Drug-coated balloon versus drug-eluting stent for young adults with STEMI
Official title: Drug Coated Balloon vs. Drug Eluting Stent in Young Patients With STEMI: The DCB-STEMI Randomized Trial
Run by National Institute of Cardiovascular Diseases, Pakistan · NCT07229248 · Data updated 2026-11-12
This study tests whether a paclitaxel-coated balloon works as well as a drug-eluting stent for adults under 50 who have a STEMI and undergo primary PCI.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 49 Years |
| Sex | All |
| Enrollment | 496 (estimated) |
| Sponsor | National Institute of Cardiovascular Diseases, Pakistan Academic / other |
| Locations | 1 site (Karachi) |
| Status | Recruiting |
| Started | November 5, 2025 |
| Main results expected | December 17, 2027 |
| Study ends | December 26, 2027 |
| Registry record updated | November 14, 2025 |
| Trial ID | NCT07229248 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–50 with first-presentation STEMI who are stable (Killip I–II), have low SYNTAX scores, total ischemic time under 8 hours, and are undergoing primary PCI are the intended candidates.
✕Probably not a fit
Patients with severe multivessel disease, intermediate or high SYNTAX scores, complex lesion anatomy, end-stage renal disease, or hemodynamic instability (Killip III–IV) are unlikely to be eligible or to benefit from the DCB strategy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, randomized controlled Phase 3 trial at the National Institute of Cardiovascular Diseases (Karachi) comparing a paclitaxel-coated balloon (3.0 µg/mm² with 30-second inflation) to standard drug-eluting stents in young adults (<50 years) presenting with STEMI undergoing primary PCI. Participants are randomized to receive either the drug-coated balloon or a DES, with the primary endpoint of 1-year vessel-oriented cardiac events (VOCE). The trial enrolls stable patients with low SYNTAX scores and total ischemic time under 8 hours, while excluding those with severe multivessel disease, high SYNTAX scores, ESRD, or complex lesions. The design tests a 'leave nothing behind' strategy intended to avoid permanent implants, potentially shorten dual antiplatelet therapy, and reduce long-term device-related complications.
Why it matters
Potential benefit: If successful, this approach could reduce lifelong stent-related risks, shorten the duration of dual antiplatelet therapy, and lower rates of restenosis and stent thrombosis in younger STEMI patients.
How similar studies have gone: Observational studies, meta-analyses, and reports including a JACC: CVI analysis have suggested comparable outcomes between DCB and DES in STEMI, but randomized Phase 3 evidence specifically in young patients is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Patients with ESRD * Severe 3 VD; Intermediate of High syntax score * Lesion type\>B
Where it's running
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National Institute of Cardiovascular Diseases
Karachi, Pakistan Recruiting
Study contacts
- Principal investigator: Abdul Hakeem, MD — Nicvd
- Study coordinator: Abdul Hakeem, MD
- Email: ahakeem@gmail.com
- Phone: +923355554342
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.