THURSDAY, 4/24/08, 5:42-6:00
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2008 ANGIOPLASTY SUMMIT TRANSCATHETER CARDIOVASCULAR THERAPEUTICS ASIA PACIFIC Oral Abstract Presentations
Acute Myocardial Infarction Sheraton Grande Walkerhill Hotel Symposium Arena Thursday, April 24, 2008 5:42 PM–6:00 PM (Abstract nos. AS-1–AS-2) Sheraton Grande Walkerhill Hotel Main Arena Thursday, April 24, 2008 11:42 AM–11:54 PM 12:06 PM–12:18 PM (Abstract nos. AS-3–AS-4) Sheraton Grande Walkerhill Hotel Room 2–3 Thursday, April 24, 2008 12:30 PM–1:20 PM (Abstract nos. AS-5–AS-9)
AS-1 Triple Versus Dual Antiplatelet Therapy in Patients with Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention. K.Y. Chen1, S.W. Rha1, Z. Jin1, Y. Minami1, J.O. Na1, C.U. Choi1, S.Y. Suh1, J.W. Kim1, E.J. Kim1, C.G. Park1, H.S. Seo1, D.J. Oh1, M.H. Jeong2. 1Korea University Guro Hospital, Seoul, Republic of Korea; 2Chonnam National University Hospital, Gwangju, Republic of Korea.
Background: Whether the safety and efficacy of triple antiplatelet strategy is superior or similar to the dual antiplatelet strategy in patients (pts) with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) remains unclear. Methods: A total of 4892 AMI pts undergoing PCI were randomly assigned to receive either dual antiplatelet therapy (aspirin plus clopidogrel, Dual Group, n ⫽ 2974) or triple antiplatelet therapy (aspirin plus clopidogrel plus cilostazol, Triple Group, n ⫽ 1,918). All major adverse cardiac events (all MACE) included total death, revascularization, and myocardial reinfarction. The bleeding complications and clinical outcomes of in-hospital, 1 and 6 months, were compared between the 2 groups. Results: The baseline characteristics were similar between the 2 groups. The early mortality and revascularization rate were lower in Triple Group up to 1 month, and all MACE were significantly lower up to 6 months. Interestingly, the Triple Group also had a significantly lower in-hospital major bleeding (Table). This result might be because the Triple Group had less history of peptic ulcer disease (0.4% vs 0.9%, p ⫽ 0.034). Variable, n (%) In-hospital Total death Reinfarction Revascularization All MACE TIMI-major bleeding At 1 month Total death Reinfarction Revascularization All MACE At 6 months Total death Reinfarction Revascularization All MACE
Dual Group (n ⴝ 2,974 pts)
Triple Group (n ⴝ 1,918 pts)
P value
89 (3.0) 12 (0.4) 41 (1.4) 142 (4.8) 12 (0.6)
34 (1.8) 9 (0.5) 12 (0.6) 55 (2.9) 3 (0.2)
0.008 0.730 0.013 0.001 0.023
106 (3.7) 25 (0.9) 71 (2.5) 202 (7.1)
50 (2.7) 10 (0.5) 26 (1.4) 86 (4.6)
0.046 0.175 0.008 0.001
124 (4.3) 34 (1.2) 150 (5.2) 308 (10.7)
65 (3.5) 13 (0.7) 75 (4.0) 153 (8.2)
0.147 0.097 0.055 0.004
Conclusion: Triple antiplatelet therapy appears to be superior in preventing MACE without increasing the major bleeding events in pts with AMI undergoing PCI compared with the conventional dual antiplatelet therapy.
