Ignite Creation Date:
2024-07-17 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470529
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2024-06-17
Brief Title:
MACE in Different Drug-Eluting Stents
Sponsor:
Shiraz University of Medical Sciences
Organization:
Shiraz University of Medical Sciences
Study Overview
Official Title:
Comparative Evaluation of Incidence of Cardiovascular Events Among Different Drug-Eluting Stent Types
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this retrospective cohort study all patients from Iranian registry were recruited and follow up after 5 years were recorded for MACE and its relation to type and demographic data were evaluated
Detailed Description:
This retrospective cohort study involved 4438 individuals who received a PCI from March 2019 to February 2021 Data was obtained from the Iranian Network of Cardiovascular Research Registry which registered post PCI patients all around Iran in more than 40 public and private hospitals and the database of Professor Kojuri Cardiology Clinic Niyayesh St Shiraz Iran wwwkojuricliniccom After each procedure expert cardiologists recorded baseline demographic data prior medical history angiography and angioplasty reports
Demographic data such as age gender body mass index BMI family history of CAD prior CAD history hypertension HTN diabetes mellitus DM hyperlipidemia HLP and kidney diseases were obtained from the database Data on the prevalence of cigarette smoking opium addiction and alcohol addiction were collected Additionally information on clinical manifestations of the disease including stable angina unstable angina ST-elevation myocardial infarction STEMI and non-ST elevation myocardial infarction NSTEMI was extracted
According to the American Heart Association AHA stage 1 hypertension is defined as a systolic blood pressure of 130-139 mmHg or diastolic blood pressure of 80-89 mmHg Hypertension was defined as stage 1 or higher blood pressure DM was defined according to The American Diabetes Association as having a hemoglobin A1c level of at least 65 a fasting plasma glucose FPG level of 126 mgdl or higher an oral glucose tolerance test OGTT level of 200 mgdl or greater or a random plasma glucose level of 200 mgdl or above For defining dyslipidemia based on the 2019 AHA guideline a low-density lipoprotein cholesterol LDL-C level exceeding 160 mgdl or a non-high-density lipoprotein cholesterol non-HDL-C over 190 mgdl were considered Individuals with 1 month of smoking cessation were considered current smokers
Angiography and angioplasty data Angiography and angioplasty data were gathered including the type and location of coronary artery lesions and the type location size diameter and number of stents Drug-eluting stents encompass a variety of types notably the biolimus-eluting stent BES amphilimus-eluting stent AES SES ZES PES and EES Within the BES category a notable example is the BioMatrix stent while SES includes options like BioMimeTM Orsiro Cre8 SUPRAFLEX ULTIMASTERTM and Coroflex ISAR ZES variants include the Resolute Onyx and Resolute Integrity stents whereas EES comprises options such as Promus PREMIER Promus Element and XIENCE Polymer-coated drug-eluting stents PC-DES include BioMatrix BioMimeTM Orsiro SUPRAFLEX ULTIMASTERTM Resolute Onyx Resolute Integrity Promus PREMIER Promus Element and XIENCE Conversely polymer-free drug-eluting stents PF-DES are exemplified by Cre8 and Coroflex ISAR Regarding generational classification the first generation includes BioMimeTM Orsiro Cre8 SUPRAFLEX ULTIMASTERTM and Coroflex ISAR Notable second-generation members are Promus PREMIER Promus Element and XIENCE alongside Resolute Onyx and Resolute Integrity Finally the BioMatrix stent represents the third generation
Data of ballooning including predilatation postdilatation and the number of balloons used were collected Different angioplasty techniques including kissing and overlapping were collected Coronary legions were classified according to the ACCAHA classification type A 10 mm non-angulated smooth little calcification not totally occlusive not ostial no major branch involvement no thrombus type B 10-20 mm eccentric moderately tortuous 45-90º irregular moderate to heavy calcification ostial bifurcation lesions some thrombus subcategories B1 one characteristic B2 two or more characteristics and type C diffuse extremely angulated 90º inability to protect major side branch degenerated vein graft
Follow-up Patients were contacted by phone to explain the study plans and obtain informed consent They were asked about MACEs occurring within two years following angioplasty which includes myocardial infarction acute heart failure stroke and death from cardiac diseases as well as any revascularization Additionally the date of MACE occurrence after angioplasty was recorded and information on non-cardiac-related deaths was collected
Demographic data such as age gender body mass index BMI family history of CAD prior CAD history hypertension HTN diabetes mellitus DM hyperlipidemia HLP and kidney diseases were obtained from the database Data on the prevalence of cigarette smoking opium addiction and alcohol addiction were collected Additionally information on clinical manifestations of the disease including stable angina unstable angina ST-elevation myocardial infarction STEMI and non-ST elevation myocardial infarction NSTEMI was extracted
According to the American Heart Association AHA stage 1 hypertension is defined as a systolic blood pressure of 130-139 mmHg or diastolic blood pressure of 80-89 mmHg Hypertension was defined as stage 1 or higher blood pressure DM was defined according to The American Diabetes Association as having a hemoglobin A1c level of at least 65 a fasting plasma glucose FPG level of 126 mgdl or higher an oral glucose tolerance test OGTT level of 200 mgdl or greater or a random plasma glucose level of 200 mgdl or above For defining dyslipidemia based on the 2019 AHA guideline a low-density lipoprotein cholesterol LDL-C level exceeding 160 mgdl or a non-high-density lipoprotein cholesterol non-HDL-C over 190 mgdl were considered Individuals with 1 month of smoking cessation were considered current smokers
Angiography and angioplasty data Angiography and angioplasty data were gathered including the type and location of coronary artery lesions and the type location size diameter and number of stents Drug-eluting stents encompass a variety of types notably the biolimus-eluting stent BES amphilimus-eluting stent AES SES ZES PES and EES Within the BES category a notable example is the BioMatrix stent while SES includes options like BioMimeTM Orsiro Cre8 SUPRAFLEX ULTIMASTERTM and Coroflex ISAR ZES variants include the Resolute Onyx and Resolute Integrity stents whereas EES comprises options such as Promus PREMIER Promus Element and XIENCE Polymer-coated drug-eluting stents PC-DES include BioMatrix BioMimeTM Orsiro SUPRAFLEX ULTIMASTERTM Resolute Onyx Resolute Integrity Promus PREMIER Promus Element and XIENCE Conversely polymer-free drug-eluting stents PF-DES are exemplified by Cre8 and Coroflex ISAR Regarding generational classification the first generation includes BioMimeTM Orsiro Cre8 SUPRAFLEX ULTIMASTERTM and Coroflex ISAR Notable second-generation members are Promus PREMIER Promus Element and XIENCE alongside Resolute Onyx and Resolute Integrity Finally the BioMatrix stent represents the third generation
Data of ballooning including predilatation postdilatation and the number of balloons used were collected Different angioplasty techniques including kissing and overlapping were collected Coronary legions were classified according to the ACCAHA classification type A 10 mm non-angulated smooth little calcification not totally occlusive not ostial no major branch involvement no thrombus type B 10-20 mm eccentric moderately tortuous 45-90º irregular moderate to heavy calcification ostial bifurcation lesions some thrombus subcategories B1 one characteristic B2 two or more characteristics and type C diffuse extremely angulated 90º inability to protect major side branch degenerated vein graft
Follow-up Patients were contacted by phone to explain the study plans and obtain informed consent They were asked about MACEs occurring within two years following angioplasty which includes myocardial infarction acute heart failure stroke and death from cardiac diseases as well as any revascularization Additionally the date of MACE occurrence after angioplasty was recorded and information on non-cardiac-related deaths was collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None