- About this Journal ·
- Abstracting and Indexing ·
- Aims and Scope ·
- Article Processing Charges ·
- Articles in Press ·
- Author Guidelines ·
- Bibliographic Information ·
- Citations to this Journal ·
- Contact Information ·
- Editorial Board ·
- Editorial Workflow ·
- Free eTOC Alerts ·
- Publication Ethics ·
- Reviewers Acknowledgment ·
- Submit a Manuscript ·
- Subscription Information ·
- Table of Contents
International Journal of Vascular Medicine
Volume 2014 (2014), Article ID 263926, 8 pages
Angiographic and Clinical Impact of Successful Manual Thrombus Aspiration in Diabetic Patients Undergoing Primary PCI
Department of Cardiology, Faculty of Medicine, Ain Shams University Hospital, Abbasia Square, P.O. Box 11381, Cairo, Egypt
Received 5 December 2013; Accepted 4 March 2014; Published 2 April 2014
Academic Editor: Robert S. Dieter
Copyright © 2014 Mohamed Shehata. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background. Diabetes mellitus is associated with worse angiographic and clinical outcomes after percutaneous coronary intervention (PCI). Aim. To investigate the impact of manual thrombus aspiration on in-stent restenosis (ISR) and clinical outcome in patients treated by bare-metal stent (BMS) implantation for ST-segment elevation myocardial infarction (STEMI). Methods. 100 diabetic patients were prospectively enrolled. They were randomly assigned to undergo either standard primary PCI (group A, 50 patients) or PCI with thrombus aspiration using Export catheter (group B, 50 patients). The primary endpoint was the rate of eight-month ISR. The secondary endpoint included follow-up for major adverse cardiac events (MACE). Results. Mean age of the study cohort was years, with 64 (64%) being males. Baseline characteristics did not differ between both groups. Eight-month angiogram showed that group B patients had significantly less late lumen loss ( versus mm, ), with lower incidence of ISR (4% versus 16.6%, ). There was a trend towards lower rate of MACE in the same group of patients. Conclusion. In diabetic patients undergoing primary PCI, manual thrombus aspiration (compared with standard PCI) was associated with better ISR rate after BMS implantation.
Acute myocardial infarction (MI) with ST-segment elevation is caused by rupture or erosion of an atherosclerotic plaque, initiating intraluminal thrombosis resulting in occlusion of a coronary artery [1–3]. Primary percutaneous coronary intervention (PCI) is the preferred treatment for MI with ST-segment elevation and is effective in opening the infarct-related artery [4–6]. However, microvascular obstruction with diminished myocardial perfusion occurs in a large proportion of patients with patent epicardial vessels after primary PCI, and this event is associated with an increased infarct size, reduced recovery of ventricular function, and increased mortality [7–11]. Microvascular obstruction is related to the embolization of plaque or thrombotic material downstream in the infarct-related artery [12, 13]. Embolization can occur spontaneously or by means of mechanical fragmentation during PCI [12–15]. The high frequency of suboptimal myocardial reperfusion after primary PCI has resulted in the development of various devices to protect the microcirculation [16–24]. Other proposed mechanisms contributing to microvascular obstruction and dysfunction include reperfusion injury, production of oxygen free radicals, neutrophil activation, endothelial and myocyte edema, loss of antioxidant enzymes, cardiomyocyte apoptosis, loss of endothelial mediated vasomotion, alteration of sympathetic innervation, plugging of platelets and neutrophils, epicardial coronary vasoconstriction, and increased myocardial cell calcium level . It is proposed that the resulting cellular dysfunction, apoptosis, and necrosis mediate myocardial stunning, no-reflow, reperfusion arrhythmias, and additional loss of myocardium (lethal reperfusion injury) .
Diabetes mellitus is an important risk factor for poor outcome after PCI using bare-metal stents [27–29]. A more diffused and accelerated form of atherosclerosis in diabetic patients, accompanied by small vessel size, long lesions, and greater plaque burden, may contribute to the well-documented increased risk of restenosis after stent implantation in these patients . In the current study, the author sought to explore the impact of upfront manual thrombus aspiration on angiographic (in-stent restenosis) and clinical outcomes, in diabetic patients treated by bare-metal stent implantation for acute ST-segment elevation myocardial infarction (STEMI).
