Randomized Evaluation of Polytetrafluoroethylene-Covered Stent in Saphenous Vein Grafts - RECOVERS

Aug 31, 2003
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Date Published:
01/01/2003
Date Updated:
08/31/2003
Original Posted Date:
08/31/2003
References

Description:

The goal of the RECOVERS trial was to evaluate the use of a polytetrafluoroethylene (PTFE)-covered stent compared with a bare stainless steel (SS) stent on angiographic restenosis and major adverse cardiac events (MACE) in patients undergoing saphenous vein graft (SVG) intervention.

Hypothesis:

Angiographic restenosis would be lower in the PTFE-covered stent group compared with the bare SS stent group.

Study Design

Study Design:

Patients Enrolled: 301
Mean Follow Up: 6 months (clinical and angiographic follow-up)
Mean Patient Age: mean age 66 years
Female: 15%
Mean Ejection Fraction: Mean EF 56% in PTFE arm and 55% in bare stent arm (p=0.82)

Patient Populations:

Age ≥18 years; not pregnant; diagnosis of stable or unstable angina or documented silent ischemia; ejection fraction (EF) >35%; and maximum of two de novo lesions in an SVG or in two vein grafts, with a reference diameter of 2.5-5.5 mm and a stenosis of 50% to <100% that required no more than one 26-mm-long covered or bare stent each on visual estimate

Exclusions:

MI within past three days; known allergy to the study medications; single remaining bypass graft (single remaining circulation); intention to treat native vessels; and presence of large thrombus (>50% vessel diameter) in the target lesion, or a lesion located close to side anastomosis

Primary Endpoints:

Angiographic restenosis (≥50% stenosis) at six-month follow-up angiography or earlier

Secondary Endpoints:

MACE at 30 days and six months, defined as composite of death, non-Q wave MI, Q wave MI, and target lesion revascularization (coronary artery bypass graft and repeat percutaneous coronary intervention)

Drug/Procedures Used:

Randomization was stratified according to the operator decision to use glycoprotein (GP) IIb/IIIa receptor blockers. Patients were randomized to PTFE-covered stent (n=156) or the bare stent (control group, n=145).

Concomitant Medications:

Patients received aspirin 325 mg/d and ticlopidine 500 mg/d or clopidogrel 75 mg/d started by the time of randomization. During the procedure, patients received intravenous heparin to maintain an activated clotting time of 250-300 seconds, and GP IIb/IIIa inhibitors were used at the discretion of the operator. Aspirin (at least 100 mg/d) was continued indefinitely.

Patients treated with the PTFE-covered stent also received ticlopidine 500 mg/d or clopidogrel 75 mg/d for three months, and patients treated with the bare SS stent were treated for one month.

Principal Findings:

There were no differences in the angiographic success (97.4% in the PTFE arm vs. 97.9% in the bare stent arm) or procedural success between the two arms (87.3% vs. 93.8%, p=0.08). Subacute stent thrombosis occurred in two patients in the PTFE arm, and no patients in the bare stent arm. The primary endpoint of six-month restenosis was similar between the two arms (24.2% vs. 24.8%, p=0.237).

MACE at 30 days occurred more frequently in the PTFE group (10.9% vs. 4.1%, p=0.047), due mainly to an increase in myocardial infarction (MI; 10.3% vs. 3.4%, p=0.037). The six-month MACE rate did not significantly differ (23.1% vs. 15.9%, p=0.153), although non-Q wave MI occurred more frequently in the PTFE arm (12.8% vs. 4.1%, p=0.013).

Interpretation:

Among patients undergoing SVG intervention, treatment with a PTFE-covered stent was not associated with a difference in the primary endpoint of angiographic restenosis compared with a bare SS stent at six-month angiographic follow-up. MACE at 30 days was higher in the PTFE arm, driven primarily by an increase in MI.

The investigators hypothesized that the coated stent would "entrap friable degenerated material and thus decrease the risk of distal embolization." However, the higher rates of MI do not bear out this potential benefit. The results from the present randomized trial were unlike previous observational studies, which reported a beneficial effect of the PTFE stent for SVG treatment.

References:

Stankovic G, Colombo A, Presbitero P, et al. Randomized evaluation of polytetrafluoroethylene-covered stent in saphenous vein grafts: the Randomized Evaluation of polytetrafluoroethylene COVERed stent in Saphenous vein grafts (RECOVERS) trial. Circulation. 2003;108:37-42.

Keywords: Polytetrafluoroethylene, Myocardial Infarction, Stainless Steel, Follow-Up Studies, Drug-Eluting Stents, Research Personnel, Thrombosis, Saphenous Vein, Constriction, Pathologic, Stents


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