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Clinical Care/Education/Nutrition/Psychosocial Research

Head-to-Head Comparison of Sirolimus- and Paclitaxel-Eluting Stent in the Same Diabetic Patient With Multiple Coronary Artery Lesions

A prospective, randomized, multicenter study

  1. Fabrizio Tomai, MD1,
  2. Bernhard Reimers, MD2,
  3. Leonardo De Luca, MD1,
  4. Alfredo R. Galassi, MD3,
  5. Achille Gaspardone, MD4,
  6. Anna S. Ghini, MD1,
  7. Valeria Ferrero, MD5,
  8. Luca Favero, MD2,
  9. Gaetano Gioffrè, MD4,
  10. Francesco Prati, MD6,
  11. Corrado Tamburino, MD3 and
  12. Flavio Ribichini, MD5
  1. 1Division of Cardiology, Department of Cardiovascular Sciences, European Hospital, Rome, Italy
  2. 2Cardiology Department, Mirano Hospital, Mirano, Italy
  3. 3Division of Cardiology, Department of Internal Medicine and Systemic Disease, Ferrarotto Hospital, University of Catania, Catania, Italy
  4. 4Division of Cardiology, S. Eugenio Hospital, Rome, Italy
  5. 5Institute of Cardiology, University of Verona, Verona, Italy
  6. 6Catheterization Laboratory, S. Giovanni Hospital, Rome, Italy
  1. Address correspondence and reprint requests to Fabrizio Tomai, MD, Division of Cardiology, Department of Cardiovascular Sciences, European Hospital, Via Portuense 700, 00149 Rome, Italy. E-mail: f.tomai{at}tiscali.it
Diabetes Care 2008 Jan; 31(1): 15-19. https://doi.org/10.2337/dc07-1377
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    Figure 1—

    Cumulative rates of in-stent LLL at follow-up angiography.

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  • Table 1—

    Baseline characteristics of the total study population

    CharacteristicsTotal population
    n60
    Age (years)65.2 ± 10
    Sex (male)44 (73.3)
    Type 1 diabetes7 (11.6)
    Type 2 diabetes53 (88.4)
    Diagnosis of diabetes (months)79.5 ± 64.1
    Fasting insulin (pmol/l)36.3 ± 12.3
    Preprocedural A1C (%)7.6 ± 1.8
    Preprocedural glycemia (mg/dl)164 ± 74.5
    Hypertension49 (81.6)
    Current smoker12 (20)
    Family history of CAD22 (36.6)
    Total cholesterol (mg/ml)179.5 ± 45.7
    Triglycerides (mg/dl)155 ± 103.2
    Chronic renal insufficiency*13 (21.6)
    Previous MI26 (43.3)
    Previous CABG2 (0.3)
    Previous PCI3 (0.5)
    ACS32 (53.3)
    Troponin I (ng/ml)0.4 ± 1.8
    Creatine kinase–MB isoenzyme (ng/ml)155 ± 5.4
    CRP (mg/dl)0.9 ± 1.2
    Multivessel disease55 (91.6)
    Ejection fraction (%)54.5 ± 8.6
    Sulphonil ureas21 (35)
    Biguanide25 (41.6)
    Other antidiabetes drugs8 (13.3)
    Statins48 (80)
    ACE inhibitors or ARBs50 (83.3)
    Aspirin53 (88.3)
    Thienopyridine-derived agents48 (80)
    Glycoprotein IIb/IIIa8 (13.3)
    Calcium channel blockers21 (35)
    β-blockers36 (60)
    • Data are means ± SD or n (%). ARB, angiotensin receptor blocker; ACS, acute coronary syndrome; CAD, coronary artery disease; CABG, coronary artery bypass grafing; CRP, C-reactive protein; MI, myocardial infarction.

    • ↵* Defined as a serum creatinine level ≥1.5 mg/dl (≥132 μmol/l).