2.1. Study Design and Data Collection
100 consecutive diabetic patients suffering from acute STEMI were prospectively enrolled in this study. They were referred to the catheterization laboratory on emergency basis, after being presented to the emergency department (ED), in the period between March 2011 and January 2013. All included patients suffered from insulin-dependent diabetes mellitus (IDDM). Other inclusion criteria included symptoms suggesting acute myocardial ischemia lasting >30 minutes, the onset of symptoms <12 hours before presentation to ED, and ST-segment elevation of >0.1 mV in two or more leads on the electrocardiogram (ECG). Exclusion criteria included patients undergoing rescue PCI after thrombolysis, patients with prior history of unstable angina or MI, those with prior PCI or coronary artery bypass graft (CABG) surgery, and those with congenital heart disease or any myocardial disease apart from ischemia. Patients with limited life expectancy due to coexistent disease, for example, malignancy, were excluded. After enrollment and before coronary angiography, patients were randomly assigned in 1 : 1 fashion to undergo either standard PCI (group A) or PCI with thrombus aspiration (group B), according to a computer-generated random series of numbers. Randomization was performed by block randomization (blocks of 10 patients). Physicians participating in PCI procedures were unaware of block randomization. Before inclusion, informed written consent was obtained from each patient and the study protocol was reviewed and approved by our local institutional human research committee, as it conforms to the ethical guidelines of the 1975 Declaration of Helsinki, as revised in 2008.
2.2. Definition of Risk Factors of Coronary Artery Disease
The presence of hypertension was defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, previously recorded by repeated noninvasive office measurements, which led to life-style modification and/or intake of antihypertensive drug therapy . The presence of diabetes mellitus was defined as fasting plasma glucose ≥126 mg/dL and/or two-hour postglucose load ≥200 mg/dL or specific antidiabetic drug therapy intake . Dyslipidemia was defined as LDL cholesterol >100 mg/dL and/or serum triglycerides >150 mg/dL and/or HDL cholesterol <40 mg/dL (<50 mg/dL in women) .
2.3. PCI and Medications
Coronary angioplasty and stent implantation were performed according to institutional standards. For all patients, the first procedural step was the passing of a floppy, steerable guide wire through the target culprit lesion; direct stenting was left to operator’s discretion and usually performed in patent vessel with no or mild calcification. In patients in the conventional PCI group (group A), this step was followed by balloon dilation to establish antegrade flow. Concerning patients in the thrombus aspiration group (group B), this step was followed by the advancing of the 6F Export Aspiration Catheter (Medtronic, Minneapolis, MN; crossing profile, 0.068 in.) into the target coronary segment during continuous aspiration. Aspiration was started proximal to the occluded site, gently pushing the catheter through the occlusion and then pulling it in a proximal direction, keeping negative pressure even when the occlusion was crossed or when there was no longer back bleeding in the syringe. Withdrawal of the catheter from the artery and from the guiding catheter was performed with permanent negative pressure. When necessary for stent delivery, balloon dilation was performed before stenting. In all patients, after the restoration of antegrade flow, intracoronary nitrates were given to ensure maximal epicardial vasodilatation, to determine the size and length of the required stent, and to facilitate stent placement. All placed stents were bare-metal stents. Pharmacological treatment before PCI included the administration of aspirin (a loading dose of 500 mg), heparin (70 IU/kg), and clopidogrel (a loading dose of 600 mg). All patients also received the glycoprotein IIb/IIIa inhibitor abciximab with an intravenous procedural bolus of 0.25 mg/kg followed by a continuous intravenous infusion of 0.125 μg/kg/min for 12 hours and postprocedural infusion without heparin.
The primary endpoint was the rate of in-stent restenosis after eight months of follow-up, defined as angiographic luminal diameter stenosis by >50% using quantitative coronary angiography (QCA). The secondary endpoint included follow-up for major adverse cardiac events (MACE), that is, a composite of death due to cardiac cause, nonfatal myocardial infarction, and target lesion revascularization (TLR).
