Article

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

Department of Cardiology, Tokai University School of Medicine, Isehara, Japan.
JACC. Cardiovascular Interventions (Impact Factor: 7.44). 08/2008; 1(4):424-31. DOI: 10.1016/j.jcin.2008.06.004
Source: PubMed

ABSTRACT This study evaluated safety and efficacy of upfront thrombus aspiration during primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI).
Distal embolization during primary PCI results in reduced myocardial perfusion and poor clinical outcomes.
The VAMPIRE (VAcuuM asPIration thrombus REmoval) study was a prospective, randomized, controlled multicenter trial conducted in 23 institutions. Patients (N = 355) presenting within 24 h of STEMI symptoms onset were randomized to primary PCI with (n = 180) or without (n = 175) upfront thrombus aspiration using Nipro's TransVascular Aspiration Catheter (Osaka, Japan).
The TransVascular Aspiration Catheter reached the lesion in 100% of cases. It successfully crossed the target obstruction in 86% without any delay in procedure time or time to reperfusion; whereas macroscopic thrombi were removed in 75% of the cases. Procedure success was similar between groups (98.9% vs. 98.3%). There was a trend toward lower incidence of slow or no reflow (primary end point-defined as a Thrombolysis In Myocardial Infarction flow grade <3) in patients treated with aspiration versus conventional primary PCI (12.4% vs. 19.4%, p = 0.07). Rate of myocardial blush grade 3 was higher in the aspiration group (46.0% vs. 20.5%, p < 0.001). Aspiration was most effective in patients presenting after 6 h of symptoms onset (slow flow rate: 8.1% vs. 37.6%, p = 0.01).
This study suggested the safety of primary PCI with upfront thrombectomy using a novel device in patients with STEMI. The study showed a trend toward improved myocardial perfusion and lower clinical events in patients treated with aspiration. Patients presenting late after STEMI appear to benefit the most from thrombectomy.

