the emergency system. No data have been reported on the impact of diabetes on treatment and outcome of STEMI patients, that was therefore the aim of the current subanalysis conducted in patients included in the International Study on Acute Coronary Syndromes-ST Elevation Myocardial Infarction (ISACS-STEMI) COVID-19.

Methods: The ISACS-STEMI COVID-19 is a retrospective registry performed in European centers with an annual volume of > 120 primary percutaneous coronary intervention (PCI) and assessed STEMI patients, treated with primary PCI during the same periods of the years 2019 versus 2020 (March and April). Main outcomes are the incidences of primary PCI, delayed treatment, and in-hospital mortality.

Results: A total of 6609 patients underwent primary PCI in 77 centers, located in 18 countries. Diabetes was observed in a total of 1356 patients (20.5%), with similar proportion between 2019 and 2020. During the pandemic, there was a significant reduction in primary PCI as compared to 2019, similar in both patients with (Incidence rate ratio (IRR) 0.79 (95% CI: 0.73-0.85, p < 0.0001) and without diabetes (IRR 0.81 (95% CI: 0.78-0.85, p < 0.0001) (p int = 0.40). We observed a significant heterogeneity among centers in the population with and without diabetes (p < 0.001, respectively). The heterogeneity among centers was not related to the incidence of death due to COVID-19 in both groups of patients. Interaction was observed for Hypertension (p = 0.024) only in absence of diabetes. Furthermore, the pandemic was independently associated with a significant increase in door-to-balloon and total ischemia times only among patients without diabetes, which may have contributed to the higher mortality, during the pandemic, observed in this group of patients.

Conclusions: The COVID-19 pandemic had a significant impact on the treatment of patients with STEMI, with a similar reduction in primary PCI procedures in both patients with and without diabetes. Hypertension had a significant impact on PCI reduction only among patients without diabetes. We observed a significant increase in ischemia time and door-to-balloon time mainly in absence of diabetes, that contributed to explain the increased mortality observed in this group of patients during the pandemic.

Trial Registration Number: NCT04412655.
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http://dx.doi.org/10.1186/s12933-020-01196-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7747477PMC
December 2020

Coronary bifurcations treated with thin-strut drug-eluting stents: a prespecified analysis of the randomized BIO-RESORT trial.

Coron Artery Dis 2021 Jan;32(1):51-57

Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente.

Background: Treatment of a coronary bifurcation lesion is often required in routine clinical practice, but data on the performance of very thin-strut biodegradable polymer drug-eluting stents are scarce.

Methods: Comparison of biodegradable polymer and durable polymer drug-eluting stents in an all comers population (BIO-RESORT) is a prospective, multicenter randomized clinical trial that included 3514 all-comer patients, who were randomized to very thin-strut biodegradable polymer-coated sirolimus- or everolimus-eluting stents, versus thin-strut durable polymer-coated zotarolimus-eluting stents. The approach of bifurcation stenting was left at the operator's discretion, and provisional stenting was generally preferred. This prespecified analysis assessed 3-year clinical outcome of all patients in whom treatment involved at least one bifurcation with a side-branch diameter ≥1.5 mm.

Results: Of all BIO-RESORT trial participants, 1236 patients were treated in bifurcation lesions and analyzed. Single- and two-stent techniques were used in 85.8% and 14.2%, respectively. 'True' bifurcation lesions (main vessel and side-branch obstructed) were treated in 31.1%. Three-year follow-up was available in 1200/1236 (97.1%) patients. The main endpoint target vessel failure (composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization) occurred in sirolimus-eluting stents in 42/412 (10.3%) and in zotarolimus-eluting stents in 49/409 (12.1%) patients (P-logrank = 0.40). In everolimus-eluting stents, target vessel failure occurred in 40/415 (9.8%) patients (vs. zotarolimus-eluting stents: P-logrank = 0.26). There was no between-stent difference in individual components of target vessel failure. Findings were consistent in patients with single-vessel treatment and patients treated with a single-stent technique.

Conclusions: Three years after stenting all-comers with bifurcation lesions, clinical outcome was similar with the sirolimus-eluting and everolimus-eluting stents versus the zotarolimus-eluting stent.
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http://dx.doi.org/10.1097/MCA.0000000000000891DOI Listing
January 2021

Cardiac procedural myocardial injury, infarction, and mortality in patients undergoing elective percutaneous coronary intervention: a pooled analysis of patient-level data.

Eur Heart J 2021 Jan;42(4):323-334

The Hatter Cardiovascular Institute, University College London, London, UK.

Aims: The prognostic importance of cardiac procedural myocardial injury and myocardial infarction (MI) in chronic coronary syndrome (CCS) patients undergoing elective percutaneous coronary intervention (PCI) is still debated.

Methods And Results: We analysed individual data of 9081 patients undergoing elective PCI with normal pre-PCI baseline cardiac troponin (cTn) levels. Multivariate models evaluated the association between post-PCI elevations in cTn and 1-year mortality, while an interval analysis evaluated the impact of the size of the myocardial injury on mortality. Our analysis was performed in the overall population and also according to the type of cTn used [52.0% had high-sensitivity cTn (hs-cTn)]. Procedural myocardial injury, as defined by the Fourth Universal Definition of MI (UDMI) [post-PCI cTn elevation ≥1 × 99th percentile upper reference limit (URL)], occurred in 52.8% of patients and was not associated with 1-year mortality [adj odds ratio (OR), 1.35, 95% confidence interval (CI) (0.84-1.77), P = 0.21]. The association between post-PCI cTn elevation and 1-year mortality was significant starting ≥3 × 99th percentile URL. Major myocardial injury defined by post-PCI ≥5 × 99th percentile URL occurred in 18.2% of patients and was associated with a two-fold increase in the adjusted odds of 1-year mortality [2.29, 95% CI (1.32-3.97), P = 0.004]. In the subset of patients for whom periprocedural evidence of ischaemia was collected (n = 2316), Type 4a MI defined by the Fourth UDMI occurred in 12.7% of patients and was strongly associated with 1-year mortality [adj OR 3.21, 95% CI (1.42-7.27), P = 0.005]. We also present our results according to the type of troponin used (hs-cTn or conventional troponin).

