CLINICAL RESEARCH: CLINICAL TRIAL
Rheolytic Thrombectomy With Percutaneous Coronary Intervention for Infarct Size Reduction in Acute Myocardial Infarction
30-Day Results From a Multicenter Randomized Study
Arshad Ali, MD*,*,
David Cox, MD ,
Nabil Dib, MD ,
Bruce Brodie, MD ,
Daniel Berman, MD||,
Navin Gupta, MD,
Kevin Browne, MD¶,
Robert Iwaoka, MD,
Michael Azrin, MD#,
Dwight Stapleton, MD*,
Cindy Setum, PhD**,
Jeffrey Popma, MD for the AIMI Investigators
* Robert Packer Hospital, Sayre, Pennsylvania
Presbyterian Hospital, Charlotte, North Carolina
Arizona Heart Institute, Phoenix, Arizona
LeBauer Heart Care, Greensboro, North Carolina
|| Cedars-Sinai Medical Center, Los Angeles, California
¶ Lakeland Regional Medical Center, Lakeland, Florida
# University of Connecticut, Farmington, Connecticut
** Possis Medical, Inc., Minneapolis, Minnesota
Brigham and Women’s Hospital, Boston, Massachusetts.
Manuscript received July 13, 2005;
revised manuscript received February 28, 2006,
accepted March 2, 2006.
* Reprint requests and correspondence: Dr. Arshad Ali, Williamsport Hospital, Williamsport, Pennsylvania 17701. (Email: Arshadali{at}aol.com).
OBJECTIVES: The goal of this work was to determine whether rheolytic thrombectomy (RT) as an adjunct to primary percutaneous coronary intervention (PCI) reduces infarction size and improves myocardial perfusion during treatment of ST-segment elevation myocardial infarction (STEMI).
BACKGROUND: Primary PCI for STEMI achieves brisk epicardial flow in most patients, but myocardial perfusion often remains suboptimal. Distal embolization of thrombus during treatment may be a contributing factor.
METHODS: This prospective, multicenter trial enrolled 480 patients presenting within 12 h of symptom onset and randomized to treatment with RT as an adjunct to PCI (n = 240) or to PCI alone (n = 240). Visible thrombus was not required. The primary end point was infarct size measured by sestamibi imaging at 14 to 28 days. Secondary end points included final Thrombolysis In Myocardial Infarction (TIMI) flow grade, tissue myocardial perfusion (TMP) blush, ST-segment resolution, and major adverse cardiac events (MACE), defined as the occurrence of death, new Q-wave myocardial infarction, emergent coronary artery bypass grafting, target lesion revascularization, stroke, or stent thrombosis at 30 days.
RESULTS: Final infarct size was higher in the adjunct RT group compared with PCI alone (9.8 ± 10.9% vs. 12.5 ± 12.13%; p = 0.03). Final TIMI flow grade 3 was lower in the adjunct RT group (91.8% vs. 97.0% in the PCI alone group; p < 0.02), although fewer patients had baseline TIMI flow grade 3 in the adjunct RT group (44% vs. 63% in the PCI alone group; p < 0.05). There were no significant differences in TMP blush scores or ST-segment resolution. Thirty-day MACE was higher in the adjunct RT group (6.7% vs. 1.7% in the PCI alone group; p = 0.01), a difference primarily driven by very low mortality rate in patients treated with PCI alone (0.8% vs. 4.6% in patients treated with adjunct RT; p = 0.02).
CONCLUSIONS: Despite effective thrombus removal, RT with primary PCI did not reduce infarct size or improve TIMI flow grade, TMP blush, ST-segment resolution, or 30-day MACE.
|
Abbreviations and Acronyms
| | AIMI = AngioJet Rheolytic Thrombectomy In Patients Undergoing Primary Angioplasty for Acute Myocardial Infarction trial | | CABG = coronary artery bypass graft | | DSMB = Data and Safety Monitoring Board | | ECG = electrocardiogram | | MACE = major adverse cardiac events | | MI = myocardial infarction | | MLD = minimal lumen diameter | | PCI = percutaneous coronary intervention | | RT = rheolytic thrombectomy | | SPECT = single-photon emission computed tomography | | STEMI = ST-segment elevation myocardial infarction | | SVG = saphenous vein graft | | TIMI = Thrombolysis In Myocardial Infarction | | TLR = target lesion revascularization | | TMP = tissue myocardial perfusion |
|
This article has been cited by other articles:
|
|
|
|
 
I. Kranjec, A. Cerne, and M. Noc
Ephedrine-Induced Acute Myocardial Infarction in a Young Athlete: A Case of Thrombus Management
Angiology,
April 1, 2009;
60(2):
254 - 258.
