| restenosis after PCI | nesiritide | not classified | versus placebo or control No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PREVENT, 2000 | P-32 vs placebo | TLR 0.26 [0.09; 0.78] binary restenosis 0.21 [0.08; 0.53] | | death ∞ [NaN; ∞] MACE 0.68 [0.29; 1.59] MI 2.50 [0.33; 19.03] TVR 0.66 [0.33; 1.35] | | INHIBIT, 2002 | P-32 vs placebo | MACE 0.70 [0.49; 0.99] TVR 0.63 [0.43; 0.94] | | death 1.00 [0.29; 3.39] MI 1.00 [0.20; 4.88] | | START, 2000 | P-32 vs placebo | MACE 0.67 [0.47; 0.94] TLR 0.56 [0.38; 0.83] TVR 0.63 [0.44; 0.91] | | death 2.73 [0.29; 26.01] MI 0.52 [0.15; 1.75] |
| Trial | Treatments | Patients | Method |
|---|
| PREVENT, 2000 | intracoronary radiotherapy with the beta-emitting (32)P, 16, 20, or 24 Gy to a depth of 1 mm in the artery wall (n=80) vs. sham procedure (n=25) | patients with de novo (70%) or restenotic (30%) lesions who were treated by stenting (61%) or balloon angioplasty (39%) | double blind Parallel groups Sample size: 80/25 Primary endpoint: MACE FU duration: 6 mo The primary objective of this study was to demonstrate the safety and performance of teh studied intracoronary
radiation therapy | | INHIBIT, 2002 | intracoronary beta radiation with a phosphorus-32 source (n=166) vs. placebo (n=166) | patients with in-stent restenosis and successful coronary intervention | double blind Parallel groups Sample size: 166/166 Primary endpoint: binary angiographic restenosis FU duration: 9 mo | | START, 2000 | intracoronary radiation with 90Sr/90Y source (n=244) vs. placebo (n=232) | patients with in-stent restenosis | double blind Parallel groups Sample size: 244/232 Primary endpoint: clinically driven TVR FU duration: 8 mo |
|
