Publications by authors named "Patrick W Serruys"

1,867 Publications

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Mortality after multivessel revascularisation involving the proximal left anterior descending artery.

Heart 2022 Jun 22. Epub 2022 Jun 22.

Department of Cardiology, National University of Ireland Galway, Galway, Ireland

Objective: We sought to investigate whether long-term clinical outcomes differ following percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with three-vessel disease (3VD) and lesions in the proximal left anterior descending artery (P-LAD).

Methods: This post-hoc analysis of the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) Extended Survival study included patients with 3VD who were classified according to the presence or absence of lesions located in the P-LAD. Ten-year all-cause death and 5-year major adverse cardiac or cerebrovascular events (MACCE) were assessed.

Results: Among 1088 patients with 3VD, 559 (51.4%) had involvement of P-LAD and their 10-year mortality was numerically higher following PCI versus CABG (28.9% vs 21.9%; HR: 1.39, 95% CI 0.99 to 1.95). Although patients without P-LAD lesions had significantly higher 10-year mortality following PCI compared with CABG, there was no evidence of a treatment-by-subgroup interaction (28.8% vs 20.2%; HR: 1.47, 95% CI 1.03 to 2.09, p=0.837). The incidence of MACCE at 5 years was significantly higher with PCI than CABG, irrespective of involvement of P-LAD (with P-LAD: HR: 1.86, 95% CI 1.36 to 2.55; without P-LAD: HR: 1.54, 95% CI 1.11 to 2.12; p=0.408). Individualised assessment using the SYNTAX Score II 2020 established that a quarter of patients with P-LAD lesions had significantly higher mortality with PCI than CABG, whereas in the remaining three-quarters CABG had similar mortality.

Conclusions: Among patients with 3VD, the presence or absence of a P-LAD lesion was not associated with any treatment effect on long-term outcomes following PCI or CABG.

Trial Registration Number: SYNTAXES: NCT03417050; SYNTAX: NCT00114972.
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http://dx.doi.org/10.1136/heartjnl-2022-320934DOI Listing
June 2022

P2Y inhibitor monotherapy in patients undergoing percutaneous coronary intervention.

Nat Rev Cardiol 2022 Jun 13. Epub 2022 Jun 13.

University of Florida College of Medicine, Jacksonville, FL, USA.

For 20 years, dual antiplatelet therapy (DAPT), consisting of the combination of aspirin and a platelet P2Y receptor inhibitor, has been the gold standard of antithrombotic pharmacology after percutaneous coronary intervention (PCI). In the past 5 years, several investigations have challenged this paradigm by testing the efficacy and safety of P2Y inhibitor monotherapy (that is, without aspirin) following a short course of DAPT. Collectively, these studies suggested a reduction in the risk of major bleeding and no significant increase in thrombotic or ischaemic events compared with guideline-recommended DAPT. Current recommendations are evolving to inform clinical practice on the ideal candidates for P2Y inhibitor monotherapy after PCI. Generalizing the results of studies of P2Y inhibitor monotherapy requires a thorough understanding of their design, populations, interventions, comparators and results. In this Review, we provide an up-to-date overview on the use of P2Y inhibitor monotherapy after PCI, including supporting pharmacodynamic and clinical evidence, practical recommendations and future directions.
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http://dx.doi.org/10.1038/s41569-022-00725-6DOI Listing
June 2022

Periprocedural Outcomes Associated With Use of a Left Atrial Appendage Occlusion Device in China.

JAMA Netw Open 2022 May 2;5(5):e2214594. Epub 2022 May 2.

Department of Cardiology, Xijing Hospital, Xi'an, China.

Importance: Left atrial appendage occlusion (LAAO) has emerged as an alternative to anticoagulation for patients with atrial fibrillation. However, the performance of LAAO among East Asian patients is unknown.

Objective: To document the procedural success rate and configurations, major adverse event rates, and antithrombotic medication regimens during and after LAAO procedures among patients in China.

Design, Setting, And Participants: In this cohort study, consecutive patients from 39 Chinese centers undergoing LAAO were prospectively enrolled between April 1, 2019, and October 31, 2020. Periprocedural and intraprocedural techniques and postprocedural medications were left to the surgeon's discretion. Data were analyzed from July 1 to November 1, 2021.

Exposure: LAAO for patients with atrial fibrillation.

Main Outcomes And Measures: The main outcomes were procedural success and complication rates periprocedure and major adverse event rates of death, stroke, systemic embolism, and bleeding events at 30 days postprocedure; the composite end point of death, stroke, and systemic embolism was also analyzed. Unadjusted and multivariable-adjusted logistic regression analyses were performed to assess the associations of periprocedural techniques (types of anesthesia, intraprocedural imaging modalities, and combined ablation procedure) with 30-day adverse events.

Results: Among 3096 enrolled participants, 1782 participants (57.6%) were men, and the mean (SD) age was 69 (9) years. Participants had a high risk of stroke (mean [SD] cardiovascular risk score, 4.0 [1.8]) and a moderate-to-high risk of bleeding (mean [SD] bleeding risk score, 2.4 [1.2]). A total of 1287 procedures (41.6%) were performed under local anesthesia, while 493 procedures (15.9%) used only fluoroscopy guidance. In 1297 procedures (41.9%), LAAO implantation was combined with radiofrequency ablation or cryoablation for atrial fibrillation. Procedural success was achieved in 3032 patients (97.9%). At 30-day follow-up, the rate of the composite end point of death, stroke, or systemic embolism was 0.52% (95% CI, 0.32%-0.84%), and the rate of any life-threatening or major bleeding was 1.23% (95% CI, 0.90%-1.68%). No significant associations were observed between the procedural success or 30-day adverse events and the types of anesthesia (general or local), intraprocedural imaging (transesophageal echocardiography, fluoroscopy, or intracardiac echocardiography), or whether a combined ablation procedure was performed or not. In centers performing at least 40 procedures per year, compared with those performing fewer than 40 procedures per year, procedural success was significantly higher (adjusted odd ratio [aOR], 1.97; 95% CI, 1.01-3.53; P = .02) and risk of life-threatening or major bleeding was significantly lower (aOR, 0.42; 95% CI, 0.21-0.87; P = .02).

