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| Xience V drug-eluting stent Image source: Abbott Vascular |
John J. Lopez, MD, of the Loyola Heart and Vascular Center in Maywood, Ill., and colleagues used the 2004-2006 EVENT (Evaluation of Drug-Eluting Stents and Ischemic Events) registry to evaluate the trends of DES use during the first three waves of the DES era.
The trial evaluated 6,444 patients and used a composite of death, MI and urgent revascularization at discharge and death, MI or target lesion revascularization (TLR) at one-year as the trial's primary endpoint. Nearly 70 percent of patients were male, all had a mean age of 64 and 33.8 percent were treated for acute coronary syndrome (ACS).
The researchers found that over time, there was an increased trend to treat less complex lesions with DES and total occlusions, but a decreased trend in the number of multivessel and bifurcation interventions.
Additionally, the use of a pre-procedural dose of clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis) increased across waves one, two and three by 24.8 percent, 28.7 percent and 36.2 percent, respectively. Conversely, heparin use decreased over the duration of the three waves, 70.1 percent, 55.3 percent and 53.1 percent, respectively.
The primary in-hospital endpoint occurred in 7.2 percent of all the patients—7.7 percent for wave one, 6.6 percent for wave two and 7.3 percent for wave three. The rates of stent thrombosis were low in waves one, two and three and did not statistically differ: 0.3, 0.1 and 0.1 percent, respectively.
The primary endpoint at one-year was averaged to be 13.5 percent for the overall patient population and did not statistically differ across the three waves. Death occurred in 2.8 percent of the overall patient population, while repeat revascularization occurred in 11.1 percent.
"The overall findings of this analysis demonstrate that the near-complete adoption of DES during this period was associated with high levels of procedural success (above 98 percent), low levels of in-hospital adverse events (approximately 7 percent) and a one-year major adverse cardiac event rate of 13.5 percent," the authors wrote.
The most surprising during the first three years of DES use, Lopez and colleagues wrote, was a notable reduction in procedural complexity and patients treated with fewer multivessel PCI procedures and ACS complications.
"Although this finding was somewhat unexpected, it suggests that U.S. interventional cardiologists either recognized limitations in this new technology relatively quickly or expanded use of DES to less complex patients over the first several years of practice," the authors wrote.
"The high-adoption DES era was associated with favorable outcomes, decreasing bleeding rates and changes in antithrombotic approach," they concluded.