| Study | Primary End point | Secondary End point | Definition of MACE | ||
|---|---|---|---|---|---|
| Gaster 2001 (28) |
6-month Recurrence of stenosis defined as: QCA diameter stenosis ≥50% or Recurrence = QCA diameter stenosis≥ 50% + CFR<2.5+ angina or Recurrence = QCA diameter stenosis≥ 50% + FFR<0.75 + angina or TVR |
Death | Q-wave MI | Clinically driven TVR = CABG + repeat target vessel PCI | |
| Repeat angio & IVUS @ 6 months | |||||
| Gaster 2003 (29) | Rehospitalization rate MACE Length of stay | Death | Q-wave MI | Clinically driven TVR = CABG + repeat target vessel PCI | |
| OPTICUS (Mudra 2001) (21) |
6-month Binary angiographic restenosis rate (>50% ↓ lumen diameter) MLD % Diameter stenosis |
1, 6 & 12 month MACE Fulfillment of ultrasound & angiographic target criteria |
Death | Q-wave MI | Clinically driven TLR= CABG + repeat PTCA |
| SIPS (Frey 2000) (25) | 6-month angiographic MLD | Acute MLD Acute & chronic cost QOL, 2-year MACE & clinically driven TLR |
Death | MI | (Total) TVR = CABG +re PTCA |
| SIPS (Mueller 2003) (24) | MACE at 28 months | 6-month angiographic restenosis rate | Death | MI | Clinically driven TLR |
| RESIST (Schiele 1998) (22) | 6-month angiographic restenosis rate (>50% stenosis) stent+5mm proximal or distal by QCA | 6 month angiographic MLD & IVUS CSA | |||
| RESIST (Schiele 2000) (23) | Six-month angiographic end points & 18 month MACE | Death | MI | TVR =CABG + re PTCA (18 month) | |
| TULIP(Oemrawsingh, 2003) (26) (long lesion) | Angiographic MLD MACE @ 6 month | Angiographic & procedural success, Angiographic restenosis & %diameter stenosis @ 6 months MACE @ 12 months |
C. Death | MI | Ischemia driven TLR |
| AVID Abstract 1997 (31) 2000 (27) | TLR @ 12 months | TLR (driven by?) | |||
| Studies on Unprotected Left Main Coronary Artery | |||||
| Park 2001 (32) | MACE | C. Death | MI* | TLR | |
| Agostoni 2005 (33) | Occurrence of MACE @ median follow-up of 433 days | - | All Death | MI* | TVR = CABG + re PTCA in stent+5mm distal or proximal |
CFR = coronary flow reserve
FFR = fractional flow reserve
CABG = coronary artery bypass graft
TLR = Target lesion revascularization
TVR = Target vessel revascularization
C. death = Cardiac death
rePTCA = repeat percutaneous transluminal coronary angioplasty
*
Non-fatal