6 research outputs found
Updated evidence on intracoronary abciximab in ST-elevation myocardial infarction: A systematic review and meta-analysis of randomized clinical trials
Abstract
Background: Intracoronary (IC) abciximab administration remains a promising approach
aimed to increase a drug concentration in the target area and possibly improve clinical
outcomes in the setting of ST-segment elevation myocardial infarction (STEMI). The goal of
this literature review and meta-analysis is to update available knowledge comparing IC and
intravenous (IV) abciximab administration in STEMI patients.
Methods: A total of 7 randomized clinical trials (RCTs) with a median follow-up of 3 months
were included in the meta-analysis (n = 3311). All-cause mortality was selected as the primary
end point while recurrent myocardial infarction (re-MI), target vessel revascularization (TVR)
and major bleeding complications were the secondary end points.
Results: IC abciximab did not provide any benefits in terms of all-cause mortality as compared
with IV abciximab (odds ratio [OR] 0.67; 95% confidence interval [CI] 0.34 1.34). However,
this neutral effect was driven by the AIDA STEMI trial. The IC route was associated with a
reduced rate of re-MI when compared with IV administration (OR 0.61; 95% CI 0.40 0.92)
but the difference disappeared after one of the RCTs was excluded from the analysis. Both
strategies were equal regarding TVR (OR 0.66; 95% CI 0.40 1.09) and major bleeding
complications (OR 1.18; 95% CI 0.76 1.83).
Conclusions: Our updated meta-analysis shows that the clinical superiority of IC over IV
abciximab administration in STEMI patients is no longer clear after the release of the AIDA
STEMI trial results. Further research in high-risk STEMI patients is warranted to finally
determine clinical advantages of IC vs IV abciximab administration. (Cardiol J 2012; 19, 3:230 242
Low-molecular-weight heparins vs. unfractionated heparin in the setting of percutaneous coronary intervention for ST-elevation myocardial infarction: a meta-analysis
Summary. Background: The aim of the current study was to
perform two separate meta-analyses of available studies
comparing low-molecular-weight heparins (LMWHs) vs.
unfractionated heparin (UFH) in ST-elevation myocardial
infarction (STEMI) patients treated (i) with primary percutaneous
coronary intervention (pPCI) or (ii) with PCI after
thrombolysis. Methods: All-cause mortality was the prespecified
primary endpoint and major bleeding complications
were recorded as the secondary endpoints. Relative risk (RR)
with a 95%confidence interval (CI) and absolute risk reduction
(ARR) were chosen as the effect measure. Results: Ten studies
comprising 16 286 patients were included. The median followup
was 2 months for the primary endpoint. Among LMWHs,
enoxaparin was the compound most frequently used. In the
pPCI group, LMWHs were associated with a reduction in
mortality [RR (95% CI) = 0.51 (0.41–0.64), P < 0.001,
ARR = 3%] and major bleeding [RR (95% CI) = 0.68
(0.49–0.94), P = 0.02, ARR = 2.0%] as compared with
UFH. Conversely, no clear evidence of benefits with LWMHs
was observed in the PCI group after thrombolysis. Metaregression
showed that patients with a higher baseline risk had
greater benefits from LMWHs (r = 0.72, P = 0.02). Conclusions:
LMWHs were associated with greater efficacy and safety
than UFH in STEMI patients treated with pPCI, with a
significant relationship between risk profile and clinical benefits.
Based on this meta-analysis, LMWHs may be considered as a
preferred anticoagulant among STEMI patients undergoing
pPCI
Drug-coated balloons in treatment of in-stent restenosis: a meta-analysis of randomised controlled trials
Background Drug-coated balloons (DCBs) have been
developed for the percutaneous treatment of coronary
artery disease. An initial focus has been the management of
in-stent restenosis (ISR) but randomised controlled trials
(RCTs) have been small and powered only for angiographic
endpoints.
Objective The aim of the work was to assess the clinical
and angiographic outcomes of patients treated for ISR with
DCB versus control (balloon angioplasty or drug-eluting
stents) by a meta-analysis of RCTs.
Methods A comprehensive search was performed of
RCTs where patients with ISR were randomly assigned to
either DCB or alternative coronary intervention. Outcome
measurements were death, myocardial infarction (MI),
target lesion revascularisation (TLR), binary definition of
restenosis and in-lesion late luminal loss (LLL).