[Abstract]
[PDF]
|
|
|
|
|
|
|
M. Srinivasan, C. Rihal, D. R. Holmes, and A. Prasad
Adjunctive Thrombectomy and Distal Protection in Primary Percutaneous Coronary Intervention: Impact on Microvascular Perfusion and Outcomes
Circulation,
March 10, 2009;
119(9):
1311 - 1319.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Napodano, A. Ramondo, G. Tarantini, D. Peluso, S. Compagno, C. Fraccaro, A. C. Frigo, R. Razzolini, and S. Iliceto
Predictors and time-related impact of distal embolization during primary angioplasty
Eur. Heart J.,
February 1, 2009;
30(3):
305 - 313.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
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
Eur. Heart J.,
December 2, 2008;
29(24):
3002 - 3010.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. A. Bavry, D. J. Kumbhani, and D. L. Bhatt
Role of adjunctive thrombectomy and embolic protection devices in acute myocardial infarction: a comprehensive meta-analysis of randomized trials
Eur. Heart J.,
December 2, 2008;
29(24):
2989 - 3001.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. C.A. Kramer, A. C. van der Wal, K. T. Koch, J. P.H.M. Ploegmakers, R. J. van der Schaaf, J. P.S. Henriques, J. Baan Jr, S. Z.H. Rittersma, M. M. Vis, J. J. Piek, et al.
Presence of Older Thrombus Is an Independent Predictor of Long-Term Mortality in Patients With ST-Elevation Myocardial Infarction Treated With Thrombus Aspiration During Primary Percutaneous Coronary Intervention
Circulation,
October 28, 2008;
118(18):
1810 - 1816.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
Y. Ikari, M. Sakurada, K. Kozuma, S. Kawano, T. Katsuki, K. Kimura, T. Suzuki, T. Yamashita, A. Takizawa, K. Misumi, et al.
Upfront Thrombus Aspiration in Primary Coronary Intervention for Patients With ST-Segment Elevation Acute Myocardial Infarction: Report of the VAMPIRE (VAcuuM asPIration thrombus REmoval) Trial
J. Am. Coll. Cardiol. Intv.,
August 1, 2008;
1(4):
424 - 431.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
G. W. Stone
Angioplasty Strategies in ST-Segment-Elevation Myocardial Infarction: Part II: Intervention After Fibrinolytic Therapy, Integrated Treatment Recommendations, and Future Directions
Circulation,
July 29, 2008;
118(5):
552 - 566.
[Full Text]
[PDF]
|
|
|
|
|
|
|
T. Chechi, S. Vecchio, G. Vittori, G. Giuliani, A. Lilli, G. Spaziani, L. Consoli, G. Baldereschi, G. G.L. Biondi-Zoccai, I. Sheiban, et al.
ST-segment elevation myocardial infarction due to early and late stent thrombosis a new group of high-risk patients.
J. Am. Coll. Cardiol.,
June 24, 2008;
51(25):
2396 - 2402.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
B. F. Uretsky, F.-P. Mongeon, M. J. Eisenberg, S. Rinfret, H. Tomoda, N. Izumi, N. Aoki, J. L. Amato Jr., F. E. Shamoon, J. I. Haft, et al.
Thrombus Aspiration during Primary Percutaneous Coronary Intervention
N. Engl. J. Med.,
June 12, 2008;
358(24):
2639 - 2641.
[Full Text]
[PDF]
|
|
|
|
|
|
|
E. R. Bates
Aspirating and Filtering Atherothrombotic Debris During Percutaneous Coronary Intervention
J. Am. Coll. Cardiol. Intv.,
June 1, 2008;
1(3):
265 - 267.