2.4. Quantitative Coronary Angiography (QCA)
Intracoronary nitroglycerine was administered before the initial, final, and follow-up angiograms to achieve maximal vasodilatation. Thrombolysis in myocardial infarction (TIMI) flow grade was recorded individually when flow restoration attempts were finalized. Contrast-filled guide catheters were used as the reference standard in QCA. Matched end-diastolic frames of the angiograms before and after PCI and at eight-month follow-up were analyzed using a contour detection minimum cost algorithm (QCA-CMS Version 3.0, MEDIS, Leiden, The Netherlands). Restenosis was defined as a stent stenosis >50% in diameter anywhere within the stent and/or within the 5 mm borders proximal or distal to the stent. Late lumen loss was defined as the difference between minimal lumen diameters (MLD) immediately after PCI and on eight-month follow-up angiography. QCA analyses were performed by an experienced technician who was blinded to patients’ assignment.
All continuous variables were statistically described in terms of mean ± standard deviation (±SD). Categorical variables were described with absolute and relative (percentage) frequencies. Comparison of continuous variables between the study groups was done using Student’s -test. For comparing categorical data, Pearson’s Chi-square test was performed. values were used to describe significance. All statistical calculations were done using Statistical Package for Social Sciences (SPSS for Windows) software (version 15.0, SPSS Inc., Chicago, IL, USA).
3.1. Baseline Clinical Characteristics
A total of 100 consecutive IDDM patients suffering from acute STEMI were prospectively enrolled in the current study, which comprises 50 patients randomly assigned to undergo conventional PCI (group A) and 50 others randomly assigned to undergo PCI with thrombus aspiration (group B). The mean age of the whole study cohort was years, with 64 (64%) being male patients. The two groups were matched regarding age, gender, and risk factors of coronary artery disease (CAD). No significant difference was recorded between the two groups; concerning baseline mean serum HbA1c levels. Table 1 shows baseline clinical characteristics of the two study groups. All patients underwent follow-up coronary angiography after eight months, except for six patients. Five (group A: three patients, group B: two patients) patients had definite late (>30 days after primary PCI) stent thrombosis and target lesion revascularization, while one patient belonging to group A died after 220 days, and thus a possible stent thrombosis is considered. So, follow-up angiograms were available in 94 (94%) patients (group A: , group B: ). Blood samples were drawn for HbA1c quantitation at the day of follow-up of coronary angiography and revealed almost the same mean results (group A: %, group B: %; ).
3.2. Lesion and Procedure Characteristics
Table 2 shows lesion and procedure characteristics. No statistically significant difference was recorded between the two study groups regarding lesion length, stent length, need for stent postdilatation, and frequency of stenting of each coronary artery. However, incidence of angiographic no-reflow was significantly less in group B patients (). Moreover, more patients in the same group showed TIMI III flow grade after culprit lesion stenting (). No serious periprocedural complications were recorded in both study groups.
3.3. Quantitative Angiographic Outcomes
Angiographic measures are shown in Table 3. Angiographic follow-up was obtained for 98 patients (98%), at a mean of days. Late luminal loss was found to be less in the group B ( mm versus ; ). Also, the percentage of stenosis (in-stent restenosis) at follow-up was less in the same group (.7 in group B versus in group A; ). The rate of in-stent restenosis (primary endpoint), defined as luminal diameter stenosis of >50 percent, was 4% () in group B versus 16.6% () in group A ().
3.4. Clinical Events
Clinical follow-up data revealed that 11 patients experienced major adverse cardiac events (MACE) as shown in Table 4, with no statistical difference between both study groups but a trend towards lower incidence in group B. Five patients suffered from definite stent thrombosis and TRL was done. Only one patient (belonging to group A) died during the follow-up period with possible stent thrombosis.
