This document summarizes a study comparing percutaneous coronary intervention (PCI) using drug-eluting stents to coronary artery bypass grafting (CABG) for treating multivessel coronary artery disease in patients with diabetes (the CARDIA trial). Some key points:
- The CARDIA trial randomized 510 diabetic patients with multivessel or complex single vessel disease to either optimal PCI using drug-eluting stents plus abciximab or to CABG.
- At 1 year, the rates of death, myocardial infarction, stroke, and the composite of these events were not significantly different between the PCI and CABG groups, indicating PCI was non-inferior to CABG.
-
ACC slides: ORBIT AF elucidates gender disparities for AF patientsTrimed Media Group
SAN FRANCISCO—The ORBIT AF registry, presented last week at the American College of Cardiology (ACC) annual scientific session, examined the quality of care, symptoms and one-year clinical outcomes for women vs. men with atrial fibrillation.
Estudio presentado por el Dr. Andre Lamy en el último ACC.2013, realizado en San Francisco, Estados Unidos, los días 9, 10 y 11 de Marzo. Más presentaciones de este evento en www.solaci.org/es/coberturas.php
Global Cancer Clinical Trials
General challenges in design, conduct, analysis and interpretation of cancer CTs
Cancer CTs currently being conducted in India
Challenges specific to India
Funding of trials in India
“Learn by hearing and doing” culture
Lack of training in good documentation and reporting
Perceptions about clinical trials in India
Uneven expertise
Following international templates
Lack of databases that would facilitate
Centre capacities and strength, recruitment rate and historical data
Lack of recognition
Evolving regulatory framework
Some solutions
ACC slides: ORBIT AF elucidates gender disparities for AF patientsTrimed Media Group
SAN FRANCISCO—The ORBIT AF registry, presented last week at the American College of Cardiology (ACC) annual scientific session, examined the quality of care, symptoms and one-year clinical outcomes for women vs. men with atrial fibrillation.
Estudio presentado por el Dr. Andre Lamy en el último ACC.2013, realizado en San Francisco, Estados Unidos, los días 9, 10 y 11 de Marzo. Más presentaciones de este evento en www.solaci.org/es/coberturas.php
Global Cancer Clinical Trials
General challenges in design, conduct, analysis and interpretation of cancer CTs
Cancer CTs currently being conducted in India
Challenges specific to India
Funding of trials in India
“Learn by hearing and doing” culture
Lack of training in good documentation and reporting
Perceptions about clinical trials in India
Uneven expertise
Following international templates
Lack of databases that would facilitate
Centre capacities and strength, recruitment rate and historical data
Lack of recognition
Evolving regulatory framework
Some solutions
Similar to Diabetes Mellitus and multivessel disease- Part ii (18)
Beta blockers in SIHD: Yes, all patients should receive them !cardiositeindia
A presentation made by Dr. Akshay Mehta on the topic- Beta blockers in SIHD: yes, all patients should receive them !.
This was presented at the SIHD conference, Mumbai, 2015.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Diabetes Mellitus and multivessel disease- Part ii
1. Diabetes
And
Multivessel Disease
Dr. Dev Pahlajani
MD,FACC,FSCAI
Chief of Interventional Cardiology, Breach
Candy Hospital, Mumbai
2. Type 2 diabetes, 1997–2010
100 Type 2 diabetes in 1997 100 Increase in Type 2
diabetes,1997–2010
80 80
Prevalence (millions)
Growth rate (%)
60 60
40 40
20 20
0 0
www.cardiositeindia.com
Amos AF et al. Diabet Med 1997;14:S1
3. Why PCI is not well tolerated by
Diabetics?
General endothelial disease
Restenosis
Involvement of multiple organs, Kidneys, brain,
PVD, eyes
Micro circulation, small, long, multiple, diffuse
lesions
Accelerated atherosclerosis
Thrombogenic factors in blood
Thrombotic occlusion of stents
Diabetic cardiomyopathy
www.cardiositeindia.com
4. Effect of DM on Formation of Coronary
Collateral
410 pts
205 Non DM 205 DM
Mean ves diam 1.42 0.65 p = 0.05
1.58 0.68
Mean Rentrop collateral score :
DM 2.41 2.20
Non DM 2.6 2.39 p = 0.034
“Poorer Collaterals in DM
www.cardiositeindia.com
Abaciel et al Circ 1999, 99, 2239
5. Which Diabetes may be considered for
multivessel PCI ?
