Publications by authors named "George Dangas"

625 Publications

Evolving Devices and Material in Transcatheter Aortic Valve Replacement: What to Use and for Whom.

J Clin Med 2022 Jul 30;11(15). Epub 2022 Jul 30.

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, NY 10029, USA.

Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of aortic stenosis, providing a viable alternative to surgical aortic valve replacement (SAVR) for patients deemed to be at prohibitive surgical risk, but also for selected patients at intermediate or low surgical risk. Nonetheless, there still exist uncertainties regarding the optimal management of patients undergoing TAVR. The selection of the optimal bioprosthetic valve for each patient represents one of the most challenging dilemmas for clinicians, given the large number of currently available devices. Limited follow-up data from landmark clinical trials comparing TAVR with SAVR, coupled with the typically elderly and frail population of patients undergoing TAVR, has led to inconclusive data on valve durability. Recommendations about the use of one device over another in given each patient's clinical and procedural characteristics are largely based on expert consensus. This review aims to evaluate the available evidence on the performance of different devices in the presence of specific clinical and anatomic features, with a focus on patient, procedural, and device features that have demonstrated a relevant impact on the risk of poor hemodynamic valve performance and adverse clinical events.
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http://dx.doi.org/10.3390/jcm11154445DOI Listing
July 2022

Outcomes After Transcatheter Aortic Valve Implantation in Men Versus Women.

Am J Cardiol 2022 Aug 4. Epub 2022 Aug 4.

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address:

Gender-based differences in outcomes after successful transcatheter aortic valve implantation (TAVI) in patients without an indication for oral anticoagulation have not been well studied. We aim to evaluate gender-based differences in clinical outcomes after TAVI. In the present analysis of the GALILEO (Global study comparing a rivaroxaban-based antithrombotic strategy to an antiplatelet-based strategy after transcatheter aortic valve replacement to optimize clinical outcomes) trial, patients with symptomatic severe aortic stenosis and who underwent successful TAVI were stratified by gender. The primary outcome was major adverse cardiac and cerebrovascular events (MACCEs), a composite of all-cause mortality or thromboembolic events (including any stroke, myocardial infarction, symptomatic valve thrombosis, systemic embolism, deep-vein thrombosis, or pulmonary embolism). Major bleeding was defined as a composite of major, life-threatening, or disabling Valve Academic Research Consortium-2 bleeding. Of 1,644 patients, 813 were female, and 831 were male. At baseline, female patients were older and at higher surgical risk (Society of Thoracic Surgeons risk score: 4.7 ± 3.6 versus 3.6 ± 3.0, p <0.0001) than male patients. After adjustment for differences in baseline clinical and procedural parameters, female patients had lower rates of MACCE (hazard ratio [HR] 0.69, 95% confidence interval [CI] 0.49 to 0.96), all-cause mortality (HR 0.54, 95% CI 0.34 to 0.87), and noncardiovascular mortality (HR 0.33, 95% CI 0.15 to 0.75) at a median of 17 months of follow-up. By landmark analyses, these differences appeared to emerge with a longer follow-up time. No significant differences in major, life-threatening, or disabling bleeding, cardiovascular mortality, and stroke were noted. In conclusion, compared with male patients, female patients with severe symptomatic aortic stenosis had a lower risk of MACCE and mortality but a similar risk of bleeding events after TAVI.
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http://dx.doi.org/10.1016/j.amjcard.2022.06.035DOI Listing
August 2022

Contrast-associated acute kidney injury: Type may not matter.

Catheter Cardiovasc Interv 2022 07;100(1):94-95

Division of Cardiology, Department of Medicine, Mount Sinai Hospital, New York, New York, USA.

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http://dx.doi.org/10.1002/ccd.30314DOI Listing
July 2022

Deploying a novel custom mobile application for STEMI activation and transfer in a large healthcare system to improve cross-team workflow. STEMIcathAID implementation project.

Am Heart J 2022 Jun 30;253:30-38. Epub 2022 Jun 30.

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address:

Background: ST-segment elevation myocardial infarction (STEMI) is a high-risk patient medical emergency. We developed a secure mobile application, STEMIcathAID, to optimize care for STEMI patients by providing a digital platform for communication between the STEMI care team members, EKG transmission, cardiac catherization laboratory (cath lab) activation and ambulance tracking. The aim of this report is to describe the implementation of the app into the current STEMI workflow in preparation for a pilot project employing the app for inter-hospital STEMI transfer.

Approach: App deployment involved key leadership stakeholders from all multidisciplinary teams taking care of STEMI patients. The team developed a transition plan addressing all aspects of the health system improvement process including the workflow analysis and redesign, app installation, personnel training including user account access to the app, and development of a quality assurance program for progress evaluation. The pilot will go live in the Emergency Department (ED) of one of the hospitals within the Mount Sinai Hospital System (MSHS) during the daytime weekday hours at the beginning and extending to 24/7 schedule over 4-6 weeks. For the duration of the pilot, ED personnel will combine the STEMIcathAID app activation with previous established STEMI activation processes through the MSHS Clinical Command Center (CCC) to ensure efficient and reliable response to a STEMI alert. More than 250 people were provisioned app accounts including ED Physicians and frontline nurses, and trained on their user-specific roles and responsibilities and scheduled in the app. The team will be provided with a feedback form that is discipline specific to complete after every STEMI case in order to collect information on user experience with the STEMIcathAID app functionality. The form will also provide quantitative metrics for the key time sensitive steps in STEMI care.

