Progress in interventional cardiology: challenges for the future

Sakine Simsekyilmaz; Elisa A. Liehn; Constantin Militaru; Felix Vogt

doi:10.1160/TH14-07-0599

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2015; 113(03): 464-472
DOI: 10.1160/TH14-07-0599

Theme Issue Article

Schattauer GmbH

Progress in interventional cardiology: challenges for the future

Authors

Sakine Simsekyilmaz

¹Institute for Molecular Cardiovascular Research, RWTH Aachen University, Germany

²Biomedical Research Center, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, China
Elisa A. Liehn

¹Institute for Molecular Cardiovascular Research, RWTH Aachen University, Germany
Constantin Militaru

³Deparment of Cardiology, Emergency Hospital, Craiova, Romania
Felix Vogt

⁴Department of Cardiology, Pulmonology, Intensive Care and Vascular Medicine, Medical Faculty, RWTH Aachen University, Germany

Abstract

Summary

Cardiovascular disease is the leading cause of death in the western and developing countries. Percutaneous transluminal coronary interventions have become the most prevalent treatment option for coronary artery disease; however, due to serious complications, such as stent thrombosis and in-stent restenosis (ISR), the efficacy and safety of the procedure remain important issues to address. Strategies to overcome these aspects are under extensive investigation. In this review, we summarise relevant milestones during the time to overcome these limitations of coronary stents, such as the development of polymer-free drug-eluting stents (DES) to avoid pro-inflammatory response due to the polymer coating or the developement of stents with cell-directing drugs to, simultaneously, improve re-endothelialisation and inhibit ISR amongst other techniques most recently developed, which have not fully entered the clinical stage. Also the novel concept of fully biodegradable DES featured by the lack of a permanent foreign body promises to be a beneficial and applicable tool to restore a natural vessel with maintained vasomotion and to enable optional subsequent surgical revascularisation.

Keywords

Coronary interventions - stent implantation - neointima formation - stent thrombosis - in-stent restenosis

