Primary percutaneous coronary intervention in acute myocardial infarction : a double edged sword Citation for published version (APA): Wijnbergen, I. F. (2015). Primary percutaneous coronary intervention in acute myocardial infarction : a double edged sword. [Phd Thesis 2 (Research NOT TU/e / Graduation TU/e), Biomedical Engineering]. Technische Universiteit Eindhoven. Document status and date: Published: 01/01/2015 Document Version: Publisher’s PDF, also known as Version of Record (includes final page, issue and volume numbers) Please check the document version of this publication: • A submitted manuscript is the version of the article upon submission and before peer-review. There can be important differences between the submitted version and the official published version of record. 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A catalogue record is available from the Eindhoven University of Technology Library ISBN 978-90-386-3842-3 Cover design: Esther Ris, www.proefschriftomslag.nl Lay-out: Esther Ris, www.proefschriftomslag.nl Printed by: Gildeprint Drukkerijen, Enschede, The Netherlands Financial support for the printing of this thesis was provided by: Pfizer bv, Abbott Vascular, St. Jude Medical Nederland, TOP Medical, Boehringer-Ingelheim, Biosensors Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction: A Double Edged Sword PROEFSCHRIFT ter verkrijging van de graad van doctor aan de Technische Universiteit Eindhoven, op gezag van de rector magnificus prof.dr.ir. F.P.T. Baaijens, voor een commissie aangewezen door het College voor Promoties, in het openbaar te verdedigen op donderdag 4 juni 2015 om 16:00 uur door Inge Franciska Wijnbergen geboren te Epe Dit proefschrift is goedgekeurd door de promotoren en de samenstelling van de promotiecommissie is als volgt: voorzitter: prof.dr. P.A.J. Hilbers 1e promotor: prof.dr. N.H.J. Pijls 2e promotor: prof.dr. J.G.P. Tijssen (UVA-AMC) copromotor(en): dr.ir. M. van ’t Veer (Catharina Ziekenhuis Eindhoven) leden: prof.dr. F. Zijlstra (EUR) dr. H.R. Michels (Catharina Ziekenhuis Eindhoven) prof.dr. ir. F.N. van de Vosse prof.dr. H.H.M. Korsten Contents Chapter 1 Introduction and outline of this thesis 7 Chapter 2 Measurement of myocardial blood flow in acute myocardial 17 infarction Chapter 3 A Novel Monorail Catheter for Volumetric Coronary Blood Flow 31 Measurement in Humans Chapter 4 Absolute Coronary Blood Flow Measurement and Microvascular 41 Resistance in ST-elevation Myocardial Infarction in the acute and subacute phase Chapter 5 A Comparison of Drug Eluting and Bare Metal Stents for Primary 59 Percutaneous Coronary Intervention with or without Abciximab in ST- segment elevation Myocardial Infarction: The Eindhoven Reperfusion Study (DEBATER) Chapter 6 Circadian and Weekly Variation and the Influence of 79 Environmental Variables in Acute Myocardial Infarction Chapter 7 Gender Differences in Long-term Outcome after Primary 95 Percutaneous Intervention for ST-segment elevation Myocardial Infarction Chapter 8 Longterm Comparison of Sirolimus-eluting and Bare-metal stents 109 in ST-Segment Elevation Myocardial Infarction Chapter 9 General discussion and future perspectives 123 Summary 130 Samenvatting 132 Curriculum vitae 135 Dankwoord 136 List of publications 137 “ When something can have both favorable and unfavorable consequences, the term double edged sword is often used.” Chapter 1 Introduction and outline of this thesis Chapter 1 Epidemiology and history of ST-segment elevation myocardial infarction (STEMI) Despite major advances in therapy, cardiovascular diseases are still the leading cause of death worldwide 1. Ischemic heart disease is responsible for over 7 million deaths annually. In The Netherlands, more than 10.000 people die annually from ischemic heart disease, of which at least 6.800 as a direct result of acute myocardial infarction 2. Clinical features of acute myocardial infarction were described in 1912 by James Herrick 3. He found that AMI was caused by a sudden obstruction of the coronary arteries and advised bed rest as treatment. For years, treatment consisted of six weeks of absolute bed rest and in-hospital mortality averaged about 50%. Over the past decades, fatality rate could be reduced to 5% by the introduction of defibrillation, coronary care units, aspirin, thrombolysis and percutaneous coronary intervention (PCI). The first percutaneous transluminal balloon angioplasty (PTCA) in humans was performed by Gruntzig in 1977. Five years later, the first primary angioplasty was used in the treatment of acute myocardial