Conclusions: We developed a uniform approach for deployment of a mobile application for STEMI activation and transfer in a large urban healthcare system to optimize the clinical workflow in STEMI care. The results of the pilot will demonstrate whether the app has a significant impact on the quality of care for transfer of STEMI patients.
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http://dx.doi.org/10.1016/j.ahj.2022.06.008DOI 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

Antithrombotic strategy variability in atrial fibrillation and obstructive coronary disease revascularised with percutaneous coronary intervention: primary results from the AVIATOR 2 international registry.

EuroIntervention 2022 Jun 3. Epub 2022 Jun 3.

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

Background: Managing percutaneous coronary intervention (PCI) patients with atrial fibrillation (AF) presents challenges given that there are several potential antithrombotic therapy (ATT) strategies.

Aims: We examined ATT patterns, agreement between subjective physician ratings and validated risk scores, physician-patient perceptions influencing ATT and 1-year outcomes.

Methods: The AVIATOR 2 prospective registry enrolled 514 non-valvular AF-PCI patients from 11 sites. Treating physicians selected ATT and completed smartphone surveys rating stroke and bleeding risks, compared against CHADS-VASc and HAS-BLED scores. Patients completed surveys regarding treatment understanding. Primary outcomes were 1-year major adverse cardiac or cerebrovascular events (MACCE: composite of death, myocardial infarction, definite/probable stent thrombosis, stroke, target lesion revascularisation) and actionable bleeding (Bleeding Academic Research Consortium 2, 3 or 5).

Results: The mean patient age was 73.2±9.0 years, including 25.8% females. Triple therapy (TT: 1 anticoagulant and 2 antiplatelet agents) was prescribed in 66.5%, dual antiplatelet therapy (DAPT) in 20.7% and dual therapy (1 anticoagulant+1 antiplatelet agent) in 12.8% of patients. Physician ratings and validated risk scores showed poor agreement (stroke: kappa=0.03; bleeding: kappa=0.07). Physicians rated bleeding-related safety (93.8%) as the main factor affecting ATT choice. Patients worried about stroke over bleeding (50.6% vs 14.8%). No group differences by ATT strategy were observed in 1-year MACCE (TT 14.1% vs dual therapy 12.7% vs DAPT 18.5%; p=0.25), or actionable bleeding (14.7% vs 7.9% vs 15.1%, respectively; p=0.89).

Conclusions: The AVIATOR 2 study is the first digital health study examining physician-patient perspectives on ATT choices after AF-PCI. TT was the most common strategy without differences in 1-year outcomes in ATT strategy. Physicians rated safety first when prescribing ATT; patients feared stroke over bleeding.

Clinicaltrials: gov: NCT02362659.
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http://dx.doi.org/10.4244/EIJ-D-21-01044DOI Listing
June 2022

Definitions and Standardized Endpoints for Treatment of Coronary Bifurcations.

J Am Coll Cardiol 2022 Jul 18;80(1):63-88. 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/10.1016/j.jacc.2022.04.024DOI Listing
July 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

A Biomarker-Enhanced Model for Prediction of Acute Kidney Injury and Cardiovascular Risk Following Angiographic Procedures: CASABLANCA AKI Prediction Substudy.

J Am Heart Assoc 2022 05 16;11(10):e025729. Epub 2022 May 16.

Massachusetts General Hospital Boston MA.

Background The 2020 Acute Disease Quality Initiative Consensus provided recommendations on novel acute kidney injury biomarkers. In this study, we sought to assess the added value of novel kidney biomarkers to a clinical score in the CASABLANCA (Catheter Sampled Blood Archive in Cardiovascular Diseases) study. Methods and Results We evaluated individuals undergoing coronary and/or peripheral angiography and added 4 candidate biomarkers for acute kidney injury (kidney injury molecule-1, interleukin-18, osteopontin, and cystatin C) to a previously described contrast-associated acute kidney injury (CA-AKI) risk score. Participants were categorized into integer score groups based on the risk assigned by the biomarker-enhanced CA-AKI model. Risk for incident cardiorenal outcomes during a median 3.7 years of follow-up was assessed. Of 1114 participants studied, 55 (4.94%) developed CA-AKI. In adjusted models, neither kidney injury molecule-1 nor interleukin-18 improved discrimination for CA-AKI; addition of osteopontin and cystatin C to the CA-AKI clinical model significantly increased the c-statistic from 0.69 to 0.73 ( for change <0.001) and resulted in a Net Reclassification Index of 59.4. Considering those with the lowest CA-AKI integer score as a reference, the intermediate, high-risk, and very-high-risk groups were associated with adverse cardiorenal outcomes. The corresponding hazard ratios of the very-high-risk group were 3.39 (95% CI, 2.14-5.38) for nonprocedural acute kidney injury, 5.58 (95% CI, 3.23-9.63) for incident chronic kidney disease, 6.21 (95% CI, 3.67-10.47) for myocardial infarction, and 8.94 (95% CI, 4.83-16.53) for all-cause mortality. Conclusions A biomarker-enhanced risk model significantly improves the prediction of CA-AKI beyond clinical variables alone and may stratify the risk of future cardiorenal outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00842868.
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http://dx.doi.org/10.1161/JAHA.122.025729DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9238548PMC
May 2022

Tailoring the therapy to the patient with mitral and tricuspid regurgitation to avoid adverse long-term outcomes.