AS-2 Improved Effect of Bone Marrow Stem Cells Myocardial Transplantation by Ultrasound Mediated Microbubble Destruction. J.Y. Li, Y. Feng, G.S. Ma, Z. Xu, Y.M. Su, Y.P. Hu, J.D. Ding. Zhongda Hospital, Nanjing, China. Background: This study was intended to investigate the effects of ultrasound-mediated microbubble destruction on bone marrow stem cell (BMSC) myocardial transplanting in animals. This method may provide new theories regarding the efficiency of BMSC myocardial transplantation for myocardial infarction patients. Methods: Twelve pigs were randomly divided into a control group (Group A, n ⫽ 4) and an experimental group (Group B, n ⫽ 8). According to time of death, Group B was divided into Group B1 (post-transplantation 0 hours, n ⫽ 4) and Group B2 (24 hours, n ⫽ 4). Bone marrow, dysjunction, and BMSCs (purely, cultivated, and labeled with superparamagnetic iron oxide nanoparticles [SPIO]) were suctioned from the pigs. They were then subjected to a closed-chest experimental myocardial infarction (MI) model. Labeled BMSCs (1– 5 ⫻ 106) were infused intracoronarily under x-ray fluoroscopy 14 days after acute myocardial infarction (AMI) mode. Group A received pure-infused BMSCs into the myocardium through the left anterior
The American Journal of Cardiology姞 APRIL 23–25 2008 ANGIOPLASTY SUMMIT ABSTRACTS/Oral
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descending branch. Group B was infused with a microbubble (SonoVue) and then with BMSC into the myocardium through the left anterior descending branch; at the same time, the MI region underwent ultrasound (1 MHz, 2 W/cm2, continued radiation 90 s). Magnetic resonance imaging (MRI) were obtained on a 1.5-T MR scanner to demonstrate the location of the BMSCs in living pigs after operation at.24 hours and compared with histology. Results: 1) MRI: the zone of SPIO-labeled BMSC accumulation showed vague darkening on T2*-weighted MRI in Groups A and B. 2) Prussian blue staining: film preparation of myocardial digests and histological analyses showed that the experimental group had more Prussian blue–positive cells than the control group (p ⬍0.01). 3) Transmission electron microscope: There was no difference in the myocardial ultrastructure between the 2 groups; however, the gap of blood vessel endothelium widened in Group B1, but not Group B2. Conclusion: This study demonstrates that ultrasound destruction of microbubbles enhances BMSC myocardial transplantation efficiency. The mechanism may result from ultrasound destruction of microbubbles, which widens blood vessel endothelium reversibility. This method may provide new theories about increasing BMSCs myocardial transplantation efficiency.
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Y. Minami, S. Mizuno, K. Sugitatsu, H. Kaneda. Heart Center of Shonankamakura General Hospital, Kamakura, Japan. Background: Recent studies have shown that the pioglitazone reduces neointimal hyperplasia after coronary stenting. In this randomized trial, we examined the safety and efficacy of pioglitazone in patients with ST elevation myocardial infarction (STEMI) treated by primary bare metal stent implantation. Methods: Diabetic or nondiabetic patients with STEMI (⬍12 hours from onset) were included between October 2005 and July 2007. Patients were randomized into the pioglitazone (15mg up to 30mg) or control groups. Primary safety endpoint was major adverse cardiac events (MACE): composite of all-cause mortality, reinfarction, target lesion revascularization, or heart failure necessitating hospitalization. Results: See Figure.
AS-3 The Efficacy of Bilateral Approach for Lesions with Chronic Total Occlusion in Acute Results and Follow-up: The CART Registry. M. Kimura, O.K. Katoh, T. Suzuki, K. Nasu, Y. Kinoshita, M. Ehara, E. Tsuchikane, M. Terashima, T. Matsubara, Y. Asakura. Toyohashi Heart Center, Toyohashi, Japan. Background: A successful percutaneous recanalization of chronic coronary occlusions (CTO) results in improved survival and enhanced left ventricular function, reduction in angina, and improved exercise tolerance. Successful recanalization of CTOs in native coronary arteries is no doubt one of the most technically challenging of lesion subsets. The aim of this study was to evaluate safety and feasibility of a new concept for CTO recanalization using a bilateral approach including a controlled antegrade and retrograde subintimal tracking technique (CART technique). Methods: A total of 170 consecutive patients (mean age 65 ⫾ 13 years; 80.7% male) were enrolled in this prospective multicenter registry. This technique combines the simultaneous use of the antegrade and retrograde approaches. A subintimal dissection is created antegradely and retrogradely, which limit the extension of the subintimal dissection within the CTO portion. Results: The consecutive 170 CTO lesions (⬎1 month) were attempted for CTO recanalization using CART technique. Of 170 cases, 121 cases (71%) had undergone previous attempts at CTO recanalization. History of prior myocardial infarction was present in 78% of the patients. The CTO lesions were most frequently located in right coronary artery (69.7%) followed by left anterior descending coronary artery (25.5%), left circumflex coronary artery (3.4%), and saphenous vein graft (1.4%). The success rate of retrograde wire cross and balloon cross were 89% (152/170) and 82% (140/170), respectively. Successful recanalization was archived in 93% (158/170) of the patients, and the procedure success rate was 91% (155/170). Conclusion: Bilateral approach for CTO lesions using CART technique is feasible, safe, and has a higher success rate than previous approaches. These results indicate that this technique can solve major concerns.