The clinical importance of embolization of atherothrombotic materials from unstable plaques in patients with myocardial infarction with ST-segment elevation has been recognized [12, 15], and the use of thrombectomy aspiration devices to reduce distal embolization, preserving tissue-level perfusion, has been tested in several studies with conflicting results [16, 17, 20–24, 34–38]. Results achieved using different techniques to explore different aspects of microvascular integrity further enhance the strength of the tested hypothesis that distal embolization during primary PCI plays a significant role in the pathogenesis of microvascular obstruction. This was because thrombus aspiration significantly reduces the severity and extent of the phenomenon . Despite early invasive strategies and optimal medical treatment, morbidity and mortality rates for STEMI continue to be high. Thus, further improvement of the initial therapy is necessary to improve patient outcome. The pivotal TAPAS (Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study) trial of patients with STEMI, which compared a strategy with thrombectomy with a strategy without thrombectomy, showed a reduction in cardiac mortality at one year . By contrast, other randomized, controlled studies did not observe superiority of thrombectomy over standard PCI with respect to surrogate endpoints of reperfusion success [40, 41]. However, meta-analyses in patients with STEMI showed a mortality-related benefit after thrombectomy compared with PCI alone [42, 43]. Therefore, the current guidelines of the European Society of Cardiology (ESC) on revascularization therapy in patients with STEMI reperfused by primary PCI have increased the recommendation class for manual thrombectomy from the previous class IIb, level of evidence B, to class IIa, level of evidence A . In line with the ESC guidelines, thrombectomy is strongly recommended by the American Heart Association/American College of Cardiology (AHA/ACC) guidelines (class IIa, level of evidence B) . The current study sought to evaluate the clinical and angiographic outcome of thrombus aspiration during primary PCI in diabetic patients presented with STEMI. Eligible patients were randomly assigned to either primary PCI with thrombus aspiration or standard PCI. Bare-metal stents were used in all patients. Bare-metal stents are still the only available option (especially on emergency basis) for percutaneous revascularization in most of centers located in developing countries. The current study was accomplished in one of these countries, where there is still a considerable cost burden concerning the use of drug-eluting stents (DESs). Patients who underwent primary PCI with thrombus aspiration showed significantly higher incidence of final TIMI III flow and less incidence of angiographic no-reflow phenomenon. Eight-month follow-up coronary angiography showed favorable QCA results concerning the same group of patients with statistically significant less incidence of in-stent restenosis, less percentage of diameter stenosis, and less late lumen loss. It is worth mentioning that mean culprit lesion length and mean used stent length did not differ between patients belonging to thrombus aspiration strategy and others belonging to standard PCI strategy. No recorded significant difference between both study groups concerning follow-up for MACE after the same period of time, that is, eight months. However, there was a recorded case of cardiac mortality, possibly stent thrombosis, and a case of definite stent thrombosis mounting to target lesion revascularization in the standard PCI group of patients. The presented results highlighted the favorable impact of thrombus aspiration, during primary PCI in diabetic patients, on incidence of in-stent restenosis and consequently the other QCA parameters. Although the favorable clinical impact of thrombus aspiration did not reach a statistical significance (when compared to the angiographic impact), numerical values still show that adopting thrombus aspiration strategy was associated with less incidence of MACE. A larger number of patients for a longer follow-up period might magnify the obtained follow-up clinical results. The author hypothesized that adopting thrombus aspiration strategy in this clinical setting could improve both angiographic and clinical outcomes encountered in diabetic patients, especially those who are managed using bare-metal stents.
4.1. Comparison with Other Studies
Previous studies demonstrated safety and merits of using thrombus aspiration devices in primary PCI prior to coronary stenting, especially concerning myocardial salvage and improved myocardial reperfusion [20, 22, 46–49]. However, this was not always associated with reduction of infarct size [42, 47]. The current study results showed better early angiographic outcomes upon using thrombus aspiration device in diabetic patients in the setting of primary PCI, in the form of higher frequency of TIMI III flow and less frequent no-reflow phenomenon. This was also demonstrated by previous trials [41, 49, 50], not specifically targeting diabetic patients. A previous trial reported the favorable impact of using thrombus aspiration (in primary PCI) on incidence of in-stent restenosis . However, this trial also was not addressing diabetic patients in particular. To the best of the author’s knowledge, the current study is a unique one, exploring the impact of aspiration thrombectomy on in-stent restenosis in diabetic patients. The current study utilized export aspiration catheter for upfront thrombus aspiration as was previously proven to be effective and safe in primary PCI [41, 49, 51]. In agreement with the results of the current study, prior trials reported satisfactory intermediate and long-term follow-up clinical outcomes, favoring adopting thrombectomy strategy in primary PCI settings [49, 51]. It is worth mentioning that all patients in both current study groups were assumed to exhibit more or less controlled blood glucose during the follow-up period as shown in mean HbA1c levels tested shortly before follow-up angiograms. So, quality of glycemic control during the follow-up period was not a determining factor for incidence of in-stent restenosis in the present study. A prior study stated that proper glycemic control was associated with lower incidence of in-stent restenosis at six-month follow-up, after acute STEMI . However, thrombectomy aspiration procedure was not included in the study protocol.