Comorbid condition not suitable for surgery
Preferably localised lesions RVD > 2.75 mm
Redo Sx – High risk for Sx
Good Glycemic control HbA1C < 7.0
No contraindication for long term dual antiplatelet
therapy
DM ON INSULIN THERAPY -CABG
www.cardiositeindia.com
7. DIABETES Study: First Randomised
Independent CYPHER Stent Trial in Diabetic
Patients
• CYPHER Stent vs BMS in de novo coronary lesions
in 160 diabetic patients
• Small diameter lesions treated
– Reference vessel diameter 2.34mm, lesion length 15mm
• Significantly smaller vessels treated in the IDDM group
– 2.21mm in the CYPHER Stent arm
www.cardiositeindia.com Sabaté M. DIABETES Study results presented at TCT 2004
8. ISAR-DIABETES – Late Loss (6m)
Late Lumen Loss (In-Segment) Late Lumen Loss (In-Stent)
CYPHER TAXUS CYPHER TAXUS
0.8 0.8
p=0.02 p<0.001
36% 0.67
0.6 0.6
58% 0.45
0.43
(mm)
(mm)
0.4 0.4
0.19
0.2 0.2
0.0 0.0
Significantly greater reduction in neo intimal hyperplasia, as measured by
late loss
www.cardiositeindia.com Kastrati A. Presented at ACC 2005
9. DIABETES Study: QCA Follow Up (9m)
In-Stent Late Loss (9m) In-Stent Restenosis (9m)
1.0 40
p<0.0001 p<0.0001
0.8
31.0
87% 0.67
30
84%
0.6
(mm)
(%)
20
0.4
10
0.2 4.9
0.09
0 0
CYPHER BMS CYPHER BMS
Significantly reduced late loss and restenosis vs BMS in
diabetic patients
www.cardiositeindia.com Sabaté M. DIABETES Study results presented at TCT 2004 and ACC 2005
10. DIABETES Study: TLR and MACE (12m)
TLR MACE
40 p<0.0001 40 p<0.0001 38.8
35
30 30
71%
79%
(%)
(%)
20 20
11.3
10 10
7.5
0 0
CYPHER BMS CYPHER BMS
Dramatic TLR and MACE reductions
No late stent thromboses occurred during the 12-month follow up
www.cardiositeindia.com Sabaté M. DIABETES Study results presented at ACC 2005
11. CYPHER Stent Superiority in Diabetes
Confirmed in Long Lesion Registry
CYPHER TAXUS Control
60
52.7
50
In-segment Restenosis (%)
40 37.1
p=0.033 p=0.001
30
58% 23.5
69% 20.2
20
10
9.9
6.3
0
n=81 n=51 n=55 n=190 n=99 n=105
Diabetic patients Non-diabetic patients
Significantly superior reduction in restenosis rates in patients with
diabetes and long lesions (>32mm)
www.cardiositeindia.com Park SJ. Presented at TCT 2004
12. DIABETES Study: TLR and Diabetes Status (12m)
BMS CYPHER
p=0.001
50
40.7
p=0.009
40 90%
80% 32.1
30
%
20
10 7.4 7.7 7.7
0
n=53 n=54 n=26 n=27
NIDDM IDDM
Reduction in TLR in insulin-dependent patients
comparable with those taking oral agents
www.cardiositeindia.com Sabaté M. DIABETES Study results presented at ACC 2005
13. DIABETES Trial
40%
35% P < .0001 40% 36%
31.3% P < .0001
30% 76%
30% 69%
25%
20% 20%
15% 11.3%
10% 7.5% 10%
5%
0% 0%
Sirolimus Stent Bare Metal Stent Sirolimus Stent Bare Metal Stent
TLR MACE
CONCLUSIONS 9 month clinical follow-up
• CYPHER Stent highly significantly reduces TLR , overall MACE,Late Loss and
Restenosis in diabetic patients at high risk for restenosis
0.8 40%
0.7 0.66 33%
0.6
88% 30%
76%
0.5
0.4 20%
0.3
0.2 10% 7.7%
0.08
0.1
0 0%
Sirolimus Stent Bare Metal Stent Sirolimus Stent Bare Metal Stent
www.cardiositeindia.com Source: Sabate, TCT 2004
In-Stent Late Loss In-Segment Restenosis
14. Diabetes Trial
0.7
0.6 In-stent Late Loss
P < .0001 for all groups
0.5
0.4 82% 92%
82%
0.3
0.2
0.1
0
Overall Oral IDDM
www.cardiositeindia.com
17. Randomized Comparison of
Percutaneous Coronary Intervention
With Coronary Artery Bypass
Grafting in Diabetic Patients
CARDIA TRIAL
Akhil Kapur, Roger J. Hall, Iqbal S. Malik, Ayesha C.
Qureshi, Jeremy Butts, et al
www.cardiositeindia.com J Am Coll Cardiol. 2010;55(5):432-440.
18. CARDIA Trial Hypothesis
In diabetic patients with multivessel disease
amenable to both CABG or PCI
Optimal PCI is no inferior to up to date CABG
www.cardiositeindia.com J Am Coll Cardiol. 2010;55(5):432-440.
