as-6: a randomized multicenter trial comparing primary angioplasty and combined fibrinolytic therapy...

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(STEMI): 4-Years Follow-Up. Feng Cao 1 , Dong Dong Sun 1 , Cheng Xiang Li 1 , Kazim Narsinh 2 , Wenyi Guo 1 , Xue Li 1 , Xu Yang Fen 1 , Haichang Wang 1 . 1 Xijing Hospital, Xi’an, China; 2 University of California, School of Medicine, San Diego, CA, USA. Background: Many clinical trials have showed the short-term outcome of bone marrow stem cell transplantation for MI patients, but few reports have demonstrated long-term follow-up results. This study was undertaken to evaluate the efficacy of and LV function improvement after autologous bone marrow mononuclear cells (BMMNC) transplan- tation in patients with ST-segment elevation myocardial infarction at 4-years follow-up. Methods: Eighty-six patients with STEMI who had successfully undergone percutaneous coronary intervention (PCI) were randomized to receive intracoronary injection of BMMNC (n 41) or saline (n 45). Left ventricular function and myocardial viability were assessed by echocardiography, single-photon emission computed tomography (SPECT) and coronary angiography. Results: Left ventricular ejection fraction, as evaluated by echo- cardiography and SPECT, was markedly improved 6 months, 1 year, and 4 years after BMMNC transplant. However, the current cell ther- apy did not improve the myocardial viability of the infarcted area as assessed by SPECT at 4 years posttransplant (0.263 0.007 in BMMNC group vs 0.281 0.008 in control group, p 0.05). During the follow-up period, 1 control group case (2.2%) of in-stent restenosis was confirmed by coronary angiography and underwent repeat PCI. Also during follow-up, 1 death (2.2%) occurred in the control group, and 1 patient (2.4%) in the BMMNC group had transient acute heart failure. Conclusion: This study indicates that intracoronary delivery of autologous BMMNC is safe and feasible for STEMI patients who have undergone PCI and can lead to long-term improvement in myocardial function. AS-6 A Randomized Multicenter Trial Comparing Primary Angioplasty and Combined Fibrinolytic Therapy with or without Rescue Angioplasty—APAMIT Extended Pilot Study. Aaron Wong 1 , Tian-Hai Koh 1 , Koon-Hou Mak 1 , Kui-Hian Sim 2 , TRL Ahmad 3 , KH Tan 4 , Ashok Seth 5 , Yean-Teng Lim 6 , Jayaram Lingamanaicker 7 , Yean-Leng Lim 8 . 1 National Heart Centre, Singapore, Singapore; 2 Sarawak General Hospital, Kuching, Malaysia; 3 Penang General Hospital, Penang, Malaysia; 4 University of Malaysia Medical Centre, Kuala Lumpur, Malaysia; 5 Escort heart Institute and Research Centre, New Delhi, India; 6 National University Hospital, Singapore, Singapore; 7 Changi General Hospital, Singapore, Singapore; 8 Western Hospital, Melbourne, Australia. Background: Although primary angioplasty is the preferred treatment modality for acute myocardial infarction (MI), in centers without primary angioplasty (PA) capabilities, fibrinolytic therapy is still the recommended alternative. Combined fibrinolytic (CF) therapy has been shown to improve infarct-related artery (IRA) patency before PA and may improve safety of rescue angioplasty (RA). A randomized multi- center pilot study was conducted in the Asia-Pacific region to compare the safety and efficacy between primary angioplasty with adjunct abciximab vs combined fibrinolytic (alteplase and abciximab) therapy with or without rescue angioplasty for the treatment of AMI. Methods: Patients with AMI 6 hours were randomized to either primary angioplasty (PA group) or 50-mg alteplase (CF group). All patients received aspirin and standard bolus and infusion dose of abciximab at randomization. In the CF group, coronary angiography was performed if ST segment resolution at 90 min was 50% and chest pain persisted. Rescue angioplasty was performed in the CF group