Conclusion: Our analysis has demonstrated that in CCS patients with normal baseline cTn levels, the post-PCI cTn elevation of ≥5 × 99th percentile URL used to define Type 4a MI is associated with 1-year mortality and could be used to detect 'major' procedural myocardial injury in the absence of procedural complications or evidence of new myocardial ischaemia.
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http://dx.doi.org/10.1093/eurheartj/ehaa885DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7850039PMC
January 2021

Treating diabetic all-comers with contemporary drug-eluting stents: Prespecified comparisons from the BIO-RESORT and the BIONYX randomized trials.

Int J Cardiol 2021 02 22;325:37-44. Epub 2020 Oct 22.

Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands. Electronic address:

Background: Patients with diabetes have more extensive coronary disease, resulting in higher risks of adverse clinical events following stenting. In all-comer patients, contemporary DES have shown excellent safety and efficacy, but data on diabetic patients are scarce. Separately for the BIO-RESORT and BIONYX trials, we assessed the 2-year clinical outcomes of diabetic patients, treated with various contemporary drug-eluting stents (DES).

Methods: We performed two prespecified secondary analyses of two randomized DES trials, which both stratified for diabetes. The main endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. Follow-up was finished before the COVID-19 pandemic.

Results: In BIO-RESORT, 624/3514 (17.8%) had diabetes: 211 received Orsiro sirolimus-eluting stents (SES), 203 Synergy everolimus-eluting stents (EES), and 210 Resolute Integrity zotarolimus-eluting stents (RI-ZES). TVF did not differ between SES (10.2%) and EES (10.0%) versus RI-ZES (12.7%) (SES vs. RI-ZES HR:0.78, 95%-CI [0.44-1.40]; p = 0.40, EES vs. RI-ZES HR:0.79, 95%-CI [0.44-1.40]; p = 0.42). In BIONYX, 510/2488 (20.5%) patients had diabetes: 250 received SES and 260 Resolute Onyx zotarolimus-eluting stents (RO-ZES). There was no difference in TVF between SES (10.7%) versus RO-ZES (12.2%) (HR:0.88, 95%-CI [0.52-1.48]; p = 0.63).

Conclusions: There was no difference in 2-year clinical outcome among patients with diabetes, who were treated with SES, or EES, versus RI-ZES. In addition there was no difference in clinical outcome in diabetic patients, who were treated with SES versus RO-ZES. These findings may be considered as a signal of safety and efficacy of the studied DES in patients with diabetes.
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http://dx.doi.org/10.1016/j.ijcard.2020.10.051DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7581320PMC
February 2021

Ticagrelor Versus Clopidogrel in Older Patients with NSTE-ACS Using Oral Anticoagulation: A Sub-Analysis of the POPular Age Trial.

J Clin Med 2020 Oct 12;9(10). Epub 2020 Oct 12.

Department of Cardiology, St. Antonius Hospital, 3435CM Nieuwegein, The Netherlands.

There are no randomised data on which antiplatelet agent to use in elderly patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) and an indication for oral anticoagulation (OAC). The randomised POPular Age trial, in patients of 70 years or older with NSTE-ACS, showed a reduction in bleeding without increasing thrombotic events in patients using clopidogrel as compared to ticagrelor. In this sub-analysis of the POPular AGE trial, we compare clopidogrel with ticagrelor in patients with a need for oral anticoagulation. The follow-up duration was one year. The primary bleeding outcome was Platelet Inhibition and Patient Outcomes (PLATO) major and minor bleeding. The primary thrombotic outcome consisted of cardiovascular death, myocardial infarction and stroke. The primary net clinical benefit outcome was a composite of all-cause death, myocardial infarction, stroke, and PLATO major and minor bleeding. A total of 184/1011 (18.2%) patients on OAC were included in this subanalysis; 83 were randomized to clopidogrel and 101 to ticagrelor. The primary bleeding outcome was lower in the clopidogrel group (17/83, 20.9%) compared to the ticagrelor group (33/101, 33.5%; = 0.051), as was the thrombotic outcome (7/83, 8.4% vs. 19/101, 19.2%; = 0.035) and the primary net clinical benefit outcome (23/83, 27.7% vs. 49/101, 48.5%; = 0.003). In this subgroup of patients using OAC, clopidogrel reduced PLATO major and minor bleeding compared to ticagrelor without increasing thrombotic risk. This analysis therefore suggests that, in line with the POPular Age trial, clopidogrel is a better option than ticagrelor in NSTE-ACS patients ≥70 years using OAC.
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http://dx.doi.org/10.3390/jcm9103249DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7601891PMC
October 2020

Sustained Safety and Performance of the Second-Generation Sirolimus-Eluting Absorbable Metal Scaffold: Pooled Outcomes of the BIOSOLVE-II and -III Trials at 3 Years.

Cardiovasc Revasc Med 2020 Sep 13;21(9):1150-1154. Epub 2020 Apr 13.

Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.

Background/purpose: To avoid long-term effects associated with permanent implants, bioresorbable vascular scaffolds were developed, as they provide transient vessel support and disappear thereafter. The aim of the BIOSOLVE-II and -III studies was to assess the safety and performance of a magnesium-based sirolimus-eluting scaffold; we report the clinical outcomes at 3 years, 2 years after scaffold resorption.

Methods/materials: BIOSOLVE-II and BIOSOLVE-III are international, prospective multi-center studies, including 184 patients with 189 de novo lesions and stable or unstable angina, or documented silent ischemia. Acute myocardial infarction, 3-vessel coronary artery disease, and heavily calcified lesions were excluded. Antiplatelet therapy was recommended for 6 months.

Results: Patients were 65.5 ± 10.8 years old, and lesions were 12.1 ± 4.5 mm long and located in vessels with a diameter of 2.7 ± 0.4 mm. More than half of the lesions (56.5%) were type B2/C lesions. At 2 years, 92.5% (160/173) of patients were symptom-free and 91.5% (151/165) at 3 years; all the other patients had stable angina. At 3 years, target lesion failure occurred in 11 patients (6.3%), consisting of 4 cardiac deaths (2.3%), one target-vessel myocardial infarction (0.6%), and 6 clinically driven target lesion revascularizations (3.4%). There was no definite or probable scaffold thrombosis.

Conclusion: In a low-risk patient population, treatment with a sirolimus-eluting magnesium bioresorbable scaffold can be considered safe, in particular with no definite or probable scaffold thrombosis.

Annotated Table Of Contents: BIOSOLVE-II and -III are prospective, international, multi-center studies including 184 patients with de novo lesions. At 3 years, target lesion failure was 6.3%, consisting of 4 cardiac deaths (2.3%), one target-vessel myocardial infarction (0.6%), and 6 clinically driven target lesion revascularizations (3.4%). There was no definite or probable scaffold thrombosis.
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http://dx.doi.org/10.1016/j.carrev.2020.04.006DOI Listing
September 2020

New-generation drug-eluting coronary stents in octogenarians: Patient-level pooled analysis from the TWENTE I-IV trials.

