Main Points

Question 1

Whats the purpose of the study?

Answer 1

1. Will OCT-based stent sizing strategy would result in a minimum stent area similar to or better than that achieved with IVUS guidance.
2. better than that achieved with angiography guidance alone.

Question 2

whats is Randomised controlled trial,

Answer 2

Randomized controlled trial: (RCT) A study in which people are allocated at random (by chance alone) to receive one of several clinical interventions.

One of these interventions is the standard of comparison or control.

The control may be a standard practice, a placebo (“sugar pill”), or no intervention at all.

Question 3

whats is the method?

Answer 3

1. we recruited patients aged 18 years or older undergoing PCI from 29 hospitals in eight countries.

2 one or more target lesions located in a native coronary artery witha visually estimated reference vessel diameter of 2·25–3·50 mm and a length of less than 40 mm.

3.Exculsions: 
patients with left main or ostial right coronary artery stenoses, 
bypass graft stenoses, 
chronic total occlusions, 
planned two-stent bifurcations, and 
in-stent restenosis. 

4. Participants were randomly assigned (1:1:1; with use of an interactive web-based system in block sizes of three, stratifi ed by site) to OCT guidance, IVUS guidance, or angiography-guided stent implantation.
5. We did OCT-guided PCI using a specific protocol to establish stent length, diameter, and expansion
   according to reference segment external elastic lamina measurements. All patients underwent final OCT imaging(operators in the IVUS and angiography groups were masked to the OCT images).

Question 4

what is the minimum efficacy end point?

Answer 4

The primary efficacy endpoint was post-PCI minimum stent area, measured by OCT at a masked independent core laboratory at completion of enrolment, in all randomly allocated participants who had primary outcome data.

Question 5

whats is the safty end point?

Answer 5

The primary safety endpoint was

procedural MACE.

Question 6

how many patients in each group?

Answer 6

we randomly allocated 450 patients
(158 [35%] to OCT,
146 [32%] to IVUS,
146 [32%] to angiography)

Question 7

How many of them hit the primary endpoint?

Answer 7

415 final OCT acquisitions analysed for the primary endpoint
(140 [34%]in the OCT group,
135 [33%] in the IVUS group,
140 [34%] in the angiography group)

Question 8

The final median minimum stent area.

Answer 8

5·79 mm² (IQR 4·54–7·34) with OCT guidance,
5·89 mm² (4·67–7·80) with IVUS guidance, and
5·49 mm² (4·39–6·59) with angiography guidance.

Question 9

What is the findings?

Answer 9

OCT guidance was non-inferior to IVUS guidance
(one-sided 97·5% lower CI –0·70 mm²; p=0·001), but not superior (p=0·42).

OCT guidance was also not superior to
angiography guidance (p=0·12).

Question 10

How many has MACE in each group?

Answer 10

We noted procedural MACE in
four (3%) of 158 patients in the OCT group,
one (1%) of 146 in the IVUS group,
one (1%) of 146 in the angiography group

(OCT vs IVUS p=0·37; OCT
vs angiography p=0·37).

Question 11

whats the interpretation of the study

Answer 11

OCT-guided PCI using a specific reference segment external elastic lamina-based stent optimisation
strategy was safe and resulted in similar minimum stent area to that of IVUS-guided PCI.

These data warrant a large
scale randomised trial to establish whether or not OCT guidance results in superior clinical outcomes to angiography guidance.

Question 12

Evidences before study?

Answer 12

1. No previous randomised controlled trials that compared all three methods
   in terms of either acute procedural success or clinical outcomes.

2.Several studies, mostly observational, but some randomised controlled trials compared intravascular ultrasound (IVUS) with angiography.

3. Meta-analyses of these studies identifi ed
   reductions in target lesion failure, stent thrombosis, major adverse cardiovascular events, and death with use of IVUS, largely as a result of larger minimum stent area.
4. Investigators of
   observational studies comparing optical coherence
   tomography (OCT) with angiography suggested that although OCT guidance frequently led physicians to change their percutaneous coronary intervention (PCI) strategy, it often led to implantation of smaller diameter stents than with angiography.

5.Only one head-to-head study of 70 patients
compared OCT with IVUS directly, in which IVUS led to larger postprocedural minimum stent area than did OCT.

Question 13

Where is this study from?

Answer 13

New York Presbyterian Hospital

and Columbia University,

Question 14

Describe the methodlogy of used in achieving optimal stent results

Answer 14

1. Measure EEL of distal and proximal.
2. Smaller of the 2 rounded of to 0.25mm
3. If EEL cannot be visualized, use Proximal and distal Lumen diameters.
4. Balloon if needed to achieve Minimum stent area of 90% (relative to closest reference segment.)
5. To avoid dissections, balloon no larger than reference EEL

or

If EEL is not visible:
no larger than 0.5mm post PCI mean reference lumen diameter