Table 1:
Best evidence papers
| Author, date, journal and country Study type (level of evidence) |
Patient group | Outcomes | Key results | Comments |
|---|---|---|---|---|
| Patti et al. (2008), Am J Cardiol, Italy [2] Meta-analysis (level 1) |
Meta-analysis of 9 randomized, clinical trials (RCT) evaluating outcome after DES vs BMS implantation in diabetic patients with a follow-up of ≥6 months (1141 patients) |
Death (cardiac and non-cardiac causes) Myocardial infarction (Q-wave and non-Q-wave) In-stent restenosis TVR Stent thrombosis |
DES vs BMS: 2.4 vs 2.3%, (P = 0.91) DES vs BMS: 3.5 vs 7.2% (52% risk decrease, P = 0.02) DES vs BMS: 8 vs 41% (OR = 0.13, 95% CI 0.09–0.20, P < 0.00001) DES vs BMS: 8 vs 27% (OR = 0.23, 95% CI 0.16–0.33, P < 0.00001) DES vs BMS: 1.1 vs 1.2%, (P = 0.98) |
This meta-analysis demonstrates that, in diabetic patients, DESs are superior to BMSs with regards to in-stent restenosis, TVR and myocardial infarction, and that there is no significant difference in stent thrombosis and mortality |
| Stettler et al. (2008), BMJ, Switzerland, Italy, Germany, UK, Netherlands, USA, Denmark, Spain, Belgium, Latvia [7] Meta-analysis (level 1) |
Meta-analysis of 35 RCTs comparing DESs (Sirolimus or Paclitaxel) with BMSs in diabetic patients with signs or symptoms of myocardial ischaemia and a follow-up of ≥6 months Restricting the analysis to trials with a duration of dual antiplatelet therapy of ≥6 months (3852 patients) |
Overall mortality Myocardial infarction TVR Stent thrombosis (as per protocol in individual trials) |
Sirolimus ES vs BMS: HR = 0.88, 95% CI 0.55–1.30 Paclitaxel ES vs BMS: HR = 0.91, 95% CI 0.60–1.38 Sirolimus ES vs BMS: HR = 0.68, 95% CI 0.43–1.12 Paclitaxel ES vs BMS: HR = 0.85, 95% CI 0.54–1.43 Sirolimus ES vs BMS: HR = 0.29, 95% CI 0.19–0.45 Paclitaxel ES vs BMS: HR = 0.38, 95% CI 0.26–0.56 Sirolimus ES vs BMS: HR = 0.20, 95% CI 0.05–0.68 Paclitaxel ES vs BMS: HR = 0.73, 95% CI 0.19–2.80 |
This meta-analysis indicates that both types of DESs are superior to BMS with respect to TVR in diabetic patients undergoing PCI. Furthermore, this study shows that DESs are not associated with an increased risk of myocardial infarction or mortality when compared with BMSs |
| Kimura et al. (2008), Am J Cardiol, USA, UK, Germany [4] Meta-analysis (level 1) |
Meta-analysis of 3 RCTs used serial intravascular ultrasound to compare Paclitaxel ES and BMS with respect to in-stent neointima formation (Diabetes was present in 273 of 956 patients) |
In-stent late loss (mm) In-stent diameter stenosis (%) In-segment late loss (mm) In-segment diameter stenosis (%) |
BMS vs Paclitaxel ES: 1.05 vs 0.48 (P < 0.0001) BMS vs Paclitaxel ES: 43.6 vs 22.5 (P < 0.0001) BMS vs Paclitaxel ES: 0.69 vs 0.29 (P < 0.0001) BMS vs Paclitaxel ES: 46.9 vs 32.3 (P < 0.0001) |
This meta-analysis shows that the use of Paclitaxel-eluting stents in diabetic patients is associated with reduced in-stent and in-segment stenosis when compared with BMSs |
| Kumbhani et al. (2008), Am Heart J, USA [5] Meta-analysis (level 1) |
Meta-analysis of 16 RCTs comparing either the Paclitaxel- or Sirolimus-eluting stent with the BMS or with each other in diabetic patients during a follow-up of at least 6 months (2951 patients) |
TVR Major adverse cardiovascular events In-segment restenosis Non-Q-wave myocardial infarction Q-wave myocardial infarction Stent thrombosis Death |
DES vs BMS: RR = 0.35, 95% CI 0.27–0.46 (P < 0.0001) DES vs BMS: RR = 0.42, 95% CI 0.31–0.56 (P < 0001) DES vs BMS: RR = 0.31, 95% CI 0.25–0.40 (P < 0.0001) DES vs BMS: RR = 0.57, 95% CI 0.32–0.99 (P = 0.046) DES vs BMS: RR = 0.72, 95% CI 0.25–2.07 (P = 0.54) DES vs BMS: RR = 0.41, 95% CI 0.13–1.27 (P = 0.12) DES vs BMS: RR = 0.64, 95% CI 0.32–1.28 (P = 0.20) |
