DCB vs. DES in Young STEMI Patients: The DCB-STEMI Trial
ConditionSTEMI (ST Elevation MI)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-49
SponsorNational Institute of Cardiovascular Diseases, Pakistan
About this trial
Background: ST Elevation Myocardial Infarction (STEMI) in young adults (\<50 yrs) carries high Percutaneous coronary intervention (PCI) risks. While drug-eluting stents (DES) reduce restenosis versus angioplasty, they increase risks of in-stent restenosis, thrombosis, prolonged dual antiplatelet therapy (DAPT), and endothelial dysfunction. Drug-coated balloons (DCB) provide a "leave nothing behind" strategy, potentially mitigating these issues. Evidence, including a JACC CVI report, suggests DCB outcomes comparable to DES in STEMI. South Asia faces a heavy burden. The national Institute of Cardiovascular diseases (NICVD), Karachi performed 17,761 primary PCIs in 2022, with 45% in patients \<50 yrs.
Study Design: This single-center Randomized Controlled Trial (RCT) compares paclitaxel-coated DCB (3.0 µg/mm², 30s inflation) vs. Drug eluting stents (DES) in young STEMI patients (\<50 yrs) undergoing primary PCI. The primary endpoint is 1-year vessel oriented cardiac events (VOCE)= Cardiovascular /all-cause death, target vessel MI, or Target lesion revascularization (TLR). Secondary endpoints include vessel-oriented CV events, bleeding, TIMI III flow, residual stenosis, abrupt closure, and bailout stenting. An intravascular ultrasound (IVUS) substudy (100 DCB pts) will evaluate remodeling and late lumen loss (LLL) at 6 months.
Methods: 496 patients (248/arm) will be randomized 1:1, powered for non-inferiority (margin 4.5%) assuming VOCE 8.5% (DES) vs. 6.25% (DCB), 80% power, and 5% dropout. Inclusion: age 18-50, STEMI. Exclusion: End stage renal disease (ESRD), severe multivessel disease, complex lesions, or high thrombus burden. All will receive ticagrelor 90 mg BID for 1 month. A pilot of 50 pts will first assess safety (abrupt closure, lesion prep).
Analysis: Intention-to-treat (ITT) will be primary; modified ITT for secondary endpoints. Statistics include chi-square/Fisher for categorical, t-test/Wilcoxon for continuous, and Kaplan-Meier/Cox for survival. Oversight by data safety monitoring board (DSMB) and Events adjudication Committee (EAC).
Significance: This trial leverages NICVD's high PCI volume to test DCB as an alternative to DES in young STEMI patients. By avoiding permanent implants, DCB may reduce long-term complications and DAPT needs. The IVUS substudy and pilot phase strengthen rigor. If non-inferiority is proven, DCB could reshape STEMI management in South Asia and similar high-burden regions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Either gender
Patient of age between 18 to 50 years
Patients with STEMI ( as first presentation of CAD) undergoing Primary PCI
Total ischemic Time less than 8 hrs.
Disqualifiers
Patients with ESRD
Severe 3 VD; Intermediate of High syntax score
Lesion type>B
Trial design
Design model
Parallel
Treatments tested in this trial
Drug coated balloon (Prevail; Medtronic Inc.)
DeviceDrug coated balloon (Prevail DCB, Medtronic Inc.)
Drug eluting stent
Devicestandard of care
Treatment groups
496 Participants
are divided into 2 treatment groupsGroup A: DCB arm (Prevail Drug Coated Balloon)Experimental treatment 1 intervention
Group B: DES arm (Limus drug eluting stent)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
VOCE
Composite of CV death, Target Vessel MI (including stent thrombosis) and TLR
Time frame
one yearSecondary outcomes
1
Proportion of Patients Experiencing Individual Components of Vessel-Oriented Composite Endpoint (VOCE)
The proportion of patients in each arm (DCB and DES) experiencing each individual component of VOCE (e.g., cardiac death, target vessel myocardial infarction, target lesion revascularization) will be measured at 12 months post-procedure. Events will be adjudicated by an independent clinical events committee using standardized definitions (e.g., Academic Research Consortium criteria). Data will be reported as the percentage of patients with each event in each arm, with 95% confidence intervals.