Conclusions And Relevance: These findings suggest that patients with a high risk of stroke and moderate to high risk of bleeding who underwent implantation of a LAAO device in Chinese centers had high rates of procedural success and low rates of short-term ischemic and bleeding events.
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http://dx.doi.org/10.1001/jamanetworkopen.2022.14594DOI Listing
May 2022

Definitions and Standardized Endpoints for Treatment of Coronary Bifurcations.

J Am Coll Cardiol 2022 May 13. Epub 2022 May 13.

Department of Cardiology, Saolta Group, Galway University Hospital, Health Service Executive and National University of Ireland Galway, Galway, Ireland.

The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients.
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http://dx.doi.org/10.1016/j.jacc.2022.04.024DOI Listing
May 2022

Predicted and Observed Mortality at 10 Years in Patients With Bifurcation Lesions in the SYNTAX Trial.

JACC Cardiovasc Interv 2022 Jun 17;15(12):1231-1242. Epub 2022 May 17.

Department of Cardiology, National University of Ireland, Galway, Galway, Ireland.

Background: Percutaneous coronary intervention (PCI) of bifurcation lesions is associated with higher rates of adverse events, and currently it is unclear whether PCI or coronary artery bypass grafting (CABG) is the safer treatment for these patients at very long-term follow-up.

Objectives: The aim of this study was to investigate the impact of bifurcation lesions on individual predicted and observed all-cause 10-year mortality in the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trial.

Methods: In the SYNTAXES (SYNTAX Extended Survival) study, 10-year observed and individual predicted mortality derived from the SYNTAX score 2020 (SS-2020) was compared between patients with ≥1 bifurcation (n = 1,300) and those with no bifurcations (n = 487).

Results: Among patients treated with PCI, patients with >1 bifurcation lesion compared with those without bifurcation lesions had a significantly higher risk for all-cause death (19.8% vs 30.1%; HR: 1.55; 95% CI: 1.12-2.14; P = 0.007), whereas following CABG, mortality was similar in patients with and those without bifurcation lesions (23.3% vs 23.0%; HR: 0.81; 95% CI: 0.59-1.12; P = 0.207; P = 0.006). In PCI patients, a 2-stent vs a 1-stent technique was associated with higher mortality (33.3% vs 25.9%; HR: 1.51; 95% CI: 1.06-2.14; P = 0.021). According to the SS-2020, among those with ≥1 bifurcation, there was equipoise for all-cause mortality between PCI and CABG in 2 quartiles of the population, whereas CABG was superior to PCI in the 2 remaining quartiles.

Conclusions: Bifurcation lesions require special attention from the heart team, considering the higher 10-year all-cause mortality associated with PCI. Careful evaluation of bifurcation lesion complexity and calculation of individualized 10-year prognosis using the SS-2020 may therefore be helpful in decision making. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES], NCT03417050; Taxus Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX], NCT00114972).
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http://dx.doi.org/10.1016/j.jcin.2022.04.025DOI Listing
June 2022

Definitions and Standardized Endpoints for Treatment of Coronary Bifurcations.

EuroIntervention 2022 May 18. Epub 2022 May 18.

Department of Cardiology, Saolta Group, Galway University Hospital, Health Service Executive and National University of -Ireland Galway, Galway, Ireland.

The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients.
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http://dx.doi.org/10.4244/EIJ-E-22-00018DOI Listing
May 2022

Letter by Kawashima et al Regarding Article, "Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention in Patients With Chronic Total Occlusion and Multivessel Disease".

Circ Cardiovasc Interv 2022 May 17;15(5):e012080. Epub 2022 May 17.

Discipline of Cardiology, Saolta Group, Galway University Hospital, Health Service Executive and CORRIB Core Lab, National University of Ireland Galway (NUIG) (H.K., P.W.S.).

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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.122.012080DOI Listing
May 2022

Impact of proton pump inhibitors on efficacy of antiplatelet strategies with ticagrelor or aspirin after percutaneous coronary intervention: Insights from the GLOBAL LEADERS trial.

Catheter Cardiovasc Interv 2022 May 2. Epub 2022 May 2.

Interventional Medicine and Innovation, National University of Ireland Galway (NUIG), Galway, Ireland.

Background: Several studies have suggested that proton pump inhibitors (PPIs) may reduce the antiplatelet effects of clopidogrel and/or aspirin, possibly leading to cardiovascular events.

Aims: We aimed to investigate the association between PPI and clinical outcomes in patients treated with ticagrelor monotherapy or conventional antiplatelet therapy after percutaneous coronary intervention (PCI).

Methods: This is a subanalysis of the randomized GLOBAL LEADERS trial, comparing the experimental antiplatelet arm (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with the reference arm (12-month aspirin monotherapy following 12-month DAPT) after PCI. Patient-oriented composite endpoints (POCEs: all-cause mortality, myocardial infarction, stroke, or repeat revascularization) and its components were assessed stratified by PPI use as a time-dependent covariate in patients with the experiment or reference antiplatelet arm.

Results: Among 15,839 patients, 2115 patients (13.5%) experienced POCE at 2 years. In the reference arm, the use of PPIs was independently associated with POCE (hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 1.12-1.44) and its individual components, whereas it was not in the experimental arm (HR: 1.04; 95% CI: 0.92-1.19; p  = 0.035). During the second-year follow-up, patients taking aspirin with PPIs had a significantly higher risk of POCE compared to those on aspirin without PPIs (HR: 1.57; 95% CI: 1.27-1.94), whereas the risk did not differ significantly irrespective of PPI in ticagrelor monotherapy group (HR: 1.03; 95% CI: 0.83-1.28; p  = 0.008).

Conclusions: In contrast to conventional antiplatelet strategy, there were no evidence suggesting the interaction between ticagrelor monotherapy and PPIs on increased cardiovascular events, which should be confirmed in further studies.

Clinical Trial Registration: URL: https://clinicaltrials.gov.
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http://dx.doi.org/10.1002/ccd.30217DOI Listing
May 2022

Non-Newtonian Endothelial Shear Stress Simulation: Does It Matter?

Front Cardiovasc Med 2022 14;9:835270. Epub 2022 Apr 14.

Department of Medicine, Faculty of Medicine, Melbourne Medical School, Dentistry and Health Sciences, University of Melbourne, Parkville, VIC, Australia.