4.2. Clinical Implications
Diabetes mellitus was proven to be associated with worse angiographic (in-stent restenosis, target lesion revascularization, and stent thrombosis) and clinical (MACE) outcomes after PCI, regardless of the type of the used stent . That is why interventionalists are always attempting to optimize the procedural circumstances, in order to achieve satisfactory short- and long-term results in diabetic patients. The current study highlighted the favorable impact of thrombus aspiration on late angiographic and clinical outcomes in diabetic patients undergoing primary PCI, using bare-metal stents. The author recommends adopting thrombus aspiration strategy, whenever possible, in the aforementioned clinical setting.
4.3. Limitations of the Study
The data presented in our study only apply for patients defined by inclusion and exclusion criteria. Moreover, this is a single-centre study with a relatively small sample size of the cohort. 2D-QCA was used for angiographic assessment in the present study. Subsequent studies are needed to verify the obtained results using 3D-QCA and/or intravascular ultrasound (IVUS). Follow-up period in the current study was limited to eight months. A longer follow-up period is warranted for confirmation of the current study results, perhaps with the use of DESs. Assessment of successful tissue reperfusion and infarct size was not included in the current study, as these parameters were outside the scope of the study protocol.
Successful upfront manual thrombus aspiration (in diabetic patients on insulin therapy) during primary PCI showed beneficial effects on the reduction of in-stent restenosis after bare-metal stent implantation compared with standard PCI.
Conflict of Interests
The author, Mohamed Shehata, declares that there is no conflict of interests regarding publication of this paper.
The author likes to express his gratitude for medical, technical, and nursing staff of cardiac catheterization laboratory in Cardiology Department of Ain Shams University for their cooperation to accomplish this work.
- E. Falk, “Plaque rupture with severe pre-existing stenosis precipitating coronary thrombosis. Characteristics of coronary atherosclerotic plaques underlying fatal occlusive thrombi,” British Heart Journal, vol. 50, no. 2, pp. 127–134, 1983.
- M. J. Davies and A. Thomas, “Thrombosis and acute coronary-artery lesions in sudden cardiac ischemic death,” The New England Journal of Medicine, vol. 310, no. 18, pp. 1137–1140, 1984.
- M. A. DeWood, J. Spores, R. Notske, et al., “Prevalence of total coronary occlusion during the early hours of transmural myocardial infarction,” The New England Journal of Medicine, vol. 303, no. 16, pp. 897–902, 1980.
- F. Zijlstra, J. C. Hoorntje, M. J. de Boer, et al., “Long-term benefit of primary angioplasty as compared with thrombolytic therapy for acute myocardial infarction,” The New England Journal of Medicine, vol. 341, no. 19, pp. 1413–1419, 1999.
- E. C. Keeley, J. A. Boura, and C. L. Grines, “Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials,” The Lancet, vol. 361, no. 9351, pp. 13–20, 2003.
- S. Silber, P. Albertsson, F. F. Avilés, et al., “Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology,” European Heart Journal, vol. 26, no. 8, pp. 804–847, 2005.
- A. W. van 't Hof, A. Liem, H. Suryapranata, J. C. Hoorntje, M. J. de Boer, and F. Zijlstra, “Angiographic assessment of myocardial reperfusion in patients treated with primary angioplasty for acute myocardial infarction: myocardial blush grade,” Circulation, vol. 97, no. 23, pp. 2302–2306, 1998.
- A. W. van 't Hof, A. Liem, M. J. de Boer, and F. Zijlstra, “Clinical value of 12-lead electrocardiogram after successful reperfusion therapy for acute myocardial infarction,” The Lancet, vol. 350, no. 9078, pp. 615–619, 1997.
- G. W. Stone, M. A. Peterson, A. J. Lansky, G. Dangas, R. Mehran, and M. B. Leon, “Impact of normalized myocardial perfusion after successful angioplasty in acute myocardial infarction,” Journal of the American College of Cardiology, vol. 39, no. 4, pp. 591–597, 2002.
