DES not associated with increased mortality at two years in APPROACH follow-up

Marlene Busko

October 27, 2006

Vancouver, BC- Analysis of two-year data from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH) study revealed that among "real-world" patients who underwent angioplasty, those who were implanted with drug-eluting stents (DES), as opposed to bare-metal stents, had significantly fewer deaths, CABG, and repeat PCI. These observational-study findings were presented in an oral session at the Canadian Cardiovascular Congress 2006[1].

Diane Galbraith (APPROACH Project Office, Calgary, AB) explained that while rates of DES use in some centers in the US are above 80%, they are lower in Canada; in Alberta, the rate of DES use is about 60%.

Dr Todd Anderson (University of Calgary, AB), the meeting's scientific program chair, told heart wire that concerns about the risk of late stent thrombosis prompted the group to examine the APPROACH database. "We are reducing the number of procedures that individuals will have to have again—from a one in 10 chance of a second procedure to a less than 5% chance. But are we trading off the risk of that patient dying suddenly down the road?" he asked.

"Our own personal experience, which prompted this evaluation of the APPROACH database, was several cases of individuals late out after their stents who presented with subacute stent thrombosis and horrible outcomes—emergency bypass surgery and death in a couple of individuals," said Anderson.

The APPROACH registry consists of data from all patients in the province of Alberta who underwent cardiac catheterization since 1995. The team compared mortality, CABG, and repeat PCI rates in 6975 consecutive patients who received angioplasties in Alberta between April 2003 and March 2005. A total of 1131 patients (16%) received DES, 5455 patients (78.2%) received bare-metal stents, and 389 patients received balloon angioplasty. The patients had a mean age of 62.5 years. The DES patients were more likely to be female and had more comorbidities than the bare-metal-stent patients.

DES performed well; prudent use is key

Kaplan-Meir curves showed that two-year event-free survival in these "real-world" patients, using the combined end points of revascularization procedures (PCI, CABG) and death of patients undergoing PCI, were significantly better among patients who received DES than among those who received bare-metal stents (log rank p=0.001).

Two-year outcomes in APPROACH patients: DES vs bare-metal stents

Outcome* DES (n=1113) Bare-metal stents (n=5455)
Survival, % 96.1 95.2
Event-free survival, % 85.8 81.3
*Events=CABG, re-PCI, or death

Mortality was very similar in the two groups; overall, during a follow-up of two years, DES tended to perform very well, despite a small (less than 0.5%) "blip" at one year, Anderson summarized. He noted that the results do not completely alleviate concerns about DES; rather, they reinforce the need for groups to be particularly careful about why they are putting in a DES as opposed to a bare-metal stent. "Use it when you need to, but do not use it nonjudiciously; optimize the technique . . . and make sure that there is no current reason that the antiplatelet therapy would have to be discontinued. If we follow those rules, I think that drug-eluting stents are still very safe and very efficacious for reducing event rates."

The four key advantages of APPROACH are that it included two types of stents (there was a 50-50 split between Cypher and Taxus stents), it was geographically inclusive, it included a longer follow-up, and it comprised "all comers" (as opposed to a specific group of patients), Galbraith said. "Databases like APPROACH offer us the opportunity for postmarketing surveillance, and we think that is critical to provide more insight into long-term DES efficacy and safety benefits."


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