Patient-specific coronary endothelial shear stress (ESS) calculations using Newtonian and non-Newtonian rheological models were performed to assess whether the common assumption of Newtonian blood behavior offers similar results to a more realistic but computationally expensive non-Newtonian model. 16 coronary arteries (from 16 patients) were reconstructed from optical coherence tomographic (OCT) imaging. Pulsatile CFD simulations using Newtonian and the Quemada non-Newtonian model were performed. Endothelial shear stress (ESS) and other indices were compared. Exploratory indices including local blood viscosity (LBV) were calculated from non-Newtonian simulation data. Compared to the Newtonian results, the non-Newtonian model estimates significantly higher time-averaged ESS (1.69 (IQR 1.36)Pa versus 1.28 (1.16)Pa, < 0.001) and ESS gradient (0.90 (1.20)Pa/mm versus 0.74 (1.03)Pa/mm, < 0.001) throughout the cardiac cycle, under-estimating the low ESS (<1Pa) area (37.20 ± 13.57% versus 50.43 ± 14.16%, 95% CI 11.28-15.18, < 0.001). Similar results were also found in the idealized artery simulations with non-Newtonian median ESS being higher than the Newtonian median ESS (healthy segments: 0.8238Pa versus 0.6618Pa, < 0.001 proximal; 0.8179Pa versus 0.6610Pa, < 0.001 distal; stenotic segments: 0.8196Pa versus 0.6611Pa, < 0.001 proximal; 0.2546Pa versus 0.2245Pa, < 0.001 distal) On average, the non-Newtonian model has a LBV of 1.45 times above the Newtonian model with an average peak LBV of 40-fold. Non-Newtonian blood model estimates higher quantitative ESS values than the Newtonian model. Incorporation of non-Newtonian blood behavior may improve the accuracy of ESS measurements. The non-Newtonian model also allows calculation of exploratory viscosity-based hemodynamic indices, such as local blood viscosity, which may offer additional information to detect underlying atherosclerosis.
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http://dx.doi.org/10.3389/fcvm.2022.835270DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9046559PMC
April 2022

External Validation of the FREEDOM Score for Individualized Decision Making Between CABG and PCI.

J Am Coll Cardiol 2022 04;79(15):1458-1473

Department of Public Health, Erasmus University Medical Center, Rotterdam, the Netherlands.

Background: Although randomized trials have established that coronary artery bypass grafting (CABG) is, on average, the most effective revascularization strategy compared with percutaneous coronary intervention (PCI) in patients with diabetes and multivessel disease (MVD), individual patients differ in many characteristics that can affect the benefits and harms of treatment. The FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus) score was developed to predict different outcomes with CABG vs PCI on the basis of 8 patient characteristics and the smoking-treatment interaction.

Objectives: This study aimed to assess the ability of the 5-year major adverse cardiovascular event (MACE) model to predict treatment benefit of CABG vs PCI in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) trials.

Methods: This study identified 702 patients with diabetes and MVD to mirror the FREEDOM participants. Discrimination was assessed by C-index, and calibration was assessed by calibration plots in the PCI and CABG arms, respectively. The ability of the FREEDOM score to predict treatment benefit of CABG vs PCI was assessed.

Results: Overall, CABG was associated with a lower rate of 5-year MACE compared with PCI (12.4% vs 20.3%; log-rank P = 0.021) irrespective of a history of smoking (P = 0.975). Both discrimination and calibration were helpful in the PCI arm (C-index: 0.69; slope: 0.96, intercept: -0.24), but moderate in the CABG arm (C-index: 0.61; slope: 0.61; intercept: -0.53). The FREEDOM score showed some heterogeneity of treatment benefit.

Conclusions: The FREEDOM score could identify some heterogeneity of treatment benefit of CABG vs PCI for 5-year MACE. Until further prospective validations are performed, these results should be taken into consideration when using the FREEDOM score in patients with diabetes and MVD. (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery [SYNTAX]; NCT00114972) (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease [BEST]; NCT00997828) (Future Revascularization Evaluation in Patients with Diabetes Mellitus [FREEDOM]; NCT00086450).
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http://dx.doi.org/10.1016/j.jacc.2022.01.049DOI Listing
April 2022

Contextualizing National Policies Regulating Access to Low-Dose Aspirin in America and Europe Using the Full Report of a Transatlantic Patient Survey of Aspirin in Preventive Cardiology.

J Am Heart Assoc 2022 04 12;11(8):e023995. Epub 2022 Apr 12.

Ciccarone Center for the Prevention of Cardiovascular Disease Division of Cardiology Department of Medicine Johns Hopkins Medical Institutions Baltimore MD.

Background Aspirin is widely administered to prevent cardiovascular disease (CVD). However, appropriate use of aspirin depends on patient understanding of its risks, benefits, and indications, especially where aspirin is available over the counter (OTC). Methods and Results We did a survey of patient-reported 10-year cardiovascular risk; aspirin therapy status; form of aspirin access (OTC versus prescription); and knowledge of the risks, benefits, and role of aspirin in CVD prevention. Consecutive adults aged ≥50 years with ≥1 cardiovascular risk factor attending outpatient clinics in America and Europe were recruited. We also systematically reviewed national policies regulating access to low-dose aspirin for CVD prevention. At each site, 150 responses were obtained (300 total). Mean±SD age was 65±10 years, 40% were women, and 41% were secondary prevention patients. More than half of the participants at both sites did not know (1) their own level of 10-year CVD risk, (2) the expected magnitude of reduction in CVD risk with aspirin, or (3) aspirin's bleeding risks. Only 62% of all participants reported that aspirin was routinely indicated for secondary prevention, whereas 47% believed it was routinely indicated for primary prevention (=0.048). In America, 83.5% participants obtained aspirin OTC compared with 2.5% in Europe (<0.001). Finally, our review of European national policies found only 2 countries where low-dose aspirin was available OTC. Conclusions Many patients have poor insight into their objectively calculated 10-year cardiovascular risk and do not know the risks, benefits, and role of aspirin in CVD prevention. Aspirin is mainly obtained OTC in America in contrast to Europe, where most countries restrict access to low-dose aspirin.
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http://dx.doi.org/10.1161/JAHA.121.023995DOI Listing
April 2022

Intravascular imaging assessment of pharmacotherapies targeting atherosclerosis: advantages and limitations in predicting their prognostic implications.