AS-4 Prospective Randomized Trial of the Safety and Efficacy of Pioglitazone in Patients with ST Elevation Myocardial Infarction Treated by Primary Stent implantation. T. Shiono, S. Saito, Y. Miyashita, S. Takahashi, H. Domae, Y. Taketani, J. Matsumi,
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Conclusion: Pioglitazone did not show a significant difference in angiographic restenosis and MACE in patients with STEMI within 6 months.
AS-5 Enoxaparin versus Unfractionated Heparin as Adjunctive Anticoagulant Therapy in Patients Treated with Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction. D.Y. Nah1, J.H. Bae1, K. Lee1, J.S. Kim1, K. Kim1, W.C. Ha1, Y.K. Kim2, M.Y. Rhee2, S.H. Na2, Y.S. Kim2, M.M. Lee2. 1Dongguk University Gyeongju Hospital, Gyeongju, Republic of Korea; 2Dongguk Uinversity Illsan Hospital, Illsan, Republic of Korea. Background: Enoxaparine (ENOX) has shown to be more effective than unfractionated heparin (UFH) for ST-segment elevation myocardial infarction (STEMI) patients treated with fibrinolysis. However, controversies remain regarding the safety and efficacy of ENOX as adjunctive anticoagulant therapy in patients treated with primary percutaneous coronary intervention (PCI) for STEMI. Methods: Between January 2005 and April 2007, 130 patients were admitted for STEMI and primary PCI was performed. We divided the patients into 2 groups with either ENOX (n ⫽ 53) or UFH (n ⫽ 77) used as the adjunctive anticoagulant. The incidence of thrombolysis in myocardial infarction (TIMI) major or minor bleeding at 48 hours and 8 days and the incidence of major adverse cardiac events (MACE: cardiac death, nonfatal myocardial infarction, urgent target vessel revascularization) at 1 month were evaluated. Results: See Table. Baseline patient characteristics were similar between the 2 groups. There was similar incidence of TIMI major and minor bleeding between 2 groups at 48 hours and 8 days. The incidence of MACE was similar between 2 groups at 1 month follow up.
The American Journal of Cardiology姞 APRIL 23–25 2008 ANGIOPLASTY SUMMIT ABSTRACTS/Oral
THURSDAY, 4/24/08, 12:30 –1:20 Enox
30 days MACE 48 hours Major or Minor bleeding 8 days Major or Minor bleeding ⴱ †
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UFH
Subtoal
No. of Cases
Subtoal
No. of Cases
%
%
P-value
51 53
4 3
7.8 5.7
74 77
11 0
14.9 0
0.235ⴱ 0.065†
53
4
7.5
77
5
6.5
1.000†
by chi-square test. by Fisher’s exact test.
Conclusion: Enox may be safe as adjunctive anticoagulant during primary PCI in patients with STEMI without increasing MACE compared with UFH. This was a preliminary study to evaluate the safety and efficacy of ENOX as anticoagulant during primary PCI in patients with STEMI. Prospective and randomized large-scale studies are essential.
AS-6 Impact of Coronary Microvascular Resistance Index Immediately after Primary Percutaneous Coronary Intervention on Myocardial Viability in Acute Myocardial Infarction. H. Kitabata, M. Kashiwagi, H. Matsumoto, H. Ikejima, Y. Arita, K. Okochi, H. Tsujioka, A. Kuroi, S. Ueno, H. Kataiwa, T. Tanimoto, T. Yamano, S. Takarada, T. Kubo, N. Nakamura, K. Hirata, A. Tanaka, M. Mizukoshi, T. Imanishi, T. Akasaka. Wakayama Medical University, Wakayama, Japan. Background: The degree of coronary microvascular damage after reperfusion is an important determinant of myocardial viability and clinical outcomes in patients with acute myocardial infarction (AMI). However, a simple and useful method for assessing coronary microcirculation has not been fully elucidated. A novel 0.014-inch dualsensor (pressure and Doppler velocity) guidewire has the ability to estimate coronary microvascular resistance. Contrast-enhanced magnetic resonance imaging (MRI) can differentiate nontransmural MI (viable) from transmural MI (nonviable). The aim of this study was to assess the relationship between coronary microvascular resistance index (MVRI) immediately after primary percutaneous coronary intervention (PCI) and myocardial viability in patients with AMI. Methods: We enrolled 27 patients (22 men, mean age 65 ⫾ 11years) who underwent primary PCI for a first anterior