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Efficacy and safety of short-term dual antiplatelet therapy (≤6 months) after percutaneous coronary intervention for acute coronary syndrome: A systematic review and meta-analysis of randomized controlled trials.

ABSTRACT:

Background

Patients who undergo percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) are at increased risk for subsequent ischemic events.

Hypothesis

Short-term dual antiplatelet therapy (DAPT) (≤6 months) is inferior to standard or long-term DAPT in patients who undergo PCI for ACS events.

Methods

We conducted a systematic review and meta-analysis of randomized controlled trials that compared short-term (≤6 months) to long-term (≥12 months) DAPT after PCI for ACS. We searched MEDLINE, EMBASE, SCOPUS, and the Cochrane Central Register of Controlled Trials database.

Results

Ten randomized controlled trials, including a total of 12 696 patients, met our inclusion criteria. For short-term DAPT, duration of therapy ranged from 3 to 6 months, while long-term DAPT ranged from 12 to 24 months. The majority of studies used clopidogrel and second-generation drug-eluting stents. No statistically significant difference was found between short-term and long-term DAPT with regard to myocardial infarction (odds ratio 1.21; 95% confidence interval 0.94-1.57; P = 0.14), stent thrombosis (odds ratio 1.54; 95% confidence interval 1.00-2.38; P = 0.052), or major bleeding events (odds ratio 0.74; 95% confidence interval 0.49-1.11; P = 0.14). There was no significant difference in all-cause mortality, cardiac death, or net adverse cardiac and cerebrovascular events.

Conclusions

Our meta-analysis demonstrated that short-term DAPT (<6 months) after PCI for ACS was not associated with increased risk of myocardial infarction or stent thrombosis when compared to long-term DAPT.

SUBMITTER: Misumida N

PROVIDER: S-EPMC6489918 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:OBJECTIVE:To evaluate the clinical utility of individualising dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in an all-comers population, including ST-elevation myocardial infarction (STEMI) patients. SETTING:Tertiary care single centre registry. PARTICIPANTS:1008 consecutive PCI patients with stent implantation, without exclusion criteria. INTERVENTION:Peri-interventional individualisation of DAPT, guided by multiple electrode aggregometry (MEA), to overcome high on-treatment platelet reactivity (HPR) to ADP-induced (?50 U) and arachidonic acid (AA)-induced aggregation (>35 U). OUTCOME MEASURES:The primary efficacy end point was definite stent thrombosis (ST) at 30 days. The primary safety end point was thrombolysis in myocardial infarction (TIMI) major and minor bleeding. Secondary end points were probable ST, myocardial infarction, cardiovascular death and the combined end point: major cardiac adverse event (MACE). RESULTS:53% of patients presented with acute coronary syndrome (9% STEMI, 44% non-ST-elevation). HPR to ADP after 600 mg clopidogrel loading occurred in 30% of patients (73±19 U vs 28±11 U; p<0.001) and was treated by prasugrel or ticagrelor (73%), or clopidogrel (27%) reloading (22±12 U; p<0.001). HPR to ADP after prasugrel loading occurred in 2% of patients (82±26 U vs 19±10 U; p<0.001) and was treated with ticagrelor (34±15 U; p=0.02). HPR to AA occurred in 9% of patients with a significant higher proportion in patients with HPR to ADP (22% vs 4%, p<0.001) and was treated with aspirin reloading. Definite ST occurred in 0.09% of patients (n=1); probable ST, myocardial infarction, cardiovascular death and MACE occurred in 0.19% (n=2), 0.09% (n=1) and 1.8% (n=18) of patients. TIMI major and minor bleeding did not differ between patients without HPR and individualised patients (2.6% for both). CONCLUSIONS:Individualisation of DAPT with MEA minimises early thrombotic events in an all-comers PCI population to an unreported degree without increasing bleeding. A randomised multicentre trial utilising MEA seems warranted. TRIAL REGISTRATION NUMBER:http://www.clinicaltrials.gov; NCT01515345.

