Distal protection device protects microvascular integrity during primary percutaneous intervention in acute myocardial infarction: A prospective, randomized, multicenter trial
Department of Cardiology, Ajou University School of Medicine, San 5 Wonchun-dong, Yeongtong-gu, Suwon, 443-721, Republic of Korea. International journal of cardiology
(Impact Factor: 4.04).
02/2008; 123(2):162-8. DOI: 10.1016/j.ijcard.2007.03.124
Distal protection during primary angioplasty in acute myocardial infarction (AMI) is the subject of recent controversy. The present study was designed to determine whether the distal embolic protection preserves myocardial microvascular integrity and improves clinical outcomes in patients with AMI.
A total of 116 AMI patients presenting within 12 h of onset of symptoms were enrolled at 7 angioplasty centers. They were randomly assigned to either primary angioplasty with distal protection group (DP; n=60) or angioplasty alone group (Controls; n=56).
After primary angioplasty, achievement of final Thrombolysis In Myocardial Infarction (TIMI) grade 3 and TIMI Myocardial Perfusion (TMP) grade 3 were more frequent in the DP group than in the control group [58/60 (96%) vs. 43/56 (81%), p=0.016; and 39/60 (65%) vs. 20/56 (38%), p=0.001, respectively]. After primary angioplasty, the baseline and hyperemic averaged peak velocities were significantly higher (23.2+/-11.5 vs. 18.0+/-6.9 cm/s, p=0.029; and 39.2+/-16.7 vs. 30.6+/-10.8 cm/s, p=0.014, respectively) and the baseline and hyperemic microvascular resistance indices were significantly lower (4.18+/-2.22 vs. 5.34+/-2.25 mm Hg cm(-1) s, p=0.036; and 2.38+/-1.39 vs. 3.11+/-1.32 mm Hg cm(-1) s, p=0.030, respectively) in the DP group. Patients in the DP group showed more favorable phasic coronary flow pattern in diastolic deceleration time (679+/-262 vs. 519+/-289 ms, p=0.035; and 751+/-246 vs. 616+/-269 ms, p=0.035, respectively). Major adverse cardiac events at 6 months occurred with similar frequency in both groups (8.7% vs. 11.1%, p=0.400).
Distal protection device effectively preserves microvascular integrity during primary angioplasty in AMI. Distal protection, however, did not improve clinical outcomes.
Available from: Ajibade Ashaye
- "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  (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.
Available from: circ.ahajournals.org
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ABSTRACT: Prevention of embolization and microvascular obstruction is vital to the management of acute atherosclerotic vascular disease. Emboli protection devices are needed that will provide optimal procedural efficacy and cause minimal or no provocation ofembolization during use.
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ABSTRACT: Several randomized trials and meta-analyses have shown that primary angioplasty is superior to thrombolysis in the treatment of ST-segment elevation myocardial infarction (MI) in terms of death, reinfarction, and stroke. However, primary angioplasty should be regarded as the preferred strategy as long as it can not be applied with a reasonable time delay to treatment, as compared with the administration of thrombolysis. In fact, time-to-treatment has been shown to be a determinant of survival not only for thrombolysis but also for primary angioplasty. Recent guidelines consider a time from first medical contact to PCI of 90 minutes or a PCI-related delay of 60 minutes as reasonable cutoffs to identify the best reperfusion strategy. The beneficial effects of primary angioplasty could be expected particularly after the first 3 hours from symptom onset, when thrombolysis, particularly streptokinase, may be less effective, whereas within the first 3 hours, thrombolysis (started in the prehospital setting, preferably) may represent a valid therapeutic option. Because the survival benefits of primary angioplasty depends on the patient's risk profile and timely application of reperfusion, we would suggest, among patients in the first hours from symptom onset, a strategy of early pharmacologic reperfusion and transfer to primary PCI centers, where the decision of performing angiography acutely may be based on the assessment of myocardial reperfusion and risk profile, whereas after the first 3 hours from symptoms onset, primary angioplasty should be considered the preferred strategy if applicable, particularly in regions when streptokinase still represents the only available lytic therapy. However, even though primary angioplasty is able to achieve thrombolysis and TIMI 3 flow in most patients, a still relevant proportion of patients experience poor myocardial reperfusion, with negative impact on acute and long-term survival. The use of platelet glycoprotein IIb/IIIa complex inhibitors has significantly improved survival, with additional benefits obtained by early administration aiming at early reperfusion, which are to be recommended, particularly among high-risk patients and those presenting within the first hours from symptom onset. The use of adjunctive mechanical devices has reduced the incidence of distal embolization without any apparent benefit in survival. Until the results of larger randomized trials become available, these devices may be considered in patients at high risk for distal embolization, such as those with large thrombotic burden. The use of coronary stenting has significantly reduced restenosis, as compared with balloon angioplasty. Several randomized trials have recently been conducted on drug-eluting stents in ST-segment elevation MI, showing the safety and significant benefits of these devices in terms of restenosis, as compared with bare metal stents (BMSs). However, because of unpredictable compliance to long-term double oral antiplatelet therapy in acute patients, caution should be taken with extensive use of drug-eluting stents in primary angioplasty.
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