NY Registry Shows Improved Outcomes with PCI vs. Medical Therapy in Stable Patients

Download this article's Factoid in PDF (& PPT for Gold Subscribers)

Despite increasing awareness and data surrounding the benefits of medical therapy without adjunct percutaneous coronary intervention (PCI) for patients with stable coronary artery disease (CAD), the majority of such patients in New York State still received PCI between 2003 and 2008, according to results appearing online March 22, 2012, ahead of print in Circulation. And, according to the study, PCI resulted in lower rates of mortality and myocardial infarction (MI).

Edward L. Hannan, PhD, of the University at Albany, State University of New York (Albany, NY), and colleagues looked at 9,586 patients with stable CAD in the New York State Cardiac Diagnostic Catheterization Database between 2003 and 2008, of whom 88.5% (n = 8,486) received PCI with routine medical treatment compared with 11.5% who received routine medical therapy alone (n = 1,100). Interestingly, the PCI percentage did not change substantially before (88.4%) or after 2008 (88.7%), the year after the COURAGE trial was published, which increased awareness concerning the benefits of medical therapy alone.

In the New York State registry, over two-thirds of PCI patients (71%) had a single stent implanted, and 20% had 2 stents. Most patients (71%) also had DES, while one-fourth had BMS; only 5% of patients did not receive a stent. Propensity matching according to 20 variables was used to compare patients who received PCI vs. routine medical therapy alone. At 4 years, PCI patients had lower rates of mortality, MI, and revascularization (table 1).

Table 1. Propensity Matched Analysis of 4-Year Outcomes

Adjusted hazard ratios also favored PCI, with higher HRs for routine medical therapy with regard to mortality/MI (HR 1.49; 95% CI 1.16-1.93; P = 0.002) and mortality (HR 1.46; 95% CI 1.08-1.97; P = 0.02).

The results were maintained across all subgroups except age (threshold of 65 years), which showed a significant interaction (P = 0.04), meaning the benefit of PCI relative to routine medical therapy may be significantly higher for patients aged 65 and older, while younger patients may show no difference between the 2.

“Our study found that in a population-based study in New York of patients with stable CAD undergoing cardiac catheterization, nearly 90% of these patients underwent PCI,” Dr. Hannan and colleagues write. “Patients who received PCI experienced lower mortality, mortality/MI, and revascularization rates.”

Routine Does Not Equal Optimal

The authors note that adverse outcome rates in the current study with routine medical therapy were higher than those in COURAGE, which may stem from 2 possible reasons. First, the medical therapy population in the New York State study was at much higher risk (because it was much less selected), and second, patients had “routine” medical therapy instead of “optimal” medical therapy, as they did in COURAGE.

The exact nature of the routine medical therapy provided to patients in the current study is “completely unknown,” the authors observe, “and undoubtedly many [routine medical therapy] patients received nonoptimal medical therapy.” In addition, medication adherence was probably poor, as opposed to COURAGE, which featured excellent adherence to both medication and lifestyle factors.

“The combination of these facts suggests that although optimal medical treatment is as effective as [PCI with optimal medical therapy] for patients with stable CAD in a tightly controlled trial with excellent adherence, different results might occur in real world situations,” the study authors conclude.

Interventional ‘Blind Spot’?

In an accompanying editorial, the principal investigator of COURAGE, William E. Boden, MD, of Albany Stratton VA Medical Center (Albany, NY), notes that “[t]hese data are troubling, and suggest that decision-making in such an important population of patients is not in conformity with existing clinical practice guidelines.” Furthermore, Dr. Boden writes, the lack of difference in treatment patterns pre- and post-COURAGE suggests that “we are either in denial that [optimal medical therapy] should be viewed as the foundation for all subsequent CAD therapies, or that there is an unacceptably sizable ‘blind spot’ in how we view the importance of [optimal medical therapy] through the prism of a ‘PCI-first’ treatment lens.”

Theodore A. Bass, MD, of the University of Florida College of Medicine (Jacksonville, FL), agreed that the New York State registry study is at odds with previous randomized trials. This is not surprising, he notes in an e-mail communication with TCTMD, given the differences in selection, follow-up, and confounding variables between the 2 types of studies.

“However, Dr. Boden’s comments regarding the cardiovascular physician community not getting it, ie, having a ‘blind spot’ regarding the importance of optimal medical therapy as a treatment option continues to be repetitively off target,” Dr. Bass said, citing Medicare and other data demonstrating a decline in overall PCI volume by as much as 20% since 2006 while “practice patterns have indeed adjusted to new emerging evidence-based data.”

Moreover, “PCI with medical therapy remains an important and proven effective treatment option providing better quality of life for many patients with CAD and chronic ischemic symptoms,” Dr. Bass said. “Far from being blinded, we are listening to our patients, providing therapeutic options and modifying our practices as new data emerges.”

Study Details

PCI patients in the New York State registry were younger and more likely to have private health insurance, a positive stress test, a medium or large area of viable myocardium at risk, proximal LAD disease and 3-vessel disease, class III angina, and a higher ejection fraction.

Related Stories:

• Meta-Analysis Questions Appropriateness of PCI in Stable CAD
• OAT Fails to Change Practice: No Decrease in Late PCI for Stable MI Patients
• The COURAGE Effect: Sustained Decline Seen in PCI for Stable Angina

Click here for a listing of companies that provide support to the Cardiovascular Research Foundation, owner and operator of TCTMD