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Available from: Ken Kozuma, Aug 28, 2015
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    • "This meta-analysis included only two small studies of MT, using AngioJet [18], and X-Sizer [27]. Another two studies registered as MT in this meta-analysis, used the TVAC, (Nipro's TransVascular Aspiration Catheter, Osaka, Japan), which is a single lumen aspiration catheter with a dedicated vacuum pump [28], and the Rescue catheter (Boston Scientific), which is an aspiration catheter [29]. On the contrary, the latest Bayesian meta-analysis of 16 AT trials and 5 MT trials (4299 patients), that reported separately the aspiration results, showed that thrombectomy in general is associated only with improved surrogate procedural end-points, with equipoise results between AT and MT [16]. "
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    ABSTRACT: Primary percutaneous coronary intervention, (pPCI), of native coronaries and saphenous vein grafts (SVGs), is the recommended reperfusion strategy for STEMI, and an early invasive approach is recommended for high risk patients with UA/NSTEMI. Although PCI effectively restores flow in the infarct related artery/culprit vessel in both situations, myocardial perfusion often remains suboptimal due to microvascular obstruction, partly attributed to distal embolization of thrombus. Hence, thrombectomy (manual or mechanical), prior to stenting may further reduce hard clinical end points in patients with ACS. This article discusses accumulated evidence regarding the safety and effectiveness of thrombectomy in culprit native coronaries and SVGs in such patients, as well as possible strategies for maximizing its benefits relative to the size of the thrombotic burden.
    Current Cardiology Reviews 08/2012; 8(3). DOI:10.2174/157340312803217265
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    • "All RCTs compared an adjunctive device plus PCI to standard PCI alone. Compared to standard PCI, 17 trials evaluated catheter aspiration devices [8-12,15-17,21-30] (n = 3355; 11 good, 3 fair and 3 poor quality trials), 5 trials evaluated mechanical thrombectomy devices [7,31-34] (n = 1374; 5 good quality), 9 trials evaluated distal balloon embolic protection devices [13,35-42] (n = 1479; 8 good and 1 fair quality), 5 trials evaluated distal filter embolic protection devices [43-47] (n = 962; 4 good and 1 fair quality), and trial evaluated proximal balloon embolic protection devices [14] (n = 284, good quality). "
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    ABSTRACT: During percutaneous coronary intervention (PCI), dislodgement of atherothrombotic material from coronary lesions can result in distal embolization, and may lead to increased major adverse cardiovascular events (MACE) and mortality. We sought to systematically review the comparative effectiveness of adjunctive devices to remove thrombi or protect against distal embolization in patients with ST-segment elevation myocardial infarction (STEMI) undergoing PCI of native vessels. We conducted a systematic literature search of Medline, the Cochrane Database, and Web of Science (January 1996-March 2011), http://www.clinicaltrials.gov, abstracts from major cardiology meetings, TCTMD, and CardioSource Plus. Two investigators independently screened citations and extracted data from randomized controlled trials (RCTs) that compared the use of adjunctive devices plus PCI to PCI alone, evaluated patients with STEMI, enrolled a population with 95% of target lesion(s) in native vessels, and reported data on at least one pre-specified outcome. Quality was graded as good, fair or poor and the strength of evidence was rated as high, moderate, low or insufficient. Disagreement was resolved through consensus. 37 trials met inclusion criteria. At the maximal duration of follow-up, catheter aspiration devices plus PCI significantly decreased the risk of MACE by 27% compared to PCI alone. Catheter aspiration devices also significantly increased the achievement of ST-segment resolution by 49%, myocardial blush grade of 3 (MBG-3) by 39%, and thrombolysis in myocardial infarction (TIMI) 3 flow by 8%, while reducing the risk of distal embolization by 44%, no reflow by 48% and coronary dissection by 70% versus standard PCI alone. In a majority of trials, the use of catheter aspiration devices increased procedural time upon qualitative assessment.Distal filter embolic protection devices significantly increased the risk of target revascularization by 39% although the use of mechanical thrombectomy or embolic protection devices did not significantly impact other final health outcomes. Distal balloon or any embolic protection device increased the achievement of MBG-3 by 61% and 20% and TIMI3 flow by 11% and 6% but did not significantly impact other intermediate outcomes versus control. Upon qualitative analysis, all device categories, with exception of catheter aspiration devices, appear to significantly prolong procedure time compared to PCI alone while none appear to significantly impact ejection fraction. Many of the final health outcome and adverse event evaluations were underpowered and the safety of devices overall is unclear due to insufficient amounts of data. In patients with STEMI, for most devices, few RCTs evaluated final health outcomes over a long period of follow-up. Due to insufficient data, the safety of these devices is unclear.
    BMC Cardiovascular Disorders 12/2011; 11:74. DOI:10.1186/1471-2261-11-74 · 1.50 Impact Factor
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    • "Our meta-analysis thus included 17 trials that randomized patients with STEMI to thrombectomy versus conventional PCI. Of these, 14 had been published in peer-reviewed journals [11-13,15-23,44,45] while two had been published only as an abstract with information on limited endpoints [25,46]. PIHRATE trial [24] was presented at Transcatheter Cardiovascular Therapeutics meeting and the data was obtained from http://www.tctmd.com "
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    ABSTRACT: Clinical trials comparing thrombectomy devices with conventional percutaneous coronary interventions (PCI) in patients with acute ST elevation myocardial infarction (STEMI) have produced conflicting results. The objective of our study was to systematically evaluate currently available data comparing thrombectomy followed by PCI with conventional PCI alone in patients with acute STEMI. Seventeen randomized trials (n = 3,909 patients) of thrombectomy versus PCI were included in this meta-analysis. We calculated the summary odds ratios for mortality, stroke, post procedural myocardial blush grade (MBG), thrombolysis in myocardial infarction (TIMI) grade flow, and post procedural ST segment resolution (STR) using random-effects and fixed-effects models. There was no difference in risk of 30-day mortality (44/1914 vs. 50/1907, OR 0.84, 95% CI 0.54-1.29, P = 0.42) among patients randomized to thrombectomy, compared with conventional PCI. Thrombectomy was associated with a significantly greater likelihood of TIMI 3 flow (1616/1826 vs. 1533/1806, OR 1.41, P = 0.007), MBG 3 (730/1526 vs. 486/1513, OR 2.42, P < 0.001), STR (923/1500 vs. 715/1494, OR 2.30, P < 0.001), and with a higher risk of stroke (14/1403 vs. 3/1413, OR 2.88, 95% CI 1.06-7.85, P = 0.04). Outcomes differed significantly between different device classes with a trend towards lower mortality with manual aspiration thrombectomy (MAT) (21/949 vs.36/953, OR 0.59, 95% CI 0.35-1.01, P = 0.05), whereas mechanical devices showed a trend towards higher mortality (20/416 vs.10/418, OR 2.07, 95% CI 0.95-4.48, P = 0.07). Thrombectomy devices appear to improve markers of myocardial perfusion in patients undergoing primary PCI, with no difference in overall 30-day mortality but an increased likelihood of stroke. The clinical benefits of thrombectomy appear to be influenced by the device type with a trend towards survival benefit with MAT and worsening outcome with mechanical devices.
    BMC Cardiovascular Disorders 02/2010; 10(1):10. DOI:10.1186/1471-2261-10-10 · 1.50 Impact Factor
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