19. STUDY DESIGN
Diabetic patients with multi vessel disease or complex single vessel disease
Surgeon and interventionalist
Amendable for both treatments Amendable for each treatment
options approach
Randomized arm
N=600(1:1) Two registry arms
DES vs CABG
Follow up: 30d,6m, 1-5 yrs
Goal: to define the most appropriate
treatment for diabetic patients
through randomized trial methods
www.cardiositeindia.com
21. CARDia Trial design
Randomization
Up to date
Diabetic patients
with multivessel
Inclusion CABG
Suitable for PCI and
disease or
exclusion
CONSENT
complex single or CABG
criteria met
vessel disease
Optimal PCI
stent +
abciximab
DES 71%
BMS 29%
www.cardiositeindia.com J Am Coll Cardiol. 2010;55(5):432-440.
22. Trial design
• CABG historically assumed to be superior to PCI(based on BARI
subset)
• Investigator initiated trial designed to show non inferiority of
PCI
• Sample size of 600 patients based on ARTS and EPI trials
And the hypothesis(test of non inferiority) to be tested is:
Ho: pe >= 1.3ps
Ha: pe < 1.3ps
• 510 patients recruited from Jan 2002 to May 2007
Early termination due to slowing recruitment but follow up extended to 5
years
www.cardiositeindia.com
J Am Coll Cardiol. 2010;55(5):432-440.
23. CARDia patient flow chart
510 patients randomized
CABG PCI
254 patients 256 patients
8= withdrew consent 2=withdrew consent
1=data not available yet 2=data not available yet
229 received CABG 252 received PCI
1=died 1=cross over to
11=cross over to PCI CABG
96% (245) in 1 98% (251) in 1
year follow up year follow up
www.cardiositeindia.com
J Am Coll Cardiol. 2010;55(5):432-440.
26. End points
Primary endpoint:
• Composite event rate at 1 year of death/non fatal MI/non fatal stroke
(time to first event)
Major secondary :
• Further revascularization at 1 year
Secondary:
• Severe bleeding complications at 30 days
• New requirement for permanent dialysis
• Neurological morbidity
• Quality of life
• Cost difference between treatments
• Change in LV function
www.cardiositeindia.com
J Am Coll Cardiol. 2010;55(5):432-440.
27. Individual 1 year outcomes
www.cardiositeindia.com
J Am Coll Cardiol. 2010;55(5):432-440.
28. PCI procedural details
Use prior to procedure of:
Aspirin-100%
Clopidogrel- 94%
Abciximab-95%
3 vessel disease- 65%
3 vessels treated in these patients-88%
o Average no. of stents per patient- 3.5
o Average stent length- 71mm
DES patients (cypher)-71% (180)
BMS patients- 29% (72)
www.cardiositeindia.com
29. CABG procedural details
3 vessel disease- 58%
3 vessels treated in these patients- 90%
Average number of grafts-2.8
LIMAs- 89%
% with at least two arterial grafts- 17%
% off pump- 31%
www.cardiositeindia.com
J Am Coll Cardiol. 2010;55(5):432-440.
30. Survival at 1 year CABG vs PCI
www.cardiositeindia.com
J Am Coll Cardiol. 2010;55(5):432-440.
32. ENPOINTS: Death ,MI, stroke and
repeat revascularization
www.cardiositeindia.com
J Am Coll Cardiol. 2010;55(5):432-440.
33. CARDia: Main conclusions
No apparent difference between PCI and CABG at 1 year in :
• Death
• Composite of death, MI and stroke
More repeat revascularization In the PCI group
PCI may now be considered a reasonable strategy in diabetic
patients with multivessel disease
Longer follow up is needed
www.cardiositeindia.com
J Am Coll Cardiol. 2010;55(5):432-440.
34. Future REvascularization Evaluation in
patients with Diabetes mellitus:
Optimal management of Multivessel
disease
Freedom trial
www.cardiositeindia.com
35. Strategies for Multivessel
Revascularization
in Patients with Diabetes
FREEDOM TRIAL
Michael E. Farkouh, Michael Domanski,
Lynn A. Sleeper,
Flora S. Siami, George Dangas, Michael
Mack, et al
www.cardiositeindia.com
37. FREEDOM Design (1)
Eligibility: DM patients with MV-CAD eligible for stent
or surgery
Exclude: Patients with acute STEMI
Randomized 1:1
MV-Stenting CABG
With Drug-eluting With or Without
CPB
All concomitant Meds shown to be beneficial were
encouraged, including: clopidogrel, ACE inhibitors, ARBs,
b-blockers, statins
www.cardiositeindia.com
39. Baseline Demographics
Treatment Arm
A B
(N=593) (N=592)
Age (mean) 63.4 63.0
Female 28.9% 29.5%
Diabetes Mellitus: Type I 4.8% 4.8%
Hypertension 83.9% 84.7%
Hyperlipidemia 85.1% 81.9%
www.cardiositeindia.com
40. Diabetes Complications
Treatment Arm
A B
(N=593) (N=592)
Complications in diabetes 18.0% 18.9%
Diabetic nephropathy 4.9% 8.6%
Diabetic neuropathy 11.2% 8.8%
Diabetic foot ulcer 2.8% 0.7%
Diabetic retinopathy 6.3% 7.6%
Extremity amputation 1.2% 0.2%
Duration of diabetes (years) 10.1 10.3
PVD above diaphragm 1.9% 3.4%
PVD below diaphragm 10.0% 8.3%
www.cardiositeindia.com
N Engl J Med 2012.
