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Current Vascular Pharmacology

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ISSN (Print): 1570-1611
ISSN (Online): 1875-6212

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Review Article

New Antithrombotic Strategies and Coronary Stent Technologies for Patients at High Bleeding Risk Undergoing Percutaneous Coronary Intervention

Author(s): Sabato Sorrentino*, Nadia Salerno, Isabella Leo, Alberto Polimeni, Jolanda Sabatino, Carmen Anna Maria Spaccarotella, Annalisa Mongiardo, Salvatore De Rosa and Ciro Indolfi*

Volume 20, Issue 1, 2022

Published on: 09 August, 2021

Page: [37 - 45] Pages: 9

DOI: 10.2174/1570161119666210809163404

Price: $65

Abstract

Patients at High Bleeding Risk (HBR) are a sizable part of the population undergoing Percutaneous Coronary Intervention (PCI) and stent implantation. This population historically lacks standardized definition, thus limiting trial design, data generalizability, and clinical decision-- making. To overcome this limitation, the Academic Research Consortium (ARC) has recently released comprehensive guidelines defining HBR criteria for study design purposes and daily clinical practices. Furthermore, several risk scores have been developed aiming to discriminate against HBR patients and support physicians for clinical decision-making when faced with this complex subset of patients. Accordingly, the first part of this review article will explore guideline-recommended risk scoring as well as ARC-HBR criteria and their relative application for daily clinical practice. The second part of this review article will explore the complex interplay between the risk of bleeding and coronary thrombotic events in patients deemed at HBR. Indeed, several features that identify these patients are also independent predictors of recurrent ischemic events, thus challenging revascularization strategies and optimal antithrombotic therapy. Accordingly, several clinical trials have been conducted to evaluate the safety and efficacy of the new generation of coronary platforms and different antithrombotic strategies for HBR patients to minimize both ischemic and bleeding events. Accordingly, in this part, we discuss current guidelines, trials, and observational data evaluating antithrombotic strategies and stent technologies for patients at HBR.

Keywords: High bleeding risk, antithrombotic therapy, stent, percutaneous coronary intervention, dual antiplatelet therapy, DAPT.

