Large-Scale PCI Outcomes Study Shows Improvements Over Time in United States

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Despite the fact that patients undergoing percutaneous coronary intervention (PCI) are now older and sicker compared with when the procedure was first introduced, major adverse cardiac events (MACE) have decreased over time. A trends study, published online June 27, 2013, ahead of print in the American Heart Journal, reports higher risk of MACE in females and older patients, suggesting a need for improvements in care for these subgroups.

Using data from the Centers for Medicare and Medicaid Services (CMS), Sunil V. Rao, MD, of Duke Clinical Research Institute, (Durham, NC), and colleagues compared patient characteristics and 3-year MACE rates in 3.3 million patients who underwent PCI across 3 eras:

  • Balloon angioplasty: January 1991-September 1995
  • BMS: February 1998-April 2003
  • DES: May 2004-October 2006

At 3 years, MACE was lowest in the DES era (44.0%) compared with both the BMS (48.7%) and balloon angioplasty eras (48.8%; P < 0.01). The risk of MACE was lower in the BMS era compared with the balloon angioplasty era (adjusted HR 0.930; 95% CI 0.926-0.935) but still lower in the DES era vs. BMS (adjusted HR 0.831; 95% CI 0.827-0.835).

The lower MACE rates in the DES and BMS eras were driven by lower rates of repeat revascularization, in particular, reduced need for subsequent CABG (table 1).

Table 1. Three-Year Outcomes


Balloon Angioplasty Era



P Value





< 0.001










< 0.001





< 0.001

Repeat PCI




< 0.001


In subgroup analyses, women had lower adjusted MACE risk in the balloon angioplasty era, but reported slightly higher risk than men in both the BMS and DES eras. Additionally, patients aged ≥ 75 years showed higher adjusted MACE risk than younger patients across all 3 time periods.

‘Approaching a Plateau’

In a telephone interview with TCTMD, Dr. Rao said different analyses of PCI clinical trial data have reflected improved outcomes over time. “We wanted to see if this is true in actual clinical practice, and there are reasons one could expect the opposite—for example, the inclusion of patients with ejection fractions of 10%, multiple comorbidities, and with multiple prior coronary interventions. But despite the higher-risk patient profiles, we found dramatic improvements overall,” he observed.

Dr. Rao noted the difficulty of demonstrating advances in the low risk patients who populated the early stent studies because current outcomes are very good. “Patients we are seeing in the OR and cath lab today include many who in the past would have been deemed too high risk and would have been treated medically,” he said. “If we are to improve, it will be in these very, very high risk patients—those in shock, in cardiac arrest, with a last remaining vessel.”

Visible improvement, he suggested, may come through strategies for hemodynamic support, myocardial and cerebral preservation, or through some kind of regenerative therapy such as the stem cell therapies in current clinical trials. “But in the low-risk and even in the low end of moderate-risk patients, I think we are approaching a plateau with current therapies,” Dr. Rao said.

Dr. Rao and colleagues urged that future studies focus on improving clinical outcomes among females and older patients.

Long-term Differences

David E. Kandzari, MD, of Piedmont Heart Institute (Atlanta, GA), told TCTMD in a telephone interview that, “it’s important to document that the transition in technology from balloon angioplasty to bare-metal stents to drug-eluting stents is making a difference over the long term.” Aside from the representative nature of the results, based on the study’s large size and unselected population, the findings indicate that the good outcomes evidenced in clinical trials are being achieved in clinical practice, he added.

Dr. Kandzari observed that the 3-year 20.4% revascularization rate in the DES era would be considered unacceptable if it reflected restenosis. “More likely,” he said, “it is a reminder that coronary artery disease is a progressive, systemic disease.”

Regarding further advances, Dr. Kandzari noted that the excellent outcomes and reduced prices of current stents have made them cost dominant. For developers of bioabsorbable stents, given the likely higher initial costs, the burden to demonstrate superiority over current designs will be a high threshold, he added.

Study Details

Over time, the risk profile of patients undergoing PCI increased, with older patients and patients with more medical comorbidities in each era.



Rao SV, Hess CN, Dai D, et al. Temporal trends in percutaneous coronary intervention outcomes among older patients in the United States. Am Heart J. 2013;Epub ahead of print.

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  • Dr. Rao reports no relevant conflicts of interest.
  • Dr. Kandzari reports receiving research and grant support from Abbott Vascular, Boston Scientific, and Medtronic and consulting honoraria from Boston Scientific and Medtronic.

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