Catheter Cardiovasc Interv 2022 05;99(6):1857-1858

Division of Cardiology, Mount Sinai Hospital, New York, New York, USA.

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http://dx.doi.org/10.1002/ccd.30221DOI Listing
May 2022

Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery.

N Engl J Med 2022 05;386(19):1864-1865

Icahn School of Medicine at Mount Sinai, New York, NY

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http://dx.doi.org/10.1056/NEJMc2202491DOI Listing
May 2022

Impact of Small Valve Size on 1-Year Outcomes After Transcatheter Aortic Valve Implantation in Women (from the WIN-TAVI Registry).

Am J Cardiol 2022 06 20;172:73-80. Epub 2022 Apr 20.

Department of Cardiology, AOUP Cisanello, University Hospital, Pisa, Italy.

Although most patients with small aortic annulus are women, there is paucity of data on the prognostic impact of small aortic prosthesis in women who underwent transcatheter aortic valve implantation (TAVI). Therefore, we aimed to evaluate the impact of small valve size on 1-year clinical outcomes after TAVI in women. The Women's INternational Transcatheter Aortic Valve Implantation is an all-women registry evaluating patients with severe aortic stenosis who underwent TAVI. Based on the size of the aortic bioprosthesis implanted, women were stratified into small (≤23 mm) and nonsmall (>23 mm) valve. The primary efficacy endpoint was the Valve Academic Research Consortium-2 composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up. Of 934 women who underwent TAVI, 388 (41.5%) received a small valve. Women with a small valve size had a lower body mass index, lower surgical risk scores, were less likely to suffer from atrial fibrillation, less often required postdilation and had a lower rate of residual aortic regurgitation grade ≥2. The occurrence of the Valve Academic Research Consortium-2 efficacy endpoint was similar between women treated with small and nonsmall valve (16.0% vs 16.3%, p = 0.881; adjusted hazard ratio 1.34, 95% confidence interval 0.90 to 2.00). Likewise, there were no significant differences in the occurrence of other secondary endpoints after multivariable adjustment. In conclusion, women with severe aortic stenosis who underwent TAVI with the implantation of a small valve bioprosthesis had similar 1-year outcomes as those receiving a nonsmall bioprosthesis.
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http://dx.doi.org/10.1016/j.amjcard.2022.02.025DOI Listing
June 2022

Double kissing crush stenting: No pain, no gain?

Catheter Cardiovasc Interv 2022 03;99(4):1045-1046

Division of Cardiology, Icahn School of Medicine at Mount Sinai, New York City, New York, US.

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http://dx.doi.org/10.1002/ccd.30183DOI Listing
March 2022

Sex-Related Outcomes of Medical, Percutaneous, and Surgical Interventions for Coronary Artery Disease: JACC Focus Seminar 3/7.

J Am Coll Cardiol 2022 04;79(14):1407-1425

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

Biological and sociocultural differences between men and women are complex and likely account for most of the variations in the epidemiology and treatment outcomes of coronary artery disease (CAD) between the 2 sexes. Worse outcomes in women have been described following both conservative and invasive treatments of CAD. For example, increased levels of residual platelet reactivity during treatment with antiplatelet drugs, higher rates of adverse cardiovascular outcomes following percutaneous coronary revascularization, and higher operative and long-term mortality after coronary bypass surgery have been reported in women compared with in men. Despite the growing recognition of sex-specific determinants of outcomes, representation of women in clinical studies remains low and sex-specific management strategies are generally not provided in guidelines. This review summarizes the current evidence on sex-related differences in patients with CAD, focusing on the differential outcomes following medical therapy, percutaneous coronary interventions, and coronary artery bypass surgery.
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http://dx.doi.org/10.1016/j.jacc.2021.07.066DOI Listing
April 2022

Perioperative Management of P2Y12 Inhibitors in Patients Undergoing Cardiac Surgery within 1 Year of PCI.

Eur Heart J Cardiovasc Pharmacother 2022 Apr 7. Epub 2022 Apr 7.

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

Objectives: To evaluate the impact of perioperative P2Y12-receptor inhibitor therapy among patients undergoing cardiac surgery within 1 year of percutaneous coronary intervention (PCI).

Methods And Results: Patients undergoing cardiac surgery in the year post-PCI at 3 tertiary-care centers between 2011-2018 were stratified into those who had received at least one dose of P2Y12 inhibitor prior to surgery (within 5 days for clopidogrel or prasugrel, or within 3 days for ticagrelor) and those who had not. The outcomes of interest were major adverse cardiac and cerebrovascular events (MACCE) and bleeding. Among 20 279 PCI patients, 359 (1.8%) underwent cardiac surgery in the ensuing year, 76.3% of whom received coronary artery bypass grafts. Overall, 33 (9.2%) MACCE and 85 (23.7%) bleeding events occurred within 30 days post-cardiac surgery. Perioperative P2Y12 inhibition (N = 133, 37%) was not associated with the risk of MACCE or bleeding, despite numerically lower rates of myocardial infarction or stent thrombosis (0.0% vs. 2.6%; p = 0.089). Patients who continued the P2Y12 inhibitor until the day of surgery (N = 60, 17%) had significantly higher bleeding risk (adjOR 2.93, 95% CI 1.53-5.59). Predictors of MACCE included a time interval from PCI to cardiac surgery of ≤ 30 days and reduced ejection fraction, whereas urgent/emergent surgery predicted bleeding. Chronic kidney disease and myocardial infarction as indication for PCI predicted both MACCE and bleeding.

