Effect of gradual computerized angioplasty on outcomes of patients undergoing coronary stenting.
Mechanical trauma caused by percutaneous coronary intervention is a major factor contributing to subsequent cardiac events, restenosis, and the need for target lesion revascularization (TLR). To minimize this trauma, we developed a Computerized Angioplasty Pressure Sensor and Inflator Device (CAPSID) for gradual inflation. The objective of the present prospective randomized study was to examine whether the use of this novel device reduced TLR, as well as cardiac events, in patients undergoing stenting. Patients undergoing coronary stenting were eligible and randomized to receive CAPSID or standard manual percutaneous coronary intervention. In the CAPSID group, slow, gradual balloon inflation was performed using a personal computer. Patients with acute ST-elevation myocardial infarction or the need for percutaneous coronary intervention for total occlusions, left main disease, and vein grafts were excluded. Clinical follow-up for major adverse cardiac events, including death, acute myocardial infarction, and TLR, was performed at 12 months. A total of 310 patients were enrolled in the study. No significant differences were found in the clinical characteristics between the CAPSID and control groups. At 1 year of follow-up, the CAPSID group had had a significantly lower rate of major adverse cardiac events (8% vs 18%, p <0.01) driven by significantly lower rates of acute myocardial infarction (1% vs 7%, p <0.01) and TLR (5% vs 12%, p <0.05). In conclusion, gradual computerized balloon inflation using CAPSID as a platform for angioplasty and stenting significantly reduced TLR and major adverse cardiac events at 1 year in patients undergoing coronary stenting. The use of this novel device may improve outcomes in patients undergoing coronary stenting.
Leibowitz
David
D
Department of Cardiology, Hadassah-Hebrew University Medical Center, Ein Kerem and Mount Scopus, Jerusalem, Israel.
Lotan
Chaim
C
Katz
Iony
I
Nassar
Hisham
H
Boguslavsky
Larissa
L
Mosseri
Morris
M
Jabara
Refat
R
Varshitzsky
Boris
B
Danenberg
Haim
H
Weiss
A Teddy
AT
D000800:Angioplasty, Balloon / Q000295:instrumentation; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy*; D011446:Prospective Studies; D015607:Stents; D013813:Therapy, Computer-Assisted / Q000295:instrumentation*; D016896:Treatment Outcome