Cardiovasc Res 2022 Apr 8. Epub 2022 Apr 8.

Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK.

Intravascular imaging has been often used over the recent years to examine the efficacy of emerging therapies targeting plaque evolution. Serial intravascular ultrasound, optical coherence tomography, or near infrared spectroscopy-intravascular ultrasound studies have allowed us to evaluate the effects of different therapies on plaque burden and morphology, providing unique mechanistic insights about the mode of action of these treatments. Plaque burden reduction, a decrease in necrotic core component or macrophages accumulation - that have been associated with inflammation - and an increase in fibrous cap thickness over fibroatheromas have been used as surrogate endpoints to assess the value of several drugs in inhibiting plaque evolution and improving clinical outcomes. However, some reports have demonstrated weak associations between the effects of novel treatments on coronary atheroma and composition and their prognostic implications. This review examines the value of invasive imaging in assessing pharmacotherapies targeting atherosclerosis. It summarizes the findings of serial intravascular imaging studies assessing the effects of different drugs on atheroma burden and morphology and compares them with the results of large-scale trials evaluating their impact on clinical outcome. Furthermore, it highlights the limited efficacy of established intravascular imaging surrogate endpoints in predicting the prognostic value of these pharmacotherapies and introduces alternative imaging endpoints based on multimodality/hybrid intravascular imaging that may enable more accurate assessment of the athero-protective and prognostic effects of emerging therapies.
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http://dx.doi.org/10.1093/cvr/cvac051DOI Listing
April 2022

A systematic review and meta-analysis of percutaneous coronary intervention compared to coronary artery bypass grafting in non-ST-elevation acute coronary syndrome.

Sci Rep 2022 03 24;12(1):5138. Epub 2022 Mar 24.

Department of Cardiothoracic Surgery, Friedrich-Schiller-University Jena, 101 Erlanger Allee, 07747, Jena, Germany.

Non-ST-elevation acute coronary syndrome (NSTE-ACS) affects millions of patients. Although an invasive strategy can improve survival, the optimal treatment [i.e., percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)] is not clear. We performed a meta-analysis of studies reporting outcomes between PCI and CABG in patients with NSTE-ACS. MEDLINE, EMBASE and Cochrane Library were assessed. The primary outcome was long-term mortality. Inverse variance method and random model were performed. We identified 13 observational studies (48,891 patients). No significant difference was found in the primary endpoint [CABG vs. PCI, incidence rate ratio (IRR) 0.93, 95% confidence interval (CI) 0.70; 1.23]. CABG was associated with lower long-term major adverse cardiovascular events (MACE) (IRR 0.64, 95% CI 0.54; 0.76) and lower long-term re-revascularization (IRR 0.37, 95% CI 0.30; 0.47). There was no significant difference in long-term myocardial infarction (CABG vs. PCI, IRR 0.96, 95% CI 0.50; 1.84) and peri-operative mortality (CABG vs. PCI, odds ratio 1.36, 95% CI 0.94; 1.95). For the treatment of NSTE-ACS, CABG and PCI are associated with similar rates of long-term mortality and myocardial infarction. CABG is associated with lower rates of long-term MACE and re-revascularization. Randomized comparisons in this setting are necessary.
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http://dx.doi.org/10.1038/s41598-022-09158-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8948200PMC
March 2022

Sirolimus-eluting stents with ultrathin struts versus everolimus-eluting stents for patients undergoing percutaneous coronary intervention: final three-year results of the TALENT trial.

EuroIntervention 2022 Mar 15. Epub 2022 Mar 15.

Department of Cardiology, National University of Ireland Galway, Galway, Ireland.

Background: In the TALENT study, the sirolimus-eluting ultrathin strut Supraflex stent was non-inferior to the XIENCE stent for a device-oriented composite endpoint (DoCE: defined as cardiac death, target-vessel myocardial infarction [TV-MI], or clinically indicated target lesion revascularisation [CI-TLR]) at 12 months.

Aims: This study investigated the 3-year outcomes of the TALENT trial and long-term impact of ultrathin drug-eluting stents (DES), compared to the XIENCE everolimus-eluting thin stent.

Methods: The TALENT trial is a prospective, multicentre, randomised all-comers trial comparing the Supraflex sirolimus-eluting stent with the XIENCE everolimus-eluting stent, with planned follow-up for 3 years.

Results: The TALENT trial enrolled 1,435 patients (Supraflex n=720, XIENCE n=715) with 3-year follow-up data available in 97.8% in the Supraflex group, and in 98.9% in the XIENCE group. At 3 years, DoCE occurred in 57 patients (8.1%) in the Supraflex group, and in 66 patients (9.4%) in the XIENCE group (p=0.406). There were no significant between-group differences in rates of cardiac death, TV-MI or CI-TLR. The rates of definite or probable stent thrombosis were low and similar between groups (1.1% vs 1.4%; p=0.640). In a meta-analysis of long-term follow-up (3-5 years), ultrathin strut DES tended to reduce DoCE (relative risk 0.89 [0.79-1.01]; p=0.068), compared to thicker strut DES. The risks for cardiac death and definite or probable stent thrombosis were similar between ultrathin strut DES and thicker strut DES.

Conclusions: At 3-year follow-up, the use of the Supraflex stent was at least as safe and efficacious as the XIENCE stent in an all-comers population.

Clinicaltrials: gov: NCT02870140.
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http://dx.doi.org/10.4244/EIJ-D-21-00766DOI Listing
March 2022

Endoscopic vs Open Vein Harvest in Drug-Eluting Stents or Bypass Surgery for Left Main Disease Trial.

Ann Thorac Surg 2022 Mar 11. Epub 2022 Mar 11.

Department of Surgery, University Hospitals Cleveland Medical Center, Cleveland, Ohio. Electronic address:

Background: We investigated outcomes of coronary artery bypass grafting (CABG) with endoscopic vein harvest (EVH) vs open vein harvest (OVH) within the Evaluation of XIENCE Versus CABG (EXCEL) trial.

Methods: All patients in EXCEL randomized to CABG were included in this study. For this analysis, the primary end points were ischemia-driven revascularization (IDR) and graft stenosis or occlusion at 5 years. Additional end points were as follows: a composite of death from any cause, stroke, or myocardial infarction; bleeding; blood product transfusion; major arrhythmia; and infection requiring antibiotics. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses.