[Full Text]
[PDF]
|
|
|
|
|
|
|
H. Kelbaek, C. J. Terkelsen, S. Helqvist, J. F. Lassen, P. Clemmensen, L. Klovgaard, A. Kaltoft, T. Engstrom, H. E. Botker, K. Saunamaki, et al.
Randomized comparison of distal protection versus conventional treatment in primary percutaneous coronary intervention: the drug elution and distal protection in ST-elevation myocardial infarction (DEDICATION) trial.
J. Am. Coll. Cardiol.,
March 4, 2008;
51(9):
899 - 905.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. A Gorog and I. Malik
Clot removal in AMI--worth the hassle?
Heart,
March 1, 2008;
94(3):
258 - 259.
[Full Text]
[PDF]
|
|
|
|
|
|
|
K. E. Kip, K. Hollabaugh, O. C. Marroquin, and D. O. Williams
The Problem With Composite End Points in Cardiovascular Studies The Story of Major Adverse Cardiac Events and Percutaneous Coronary Intervention.
J. Am. Coll. Cardiol.,
February 19, 2008;
51(7):
701 - 707.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
T. Svilaas, P. J. Vlaar, I. C. van der Horst, G. F.H. Diercks, B. J.G.L. de Smet, A. F.M. van den Heuvel, R. L. Anthonio, G. A. Jessurun, E.-S. Tan, A. J.H. Suurmeijer, et al.
Thrombus Aspiration during Primary Percutaneous Coronary Intervention
N. Engl. J. Med.,
February 7, 2008;
358(6):
557 - 567.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
W. F. Fearon, M. Shah, M. Ng, T. Brinton, A. Wilson, J. A. Tremmel, I. Schnittger, D. P. Lee, R. H. Vagelos, P. J. Fitzgerald, et al.
Predictive value of the index of microcirculatory resistance in patients with ST-segment elevation myocardial infarction.
J. Am. Coll. Cardiol.,
February 5, 2008;
51(5):
560 - 565.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
I. Kusama, K. Hibi, M. Kosuge, N. Nozawa, H. Ozaki, H. Yano, S. Sumita, K. Tsukahara, J. Okuda, T. Ebina, et al.
Impact of Plaque Rupture on Infarct Size in ST-Segment Elevation Anterior Acute Myocardial Infarction
J. Am. Coll. Cardiol.,
September 25, 2007;
50(13):
1230 - 1237.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. J. Gibbons, P. A. Araoz, and E. E. Williamson
The Year in Cardiac Imaging
J. Am. Coll. Cardiol.,
September 4, 2007;
50(10):
988 - 1003.
[Full Text]
[PDF]
|
|
|
|
|
|
|
G. Sianos, M. I. Papafaklis, J. Daemen, S. Vaina, C. A. van Mieghem, R. T. van Domburg, L. K. Michalis, and P. W. Serruys
Angiographic Stent Thrombosis After Routine Use of Drug-Eluting Stents in ST-Segment Elevation Myocardial Infarction: The Importance of Thrombus Burden
J. Am. Coll. Cardiol.,
August 14, 2007;
50(7):
573 - 583.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. R. Dixon, C. L. Grines, and W. W. O'Neill
The Year in Interventional Cardiology
J. Am. Coll. Cardiol.,
July 17, 2007;
50(3):
270 - 285.
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. Mandava and T. A. Kent
Intra-arterial therapies for acute ischemic stroke
Neurology,
June 12, 2007;
68(24):
2132 - 2139.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. J. Piek
Beyond Epicardial Reperfusion
N. Engl. J. Med.,
May 3, 2007;
356(18):
1880 - 1882.
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. I. Worthley and S. G. Worthley
Is thrombus aspiration the appropriate "remedy"?
J. Am. Coll. Cardiol.,
April 17, 2007;
49(15):
1670 - 1670.
[Full Text]
[PDF]
|
|
|
|
|
|
|
F. Burzotta, F. Crea, and L. Galiuto
Reply.
J. Am. Coll. Cardiol.,
April 17, 2007;
49(15):
1671 - 1671.
[Full Text]
[PDF]
|
|
|
|
|
|
|
Thrombectomy: No Benefit in Primary PCI
Journal Watch Cardiology,
August 30, 2006;
2006(830):
4 - 4.
[Full Text]
|
|
|
|