AMI within 12 hours of the onset of symptoms. Immediately after primary PCI, a 0.014-inch dual-sensor guidewire was placed distally to the culprit lesion to take per-beat averages of pressure and flow velocity simultaneously. MVRI was determined as the ratio of mean distal pressure to average peak flow velocity during maximal hyperemia. Peak creatine kinase-MB (CK-MB) fraction values were derived from serial CK-MB measurements. Delayed contrast-enhanced MRI (DeMRI) was also performed in all patients 2 weeks after the onset of AMI. Using a 17-segment model, the transmural extent of infarction (TEI) by DeMRI was graded from 1 to 4 based on the extent of hyperenhanced tissue (grade 1 ⫽ 0% to 25% of hyperenhanced extent of left ventricular (LV) wall, grade 2 ⫽ 26% to 50%, grade 3 ⫽ 51% to 75%, and grade 4 ⫽ 76% to 100%). The highest grade among 16 segments except LV apex was defined as the TEI grade of each case. Infarct size by MRI was defined as follows: (volume of enhanced tissue ⫻ 100 / total volume of LV myocardium)(%). Results: The average time from symptom onset to the evaluation of coronary microcirculation was 4.9 ⫾ 2.1 hours. A significant positive correlation was observed between MVRI and the TEI-grade (p ⬍0.0002). Furthermore, MVRI was strongly correlated with peak CK-MB value (r ⫽ 0.77, p ⬍0.0003) and infarct size by MRI (r ⫽ 0.80,
p ⬍0.0004). The best cutoff value of MVRI for the prediction of transmural MI (TEI grade 4) was 3.2 mm Hg 䡠 cm-1 䡠 s (sensitivity 100%, specificity 88.9%, positive predictive value 75%, and negative predictive value 100%). Conclusion: MVRI immediately after primary PCI is a useful coronary physiologic parameter for predicting myocardial viability in patients with AMI.
AS-7 Systematic Review of the Effect of Intracoronary Autologous Bone Marrow Stem Cells Transfer on Left Ventricular Function after Acute Myocardial Infarction. S.N. Zhang, A.J. Sun, J.B. Ge, K. Yao, Z.Y. Huang, K.Q. Wang, Y.Z. Zou. Zhongshan Hospital, Shanghai, China. Background: Conflicting results exist on the effect of intracoronary bone marrow stem cells (BMSC) transfer on left ventricular ejection fraction in patients with acute myocardial infarction. This study sought to analyze the efficacy of the procedure by performing a meta-analysis based on published randomized controlled trials. Methods: A systematic literature search of PubMed, MEDLINE, BIOSIS, EBM Reviews, and the Chinese Journal Full-Text Database between January 1990 and May 2007 was performed for relevant published studies. Inclusion criteria required that patients received intracoronary BMSC transfer after coronary reperfusion therapy for primary acute myocardial infarction; study design involved patient randomization, double-blinding, and matching placebo; detailed data on left ventricular function at ⬎3 months follow-up were available from the trials. Studies with fewer than 10 subjects were excluded. Results: Seven trials with 545 patients were available for analysis. The mean increase in left ventricular ejection fraction between baseline and 4.9-month follow-up after BMSC transfer was 8.89% (95% confidence interval [CI] 3.42–14.36; p ⫽ 0.001), and the effect of BMSC treatment on the change in left ventricular ejection fraction was an increase of 5.65% (95% CI 2.24 –9.06; p ⫽ 0.001). The pooled statistics showed the beneficial effect on left ventricular end-diastolic volume at baseline in the BMSC group (p ⫽ 0.01), and there was no significant difference between the 2 groups (standardized mean difference 95% CI – 0.59 to 0.12; p ⫽ 0.20). In the BMSC group, there was no significant difference in left ventricular end-systolic volume between baseline and follow-up (p ⫽ 0.33). However, compared with control, BMSC transfer significantly decreased left ventricular end-systolic volume (standardized mean difference 95%CI – 0.53 to – 0.09; p ⫽ 0.005). Conclusion: BMSC transplantation significantly promotes the recovery of left ventricular ejection fraction and prevents left ventricular end-systolic volume enlargement but has no effect on left ventricular remodeling after acute myocardial infarction.