Results Four studies were identified that fulfilled the
inclusion criteria. Pooled odds ratios (ORs) were calculated
for patients treated for ISR (n = 399). Mean follow-up
duration was 14.5 months. DCBs were associated with
lower rates of TLR [8.8 vs. 29.7 % OR (95 % confidence
interval, CI) 0.20 (0.11–0.36), p\0.0001], binary restenosis
[10.3 vs. 41.3 % OR (95 % CI) 0.13 (0.07–0.24),
p\0.00001] and MI [0.5 vs. 3.8 %, OR (95 % CI) 0.21
(0.04–1.00), p = 0.05]. No significant heterogeneity was
identified.
Conclusion Drug-coated balloons appear to be effective
versus control in reducing TLR and possibly MI versus
balloon angioplasty or drug-eluting stents in the management
of ISR
Optimal Timing of Coronary Invasive Strategy in Non–ST-Segment Elevation Acute Coronary Syndromes
Background: The optimal timing of coronary intervention in patients
with non–ST-segment elevation acute coronary syndromes
(NSTE-ACSs) is a matter of debate. Conflicting results among published
studies partly relate to different risk profiles of the studied
populations.
Purpose: To do the most comprehensive meta-analysis of current
evidence on early versus delayed invasive treatment in NSTE-ACS.
Data Sources: MEDLINE, PubMed Central, and Google Scholar
databases; conference proceedings; ClinicalTrials.gov registry; and
Current Controlled Trials registry through May 2012.
Study Selection: Available randomized, controlled trials (RCTs) and
observational studies comparing early versus delayed intervention in
the NSTE-ACS population.
Data Extraction: Data were extracted for populations, interventions,
outcomes, and risk of bias. All-cause mortality was the prespecified
primary end point. The longest follow-up available in each
study was chosen. The odds ratio with 95% CI was the effect
measure.
Data Synthesis: Seven RCTs (5370 patients) and 4 observational
studies (77 499 patients) were included. Early intervention was less
than 20 hours after hospitalization or randomization for RCTs and
24 hours or less for observational studies. Meta-analysis of the
RCTs was inconclusive for a survival benefit associated with the
early invasive strategy (odds ratio, 0.83 [95% CI, 0.64 to 1.09];
P 0.180); a similar result emerged from the observational studies.
With early versus late intervention, the odds ratios in the RCTs
were 1.15 (CI, 0.65 to 2.01; P 0.63) and 0.76 (CI, 0.56 to 1.04;
P 0.090) for myocardial infarction and major bleeding during
follow-up, respectively.
Limitation: Current evidence from RCTs is limited by the small
overall sample size, low numbers of events in some trials, and
heterogeneity in the timing of intervention and in patient risk
profiles.
Conclusion: At present, there is insufficient evidence either in favor
of or against an early invasive approach in the NSTE-ACS population.
A more definitive RCT is warranted to guide clinical practice.
Primary Funding Source: None
Low-dose of oral factor Xa inhibitors in patients with a recent acute coronary syndrome: A systematic review and meta-analysis of randomized trials
BACKGROUND:
Recently, randomized controlled trials (RCTs) have shown that therapy with new oral activated factor X (Xa) inhibitors in acute coronary syndrome (ACS) yielded a reduction of ischemic events. However, this therapy was associated with a dose-related increase in major bleeding complications. We aimed to perform a systematic review and meta-analysis to appraise the clinical efficacy and safety of the lowest doses of oral factor Xa inhibitors compared with placebo in patients after a recent ACS.
METHODS:
The primary endpoint was cardiovascular mortality. The rate of new myocardial infarction (MI) was the secondary efficacy endpoint, whereas major bleeding complications were recorded as a safety endpoint. Five RCTs were included in the meta-analysis enrolling a total of 25,643 patients.
RESULTS:
There was no significant difference in mortality between patients treated with new antithrombotics compared with those receiving the standard therapy: odds ratio (OR), [95% confidence interval (CI)] = 0.97 [0.72-1.31], p = 0.86. Recurrent MI rates were decreased in the anti-Xa group: OR [95%CI] = 0.86 [0.76-0.98], p = 0.02, number needed to treat (NNT) = 189. The administration of new oral anticoagulants was associated with a strongly increased risk of major bleedings compared with the standard treatment: OR [95%CI] = 3.24 [2.29-4.59], p < 0.001, number needed to harm (NNH) = 104; similarly, intracranial bleeding rates were significantly higher in the anti-Xa arm.
CONCLUSIONS:
The addition of the new oral anticoagulants on top of standard therapy in the setting of ACS results in an excessive risk of major bleedings without any clear evidence of outweighing clinical benefits