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This is a Comparative Effectiveness Review examining the benefits to harms of adjunctive devices to remove thrombi or protect against embolization in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) of native vessels.
MEDLINE®, Cochrane Database, and abstracts from major cardiology meetings were searched from 1996 through March 2011, as were www.clinicaltrials.gov and references from identified citations.
Randomized controlled trials (RCTs), controlled observational studies enrolling ≥500 patients, and systematic reviews were eligible for inclusion. Data amenable to meta-analysis were pooled as relative risks (RRs) with accompanying 95-percent confidence intervals using a random-effects model.
A total of 175 articles were included. Three direct comparative RCTs were identified comparing catheter aspiration with distal balloon protection devices or other catheter aspiration devices; they showed no significant differences for evaluated outcomes. The data comparing adjunctive devices with standard PCI (control) are predominantly in patients with ST-segment elevation myocardial infarction (STEMI).
In RCTs conducted in STEMI patients, catheter aspiration devices decreased the risk of a major adverse cardiovascular event (MACE) [RR 0.73 (0.61-0.88)] versus control. Catheter aspiration devices increased the achievement of ST-segment resolution [RR 1.51 (1.32-1.73)], myocardial blush grade of 3 (MBG-3) [RR 1.61 (1.41-1.84)], and thrombolysis in myocardial infarction (TIMI) 3 flow [RR 1.08 (1.04-1.12)], while reducing distal embolization [RR 0.56 (0.39-0.79)], no reflow [RR 0.52 (0.35-0.76)], and coronary dissection [RR 0.30 (0.12-0.75)] versus control. Other final health and intermediate outcomes were not significantly impacted by catheter aspiration devices versus control. In a majority of trials, the use of catheter aspiration devices increased procedural time upon qualitative assessment.
Distal filter embolic protection devices increased the risk of target revascularization [RR 1.61 (1.03-2.54)], although the use of mechanical thrombectomy or embolic protection devices did not significantly impact other final health outcomes or harms in RCTs. Qualitative assessment indicated that procedure time was increased versus control. Distal balloon or any embolic protection device increased the achievement of MBG-3 [RR 1.39 (1.15-1.69) and RR 1.20 (1.02-1.40), respectively] and TIMI-3 flow [RR 1.11 (1.03-1.19) and RR 1.06 (1.01-1.12), respectively] but did not significantly impact other intermediate outcomes versus control. Mechanical thrombectomy, distal filter, or proximal balloon embolic protection devices did not significantly impact any of the intermediate outcomes evaluated versus control. The associations between predetermined factors and outcomes in people receiving adjunctive devices were generally insufficient.
For most devices, there are few RCTs evaluating final health outcomes over a long period of followup, and furthermore the data outside of STEMI are scarce. Due to insufficient data, the safety of these devices is unclear.
Sobieraj DM, White CM, Kluger J, et al. Systematic review: comparative effectiveness of adjunctive devices in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention of native vessels. BMC Cardiovasc Disord 2011 Dec 20;11(1):74 [Epub ahead of print]. PMID: 22185559.