if thrombolysis in myocardial infarction (TIMI) flow grade (TF) in IRA was 3. TF was assessed pre- and posttreatment(s) in both groups. Major cardiac adverse events (MACE), defined as recurrent ischaemia, nonfatal MI, target vessel revascularization (TVR), stroke, or death, was assessed at 1, 6, and 12 months. Results: Sixty-four patients (PA 29, CF 35) with mean age of 54 11 were enrolled, and 92% were male. Baseline demo- graphic characteristics were similar in both groups. Symptoms to door (SD), door to treatment (DT), TF pre- and posttreatment, bleeding complications, and MACE are shown in the Table. Overall treatment success rate (defined as TF 3) were equally high with a trend favoring PA group (96% vs 83%, p ns). There were 2 in-hospital deaths, 1 in each group, and none during the subsequent follow-up. There was significant difference in in-hospital, 1, 6, and 12-month clinical events mainly due to in-hospital TVR and sub- sequent recurrent ischaemia requiring TVR. SD DT TIMI 3 MACE min min pre post Bleeding In-hospital 1m 6m 12m PA (n 29) 105 109 12% 96% 0 3% 10% 17% 28% CF (n 35) 120 65 29% 80% 6% 31% 37% 51% 66% p-value ns 0.01 ns ns ns 0.01 0.02 0.01 0.01 Patients underwent rescue angioplasty. Conclusion: PA and CF with or without rescue angioplasty based on clinical reperfusion criteria at 90 min were equally effective in achieving TIMI 3 flow in patients with AMI. However, subsequent TVR rate of IRA was high in the CF group because of residual ischemia, suggesting that PA, if available, should be the preferred treatment for AMI. AS-7 Relationship between Coronary Microvascular Resistance Index and Myocardial Blush Grade in Patients with ST-Elevation Acute Myocardial Infarction Achieving TIMI Grade 3 Reperfusion. Kenichi Komukai, Hironori Kitabata, Yuichi Ozaki, Aiko Shimokado, Manabu Kashiwagi, Hiroki Matsumoto, Yu Arita, Hideyuki Ikejima, Keishi Okochi, Hiroto Tsujioka, Akio Kuroi, Kohei Ishibashi, Hideaki Kataiwa, Takashi Tanimoto, Shigeho Takarada, Nobuo Nakamura, Kumiko Hirata, Atsushi Tanaka, Masato Mizukoshi, Toshio Imanishi, Takashi Akasaka. Wakayama Medical University, Wakayama, Japan. Background: Angiographic myocardial blush grade (MBG) after reperfusion therapy is an independent predictor of long-term mor- tality in patients with acute myocardial infarction (AMI). However, MBG is a semiquantitative measure for the assessment of micro- vascular dysfunction. Microvascular resistance index (MVRI) mea- sured by the simultaneous measurement of pressure and flow veloc- ity allows us to evaluate the status of microvascular dysfunction directly and quantitatively. The purpose of this study was to inves- tigate the relationship between MVRI and MBG after successful primary percutaneous coronary intervention (PCI) in patients with anterior AMI. Methods: In 24 patients with thrombolysis in myocardial infarction (TIMI) grade 3 flow after primary PCI for a first anterior AMI, using a dual-sensor guidewire, MVRI was calculated as the ratio of mean distal pressure to average peak flow velocity during maximal hyper- emia. MBG was graded 0; absent blush, 1; minimal blush, 2; reduced blush, and 3; normal blush. According to MBG, patients were divided into 3 groups: MBG 0/1 (n 9), MBG 2 (n 8), and MBG 3 (n 7). Results: Patients with MBG 3, 2, and 0/1 had enzymatic infarct size by peak creatine kinase-MB of 151 128 IU/L, 296 173 IU/L, and 401 74 IU/L, respectively (p 0.003), and infarct size by The American Journal of Cardiology APRIL 22–24 2009 ANGIOPLASTY SUMMIT ABSTRACTS/Oral 3B O R A L A B S T R A C T S WEDNESDAY, APRIL 22, 2009

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(STEMI): 4-Years Follow-Up. Feng Cao1, Dong Dong Sun1,Cheng Xiang Li1, Kazim Narsinh2, Wenyi Guo1, Xue Li1,Xu Yang Fen1, Haichang Wang1. 1Xijing Hospital, Xi’an, China;2University of California, School of Medicine, San Diego, CA, USA.