Full Text

References

References
1 Mueller RL, Sanborn TA. The history of interventional cardiology: cardiac catheterisation, angioplasty, and related interventions. Am Heart J 1995; 129: 146-172.
2 Heiss HW. Werner Forssmann: a German problem with the Nobel Prize. Clin Cardiol 1992; 15: 547-549.
3 Schlumpf M. 30 Jahre Ballonkatheter: Andreas Grüntzig, ein Pionier in Zürich. Schweiz Ärztezeit 2004; 85: 3460.
4 Sigwart U. et al. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med 1987; 316: 701-706.
5 Iakovou I. et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. J Am Med Assoc 2005; 293: 2126-2130.
6 Mauri L. et al. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med 2007; 356: 1020-1029.
7 Liehn EA. et al. Blockade of keratinocyte-derived chemokine inhibits endothelial recovery and enhances plaque formation after arterial injury in ApoE-deficient mice. Arterioscl Thromb Vasc Biol 2004; 24: 1891-1896.
8 Raymond C, Menon V. Dual antiplatelet therapy in coronary artery disease: a case-based approach. Clevel Clin J Med 2009; 76: 663-670.
9 Leon MB. et al. A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. Stent Anticoagulation Restenosis Study Investigators. N Engl J Med 1998; 339: 1665-1671.
10 Yeh SP. et al. Ticlopidine-associated aplastic anemia. A case report and review of literature. Ann Hematol 1998; 76: 87-90.
11 Page Y. et al. Thrombotic thrombocytopenic purpura related to ticlopidine. Lancet 1991; 337: 774-776.
12 Steinhubl SR. et al. Incidence and clinical course of thrombotic thrombocytopenic purpura due to ticlopidine following coronary stenting. EPISTENT Investigators. Evaluation of Platelet IIb/IIIa Inhibitor for Stenting. J Am Med Assoc 1999; 281: 806-810.
13 Mangalpally KK, Kleiman NS. The safety of clopidogrel. Expert Opin Drug Saf 2011; 10: 85-95.
14 Kam PC, Nethery CM. The thienopyridine derivatives (platelet adenosine diphosphate receptor antagonists), pharmacology and clinical developments. Anaesthesia 2003; 58: 28-35.
15 Wiviott SD. et al. Greater clinical benefit of more intensive oral antiplatelet therapy with prasugrel in patients with diabetes mellitus in the trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrel-Thrombolysis in Myocardial Infarction 38. Circulation 2008; 118: 1626-1636.
16 Wiviott SD. et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2007; 357: 2001-2015.
17 Wallentin L. et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2009; 361: 1045-1057.
18 Windecker S. et al. 2014 ESC/EACTS Guidelines on myocardial revasculari-sation: The Task Force on Myocardial Revascularisation of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Epub ahead of print.
19 Asencio LA. et al. Combining Antiplatelet and Antithrombotic Therapy (Triple Therapy): What Are the Risks and Benefits?. Am J Med 2014; 127: 579-585.
20 Holmes Jr. DR. et al. Combining antiplatelet and anticoagulant therapies. J Am Coll Cardiol 2009; 54: 95-109.
21 Heidbuchel H. et al. European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace 2013; 15: 625-651.
22 Heidbuchel H. et al. EHRA practical guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation: executive summary. Eur Heart J 2013; 34: 2094-2106.
23 Dickneite G. Prothrombin Complex Concentrates as Reversal Agents for New Oral Anticoagulants: Lessons from Preclinical Studies with Beriplex. Clin Lab Med 2014; 34: 623-635.
24 Faraoni D. et al. Perioperative Management of Patients Receiving New Oral Anticoagulants: An International Survey. Clin Lab Med 2014; 34: 637-654.
25 Amsterdam EA. et al. AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Guidelines Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Epub ahead of print.
26 Auer J. et al. Long-term outcomes following coronary drug-eluting- and bare-metal-stent implantation. Atherosclerosis 2010; 210: 503-509.
27 van Werkum JW. et al. Long-term clinical outcome after a first angiographically confirmed coronary stent thrombosis: an analysis of 431 cases. Circulation 2009; 119: 828-834.
28 Lagerqvist B. et al. Stent thrombosis in Sweden: a report from the Swedish Coronary Angiography and Angioplasty Registry. Circulation Cardiovasc Interv 2009; 2: 401-408.
29 Sarno G. et al. Stent Thrombosis in New-Generation Drug-Eluting Stents in Patients With STEMI Undergoing Primary PCI: A Report From SCAAR. J Am Coll Cardiol 2014; 64: 16-24.