Project description:IntroductionDual antiplatelet therapy (DAPT) is routinely given to patients after percutaneous coronary intervention (PCI) with stenting; however, there is ongoing debate about the optimal duration, especially in specific patient groups. In the proposed systematic review, we intend to assess the optimal duration of DAPT following PCI with stenting, with a focus on clinically relevant patient subgroups.Methods and analysisWe will perform a comprehensive search of the published literature for randomised controlled trials (RCTs) assessing the benefits and harms of extended DAPT (>12 months) compared with short-term DAPT (6-12 months) following PCI with stenting (bare metal or drug eluting). ClinicalTrials.gov and ICTRP will also be searched to identify ongoing and completed clinical trials. Two independent reviewers will select studies for inclusion, and the risk of bias will be assessed by use of Cochrane's Risk of Bias tool. The primary outcome of interest is death (all-cause, cardiovascular, non-cardiovascular). Secondary outcomes are bleeding (major, minor, gastrointestinal), urgent target vessel revascularisation, major adverse cardiovascular events, myocardial infarction, stroke and stent thrombosis. Subgroup data will be sought for patients with prior myocardial infarction, acute coronary syndrome at presentation and diabetes, and based on smoking status and age group. Data will be analysed by random-effects meta-analysis, and separate analyses will be performed for patient subgroups. Bayesian network meta-analysis will be performed to investigate the effect of individual P2Y12 inhibitors at different DAPT durations longer than 6 months.Ethics and disseminationThis review will provide a comprehensive overview of the available evidence of the benefits and harms associated with extending DAPT beyond 12 months following PCI with stenting and the effects on clinically important subgroups. The results of this review will inform clinical and policy decisions regarding the optimal treatment duration of DAPT following PCI with stenting.Systematic review registrationPROSPERO no. CRD42018082587.

Project description:Background and Objective: Dual antiplatelet therapy (DAPT) is the basis for preventing ischemic events after percutaneous coronary intervention (PCI), and DAPT for 12 months has been the standard strategy recommended by the guidelines. However, patients with acute coronary syndrome (ACS) have a higher risk of thrombosis, and the application of very short-term DAPT (1-3 months) in patients with ACS is consistently controversial. The purpose of this study is to explore the efficacy and safety of DAPT for 1-3 months in patients with ACS who were implanted with drug-eluting stents (DES). Methods: We conducted a systematic review and meta-analysis of randomized controlled trials that compared the very short-term (3 months or less) with long-term (12 months or more) DAPT in patients with ACS after PCI. The randomized controlled trials were included by searching PubMed, EMBASE, and Cochrane Library database. The relative risk (RR) and 95% CIs for endpoint events were calculated by the fixed effects model, and trial sequential analysis was applied to calculate the anticipated sample size and assess the results. Result: A total of eight randomized controlled trials with 16,492 patients who met the inclusion criteria were conducted. There were no significant statistic differences in myocardial infarction (RR 1.05, 0.82-1.35, P = 0.68), stents thrombosis (RR 1.32, 0.85-2.07, P = 0.22), all-cause death (RR 0.87, 0.66-1.13, P = 0.29), and target vessel revascularization (RR 0.93, 0.76-1.13, P = 0.47). However, there were significant differences in major bleeding (RR 0.60, 0.50-0.73, P < 0.00001) and the net adverse cardiac and cerebrovascular events (RR 0.84, 0.74-0.95, P = 0.007). Conclusions: The strategy of DAPT for 1-3 months not only has a significant effect in patients with ACS who were implanted with DES but also reduces the risk of major bleeding. The scheme of short-term DAPT followed by P2Y12 receptor inhibitor monotherapy is especially beneficial for patients with ACS. The results of this systematic review and meta-analysis are based on the application of new generation DES and new oral antiplatelet drugs in patients with ACS, which are difficult to use in the general population (Registered by PROSPERO, CRD 42020210520). Systematic Review Registration:https://www.crd.york.ac.uk/PROSPERO/, identifier: CRD 42020210520.