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Archive for February, 2015

Fractional Flow Reserve Meta-analysis

FFR meta-analysis is available here.

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Categories: Uncategorized

Journal Club 25 February 2015

Paper

Long-Term Survival Benefit of Revascularization Compared With
Medical Therapy in Patients With Coronary Chronic Total Occlusion and Well-Developed Collateral Circulation

Presenter

SB

Summary

OBJECTIVES

The purpose of this study was to compare the long-term clinical outcomes of patients with chronic total
occlusion (CTO) and well-developed collateral circulation treated with revascularization versus medical therapy.

BACKGROUND

Little is known about the clinical outcomes and optimal treatment strategies of CTO with well developedcollateral circulation.

ETHODS

We screened 2,024 consecutive patients with at least 1 CTO detected on coronary angiogram. Of these, we
analyzed data from 738 patients with Rentrop 3 grade collateral circulation who were treated with medical therapy alone
(n ¼ 236), coronary artery bypass grafting (n ¼ 170) or percutaneous coronary intervention (n ¼ 332; 80.1% successful).
Patients who underwent revascularization and medical therapy (revascularization group, n ¼ 502) were compared with
those who underwent medical therapy alone (medication group, n ¼ 236) in terms of cardiac death and major adverse
cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, and repeat revascularization.

RESULTS

During a median follow-up duration of 42 months, multivariate analysis revealed a significantly lower incidence
of cardiac death (hazard ratio [HR]: 0.29; 95% confidence interval [CI]: 0.15 to 0.58; p < 0.01) and MACE (HR:
0.32; 95% CI: 0.21 to 0.49; p < 0.01) in the revascularization group compared with the medication group. After propensity
score matching, the incidence of cardiac death (HR: 0.27; 95% CI: 0.09 to 0.80; p ¼ 0.02) and MACE (HR: 0.44;
95% CI: 0.23 to 0.82; p ¼ 0.01) were still significantly lower in the revascularization group than in the medication group.

CONCLUSIONS

In patients with coronary CTO and well-developed collateral circulation, aggressive revascularization
may reduce the risk of cardiac mortality and MACE.

Supplementary Material

Editorial is here.

Duration of Dual Antiplatelet therapy for DES

The following useful summary of recent trial regarding duration of antiplatelet therapy for drug eluting stents. The material has kindly been provided by E Blattman from Abbott Vascular. The information is from peer reviewed literature and is posted as important information. The information is publicly available and from peer reviewed literature.

From E Blattman

Here is a link directly to the published article in the New England Journal of Medicine (Mauri):

http://www.nejm.org/doi/full/10.1056/NEJMoa1409312

Link to associated editorial (Colombo and Cheiffo):

http://www.nejm.org/doi/full/10.1056/NEJMe1413297

Medscape summary:

http://www.medscape.com/viewarticle/835006

The primary results of the largest randomized DAPT study were presented at AHA in a Late-Breaking Clinical Trial Session by Dr. Laura Mauri of the Harvard Clinical Research Institute (HCRI)

The HCIR DAPT study is to be used by the FDA to make policy and the FDA have already reacted to these results with a statement to the press (http://www.fda.gov/Drugs/DrugSafety/ucm423079.htm).

1. HCRI DAPT Study – DES Primary Results, N=9,961 (Mauri)

Trial Design:

· Independent, multi-centre study, patients randomized according to site, thienopyridine drug type, and presence of risk factors for ST

· Objective: To determine the optimal DAPT duration following stent implantation

· 12 Month run in for both arms with people with events in this timeframe excluded from the trial..

· 1:1 randomization of 12 vs. 30 month DAPT; Patients followed for an additional 3 months after DAPT discontinuation (33 months total) to assess possible rebound effect

· DES: XIENCE/Promus (47.2%), Taxus (26.8%), Endeavor (12.7%), Cypher (11.2%)

· Drugs: Plavix (65.3%) or Prasugrel (34.7)

· Co-Primary Effectiveness Endpoints:

o ARC Def/Prob ST at 12-30 months post-procedure

o MACCE (death, MI or stroke) at 12-30 months post-procedure

· Primary Safety Endpoint: Moderate or severe bleeding at 12-30 months post-procedure

· Interruption was allowed for up to 14 days.