30 Nakazawa G. et al. Coronary responses and differential mechanisms of late stent thrombosis attributed to first-generation sirolimus- and paclitaxel-eluting stents. J Am Coll Cardiol 2011; 57: 390-398.
31 Virmani R. et al. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious?. Circulation 2004; 109: 701-705.
32 Choi SY. et al. Intravascular ultrasound findings of early stent thrombosis after primary percutaneous intervention in acute myocardial infarction: a Harmonizing Outcomes with Revascularisation and Stents in Acute Myocardial Infarction (HORIZONS-AMI) substudy. Circulation Cardiovasc Interv 2011; 4: 239-247.
33 Mamas MA. et al. Stent fracture: Insights on mechanisms, treatments, and outcomes from the food and drug administration manufacturer and user facility device experience database. Catheter Cardiovasc Interv 2014; 83: E251-259.
34 Dangas GD. et al. Effect of switching antithrombin agents for primary angio-plasty in acute myocardial infarction: the HORIZONS-SWITCH analysis. J Am Coll Cardiol 2011; 57: 2309-2316.
35 Fischman DL. et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med 1994; 331: 496-501.
36 Krone RJ. et al. Evaluation of the American College of Cardiology/American Heart Association and the Society for Coronary Angiography and Interventions lesion classification system in the current “stent era” of coronary interventions (from the ACC-National Cardiovascular Data Registry). Am J Cardiol 2003; 92: 389-394.
37 Raval FM, Nikolajczyk BS. The Bidirectional Relationship between Metabolism and Immune Responses. Discoveries 2013; 1: e6.
38 Silvestre-Roig C. et al. Atherosclerotic plaque destabilisation: mechanisms, models, and therapeutic strategies. Circ Res 2014; 114: 214-226.
39 Stary HC. et al. A definition of advanced types of atherosclerotic lesions and a histological classification of atherosclerosis. A report from the Committee on Vascular Lesions of the Council on Arteriosclerosis, American Heart Association. Circulation 1995; 92: 1355-1374.
40 Cutlip DE. et al. Clinical restenosis after coronary stenting: perspectives from multicenter clinical trials. J Am Coll Cardiol 2002; 40: 2082-2089.
41 Roukoz H. et al. Comprehensive meta-analysis on drug-eluting stents versus bare-metal stents during extended follow-up. Am J Med 2009; 122: 581-e1-10.
42 Pacurari M. et al. The role of microRNAs in Rennin-Angiotensin-Aldosterone System (RAAS)-mediated Vascular Inflammation and Remodeling. Discoveries 2013; 1: e4.
43 Costa MA, Simon DI. Molecular basis of restenosis and drug-eluting stents. Circulation 2005; 111: 2257-2273.
44 Morice MC. et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularisation. N Engl J Med 2002; 346: 1773-1780.
45 Stone GW. et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004; 350: 221-231.
46 Capodanno D. et al. Novel drug-eluting stents in the treatment of de novo coronary lesions. Vasc Health Risk Manag 2011; 7: 103-118.
47 Serruys PW. et al. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med 2010; 363: 136-146.
48 Byrne RA. et al. Biodegradable polymer versus permanent polymer drug-eluting stents and everolimus- versus sirolimus-eluting stents in patients with coronary artery disease: 3-year outcomes from a randomized clinical trial. J Am Coll Cardiol 2011; 58: 1325-1331.
49 Garg S. et al. The twelve-month outcomes of a biolimus eluting stent with a biodegradable polymer compared with a sirolimus eluting stent with a durable polymer. EuroInterv 2010; 6: 233-239.
50 Scheller B. et al. Treatment of coronary in-stent restenosis with a paclitaxelcoated balloon catheter. N Engl J Med 2006; 355: 2113-2124.
51 Unverdorben M. et al. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation 2009; 119: 2986-2994.
52 Erbel R. et al. Temporary scaffolding of coronary arteries with bioabsorbable magnesium stents: a prospective, non-randomised multicentre trial. Lancet 2007; 369: 1869-1875.
53 Mahnken AH. et al. Coronary artery stents in multislice computed tomography: in vitro artifact evaluation. Invest Radiol 2004; 39: 27-33.
54 Serruys PW. et al. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol 2011; 58: 1578-1588.
55 Serruys PW. et al. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet 2009; 373: 897-910.