Conclusions: Among patients undergoing cardiac surgery in the year after PCI, the perioperative risk of ischemic and bleeding events might be influenced by P2Y12 inhibitor therapy in addition to other risk parameters, including the timing and urgency of the procedure.
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http://dx.doi.org/10.1093/ehjcvp/pvac024DOI Listing
April 2022

Outcomes in Valve-in-Valve Transcatheter Aortic Valve Implantation.

Am J Cardiol 2022 06 26;172:81-89. Epub 2022 Mar 26.

Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam University Medical Center, University of Amsterdam, Netherlands. Electronic address:

The use of valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) is increasing, but studies evaluating clinical outcomes in these patients are scarce. Also, there are limited data to guide the choice of valve type in ViV-TAVI. Therefore, this CENTER-study evaluated clinical outcomes in patients with ViV-TAVI compared to patients with native valve TAVI (NV-TAVI). In addition, we compared outcomes in patients with ViV-TAVI treated with self-expandable versus balloon-expandable valves. A total of 256 patients with ViV-TAVI and 11333 patients with NV-TAVI were matched 1:2 using propensity score matching, resulting in 256 patients with ViV-TAVI and 512 patients with NV-TAVI. Mean age was 81±7 years, 58% were female, and the Society of Thoracic Surgeons Predicted Risk of Mortality was 6.3% (4.0% to 12.8%). Mortality rates were comparable between ViV-TAVI and NV-TAVI patients at 30 days (4.1% vs 5.9%, p = 0.30) and 1 year (14.2% vs 17.3%, p = 0.34). Stroke rates were also similar at 30 days (2.8% vs 1.8%, p = 0.38) and 1 year (4.9% vs 4.3%, p = 0.74). Permanent pacemakers were less frequently implanted in patients with ViV-TAVI (8.8% vs 15.0%, relative risk 0.59, 95% confidence interval [CI] 0.37 to 0.92, p = 0.02). Patients with ViV-TAVI were treated with self-expandable valves (n = 162) and balloon-expandable valves (n = 94). Thirty-day major bleeding was less frequent in patients with self-expandable valves (3% vs 13%, odds ratio 5.12, 95% CI 1.42 to 18.52, p = 0.01). Thirty-day mortality was numerically lower in patients with self-expandable valves (3% vs 7%, odds ratio 3.35, 95% CI 0.77 to 14.51, p = 0.11). In conclusion, ViV-TAVI seems a safe and effective treatment for failing bioprosthetic valves with low mortality and stroke rates comparable to NV-TAVI for both valve types.
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http://dx.doi.org/10.1016/j.amjcard.2022.02.028DOI Listing
June 2022

Randomized Clinical Trial on Prevention of Radial Occlusion After Transradial Access Using Nitroglycerin: PATENS Trial.

JACC Cardiovasc Interv 2022 05 21;15(10):1009-1018. Epub 2022 Mar 21.

Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.

Objectives: The aim of this study was to evaluate whether administration of nitroglycerin at the beginning or end of a transradial approach (TRA) procedure would preserve radial patency.

Background: The TRA is becoming the preferred vascular access route in coronary interventions. Radial artery occlusion (RAO) is the most frequent complication. Routine vasodilator treatment aims to reduce spasm and possibly prevent RAO.

Methods: The authors designed a prospective, multicenter, randomized, double-blind, 2-by-2 factorial, placebo-controlled trial encompassing patients undergoing the TRA. Patients were randomized to either 500 μg nitroglycerin or placebo; each arm was also subrandomized to early (upon sheath insertion) or late (right before sheath removal) nitroglycerin administration to evaluate the superiority of nitroglycerin in the prevention of RAO with 24 hours on Doppler ultrasound.

Results: A total of 2,040 patients were enrolled. RAO occurred in 49 patients (2.4%). Fifteen of these patients (30.6%) showed re-establishment of flow at 30 days. Nitroglycerin, compared with placebo, did not reduce the risk for RAO at either of the 2 time points (early, 2.5% vs 2.3% [P = 0.66]; late, 2.3% vs 2.5% [P = 0.66]). By multivariable analysis, the presence of spasm (OR: 3.53; 95% CI: 1.87-6.65; P < 0.001) and access achieved with more than 1 puncture attempt (OR: 2.58; 95% CI: 1.43-4.66; P = 0.002) were independent predictors of RAO.

Conclusions: The routine use of nitroglycerin was not associated with a reduction in the rate of RAO, regardless of the time of administration (at the beginning or end of the TRA procedure).
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http://dx.doi.org/10.1016/j.jcin.2022.02.026DOI Listing
May 2022

Ticagrelor monotherapy after PCI in patients with concomitant diabetes mellitus and chronic kidney disease: TWILIGHT DM-CKD.

Eur Heart J Cardiovasc Pharmacother 2022 Mar 23. Epub 2022 Mar 23.

Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.

Aims: We aimed to evaluate the treatment effects of ticagrelor monotherapy in the very high-risk cohort of patients with concomitant diabetes mellitus (DM) and chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI).