Background: Many clinical trials have showed the short-term outcomeof bone marrow stem cell transplantation for MI patients, but fewreports have demonstrated long-term follow-up results. This study wasundertaken to evaluate the efficacy of and LV function improvementafter autologous bone marrow mononuclear cells (BMMNC) transplan-tation in patients with ST-segment elevation myocardial infarction at4-years follow-up.

Methods: Eighty-six patients with STEMI who had successfullyundergone percutaneous coronary intervention (PCI) were randomizedto receive intracoronary injection of BMMNC (n � 41) or saline (n �45). Left ventricular function and myocardial viability were assessed byechocardiography, single-photon emission computed tomography(SPECT) and coronary angiography.

Results: Left ventricular ejection fraction, as evaluated by echo-cardiography and SPECT, was markedly improved 6 months, 1 year,and 4 years after BMMNC transplant. However, the current cell ther-apy did not improve the myocardial viability of the infarcted area asassessed by SPECT at 4 years posttransplant (0.263 � 0.007 inBMMNC group vs 0.281 � 0.008 in control group, p �0.05). Duringthe follow-up period, 1 control group case (2.2%) of in-stent restenosiswas confirmed by coronary angiography and underwent repeat PCI.Also during follow-up, 1 death (2.2%) occurred in the control group,and 1 patient (2.4%) in the BMMNC group had transient acute heartfailure.

Conclusion: This study indicates that intracoronary delivery ofautologous BMMNC is safe and feasible for STEMI patients who haveundergone PCI and can lead to long-term improvement in myocardialfunction.

AS-6A Randomized Multicenter Trial Comparing PrimaryAngioplasty and Combined Fibrinolytic Therapy with or withoutRescue Angioplasty—APAMIT Extended Pilot Study.Aaron Wong1, Tian-Hai Koh1, Koon-Hou Mak1, Kui-Hian Sim2,TRL Ahmad3, KH Tan4, Ashok Seth5, Yean-Teng Lim6,Jayaram Lingamanaicker7, Yean-Leng Lim8. 1National Heart Centre,Singapore, Singapore; 2Sarawak General Hospital, Kuching,Malaysia; 3Penang General Hospital, Penang, Malaysia; 4Universityof Malaysia Medical Centre, Kuala Lumpur, Malaysia; 5Escort heartInstitute and Research Centre, New Delhi, India; 6NationalUniversity Hospital, Singapore, Singapore; 7Changi GeneralHospital, Singapore, Singapore; 8Western Hospital, Melbourne,Australia.

Background: Although primary angioplasty is the preferred treatmentmodality for acute myocardial infarction (MI), in centers withoutprimary angioplasty (PA) capabilities, fibrinolytic therapy is still therecommended alternative. Combined fibrinolytic (CF) therapy has beenshown to improve infarct-related artery (IRA) patency before PA andmay improve safety of rescue angioplasty (RA). A randomized multi-center pilot study was conducted in the Asia-Pacific region to comparethe safety and efficacy between primary angioplasty with adjunctabciximab vs combined fibrinolytic (alteplase and abciximab) therapywith or without rescue angioplasty for the treatment of AMI.

Methods: Patients with AMI �6 hours were randomized to eitherprimary angioplasty (PA group) or 50-mg alteplase (CF group). Allpatients received aspirin and standard bolus and infusion dose ofabciximab at randomization. In the CF group, coronary angiographywas performed if ST segment resolution at 90 min was �50% and chestpain persisted. Rescue angioplasty was performed in the CF group if

thrombolysis in myocardial infarction (TIMI) flow grade (TF) in IRAwas �3. TF was assessed pre- and posttreatment(s) in both groups.Major cardiac adverse events (MACE), defined as recurrent ischaemia,nonfatal MI, target vessel revascularization (TVR), stroke, or death,was assessed at 1, 6, and 12 months.