This study demonstrates that diabetic patients who receive DESs have a significantly lower incidence of TVR, in-segment restenosis and myocardial infarction at 6–12 months, compared with BMSs and that there is no difference in mortality and stent thrombosis |
| Kirtane et al. (2008), J Am Coll Cardiol. USA, UK, Italy Germany [6] Pooled analysis (level 1) |
Pooled analysis of 5 RCTs of Paclitaxel ESs vs BMSs in single, non-complex lesions over a 4-year follow-up (827 of 3513 patients were diabetic) |
Death Myocardial infarction Stent thrombosis TVR |
Paclitaxel ES vs BMS: 8.4% vs 10.3% (P = 0.61) Paclitaxel ES vs BMS: 6.9 vs 8.9% (P = 0.17) Paclitaxel ES vs BMS: 1.4 vs 1.2% (P = 0.92) Paclitaxel ES vs BMS: 12.4 vs 24.7% (P < 0.0001) |
This study showed that there was no significant difference between DESs and BMSs in terms of mortality, in-stent restenosis and stent thrombosis. On the other hand, the study demonstrates DESs require significantly less target lesion revascularization |
| Boyden et al. (2007), Am J Cardiol, USA [3] Meta-analysis (level 1) |
Meta-analysis of 8 RCTs comparing either Paclitaxel or Sirolimus ESs vs BMSs in diabetic patients and providing data on ≥1 of the following outcomes: late lumen loss, in-stent restenosis or target lesion revascularization (1520 patients) |
Mean late lumen losses In-stent restenosis TVR |
BMS vs DES: 0.93 mm (95% CI 0.51–1.34) vs 0.18 mm (95% CI 0.08–0.45) BMS vs DES: 42% (239/569) vs 5.9% (30/510). 86% decrease in risk of developing restenosis (RR = 0.14, 95% CI 0.10–0.22, [P < 0.001]) BMS vs DES: 22.9% (177/773) vs 7.5% (53/703). 66% decrease in the need for TVR (RR = 0.34, 95% CI 0.26–0.45, [P < 0.001]) |
This study shows that, in diabetic patients, DESs are superior to BMSs with respect to late lumen loss, in-stent restenosis and target lesion revascularization |
| Bangalore et al. (2012), BMJ, USA, Germany [8] Meta-analysis (level 1) |
Meta-analysis of 42 RCTs comparing different DESs (Sirolimus, Paclitaxel, Everolimus and Zotarolimus) vs BMSs (in de novo coronary lesions). In 34 of the 42 trials, clopidogrel was used for at least 6 months in the drug-eluting stents arm (10 714 patients) |
TVR Death Myocardial infarction Any stent thrombosis |
BMS vs Sirolimus ES: RR = 0.34 (95% CI 0.25–0.44) BMS vs Paclitaxel ES: RR = 0.46 (95% CI 0.34–0.63) BMS vs Everolimus ES: RR = 0.28 (95% CI 0.15–0.45) BMS vs Zotarolimus ES: RR = 0.77 (95% CI 0.47–1.31) BMS vs Sirolimus ES: RR = 1.00 (95% CI 0.73–1.39) BMS vs Paclitaxel ES: RR = 0.96 (95% CI 0.70–1.38) BMS vs Everolimus ES: R = 0.83 (95% CI 0.42–1.46) BMS vs Zotarolimus ES: RR = 1.14 (95% CI 0.58–2.27) BMS vs Sirolimus ES: RR = 0.71 (95% CI 0.49–1.05) BMS vs Paclitaxel ES: RR = 0.82 (95% CI 0.21–1.09) BMS vs Everolimus ES: RR = 0.52 (95% CI 0.21–1.09) BMS vs Zotarolimus ES: RR = 2.16 (95% CI 0.91–8.45) BMS vs Sirolimus ES: RR = 0.64 (95% CI 0.36–1.14) BMS vs Paclitaxel ES: RR = 0.78 (95% CI 0.45–1.54) BMS vs Everolimus ES: RR = 0.56 (95% CI 0.20–1.46) BMS vs Zotarolimus ES: RR = 2.75 (95% CI 0.60–14.85) |
This study shows that in diabetic patients who have undergone PCI; Sirolimus, Paclitaxel and Everolimus ESs are superior to BMSs with regards to target lesion revascularization. Zotarolimus was not shown to be superior. Death, myocardial infarction and stent thrombosis were all non-significant |
DES: drug-eluting stent; BMS: bare-metal stent; TVR: target vessel revascularization; PCI: percutaneous coronary intervention.