41. History of Present Illness
A B
(N=593) (N=592)
Stable Coronary Heart Disease 68.3% 71.4%
Acute Coronary Syndrome (ACS) 31.7% 28.6%
ST elevation MI(>72 hrs prior to 17.1% 17.3%
admission 82.9% 82.7%
Non-ST elevation ACS
NYHA CHF Classification (Class III/IV
excluded)
Class I 74.5% 72.6%
www.cardiositeindia.com
N Engl J Med 2012.
42. Interventional – Pre-Stent Process
• Prior to PCI: Clinical suitability of each lesion
– left main was an absolute exclusion -
Certified operator
PCI within 14 days of randomization
• DES: For all lesions
Only one type for any given FREEDOM patient
• Antithr: Oral ASA 325 mg + Clopid. > 300 mg load ,
Unfractionated Heparin or Bivalirudin,
Abciximab on the initial PCI
ASA 81-100 mg + Clopid. 75 mg/day 1-yr
www.cardiositeindia.com N Engl J Med 2012
43. PCI Procedure Summary
PCI/DES
Staging: % unstaged procedure
65.9%
% staged procedure
34.1%
% staged procedures involving >1
67.7%
hospitalization
Mean total # of lesions attempted 3.6 ± 1.4
Mean total # drug-eluting stents placed per patient
(across all stages) 4.2 ± 1.9
Reopro used during index procedure (stage 1 for
staged procedures) 54.9%
Heparin administered 83.1%
Bivalirudin administered 16.3%
www.cardiositeindia.com
N Engl J Med 2012.
44. CABG Management
• The use of an internal mammary artery (IMA) to the left
anterior descending (LAD) was strongly recommended in
all patients
• The surgical approach - conventional CABG with
cardiopulmonary bypass and cardioplegic arrest or off-
pump CABG with beating heart - was left to the individual
surgeon’s judgement
www.cardiositeindia.com
45. CABG Procedure Summary
CABG
Off – pump 22.1%
LIMA to LAD 88.2%
www.cardiositeindia.com
N Engl J Med 2012.
46. ENDPOINTS
Events
Endpoint PCI CABG Relative Risk 95% Ci
CV Events 205 / 953 147 / 947 1,39 [1,14;1,68]
(21,5%) (15,5%)
Death From Any 118 / 953 86 / 947 1,36 [1,05;1,77]
Cause (12,4%) (9,1%)
MI 99 / 953 48 / 947 2,05 [1,47;2,86]
(10,4%) (5,1%)
Stroke 22 / 953 37 / 947 0,59 [0,35;0,99]
(2,3%) (3,9%)
Cardiovascular 75 / 953 55 / 947 1,36 [0,97;1,90]
Death (7,9%) (5,8%)
www.cardiositeindia.com
N Engl J Med 2012.
53. FREEDOM Trial conclusion
For patients with diabetes and advanced Coronary
artery disease
CABG was superior to PCI
CABG significantly reduced rates of death and
myocardial infarction,
But had a higher rate of stroke.
www.cardiositeindia.com
N Engl J Med 2012.
54. Limitations of the Trial
On a long term disease, this is a relatively short term study – 7
years, with a minimum of 2 years and a median of 3.8 years.
Longer term follow up of FREEDOM will lead to better
understanding of the comparative benefit by CABG, specifically on
mortality
www.cardiositeindia.com
55. Critical Analysis of FREEDOM Trial
• 1010 patients: smaller sample
• Average age of participants is 62; whereas most
diabetic patients fall in 70- 80 and higher age group
• The average syntax score was 46, and 1/3rd
population fell into greater than 33 syntax score
which anyway qualifies them for CABG
Hence is DM a further risk?
• Inspite of flaws this trial gives a general guideline in
management of diabetes with multivessel disease
www.cardiositeindia.com
Diabetes is a landmark trial from Spain by Dr.Manel Sabate in which (100%) 80pts with diabetes were treated with Cypher and there was remarkable reduction in TLR MACE Instent LL and Insegment RR.TLR was only 7.5%,MACE only11.3%,LL only0.08 and RR 0nly 7.7%.