Results: Of the 957 patients randomized to CABG, 686 (71.7%) received at least 1 venous graft with 257 (37.5%) patients in the EVH group and 429 (62.5%) patients in the OVH group. At 5 years, IDR was higher (11.5% vs 6.7%; P = .047) in the EVH group. At 5 years, rates of graft stenosis or occlusion (9.7% vs 5.4%; P = .054) and the primary end point (17.4% vs 20.9%; P = .27) were similar. In-hospital bleeding (11.3% vs 13.8%; P = .35), in-hospital blood product transfusion (12.8% vs 13.1%; P = .94), and infection requiring antibiotics within 1 month (13.6% vs 16.8%; P = .27) were similar between EVH and OVH patients. Major arrhythmia in the hospital (19.8% vs 13.5%; P = .03) and within 1 month (21.8% vs 15.4%; P = .03) was higher in EVH patients.

Conclusions: IDR at 5 years was higher in the EVH group. EVH and OVH patients had similar rates of graft stenosis or occlusion and the composite of death, stroke, or myocardial infarction at 5 years.
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http://dx.doi.org/10.1016/j.athoracsur.2021.12.079DOI Listing
March 2022

Ticagrelor monotherapy versus aspirin monotherapy at 12 months after percutaneous coronary intervention: a landmark analysis of the GLOBAL LEADERS trial.

EuroIntervention 2022 Mar 9. Epub 2022 Mar 9.

Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.

Background: The optimal antiplatelet strategy in the second year after percutaneous coronary intervention (PCI) remains unclear.

Aims: We aimed to compare ticagrelor monotherapy with aspirin monotherapy on clinical outcomes beyond 1 year post-PCI.

Methods: This post hoc subanalysis of the open-label, all-comers, randomised GLOBAL LEADERS trial, which compared 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT), with 12-month aspirin monotherapy following 12-month DAPT, only included patients who, at 12 months, were free from ischaemic and bleeding events, and adherent to their assigned antiplatelet therapy. The incidences of ischaemic events (all-cause death, any myocardial infarction, or any stroke) and bleeding events (Bleeding Academic Research Consortium [BARC] type 3 or 5 bleeding) during the second year (12-24 months) were compared between patients receiving either ticagrelor or aspirin monotherapy.

Results: The present analysis included 11,121 (ticagrelor monotherapy n=5,308, and aspirin monotherapy n=5,813) of the 15,991 patients enrolled in GLOBAL LEADERS. During the second year, the ischaemic composite endpoint was lower with ticagrelor monotherapy compared to aspirin monotherapy (1.9% vs 2.6%: log-rank p=0.014, adjusted hazard ratio [HR] 0.74, 95% confidence interval [CI]: 0.58-0.96; p=0.022), which was primarily driven by a reduced risk of myocardial infarction. In contrast, BARC type 3 or 5 bleeding was numerically higher with ticagrelor monotherapy (0.5% vs 0.3%: log-rank p=0.051, adjusted HR 1.89, 95% CI: 1.03-3.45; p=0.005).

Conclusions: Patients free from events at the end of the first year post-PCI and who adhered to their prescribed regimen had a reduced risk of ischaemic events compared to aspirin monotherapy in the second year post-PCI.

Clinicaltrials: gov: NCT01813435.
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http://dx.doi.org/10.4244/EIJ-D-21-00870DOI Listing
March 2022

Diagnostic concordance and discordance between angiography-based quantitative flow ratio and fractional flow reserve derived from computed tomography in complex coronary artery disease.

J Cardiovasc Comput Tomogr 2022 Feb 19. Epub 2022 Feb 19.

Discipline of Cardiology, Saolta Group, Galway University Hospital, Health Service Executive and CORRIB Core Lab, National University of Ireland Galway (NUIG), Galway, Ireland; CÚRAM, The SFI Research Centre for Medical Devices, Galway, Ireland.

Background: Both quantitative flow ratio (QFR) and fractional flow reserve derived from computed tomography (FFR) have shown significant correlations with invasive wire-based fractional flow reserve. However, the correlation between QFR and FFR is not fully investigated in patients with complex coronary artery disease (CAD). The aim of this study is to investigate the correlation and agreement between QFR and FFR in patients with de novo three-vessel disease and/or left main CAD.

Methods: This is a post-hoc sub-analysis of the international, multicenter, and randomized SYNTAX III REVOLUTION trial, in which both invasive coronary angiography and coronary computed tomography angiography were prospectively obtained prior to the heart team discussion. QFR was performed in an independent core laboratory and compared with FFR analyzed by HeartFlow™. The correlation and agreement between QFR and FFR were assessed per vessel. Furthermore, independent factors of diagnostic discordance between QFR and FFR were evaluated.

Results: Out of 223 patients, 40 patients were excluded from this analysis due to the unavailability of FFR and/or QFR, and a total of 469 vessels (183 patients) were analyzed. There was a strong correlation between QFR and FFR (R ​= ​0.759; p ​< ​0.001), and the Bland-Altman analysis demonstrated a mean difference of -0.005 and a standard deviation of 0.116. An independent predictor of diagnostic concordance between QFR and FFR was the lesion location in right coronary artery (RCA) (odds ratio 0.395; 95% confidence interval 0.174-0.894; P ​= ​0.026).

Conclusion: In patients with complex CAD, QFR and FFR were strongly correlated. The location of the lesion in RCA was associated with the highest diagnostic concordance between QFR and FFR.
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http://dx.doi.org/10.1016/j.jcct.2022.02.004DOI Listing
February 2022

Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation: Per-Protocol Analysis of the GLOBAL LEADERS Trial.

J Am Heart Assoc 2022 May 1;11(10):e024291. Epub 2022 Mar 1.

Department of Cardiology, Inselspital University of Bern Switzerland.