56 Tamai H. et al. Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans. Circulation 2000; 102: 399-404.
57 Vogt F. et al. Long-term assessment of a novel biodegradable paclitaxel-eluting coronary polylactide stent. Eur Heart J 2004; 25: 1330-1340.
58 van der Giessen WJ. et al. Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation 1996; 94: 1690-1697.
59 Onuma Y. et al. Bioresorbable scaffold technologies. Circulation J 2011; 75: 509-520.
60 Grundeken MJ. et al. Treatment of coronary bifurcation lesions with the Absorb bioresorbable vascular scaffold in combination with the Tryton dedicated coronary bifurcation stent: evaluation using two- and three-dimensional optical coherence tomography. EuroInterv. 2014 Epub ahead of print.
61 Seth A. et al. Salvage of side branch by provisional “TAP technique” using Absorb bioresorbable vascular scaffolds for bifurcation lesions: first case reports with technical considerations. Catheter Cardiovasc Interv 2014; 84: 55-61.
62 Zamiri P. et al. The biocompatibility of rapidly degrading polymeric stents in porcine carotid arteries. Biomaterials 2010; 31: 7847-7855.
63 Grabow N. et al. Development of a sirolimus-eluting poly (L-lactide)/poly(4-hy-droxybutyrate) absorbable stent for peripheral vascular intervention. Biomed Tech 2013; 58: 429-437.
64 Onuma Y, Serruys PW. Bioresorbable scaffold: the advent of a new era in percutaneous coronary and peripheral revascularisation?. Circulation 2010; 123: 779-797.
65 Chen SL. et al. Perspective on bifurcation PCI. J Interv Cardiol 2009; 22: 99-109.
66 Iakovou I. et al. New strategies in the treatment of coronary bifurcations. Herz 2011; 36: 198-212.
67 Lee MS, Finch W. Stenting techniques for patients with bifurcation coronary artery disease. Rev Cardiovasc Med 2011; 12: 231-239.
68 Moussa ID. Coronary artery bifurcation interventions: the disconnect between randomized clinical trials and patient centered decision-making. Catheter Cardiovasc Interv 2011; 77: 537-545.
69 Liehn EA. et al. Chemokines: inflammatory mediators of atherosclerosis. Arch Physiol Biochem 2006; 112: 229-238.
70 Zeiffer U. et al. Neointimal smooth muscle cells display a proinflammatory phenotype resulting in increased leukocyte recruitment mediated by P-selectin and chemokines. Circ Res 2004; 94: 776-784.
71 Zernecke A. et al. SDF-1alpha/CXCR4 axis is instrumental in neointimal hyperplasia and recruitment of smooth muscle progenitor cells. Circ Res 2005; 96: 784-791.
72 Hristov M. et al. Importance of CXC chemokine receptor 2 in the homing of human peripheral blood endothelial progenitor cells to sites of arterial injury. Circ Res 2007; 100: 590-597.
73 Hristov M. et al. Regulation of endothelial progenitor cell homing after arterial injury. Thromb Haemost 2007; 98: 274-277.
74 Blindt R. et al. A novel drug-eluting stent coated with an integrin-binding cyclic Arg-Gly-Asp peptide inhibits neointimal hyperplasia by recruiting endothelial progenitor cells. J Am Coll Cardiol 2006; 47: 1786-1795.
75 Soehnlein O. et al. Neutrophil-derived cathelicidin protects from neointimal hy-perplasia. Science Transl Med 2011; 3: 103ra98.
76 Aoki J. et al. Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) Registry. J Am Coll Cardiol 2005; 45: 1574-1579.
77 Hoffmann J. et al. Immobilized DNA aptamers used as potent attractors for porcine endothelial precursor cells. J Biomed Materials Res Part A 2008; 84: 614-621.
78 Schober A. et al. Crucial role of the CCL2/CCR2 axis in neointimal hyperplasia after arterial injury in hyperlipidemic mice involves early monocyte recruitment and CCL2 presentation on platelets. Circ Res 2004; 95: 1125-1133.
79 Liehn EA. et al. A new monocyte chemotactic protein-1/chemokine CC motif ligand-2 competitor limiting neointima formation and myocardial ischemia/ reperfusion injury in mice. J Am Coll Cardiol 2010; 56: 1847-1857.
80 Zernecke A. et al. Deficiency in CCR5 but not CCR1 protects against neointima formation in atherosclerosis-prone mice: involvement of IL-10. Blood 2006; 107: 4240-4243.
81 Postea O. et al. Contribution of platelet CX(3)CR1 to platelet-monocyte complex formation and vascular recruitment during hyperlipidemia. Arterioscl Thromb Vasc Biol 2012; 32: 1186-1193.
82 Shagdarsuren E. et al. C5a receptor targeting in neointima formation after arterial injury in atherosclerosis-prone mice. Circulation 2010; 122: 1026-1036.
