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

RecruitingPhase 3Ages 18 Years - 49 YearsAllNational Institute of Cardiovascular Diseases, Paโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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 ยตg/mmยฒ, 30s inflation) vs. Drug eluting stents (DES) in young STEMI patients (\<50 yrs)

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๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Drug coated balloon (Prevail; Medtronic Inc.)
  • Drug eluting stent
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Where

1 site
National Institute of Cardiovascular Diseases
Karachi, Pakistan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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