The DIABETES (Diabetes and Sirolimus Eluting Stent) Trial: One-Month Clinical Follow-up

Luis Gruberg, MD, FACC

Disclosures

December 30, 2003

Editorial Collaboration

Medscape &

Presenter: Manuel Sabate, MD, Hospital Clínico San Carlos (Madrid, Spain)

Diabetic patients exhibit a higher incidence of restenosis and major adverse cardiac events (MACE) after percutaneous coronary intervention (PCI) compared with the nondiabetic population. Although sirolimus-eluting stents have been shown to be effective for the prevention of restenosis in coronary artery lesions of low to moderate risk, their effectiveness in diabetic patients has yet to be fully elucidated.

Aim

The Diabetes and Sirolimus Eluting Stent (DIABETES) trial was conducted to assess the efficacy of sirolimus-eluting stents in diabetic patients with de novo coronary artery lesions.

Endpoints

The study's primary endpoint was in-stent and edge late lumen loss as assessed by quantitative coronary angiography at 9-month follow-up. Secondary endpoints included:

  • Mean in-stent and edge neointimal hyperplasia and percent volume obstruction as assessed by intravascular ultrasound (IVUS) at 9-month follow-up

  • MACE

  • Development of complications, such as aneurysm formation, late thrombosis, edge effect, and late stent malapposition.

It should be noted that only 1-month clinical follow-up results were reported at the meeting.

Study Design

This was a prospective, randomized, multicenter study performed in 4 medical centers in Spain. Patients were included in the study if they had diabetes (insulin or non-insulin dependent) and had lesions in a native coronary artery. Diabetic patients treated only by diet were excluded from the study, as well as patients with bifurcation lesions, saphenous vein graft lesions, in-stent restenosis, chronic renal insufficiency, previous brachytherapy, and acute coronary syndromes < 72 hours.

Results

A total of 1087 patients were screened for the study; 143 patients were eligible for participation and 140 were randomized to either the Cypher (Cordis Corporation; Miami, Florida) sirolimus-eluting stent or to a bare metal stent. There were no differences in baseline clinical characteristics between the 2 groups (Table 1).

Table 1. DIABETES: Baseline Clinical Characteristics
Sirolimus-Eluting Stent
(n = 70)
Bare Metal Stent
(n = 70)
Age (yrs) 66 67
Male (%) 60 65
Insulin-treated diabetes (%) 33 33
Non-insulin-treated diabetes (%) 67 67
Hypertension (%) 62 67
Hyperlipidemia (%) 65 61
S/P MI (%) 30 45
Prior PCI (%) 22 15
Prior CABG (%) 3 4
Ejection fraction (%) 68 64
CABG, coronary artery bypass graft surgery; MI, myocardial infarction; PCI, percutaneous coronary intervention; S/P, status post

The majority of patients had unstable angina at the time of treatment and the most frequently treated artery was the left anterior descending coronary artery followed by the right coronary artery. There were no differences in procedural characteristics between the 2 groups (Table 2).

Table 2. DIABETES: Procedural Characteristics
Sirolimus-Eluting Stent
(n = 70)
Bare Metal Stent
(n = 70)
Multivessel stenting (%) 25 26
Stenosis/patient 1.4 1.4
Stent/patient 1.5 1.7
Total occlusion (%) 13 12
Direct stenting (%) 32 39
Stent length (mm) 22 ± 11 23 ± 12
Stent size 2.8 ± 0.3 3.1 ± 0.5

In-hospital outcomes were good; only 1 fatality (cardiac rupture) and 2 non-Q-wave myocardial infarctions were reported (all in the bare metal stent arm).

Conclusions

Investigators concluded that:

  • As compared with bare metal stents, sirolimus-eluting stents may be safely implanted in diabetic patients with high-risk features, without any deleterious effects at 1-month follow-up.

  • This ongoing randomized trial will demonstrate the efficacy of this stent in the prevention of restenosis in this high-risk group of patients.

Commentary: Richard W. Nesto, MD; Burlington, Massachusetts

Diabetes has been found in all studies to be a prognostic factor for poor outcome in patients undergoing PCI. Although the present study only involves a small number of patients, it may help answer some key outstanding questions regarding the use of drug-eluting stents in diabetic patients. The selection of late loss as a primary outcome measure and the type of lesions selected in the study seem particularly appropriate. Dr. Nesto noted that it will be extremely interesting to see the outcomes of insulin-treated patients vs those of non-insulin-treated patients.

Editorial Commentary

There is not much that can be said from these 1-month clinical follow-up results of 140 patients. We know from a subgroup analysis from the Sirolimus-Eluting Stent in De Novo Native Coronary Lesions (SIRIUS) study that diabetic patients have a worse outcome with regard to restenosis rates when compared with nondiabetic patients, even in the era of drug-eluting stents.[1] As Dr. Nesto said, this is a study in a small number of patients, and it will be interesting to see the final outcome of the study.

Reference
  1. Leon MB, Holmes DR, Simonton C, et al. The impact of sirolimus-eluting stents in diabetics: Results from the SIRIUS Trial. J Am Coll Cardiol. 2003;41(Suppl II):54A. Abstract 839FO-6.

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