Drug Coated Balloon vs. Drug Eluting Stent in Young Patients With STEMI: The DCB-STEMI Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 496
- 试验地点
- 1
- 主要终点
- VOCE
研究概览
简要总结
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.
详细描述
INTRODUCTION Patients with acute myocardial infarction (AMI) are among the highest-risk patients undergoing PCI and are mostly treated with drug-eluting stents (DES). Stenting reduces elastic recoil, restenosis, and flow-limiting dissections associated with balloon angioplasty. However, it increases the risk of in-stent restenosis (ISR), bleeding from prolonged dual antiplatelet therapy (DAPT), early and late stent thrombosis, and endothelial and vasomotor dysfunction.
In young patients (<50 years), lifetime management after stenting carries unique economic and social consequences. Stent implantation means a lifelong risk of ISR, stent thrombosis, and strict adherence to DAPT-a major compliance and financial issue in this age group.
These limitations have led to the development of drug-coated balloons (DCB), which deliver antiproliferative drugs into the vessel wall without leaving a permanent implant. This "leave nothing behind" strategy is particularly attractive in young patients and those with high bleeding risk. DCBs have shown promise in ISR, small vessel disease, and STEMI. Paclitaxel-coated balloons are most commonly used, delivering 2.0-3.5 µg/mm² of paclitaxel with cytotoxicity lasting at least 14 days. With a 30-second balloon inflation, about 16% of the drug is transferred to the vessel wall, ensuring homogenous delivery while avoiding permanent implants, stent thrombosis, ISR, and prolonged DAPT.
Several studies and meta-analyses have demonstrated comparable outcomes between DCBs and DES in AMI, including STEMI. In a large multicenter analysis of STEMI patients, DCBs were associated with similar mortality and target lesion revascularization compared to DES. Other feasibility studies confirmed no excess risk of abrupt closure, thrombosis, or target vessel failure when DCBs were used in primary PCI.
Cardiovascular disease, especially AMI, remains the leading global cause of death. South Asia bears a particularly high burden, with Pakistan at the top for premature MI. The National Institute of Cardiovascular Diseases (NICVD), Karachi, has become the world's largest primary PCI center, performing 17,761 primary PCIs in 2022. Notably, 45% were in young patients (<50 years) and 12% in very young (<40 years). This provides a unique opportunity to study DCB vs DES in a high-volume RCT focused on young STEMI patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Endpoint assessment will be blinded ie the adjudication committee members will be blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Patients with ESRD
- •Severe 3 VD; Intermediate of High syntax score
- •Lesion type>B
结局指标
主要结局
VOCE
时间窗: one year
Composite of CV death, Target Vessel MI (including stent thrombosis) and TLR
次要结局
- 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)
- Proportion of Patients with BARC Type 3, or 5 Bleeding Events(12 months)
研究者
Professor Abdul Hakeem
Professor and Program Director, Interventional Cardiology, Director Cardiac Catheterization Labs
National Institute of Cardiovascular Diseases, Pakistan