Methods And Results: In the TWILIGHT trial, after 3-month dual antiplatelet therapy with ticagrelor and aspirin post-PCI, event-free patients were randomized to either aspirin or placebo in addition to ticagrelor for 12 months. Those with available information on DM and CKD status were included in this subanalysis and were stratified by the presence or absence of either condition: 3391 (54.1%) had neither DM nor CKD (DM-/CKD-), 1822 (29.0%) had DM only (DM+/CKD-), 561 (8.9%) had CKD only (DM-/CKD+), and 8.0% had both DM and CKD (DM+/CKD+). The incidence of the primary endpoint of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding did not differ according to DM/CKD status (p-trend = 0.13), but there was a significant increase in BARC 3 or 5 bleeding (p-trend<0.001) as well as the key secondary endpoint of death, myocardial infarction, or stroke (p-trend<0.001). Ticagrelor plus placebo reduced bleeding events compared with ticagrelor plus aspirin across all four groups, including DM+/CKD+ patients with respect to BARC 2-5 (4.5% vs. 8.7%; HR 0.49, 95% CI 0.24-1.01) as well as BARC 3-5 (0.8% vs. 5.3%; HR 0.15, 95% CI 0.03-0.53) bleeding, with no evidence of heterogeneity. The risk of death, myocardial infarction, or stroke was similar between treatment arms across all groups.

Conclusions: Irrespective of the presence of DM, CKD, and their combination, ticagrelor monotherapy reduced the risk of bleeding without a significant increase in ischemic events compared with ticagrelor plus aspirin.
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http://dx.doi.org/10.1093/ehjcvp/pvac016DOI Listing
March 2022

Ticagrelor With or Without Aspirin in Chinese Patients Undergoing Percutaneous Coronary Intervention: A TWILIGHT China Substudy.

Circ Cardiovasc Interv 2022 04 23;15(4):e009495. Epub 2022 Mar 23.

Department of Cardiology' Hamilton Health Sciences, Canada (M.K., E.M.O.).

Background: The risk/benefit tradeoff of dual antiplatelet therapy after percutaneous coronary intervention may vary in East Asian patients as compared with their non-East Asian counterparts.

Methods: The double-blind, placebo-controlled, randomized TWILIGHT trial (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) enrolled patients undergoing high-risk percutaneous coronary intervention. After 3 months of treatment with ticagrelor plus aspirin, event-free and adherent patients remained on ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding; the key secondary end point was the first occurrence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke.

Results: Of 9006 enrolled and 7119 randomized patients in TWILIGHT, 1169 patients (13.0%) were enrolled at 27 Chinese sites in this prespecified substudy, of whom 1028 (14.4%) patients were randomized after 3 months. The incidence of the primary end point was 6.2% in the ticagrelor+aspirin group versus 3.5% in the ticagrelor+placebo group between randomization and 1 year (hazard ratio, 0.56 [95% CI, 0.31-0.99]; =0.048). The key secondary end point occurred in 3.4% of patients in the ticagrelor+aspirin group versus 2.4% in the ticagrelor+placebo group (hazard ratio, 0.70 [95% CI, 0.33-1.46]; =0.34). There was no interaction between the region of randomization (China versus the rest of the world) and randomized treatment assignment in terms of the primary or key secondary end points.

Conclusions: Ticagrelor monotherapy significantly reduced clinically relevant bleeding without increasing ischemic events as compared with ticagrelor plus aspirin in Chinese patients undergoing high-risk percutaneous coronary intervention.

Registration: URL: https://www.

Clinicaltrials: gov; Unique identifier: NCT02270242.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.009495DOI Listing
April 2022

Outcomes and feasibility of redo-TAVR after Sapien 3 Ultra TAVR in extremely-undersized versus nominally-sized annuli.

Catheter Cardiovasc Interv 2022 05 21;99(6):1935-1944. Epub 2022 Mar 21.

Division of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, Canada.

Objectives: To compare outcomes in Sapien 3 Ultra (S3U) transcatheter aortic valve replacement (TAVR) with extreme annular undersizing (EAU) versus nominal annular sizing (NAS).

Background: The Edwards S3U valve has reduced paravalvular leak (PVL) in TAVR but outcomes remain unknown in extremely undersized anatomy. Implanting a smaller S3U valve may facilitate future redo-TAVR but risk compromising hemodynamics.

Methods: From December 2019 to July 2021, 366 patients with native aortic stenosis underwent S3U TAVR. Patients with EAU (annular areas >430 mm for 23 mm or >546 mm for 26 mm) were compared to NAS (338-430 mm for 23 mm or 430-546 mm for 26 mm). In-hospital and 30-day outcomes, and redo-TAVR feasibility were determined.

Results: There were 79 (21.6%) EAU patients, with more bicuspid (p = 0.0014) and ≥moderate annular/left ventricular outflow tract calcification (p < 0.001). The EAU group had less annular oversizing than NAS group (23 mm: -8.2 ± 2.6% vs. 4.0 ± 7.0%, p < 0.001; 26 mm: -8.9 ± 2.2% vs. 6.7 ± 6.9%, p < 0.001), more balloon overfilling (71.3% vs. 11.6%, p < 0.001), and postdilatation (15.0% vs. 5.8%, p = 0.016). No differences were found in in-hospital or 30-day mortality and stroke (p > 0.05). Mild PVL (13.4% EAU vs. 11.5% NAS, p = 0.56) and mean gradients (23 mm: 13.0 ± 4.5 vs. 14.1 ± 5.4 mmHg, p = 0.40; 26 mm: 11.4 ± 4.1 vs. 11.5 ± 3.9 mmHg, p = 1.0) were similar at 30 days. Had the EAU group undergone NAS with the larger Sapien 3/S3U, by computed tomography analysis simulating 80:20 or 90:10 target implant depth, 33.3%-60.9% (vs. 4.3%-23.2%) would not be feasible for redo-TAVR due to high risk of coronary obstruction.

