RECENT TRIALS

SCORE 2019
PRASANNA SIMHA MOHAN RAO
PROF CVTS SJIC&R
 HEADINGS -1
1. WHAT IS THE PROBLEM TO BE ADDRESSED ?
2. WHAT DO WE KNOW ?
3. AIM
4. TYPE OF TRIAL
5. CONTROL GROUP
6. TEST GROUP
7. SAMPLE SIZE ,ANALYSIS
8. INCLUSION CRITERIA
9. EXCLUSION CRITERIA
 HEADINGS -1
10.FOLLOW UP
11.PRIMARY ENDPOINT
12.SECONDARY ENDPOINT
13.SPECIFIC FEATURES
14.DETAILS
15.CONCLUSION
16.WHAT IS NEW THAT WE LEARNT IN THE TRIAL
17.LIMITATIONS OF THE TRIAL
18.HOW DOES THIS CHANGE OUR PRACTICE ?
 ART TRIAL (ARTERIAL REVASCULARIZATION
TRIAL) 10 YEAR DATA
1. WHAT IS THE PROBLEM TO BE ADDRESSED ?
• IS BITA BENEFICIAL
2. WHAT DO WE KNOW ?
• 5 YEAR RESULTS OF ART SHOWED NO BENEFIT
3. AIM
• HAS BIMA GOT AN ADVANTAGE OVER SIMA GRAFTING
4. TYPE OF TRIAL
• PROSPECTIVE RCT
5. CONTROL GROUP
• SIMA 1554
6. TEST GROUP
• BIMA 1548
 ART TRIAL (ARTERIAL REVASCULARIZATION
TRIAL) 5 YEAR DATA AT 2016
7. SAMPLE SIZE ,ANALYSIS N = 3102 INTENTION TO TREAT
8. INCLUSION CRITERIA
• MULTIVESSEL CABG
9. EXCLUSION CRITERIA
• SVD REDO EVOLVING MI AND VALVE SURGERY
10. FOLLOW UP
• TILL 2018(10 YEAR) NOW 10YEAR DATA
11. PRIMARY ENDPOINT
• SURVIVAL
12. SECONDARY ENDPOINT
• CAUSE SPECIFIC MORTALITY
• REINTERVENTION
 ART TRIAL (ARTERIAL REVASCULARIZATION
TRIAL) 5 YEAR DATA AT 2016
13. SPECIFIC FEATURES 5 YR DATA DEATH SIMA 8.4% VS BIMA 8.7%
14. DETAILS
• LAST 10 YEAR FU 2017 COMPOSITE DEATH SIMA 21.2 % BIMA 20.4%
15. CONCLUSION
• AT 10 YEARS BIMA HAS NO SURVIVAL BENEFIT
16. WHAT IS NEW THAT WE LEARNT IN THE TRIAL
• BIMA BENEFIT NOT SEEN TILL 10YEARS
17. LIMITATIONS OF THE TRIAL
• ANALYSIS OF INTENTION TO TREAT VRSUS AS TREATED NOT PRESPECIFIED
18. HOW DOES THIS CHANGE OUR PRACTICE ?
• FOR PATIENTS WITH EXPECTED SURVIVAL OF LESS THAN 10 YEARS BIMA MAY HAVE NO
BENEFITMEDICAL
• THERAPY FOR VEIN GRAFT DISEASE IS GETTING BETTER
• IF YOU WANT TO GIVE TAR ACTUALLY GIVE IT !! ?
 MORTALITY AT 10 YEARS (Intention To Treat)
25

Single
Patients Who Died (%)
20
HR (95% CI) = 0.96 (0.82, 1.12) ITA
p = 0.62
15 Bilateral
ITA
10

0
0 2 4 6 8 10
Time from randomisation (years)
No. at risk
Bilateral graft 1548 1481 1417 1359 1283 882
Single graft 1554 1484 1432 1370 1283 894
 MORTALITY AT 10 YEARS (As Treated)
25

Single Arterial
Patients Who Died (%)
20
Graft

15 HR (95% CI) = 0.81 (0.68, 0.95)

10 Multiple Arterial
Grafts

0
0 2 4 6 8 10
Time from enrolment (years)
No. at risk
MAG 1690 1632 1567 1510 1430 998
SAG 1330 1270 1222 1163 1081 750
 DEATH/MI/STROKE AT 10 YEARS (Intention To Treat)
30
Single
25 ITA
Patients With Event (%)

HR (95% CI) = 0.90 (0.78, 1.03)

20 p = 0.12
Bilateral
ITA
15

10

0
0 2 4 6 8 10
Time from randomisation (years)
No. at risk
Bilateral graft 1548 1435 1362 1299 1214 830
Single graft 1554 1427 1366 1296 1194 821
 DEATH/MI/STROKE AT 10 YEARS (As Treated)
30
Single Arterial
25 Graft
Patients With Event (%)

20
HR (95% CI) = 0.80 (0.69, 0.93)
Multiple Arterial
15 Grafts

10

0
0 2 4 6 8 10
Time from enrolment (years)
No. at risk
MAG 1690 1591 1510 1442 1353 934
SAG 1330 1212 1162 1101 1006 692
 Why No Difference in Bilateral vs Single ITA Grafts @ 10 years
(Intention To Treat) ?