Results: Sixty-four patients (PA � 29, CF � 35) with mean ageof 54 � 11 were enrolled, and 92% were male. Baseline demo-graphic characteristics were similar in both groups. Symptoms todoor (SD), door to treatment (DT), TF pre- and posttreatment,bleeding complications, and MACE are shown in the Table. Overalltreatment success rate (defined as TF � 3) were equally high witha trend favoring PA group (96% vs 83%, p � ns). There were 2in-hospital deaths, 1 in each group, and none during the subsequentfollow-up. There was significant difference in in-hospital, 1, 6, and12-month clinical events mainly due to in-hospital TVR and sub-sequent recurrent ischaemia requiring TVR.

SD DT TIMI 3 MACE

min min pre post Bleeding In-hospital 1m 6m 12m

PA (n � 29) 105 109 12% 96% 0 3% 10% 17% 28%

CF (n � 35) 120 65 29%� 80%� 6% 31% 37% 51% 66%

p-value ns �0.01 ns ns ns �0.01 �0.02 �0.01 �0.01

�Patients underwent rescue angioplasty.

Conclusion: PA and CF with or without rescue angioplasty basedon clinical reperfusion criteria at 90 min were equally effective inachieving TIMI 3 flow in patients with AMI. However, subsequentTVR rate of IRA was high in the CF group because of residualischemia, suggesting that PA, if available, should be the preferredtreatment for AMI.

AS-7Relationship between Coronary Microvascular Resistance Indexand Myocardial Blush Grade in Patients with ST-ElevationAcute Myocardial Infarction Achieving TIMI Grade 3Reperfusion. Kenichi Komukai, Hironori Kitabata, Yuichi Ozaki,Aiko Shimokado, Manabu Kashiwagi, Hiroki Matsumoto, Yu Arita,Hideyuki Ikejima, Keishi Okochi, Hiroto Tsujioka, Akio Kuroi,Kohei Ishibashi, Hideaki Kataiwa, Takashi Tanimoto,Shigeho Takarada, Nobuo Nakamura, Kumiko Hirata,Atsushi Tanaka, Masato Mizukoshi, Toshio Imanishi,Takashi Akasaka. Wakayama Medical University, Wakayama, Japan.

Background: Angiographic myocardial blush grade (MBG) afterreperfusion therapy is an independent predictor of long-term mor-tality in patients with acute myocardial infarction (AMI). However,MBG is a semiquantitative measure for the assessment of micro-vascular dysfunction. Microvascular resistance index (MVRI) mea-sured by the simultaneous measurement of pressure and flow veloc-ity allows us to evaluate the status of microvascular dysfunctiondirectly and quantitatively. The purpose of this study was to inves-tigate the relationship between MVRI and MBG after successfulprimary percutaneous coronary intervention (PCI) in patients withanterior AMI.

Methods: In 24 patients with thrombolysis in myocardial infarction(TIMI) grade 3 flow after primary PCI for a first anterior AMI, usinga dual-sensor guidewire, MVRI was calculated as the ratio of meandistal pressure to average peak flow velocity during maximal hyper-emia. MBG was graded 0; absent blush, 1; minimal blush, 2; reducedblush, and 3; normal blush. According to MBG, patients were dividedinto 3 groups: MBG 0/1 (n � 9), MBG 2 (n � 8), and MBG 3 (n � 7).

Results: Patients with MBG 3, 2, and 0/1 had enzymatic infarctsize by peak creatine kinase-MB of 151 � 128 IU/L, 296 � 173 IU/L,and 401 � 74 IU/L, respectively (p � 0.003), and infarct size by

The American Journal of Cardiology� APRIL 22–24 2009 ANGIOPLASTY SUMMIT ABSTRACTS/Oral 3B

ORAL

ABSTRACTS

WEDNESDAY, APRIL 22, 2009