DCB vs. DES in Young STEMI Patients: The DCB-STEMI Trial

NCT07229248 | Recruiting Phase 3 DMC

• 1 other identifier: NICVD IRB-32/2025
• Study Type: interventional
• Target: 496
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

STEMI (ST Elevation MI)

Keywords

Drug coated balloon; STEMI; RCT; DES; MACE

Outcome Measures

Primary Outcomes (1)

• VOCE

  Composite of CV death, Target Vessel MI (including stent thrombosis) and TLR

  one year

Secondary Outcomes (6)

• Proportion of Patients Experiencing Individual Components of Vessel-Oriented Composite Endpoint (VOCE)

  one year

• Proportion of Patients Achieving TIMI III Flow Post-Procedure

  immediate post procedure

• Proportion of Patients with Angiographic Residual Stenosis Exceeding Thresholds (>30% for DCB, >20% for DES)

  Immediate post procedure

• Rate of Abrupt Vessel Closure Post-Procedure

  within 24 hours post procedure

• Proportion of Patients Requiring Bail-Out Stenting in the DCB Arm

  intra procedure

Other Outcomes (3)

• Mean Late Lumen Loss in the DCB Arm at 6 Months Post-Procedure

  6 months

• Mean Minimum Lumen Diameter in the DCB Arm at Baseline, Post-Procedure, and 6 Months

  Baseline (pre-DCB), immediately post-procedure, and 6 months post-procedure

• Mean Percent Diameter Stenosis in the DCB Arm at Baseline, Post-Procedure, and 6 Months

  Baseline (pre-DCB), immediately post-procedure, and 6 months post-procedure

Study Arms (2)

DCB arm (Prevail Drug Coated Balloon)

EXPERIMENTAL

Patients assigned to drug coated balloon

Device: Drug coated balloon (Prevail; Medtronic Inc.)

DES arm (Limus drug eluting stent)

ACTIVE COMPARATOR

Patients receiving standard of care Drug eluting stent

Device: Drug eluting stent

Interventions

Drug coated balloon (Prevail; Medtronic Inc.) DEVICE

Drug coated balloon (Prevail DCB, Medtronic Inc.)

DCB arm (Prevail Drug Coated Balloon)

Drug eluting stent DEVICE

standard of care

DES arm (Limus drug eluting stent)

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Low syntax score
• Stable (Killip I-II)

You may not qualify if:

• Patients with ESRD
• Severe 3 VD; Intermediate of High syntax score
• Lesion type\>B

Sponsors & Collaborators

• National Institute of Cardiovascular Diseases, Pakistan: lead

Study Sites (1)

National Institute of Cardiovascular Diseases

Karachi, Pakistan

RECRUITING

Related Publications (3)

• Mangner N, Farah A, Ohlow MA, Mobius-Winkler S, Weilenmann D, Wohrle J, Linke A, Stachel G, Markovic S, Leibundgut G, Rickenbacher P, Cattaneo M, Gilgen N, Kaiser C, Scheller B, Jeger RV; BASKET-SMALL 2 Investigators. Safety and Efficacy of Drug-Coated Balloons Versus Drug-Eluting Stents in Acute Coronary Syndromes: A Prespecified Analysis of BASKET-SMALL 2. Circ Cardiovasc Interv. 2022 Feb;15(2):e011325. doi: 10.1161/CIRCINTERVENTIONS.121.011325. Epub 2022 Jan 10.

  PMID: 35000455 RESULT

• Huang KN, Grandi SM, Filion KB, Eisenberg MJ. Late and very late stent thrombosis in patients with second-generation drug-eluting stents. Can J Cardiol. 2013 Nov;29(11):1488-94. doi: 10.1016/j.cjca.2013.04.001. Epub 2013 Jul 4.

  PMID: 23830291 RESULT

• McKavanagh P, Zawadowski G, Ahmed N, Kutryk M. The evolution of coronary stents. Expert Rev Cardiovasc Ther. 2018 Mar;16(3):219-228. doi: 10.1080/14779072.2018.1435274. Epub 2018 Feb 5.

  PMID: 29381087 RESULT

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Abdul Hakeem, MD

  NICVD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdul Hakeem, MD

CONTACT

+923355554342; ahakeem@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Endpoint assessment will be blinded ie the adjudication committee members will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Program Director, Interventional Cardiology, Director Cardiac Catheterization Labs

Model Details: Randomized, non-inferiority, parallel-group trial comparing DCB versus DES in young STEMI patients.

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: November 14, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): December 17, 2027
• Study Completion (Estimated): December 26, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After the publication of the results untill 2 hours.
• Access Criteria: IPD will be shared upon reasonable request and submission to the PI. The proposition will be formally reviewed by the steering committee.

Locations

PA (1)