Am Heart J 2020 10 12;228:109-115. Epub 2020 Jul 12.

Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands. Electronic address:

Background: Patients aged ≥80 years are often treated with new-generation drug-eluting stents (DES), but data from randomized studies are scarce owing to underrepresentation in most trials. We assessed 1-year clinical outcome of octogenarians treated with new-generation DES versus younger patients.

Methods: We pooled patient-level data of 9,204 participants in the TWENTE, DUTCH PEERS, BIO-RESORT, and BIONYX (TWENTE I-IV) randomized trials. The main clinical end point was target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction (MI), or clinically indicated target vessel revascularization.

Results: The 671 octogenarian trial participants had significantly more comorbidities. TVF was higher in octogenarians than in 8,533 patients <80 years (7.3% vs 5.3%, hazard ratio [HR]: 1.36, 95% CI: 1.0-1.83, P = .04). The cardiac death rate was higher in octogenarians (3.9% vs 0.8%, P < .001). There was no significant between-group difference in target vessel MI (2.3% vs 2.3%, P = .88) and repeat target vessel revascularization (1.9% vs 2.8%, P = .16). In multivariate analyses, age ≥ 80 years showed no independent association with TVF (adjusted HR: 1.04, 95% CI: 0.76-1.42), whereas the risk of cardiac death remained higher in octogenarians (adjusted HR: 3.38, 95% CI: 2.07-5.52, P < .001). In 6,002 trial participants, in whom data on major bleeding were recorded, octogenarians (n = 459) showed a higher major bleeding risk (5.9% vs 1.9%; HR: 3.08, 95% CI: 2.01-4.74, P < .001).

Conclusions: Octogenarian participants in 4 large-scale randomized DES trials had more comorbidities and a higher incidence of the main end point TVF. Cardiac mortality was higher in octogenarians, whereas there was no increase in MI or target vessel revascularization rates. Treatment of octogenarian patients with new-generation DES appears to be safe and effective.
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http://dx.doi.org/10.1016/j.ahj.2020.07.003DOI Listing
October 2020

Effect of Adding Ticagrelor to Standard Aspirin on Saphenous Vein Graft Patency in Patients Undergoing Coronary Artery Bypass Grafting (POPular CABG): A Randomized, Double-Blind, Placebo-Controlled Trial.

Circulation 2020 Nov 31;142(19):1799-1807. Epub 2020 Aug 31.

Department of Cardiology (L.M.W., P.W.A.J., J.P., D.R.P.P.C.P.Y., M.E.G., K.F.B., J.C.K., B.J.W.M.R., M.J.S., J.M.t.B.), St Antonius Hospital, Nieuwegein, The Netherlands.

Background: Approximately 15% of saphenous vein grafts (SVGs) occlude during the first year after coronary artery bypass graft surgery (CABG) despite aspirin use. The POPular CABG trial (The Effect of Ticagrelor on Saphenous Vein Graft Patency in Patients Undergoing Coronary Artery Bypass Grafting Surgery) investigated whether ticagrelor added to standard aspirin improves SVG patency at 1 year after CABG.

Methods: In this investigator-initiated, randomized, double-blind, placebo-controlled, multicenter trial, patients with ≥1 SVGs were randomly assigned (1:1) after CABG to ticagrelor or placebo added to standard aspirin (80 mg or 100 mg). The primary outcome was SVG occlusion at 1 year, assessed with coronary computed tomography angiography, in all patients that had primary outcome imaging available. A generalized estimating equation model was used to perform the primary analysis per SVG. The secondary outcome was 1-year SVG failure, which was a composite of SVG occlusion, SVG revascularization, myocardial infarction in myocardial territory supplied by a SVG, or sudden death.

Results: Among 499 randomly assigned patients, the mean age was 67.9±8.3 years, 87.1% were male, the indication for CABG was acute coronary syndrome in 31.3%, and 95.2% of procedures used cardiopulmonary bypass. Primary outcome imaging was available in 220 patients in the ticagrelor group and 223 patients in the placebo group. The SVG occlusion rate in the ticagrelor group was 10.5% (51 of 484 SVGs) versus 9.1% in the placebo group (43 of 470 SVGs), odds ratio, 1.29 [95% CI, 0.73-2.30]; =0.38. SVG failure occurred in 35 (14.2%) patients in the ticagrelor group versus 29 (11.6%) patients in the placebo group (odds ratio, 1.22 [95% CI, 0.72-2.05]).

Conclusions: In this randomized, placebo-controlled trial, the addition of ticagrelor to standard aspirin did not reduce SVG occlusion at 1 year after CABG. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02352402.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.050749DOI Listing
November 2020

Thin, very thin, or ultrathin-strut biodegradable or durable polymer-coated drug-eluting stents.

Curr Opin Cardiol 2020 11;35(6):705-711

Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente.

Purpose Of Review: The current article will review recently published clinical studies that evaluate very thin or ultrathin-strut drug-eluting stents (DES), focusing on major randomized clinical trials in broad patient populations.

Recent Findings: Multiple randomized trials recently assessed the clinical performance of novel very thin to ultrathin-strut DES. Most randomized trials established noninferiority of the novel device. To date, only one major randomized clinical trial (i.e., BIOFLOW V) showed superiority of an ultrathin-strut biodegradable polymer-coated sirolimus-eluting stent over a very thin-strut durable polymer-coated everolimus-eluting stent in a relatively broad patient population. There are signals that the same ultrathin-strut biodegradable polymer-coated sirolimus-eluting stent may improve clinical outcome in specific patient populations. For example, in the randomized BIOSTEMI trial, 1-year superiority of the ultrathin-strut DES was found in patients presenting with an acute ST-segment elevation myocardial infarction. Yet, substudies of large randomized trials that assessed patients with small-vessel treatment showed equivocal results.

Summary: Although two randomized trials showed advantages for ultrathin-strut DES, other clinical trials provided no significant evidence that ultrathin-strut DES improve clinical outcome. The question whether ultrathin-strut DES may reduce the repeat revascularization risk following implantation in small vessels is a matter of further debate and future research.
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http://dx.doi.org/10.1097/HCO.0000000000000786DOI Listing
November 2020

Prognostic Impact of Race in Patients Undergoing PCI: Analysis From 10 Randomized Coronary Stent Trials.

