Add PCI to Meds in Stable CAD? Meta-Analysis Adds to Debate

August 07, 2012

August 7, 2012 (Dallas, Texas)— A new installment in a continuing saga suggests that adding PCI to optimal medical therapy (OMT) in patients with stable coronary artery disease may give patients a slight edge by alleviating more angina, but it doesn't protecting any better against death or MI [1].

The latest meta-analysis to grapple with the issue following the 2007 release of the seminal COURAGE trial, published online today in Circulation: Cardiovascular Interventions with lead author Dr Seema Pursnani (Johns Hopkins University, Baltimore MD), is "more comprehensive and robust" than previous efforts, according to senior author Dr Sripal Bangalore (New York University School of Medicine, NY).

That's because it used a sharper definition of stable CAD when screening clinical trials for analysis, Bangalore told heartwire ; for example, it excluded patients with acute coronary syndromes within a week of entering the study. It also considered duration of follow-up in its 12 trials, making its conclusions "statistically more valid."

For example, a meta-analysis published earlier this year also pointed to comparable outcomes for the two strategies in terms of death or MI, and it also ruled out an angina-reduction benefit to adding PCI [2]. But its methods have been questioned [3], Bangalore noted. It included only eight trials, and some of them focused on patients with stable disease after an MI.

Moreover, he cautioned--as have others--that the trials in all such analyses so far are outdated in terms of PCI technology: many did not use stents and very few patients overall received drug-eluting stents (DES). "Newer-generation" DES have been shown to cut the risk of MI compared with bare-metal stents, questioning the "applicability" of the trials and meta-analyses based on them, including the current one, according to Bangalore.

It included trials that entered 7182 patients with stable CAD as defined by angiography or stress testing and excluded any that allowed patients with any form of ACS within a week of entry.

PCI wasn't associated with a significant reduction in hard clinical end points but did provide more freedom from angina. The results held true overall and with stratification by trial follow-up duration of less than one, one to five, and more than five years.

Effect of Adding PCI to Optimal Medical Therapy in Stable CAD Over 12 Randomized Trials

End point RR (95% CI)
All-cause mortality 0.85 (0.71–1.01)
Cardiac death 0.71 (0.47–1.06)
Nonfatal MI 0.93 (0.70–1.24)
Repeat PCI or CABG* 0.93 (0.76–1.14)
Freedom from angina 1.20 (1.06–1.37)

*Symptom-driven

"PCI appeared to show a benefit for all-cause mortality and cardiac death that was attenuated when recent studies (with more aggressive medical therapy) with a high proportion of stent use were analyzed," the group writes. For example, considering only trials with >50% stent use, the relative risk effect of PCI on all-cause mortality rose to 0.93 (0.78-1.11).

Bangalore said the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial is up and running and is expected to "answer these questions more robustly than has been done in the past."

Patients who show moderate to severe ischemia at stress testing will go on to coronary computed-tomography (CT) angiography to exclude left main disease and to confirm whether they have obstructive CAD.

Bangalore said its results are expected in 2019 or 2020.

None of the authors had disclosures.

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