ENDEAVOR I: Safety and Efficacy of the ABT-578-Coated Endeavor Stent -- 12-Month Follow-up
ENDEAVOR I: Safety and Efficacy of the ABT-578-Coated Endeavor Stent -- 12-Month Follow-up
Presenter: Ian T. Meredith, MD, Monash Medical Centre (Melbourne, Australia)
The Endeavor (Medtronic, Minneapolis, Minnesota) drug-eluting stent is made of cobalt alloy and is coated with a phosphorylcholine coating (PC) technology that has the capability to deliver ABT-578, a rapamycin analog that inhibits cellular proliferation, thereby preventing restenosis.
ENDEAVOR I is a 100-patient, prospective, multicenter study designed to evaluate the safety and efficacy of the Endeavor stent in patients with de novo, simple, native coronary artery lesions (type A-B2, 3.0-3.5 mm reference vessel diameter, < 15 mm lesion length).
Primary Endpoint
Safety Endpoint
Baseline characteristics of patients enrolled in ENDEAVOR are shown in Table 1.
Table 1. ENDEAVOR I: Baseline Clinical Characteristics
MI = myocardial infarction; S/P = status post
The results at 30 days remained consistent throughout 4- and 12-month follow-up, with no clinical events reported beyond the first 4 months of follow-up. There were no reported deaths at any time during the follow-up period; 1% of patients experienced myocardial infarction (MI), all of which were non-Q wave; and TVF was reported in 2% of patients at 4 months and remained unchanged at 12 months (Table 2).
Table 2. ENDEAVOR I: Hierarchical MACE
MACE = major adverse cardiac events; MI = myocardial infarction; TLR = target lesion revascularization; TVF = target vessel failure; TVR = target vessel revascularization
In-stent and in-segment late loss increased from 4- to 12-month follow-up (Figure), but there was no edge effect or late stent malapposition. At 12 months, binary restenosis was 3.3% and percent volume obstruction was 9.7%.
Figure. ENDEAVOR I: late loss at 4- and 12-month follow-up.
Conclusions
On the basis of the ENDEAVOR I study, investigators concluded:
This preliminary study in a small number of patients with very simple lesions (reference vessel diameter 3-3.5 mm and lesion length < 15 mm) provided satisfactory clinical results. Due to the in-stent late loss observed, it will be crucial to follow the outcome of patients with more complex lesions treated with the Endeavor stent in other studies making up the ENDEAVOR stent program. However, at this point in time, it may be too early to speculate on the clinical implications of the increased late loss.
The Endeavor (Medtronic, Minneapolis, Minnesota) drug-eluting stent is made of cobalt alloy and is coated with a phosphorylcholine coating (PC) technology that has the capability to deliver ABT-578, a rapamycin analog that inhibits cellular proliferation, thereby preventing restenosis.
ENDEAVOR I is a 100-patient, prospective, multicenter study designed to evaluate the safety and efficacy of the Endeavor stent in patients with de novo, simple, native coronary artery lesions (type A-B2, 3.0-3.5 mm reference vessel diameter, < 15 mm lesion length).
Primary Endpoint
Major adverse cardiac events (MACE) at 30 days and late loss at 4 months by quantitative coronary angiography.
Safety Endpoint
Target vessel failure (TVF) and target lesion revascularization (TLR) at 12 months.
Late loss at 12 months by intravascular ultrasound at 4 and 12 months.
Baseline characteristics of patients enrolled in ENDEAVOR are shown in Table 1.
Table 1. ENDEAVOR I: Baseline Clinical Characteristics
| Characteristic | Patients (N = 100) |
|---|---|
| Age (yrs) | 59 |
| Male (%) | 79 |
| Diabetes (%) | 16 |
| Unstable angina (%) | 39 |
| Hyperlipidemia (%) | 92 |
| Smoker (%) | 34 |
| S/P MI (%) | 47 |
The results at 30 days remained consistent throughout 4- and 12-month follow-up, with no clinical events reported beyond the first 4 months of follow-up. There were no reported deaths at any time during the follow-up period; 1% of patients experienced myocardial infarction (MI), all of which were non-Q wave; and TVF was reported in 2% of patients at 4 months and remained unchanged at 12 months (Table 2).
Table 2. ENDEAVOR I: Hierarchical MACE
| N = 100 | 30 Days | 4 Months | 12 Months |
|---|---|---|---|
| Death | 0 | 0 | 0 |
| MI (%) | 1 | 1 | 1 |
| Q wave | 0 | 0 | 0 |
| Non-Q wave | 1 | 1 | 1 |
| TLR (%) | 0 | 1 | 1 |
| TVR (%) | 0 | 0 | 0 |
| TVF (%) | 0 | 2 | 2 |
| MACE (%) | 1 | 2 | 2 |
In-stent and in-segment late loss increased from 4- to 12-month follow-up (Figure), but there was no edge effect or late stent malapposition. At 12 months, binary restenosis was 3.3% and percent volume obstruction was 9.7%.
On the basis of the ENDEAVOR I study, investigators concluded:
The Endeavor stent is a safe device that is associated with low MACE rates at 12 months.
There were no cases of late thrombosis.
This stent was effective, with only mild in-stent and in-segment restenosis rates and no edge effect.
The results provide a strong platform for further clinical trials in more complex lesion subsets.
This preliminary study in a small number of patients with very simple lesions (reference vessel diameter 3-3.5 mm and lesion length < 15 mm) provided satisfactory clinical results. Due to the in-stent late loss observed, it will be crucial to follow the outcome of patients with more complex lesions treated with the Endeavor stent in other studies making up the ENDEAVOR stent program. However, at this point in time, it may be too early to speculate on the clinical implications of the increased late loss.
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