infarction. This procedure was based on observational studies on total occlusion of the coronary arteries by a thrombus in the first hours of acute myocardial infarction 4. It became clear that early opening of the infarct-related coronary artery improved survival 5. Since a number of years, primary PCI has become the treatment of choice in acute myocardial infarction 6. Outcomes after primary PCI have improved by using stents, thrombosuction and adjunctive pharmacotherapy. Furthermore, improved logistics with prehospital triage in the ambulance and skilled personnel have made primary PCI accessible for almost all patients with STEMI in The Netherlands and set up of such advanced logistic system has been described by Brueren in his thesis in 2005 7. Further improvement of this system has reduced door-to-balloon times leading to better outcomes 8. Management of STEMI According to the European guidelines primary PCI is recommended in STEMI as soon as possible in patients who present within 12 hours after pain onset 9, 10. By using a well- functioning network based on pre-hospital diagnosis, the patient must be transported to the closest available primary-PCI capable centre as soon as possible and PCI must be performed within 90 minutes from the first medical contact. In early presenters and high risk cases, PCI must be performed within 60 minutes from the first medical contact 11. Besides pharmacotherapy consisting of heparin, aspirin and an ADP-receptor blocker, standard therapy includes stenting of the infarct-related artery. Stenting of the infarct- related lesion has proved to reduce the need for repeat revascularization and decreases 8 Introduction and outline of this thesis the infarction rate resulting in a reduction of long term mortality, when compared to balloon angioplasty alone 12-16. Prior to the introduction of a balloon or stent into the coronary artery, routine use of manual thrombus aspiration may be associated with an improvement in indices of myocardial reperfusion, such as ST-segment resolution and myocardial blush grade, and a reduction in mortality after one year 17-19. Post procedural treatment with adjunctive glycoprotein 2B3A inhibitors is left to the decision of the 1 operator, but continuation of dual anti-platelet therapy after primary PCI is paramount. No reflow phenomenon While impressive progress has been made in the treatment of acute myocardial infarction, knowledge on pathophysiological processes in the myocardium during and after the acute phase is far behind. Whereas epicardial coronary blood flow and hemodynamics can be easily assessed directly after primary PCI by standard cathlab techniques, complex and poorly understood phenomena might occur in the myocardial microvasculature immediately after primary PCI and persist for several days. Prognosis of a patient on the longterm and preservation of left ventricular ejection fraction is most likely determined to a considerable degree by these processes in the unvisible part of the coronary circulation. Unravelling the unsolved issues with respect to regulation, distribution and restoration of coronary and myocardial perfusion is not only interesting from a scientific point of view, but also paramount from the clinical point of view and for developing additional targets of treatment. Reperfusion therapy was earlier referred to as a “double edged sword”, because with the obtained ability to open a coronary artery and thereby reducing ischemic cell death, a new problem was observed: the “no reflow phenomenon”, also referred to as reperfusion injury 20. No reflow is the inability to adequately perfuse myocardium after temporary occlusion of an epicardial coronary artery without evidence of persistent epicardial obstruction, thus implying ongoing myocardial ischemia. In 1974, Kloner et al described this phenomenon in dogs and showed that, after temporary occlusion of a coronary artery, subendocardial perfusion defects were detectable and persistent after 90 minutes of occlusion 21. Failure of reflow was associated with extensive capillary damage and myocardial cell swelling and led to damage of the myocardial microvasculature. The pathogenesis of no-reflow has not been elucidated completely and seems to be complex and multifactorial. During the past decade, several potential mediators of the no reflow phenomenon have been suggested and are referred to as the oxygen, calcium and pH paradox 22. The oxygen paradox means that reoxygenation of the ischemic myocardium with an increase in myocardial pO2 leads to the production of toxic reactive 9