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The purpose of this study is to determine whether prolonged inflation time on drug-eluting stents deployment for ST-elevation myocardial Infarction was better than conventional stents deployment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prolonged deployment strategy group | Experimental | in "deploying the Drug-eluting Stents with a prolonged time" group,the inflation time was more than 30 seconds when the Drug-eluting Stents deploying,unless the patients was unstable. |
|
| rapid deployment strategy group | Active Comparator | in "deploying the Drug-eluting Stents with a conventional time" group, a conventional method was used to deploying drug-eluting stents,the actual inflation time was within 10s determined by interventional cardiologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deploying the Drug-eluting Stents with a prolonged time | Device | the inflation time was more than 30 seconds when the Drug-eluting Stents deploying.The PROMUS Element Plus Stent or Co-Cr sirolimus-eluting coronary stent system（GuReater）was used in this study |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With TIMI 3 | TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion.TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed.TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory.TIMI 3 is normal flow which fills the distal coronary bed completely | 1 minute after sent was deployed |
| corrected TIMI frame count(frames) | Grading was done on cinefilm at 15frames/s made in a Philips digital coronary imaging catheterization laboratory. | 1 minute after sent was deployed |
| myocardial blush grade | 0, no myocardial blush or contrast density; 1, minimal myocardial blush or contrast density; 2,moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral non- infarct-related coronary artery; and 3, normal myocardial blush or contrast density, comparable with that obtained during angiography of a contralateral or ipsilateral non-infarct-related coronary artery | 1 minute after sent was deployed |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants ST-segment resolution | 1, normalized, defined as no residual ST-segment elevation; 2, improved, defined as a residual ST-segment elevation ,70% of with that on the first ECG; and 3, unchanged, defined as a residual ST-segment elevation 70% of that on the first ECG | 60min after the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural time | minute | form start puncturing vascular until the operation was completed intraoperative |
| Radiation exposure time | minute | form start puncturing vascular until the operation was completed intraoperative |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| He yong | Contact | +8618980602038 | zznnyeah@163.com |
| Name | Affiliation | Role |
|---|---|---|
| He yong | west china hospital of sichuan univercity | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Recruiting | Chengdu | Sichuan | 621000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12075259 | Background | Sabatier R, Hamon M, Zhao QM, Burzotta F, Lecluse E, Valette B, Grollier G. Could direct stenting reduce no-reflow in acute coronary syndromes? A randomized pilot study. Am Heart J. 2002 Jun;143(6):1027-32. doi: 10.1067/mhj.2002.122509. | |
| 17022381 | Background | Ozdemir R, Sezgin AT, Barutcu I, Topal E, Gullu H, Acikgoz N. Comparison of direct stenting versus conventional stent implantation on blood flow in patients with ST-segment elevation myocardial infarction. Angiology. 2006 Aug-Sep;57(4):453-8. doi: 10.1177/0003319706290620. |
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| deploying the Drug-eluting Stents with a conventional time | Device | the actual inflation time was within 10s determined by interventional cardiologist.The PROMUS Element Plus Stent or Co-Cr sirolimus-eluting coronary stent system（GuReater）was used in this study |
|
| Number of Participants Death from cardiac causes |
death from acute myocardial infarction, cardiac perforation, or pericardial tamponade; an arrhythmia or conduction abnormality; complications of the interventional procedure at baseline |
| one month after the operation |
| Number of Participants Target-vessel revascularization | any revascularization intervention (PCI or CABG) occurring in a treated vessel at any time after the index intervention. | one month after the operation |
| Number of Participants stent thrombosis | evidence of any myocardial infarction with angiographic confirmation of in-stent thrombus or unexplained death within 30 days after the procedure as stent thrombosis | one month after the operation |
| Number of Participants had Major bleeding | any symptomatic intracranial hemorrhage, or clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of>= g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of>=15%) | one month after the operation |
| 25964649 | Background | Li C, Zhang B, Li M, Liu J, Wang L, Liu Y, Wang Z, Wen S. Comparing Direct Stenting With Conventional Stenting in Patients With Acute Coronary Syndromes: A Meta-Analysis of 12 Clinical Trials. Angiology. 2016 Apr;67(4):317-25. doi: 10.1177/0003319715585662. Epub 2015 May 11. |
| 22109977 | Background | Hovasse T, Mylotte D, Garot P, Salvatella N, Morice MC, Chevalier B, Pichard A, Lefevre T. Duration of balloon inflation for optimal stent deployment: five seconds is not enough. Catheter Cardiovasc Interv. 2013 Feb;81(3):446-53. doi: 10.1002/ccd.23343. Epub 2012 Jan 10. |
| 9639373 | Background | van 't Hof AW, Liem A, Suryapranata H, Hoorntje JC, de Boer MJ, Zijlstra F. Angiographic assessment of myocardial reperfusion in patients treated with primary angioplasty for acute myocardial infarction: myocardial blush grade. Zwolle Myocardial Infarction Study Group. Circulation. 1998 Jun 16;97(23):2302-6. doi: 10.1161/01.cir.97.23.2302. |
| 10208996 | Background | Gibson CM, Murphy SA, Rizzo MJ, Ryan KA, Marble SJ, McCabe CH, Cannon CP, Van de Werf F, Braunwald E. Relationship between TIMI frame count and clinical outcomes after thrombolytic administration. Thrombolysis In Myocardial Infarction (TIMI) Study Group. Circulation. 1999 Apr 20;99(15):1945-50. doi: 10.1161/01.cir.99.15.1945. |
| 8598078 | Background | Gibson CM, Cannon CP, Daley WL, Dodge JT Jr, Alexander B Jr, Marble SJ, McCabe CH, Raymond L, Fortin T, Poole WK, Braunwald E. TIMI frame count: a quantitative method of assessing coronary artery flow. Circulation. 1996 Mar 1;93(5):879-88. doi: 10.1161/01.cir.93.5.879. |
| 35120436 | Derived | Ma M, Wang L, Diao KY, Liang SC, Zhu Y, Wang H, Wang M, Zhang L, Yang ZG, He Y. A randomized controlled clinical trial of prolonged balloon inflation during stent deployment strategy in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a pilot study. BMC Cardiovasc Disord. 2022 Feb 4;22(1):30. doi: 10.1186/s12872-022-02477-0. |