Diabetes mellitus in patients undergoing percutaneous drug-eluting stent implantation: short and long-term results Claudio Moretti, M.D. Division of Cardiology, University of Turin, Turin, Italy on behalf of the University of Turin Registry Investigators: G. Longo, F. D’Ascenzo, A. Gonella, A. Pullara, G. Biondi Zoccai, F. Sciuto, P.L. Omedè, G. P. Trevi, I. Sheiban

Background The introduction of drug-eluting stents (DES) has markedly improved mid-term results of percutaneous coronary intervention (PCI) in diabetics. Furthermore it is unclear whether the risk-benefit balance of DES in diabetics is maintained also at long-term and in insulin requiring patients. We aimed to appraise long-term outcomes of diabetic patients treated with PCI with DES, stratifying according to insulin therapy.

Methods Patients undergoing PCI with DES from July 2002 to June 2004 at our center, and thus eligible for at least 5-year follow-up N=1277 insulin-requiring diabetics 37/1277 (3%) without diabetes 954/1277 (75%) non-insulin-requiring diabetics 275/1277 (22%)

Methods The primary end-point was the long-term rate of major adverse cardiac events (MACE, ie the composite of death, myocardial infarction, or target vessel revascularization). Secondary end-points were the individual components of MACE, as well as death divided according to its etiology. We also considered stent thrombosis according to the Academic Research Consortium definitions.

Clinical characteristics of patients 30% 81% 34% 75% 54% 32% There were significant differences across groups in prevalence of male gender (respectively, 32%, 81% and 75%, p<0.001), and DES usage (54%, 34% and 30%, p=0.007).

Age of patients The mean age of patients is comparable in the three groups.

Early clinical outcomes 30-day MACE occurred with similar frequency in the three groups (8%, 7% and 6%, p=0.78), with death in 3%, 2%, and 1% (p=0.71) and myocardial infarction in 5%, 2% and 1% (p=0.02).

INSULIN-REQUIRING DIABETICS NON-INSULIN-REQUIRING DIABETICS 30-DAY OUTCOMES INSULIN-REQUIRING DIABETICS NON-INSULIN-REQUIRING DIABETICS WITHOUT DIABETICS P MACE 3/37 (8,.1%) 20/275 (7.3%) 60/954 (6.3%) 0.78 Death 1/37 (2.7%) 5/275 (1.8%) 13/954 (1.4%) 0.71 Sudden death 0/37 (0%) 1/275 (0.4%) 5/954 (0.5%) 086 Non-sudded ischemic death 3/275 (1.1%) 7/954 (0.7%) Non-ischemic cardiac death 0/275 (0%) 0/954 (0%) <0.001 Non-cardiac vascular death Non-cardiovascular death 0.16 Myocardial infarction 2/37 (5.4%) 8/954 (0.8%) 0.02 non Q 2/275 (0.7%) 0.25 Q 2/954 (0.2%) 0.85 Repeat PCI 10/275 (3.6%) 43/954 (4.5%) CABG Stroke 4/954 (0.4%) 0.51 Stent thrombosis 9/954 (0.9%) 0.31 Definite Probable Possible

30- days outcomes: causes of death

Late clinical outcomes After a median follow-up period of 58 months, MACE occurred in 59% of patients with insulin-requiring diabetes, in 51% of non-insulin-requiring diabetics, and in 39% of non-diabetics (p<0.001), with death in 24%, 17% and 9% (p<0.001), myocardial infarction in 11%, 7%, and 5% (p=0.25), repeat revascularization in 46%, 32%, and 30% (p=0.11), and definite stent thrombosis occurred in in 0%, 1%, and 1% (p=0.78).

<0.001 0.001 0.034 LATE CLINICAL OUTCOMES MACE Death Sudden death INSULIN-REQUIRING DIABETICS NON-INSULIN-REQUIRING DIABETICS WITHOUT DIABETICS P MACE 22/37 (59.5%) 139/275 (50.6%) 371/954 (38.9%) <0.001 Death 9/37 (24.3%) 48/275 (17.5%) 81/954 (8.5%) Sudden death 1/37 (2.3%) 10/275 (3.6%) 18/954 (1.9%) 0.229 Non-sudden ischemic death 0/37 (0%) 9/275 (3.3%) 17/954 (1.8%) 0,206 Non-ischemic cardiac death 2/37 (5.4%) 11/954 (1.5%) Non-cardiac vascular death 2/275 (0.7%) 10/954 (1.1%) 0.74 Non-cardiovascular death 5/37 (13.5%) 16/275 (5.8%) 35/954 (3.7%) 0.007 Myocardial infarction 4/37 (10.8%) 18/275 (6.6%) 49/954 (5.1%) 0.25 non Q 1/37 (2.7%) 27/954 (2.8%) 0.93 Q 6/275 (2.2%) 2/954 (0.2%) 0.001 Repeat PCI 17/37 (45.9%) 87/275 (31.6%) 285/954 (29.7%) 0.12 CABG 16/954 (1.7%) Stroke 0/37 (2.7%) 5/275 (1.8%) 25/954 (2.6%) 0.47 Stent thrombosis 1/37 (0%) 16/954 (1.6%) 0.79 Definite 3/275 (1.1%) 12/954 (1.2%) 0.78 Probable 0.034 Possible 1/275 (0.4%) 0.86

Late clinical outcomes: causes of death

Conclusions This long-term retrospective study emphasizes the very high risk of long-term adverse events faced by insulin requiring and non-insulin-requiring diabetics undergoing PCI with DES. Further research on additional pharmacologic treatments or hybrid revascularization strategies to mitigate their burden of morbidity and mortality is warranted.

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