Study | Method of Randomization/ Concealment |
Spectrum | Blinding – patient & operator | Interpretation of CAG, IVUS & clinical outcomes | Documentary IVUS in Angio group | Statistical Power | ITT |
---|---|---|---|---|---|---|---|
Gaster 2001, 2003 (28) | Drawing lots from sealed opaque envelops Concealed |
Males with stable angina scheduled for PCI | No | CAG – blinded IVUS- unblinded Clinical assessment-blinded |
Yes | No stated | Yes |
SIPs 2000 (25) | Day-to-day block schedule each morning Concealment not stated |
All patients undergoing PTCA or primary stenting in vessel 2.2–4.6 mm in diameter |
No | Not stated | Not stated | Powered to detect 0.104mm chronic difference in MLD | Yes |
OPTICUS 2001 (21) | By fax from central office before start of procedure Concealed |
Patients with angina or documented ischemia, no long lesions or small vessel | No | Angiographic & IVUS measured blind | Not stated | Powered to detect 10% absolute ↓ in binary restenosis rate | Yes |
RESIST 1998, (22) 2000 (23) | After satisfactory QCA stent deployment Method of randomization unknown Concealment unknown |
Symptomatic CAD>70% stenosis in 1 or more coronary undergoing PTCA+ stenting | No | Angio analysis blinded to IVUS results | Yes | 40% power to detect a 15% absolute ↓ in restenosis rate | Yes |
TULIP 2003 (26) | Just before the procedure. Method not stated. Concealment unknown |
Consecutive patients for elective PCI, Only long lesions ≥ 20 mm, no narrow vessels. | No | Angio analysis blinded to IVUS assignment | Not stated | Powered to detect >0.25mm difference in MLD in 6 months | Yes |
AVID 1997 (31) 2000 (27)(Abstract) | Method not stated Concealment unknown |
Undergoing elective stenting in vessel >2.5mm, & @ low risk for complications | No | Not stated | Yes | Not reported | Not reported |
Angio or QCA quantitative coronary angiography; IVUS intravascular ultrasound; CAD coronary artery disease; MLD minimal lumen diameter; ITT intention-to-treat analysis