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Published on: May 28, 2019
Transmyocardial laser revascularization versus medical therapy for refractory angina
Eduardo Briones1, Juan Ramon Lacalle, Ignacio Marin
1Quality and Health Information , Valme University Hospital, Avda Bellavista s.n., Sevilla, Spain, 41014. eduardo.briones.sspa@juntadeandalucia.es
Insights
Transmyocardial laser revascularization (TMLR) shows some benefit for refractory angina but carries significant early mortality risks. More evidence is needed to confirm its clinical benefits outweigh potential harms.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Technology
Background:
- Chronic angina and advanced coronary disease are prevalent, with some patients experiencing refractory symptoms despite existing treatments.
- Transmyocardial laser revascularization (TMLR) has been explored as a potential treatment for these challenging cases.
- Optimal medical treatment serves as a benchmark for evaluating new interventions in refractory angina.
Purpose of the Study:
- To evaluate the efficacy and safety of Transmyocardial Laser Revascularization (TMLR) compared to optimal medical treatment.
- To assess TMLR's impact on angina severity, patient survival, and cardiac function.
- To provide evidence for the clinical decision-making process in managing refractory angina.
Main Methods:
- A systematic review and meta-analysis of randomized controlled trials (RCTs) were conducted.
- Searches included major databases (Cochrane, MEDLINE, EMBASE) and trial registries up to June 2007.
- Seven RCTs involving 1137 patients with severe angina excluded from other revascularization were analyzed, despite methodological weaknesses in the included studies.
Main Results:
- TMLR demonstrated a significant improvement in reducing angina severity, with 43.8% of patients experiencing a two-class decrease versus 14.8% in the control group (OR 4.63).
- Intention-to-treat analysis showed similar 30-day and 1-year mortality rates between TMLR and control groups (4.0% vs 3.5% at 30 days; 12.2% vs 11.9% at 1 year).
- However, 'as treated' analysis revealed a statistically significant higher 30-day mortality in the TMLR group (6.8%) compared to the control group (0.8%), primarily due to crossover patients.
Conclusions:
- Current evidence is insufficient to definitively conclude that the clinical benefits of TMLR outweigh its risks.
- Transmyocardial laser revascularization is associated with a notable increase in early mortality.
- Further high-quality research is warranted to clarify the role of TMLR in refractory angina management.
Background:
Chronic angina and advanced forms of coronary disease are increasingly more frequent. Although the improved efficacy of available revascularization treatments, a subgroup of patients present with refractory angina. Transmyocardial laser revascularization (TMLR) has been proposed to improve the clinical situation of these patients.
Objectives:
To assess the efficacy and safety of TMLR versus optimal medical treatment in patients with refractory angina in alleviating the severity of angina and improving survivorship and heart function.
Search Strategy:
We searched the Cochrane Central Register of Controlled Trials on The Cochrane Library (Issue 2 2007), MEDLINE (January 2006 to June 2007), EMBASE ( 2004 to June 2007) and ongoing studies were sought using the metaRegister of Controlled Trials database (mRCT) and ClinicalTrials.gov databases. No languages restrictions were applied. Reference lists of relevant papers were also checked.
Selection Criteria:
Studies were selected if they fulfilled the following criteria: randomized controlled trials of TMLR, by thoracotomy, in patients with angina grade III-IV who were excluded from other revascularization procedures. From a total of 181 references, 20 papers were selected, reporting data from seven studies.
Data Collection And Analysis:
Two reviewers abstracted data from selected papers; . The reviewers performed independently both quality assessment and data extraction. Selected studies present methodological weaknesses. None of them fulfilled all the quality criteria.
Main Results:
Seven studies (1137 participants of which 559 randomized to TMLR) were included. Overall, 43.8 % of patients in the treatment group decreased two angina classes as compared with 14.8 % in the control group, odds ratio (OR) of 4.63 (95% confidence interval (CI) 3.43 to 6.25), and heterogeneity was statistically significant. Mortality by intention-to-treat analysis at both 30 days (4.0 % in the TMLR group and 3.5 % in the control group) and 1 year (12.2 % in the TMLR group and 11.9 % in the control group) was similar in both groups. The 30-days mortality as treated was 6.8% in TMLR group and 0.8% in the control group, showing a statistically significant difference. The pooled OR was 3.76 (95% CI 1.63 to 8.66), because of the higher mortality in patients crossing from standard treatment to TMLR.
Authors' Conclusions:
There is insufficient evidence to conclude that the clinical benefits of TMLR outweigh the potential risks. The procedure is associated with a significant early mortality.
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