Sirolimus-eluting stents inhibit neointimal hyperplasia in diabetic patients. Insights from the RAVEL Trial.
Patients with diabetes mellitus have less favourable outcomes after percutaneous coronary intervention (PCI) than non-diabetics. We performed a subgroup analysis of the multicentre RAVEL trial to examine the impact of the sirolimus-eluting stent (SES) on outcomes in diabetic patients. The RAVEL study randomized 238 patients to treatment with either sirolimus-eluting or bare metal stents. Forty-four patients were diabetic; 19 received sirolimus-eluting stents and 25 were treated with bare metal stents. The differences in outcomes between diabetic and non-diabetic patients treated with SES (n=101) were also assessed. Follow-up angiography was performed at 6 months. Major adverse cardiac events (MACE) defined as death, myocardial infarction (MI), or target lesion revascularization (TLR) were analysed at 12-month follow-up. Six-month in-stent late lumen loss was significantly lower for the diabetic SES than the bare stent group (0.07+/-0.2 vs 0.82+/-0.5mm; P<0.001) and similar to that in non-diabetics treated with SES (-0.03+/-0.27mm). There was zero restenosis in the SES groups (diabetic and non-diabetic) compared to a 42% rate in the diabetic population assigned to bare metal stents (P=0.001). After 12 months, there was one non-Q-wave MI and one non-cardiac death in the diabetic SES group, while 12 patients in the bare metal stent group had MACE (one death, two MI, nine TLR) (P=0.01)-an event-free survival rate of 90% vs 52%, respectively (P<0.01). There were no TLRs in both SES groups compared to 36% rate in the diabetic bare metal stent group (P=0.007). Conclusion Diabetics treated with SES were associated with a virtual abolition of neointimal proliferation and low event rates at long-term follow-up.
Abizaid
Alexandre
A
Institute Dante Pazzanese of Cardiology, Sao Paulo, Brazil. aabizaid@uol.com.br
Costa
Marco A
MA
Blanchard
Didier
D
Albertal
Mariano
M
Eltchaninoff
Hélèn
H
Guagliumi
Giulio
G
Geert-Jan
Laarman
L
Abizaid
Andrea S
AS
Sousa
Amanda G M R
AG
Wuelfert
Egon
E
Wietze
Lindeboom
L
Sousa
J Eduardo
JE
Serruys
Patrick W
PW
Morice
Marie-Claude
MC
D023903:Coronary Restenosis / Q000473:pathology / Q000517:prevention & control; D023921:Coronary Stenosis / Q000188:drug therapy* / Q000473:pathology; D003925:Diabetic Angiopathies / Q000188:drug therapy*; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006965:Hyperplasia / Q000188:drug therapy; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D017539:Tunica Intima / Q000473:pathology*
D007166:Immunosuppressive Agents; D020123:Sirolimus