83 Simsekyilmaz S. et al. Role of extracellular RNA in atherosclerotic plaque formation in mice. Circulation 2014; 129: 598-606.
84 Tilstam PV. et al. Bone marrow-specific knock-in of a non-activatable Ikkalpha kinase mutant influences haematopoiesis but not atherosclerosis in Apoe-deficient mice. PloS One 2014; 9: e87452.
85 Hanekamp CE. et al. Randomized study to compare balloon angioplasty and elective stent implantation in venous bypass grafts: the Venestent study. Catheter Cardiovasc Interv 2003; 60: 452-457.
86 Reifart N. et al. Randomized comparison of angioplasty of complex coronary lesions at a single center. Excimer Laser, Rotational Atherectomy, and Balloon Angioplasty Comparison (ERBAC) Study. Circulation 1997; 96: 91-98.
87 Bloom JM. Stent placement compared with balloon angioplasty for obstructed coronary bypass grafts. N Engl J Med 1998; 338: 198-199.
88 de Feyter PJ. et al. Balloon angioplasty for the treatment of lesions in saphenous vein bypass grafts. J Am Coll Cardiol 1993; 21: 1539-1549.
89 Rittger H. et al. A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study. J Am Coll Cardiol 2012; 59: 1377-1382.
90 Stella PR. et al. A multicenter randomized comparison of drug-eluting balloon plus bare-metal stent versus bare-metal stent versus drug-eluting stent in bifurcation lesions treated with a single-stenting technique: six-month angiographic and 12-month clinical results of the drug-eluting balloon in bifurcations trial. Catheter Cardiovasc Interv 2012; 80: 1138-1146.
91 Bansal D. et al. Percutaneous intervention in saphenous vein bypass graft disease: case against the use of drug-eluting stents. J Am Coll Cardiol 2008 51: 970-971; author reply 971-972.
92 Wong SC. et al. Immediate results and late outcomes after stent implantation in saphenous vein graft lesions: the multicenter U. S. Palmaz-Schatz stent experience. The Palmaz-Schatz Stent Study Group. J Am Coll Cardiol 1995; 26: 704-712.
93 Lee MS. et al. Saphenous vein graft intervention. J Am Coll Cardiol 2011; 4: 831-843.
94 Kim WJ. et al. Randomized comparison of everolimus-eluting stent versus sirolimus-eluting stent implantation for de novo coronary artery disease in patients with diabetes mellitus (ESSENCE-DIABETES): results from the ESSENCE-DIABETES trial. Circulation 2011; 124: 886-892.
95 Hoffmann R. et al. Implantation of paclitaxel-eluting stents in saphenous vein grafts: clinical and angiographic follow-up results from a multicentre study. Heart 2007; 93: 331-334.
96 Bansal D. et al. Percutaneous intervention on the saphenous vein bypass grafts-long-term outcomes. Catheter Cardiovasc Interv 2008; 71: 58-61.
97 Elezi S. et al. Vessel size and outcome after coronary drug-eluting stent placement: results from a large cohort of patients treated with sirolimus- or paclitaxel-eluting stents. J Am Coll Cardiol 2006; 48: 1304-1309.
98 Costopoulos C. et al. Comparison of first- and second-generation drug-eluting stents in saphenous vein grafts used as aorto-coronary conduits. Am J Cardiol 2013; 112: 318-322.
99 Medina A. et al. Sirolimus-eluting stents for treatment of in-stent restenosis: immediate and late results. Texas Heart Inst J 2005; 32: 11-15.
100 Yang HM. et al. Long-term clinical and angiographic outcomes after implantation of sirolimus-eluting stents with a “modified mini-crush” technique in coronary bifurcation lesions. Catheter Cardiovasc Interv 2009; 74: 76-84.
101 Papayannis AC. et al. Optical coherence tomography analysis of the stenting of saphenous vein graft (SOS) Xience V Study: use of the everolimus-eluting stent in saphenous vein graft lesions. J Invas Cardiol 2012; 24: 390-394.
102 Liistro F. et al. Long-term effectiveness and safety of sirolimus stent implantation for coronary in-stent restenosis results of the TRUE (Tuscany Registry of sirolimus for unselected in-stent restenosis) registry at 4 years. J Am Coll Cardiol 2010; 55: 613-616.
103 Jaguszewski M. et al. Feasibility of second-generation bioresorbable vascular scaffold implantation in complex anatomical and clinical scenarios. Clin Res Cardiol. 2014 Epub ahead of print.
104 Serruys PW. et al. Dynamics of vessel wall changes following the implantation of the absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months. EuroInterv 2014; 9: 1271-1284