Three Months of Antiplatelet Therapy with Endeavor Equal to 1 Year with Other DES
CHICAGO, IL—Clinical outcomes after 1 year in patients receiving Endeavor zotarolimus-eluting stents (ZES) plus three months of dual antiplatelet therapy are noninferior to those of patients receiving other drug-eluting stents (DES) plus a full year of aspirin and clopidogrel. The research, presented March 24, 2012, at the annual American College of Cardiology/i2 Scientific Session, may have implications for patients who need DES and a shorter course of antiplatelet therapy.
Researchers led by Myeong-Ki Hong, MD, PhD, of Yonsei University College of Medicine (Seoul, South Korea), randomized over 2,000 patients receiving elective PCI at 26 centers in South Korea to 2 groups:
- Endeavor ZES plus 3 months of dual antiplatelet therapy (n = 1,059)
- Other DES (Resolute ZES, sirolimus eluting stents, everolimus eluting stents) plus 12 months of dual therapy (n = 1,058)
Baseline characteristics were similar in both groups, as were pre- and postintervention quantitative angiographic results including minimum lumen diameter and percent diameter stenosis.
On intention-to-treat analysis, patients receiving Endeavor ZES and 3 months of dual therapy achieved noninferiority compared to those receiving other DES and 12 months of therapy with regard to the primary endpoint of cardiovascular death, MI, stent thrombosis (ARC criteria), TVR, or bleeding (TIMI criteria). All of the component endpoints were also similar between groups (table 1).
Table 1. Clinical Outcomes at 1 Year
|
|
Endeavor plus 3 Months Dual Therapy |
Other DES plus 12 Months Dual Therapy |
P Value |
|
Primary Endpoint |
4.7% |
4.7% |
< 0.01a |
|
Death, MI, Stent Thrombosis |
1.3% |
0.8% |
0.48 |
|
Death |
0.5% |
1.0% |
0.39 |
|
MI |
0.2% |
0.4% |
0.41 |
|
TVR |
3.9% |
3.7% |
0.70 |
|
Stent Thrombosis |
0.2% |
0.3% |
0.65 |
|
Major or Minor Bleeding |
0.5% |
1.0% |
0.2 |
aP value for noninferiority.
For stent thrombosis, there were 2 early (< 30 days) cases in the Endeavor-plus-3-months-dual-therapy group and 3 late cases (from 3 months to 1 year) in the group receiving other DES and 12 months of dual therapy. The rate of stroke/TIA was also equivalent between the 2 groups (0.6% with Endeavor vs. 0.7% with other DES; P = 0.96).
On subgroup analysis, the results for the primary endpoint did not change according to age (threshold age 65), gender, diabetes status, congestive heart failure, multivessel disease, reference vessel diameter (threshold of 3 mm), lesion length (threshold of 20 mm), or ACS.
In the Endeavor-plus-3-months dual therapy group, 62 patients (5.9%) interrupted antiplatelet therapy for reasons including:
- Physician mistake or failure of monitoring
- Physician discretion
- Patient disagreement
- Repeat revascularization
On a per-protocol analysis, when these patients were excluded, results for the primary endpoint and all other clinical outcomes at 1 year remained unchanged.
Some Patients May Need Shorter Dual Therapy Course
“Endeavor zotarolimus eluting stents plus 3 months dual antiplatelet therapy could be safe and beneficial for the selected patients with coronary artery disease who may need to stop dual antiplatelet therapy early after DES implantation,” Dr. Hong concluded.
He noted that such patients could include those:
- At risk for bleeding complications
- At risk of poor compliance with medication, especially in the elderly population
- With a high probability of unexpected non-cardiac surgery or invasive procedures
- With a low risk of stent thrombosis
Panel member Matthew J. Price, MD, of the Scripps Translational Research Institute (La Jolla, CA), cited 2 main take-away messages from the study.
“First, it shows in this group of patients with fairly low angiographic risk that event rates are low no matter what you do,” he said. “We’re getting really good in these patients with low anatomical risk.”
Secondly, Dr. Price continued, the trial exemplifies “how hard it’s going to be to definitively prove that shortened duration of [dual antiplatelet therapy] is safe. Here we have a fantastic noninferiority study with a relative noninferiority margin of 40 percent. So you still may have a safety signal but yet have noninferiority.”
From the audience, Antonio Colombo, MD, of San Raffaele Hospital (Milan, Italy), commented that studies with Asian populations typically feature “stent thrombosis rates on average half of the ones we see in the West. It’s not easy to translate these conclusions to other populations.” He cited genetic or other factors that “may play a role in these low thrombosis rates.”
Panel co-chair George D. Dangas, MD, PhD, of Mount Sinai Medical Center (New York, NY), agreed, noting that “the CAD may not be as extensive or calcified.”
Source:
Hong M-K. A new strategy for discontinuation of dual antiplatelet therapy: Real safety and efficacy of 3-month dual antiplatelet therapy following zotarolimus-eluting stent implantation: RESET trial. Presented at: American College of Cardiology Scientific Session; March 24, 2012; Chicago, IL.
Disclosures:
- Dr. Hong reports receiving support from the Cardiovascular Research Center (Seoul, South Korea), and Medtronic, and grants from the Korea Healthcare Technology Research and Development Project, Ministry for Health, Welfare and Family Affairs.
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