Distal protection device protects microvascular integrity during primary percutaneous intervention in acute myocardial infarction: A prospective, randomized, multicenter trial
ABSTRACT 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.
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ABSTRACT: A growing amount of data is increasingly showing the relevance of coronary microvascular dysfunction (CMVD) in several clinical contexts. This article reviews techniques and clinical investigations of the main noninvasive and invasive methods proposed to study coronary microcirculation and to identify CMVD in the presence of normal coronary arteries, also trying to provide indications for their application in clinical practice.Journal of Cardiovascular Medicine 01/2013; 14(1):1-18. DOI:10.2459/JCM.0b013e328351680f · 1.41 Impact Factor
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ABSTRACT: We evaluated a hypothesis that thrombus aspiration with distal protection is superior to simple thrombus aspiration in patients treated with primary percutaneous coronary intervention (PCI). A total of 176 consecutive patients with ST-segment elevation myocardial infarction were enrolled in this study and assigned to either the thrombus aspiration group (A, n = 104) or the thrombus aspiration with distal protection group using a filter device system (A + DP, n = 72). We compared the angiographic reperfusion grade, left ventricular (LV) function, and clinical outcomes between the 2 groups. There were no significant differences in age, gender distribution, the onset-to-reperfusion time, the peak levels of creatine kinase, or 6-month mortality between the 2 groups. The rate of achieving a Thrombolysis In Myocardial Infarction flow grade of 3 and a myocardial blush grade of 3 was higher in the A + DP group than in the A group. Among the patients who underwent follow-up catheterization 6 months after PCI (A, n = 62; A + DP, n = 52), there were no significant differences in the LV end-diastolic volume index, LV end-systolic volume index, or LV ejection fraction between the 2 groups at the time of PCI or 6 months after PCI. In conclusion, thrombus aspiration with distal protection may be more effective in initially restoring the coronary blood flow than thrombus aspiration alone, although it may not be superior to thrombus aspiration in preventing LV remodeling or preserving the LV function in patients with ST-segment elevation myocardial infarction.The American journal of cardiology 09/2013; 112(11). DOI:10.1016/j.amjcard.2013.07.039 · 3.43 Impact Factor
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ABSTRACT: The use of embolic protection devices to decrease major adverse cardiac events (MACEs) in patients with saphenous vein graft lesions is considered class I therapy by the recent practice guidelines. However, the benefits of adjunctive protection devices to prevent distal embolization in patients with native coronary artery lesions are still a matter of debate. Therefore, we performed the meta-analysis to determine whether the use of distal protection devices during revascularization can improve myocardial perfusion and reduce the occurrence of MACEs compared with primary percutaneous coronary intervention (PCI) alone. Studies were identified in English-language articles by search of Medline and Embase database (inception to December 2011). A total of 15 prospective randomized controlled trials involving 2783 patients were included for analysis (1378 patients in the distal protection device group and 1405 cases in the control group). Overall, adjunctive embolic protection was associated with significantly improved postprocedural TIMI 3 (thrombolysis in myocardial infarction 3) flow (OR 1.71; 95% CI 1.13-2.57; P = 0.01) and MBG 3 (myocardial blush grade 3) (OR 1.50; 95% CI 1.09-2.07; P = 0.01), whereas the overall MACEs analysis demonstrated that a nonsignificant trend was observed toward better clinical outcomes associated with adjunctive protection devices at 1 month (OR 0.80; 95% CI 0.55-1.15; P = 0.23) and at 6 months (OR 0.80; 95% CI 0.55-1.17; P = 0.24). When stratified by MACEs, no statistical differences were found among mortality, reinfarction, and target vessel revascularization (TVR), respectively. The meta-analysis indicated an improvement of myocardial perfusion in AMI patients treated with adjunctive protection devices. However, a nonsignificant trend was observed toward a lower risk of MACEs in the distal protection device group when compared with the control group.Current Medical Research and Opinion 04/2012; 28(6):871-6. DOI:10.1185/03007995.2012.686445 · 2.37 Impact Factor