Time frame
one year2
Proportion of Patients Achieving TIMI III Flow Post-Procedure
The proportion of patients in each arm (DCB and DES) achieving Thrombolysis in Myocardial Infarction (TIMI) grade III flow (normal coronary blood flow) immediately post-procedure will be assessed via coronary angiography using standardized angiographic criteria. Data will be reported as the percentage of patients with TIMI III flow in each arm, with 95% confidence intervals
Time frame
immediate post procedure3
Proportion of Patients with Angiographic Residual Stenosis Exceeding Thresholds (>30% for DCB, >20% for DES)
The proportion of patients with residual stenosis (percentage of vessel diameter narrowing) exceeding 30% in the DCB arm and 20% in the DES arm will be measured via coronary angiography immediately post-procedure. Data will be reported as the percentage of patients exceeding the respective thresholds in each arm, with 95% confidence intervals.
Time frame
Immediate post procedure4
Rate of Abrupt Vessel Closure Post-Procedure
The rate of abrupt vessel closure (complete occlusion of the target vessel) in each arm (DCB and DES) will be assessed via coronary angiography during the index procedure or within 24 hours post-procedure. Closure events will be confirmed by the event adjudication committee. Data will be reported as the percentage of patients experiencing abrupt vessel closure in each arm, with 95% confidence intervals.
Time frame
within 24 hours post procedureOther outcomes
1
Mean Late Lumen Loss in the DCB Arm at 6 Months Post-Procedure
We seek to evaluate 100 randomized patients of the DCB arm to establish baseline IVUS features prior to DCB after DCB at the completion of the procedure and at 6 months follow up. Primary IVUS Outcome (for the substudy) Late lumen loss (LLL) will be calculated as the difference between the minimum lumen diameter (MLD, in millimeters) measured by intravascular ultrasound (IVUS) immediately post-procedure and the MLD at 6-month follow-up in the DCB arm. IVUS will be performed using a standardized protocol by an independent core laboratory. LLL will be reported as the mean ± standard deviation (SD) across the 100 randomized patients in the DCB arm, with 95% confidence intervals.
Time frame
6 months2
Mean Minimum Lumen Diameter in the DCB Arm at Baseline, Post-Procedure, and 6 Months
Minimum lumen diameter (MLD) will be measured by intravascular ultrasound (IVUS) at three time points: baseline (pre-DCB), immediately post-procedure, and at 6-month follow-up in the DCB arm. IVUS measurements will be conducted by an independent team using standardized software. MLD will be reported as the mean ± standard deviation (SD) for each time point across the 100 randomized patients in the DCB arm, with 95% confidence intervals. Changes in MLD between time points will be analyzed using paired t-tests or equivalent non-parametric tests.
Time frame
Baseline (pre-DCB), immediately post-procedure, and 6 months post-procedure3
Mean Percent Diameter Stenosis in the DCB Arm at Baseline, Post-Procedure, and 6 Months
Percent diameter stenosis (%DS) will be calculated by intravascular ultrasound (IVUS) as (reference vessel diameter- minimal lumen diameter/ reference vessel diameter x 100) at three time points: baseline (pre-DCB), immediately post-procedure, and at 6-month follow-up in the DCB arm. IVUS measurements will be performed by an independent team using standardized software. %DS will be reported as the mean ± standard deviation (SD) for each time point across the 100 randomized patients in the DCB arm, with 95% confidence intervals. Changes in %DS between time points will be analyzed using paired t-tests or equivalent non-parametric tests.
Time frame
Baseline (pre-DCB), immediately post-procedure, and 6 months post-procedureSponsors and contacts
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Source ClinicalTrials.gov