A randomised trial of paclitaxel-eluting balloon after bare metal stent implantation vs. bare metal stent in ST-elevation myocardial infarction (the PEBSI study)

被引：15

作者：

Garcia-Touchard, Arturo ^{[1
]}

Goicoleal, Javier ^{[1
]}

Sabate, Manel ^{[2
]}

Alfonso, Fernando ^{[3
]}

Ruiz-Salmeron, Rafael ^{[4
]}

Bethencourt, Armando ^{[5
]}

Gonzalo, Nieves ^{[6
]}

Miranda, Faustino ^{[7
]}

Garcia del Blanco, Bruno ^{[8
]}

Jimenez-Mazuecos, Jesus ^{[9
]}

Melgares, Rafael ^{[10
]}

Martinez-Romero, Pedro ^{[11
]}

Maria Hernandez-Garcia, Jose ^{[12
]}

Lezaun, Roman ^{[13
]}

Antonio Bullones, Juan ^{[14
]}

Fernandez-Portales, Javier ^{[15
]}

Ramon Rumoroso, Jose ^{[16
]}

Ortas, Rosario ^{[17
]}

Valdes, Mariano ^{[18
]}

Trillo, Ramiro ^{[19
]}

Brugaletta, Salvatore ^{[2
]}

Otzuki, Shuji ^{[2
]}

Jose Hernandez-Perez, Francisco ^{[1
]}

Alonso-Pulpon, Luis ^{[1
]}

机构：

[1] Hosp Univ Puerta Hierro, Majadahonda, Spain

[2] Hosp Clin Barcelona, Barcelona, Spain

[3] Hosp Princesa, Madrid, Spain

[4] Hosp Virgen Macarena, Seville, Spain

[5] Hosp Univ Son Espases, Balearic Islands, Spain

[6] Hosp Clin San Carlos, Madrid, Spain

[7] Hosp del Mar, Barcelona, Spain

[8] Hosp Univ Vall Hebron, Barcelona, Spain

[9] Complejo Hosp Univ Albacete, Albacete, Spain

[10] Hosp Univ Virgen De Las Nieves, Granada, Spain

[11] Hosp Puerto Real, Puerto Real, Spain

[12] Hosp Univ Virgen De La Victoria, Malaga, Spain

[13] Hosp Univ Navarra, Navarra, Spain

[14] Hosp Carlos Haya, Malaga, Spain

[15] Hosp San Pedro De Alcantara, Caceres, Spain

[16] Hosp Galdakao Usansolo, Galdakao, Spain

[17] Hosp Arnau Vilanova, Lleida, Spain

[18] Hosp Virgen Arrixaca, Murcia, Spain

[19] Hosp Clin Univ Santiago, La Corttna, Spain

来源：

EUROINTERVENTION | 2017年 / 12卷 / 13期

关键词：

myocardial infarction; paclitaxel-eluting balloon; primary angioplasty; stent; ST-segment elevation; PERCUTANEOUS CORONARY INTERVENTION;

D O I：

10.4244/EIJ-D-16-00128

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Aims: Our aim was to assess the safety and efficacy of paclitaxel-eluting balloon (PTX-B) treatment after bare metal stent (BMS) implantation in patients undergoing primary angioplasty. Methods and results: After BMS implantation, patients were randomised (1:1) to treatment with a PTX-B or no PTX-B treatment (BMS group). The primary endpoint was in-stent late luminal loss (LLL) at nine month follow-up. OCT was carried out on the first 20% of consecutive patients included in the study. Two hundred and twenty-three patients were randomised (BMS: 112, PTX-B: 111). At nine months, median LLL was 0.80 mm (interquartile range [IQR] 0.36-1.26) in the BMS group vs. 0.31 mm (IQR 0.00-0.58) in the PTX-B group, p<0.0001. Binary restenosis was significantly lower in the PTX-B group: 29.8% vs. 2.2%, p<0.0001, 95% confidence interval (CI): 3.2-54.2. Nine-month OCT showed good strut coverage in both groups but greater in the BMS group (100 +/- 0.0% vs. 99.52 +/- 1.11%, p=0.03) with very low rates of malapposed struts per lesion. One-year MACE was significantly lower in the PTX-B group (12.5% vs. 3.6%, p=0.016). Conclusions: PTX-B after successful BMS implantation resulted in less LLL and better clinical outcomes as compared with a BMS-only strategy. This was associated with good stent strut coverage and very low rates of malapposed struts. PEBSI trial (NCT 01839890)

引用

页码：1587 / 1594

页数：8

共 11 条

[1] First Results of the DEB-AMI (Drug Eluting Balloon in Acute ST-Segment Elevation Myocardial Infarction) Trial A Multicenter Randomized Comparison of Drug-Eluting Balloon Plus Bare-Metal Stent Versus Bare-Metal Stent Versus Drug-Eluting Stent in Primary Percutaneous Coronary Intervention With 6-Month Angiographic, Intravascular, Functional, and Clinical Outcomes [J].