CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY
Thrombus Aspiration Before Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction
The DEAR-MI (Dethrombosis to Enhance Acute Reperfusion in Myocardial Infarction) Study
Pedro Silva-Orrego, MD*,*,
Paola Colombo, MD, PhD*,
Riccardo Bigi, MD ,
Dario Gregori, MA, PhD ,
Anabella Delgado, MD*,
Paolo Salvade, MD*,
Jacopo Oreglia, MD*,
Paola Orrico, RN*,
Anna de Biase, MD*,
Giacomo Piccalò, MD*,
Irene Bossi, MD* and
Silvio Klugmann, MD*
* Interventional Cardiology, A. De Gasperis Department, Niguarda Hospital, Milan, Italy
Cardiology, Department of Medicine and Surgery, University School of Medicine, Milan, Italy
Department of Public Health and Microbiology, University of Turin, Turin, Italy
Manuscript received December 2, 2005;
revised manuscript received March 7, 2006,
accepted March 7, 2006.
* Reprint requests and correspondence: Dr. Pedro Silva-Orrego, Interventional Cardiology, A. De Gasperis Department, Niguarda Hospital, piazza Ospedale Maggiore 3, 20162 Milan, Italy. (Email: pedrosilva{at}tiscali.it).
OBJECTIVES: This study sought to test the hypothesis that thrombus removal, with a new manual thrombus-aspirating device, before primary percutaneous coronary intervention (PPCI) may improve myocardial reperfusion compared with standard PPCI in patients with ST-segment elevation acute myocardial infarction (STEMI).
BACKGROUND: In STEMI patients, PPCI may cause thrombus dislodgment and impaired microcirculatory reperfusion. Controversial results have been reported with different systems of distal protection or thrombus removal.
METHODS: One-hundred forty-eight consecutive STEMI patients, admitted within 12 h of symptom onset and scheduled for PPCI, were randomly assigned to PPCI (group 1) or manual thrombus aspiration before standard PPCI (group 2). Patients with cardiogenic shock, previous infarction, or thrombolytic therapy were excluded. Primary end points were complete (>70%) ST-segment resolution (STR) and myocardial blush grade (MBG) 3.
RESULTS: Baseline clinical and angiographic characteristics were similar in the 2 groups. Comparing groups 1 and 2: complete STR 50% versus 68% (p < 0.05); MBG-3 44% versus 88% (p < 0.0001); coronary Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 78% versus 89% (p = NS); corrected TIMI frame count 21.5 ± 12 versus 17.3 ± 6 (p < 0.01); no reflow 15% versus 3% (p < 0.05); angiographic embolization 19% versus 5% (p < 0.05); direct stenting 24% versus 70% (p < 0.0001); and peak creatine kinase-mass band fraction 910 ± 128 µg/l versus 790 ± 132 µg/l (p < 0001). In-hospital clinical events were similar in the 2 groups. After adjusting for confounding factors, multivariate analysis showed thrombus aspiration to be an independent predictor of complete STR and MBG-3.
CONCLUSIONS: Manual thrombus aspiration before PPCI leads to better myocardial reperfusion and is associated with lower creatine kinase mass band fraction release, lower risk of distal embolization, and no reflow compared with standard PPCI. (Thrombus Aspiration Before Standard Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction; http://clinicaltrials.gov/ct/show/NCT00257153).
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Abbreviations and Acronyms
| | CI = confidence interval | | CK-MB = creatine kinase mass band fraction | | ECG = electrocardiogram | | IRA = infarct-related artery | | MBG = myocardial blush grade | | PPCI = primary percutaneous coronary intervention | | STmax = maximal ST-segment elevation | | STEMI = ST-segment elevation acute myocardial infarction | | STR = ST-segment resolution | | TIMI = Thrombolysis In Myocardial Infarction |
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