Conclusions: In this first report of EAU with S3U TAVR, similar excellent short-term outcomes can be achieved compared to NAS, and may preserve future redo-TAVR option.
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http://dx.doi.org/10.1002/ccd.30146DOI Listing
May 2022

Long-Term Clinical Impact of Contrast-Associated Acute Kidney Injury Following PCI: An ADAPT-DES Substudy.

JACC Cardiovasc Interv 2022 04 16;15(7):753-766. Epub 2022 Mar 16.

Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA; DeMatteis Cardiovascular Institute, St. Francis Hospital, Roslyn, New York, USA. Electronic address:

Objectives: This study sought to determine correlates and consequences of contrast-associated acute kidney injury (CA-AKI) on clinical outcomes in patients with or without pre-existing chronic kidney disease (CKD).

Background: The incidence and impact of CA-AKI on clinical outcomes during contemporary percutaneous coronary intervention (PCI) are not fully defined.

Methods: The ADAPT-DES (Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents) study was a prospective, multicenter registry of 8,582 patients treated with ≥1 drug-eluting stent(s). CA-AKI was defined as a post-PCI increase in serum creatinine of >0.5 mg/dL or a relative increase of ≥25% compared with pre-PCI. CKD was defined as estimated glomerular filtration rate <60 mL/min/1.73 m. The primary endpoint was the 2-year rate of net adverse clinical events (NACE): All-cause mortality, myocardial infarction (MI), definite or probable stent thrombosis, or major bleeding.

Results: Of 7287 (85%) patients with evaluable data, 476 (6.5%) developed CA-AKI. In a multivariable model, older age, female sex, Caucasian race, congestive heart failure, diabetes, hypertension, CKD, presentation with ST-segment elevation MI, Killip class II to IV, radial access, intra-aortic balloon pump use, hypotension, and number of stents were independent predictors of CA-AKI. The 2-year NACE rate was higher in patients with CA-AKI (adjusted HR: 1.88; 95% CI: 1.42-2.49), as was each component of NACE (all-cause mortality, HR: 1.77; 95% CI: 1.22-2.55; MI, HR: 1.67; 95% CI: 1.18-2.36; definite/probable stent thrombosis, HR: 1.71; 95% CI: 1.10-2.65; and major bleeding, HR: 1.38; 95% CI: 1.06-1.80). Compared with the CA-AKI-/CKD- group, the CA-AKI+/CKD- (HR: 1.83; 95% CI: 1.33-2.52), CA-AKI-/CKD+ (HR: 1.56; 95% CI: 1.15-2.13), CA-AKI+/CKD+ (HR: 3.29; 95% CI: 1.92-5.67), and maintenance dialysis (HR: 2.67; 95% CI: 1.65-4.31) groups were at higher risk of NACE.

Conclusions: CA-AKI was relatively common after contemporary PCI and was associated with increased 2-year rates of NACE. Patients with pre-existing CKD were at particularly high risk for NACE after CA-AKI.
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http://dx.doi.org/10.1016/j.jcin.2021.11.026DOI Listing
April 2022

Left Ventricular Thrombus Following Acute Myocardial Infarction: JACC State-of-the-Art Review.

J Am Coll Cardiol 2022 03;79(10):1010-1022

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

The incidence of left ventricular (LV) thrombus following acute myocardial infarction has markedly declined in recent decades caused by advancements in reperfusion and antithrombotic therapies. Despite this, embolic events remain the most feared complication of LV thrombus necessitating systemic anticoagulation. Mechanistically, LV thrombus development depends on Virchow's triad (ie, endothelial injury from myocardial infarction, blood stasis from LV dysfunction, and hypercoagulability triggered by inflammation, with each of these elements representing potential therapeutic targets). Diagnostic modalities include transthoracic echocardiography with or without ultrasound-enhancing agents and cardiac magnetic resonance. Most LV thrombi develop within the first 2 weeks post-acute myocardial infarction, and the role of surveillance imaging appears limited. Vitamin K antagonists remain the mainstay of therapy because the efficacy of direct oral anticoagulants is less well established. Only meager data support the routine use of prophylactic anticoagulation, even in high-risk patients.
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http://dx.doi.org/10.1016/j.jacc.2022.01.011DOI Listing
March 2022

Endothelial Progenitor Cells in Coronary Atherosclerosis and Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis.

Cardiovasc Revasc Med 2022 Sep 27;42:94-99. Epub 2022 Feb 27.

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America.

Introduction: The role of endothelial progenitor cells (EPCs) in atherosclerosis progression and neointimal growth after percutaneous coronary intervention (PCI) remains controversial. The purpose of this study was to perform a systematic review and meta-analysis of studies on EPCs in patients who had PCI.

Methods: We searched Pubmed, Embase and Cochrane databases and reviewed cited references up to August 31, 2021. Overall, we selected 9 studies, including 4612 patients.