Background In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intention-to-treat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intention-to-treat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a per-protocol analysis of patients who did not deviate from the study protocol. Methods and Results Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived time-varying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary end point was a composite of all-cause mortality or nonfatal Q-wave myocardial infarction at 2 years. At 2-year follow-up, 1103 (13.8%) of 7980 patients in the experimental group and 785 (9.8%) of 7988 patients in the control group qualified as protocol deviators. At per-protocol analysis, the rate ratio for the primary end point was 0.88 (95% CI, 0.75-1.03; =0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety end point of major bleeding was 1.00 (95% CI, 0.79-1.26; =0.99). The per-protocol and intention-to-treat effect estimates were overall consistent. Conclusions Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy was not superior to 1-year standard dual antiplatelet therapy followed by aspirin alone at 2 years after coronary stenting. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435.
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http://dx.doi.org/10.1161/JAHA.121.024291DOI Listing
May 2022

Machine learning for atherosclerotic tissue component classification in combined near-infrared spectroscopy intravascular ultrasound imaging: Validation against histology.

Atherosclerosis 2022 03 29;345:15-25. Epub 2022 Jan 29.

Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London, UK; Cardiovascular Devices Hub, Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, UK; Institute of Cardiovascular Sciences, University College London, London, UK. Electronic address:

Background And Aims: Accurate classification of plaque composition is essential for treatment planning. Intravascular ultrasound (IVUS) has limited efficacy in assessing tissue types, while near-infrared spectroscopy (NIRS) provides complementary information to IVUS but lacks depth information. The aim of this study is to train and assess the efficacy of a machine learning classifier for plaque component classification that relies on IVUS echogenicity and NIRS-signal, using histology as reference standard.

Methods: Matched NIRS-IVUS and histology images from 15 cadaveric human coronary arteries were analyzed (10 vessels were used for training and 5 for testing). Fibrous/pathological intimal thickening (F-PIT), early necrotic core (ENC), late necrotic core (LNC), and calcific tissue regions-of-interest were detected on histology and superimposed onto IVUS frames. The pixel intensities of these tissue types from the training set were used to train a J48 classifier for plaque characterization (ECHO-classification). To aid differentiation of F-PIT from necrotic cores, the NIRS-signal was used to classify non-calcific pixels outside yellow-spot regions as F-PIT (ECHO-NIRS classification). The performance of ECHO and ECHO-NIRS classifications were validated against histology.

Results: 262 matched frames were included in the analysis (162 constituted the training set and 100 the test set). The pixel intensities of F-PIT and ENC were similar and thus these two tissues could not be differentiated by echogenicity. With ENC and LNC as a single class, ECHO-classification showed good agreement with histology for detecting calcific and F-PIT tissues but had poor efficacy for necrotic cores (recall 0.59 and precision 0.29). Similar results were found when F-PIT and ENC were treated as a single class (recall and precision for LNC 0.78 and 0.33, respectively). ECHO-NIRS classification improved necrotic core and LNC detection, resulting in an increase of the overall accuracy of both models, from 81.4% to 91.8%, and from 87.9% to 94.7%, respectively. Comparable performance of the two models was seen in the test set where the overall accuracy of ECHO-NIRS classification was 95.0% and 95.5%, respectively.

Conclusions: The combination of echogenicity with NIRS-signal appears capable of overcoming limitations of echogenicity, enabling more accurate characterization of plaque components.
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http://dx.doi.org/10.1016/j.atherosclerosis.2022.01.021DOI Listing
March 2022

Comparative Quantitative Aortographic Assessment of Regurgitation in Patients Treated With VitaFlow Transcatheter Heart Valve vs. Other Self-Expanding Systems.

Front Cardiovasc Med 2021 25;8:747174. Epub 2022 Jan 25.

Department of Cardiology, CORRIB Research Center for Advanced Imaging and Core Laboratory, National University of Ireland, NUIG, Galway, Ireland.

Objectives: To compare the quantitative angiographic aortic regurgitation (AR) of six self-expanding valves after transcatheter aortic valve replacement (TAVR).

Background: Quantitative videodensitometric aortography (LVOT-AR) is an accurate and reproducible tool for assessment of AR following TAVR.

Methods: This is a retrospective central core-lab analysis of 1,257 consecutive cine aortograms performed post-TAVR. The study included 107 final aortograms of consecutive patients who underwent TAVR with first-generation VitaFlow in four Chinese centers and 1,150 aortograms with five other transcatheter aortic valves (Evolut Pro, Evolut R, CoreValve, Venus A-Valve, and Acurate Neo). LVOT-AR analyses of these five valves were retrieved from a previously published pooled database.

Results: Among 172 aortograms of patients treated with VitaFlow, 107 final aortograms (62.2%) were analyzable by LVOT-AR. In this first in man eight cases necessitated a procedural valve in valve due to inappropriate TAVR positioning and severe aortic paravalvular regurgitation. In the VitaFlow group, the mean LVOT-AR of the intermediate aortograms was 7.3 ± 7.8% and the incidence of LVOT-AR >17% was 8.6%. The mean LVOT-AR of the final aortogram was 6.1 ± 6.4% in the VitaFlow group, followed by Evolut Pro (7.3 ± 6.5%), Evolut R (7.9 ± 7.4%), Venus A-valve (8.9 ± 10.0%), Acurate Neo (9.6 ± 9.2%), and lastly CoreValve (13.7 ± 10.7%) (analysis of variance < 0.001). Post hoc 2-by-2 testing showed that CoreValve had significantly higher LVOT-AR compared with each of the other five THVs. No statistical difference in LVOT-AR was observed between VitaFlow, Evolut Pro, Evolut R, Acurate Neo, and Venus A-valves. The VitaFlow system had the lowest proportion of patients with LVOT-AR >17% (4.7%) (AR after the final aortograms), followed by Evolut Pro (5.3%), Evolut R (8.8%), Acurate Neo (11.3%), Venus A-valve (14.2%), and CoreValve (30.1%) (chi-square < 0.001).

Conclusion: Compared to other commercially available self-expanding valves, VitaFlow seems to have a low degree of AR and a low proportion of patients with ≥moderate/severe AR as assessed by quantitative videodensitometric angiography. Once the learning phase is completed, comparisons of AR between different transcatheter heart valves should be attempted in a prospective randomized trial.
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http://dx.doi.org/10.3389/fcvm.2021.747174DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8821967PMC
January 2022

Survival or survivors?

Eur Heart J 2022 03;43(13):1362

Department of Cardiology, National University of Ireland, Galway, University Road, Galway H91 TK33, Ireland.

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http://dx.doi.org/10.1093/eurheartj/ehac006DOI Listing
March 2022

Acute and chronic exercise training in patients with Class II pulmonary hypertension: effects on haemodynamics and symptoms.