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Graphical Abstract

[1]
Valgimigli M, Bueno H, Byrne RA, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the european association for cardio-thoracic surgery (EACTS). Eur Heart J 2018; 39(3): 213-60.
[http://dx.doi.org/10.1093/eurheartj/ehx419] [PMID: 28886622]
[2]
Steg PG, Huber K, Andreotti F, et al. Bleeding in acute coronary syndromes and percutaneous coronary interventions: position paper by the working group on thrombosis of the European Society of Cardiology. Eur Heart J 2011; 32(15): 1854-64.
[http://dx.doi.org/10.1093/eurheartj/ehr204] [PMID: 21715717]
[3]
Baber U, Mehran R, Giustino G, et al. Coronary thrombosis and major bleeding after PCI with drug-eluting stents: Risk scores from PARIS. J Am Coll Cardiol 2016; 67(19): 2224-34.
[http://dx.doi.org/10.1016/j.jacc.2016.02.064] [PMID: 27079334]
[4]
Sorrentino S, Sartori S, Baber U, et al. Bleeding risk, dual antiplatelet therapy cessation, and adverse events after percutaneous coronary intervention: The PARIS registry. Circ Cardiovasc Interv 2020; 13(4): e008226.
[http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008226] [PMID: 32216472]
[5]
Wiviott SD, Braunwald E, McCabe CH, et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2007; 357(20): 2001-15.
[http://dx.doi.org/10.1056/NEJMoa0706482] [PMID: 17982182]
[6]
Sorrentino S, Baber U, Claessen BE, et al. Determinants of significant out-of-hospital bleeding in patients undergoing percutaneous coronary intervention. Thromb Haemost 2018; 118(11): 1997-2005.
[http://dx.doi.org/10.1055/s-0038-1673687] [PMID: 30312975]
[7]
Knuuti J, Wijns W, Saraste A, et al. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J 2020; 41(3): 407-77.
[http://dx.doi.org/10.1093/eurheartj/ehz425] [PMID: 31504439]
[8]
Roffi M, Patrono C, Collet JP, et al. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J 2016; 37(3): 267-315.
[http://dx.doi.org/10.1093/eurheartj/ehv320] [PMID: 26320110]
[9]
Sorrentino S, Claessen BE, Chandiramani R, et al. Long-term safety and efficacy of durable polymer cobalt-chromium everolimus-eluting stents in patients at high bleeding risk: A patient-level stratified analysis from four postapproval studies. Circulation 2020; 141(11): 891-901.
[http://dx.doi.org/10.1161/CIRCULATIONAHA.119.041619] [PMID: 31992063]
[10]
Marquis-Gravel G, Dalgaard F, Jones AD, et al. Post-Discharge bleeding and mortality following acute coronary syndromes with or without PCI. J Am Coll Cardiol 2020; 76(2): 162-71.
[http://dx.doi.org/10.1016/j.jacc.2020.05.031] [PMID: 32646565]
[11]
Mehran R, Pocock S, Nikolsky E, et al. Impact of bleeding on mortality after percutaneous coronary intervention results from a patient-level pooled analysis of the REPLACE-2 (randomized evaluation of PCI linking angiomax to reduced clinical events), ACUITY (acute catheterization and urgent intervention triage strategy), and HORIZONS-AMI (harmonizing outcomes with revascularization and stents in acute myocardial infarction) trials. JACC Cardiovasc Interv 2011; 4(6): 654-64.
[http://dx.doi.org/10.1016/j.jcin.2011.02.011] [PMID: 21700252]
[12]
Valgimigli M, Costa F, Lokhnygina Y, et al. Trade-off of myocardial infarction vs. bleeding types on mortality after acute coronary syndrome: Lessons from the Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER) randomized trial. Eur Heart J 2017; 38(11): 804-10.
[PMID: 28363222]
[13]
Yeh RW, Secemsky EA, Kereiakes DJ, et al. Development and validation of a prediction rule for benefit and harm of dual antiplatelet therapy beyond 1 year after percutaneous coronary intervention. JAMA 2016; 315(16): 1735-49.
[http://dx.doi.org/10.1001/jama.2016.3775] [PMID: 27022822]
[14]
Costa F, van Klaveren D, James S, et al. Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: A pooled analysis of individual-patient datasets from clinical trials. Lancet 2017; 389(10073): 1025-34.
[http://dx.doi.org/10.1016/S0140-6736(17)30397-5] [PMID: 28290994]
[15]
Cao D, Mehran R, Dangas G, et al. Validation of the academic research consortium high bleeding risk definition in contemporary PCI Patients. J Am Coll Cardiol 2020; 75(21): 2711-22.
[http://dx.doi.org/10.1016/j.jacc.2020.03.070] [PMID: 32466887]
[16]
Urban P, Mehran R, Colleran R, et al. Defining high bleeding risk in patients undergoing percutaneous coronary intervention. Circulation 2019; 140(3): 240-61.
[http://dx.doi.org/10.1161/CIRCULATIONAHA.119.040167] [PMID: 31116032]
[17]
Schömig A, Neumann FJ, Kastrati A, et al. A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents. N Engl J Med 1996; 334(17): 1084-9.
[http://dx.doi.org/10.1056/NEJM199604253341702] [PMID: 8598866]
[18]
Hoffmann R, Mintz GS, Dussaillant GR, et al. Patterns and mechanisms of in-stent restenosis. A serial intravascular ultrasound study. Circulation 1996; 94(6): 1247-54.
[http://dx.doi.org/10.1161/01.CIR.94.6.1247] [PMID: 8822976]
[19]
Palmerini T, Biondi-Zoccai G, Della Riva D, et al. Clinical outcomes with bioabsorbable polymer-versus durable polymer-based drug-eluting and bare-metal stents: Evidence from a comprehensive network meta-analysis. J Am Coll Cardiol 2014; 63(4): 299-307.
[http://dx.doi.org/10.1016/j.jacc.2013.09.061] [PMID: 24211507]
[20]
Morice MC, Serruys PW, Sousa JE, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002; 346(23): 1773-80.
[http://dx.doi.org/10.1056/NEJMoa012843] [PMID: 12050336]
[21]
Stone GW, Ellis SG, Cox DA, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004; 350(3): 221-31.
[http://dx.doi.org/10.1056/NEJMoa032441] [PMID: 14724301]