JACC Cardiovasc Interv 2020 07;13(13):1586-1595

Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address:

Objectives: The aim of this study was to assess race-based differences in patients undergoing percutaneous coronary intervention from a large pooled database of randomized controlled trials.

Background: Data on race-based outcomes after percutaneous coronary intervention are limited, deriving mainly from registries and single-center studies.

Methods: Baseline characteristics and outcomes at 30 days, 1 year, and 5 years were assessed across different races, from an individual patient data pooled analysis from 10 randomized trials. Endpoints of interest included death, myocardial infarction, and major adverse cardiac events (defined as cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization). Multivariate Cox proportional hazards regression was performed to assess associations between race and outcomes, controlling for differences in 12 baseline covariates.

Results: Among 22,638 patients, 20,585 (90.9%) were white, 918 (4.1%) were black, 404 (1.8%) were Asian, and 473 (2.1%) were Hispanic. Baseline and angiographic characteristics differed among groups. Five-year major adverse cardiac event rates were 18.8% in white patients (reference group), compared with 23.9% in black patients (p = 0.0009), 11.2% in Asian patients (p = 0.0007), and 21.5% in Hispanic patients (p = 0.07). Multivariate analysis demonstrated an independent association between black race and 5-year risk for major adverse cardiac events (hazard ratio: 1.28; 95% confidence interval: 1.05 to 1.57; p = 0.01).

Conclusions: In the present large-scale individual patient data pooled analysis, comorbidities were significantly more frequent in minority-group patients than in white patients enrolled in coronary stent randomized controlled trials. After accounting for these differences, black race was an independent predictor of worse outcomes, whereas Hispanic ethnicity and Asian race were not. Further research examining race-based outcomes after percutaneous coronary intervention is warranted to understand these differences.
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http://dx.doi.org/10.1016/j.jcin.2020.04.020DOI Listing
July 2020

Impact of coronary lesion complexity in percutaneous coronary intervention: one-year outcomes from the large, multicentre e-Ultimaster registry.

EuroIntervention 2020 Sep;16(7):603-612

Keele Cardiovascular Research Group, Centre for Prognosis Research, Institutes of Applied Clinical Science and Primary Care and Health Sciences, Keele University, Keele, Newcastle, United Kingdom.

Aims: The present study sought to examine the prevalence, clinical characteristics and one-year outcomes of patients undergoing percutaneous coronary intervention (PCI) to complex lesions (multivessel PCI, ≥3 stents, ≥3 lesions, bifurcation with ≥2 stents, total stent length >60 mm or chronic total occlusion [CTO]) in a prospective multicentre registry.

Methods And Results: Using the e-Ultimaster multicentre registry, a post hoc subgroup analysis was performed on 35,839 patients undergoing PCI, stratified by procedure complexity, and further by number and type of complex features. Overall, complex PCI patients (n=9,793, 27.3%) were older, more comorbid and were associated with an increased hazard ratio (HR) of the composite endpoint at one year (target lesion failure [TLF]: 1.41 [1.25; 1.59]), driven by an increased hazard of cardiac death (1.28 [1.05; 1.55]), target vessel myocardial infarction (1.48 [1.18; 1.86]) and clinically driven target lesion revascularisation. The hazard of complications increased with the rising number of complex features (3-6 vs 1-2 vs none) for all outcomes. All individual complex features were associated with an increased hazard of composite complications (except CTO) and definite/probable stent thrombosis.

Conclusions: Overall, complex PCI is associated with an increased risk of mortality and complications at one year. The number and types of complex features have differing impacts on long-term outcomes.
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http://dx.doi.org/10.4244/EIJ-D-20-00361DOI Listing
September 2020

Coronary Calcification and Long-Term Outcomes According to Drug-Eluting Stent Generation.

JACC Cardiovasc Interv 2020 06;13(12):1417-1428

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. Electronic address:

Objectives: The aim of this study was to evaluate the long-term impact of coronary artery calcification (CAC) on outcomes after percutaneous coronary intervention and the respective performance of first- and second-generation drug-eluting stents (DES).

Background: Whether contemporary DES have improved the long-term prognosis after percutaneous coronary intervention in lesions with severe CAC is unknown.

Methods: Individual patient data were pooled from 18 randomized trials evaluating DES, categorized according to the presence of angiography core laboratory-confirmed moderate or severe CAC. Major endpoints were the patient-oriented composite endpoint (death, myocardial infarction [MI], or any revascularization) and the device-oriented composite endpoint of target lesion failure (cardiac death, target vessel MI, or ischemia-driven target lesion revascularization). Multivariate Cox proportional regression with study as a random effect was used to assess 5-year outcomes.

Results: A total of 19,833 patients were included. Moderate or severe CAC was present in 1 or more target lesions in 6,211 patients (31.3%) and was associated with increased 5-year risk for the patient-oriented composite endpoint (adjusted hazard ratio [adjHR]: 1.12; 95% confidence interval [CI]: 1.05 to 1.20) and target lesion failure (adjHR: 1.21; 95% CI: 1.09 to 1.34), as well as death, MI, and ischemia-driven target lesion revascularization. In patients with CAC, use of second-generation DES compared with first-generation DES was associated with reductions in the 5-year risk for the patient-oriented composite endpoint (adjHR: 0.88; 95% CI: 0.78 to 1.00) and target lesion failure (adjHR: 0.73; 95% CI: 0.61 to 0.87), as well as death or MI, ischemia-driven target lesion revascularization, and stent thrombosis. The relative treatment effects of second-generation compared with first-generation DES were consistent in patients with and without moderate or severe CAC, although outcomes were consistently better with contemporary devices.

Conclusions: In this large-scale study, percutaneous coronary intervention of target lesion moderate or severe CAC was associated with adverse patient-oriented and device-oriented adverse outcomes at 5 years. These detrimental effects were mitigated with second-generation DES.
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http://dx.doi.org/10.1016/j.jcin.2020.03.053DOI Listing
June 2020

Thin Composite-Wire-Strut Zotarolimus-Eluting Stents Versus Ultrathin-Strut Sirolimus-Eluting Stents in BIONYX at 2 Years.

JACC Cardiovasc Interv 2020 05;13(9):1100-1109

Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands. Electronic address:

Objectives: The aim of this study was to assess 2-year safety and efficacy of the current-generation thin composite-wire-strut durable-polymer Resolute Onyx zotarolimus-eluting stent (ZES), compared with the ultrathin-strut biodegradable-polymer Orsiro sirolimus-eluting stent (SES) in all-comers and a pre-specified small-vessel subgroup analysis.

