EES Outperform First-Generation DES in Treatment of CTOs

Data from a large registry of patients undergoing percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) suggest that everolimus-eluting stents (EES) have a substantially lower rate of reocclusion in this population compared with 2 prominent first-generation stents. The study was published online December 26, 2012, ahead of print in the Journal of the American College of Cardiology.

Investigators led by David Antoniucci, MD, of Careggi Hospital (Florence, Italy), looked at angiographic and clinical outcomes in 802 patients who underwent successful PCI for at least 1 CTO between 2003 and 2010. DES used included the first-generation sirolimus-eluting Cypher stent (Cordis, Miami Lakes, FL) and the paclitaxel-eluting Taxus Express or Taxus Liberté stents (Boston Scientific, Natick, MA) and the second-generation everolimus-eluting Xience V (Abbott Vascular, Santa Clara, CA) or Promus stents (Boston Scientific). Overall, first-generation DES were implanted in 66% and EES in 34% of patients.

All patients were enrolled in the single-center Florence CTO PCI registry and 82% underwent angiographic follow up between 6 and 9 months after the procedure.

Second-Generation DES Take the Lead

EES were associated with a lower reocclusion rate than first-generation DES (3.0% vs. 10.1%; P = 0.001). In multivariable analysis, the only variables related to reocclusion were use of the subintimal tracking and re-entry (STAR) technique (OR 29.5; 95% CI 11.9-73.2; P < 0.001) and EES (OR 0.22; 95% CI 0.09-0.54; P = 0.001). Additionally, right coronary artery CTO was the only variable related to the risk of nonocclusive restenosis (OR 1.64; 95% CI 1.02-2.62; P = 0.040).

At 1-year follow-up, cardiac mortality was 3.2%, MI was 0.9%, and the rate of repeat PCI for restenosis or reocclusion of the CTO target vessel was 12.8%. The rate of major adverse cardiac events (MACE) was lower in those treated with EES than with first-generation DES (11.6% vs. 19%; P = 0.005) as was the target CTO revascularization rate (10.5% vs. 14.1%; P = 0.139). The findings were further strengthened in propensity-matched analysis showing that those treated with EES had better clinical and angiographic outcomes at 1 year than those treated with the first-generation DES (table 1).

Table 1. Propensity-Matched Clinical and Angiographic Outcomes

1-Year

First-Generation DES
(n = 294)

EES
(n = 294)

P Value

MACE

22.4%

11.6%

< 0.001

Cardiac Death

4.8%

1.0%

0.007

MI

2.0%

0.03%

0.019

Repeat PCI (CTO)

17%

10.5%

0.023

Definite Stent Thrombosis

1.0%

0

0.082

In-segment Restenosis or Reocclusion

27%

13%

< 0.001

Reocclusion

10%

3.0%

0.002


Overall, the 3-year event-free survival rate was 76 ± 2%. In multivariable analysis, age > 75 years, left ventricular ejection fraction < 0.40, left anterior descending artery CTO and complete revascularization were related to increased cardiac mortality, while age > 75 years, STAR technique, left ventricular ejection fraction < 0.40 and left anterior descending artery CTO were related to increased MACE.

End of the Line for First-Generation DES?

In an editorial accompanying the study, Joachim Schofer, MD, of Hamburg University Cardiovascular Center (Hamburg, Germany) notes that while it has been shown that second-generation DES perform better than the first generation for nonocclusive lesions, CTO data on this issue are scarce. While commending the researchers for their work, he says the single-center nature of the registry coupled with the inability to extrapolate the findings to other second-generation DES beyond those containing everolimus suggests that it is too soon to “put the whammy” on the use of first-generation devices for treating CTOs.

According to Dr. Schofer, this treatment strategy “will stay alive until randomized trials have clearly demonstrated their inferiority in terms of safety and efficacy compared with that of newer generation DES, but they are in danger of extinction.”

Study Details

The mean age of patients was 68 ± 11 years. The majority (82%) had multivessel disease, with nearly 50% having 3-vessel disease. Approximately 12% of patients required treatment for 2 or 3 CTOs.

 


Sources:
1. Valenti R, Vergara R, Migliorini A, et al. Predictors of reocclusion after successful drug-eluting stent–supported percutaneous coronary intervention of chronic total occlusion. J Am Coll Cardiol. 2012;Epub ahead of print.

2. Schofer J. First-generation drug-eluting stents for chronic total occlusion: In danger of extinction? J Am Coll Cardiol. 2012;Epub ahead of print.

 

 

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Disclosures
  • Drs. Antoniucci and Schofer report no relevant conflicts of interest.

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