Key Results:

All DES Results, n=9,961:

· Primary Safety endpoint results:

o Def/Prob Stent Thrombosis: 0.4% for the 30-month DAPT arm and 1.4% for the 12-month arm, p<0.001

o MACCE:4.3% for the 30-month DAPT arm and 5.9% for the 12-month arm, p <0.001

§ MI: 2.1% for 30-month arm and 4.1% for 12 month arm, p<0.001

§ Death: 2.0% for 30-month arm and 1.5% for 12-month arm, p=0.05

· Primary Efficacy Endpoint results – Rate of Moderate/Severe Bleeding:2.5% for 30-month arm and 1.6% for 12-month arm, p=0.001

· All primary endpoints statically in favour of 30 month DAPT vs 12 month DAPT with the secondary endpoint of bleeding being less with 12 month DAPT as expected but there was no difference in fatal or severe bleeds as a combined endpoint.

· More Deaths in the 30 month DAPT but this was due to play of chance in the randomization with 8 Cancer patients in the 30 month arm and 1 Cancer patient in the 12 month arm.

CoCr EES Results, n=4,703:

· Primary Safety endpoint results:

o Def/Prob Stent Thrombosis: 0.3% for the 30-month DAPT arm and 0.7% for the 12-month arm

o MACCE:4.3% for the 30-month DAPT arm and 4.5% for the 12-month arm

· These subgroup analyses were not powered and between stent comparisons were not adjusted.*

DAPT Study reaffirms that Xience (EES) is the best choice when it comes to metallic stents. Xience has proven, trial after trial, consistently low ST rates, which was shown again in DAPT study.

This study does raise the question that when a patient receives a permanent metallic implant, there is an ongoing benefit of longer-term DAPT for at least 30 months

SECONDARY ANALYSIS – Is BMS safer?

Dr. Dean Kereiakes (co-author of the DAPT trial) also presented data from a secondary analysis of the DAPT trial at AHA. I have included the link to the Medscape summary for you. This analysis focused on the comparison of how the DES patient population compared to the BMS patient population in the DAPT trial and it showed that drug-eluting stents (DES) are not associated with increased rate of stent thrombosis or major ischemic events compared with bare-metal stents, according to the results of a propensity analysis based on the DAPT study.

http://www.medscape.com/viewarticle/835157#vp_1

Journal Club 18 February 2015

Paper

Evidence from randomised controlled trials did not support the introduction
of dietary fat guidelines in 1977 and 1983: a systematic review and meta-analysis

Presenter

MD

Summary

Objectives

National dietary guidelines were
introduced in 1977 and 1983, by the US and UK
governments, respectively, with the ambition of
reducing coronary heart disease (CHD) by reducing fat
intake. To date, no analysis of the evidence base for
these recommendations has been undertaken. The
present study examines the evidence from randomised
controlled trials (RCTs) available to the US and UK
regulatory committees at their respective points of
implementation.

Methods

A systematic review and meta-analysis were
undertaken of RCTs, published prior to 1983, which
examined the relationship between dietary fat, serum
cholesterol and the development of CHD.

Results

2467 males participated in six dietary trials:
five secondary prevention studies and one including
healthy participants. There were 370 deaths from allcause
mortality in the intervention and control groups.
The risk ratio (RR) from meta-analysis was 0.996
(95% CI 0.865 to 1.147). There were 207 and 216
deaths from CHD in the intervention and control
groups, respectively. The RR was 0.989 (95% CI 0.784
to 1.247). There were no differences in all-cause
mortality and non-significant differences in CHD
mortality, resulting from the dietary interventions.
The reductions in mean serum cholesterol levels were
significantly higher in the intervention groups; this did
not result in significant differences in CHD or all-cause
mortality. Government dietary fat recommendations
were untested in any trial prior to being introduced.

Conclusions

Dietary recommendations were
introduced for 220 million US and 56 million UK
citizens by 1983, in the absence of supporting
evidence from RCTs.

Journal Club 11 February 2015

Paper

Efficacy of a Device to Narrow the Coronary Sinus in Refractory Angina

Presenter

AB

Summary

BACKGROUND

Many patients with coronary artery disease who are not candidates for revascularization
have refractory angina despite standard medical therapy. The balloonexpandable,
stainless steel, hourglass-shaped, coronary-sinus reducing device creates
a focal narrowing and increases pressure in the coronary sinus, thus redistributing
blood into ischemic myocardium.

METHODS

We randomly assigned 104 patients with Canadian Cardiovascular Society (CCS)
class III or IV angina (on a scale from I to IV, with higher classes indicating greater
limitations on physical activity owing to angina) and myocardial ischemia, who
were not candidates for revascularization, to implantation of the device (treatment
group) or to a sham procedure (control group). The primary end point was the proportion
of patients with an improvement of at least two CCS angina classes at
6 months.

