Background: During percutaneous coronary intervention (PCI), dislodgement of atherothrombotic material from\r\ncoronary lesions can result in distal embolization, and may lead to increased major adverse cardiovascular events\r\n(MACE) and mortality. We sought to systematically review the comparative effectiveness of adjunctive devices to\r\nremove thrombi or protect against distal embolization in patients with ST-segment elevation myocardial infarction\r\n(STEMI) undergoing PCI of native vessels.\r\nMethods: We conducted a systematic literature search of Medline, the Cochrane Database, and Web of Science\r\n(January 1996-March 2011), http://www.clinicaltrials.gov, abstracts from major cardiology meetings, TCTMD, and\r\nCardioSource Plus. Two investigators independently screened citations and extracted data from randomized\r\ncontrolled trials (RCTs) that compared the use of adjunctive devices plus PCI to PCI alone, evaluated patients with\r\nSTEMI, enrolled a population with 95% of target lesion(s) in native vessels, and reported data on at least one prespecified\r\noutcome. Quality was graded as good, fair or poor and the strength of evidence was rated as high,\r\nmoderate, low or insufficient. Disagreement was resolved through consensus.\r\nResults: 37 trials met inclusion criteria. At the maximal duration of follow-up, catheter aspiration devices plus PCI\r\nsignificantly decreased the risk of MACE by 27% compared to PCI alone. Catheter aspiration devices also\r\nsignificantly increased the achievement of ST-segment resolution by 49%, myocardial blush grade of 3 (MBG-3) by\r\n39%, and thrombolysis in myocardial infarction (TIMI) 3 flow by 8%, while reducing the risk of distal embolization\r\nby 44%, no reflow by 48% and coronary dissection by 70% versus standard PCI alone. In a majority of trials, the use\r\nof catheter aspiration devices increased procedural time upon qualitative assessment.\r\nDistal filter embolic protection devices significantly increased the risk of target revascularization by 39% although\r\nthe use of mechanical thrombectomy or embolic protection devices did not significantly impact other final health\r\noutcomes. Distal balloon or any embolic protection device increased the achievement of MBG-3 by 61% and 20%\r\nand TIMI3 flow by 11% and 6% but did not significantly impact other intermediate outcomes versus control. Upon\r\nqualitative analysis, all device categories, with exception of catheter aspiration devices, appear to significantly\r\nprolong 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\r\nunclear due to insufficient amounts of data.\r\nConclusions: In patients with STEMI, for most devices, few RCTs evaluated final health outcomes over a long\r\nperiod of follow-up. Due to insufficient data, the safety of these devices is unclear.
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