Table 1B.
Studies on antithrombotic therapy in patients after peripheral revascularization.
| Study name | Patients, number of patients with PAD | Comparison | Primary endpoint | Safety endpoint |
|---|---|---|---|---|
| Management of peripheral arterial interventions with mono or dual antiplatelet therapy (MIRROR) (18) | PAD after peripheral intervention N=80 | Clopidogrel 75 mg or placebo in addition to ASA 100 mg | Platelet activation Clopidogrel of placebo ß-TG 365.5 vs. 224.5 (P = 0.03) CD40L was 127 and 206.5 (P = 0.05) |
Bleeding Clopidogrel vs. placebo N = 1 vs. N = 2 minor bleedings (P = ns) |
| The Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) (19) | PAD after peripheral intervention N = 200 |
Cilostazol with ASA 100 mg vs. placebo with ASA 100 mg | Restenosis Cilostazol vs. placebo OR [95% CI] = 0.26 [0.13–0.53] (P = 0.0001) |
Bleeding risk similar in both groups, no detailed information in the publication |
| Edoxaban in Peripheral Arterial Disease (ePAD) (20) | PAD after peripheral intervention N=203 | Edoxaban vs. placebo | Restenosis / reocclusion Edoxaban vs. placebo RR [95% CI] = 0.89 [0.59–1.34] (P = ns) |
Major bleeding (TIMI) Edoxaban vs. placebo RR [95% CI] = 0.56 [0.19–1.62] (P = ns) |
| Dutch BOA (the Dutch Bypass Oral anticoagulants or Aspirin) (21) | PAD after bypass surgery N = 2,690 | VKA vs. ASA 80 mg o.d. | Graft occlusion VKA vs. ASA 80 mg HR [95% CI] = 0.95 [0.82–1.11] (P = ns) |
Major bleeding HR [95% CI] = 1.96 [1.42–2.71] (P < 0.001) |
| Sarac et al. (22) | PAD after bypass surgery N = 56 |
ASA vs. VKA and ASA 325 mg o.d. | Primary graft patency (3 years) VKA vs. VKA and ASA 51 vs. 74% (P = 0.04) |
Haematoma VKA vs. VKA and ASA 4 vs. 32% (P < 0.05) |
| CASPAR (Clopidogrel and Acetylsalicylacid in Bypass Surgery for Peripheral Arterial Disease) (23) | PAD after bypass surgery (below the knee) N = 851 | Clopidogrel 75 mg o.d. vs. placebo in addition to ASA 75–100 mg | Graft occlusion, index bypass revision, index leg amputation Clopidogrel vs. placebo HR [95% CI] = 0.98 (0.78–1.23) (P = ns) |
Moderate or severe bleeding Clopidogrel vs. placebo HR [95% CI] = 2.84 [1.32–6.08] (P = 0.007) |
| Vascular Outcomes Study of Aspirin along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD (VOYAGER PAD) (9, 24, 25) | After endovascular or surgical revascularization N = 6,564 | ASA 100 mg o.d. or Rivaroxaban 2.5 mg b.d. and ASA 100 mg | MACE, acute limb ischemia or amputation ASA + rivaroxaban vs. ASA HR [95% CI] = 0.85 [0.76–0.96] (P = 0.009) |
Major bleeding (ISTH) ASA + rivaroxaban vs. ASA HR [95% CI] = 1.42 [1.10–1.84]; (P = 0.007) |
Significant P-values are displayed in bold.
PAD, peripheral arterial disease; CVD, cardiovascular disease; MI, myocardial infarction; ASA, acetylic salicylic acid; VKA, vitamin K antagonists; MACE, Major adverse cardiovascular event; MALE, Major adverse limb event. RR, relative risk; HR, hazard ratio; OR, odds ratio; CI, confidence interval; ICH, intracranial hemorrhage; GIB, gastrointestinal bleeding; o.d., omne in die, once daily; b.d., bis in die, twice daily.