Background: The Resolute Onyx ZES is widely used in clinical practice, but no follow-up data beyond 1 year have been published. The randomized BIONYX (Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents) trial (NCT02508714) established the noninferiority of ZES versus SES regarding target vessel failure (TVF) rates.

Methods: A total of 2,488 all-comer patients were treated at 7 coronary intervention centers in Belgium, Israel, and the Netherlands. The main endpoint, TVF, was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (clinically indicated target vessel revascularization). Two-year follow-up data were analyzed using Kaplan-Meier methods.

Results: Two-year follow-up data were available for 2,460 of 2,488 patients (98.9%). TVF occurred in 93 of 1,243 patients (7.6%) assigned to ZES versus 87 of 1,245 patients (7.1%) assigned to SES (log-rank p = 0.66). There was no significant between-stent difference in individual components of this endpoint. The incidence of definite-or-probable stent thrombosis was low for both treatment arms (0.4% vs. 1.1%; log-rank p = 0.057). In patients stented in small vessels, there was no between-stent difference (TVF 8.2% vs. 8.7% [log-rank p = 0.75], target lesion revascularization 4.0% vs. 4.4% [log-rank p = 0.77]).

Conclusions: At 2-year follow-up, the novel thin composite-wire-strut durable-polymer Resolute Onyx ZES showed in all-comers similar safety and efficacy compared with the ultrathin cobalt-chromium-strut biodegradable-polymer Orsiro SES. The analysis of patients who were treated in small vessels also suggested no advantage for either stent.
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http://dx.doi.org/10.1016/j.jcin.2020.01.230DOI Listing
May 2020

Clopidogrel versus ticagrelor or prasugrel in patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE): the randomised, open-label, non-inferiority trial.

Lancet 2020 04;395(10233):1374-1381

Department of Cardiology, St Antonius Hospital, Nieuwegein, Netherlands. Electronic address:

Background: Current guidelines recommend potent platelet inhibition with ticagrelor or prasugrel in patients after an acute coronary syndrome. However, data about optimal platelet inhibition in older patients are scarce. We aimed to investigate the safety and efficacy of clopidogrel compared with ticagrelor or prasugrel in older patients with non-ST-elevation acute coronary syndrome (NSTE-ACS).

Methods: We did the open-label, randomised controlled POPular AGE trial in 12 sites (ten hospitals and two university hospitals) in the Netherlands. Patients aged 70 years or older with NSTE-ACS were enrolled and randomly assigned in a 1:1 ratio using an internet-based randomisation procedure with block sizes of six to receive a loading dose of clopidogrel 300 mg or 600 mg, or ticagrelor 180 mg or prasugrel 60 mg, and then a maintenance dose for the duration of 12 months (clopidogrel 75 mg once daily, ticagrelor 90 mg twice daily, or prasugrel 10 mg once daily) on top of standard care. Patient and treating physicians were aware of the allocated treatment strategy, but the outcome assessors were masked to treatment allocation. Primary bleeding outcome consisted of PLATelet inhibition and patient Outcomes (PLATO; major or minor bleeding [superiority hypothesis]). Co-primary net clinical benefit outcome consisted of all-cause death, myocardial infarction, stroke, PLATO major and minor bleeding (non-inferiority hypothesis, margin of 2%). Follow-up duration was 12 months. Analyses were done on intention-to-treat basis. This trial is registered with the Netherlands Trial Register (NL3804), ClinicalTrials.gov (NCT02317198), and EudraCT (2013-001403-37).

Findings: Between June 10, 2013, and Oct 17, 2018, 1002 patients were randomly assigned to clopidogrel (n=500) or ticagrelor or prasugrel (n=502). Because 475 (95%) patients received ticagrelor in the ticagrelor or prasugrel group, we will refer to this group as the ticagrelor group. Premature discontinuation of the study drug occurred in 238 (47%) of 502 ticagrelor group patients randomly assigned to ticagrelor, and in 112 (22%) of 500 patients randomly assigned to clopidogrel. Primary bleeding outcome was significantly lower in the clopidogrel group (88 [18%] of 500 patients) than in the ticagrelor group (118 [24%] of 502; hazard ratio 0·71, 95% CI 0·54 to 0·94; p=0·02 for superiority). Co-primary net clinical benefit outcome was non-inferior for the use of clopidogrel (139 [28%]) versus ticagrelor (161 [32%]; absolute risk difference -4%, 95% CI -10·0 to 1·4; p=0·03 for non-inferiority). The most important reasons for discontinuation were occurrence of bleeding (n=38), dyspnoea (n=40), and the need for treatment with oral anticoagulation (n=35).

Interpretation: In patients aged 70 years or older presenting with NSTE-ACS, clopidogrel is a favourable alternative to ticagrelor, because it leads to fewer bleeding events without an increase in the combined endpoint of all-cause death, myocardial infarction, stroke, and bleeding. Clopidogrel could be an alternative P2Y12 inhibitor especially for elderly patients with a higher bleeding risk.

Funding: ZonMw.
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http://dx.doi.org/10.1016/S0140-6736(20)30325-1DOI Listing
April 2020

Heterogeneity in Preferences for Anti-coagulant Use in Atrial Fibrillation: A Latent Class Analysis.

Patient 2020 08;13(4):445-455

Department of Health Technology and Services Research, Technical Medical Centre, University of Twente, Enschede, The Netherlands.

Introduction: Recent reviews on patients' preferences towards attributes of oral anti-coagulant therapy have shown that preference for convenience of therapy is heterogeneous. In this study, we used a novel approach-latent class analysis (LCA)-to assess heterogeneity.

Methods: We developed a health preference survey that consisted of 12 discrete choice questions. The following attributes of convenience were included: intake frequency; need for regular coagulation monitoring; diet or drug interactions; relation between medication and food intake; and pill type. Background questions about gender, age, current therapy [i.e., direct-acting oral anti-coagulant (DOAC) or vitamin K antagonist (VKA)], self-reported medication adherence, and pill burden were included. Mixed logit analysis (MLA) and LCA were performed. The scale-adjusted LCA model with two scale classes and four preference classes emerged as the model with the best fit and interpretability.