Results: Lower baseline EPC count was associated with a significantly greater occurrence of in-stent restenosis (HR 1.33; 95% CI 0.97-1.82, P = 0.045). As for EPC coating, there was no significant difference in the 1-year occurrence of cardiac death between EPCs-capturing drug-eluting stents (DES) and standard DES (Relative Risk [RR] 1.146; 95% CI 0.666-1.974, P = 0.98), but target lesion revascularization (RR 1.727; 95% CI: 1.199-2.487, P = 0.025), and target vessel failure (RR 1.591; 95% CI 1.213-2.088, P = 0.04) were significantly more common with EPCs-capturing DES than with standard DES.

Conclusion: Circulating EPC count might improve risk stratification after PCI, as it is correlated with the occurrence of in-stent restenosis. Currently available EPCs-capturing DES use was associated with an increased risk of 1-year adverse events, mainly driven by an increase in target lesion revascularization and target vessel failure, not cardiac death.
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http://dx.doi.org/10.1016/j.carrev.2022.02.025DOI Listing
September 2022

Hypoattenuated Leaflet Thickening After Transcatheter Aortic Valve Replacement: Additional Data, Yet Still Many Unanswered Questions.

Circ Cardiovasc Interv 2022 03 3;15(3):e011828. Epub 2022 Mar 3.

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

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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.122.011828DOI Listing
March 2022

Is cardiac surgery backup required for left main stenting?

Catheter Cardiovasc Interv 2022 02;99(3):607-608

Mount Sinai School of Medicine-Cardiovascular Institute, New York, New York, USA.

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http://dx.doi.org/10.1002/ccd.30127DOI Listing
February 2022

Edoxaban or Vitamin K Antagonist for Atrial Fibrillation after TAVR. Reply.

N Engl J Med 2022 02;386(8):804

Mount Sinai Hospital, New York, NY

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http://dx.doi.org/10.1056/NEJMc2120127DOI Listing
February 2022

Timing of mechanical circulatory support during primary angioplasty in acute myocardial infarction and cardiogenic shock: Systematic review and meta-analysis.

Catheter Cardiovasc Interv 2022 03 19;99(4):998-1005. Epub 2022 Feb 19.

Department of Innovative Technologies in Medicine & Odontology, Institute of Cardiology, "G. d'Annunzio" University, Chieti, Italy.

Objectives: We aim to define whether the timing of microaxial left ventricular assist device (IMLVAD) implantation might impact on mortality in acute myocardial infarction (AMI) cardiogenic shock (CS) patients who underwent primary percutaneous coronary intervention (PPCI).

Background: Despite the widespread use of PPCI, mortality in patients with AMI and CS remains high. Mechanical circulatory support is a promising bridge to recovery strategy, but evidence on its benefit is still inconclusive and the optimal timing of its utilization remains poorly explored.

Methods: We compared clinical outcomes of upstream IMLVAD use before PPCI versus bailout use after PPCI in patients with AMI CS. A systematic review and meta-analysis of studies comparing the two strategies were performed. Effect size was reported as odds ratio (OR) using bailout as reference group and a random effect model was used. Study-level risk estimates were pooled through the generic inverse variance method (random effect model).

Results: A total of 11 observational studies were identified, including a pooled population of 6759 AMI-CS patients. Compared with a bailout approach, upstream IMLVAD was associated with significant reduction of 30-day (OR = 0.65; 95% confidence interval [CI] = 0.51-0.82; I  = 43%, adjusted OR = 0.54; 95% CI = 0.37-0.59; I  = 3%, test for subgroup difference p = 0.30), 6-month (OR = 0.51; 95% CI = 0.27-0.96; I  = 66%), and 1-year (OR = 0.56; 95% CI = 0.39-0.79; I  = 0%) all-cause mortality. Incidence of access-related bleeding, acute limb ischemia and transfusion outcomes were similar between the two strategies.

Conclusion: In patients with AMI-CS undergoing PPCI, upstream IMLVAD was associated with reduced early and midterm all-cause mortality when compared with a bailout strategy.
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http://dx.doi.org/10.1002/ccd.30137DOI Listing
March 2022

Prognostic Value of Baseline Inflammation in Diabetic and Nondiabetic Patients Undergoing Percutaneous Coronary Intervention.

Can J Cardiol 2022 06 10;38(6):792-800. Epub 2022 Feb 10.

Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address:

Background: There is a paucity of data on the prognostic value of high-sensitivity C-reactive protein (hsCRP) levels in diabetic and nondiabetic patients undergoing percutaneous coronary intervention (PCI).

Methods: All patients with known baseline hsCRP undergoing PCI at a single tertiary care centre from 2010 to 2017 were included. High hsCRP was defined as > 3 mg/L. Known causes of elevated hsCRP levels and hsCRP > 10 mg/L represented exclusion criteria. The 1-year primary outcome was major adverse cardiovascular events (MACE), including all-cause mortality, myocardial infarction (MI), and target-vessel revascularisation (TVR).

