SAN FRANCISCO, CA – October 28, 2013 – Findings from a new meta-analysis of randomized controlled trials demonstrate that percutaneous coronary intervention (PCI) significantly reduces all-cause mortality in stable patients selected on the basis of ischemia. Results were presented today at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.

Results of a Meta-Analysis of Randomized Controlled Trials Presented at TCT 2013
 
 
 

Findings from a new meta-analysis of randomized controlled trials demonstrate that percutaneous coronary intervention (PCI) significantly reduces all-cause mortality in stable patients selected on the basis of ischemia. Results were presented today at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.  

Recent randomized controlled trials (RCTs) including the COURAGE trial have demonstrated no significant reduction in death or myocardial infarction (MI) with PCI compared with optimal medical therapy (MT) in patients with stable ischemic heart disease (SIHD). However, the majority of these trials randomized an unselected group of patients, including those with and without objective testing for ischemia or a reduction in coronary blood flow. These trials also combined death with MI events. The new meta-analysis examined the mortality endpoint alone, and reviewed RCTs that specifically compared PCI with medical therapy in patients with coronary artery disease and either ischemia (identified on non-invasive testing) or abnormal fractional flow reserve (FFR). 

The analysis identified a total of 1,769 patients from four randomized controlled trials (ACME, the baseline ischemia sub study of COURAGE, FAME-2 and SWISSI-II). Within these trials, 871 patients were randomized to PCI and 898 were randomized to MT alone.

The analysis found a significant 44 percent reduction in mortality in patients that underwent PCI compared to medical therapy (Hazard Ratio 0.56; p=0.02). Inclusion of two additional studies (ACIP, DANAMI) with a revascularization vs. medical therapy arm with a predominance of PCI patients demonstrated a consistent treatment effect, with a 39 percent reduction in mortality (Hazard Ratio 0.61, p=0.01). 

“Conventional conclusions drawn from existing RCT data are that PCI and medical therapy result in comparable outcomes in patients with stable ischemic heart disease with more adverse outcomes related to up-front PCI. However, these conclusions are based upon assessments of combined death and MI rather than mortality alone,” said lead investigator Ajay J. Kirtane, MD, SM. Dr. Kirtane is Chief Academic Officer and Associate Professor of Medicine at Columbia University Medical Center/NewYork-Presbyterian Hospital. 

“When analyses are restricted to RCT patients with objective ischemia (or the FFR equivalent), PCI compared with medical therapy is associated with a significant reduction in all-cause mortality. These data, while underpowered, call into question the conventional dictum that the role of PCI should only be limited to improving symptoms and quality of life.” 

The meta-analysis did not receive any funding. Dr. Kirtane reported the following disclosures: no personal funds received; institutional research grants for clinical trials from Medtronic, Boston Scientific, St. Jude Medical, and Abiomed.

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