[22]
Stone GW, Moses JW, Ellis SG, et al. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med 2007; 356(10): 998-1008.
[http://dx.doi.org/10.1056/NEJMoa067193] [PMID: 17296824]
[23]
Tada N, Virmani R, Grant G, et al. Polymer-free biolimus a9-coated stent demonstrates more sustained intimal inhibition, improved healing, and reduced inflammation compared with a polymer-coated sirolimus-eluting cypher stent in a porcine model. Circ Cardiovasc Interv 2010; 3(2): 174-83.
[http://dx.doi.org/10.1161/CIRCINTERVENTIONS.109.877522] [PMID: 20407114]
[24]
Urban P, Meredith IT, Abizaid A, et al. Polymer-free drug-coated coronary stents in patients at high bleeding risk. N Engl J Med 2015; 373(21): 2038-47.
[http://dx.doi.org/10.1056/NEJMoa1503943] [PMID: 26466021]
[25]
Garot P, Morice M-C, Tresukosol D, et al. 2-year outcomes of high bleeding risk patients after polymer-free drug-coated stents. J Am Coll Cardiol 2017; 69(2): 162-71.
[http://dx.doi.org/10.1016/j.jacc.2016.10.009] [PMID: 27806919]
[26]
Krucoff MW, Urban P, Tanguay JF, et al. Global approach to high bleeding risk patients with polymer-free drug-coated coronary stents: The LF II Study. Circ Cardiovasc Interv 2020; 13(4): e008603.
[http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008603] [PMID: 32279567]
[27]
Varenne O, Cook S, Sideris G, et al. Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): A randomised single-blind trial. Lancet 2018; 391(10115): 41-50.
[http://dx.doi.org/10.1016/S0140-6736(17)32713-7] [PMID: 29102362]
[28]
Mauri L, Kirtane AJ, Windecker S, et al. Rationale and design of the EVOLVE Short DAPT Study to assess 3-month dual antiplatelet therapy in subjects at high risk for bleeding undergoing percutaneous coronary intervention. Am Heart J 2018; 205: 110-7.
[http://dx.doi.org/10.1016/j.ahj.2018.08.004] [PMID: 30218844]
[29]
Kirtane AJ, Stoler R, Feldman R, et al. Primary results of the EVOLVE Short DAPT study: Evaluation of 3-month dual antiplatelet therapy in high bleeding risk patients treated with a bioabsorbable polymer-coated everolimus-eluting stent. Circ Cardiovasc Interv 2021; 14(3): e010144.
[http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.010144] [PMID: 33641374]
[30]
Valgimigli M, Patialiakas A, Thury A, et al. Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates. J Am Coll Cardiol 2015; 65(8): 805-15.
[http://dx.doi.org/10.1016/j.jacc.2014.11.053] [PMID: 25720624]
[31]
Ariotti S, Adamo M, Costa F, et al. Is bare-metal stent implantation still justifiable in high bleeding risk patients undergoing percutaneous coronary intervention?: A pre-specified analysis from the ZEUS trial. JACC Cardiovasc Interv 2016; 9(5): 426-36.
[http://dx.doi.org/10.1016/j.jcin.2015.11.015] [PMID: 26965932]
[32]
Windecker S, Latib A, Kedhi E, et al. Polymer-based or polymer-free stents in patients at high bleeding risk. N Engl J Med 2020; 382(13): 1208-18.
[http://dx.doi.org/10.1056/NEJMoa1910021] [PMID: 32050061]
[33]
Mehran M. The XIENCE short DAPT program: XIENCE 90/28 evaluating the safety of 3- and 1-month DAPT in HBR patients. 2020. https://www.tctmd.com/slide/xience-short-dapt-program- xience-9028-evaluating-safety-3-month-and-1-month-dapt-hbr-patients
[34]
Valgimigli M, Cao D, Makkar RR, et al. Design and rationale of the XIENCE short DAPT clinical program: An assessment of the safety of 3-month and 1-month DAPT in patients at high bleeding risk undergoing PCI with an everolimus-eluting stent. Am Heart J 2021; 231: 147-56.
[http://dx.doi.org/10.1016/j.ahj.2020.09.019] [PMID: 33031789]
[35]
Cannon CP, Bhatt DL, Oldgren J, et al. Dual antithrombotic therapy with dabigatran after PCI in atrial fibrillation. N Engl J Med 2017; 377(16): 1513-24.
[http://dx.doi.org/10.1056/NEJMoa1708454] [PMID: 28844193]
[36]
Lopes RD, Heizer G, Aronson R, et al. Antithrombotic therapy after acute coronary syndrome or PCI in atrial fibrillation. N Engl J Med 2019; 380(16): 1509-24.
[http://dx.doi.org/10.1056/NEJMoa1817083] [PMID: 30883055]
[37]
Cuisset T, Deharo P, Quilici J, et al. Benefit of switching dual antiplatelet therapy after acute coronary syndrome: The TOPIC (timing of platelet inhibition after acute coronary syndrome) randomized study. Eur Heart J 2017; 38(41): 3070-8.
[http://dx.doi.org/10.1093/eurheartj/ehx175] [PMID: 28510646]
[38]
Sibbing D, Aradi D, Jacobshagen C, et al. Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial. Lancet 2017; 390(10104): 1747-57.
[http://dx.doi.org/10.1016/S0140-6736(17)32155-4] [PMID: 28855078]
[39]
Collet J-P, Thiele H, Barbato E, et al. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J 2021; 42(14): 1289-367.
[http://dx.doi.org/10.1093/eurheartj/ehaa575] [PMID: 32860058]
[40]
Mehran R, Baber U, Sharma SK, et al. Ticagrelor with or without aspirin in high-risk patients after PCI. N Engl J Med 2019; 381(21): 2032-42.
[http://dx.doi.org/10.1056/NEJMoa1908419] [PMID: 31556978]
[41]
Joyce LC, Baber U, Claessen BE, et al. Dual-antiplatelet therapy cessation and cardiovascular risk in relation to age: Analysis from the PARIS Registry. JACC Cardiovasc Interv 2019; 12(10): 983-92.
[http://dx.doi.org/10.1016/j.jcin.2019.02.033] [PMID: 31122354]
[42]
Hahn JY, Song YB, Oh JH, et al. Effect of P2Y12 inhibitor monotherapy vs. dual antiplatelet therapy on cardiovascular events in patients undergoing percutaneous coronary intervention: The smart-choice randomized clinical trial. JAMA 2019; 321(24): 2428-37.
[http://dx.doi.org/10.1001/jama.2019.8146] [PMID: 31237645]

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