RESULTS

A total of 35% of the patients in the treatment group (18 of 52 patients), as compared
with 15% of those in the control group (8 of 52), had an improvement of at
least two CCS angina classes at 6 months (P = 0.02). The device was also associated
with improvement of at least one CCS angina class in 71% of the patients in the
treatment group (37 of 52 patients), as compared with 42% of those in the control
group (22 of 52) (P = 0.003). Quality of life as assessed with the use of the Seattle
Angina Questionnaire was significantly improved in the treatment group, as compared
with the control group (improvement on a 100-point scale, 17.6 vs. 7.6 points;
P = 0.03). There were no significant between-group differences in improvement in
exercise time or in the mean change in the wall-motion index as assessed by means
of dobutamine echocardiography. At 6 months, 1 patient in the treatment group
had had a myocardial infarction; in the control group, 1 patient had died and 3 had
had a myocardial infarction.

CONCLUSIONS

In this small clinical trial, implantation of the coronary-sinus reducing device was
associated with significant improvement in symptoms and quality of life in patients
with refractory angina who were not candidates for revascularization.

Radial Artery Access

theheart.org has a short but instructive video discussion on radial access.
Some discussion points:

  • pre-procedural testing: recent trial data suggests that low risk of occlusion and complications even in patients with poor integrity palmar arch assessed Barbos palmar arch testing.
  • procedural:
    • adjunctive heparin reduces risk of radial artery occlusion
    • standard dose of herpain 5000 units but  dose and timing need more evidence
    • some evidence that heparin may be needed in patient’s with therapeutic INR wrt end-point radial artery occlusion
    • use of left radial may be prudent in elderly and patients < 5ft 5 in , female (1.65 m) in addition to graft study patients
    • future directions:
      • ultrasound guidance: increase success puncture and brachial scanning can identify radial loops
      • use of ulnar artery (e.g. after failed radial)
  • post-procedural care:
    • minimal pressure v patency strategies uncertain benefit. Currentl radial artery occlusion rates low.

 

Categories: Uncategorized

Journal Club 4 February 2015

Paper

Surgical Treatment of Moderate Ischemic Mitral Regurgitation

Presenter

AL

Summary

Background

Ischemic mitral regurgitation is associated with increased mortality and morbidity.
For surgical patients with moderate regurgitation, the benefits of adding mitralvalve
repair to coronary-artery bypass grafting (CABG) are uncertain.

Methods

We randomly assigned 301 patients with moderate ischemic mitral regurgitation to
CABG alone or CABG plus mitral-valve repair (combined procedure). The primary end
point was the left ventricular end-systolic volume index (LVESVI), a measure of left
ventricular remodeling, at 1 year. This end point was assessed with the use of a
Wilcoxon rank-sum test in which deaths were categorized as the lowest LVESVI rank.

Results

At 1 year, the mean LVESVI among surviving patients was 46.1±22.4 ml per square
meter of body-surface area in the CABG-alone group and 49.6±31.5 ml per square meter
in the combined-procedure group (mean change from baseline, −9.4 and −9.3 ml per
square meter, respectively). The rate of death was 6.7% in the combined-procedure
group and 7.3% in the CABG-alone group (hazard ratio with mitral-valve repair, 0.90;
95% confidence interval, 0.38 to 2.12; P = 0.81). The rank-based assessment of LVESVI
at 1 year (incorporating deaths) showed no significant between-group difference
(z score, 0.50; P = 0.61). The addition of mitral-valve repair was associated with a longer
bypass time (P<0.001), a longer hospital stay after surgery (P = 0.002), and more neurologic
events (P = 0.03). Moderate or severe mitral regurgitation was less common in the
combined-procedure group than in the CABG-alone group (11.2% vs. 31.0%, P<0.001).
There were no significant between-group differences in major adverse cardiac or cerebrovascular
events, deaths, readmissions, functional status, or quality of life at 1 year.

Conclusions

In patients with moderate ischemic mitral regurgitation, the addition of mitral-valve
repair to CABG did not result in a higher degree of left ventricular reverse remodeling.
Mitral-valve repair was associated with a reduced prevalence of moderate or severe mitral
regurgitation but an increased number of untoward events. Thus, at 1 year, this trial did
not show a clinically meaningful advantage of adding mitral-valve repair to CABG.
Longer-term follow-up may determine whether the lower prevalence of mitral regurgitation
translates into a net clinical benefit.

Supplementary Material

Editorial