ESC Heart Fail 2022 04 7;9(2):791-799. Epub 2022 Feb 7.

Department of Cardiology, Saolta Group, Galway University Hospital, Health Service Executive and National University of Ireland Galway (NUIG), Galway, Ireland.

More than half of heart failure (HF) patients have concomitant pulmonary hypertension, impacting symptoms and prognosis. The role of exercise in this category of patients is still unclear, probably because of the lack of a clear relationship between exercise and acute and chronic pulmonary artery pressure variations and related changes in symptoms. The limited evidence on this topic is contradictory and hardly comparable due to use of different exercise programmes and pulmonary artery pressure assessment techniques. This is further compounded by different functional and structural classes of HF making definite assessments and interpretations of exercise effect on outcomes difficult. Exercise training programmes were proven beneficial in HF patients; however, the lack of data about their pulmonary haemodynamic effects prevents clear indications on the best exercise types for patients presenting secondary pulmonary hypertension and different HF categories. Indeed, some data suggest that not all HF patients have similar responses to training, leading to either beneficial or detrimental effects, depending on the HF type. Future studies, involving modern technologies such as continuous pulmonary artery pressure monitoring implantable devices, may clarify the current gaps in this field, aiming at patient-tailored exercise training rehabilitation programmes, in order to improve clinical outcomes, quality of life, and hopefully prognosis.
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http://dx.doi.org/10.1002/ehf2.13819DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8934934PMC
April 2022

Healed Coronary Plaque Assessed by Light-Based Intracoronary Imaging Techniques - The Good, the Bad, and the Ugly?

Circ J 2022 04 2;86(5):855-856. Epub 2022 Feb 2.

Department of Cardiology, National University of Ireland Galway.

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http://dx.doi.org/10.1253/circj.CJ-21-1079DOI Listing
April 2022

Reply: Composite endpoints in clinical trials - simplicity or perfection?

EuroIntervention 2022 01;17(13):1121-1122

Department of Cardiology, National University of Ireland, Galway, Ireland.

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http://dx.doi.org/10.4244/EIJ-D-21-00440RDOI Listing
January 2022

EuroIntervention: the 200th issue.

EuroIntervention 2022 Jan;17(13):1041-1043

Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland.

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http://dx.doi.org/10.4244/EIJ-E-21-00004DOI Listing
January 2022

One-year performance of biorestorative polymeric coronary bypass grafts in an ovine model: correlation between early biomechanics and late serial Quantitative Flow Ratio.

Eur J Cardiothorac Surg 2022 May;61(6):1402-1411

Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland.

Objectives: This study aimed to investigate the impact of mechanical factors at baseline on the patency of a restorative conduit for coronary bypass grafts in an ovine model at serial follow-up up to 1 year.

Methods: The analyses of 4 mechanical factors [i.e. bending angle, superficial wall strain and minimum and maximum endothelial shear stress (ESS)] were performed in 3D graft models reconstructed on baseline (1-month) angiograms frame by frame by a core laboratory blinded for the late follow-up. The late patency was documented by Quantitative Flow Ratio (QFR®) that reflects the physiological status of the graft. The correlation between 4 mechanical factors and segmental QFR (△QFR) were analysed on 10 equal-length segments of each graft.

Results: A total of 69 graft geometries of 7 animals were performed in the study. The highest △QFR at 12 months was colocalized in segments of the grafts with the largest bending angles at baseline. Higher △QFR at 3 months were both at the anastomotic ends and were colocalized with the highest superficial wall strain at baseline. High baseline ESS was topographically associated with higher △QFR at the latest follow-up. Correlations of minimum and maximum ESS with △QFR at 3 months were the strongest among these parameters (ρ = 0.30, 95% CI [-0.05 to 0.56] and ρ = 0.27, 95% CI [-0.05 to 0.54], respectively).

Conclusions: Despite the limited number of grafts, this study suggests an association between early abnormal mechanical factors and late flow metrics of the grafts. The understanding of the mechanical characteristics could help to improve this novel conduit.
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http://dx.doi.org/10.1093/ejcts/ezab554DOI Listing
May 2022

CVIT expert consensus document on primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) update 2022.

Cardiovasc Interv Ther 2022 Jan 12;37(1):1-34. Epub 2022 Jan 12.

The Cardiovascular Institute, Tokyo, Japan.

Primary Percutaneous Coronary Intervention (PCI) has significantly contributed to reducing the mortality of patients with ST-segment elevation myocardial infarction (STEMI) even in cardiogenic shock and is now the standard of care in most of Japanese institutions. The Task Force on Primary PCI of the Japanese Association of Cardiovascular Interventional and Therapeutics (CVIT) society proposed an expert consensus document for the management of acute myocardial infarction (AMI) focusing on procedural aspects of primary PCI in 2018. Updated guidelines for the management of AMI were published by the European Society of Cardiology (ESC) in 2017 and 2020. Major changes in the guidelines for STEMI patients included: (1) radial access and drug-eluting stents (DES) over bare-metal stents (BMS) were recommended as a Class I indication, (2) complete revascularization before hospital discharge (either immediate or staged) is now considered as Class IIa recommendation. In 2020, updated guidelines for Non-ST-Elevation Myocardial Infarction (NSTEMI) patients, the followings were changed: (1) an early invasive strategy within 24 h is recommended in patients with NSTEMI as a Class I indication, (2) complete revascularization in NSTEMI patients without cardiogenic shock is considered as Class IIa recommendation, and (3) in patients with atrial fibrillation following a short period of triple antithrombotic therapy, dual antithrombotic therapy (e.g., DOAC and single oral antiplatelet agent preferably clopidogrel) is recommended, with discontinuation of the antiplatelet agent after 6 to 12 months. Furthermore, an aspirin-free strategy after PCI has been investigated in several trials those have started to show the safety and efficacy. The Task Force on Primary PCI of the CVIT group has now proposed the updated expert consensus document for the management of AMI focusing on procedural aspects of primary PCI in 2022 version.
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http://dx.doi.org/10.1007/s12928-021-00829-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8789715PMC
January 2022

Angiography-derived physiology guidance vs usual care in an All-comers PCI population treated with the healing-targeted supreme stent and Ticagrelor monotherapy: PIONEER IV trial design.

Am Heart J 2022 04 3;246:32-43. Epub 2022 Jan 3.