  • Table 2—

    Angiographic and procedural characteristics

    CharacteristicsSESPESP
    n6060
    DES implanted69670.8
    Location of treated lesion0.45
        Left anterior descending coronary     artery21 (35)27 (45)
        Left circumflex coronary artery21 (35)20 (33)
        Right coronary artery18 (30)13 (22)
    Vessel site0.58
        Proximal29 (48)26 (43)
        Middle distal31 (52)34 (57)
    Lesion type0.2
        A-B130 (50)23 (38)
        B2-C30 (50)37 (62)
    CTO1 (1.7)2 (3.3)0.9
    Bifurcation lesions0.8
        1 DES9 (15)11 (18.3)
        2 DES2 (3.3)1 (1.6)
    Baseline TIMI flow0.9
        03 (5)4 (6.7)
        113 (21.7)12 (20)
        211 (18.3)11 (18.3)
        333 (55)33 (55)
    Post-procedural TIMI flow0.2
        11 (1.7)1 (1.7)
        203 (5)
        359 (98.3)56 (93.3)
    Direct stenting23 (38.3)15 (25)0.1
    Postdilation10 (16.7)16 (26.7)0.2
    Stent length (mm)25.7 ± 14.226.1 ± 11.80.9
    Stent diameter (mm)2.96 ± 0.32.97 ± 0.30.9
    Lesion length (mm)21.8 ± 15.719.7 ± 8.10.3
    Reference vessel diameter (mm)2.9 ± 0.42.9 ± 0.30.7
    Preprocedural MLD (mm)0.9 ± 0.30.87 ± 0.30.5
    Postprocedural MLD (mm)2.9 ± 0.32.9 ± 0.30.7
    In-lesion acute gain (mm)1.9 ± 0.32.0 ± 0.40.1
    Preprocedural diameter stenosis (%)66.9 ± 10.567.7 ± 10.60.7
    Postprocedural diameter stenosis (%)4.3 ± 3.24.4 ± 3.60.8
    Stent volume (mm3)177 ± 104184 ± 840.7
    • Data are means ± SD, n, or n (%). CTO, chronic total occlusion; TIMI, thrombolysis in myocardial infarction.

  • Table 3—

    Angiographic findings at follow-up among the 59 patients alive at 8 months

    Quantitative coronary angiography dataSESPESP
    n5959
    In-stent restenosis3 (5.1)5 (8.5)0.5
    In-lesion restenosis5 (8.5)8 (13.5)0.4
    In-stent diameter stenosis (%)11.2 ± 14.617.2 ± 18.80.05
    In-lesion diameter stenosis (%)15.2 ± 19.920.5 ± 21.40.2
    In-stent MLD (mm)2.6 ± 0.52.4 ± 0.60.05
    In-lesion MLD (mm)2.5 ± 0.72.3 ± 0.70.1
    In-stent LLL (mm)0.26 ± 0.40.50 ± 0.60.01
    In-lesion LLL (mm)0.41 ± 0.60.68 ± 0.60.04
    Lumen volume (mm3)159 ± 105142 ± 610.3
    Neointimal volume (mm3)17.6 ± 28.641.9 ± 51.30.002
    Neointimal obstruction (%)10.2 ± 15.519.5 ± 19.30.005
    • Data are means ± SD, percentages, or n (%).

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Head-to-Head Comparison of Sirolimus- and Paclitaxel-Eluting Stent in the Same Diabetic Patient With Multiple Coronary Artery Lesions
Fabrizio Tomai, Bernhard Reimers, Leonardo De Luca, Alfredo R. Galassi, Achille Gaspardone, Anna S. Ghini, Valeria Ferrero, Luca Favero, Gaetano Gioffrè, Francesco Prati, Corrado Tamburino, Flavio Ribichini
Diabetes Care Jan 2008, 31 (1) 15-19; DOI: 10.2337/dc07-1377

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Head-to-Head Comparison of Sirolimus- and Paclitaxel-Eluting Stent in the Same Diabetic Patient With Multiple Coronary Artery Lesions
Fabrizio Tomai, Bernhard Reimers, Leonardo De Luca, Alfredo R. Galassi, Achille Gaspardone, Anna S. Ghini, Valeria Ferrero, Luca Favero, Gaetano Gioffrè, Francesco Prati, Corrado Tamburino, Flavio Ribichini
Diabetes Care Jan 2008, 31 (1) 15-19; DOI: 10.2337/dc07-1377
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