Primary Objective The primary objective is to compare the rate of TIMI III flow
achievement, slow flow/no-reflow, and ST-segment resolution between POP versus
conventional stent deployment strategy during Primary PCI.
Secondary Objective The secondary objective is in-hospital outcome (to compare the rate
of major adverse cardiovascular events (MACE) during hospitalization between POP versus
conventional stent deployment strategy during Primary PCI.) Material and Methods Study
design: An open-label randomized controlled trial (RCT) with blinded outcome assessment
Setting: Cath Lab NICVD Karachi ,Hyderabad and Sukkur Duration of study: 6 months Stent
Deployment Protocol: Patients will be randomly assigned to either POP or conventional
stent deployment approach groups in 1:1 ratio using the block randomization method.
SAMPLE SIZE : 400 patients will be randomized into 2 groups with 1:1 Concealment:
Allocation schema will remain accessible to the randomization and allocation team and
will be communicated to the screening and recruitment team on a patient-on-patient basis.
Blinding: This will be an open-label study, however, the outcome assessment will be
blinded. A de-identified CD and post-PCI ECG with a unique tracking ID will be evaluated
by the team of independent consultants, who will be blinded to the stent placement
approach, and primary outcome variables i.e. TIMI flow, slow-flow/no-reflow, and
ST-segment resolution will be assessed.
Immediately post-procedure, a de-identified CD and post-PCI ECG with a unique tracking ID
will be evaluated by the team of independent consultants, who will be blinded to the
stent placement approach, and primary outcome variables i.e. TIMI flow,
slow-flow/no-reflow, and ST-segment resolution will be assessed. All the patients will be
followed at 30 days and incidence of MACE will be recorded.
In order to ensure the integrity and reliability of the data, all procedures and imaging
assessments will be carried out by clinicians and technicians trained and standardized in
the respective methodologies. Moreover, data will be stored in a secure, electronic
database with restricted access to maintain patient confidentiality and data security.
Regular data audits will be conducted to ensure accuracy and consistency throughout the
trial.
Data Analysis:
Firstly, patient demographics and baseline clinical characteristics will be summarized
using means and standard deviations for continuous variables and frequencies with
percentages for categorical variables. Kaplan-Meier survival analysis will be used to
determine the time-to-event data for outcomes such as target vessel failure, target
vessel revascularization, cardiac death, and myocardial infarction. Log-rank tests will
be employed to compare survival curves between the POP and Rapid I/D groups. Cox
proportional hazards models will be used to compute hazard ratios (HRs) and their 95%
confidence intervals (CIs) for each outcome of interest, adjusting for potential
confounders.
For categorical outcomes, chi-squared tests or Fisher's exact tests will be used, as
appropriate. Continuous outcomes will be assessed using t-tests or Mann-Whitney U tests
based on data distribution. Any unmatched or imbalanced variables between the two groups
will be controlled using propensity score matching. To address potential confounding
factors and biases, a sensitivity analysis will be performed.
Lastly, all statistical analyses will be two-tailed, with a significance level set at p <
0.05. Statistical software such as SPSS or R will be utilized for the analysis.