Results: A total of 508 patients with non-valvular atrial fibrillation from five European countries (Germany, Italy, Spain, France, and the UK) were surveyed in August 2017. The most important attributes were need for monitoring (37%) and intake frequency (27%). Patient preferences were significantly influenced by country, gender, and current anti-coagulant therapy. Four different preference classes of patients were identified in the LCA. First, most patients (57%) were in the "no need for regular coagulation monitoring" class. Current DOAC users and patients who were the least adherent to therapy were more likely to prefer no coagulation monitoring. Second, 20% of patients were in the "balanced" class of patients. Current VKA users with moderate adherence were more likely to be in this class. Patients who reported the lowest adherence were most likely in the "once daily, interactions likely" class (16%). Fourth, current VKA users and highly adherent patients were most likely to prefer therapies with a need for regular coagulation monitoring (7%).

Conclusions: This study demonstrated significant preference heterogeneity among patients with atrial fibrillation and linked these preferences to differences in background characteristics. Country of residence and currently prescribed therapy influenced patient preferences in both the MLA and LCA models.
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http://dx.doi.org/10.1007/s40271-020-00420-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7340663PMC
August 2020

Long-Term Outcomes After Revascularization for Stable Ischemic Heart Disease: An Individual Patient-Level Pooled Analysis of 19 Randomized Coronary Stent Trials.

Circ Cardiovasc Interv 2020 04 13;13(4):e008565. Epub 2020 Apr 13.

Cardiovascular Research Foundation, New York, NY (M.V.M., B.R., Z.A.A., M.P., B.S., Z.Z., R.M., A.M., M.B.L., A.J.K., G.W.S.).

Background: Whether revascularization improves prognosis in stable ischemic heart disease is controversial.

Methods: Individual patient-level data from 19 prospective, randomized stent trials were pooled. Rates of 5-year major adverse cardiovascular events (MACE; a composite of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization) were assessed and compared after percutaneous coronary intervention with bare-metal stents (BMS) and first-generation and second-generation drug-eluting stents (DES1 and DES2, respectively). Poisson multivariable regression analysis was performed to identify predictors of adverse events.

Results: Among 10 987 patients treated with percutaneous coronary intervention for stable ischemic heart disease, 1550, 2776, and 6661 received BMS, DES1, and DES2, respectively. The 5-year rates of MACE progressively declined with evolution in stent technology (BMS: 24.1% versus DES1: 17.9% versus DES2: 13.4%, <0.0001). However, MACE rates between 1 and 5 years increased from BMS to DES1, then declined with DES2 (BMS: 7.4% versus DES1: 10.2%, DES2: 8.5%, =0.02).

Conclusions: Patients with stable ischemic heart disease remain at substantial risk for long-term MACE after revascularization with percutaneous coronary intervention, even with contemporary DES. New approaches to reduce the ongoing risk of MACE beyond 1 year after stent implantation are necessary.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008565DOI Listing
April 2020

1-Year Clinical Outcomes of All Comers Treated With 2 Bioresorbable Polymer-Coated Sirolimus-Eluting Stents: Propensity Score-Matched Comparison of the COMBO and Ultrathin-Strut Orsiro Stents.

JACC Cardiovasc Interv 2020 04;13(7):820-830

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

Objectives: The aim of this study was to determine 1-year safety and efficacy after treatment with the COMBO and Orsiro stents.

Background: The COMBO stainless-steel stent has an anti-CD34 antibody coating to capture endothelial progenitor cells, thereby promoting faster endothelialization. The Orsiro is an ultrathin-strut cobalt-chromium stent, covered by an extremely thin layer of amorphous silicon carbide to minimize ion leakage. Both devices elute sirolimus from biodegradable polymers.

Methods: For this analysis we included European patients from the COMBO collaboration, a patient-level pooling of 2 prospective all-comers registries of COMBO stent implantation (n = 2,775), and all patients randomized to the Orsiro stent (n = 1,169) from the Dutch BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) randomized trial. The main outcome of interest was 1-year target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization evaluated using propensity score-matched analysis.

Results: At baseline, COMBO patients were older and had more insulin-treated diabetes, renal insufficiency, and other comorbidities. However, Orsiro patients included more current smokers and more acute coronary syndrome presentations. Orsiro patients also received longer stents and had more complex target lesions. After propensity score-matched analysis (n = 862/arm), 1-year target lesion failure occurred in 4.1% of COMBO-treated and 2.7% of Orsiro-treated patients (hazard ratio: 1.55; 95% confidence interval: 0.92 to 2.62; p = 0.10). Definite stent thrombosis occurred in 0.5% of COMBO-treated and 0.5% of Orsiro-treated patients (p = 0.99).

Conclusions: A propensity score-matched comparison of all comers treated with the COMBO or Orsiro stent showed no statistically significant differences. Stent thrombosis risk was low and similar between the stents. (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population [BIO-RESORT], NCT01674803; MASCOT-Post Marketing Registry [MASCOT], NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the Combo Stent [REMEDEE Reg], NCT01874002).
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http://dx.doi.org/10.1016/j.jcin.2019.11.023DOI Listing
April 2020

Long-Term Outcomes in Women and Men Following Percutaneous Coronary Intervention.

J Am Coll Cardiol 2020 04;75(14):1631-1640

Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address:

Background: Studies examining sex-related outcomes following percutaneous coronary intervention (PCI) have reported conflicting results.

Objectives: The purpose of this study was to examine the sex-related risk of 5-year cardiovascular outcomes after PCI.

Methods: The authors pooled patient-level data from 21 randomized PCI trials and assessed the association between sex and major adverse cardiac events (MACE) (cardiac death, myocardial infarction [MI], or ischemia-driven target lesion revascularization [ID-TLR]) as well as its individual components at 5 years.

Results: Among 32,877 patients, 9,141 (27.8%) were women. Women were older and had higher body mass index, more frequent hypertension and diabetes, and less frequent history of surgical or percutaneous revascularization compared with men. By angiographic core laboratory analysis, lesions in women had smaller reference vessel diameter and shorter lesion length. At 5 years, women had a higher unadjusted rate of MACE (18.9% vs. 17.7%; p = 0.003), all-cause death (10.4% vs. 8.7%; p = 0.0008), cardiac death (4.9% vs. 4.0%; p = 0.003) and ID-TLR (10.9% vs. 10.2%; p = 0.02) compared with men. By multivariable analysis, female sex was an independent predictor of MACE (hazard ratio [HR:]: 1.14; 95% confidence interval [CI:]: 1.01 to 1.30; p = 0.04) and ID-TLR (HR: 1.23; 95% CI: 1.05 to 1.44; p = 0.009) but not all-cause death (HR: 0.91; 95% CI: 0.75 to 1.09; p = 0.30) or cardiac death (HR: 0.97; 95% CI: 0.73 to 1.29; p = 0.85).