- M. G. McLaughlin, G. W. Stone, E. Aymong, et al., “Prognostic utility of comparative methods for assessment of ST-segment resolution after primary angioplasty for acute myocardial infarction: the controlled abciximab and device investigation to lower late angioplasty complications (CADILLAC) trial,” Journal of the American College of Cardiology, vol. 44, no. 6, pp. 1215–1223, 2004.
- A. Poli, R. Fetiveau, P. Vandoni, et al., “Integrated analysis of myocardial blush and ST-segment elevation recovery after successful primary angioplasty: real-time grading of microvascular reperfusion and prediction of early and late recovery of left ventricular function,” Circulation, vol. 106, no. 3, pp. 313–318, 2002.
- E. J. Topol and J. S. Yadav, “Recognition of the importance of embolization in atherosclerotic vascular disease,” Circulation, vol. 101, no. 5, pp. 570–580, 2000.
- J. Kotani, S. Nanto, G. S. Mintz, et al., “Plaque gruel of atheromatous coronary lesion may contribute to the no-reflow phenomenon in patients with acute coronary syndrome,” Circulation, vol. 106, no. 13, pp. 1672–1677, 2002.
- J. P. Henriques and F. Zijlstra, “Frequency and sequelae of ST elevation acute myocardial infarction caused by spontaneous distal embolization from unstable coronary lesions,” The American Journal of Cardiology, vol. 91, no. 6, pp. 708–711, 2003.
- J. P. Henriques, F. Zijlstra, J. P. Ottervanger, et al., “Incidence and clinical significance of distal embolization during primary angioplasty for acute myocardial infarction,” European Heart Journal, vol. 23, no. 14, pp. 1112–1117, 2002.
- M. Napodano, G. Pasquetto, S. Saccà, et al., “Intracoronary thrombectomy improves myocardial reperfusion in patients undergoing direct angioplasty for acute myocardial infarction,” Journal of the American College of Cardiology, vol. 42, no. 8, pp. 1395–1402, 2003.
- D. Antoniucci, R. Valenti, A. Migliorini, et al., “Comparison of rheolytic thrombectomy before direct infarct artery stenting versus direct stenting alone in patients undergoing percutaneous coronary intervention for acute myocardial infarction,” The American Journal of Cardiology, vol. 93, no. 8, pp. 1033–1035, 2004.
- T. Lefèvre, E. Garcia, B. Reimers, et al., “X-sizer for thrombectomy in acute myocardial infarction improves ST-segment resolution,” Journal of the American College of Cardiology, vol. 46, no. 2, pp. 246–252, 2005.
- G. W. Stone, J. Webb, D. A. Cox, et al., “Distal microcirculatory protection during percutaneous coronary intervention in acute ST-segment elevation myocardial infarction: a randomized controlled trial,” The Journal of the American Medical Association, vol. 293, no. 9, pp. 1063–1072, 2005.
- F. Burzotta, C. Trani, E. Romagnoli, et al., “Manual thrombus-aspiration improves myocardial reperfusion: the randomized evaluation of the effect of mechanical reduction of distal embolization by thrombus-aspiration in primary and rescue angioplasty (REMEDIA) trial,” Journal of the American College of Cardiology, vol. 46, no. 2, pp. 371–376, 2005.
- G. de Luca, H. Suryapranata, and M. Chiariello, “Aspiration thrombectomy and primary percutaneous coronary intervention,” Heart, vol. 92, no. 7, pp. 867–869, 2006.
- P. Silva-Orrego, P. Colombo, R. Bigi et al., “Thrombus aspiration before primary angioplasty improves myocardial reperfusion in acute myocardial infarction: the DEAR-MI (Dethrombosis to Enhance Acute Reperfusion in Myocardial Infarction) Study,” Journal of the American College of Cardiology, vol. 48, no. 8, pp. 1552–1559, 2006.
- A. Ali, D. Cox, N. Dib, et al., “Rheolytic thrombectomy with percutaneous coronary intervention for infarct size reduction in acute myocardial infarction: 30-day results from a multicenter randomized study,” Journal of the American College of Cardiology, vol. 48, 2, no. 2, pp. 244–252, 2006.
