Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting - EXCELLENT (EES vs. SES)
Although second-generation stents such as everolimus-eluting stents (EES) are routinely used, very few randomized data exist that directly compare EES to first-generation stents such as sirolimus-eluting stents (SES). The EXCELLENT trial sought to compare outcomes after EES and SES implantation in a real-world population of patients presenting with coronary artery disease (CAD).
EES would be noninferior to SES in reducing neointimal hyperplasia at 9 months in patients presenting with CAD.
- >50% stenosis by visual estimation
- Evidence of myocardial ischemia
- Stable angina
- Unstable angina
- Recent infarction, silent ischemia
- Positive functional study or reversible changes in the ECG consistent with ischemia
- Target lesion must be located in a native coronary artery
- Reference vessel diameter between 2.25 mm and 4.25 mm
Number of enrollees: 1,443
Duration of follow-up: 12 months
Mean patient age: 63 years
Percentage female: 36%
Ejection fraction: 61%
- Gastrointestinal or genitourinary bleeding ≤3 months, major surgery ≤2 months
- Hemoglobin <10 g/dl, platelet count <100K
- Elective surgical procedure planned ≤12 months
- Left ventricular ejection fraction <25%, or in shock
- MI ≤72 hours
- Creatinine level ≥3.0 mg/dl or dependence on dialysis
- Severe hepatic dysfunction (aspartate aminotransferase [AST], alanine aminotransferase [ALT] ≥x3 upper limit of normal)
- Patients who had received any stent implantation in the target vessel prior to enrollment
- Patients with significant left main stenosis
- Bare-metal stent or drug-eluting stent in-stent restenosis
- Chronic total occlusion
- True bifurcation lesions requiring two stents
- In-segment late luminal loss at 9 months
- In-stent late luminal loss at 9 months
- All-cause mortality at 12 months
- Cardiovascular mortality at 12 months
- MI at 12 months
- TLR at 12 months
- Stent thrombosis at 12 months
Patients were randomized in a 3:1 fashion to either EES (Xience V or Promus) or SES (Cypher Select).
- All patients received at least 300 mg of aspirin and 300-600 mg of clopidogrel. Unfractionated heparin was used to maintain an activated clotting time (ACT) of ≥250 seconds.
- Dual antiplatelet therapy mandated for a minimum of 12 months in both arms
- Glycoprotein IIb/IIIa inhibitors (1.6%)
- Statins (83%)
- Beta-blockers (61%)
A total of 1,443 patients were randomized, 1,079 to EES and 364 to SES. Baseline characteristics were fairly similar between the two arms. About 38% had diabetes, and 9% had undergone prior percutaneous coronary intervention (PCI). About 52% of patients presented with acute coronary syndromes, including 3% with ST-elevation myocardial infarction (STEMI). The left anterior descending artery was the target vessel in about 50% of the patients. Multivessel disease was noted in about 52% of the patients, and 11% were bifurcation lesions. The mean number of stents used per patient was 1.6, with a mean stented length of about 28 mm per lesion. Intravascular ultrasound was used in about 44% of the patients. The minimal in-segment luminal diameter (MLD) at baseline was 2.22 mm.
At 9 months, the primary endpoint of in-segment late luminal loss was similar between the EES and SES arms, and met the predefined criteria for noninferiority (0.11 vs. 0.06 mm, p for noninferiority = 0.038). Similarly, in-stent late loss was also similar (0.19 vs. 0.15 mm, p for noninferiority = 0.012). Clinical outcomes at 12 months, including target lesion revascularization (TLR) (2.4% vs. 1.7%, p = 0.39), all-cause mortality (0.7% vs. 1.1% p = 0.48), MI (1.4% vs. 1.4%, p = 0.98), cardiac death or MI (2.1% vs. 2.5%, p = 0.63), and definite or probable stent thrombosis (0.4% vs. 0.8%, p = 0.38) were similar between the EES and SES arms, respectively. No significant interactions in various subgroups tested were noted.
The results of the EXCELLENT trial in patients with CAD from South Korea indicate that EES is noninferior to SES in inhibiting late lumen loss at 9 months and clinical outcomes including stent thrombosis at 12 months. This trial adds to recently presented data from ISAR-TEST-4 and SORT OUT IV comparing EES to SES, which also demonstrated similar outcomes between EES and SES. Further long-term follow-up data and cost-effectiveness analyses are awaited.
Park KW, Chae IH, Lim DS, et al. Everolimus-Eluting Versus Sirolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: The EXCELLENT (Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting) Randomized Trial. J Am Coll Cardiol 2011;58:1844-1854.
Presented by Dr. Hyo-Soo Kim at the Transcatheter Cardiovascular Therapeutics Meeting (TCT 2010), Washington, DC, September 25, 2010.
Clinical Topics: Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Atherosclerotic Disease (CAD/PAD), Interventions and ACS, Interventions and Coronary Artery Disease, Chronic Angina
Keywords: Coronary Artery Disease, Myocardial Infarction, Republic of Korea, Acute Coronary Syndrome, Follow-Up Studies, Angina, Stable, Immunosuppressive Agents, Constriction, Pathologic, Electrocardiography, Sirolimus, Hyperplasia, Percutaneous Coronary Intervention, Stents, Thrombosis, Diabetes Mellitus
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