Conclusions: In the present large-scale, individual patient data pooled analysis of contemporary PCI trials, women had a higher risk of MACE and ID-TLR compared with men at 5 years following PCI.
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http://dx.doi.org/10.1016/j.jacc.2020.01.056DOI Listing
April 2020

Three contemporary thin-strut drug-eluting stents implanted in severely calcified coronary lesions of participants in a randomized all-comers trial.

Catheter Cardiovasc Interv 2020 Nov 1;96(5):E508-E515. Epub 2020 Apr 1.

Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.

Objective: The objective was to assess the 2-year clinical performance of three drug-eluting stents in all-comer patients with severely calcified coronary lesions.

Background: Severe lesion calcification increases cardiovascular event risk after coronary stenting, but there is a lack of data on the clinical outcome of all-comers with severely calcified lesions who were treated with more recently introduced drug-eluting stents.

Methods: The BIO-RESORT trial (clinicaltrials.gov: NCT01674803) randomly assigned 3,514 all-comer patients to biodegradable polymer Synergy everolimus-eluting stents (EES) or Orsiro sirolimus-eluting stents (SES), versus durable polymer Resolute Integrity zotarolimus-eluting stents (ZES). In a post hoc analysis, we assessed 783 patients (22.3%) with at least one severely calcified target lesion.

Results: At 2-year follow-up (available in 99% of patients), the main composite endpoint target vessel failure occurred in 19/252 (7.6%) of the EES and in 33/265 (12.6%) of the ZES-treated patients (p = .07). Target vessel failure occurred in 24/266 (9.1%) of the SES-treated patients (vs. ZES: p = .21). There was a difference in target vessel revascularization, which was required in EES in 6/252 (2.4%) patients and in ZES in 20/265 (7.7%) patients (p = .01); the target vessel revascularization rate in SES was 9/266 (3.4%, vs. ZES: p = .04). Multivariate analysis showed that implantation of EES, but not SES, was independently associated with lower target vessel revascularization rates than in ZES.

Conclusions: In BIO-RESORT participants with severely calcified target lesions, treatment with EES was associated with a lower 2-year target vessel revascularization rate than treatment with ZES.
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http://dx.doi.org/10.1002/ccd.28886DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7687234PMC
November 2020

Proximal LAD Treated With Thin-Strut New-Generation Drug-Eluting Stents: A Patient-Level Pooled Analysis of TWENTE I-III.

JACC Cardiovasc Interv 2020 04 11;13(7):808-816. Epub 2020 Mar 11.

Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands. Electronic address:

Objectives: This study sought to assess 2-year clinical outcome following percutaneous coronary intervention (PCI) with thin-strut new-generation drug-eluting stents (DES) in patients treated in proximal left anterior descending artery (P-LAD) versus non-P-LAD lesions.

Background: In current revascularization guidelines, P-LAD coronary artery stenosis is discussed separately, mainly because of a higher adverse event risk and benefits of bypass surgery.

Methods: The study included 6,037 patients without previous bypass surgery or left main stem involvement from the TWENTE I, II, and III randomized trials. A total of 1,607 (26.6%) patients had at least 1 DES implanted in P-LAD and were compared with 4,430 (73.4%) patients who were exclusively treated in other (non-P-LAD) segments.

Results: Two-year follow-up was available in 5,995 (99.3%) patients. At baseline, P-LAD patients had more multivessel treatment and longer total stent length. The rate of the patient-oriented composite clinical endpoint (any death, any myocardial infarction, or any revascularization) was similar in P-LAD versus non-P-LAD patients (11.4% vs. 11.6%; p = 0.87). In P-LAD patients, the rate of the device-oriented composite clinical endpoint (cardiac death, target vessel myocardial infarction, or target lesion revascularization) was higher (7.6% vs. 6.0%; p = 0.020), driven by a higher rate of target vessel myocardial infarction (4.1% vs. 2.6%; p = 0.002). However, multivariate analysis showed no independent association between stenting P-LAD lesions and clinical endpoints.

Conclusions: In this patient-level pooled analysis of 3 large-scale contemporary DES trials, treatment of P-LAD lesions was not independently associated with higher 2-year adverse clinical event rates. These results imply that separate consideration in future revascularization guidelines may not be mandatory any longer.
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http://dx.doi.org/10.1016/j.jcin.2019.11.018DOI Listing
April 2020

Platelet Inhibition, Endothelial Function, and Clinical Outcome in Patients Presenting With ST-Segment-Elevation Myocardial Infarction Randomized to Ticagrelor Versus Prasugrel Maintenance Therapy: Long-Term Follow-Up of the REDUCE-MVI Trial.

J Am Heart Assoc 2020 03 3;9(5):e014411. Epub 2020 Mar 3.

Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.

Background Off-target properties of ticagrelor might reduce microvascular injury and improve clinical outcome in patients with ST-segment-elevation myocardial infarction. The REDUCE-MVI (Evaluation of Microvascular Injury in Revascularized Patients with ST-Segment-Elevation Myocardial Infarction Treated With Ticagrelor Versus Prasugrel) trial reported no benefit of ticagrelor regarding microvascular function at 1 month. We now present the follow-up data up to 1.5 years. Methods and Results We randomized 110 patients with ST-segment-elevation myocardial infarction to either ticagrelor 90 mg twice daily or prasugrel 10 mg once a day. Platelet inhibition and peripheral endothelial function measurements including calculation of the reactive hyperemia index and clinical follow-up were obtained up to 1.5 years. Major adverse clinical events and bleedings were scored. An intention to treat and a per-protocol analysis were performed. There were no between-group differences in platelet inhibition and endothelial function. At 1 year the reactive hyperemia index in the ticagrelor group was 0.66±0.26 versus 0.61±0.28 in the prasugrel group (=0.31). Platelet inhibition was lower at 1 month versus 1 year in the total study population (61% [42%-81%] versus 83% [61%-95%]; <0.001), and per-protocol platelet inhibition was higher in patients randomized to ticagrelor versus prasugrel at 1 year (91% [83%-97%] versus 82% [65%-92%]; =0.002). There was an improvement in intention to treat endothelial function in patients randomized to ticagrelor (=0.03) but not in patients randomized to prasugrel (=0.88). Major adverse clinical events (10% versus 14%; =0.54) and bleedings (47% versus 63%; =0.10) were similar in the intention-to-treat analysis in both groups. Conclusions Platelet inhibition at 1 year was higher in the ticagrelor group, without an accompanying increase in bleedings. Endothelial function improved over time in ticagrelor patients, while it did not change in the prasugrel group. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique Identifier: NCT02422888.
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http://dx.doi.org/10.1161/JAHA.119.014411DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7335553PMC
March 2020

Stent-Related Adverse Events >1 Year After Percutaneous Coronary Intervention.