Results: Among a total of 11,979 patients included, high hsCRP levels were observed in 24.7% of patients without diabetes and 29.8% of patients with diabetes (P < 0.001). Both diabetics and nondiabetics with high hsCRP levels had increased rates of MACE compared with their counterparts with low hsCRP (diabetics: adjusted hazard ratio [aHR] 1.58, 95% CI 1.27-1.96; nondiabetics: aHR 1.45, 95% CI 1.13-1.86; P interaction = 0.981) primarily driven by increased rates all-cause deaths (diabetics: aHR 2.32, 95% CI 1.42-3.80; nondiabetics: aHR 3.14, 95% CI 1.74-5.65; P interaction = 0.415). Although high hsCRP levels were associated with increased rates of TVR (aHR 1.35, 95% CI 1.04-1.75) and MI (aHR 1.86, 95% CI 1.18-2.93) only in patients with diabetes, no significant interactions were observed between inflammation and diabetes (P interaction = 0.749 and 0.602, respectively).

Conclusions: Patients undergoing PCI with high levels of hsCRP, defined as > 3 mg/L, have worse ischemic outcomes regardless of diabetes status.
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http://dx.doi.org/10.1016/j.cjca.2022.02.002DOI Listing
June 2022

Effect of Elevated C-Reactive Protein on Outcomes After Complex Percutaneous Coronary Intervention for Angina Pectoris.

Am J Cardiol 2022 04 19;168:47-54. Epub 2022 Jan 19.

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, New York. Electronic address:

Inflammation and procedural complexity are individually associated with adverse outcomes after percutaneous coronary intervention (PCI). We aimed to evaluate the association of high sensitivity C-reactive protein (hsCRP) with adverse events according to PCI complexity. We included patients with available hsCRP levels who underwent PCI at our center from 2012 to 2017. We compared patients with hsCRP ≥3 versus <3 mg/L. Complex PCI was defined as having ≥1 of the following: ≥3 different target vessels, ≥3 lesions treated, ≥3 stents implanted, bifurcation lesion treated with 2 stents, chronic total occlusion as target lesion, or total stent length >60 mm. The primary end point was major adverse cardiac events (MACEs) (composite of all-cause death, myocardial infarction, or target vessel revascularization) at 1 year. A total of 11,979 patients were included, of which 2,840 (24%) underwent complex PCI. In those, 767 (27%) had hsCRP ≥3 mg/L. The 1-year incidence of MACE was 6% (noncomplex PCI, low hsCRP), 10% (noncomplex PCI, high hsCRP), 10% (complex PCI, low hsCRP), and 15% (complex PCI, high hsCRP). Overall, hsCRP ≥3 mg/L was associated with an increased risk of MACE compared with hsCRP <3 mg/L; this was independent of the number of complex PCI features: 0 (adjusted hazard ratio [HR] 1.53; 95% confidence interval [CI] 1.27 to 1.86), 1 (adjusted HR 1.77; 95% CI 1.21 to 2.60), or ≥2 (adjusted HR 1.21; 95% CI 0.80 to 1.83) (p = 0.42). In conclusion, in patients who underwent PCI, elevated hsCRP is associated with an increased risk of ischemic events. The effect of elevated hsCRP on cardiovascular risk is consistent regardless of PCI complexity.
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http://dx.doi.org/10.1016/j.amjcard.2021.12.042DOI Listing
April 2022

Ticagrelor Monotherapy After PCI in High-Risk Patients With Prior MI: A Prespecified TWILIGHT Substudy.

JACC Cardiovasc Interv 2022 02 12;15(3):282-293. Epub 2022 Jan 12.

Groupe Hospitalier Bichat-Claude-Bernard, Paris, France.

Objectives: The aim of this study was to evaluate if patients with prior myocardial infarction (MI) could benefit from ticagrelor monotherapy in terms of bleeding reduction without any compromise in ischemic event prevention.

Background: Patients with history of MI who undergo percutaneous coronary intervention (PCI) remain at risk for recurrent ischemic events. The optimal antithrombotic strategy for this cohort remains debated.

Methods: In this prespecified analysis of the randomized TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial, the authors evaluated the impact of history of MI on treatment effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients undergoing PCI with drug-eluting stent with at least 1 clinical and 1 angiographic high-risk feature and free from adverse events at 3 months after index PCI. The primary endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, and the key secondary endpoint was the composite of all-cause death, MI, or stroke, both at 12 months after randomization.

Results: A total of 1,937 patients (29.7%) with and 4,595 patients (70.3%) without prior MI were randomized to ticagrelor and placebo or ticagrelor and aspirin. At 1 year after randomization, patients with prior MI experienced higher rates of death, MI, or stroke (5.7% vs 3.2%; P < 0.001) but similar BARC types 2 to 5 bleeding (5.0% vs 5.5%; P = 0.677) compared with patients without prior MI. Ticagrelor monotherapy consistently reduced the risk for the primary bleeding outcome in patients with (3.4% vs 6.7%; HR: 0.50; 95% CI: 0.33-0.76) and without (4.2% vs 7.0%; HR: 0.58; 95% CI: 0.45-0.76; P = 0.54) prior MI. Rates of the key secondary ischemic outcome were not significantly different between treatment groups irrespective of history of MI (prior MI, 6.0% vs 5.5% [HR: 1.09; 95% CI: 0.75-1.58]; no prior MI, 3.1% vs 3.3% [HR: 0.92; 95% CI: 0.67-1.28]; P = 0.52).

Conclusions: Ticagrelor monotherapy is associated with significantly lower risk for bleeding events compared with ticagrelor plus aspirin, without any compromise in ischemic prevention, among high-risk patients with history of MI undergoing PCI. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242).
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http://dx.doi.org/10.1016/j.jcin.2021.11.005DOI Listing
February 2022
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