Department of Cardiology, Medical Centre Leeuwarden, Leeuwarden, the Netherlands.

Background: Current ESC guidelines recommend the use of intra-coronary pressure guidewires for functional assessment of intermediate-grade coronary stenoses. Angiography-derived quantitative flow ratio (QFR) is a novel method of assessing these stenoses, and guiding percutaneous coronary intervention (PCI).

Methods/design: The PIONEER IV trial is a prospective, all-comers, multi-center trial, which will randomize 2,540 patients in a 1:1 ratio to PCI guided by angiography-derived physiology or usual care, with unrestricted use in both arms of the Healing-Targeted Supreme sirolimus-eluting stent (HT Supreme). The stent's fast, biologically healthy, and robust endothelial coverage allows for short dual-antiplatelet therapy (DAPT); hence the antiplatelet regimen of choice is 1-month DAPT, followed by ticagrelor monotherapy. In the angiography-derived physiology guided arm, lesions will be functionally assessed using on-line QFR, with stenting indicated in lesions with a QFR ≤0.80. Post-stenting, QFR will be repeated in the stented vessel(s), with post-dilatation or additional stenting recommended if the QFR<0.91 distal to the stent, or if the delta QFR (across the stent) is >0.05. Usual care PCI is performed according to standard clinical practice. The primary endpoint is a non-inferiority comparison of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization with a non-inferiority risk-difference margin of 3.2%, at 1-year post-procedure. Clinical follow-up will be up to 3 years.

Summary: The PIONEER IV trial aims to demonstrate non-inferiority of QFR-guided PCI to usual care PCI with respect to POCE at 1-year in patients treated with HT Supreme stents and ticagrelor monotherapy.

Clinical Trial Registration: ClinicalTrials.gov UNIQUE IDENTIFIER: NCT04923191 CLASSIFICATIONS: Interventional Cardiology.
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http://dx.doi.org/10.1016/j.ahj.2021.12.018DOI Listing
April 2022

Myval versus alternative balloon- and self-expandable transcatheter heart valves: A central core lab analysis of conduction disturbances.

Int J Cardiol 2022 Mar 1;351:25-31. Epub 2022 Jan 1.

CIBERCV, Hospital Clinico Universitario de Valladolid, Spain. Electronic address:

Background: Several studies have compared surface electrocardiographic changes following different self-expandable (SE) (Evolut (Medtronic, USA); Acurate (Boston Scientific, USA); Portico (Abbott, USA); and Allegra (NVT, Germany)) and balloon-expandable (BE) Sapien-3 (Edwards Lifesciences, USA) transcatheter heart valves. We aimed to compare these prosthesis with the novel Myval BE prosthesis (Meril Life, India).

Methods: Academic European registry of consecutive patients with severe aortic stenosis who received any of the 6 aforementioned valves. Baseline, post-procedural, and discharge 12‑leads electrocardiograms (ECG) were centrally analyzed and compared.

Results: A total of 1131 patients were included: 135 Myval (11.9%), 290 Sapien-3 (25.6%), 298 Evolut (26.3%), 180 Acurate (15.9%), 125 Portico (11.1%), and 103 Allegra (9.1%). There were no baseline differences in intraventricular conduction disturbances rate. Compared to the novel BE Myval, there were similar procedural and in-hospital outcomes. Similar rates of early new permanent pacemaker implant (PPI) were observed amongst Myval (7.4%), Sapien-3 (13.4%), and Acurate (9.1%), but Evolut, Portico, and Allegra presented significantly higher rates (18.5%, p = 0.003; 29.5% p < 0.001 and 22%, p = 0.001, respectively). Central analysis of ECGs, unraveled significant prolongation of the PR segment with Evolut, Portico and Allegra whereas Evolut, Acurate, and Portico showed significant QRS widening compared to Myval. However, at discharge no differences in PR segment duration were observed while, Evolut, and Portico- but not Acurate, Allegra or Sapien-3 - still presented significant widening of QRS segment compared to Myval.

Conclusions: After blinded central ECG analysis, the novel Myval balloon-expandable prosthesis was associated with a low rate of early conduction disturbances.
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http://dx.doi.org/10.1016/j.ijcard.2021.12.049DOI Listing
March 2022

10-Year All-Cause Mortality Following Percutaneous or Surgical Revascularization in Patients With Heavy Calcification.

JACC Cardiovasc Interv 2022 01 29;15(2):193-204. Epub 2021 Dec 29.

Department of Cardiology, National University of Ireland, Galway, Galway, Ireland.

Objectives: The aim of this study was to assess 10-year all-cause mortality in patients with heavily calcified lesions (HCLs) undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

Background: Limited data are available on very long term outcomes in patients with HCLs according to the mode of revascularization.

Methods: This substudy of the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study assessed 10-year all-cause mortality according to the presence of HCLs within lesions with >50% diameter stenosis and identified during the calculation of the anatomical SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score among 1,800 patients with the 3-vessel disease and/or left main disease randomized to PCI or CABG in the SYNTAX trial. Patients with HCLs were further stratified according to disease type (3-vessel disease or left main disease) and assigned treatment (PCI or CABG).

Results: The 532 patients with ≥1 HCL had a higher crude mortality rate at 10 years than those without (36.4% vs 22.3%; HR: 1.79; 95% CI: 1.49-2.16; P < 0.001). After adjustment, an HCL remained an independent predictor of 10-year mortality (HR: 1.36; 95% CI: 1.09-1.69; P = 0.006). There was a significant interaction in mortality between treatment effect (PCI and CABG) and the presence or absence of HCLs (P = 0.005). In patients without HCLs, mortality was significantly higher after PCI than after CABG (26.0% vs 18.8%; HR: 1.44; 95% CI: 0.97-1.41; P = 0.003), whereas in those with HCLs, there was no significant difference (34.0% vs 39.0%; HR: 0.85; 95% CI: 0.64-1.13; P = 0.264).

Conclusions: At 10 years, the presence of an HCL was an independent predictor of mortality, with a similar prognosis following PCI or CABG. Whether HCLs require special consideration when deciding the mode of revascularization beyond their current contribution to the anatomical SYNTAX score deserves further evaluation. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES], NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX], NCT00114972).
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http://dx.doi.org/10.1016/j.jcin.2021.10.026DOI Listing
January 2022
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