- A. Kaltoft, M. Bottcher, S. S. Nielsen, et al., “Routine thrombectomy in percutaneous coronary intervention for acute ST-segment-elevation myocardial infarction: a randomized, controlled trial,” Circulation, vol. 114, no. 1, pp. 40–47, 2006.
- R. Ramaraj and M. R. Movahed, “Microvascular dysfunction following primary percutaneous coronary intervention in the setting of ST-elevation myocardial infarction,” The Journal of Invasive Cardiology, vol. 20, no. 11, pp. 603–614, 2008.
- D. M. Yellon and D. J. Hausenloy, “Myocardial reperfusion injury,” The New England Journal of Medicine, vol. 357, no. 11, pp. 1121–1135, 2007.
- A. Abizaid, R. Kornowski, G. S. Mintz et al., “The influence of diabetes mellitus on acute and late clinical outcomes following coronary stent implantation,” Journal of the American College of Cardiology, vol. 32, no. 3, pp. 584–589, 1998.
- J. D. Flaherty and C. J. Davidson, “Diabetes and coronary revascularization,” The Journal of the American Medical Association, vol. 293, no. 12, pp. 1501–1508, 2005.
- R. Komowski, G. S. Mintz, K. M. Kent et al., “Increased restenosis in diabetes mellitus after coronary interventions is due to exaggerated intimal hyperplasia: a serial intravascular ultrasound study,” Circulation, vol. 95, no. 6, pp. 1366–1369, 1997.
- L. O. Jensen, M. Maeng, P. Thayssen et al., “Late lumen loss and intima hyperplasia after sirolimus-eluting and zotarolimus-eluting stent implantation in diabetic patients: the diabetes and drug-eluting stent (DiabeDES III) angiography and intravascular ultrasound trial,” EuroIntervention, vol. 7, no. 3, pp. 323–331, 2011.
- G. Mancia, R. Fagard, K. Narkiewicz, et al., “2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC),” European Heart Journal, vol. 34, no. 28, pp. 2159–2219, 2013.
- The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus, “Report of the expert committee on the diagnosis and classification of diabetes mellitus,” Diabetes Care, vol. 26, supplement 1, pp. S5–S20, 2003.
- Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, “Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III),” The Journal of the American Medical Association, vol. 285, no. 19, pp. 2486–2497, 2001.
- T. Lefevre, E. Garcia, B. Reimers et al., “X-sizer for thrombectomy in acute myocardial infarction improves ST-segment resolution: results of the X-sizer in AMI for negligible embolization and optimal ST resolution (X AMINE ST) trial,” Journal of the American College of Cardiology, vol. 46, no. 2, pp. 246–252, 2005.
- G. Sardella, M. Mancone, B. L. Nguyen et al., “The effect of thrombectomy on myocardial blush in primary angioplasty: the randomized evaluation of thrombus aspiration by two thrombectomy devices in acute myocardial infarction (RETAMI) trial,” Catheterization and Cardiovascular Interventions, vol. 71, no. 1, pp. 84–91, 2008.
- B. Chevalier, M. Gilard, I. Lang et al., “Systematic primary aspiration in acute myocardial percutaneous intervention: a multicentre randomised controlled trial of the export aspiration catheter,” EuroIntervention, vol. 4, no. 2, pp. 222–228, 2008.
- T. Svilaas, P. J. Vlaar, I. C. van der Horst et al., “Thrombus aspiration during primary percutaneous coronary intervention,” The New England Journal of Medicine, vol. 358, no. 6, pp. 557–567, 2008.
- P. J. Vlaar, T. Svilaas, I. C. van der Horst et al., “Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study,” The Lancet, vol. 371, no. 9628, pp. 1915–1920, 2008.
- L. Francesco, G. Simone, A. Paolo et al., “Impact of thrombus aspiration on myocardial tissue reperfusion and left ventricular functional recovery and remodeling after primary angioplasty,” Circulation: Cardiovascular Interventions, vol. 2, no. 5, pp. 376–383, 2009.
- G. W. Stone, A. Maehara, B. Witzenbichler et al., “Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial,” The Journal of the American Medical Association, vol. 307, no. 17, pp. 1817–1826, 2012.
