Early Invasive Strategy After Fibrinolysis vs Standard Management in STEMI Patients: Results From an Individual Patient Data Meta-analysis (OTTER Meta-analysis) OTTER: Optimal Timing for Post-Thrombolysis Elective Revascularization
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Combined death/reinfarction
研究概览
简要总结
Several recent trials (1,2) suggest that all STEMI patients receiving fibrinolysis in non-PCI centres should be routinely transferred for elective early PCI within 24 hours from hospitalization, with no additive risk of major bleeding complications or other severe adverse events compared standard therapy. These results in favour of a routine invasive strategy in STEMI patients suggest a potential change to the current approach of awaiting the response to treatment in patients receiving fibrinolysis, and draw the attention to the potential need for an appropriate network organization with adequate first hospitalization treatment (spoke) and prompt transfer to centres with 24/7 PCI capabilities (hub). The recent ESC (3) and ACC (4) guidelines on STEMI are consistent with the early ESC PCI Guidelines, recommending that angioplasty after fibrinolysis should be performed within a time-window ranging between 3 and 24 hours after successful lytic administration (level evidence IIA). The reason for the weighting of the recommendation is due to the heterogeneity of trial results with different planned-revascularization strategies, variable primary end-points definitions, and small individual trial sample sizes. Therefore, a consistent analysis of single patient dataset from all published randomized trials would be of value to better define the magnitude and duration of clinical benefit of the routine invasive strategy after lytic treatment as well as the potential optimal timing of such a strategy.
The main aim of the OTTER meta-analysis is to define the benefits of immediate PCI after fibrinolysis for STEMI patients. Moreover, the OTTER meta-analysis will investigate the optimal timing of post-fibrinolysis elective revascularization.
详细描述
All published randomized controlled trials that compared a routine invasive strategy with early PCI and a standard therapy in STEMI patients after fibrinolysis will be included in this analysis.
We will exclude all non-randomized trials, randomized studies if the individual patient data will not be available for analysis, randomized studies in which angioplasty was mainly performed without stenting (<80% stenting population) and in which the type of lytic therapy was different from modern fibrin-specific agents. Two investigators independently will evaluate studies for possible inclusion. The quality of searched trials will be evaluated based on the 5-point scale outlined by Jadad et al (5), with criteria for randomization with proper concealment of the allocation sequence, blinding of the patient and investigators to treatment allocation with description of the blinding method, and completeness of follow-up.
Recruitment:
An electronic database will be compiled consisting of data from each single patient of all enrolled trials, according to the guidelines for the performance of individual patient meta-analysis.(6-7-8). The database will include demographic data and baseline characteristics. Attention will be paid to clinical complications during transfer for early PCI and to the precise calculation of the following times-window: from symptoms onset to lytic therapy, from lytic therapy to early or rescue PCI, from randomization to all adverse events as defined below. Data will be checked for completeness and for consistency with published reports. Two investigators independently will extract all data, with disagreements resolved in consultation with a third investigator.
End-points
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STEMI patients enrolled within 12 hours from onset of symptoms
- •Controlled randomized trials comparing a routine invasive strategy with standard therapy in STEMI patients
- •Modern fibrin-specific therapy in both groups
- •Stenting PCI > 80% of invasive procedures
- •English language
排除标准
- •Cardiogenic shock at presentation
- •Need for concomitant
- •Major surgery
- •Severe chronic renal or hepatic impairment
- •Myocardial infarction within the previous 2 weeks
- •Contraindications to thrombolytic therapy, abciximab, aspirin, or clopidogrel
- •Non randomized trials
- •Single patient data not available
- •Non fibrin-specific lytic therapy
- •Stenting PCI < 80% of invasive procedures
- •Not English language
结局指标
主要结局
Combined death/reinfarction
时间窗: 30 days
次要结局
- Death, reinfarction, recurrent ischemia and urgent revascularization(30 days)
- Combined death/reinfarction/recurrent ischemia/urgent revascularization and new presentation CHF and shock(30 days.)
- Major bleeding and hemorrhagic stroke(30 days)
- Combined death/reinfarction and combined revascularization/recurrent ischemia(6-12 months)
- Influence of Optimal Timing of Post-Thrombolysis early revascularization on primary and secondary clinical end-points(0-24 hours from thrombolysis)