J Am Coll Cardiol 2020 02;75(6):590-604

Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address:

Background: The majority of stent-related major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI) are believed to occur within the first year. Very-late (>1-year) stent-related MACE have not been well described.

Objectives: The purpose of this study was to assess the frequency and predictors of very-late stent-related events or MACE by stent type.

Methods: Individual patient data from 19 prospective, randomized metallic stent trials maintained at a leading academic research organization were pooled. Very-late MACE (a composite of cardiac death, myocardial infarction [MI], or ischemia-driven target lesion revascularization [ID-TLR]), and target lesion failure (cardiac death, target-vessel MI, or ID-TLR) were assessed within year 1 and between 1 and 5 years after PCI with bare-metal stents (BMS), first-generation drug-eluting stents (DES1) and second-generation drug-eluting stents (DES2). A network meta-analysis was performed to evaluate direct and indirect comparisons.

Results: Among 25,032 total patients, 3,718, 7,934, and 13,380 were treated with BMS, DES1, and DES2, respectively. MACE rates within 1 year after PCI were progressively lower after treatment with BMS versus DES1 versus DES2 (17.9% vs. 8.2% vs. 5.1%, respectively, p < 0.0001). Between years 1 and 5, very-late MACE occurred in 9.4% of patients (including 2.9% cardiac death, 3.1% MI, and 5.1% ID-TLR). Very-late MACE occurred in 9.7%, 11.0%, and 8.3% of patients treated with BMS, DES1, and DES2, respectively (p < 0.0001), linearly increasing between 1 and 5 years. Similar findings were observed for target lesion failure in 19,578 patients from 12 trials. Findings were confirmed in the network meta-analysis.

Conclusions: In this large-scale, individual patient data pooled study, very-late stent-related events occurred between 1 and 5 years after PCI at a rate of ∼2%/year with all stent types, with no plateau evident. New approaches are required to improve long-term outcomes after PCI.
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http://dx.doi.org/10.1016/j.jacc.2019.11.058DOI Listing
February 2020

Involving the patient's perspective and preferences concerning coronary angiography and percutaneous coronary intervention.

EuroIntervention 2020 Feb;15(14):1228-1231

Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.

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http://dx.doi.org/10.4244/EIJV15I14A221DOI Listing
February 2020

Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12 months: Pooled patient level analysis from BIOSOLVE II-III and BIOFLOW II trials.

Int J Cardiol 2020 02 6;300:60-65. Epub 2019 Nov 6.

Lukaskrankenhaus Neuss, Neuss, Germany.

Background: The aim of this study was to compare the 12-month clinical outcomes of patients treated with Magmaris or Orsiro. Second generation drug-eluting absorbable metal scaffold Magmaris (Dreams 2G) has proved to be safe and effective in the BIOSOLVE-II study. Similarly, biodegradable polymer sirolimus-eluting stent, Orsiro has shown notable clinical results even in all-comer populations.

Methods: Magmaris group patients were taken from the BIOSOLVE-II and BIOSOLVE-III trials, while the patients from Orsiro group were enrolled in BIOFLOW-II trial. The primary outcome was explored using a time-to-event assessment of the unadjusted clinical outcomes for target lesion failure (TLF) at 12 months, followed by a multivariate analysis adjusting for all the significantly different covariates between the groups.

Results: The study population consisted of 482 patients (521 lesions), 184 patients (189 lesions) in Magmaris group and 298 patients (332 lesions) in Orsiro group. The mean age was 65.5 ± 10.8 and 62.7 ± 10.4 years in Magmaris and Orsiro groups, respectively (p = 0.005). Magmaris and Orsiro unadjusted TLF rates were 6.0 and 6.4% with no significant difference between the groups (p = 0.869). In the multivariate analysis, there were no meaningful differences between Magmaris and Orsiro groups. Finally, none of the groups presented device thrombosis cases at 12 months.

Conclusion: At 12 months there were no significant differences between Magmaris and Orsiro groups neither in the unadjusted assessment nor in the multivariate analysis for target lesion failure. These results should be taken as hypothesis generating and may warrant a head to head comparison on a randomized fashion.
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http://dx.doi.org/10.1016/j.ijcard.2019.11.003DOI Listing
February 2020

The obesity paradox revisited: body mass index and -long-term outcomes after PCI from a large pooled patient-level database.

EuroIntervention 2020 Jan;15(13):1199-1208

Institute of Cardiology, Warsaw, Poland.

Aims: The aim of this study was to evaluate the relationship between body mass index (BMI) and outcomes in patients with coronary artery disease undergoing percutaneous revascularisation.

Methods And Results: In 13 randomised trials, 22,922 patients were stratified (in kg/m2) as underweight (BMI <18.5), normal weight (18.5 ≤BMI <25, used as reference), overweight (25 ≤BMI <30), and obese (Class I [30 ≤BMI <35], Class II [35 ≤BMI <40], or Class III [BMI ≥40]). The primary endpoint was all-cause death at five years. Secondary endpoints were cardiac and non-cardiac death, target (TLR) and non-target lesion revascularisation (NTLR), myocardial infarction (MI), and definite/probable stent thrombosis. Despite adjustment for multiple confounders, overweight and Class I obesity were associated with lower all-cause mortality versus normal weight (HR 0.83, 95% CI: 0.71-0.96, and HR 0.83, 95% CI: 0.69-0.96, respectively); however, non-cardiac death was the major contributor to this effect (HR 0.77, 95% CI: 0.63-0.94 for overweight). Conversely, cardiac mortality was higher in severely obese individuals (HR 1.62, 95% CI: 1.05-2.51 for Class III obesity). Obesity was associated with higher rates of NTLR (HR 1.28, 95% CI: 1.04-1.58 for Class II obesity) but not with TLR, MI and stent thrombosis.

Conclusions: Moderately increased BMI is associated with improved survival post PCI, mostly due to lower non-cardiac but not cardiac mortality.
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http://dx.doi.org/10.4244/EIJ-D-19-00467DOI Listing
January 2020