① Genuinely NO Difference:
(Concept of Complete vs Incomplete Revascularization ?)

② Guideline Based Medical Therapy: in >

80% (slows vein graft failure ?)

③ Radial Artery Use:

22% of Single ITA: (superior 5yr patency and clinical outcomes)

④ Differential X-over: 14% of

Bilateral ITA  Single ITA; 4% Single ITA  Bilateral ITA

⑤ Surgeon Experience:
Individual Surgeon X-over from Bilateral ITA to Single ITA : 0%-100%
MAIN COMPARE
• WHAT IS THE PROBLEM TO BE ADDRESSED ?
• PCI VERSUS CABG IN UNPROTECTED LEFT MAIN DISEASE
• WHAT DO WE KNOW ?
• PCI CAN BE USED IN LOWER SYNTAX SCORES
• AIM
• To compare 10-year outcomes after PCI and CABG for LMCA disease.
• TYPE OF TRIAL
• OBSERVATIONAL
• CONTROL GROUP
• PCI (N=1,102)
• TEST GROUP
• CABG (N=1138)
 MAIN COMPARE
• NO BETWEEN-GROUP DIFFERENCE IN ADJUSTED RISKS OF DEATH AND THE
COMPOSITE OUTCOME UP TO 10 YEARS IN THE OVERALL COHORT.
• THE RISK OF TARGET-VESSEL REVASCULARIZATION WAS SIGNIFICANTLY
HIGHER IN THE PCI GROUP.
• IN THE COHORT COMPARING DES AND CONCURRENT CABG, IN THE RISKS OF
DEATH AND THE COMPOSITE OUTCOME WERE SIMILAR UP TO 5 YEARS.
• HOWEVER, AFTER 5 YEARS, DES WAS ASSOCIATED WITH HIGHER RISKS OF
DEATH AND SERIOUS COMPOSITE OUTCOME COMPARED TO CABG.
SYNTAX 3 REVOLUTION
• Coronary Computed Tomography Angiography for Heart Team Decision-making in
Multivessel Coronary Artery Disease: the SYNTAX III REVOLUTION trial
• Objectives:
• The trial was designed to determine the agreement between two heart teams (cardiac
surgeon, cardiologist and radiologist) on treatment recommendation and planning based
either on coronary CTA (with and without FFRCT) or conventional angiography.
• An international, multicenter study, randomizing two heart teams to make a treatment
decision between CABG and PCI, using either coronary CTA or conventional angiography
while blinded to the other imaging modality.
• Any anatomical SYNTAX score was eligible for screening and patients with anatomical
SYNTAX score >33 were not excluded. However, patients with prior revascularization
were excluded.
• In patients with left main or three-vessel coronary artery disease, a heart team treatment
decision-making based on coronary CTA showed an almost perfect agreement with the
decision derived from conventional coronary angiography suggesting the potential
feasibility of a treatment decision-making and planning based solely on this non-invasive
imaging modality.
 MOMENTUM 3
• What we know
Magnetically levitated centrifugal continuous-flow circulatory pump was found to improve clinical
outcomes, as compared with a mechanical-bearing axial continuous-flow pump, at 6 months in
patients with advanced heart failure.
• Comparators
• centrifugal-flow pump with the axial-flow pump in patients with advanced heart failure,
irrespective of the intended goal of support 
•  Primary end point 
• survival at 2 years free of disabling stroke or survival free of reoperation to replace or remove
a malfunctioning device. 
• Secondary end points
• Adverse events such as stroke, bleeding, right heart failure, and infection; actuarial survival;
functional status; and quality of life
• N=366 190 centrifugal (heart mate 3 )176 axial (heartmate 2)
 MOMENTUM 3
• Intention-to-treat population, which included all the patients who underwent
randomization

• Primary endpoint achieved 79.5% (3) vs. 60.2% (2)

• The difference between groups was primarily driven by reoperation or device removal for
pump malfunction,(1 (HM 3) 15 (HM 2) the rates of which were significantly lower in the
centrifugal-flow pump group than in the axial-flow pump group
MEDICAL TRIALS TO BE AWARE OF
• FAME 2 (FFR PCI+OMT BETTER THAN OMT IF ISCHEMIA + OTHERWISE OMT
BETTER)
• SWEED HEART DEFINE FLAIR (IFR/FFR (NONINFERIOR SO NO ADENSOISNE
REQUIRED)
• NOBLE EXCEL PCI VERSUS SURGERY – LM MORE ISCHEMIA DRIVEN
REVASCULARIZATION MORE EVENTS LONG TERM IN PCI
IMPORTANT TRIALS (UPCOMING THAT MAY
CHANGE PRACTICE)
• PARTNER 3 EVOLUT TRIAL(LOW RISK TAVI VERSUS SAVR)
• PARTNER 5 AVIV (TAVI IN BIOPROSTHETIC DEGENERATION
• GRAFFITI – FFR GUIDED CABG