- J. Lipiecki, S. Monzy, N. Durel et al., “Effect of thrombus aspiration on infarct size and left ventricular function in high-risk patients with acute myocardial infarction treated by percutaneous coronary intervention. Results of a prospective controlled pilot study,” American Heart Journal, vol. 157, no. 3, pp. 583.e1–583.e7, 2009.
- F. Burzotta, M. de Vita, Y. L. Gu, et al., “Clinical impact of thrombectomy in acute ST-elevation myocardial infarction: an individual patient-data pooled analysis of 11 trials,” European Heart Journal, vol. 30, no. 18, pp. 2193–2203, 2009.
- G. de Luca, D. Dudek, G. Sardella, P. Marino, B. Chevalier, and F. Zijlstra, “Adjunctive manual thrombectomy improves myocardial perfusion and mortality in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction: a meta-analysis of randomized trials,” European Heart Journal, vol. 29, no. 24, pp. 3002–3010, 2008.
- W. Wijns, P. Kolh, N. Danchin, et al., “Guidelines on myocardial revascularization,” European Heart Journal, vol. 31, no. 20, pp. 2501–2555, 2010.
- F. G. Kushner, M. Hand, S. C. Smith Jr., et al., “2009 Focused Updates: ACC/AHA Guidelines for the Management of Patients with ST-Elevation Myocardial Infarction (updating the 2004 Guideline and 2007 Focused Update) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention (updating the 2005 Guideline and 2007 Focused Update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines,” Circulation, vol. 120, no. 22, pp. 2271–2306, 2009.
- M. de Carlo, G. D. Aquaro, C. Palmieri, et al., “A prospective randomized trial of thrombectomy versus no thrombectomy in patients with ST-segment elevation myocardial infarction and thrombus-rich lesions: MUSTELA (MUltidevice Thrombectomy in Acute ST-Segment ELevation Acute Myocardial Infarction) trial,” JACC: Cardiovascular Interventions, vol. 5, no. 12, pp. 1223–1230, 2012.
- M. Ciszewski, J. Pregowski, A. Teresińska et al., “Aspiration coronary thrombectomy for acute myocardial infarction increases myocardial salvage: single center randomized study,” Catheterization and Cardiovascular Interventions, vol. 78, no. 4, pp. 523–531, 2011.
- D. Dudek, W. Mielecki, F. Burzotta et al., “Thrombus aspiration followed by direct stenting: a novel strategy of primary percutaneous coronary intervention in ST-segment elevation myocardial infarction. Results of the Polish-Italian-Hungarian RAndomized ThrombEctomy Trial (PIHRATE Trial),” American Heart Journal, vol. 160, no. 5, pp. 966–972, 2010.
- G. Sardella, M. Mancone, E. Canali et al., “Impact of thrombectomy with EXPort Catheter in Infarct-Related Artery during Primary Percutaneous Coronary Intervention (EXPIRA Trial) on cardiac death,” American Journal of Cardiology, vol. 106, no. 5, pp. 624–629, 2010.
- H. Ai, C.-M. Wang, X.-L. Zhu, H. Gao, and N. Li, “Effect of aspiration of coronary thrombus upon prognosis of patients in primary percutaneous coronary intervention,” Zhonghua Yi Xue Za Zhi, vol. 90, no. 11, pp. 728–731, 2010.
- J. Bulum, A. Ernst, and M. Strozzi, “The impact of successful manual thrombus aspiration on in-stent restenosis after primary PCI: angiographic and clinical follow-up,” Coronary Artery Disease, vol. 23, no. 7, pp. 487–491, 2012.
- M. Raffaele, C. S. Ferdinando, S. Mario, et al., “Peri-procedural tight glycemic control during early percutaneous coronary intervention is associated with a lower rate of in-stent restenosis in patients with acute ST-elevation myocardial infarction,” The Journal of Clinical Endocrinology & Metabolism, vol. 97, no. 8, pp. 2862–2871, 2012.
- S. Y. Qin, Y. Zhou, H. X. Jiang, et al., “The association of diabetes mellitus with clinical outcomes after coronary stenting: a meta-analysis,” PLoS ONE, vol. 8, no. 9, article e72710, 2013.