AS-8 Myocardial Viability Assessed with Fluorodeoxyglucose Positron Emission Tomography as a Predictor of Cardiac Events in Patients with Acute Myocardial Infarction. M. Tsurugida1, S. Hamasaki2, K. Kihara1, R. Arikawa1, K. Kusumoto1, C. Tei2. 1 Fujimoto Hayasuzu Hospital, Miyazaki, Japan; 2Kagoshima University, Kagoshima, Japan. Background: Prediction of cardiac events by myocardial viability has not been reported in patients with acute myocardial infarction (AMI). The purpose of this study was to examine whether myocardial viability assessed by fluorodeoxyglucose positron emission tomography (FDGPET) in the acute phase of AMI can be a predictor of cardiac events in patients with AMI. Methods: Thirty-seven patients with reperfused first anteroseptal AMI were studied. FDG-PET was performed 2 weeks after percutane-
The American Journal of Cardiology姞 APRIL 23–25 2008 ANGIOPLASTY SUMMIT ABSTRACTS/Oral
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ous coronary intervention (PCI). Myocardial viability was assessed by viability score (VS), which is derived from the mean value of the score of FDG-PET uptake for infarcted areas with a 5-point scoring system (no uptake ⫽ 0, best uptake ⫽ 4). We divided the patients into 2 groups: good viability ⫽ VS ⬎2 (n ⫽ 23) and poor viability group ⫽ VS ⬍2 (n ⫽ 14). We examined whether there was a difference in the appearance of subsequent cardiac events (death, heart failure, coronary artery bypass graft, re-PCI, and serious arrhythmia) by Kaplan-Meier method as an endpoint of the duration from the onset of AMI to the day of cardiac events. Results: The average observation period was 692 days. The eventfree survival rate assessed by Kaplan-Meier method was significantly reduced (p ⫽ 0.02) in the good viability group. See Figure.
Conclusion: This study demonstrated that the preservation of good myocardial viability can predict subsequent cardiac events. Myocardial viability assessed by FDG-PET is useful to predict clinical outcome in patients with AMI.
AS-9 Clinical Safety of Drug-Eluting Stents in Korea Acute Myocardial Infarction Registry. S.R. Lee1, M.H. Jeong2, Y.K. Ahn2, S.C. Chae3, S.H. Hur4, Y.J. Kim5, I.H. Seong6, J.K. Chae1, T.J. Hong7, J.Y. Rhew8, M.C. Cho9, J.H. Bae10, S.W. Rha11, C.J. Kim12, Y.S. Jang13, S.J. Park14.
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1
Chonbuk National University, Jeongju, Republic of Korea; Chonnam National University Hospital, Gwangju, Republic of Korea; 3Kyungpook National University Hospital, Daegu, Republic of Korea; 4Keimyung University Hospital, Daegu, Republic of Korea; 5Yeungnam University Hospital, Daegu, Republic of Korea; 6 Chungnam National University Hospital, Daejeon, Republic of Korea; 7Pusan National University Hospital, Busan, Republic of Korea; 8Jeongju Christian Hospital, Jeongju, Republic of Korea; 9 Chungbuk National University Hospital, Cheongju, Republic of Korea; 10Keonyang University Hospital, Daejeon, Republic of Korea; 11Korea University Hospital, Seoul, Republic of Korea; 12 Kyunehee University Hospital, Seoul, Republic of Korea; 13Yonsei University Hospital, Seoul, Republic of Korea; 14Asan Medical Center, Seoul, Republic of Korea. 2
Background: Percutaneous coronary intervention (PCI) with drugeluting stents (DES) may be useful in patients with acute myocardial infarction (AMI); however, safety issues must be resolved. This study was undertaken to determine the incidence of major adverse cardiac events (MACE) and stent thrombosis in DES implanted in AMI patients in clinical practice. Methods: An online AMI registry (see http://www.kamir.or.kr/) has been created from 41 primary percutaneous coronary intervention (PCI) centers in Korea. Between November 2005 and September 2006, 1541 patients who were implanted with Cypher or Taxus stents, enrolled in Korea Acute Myocardial Infarction Registry (KAMIR), and discharged from the hospital, were analyzed during 6-month clinical follow-up. Results: There for the 2 groups were as follows: Group I (834 patients, 61.9 ⫾ 11.9 years; sirolimus-eluting stent [Cypher]), Group II (707 patients, 62.9 ⫾ 12.0 years: paclitaxel-eluting stent [Taxus]). One-month and 6-month MACE were not significantly different between the 2 groups. There were 17 stent thrombosis; however, incidence was not significantly different between groups (Group I ⫽ 9 [1.1%]; Group II: 8 [1.1%], p ⫽ 1.000). The stent type, length, and number as well as lesion complexity and presence of diabetes were not significant for the incidence of MACE and stent thrombosis after adjustment. Conclusion: MACE and stent thrombosis were not different between 2 types of DES in the KAMIR. DES can be used in patients with AMI with a relatively low 6-month MACE rate.
The American Journal of Cardiology姞 APRIL 23–25 2008 ANGIOPLASTY SUMMIT ABSTRACTS/Oral