SHA24/058002

Impact of Optimal Medical Therapy, Versus Optimal Medical Therapy Plus Revascularizations, on All-cause Mortality, in Patients with Stable Ischemic Heart Disease

Iyad Farah King Abdul-Aziz Cardiac Center

Background 

Compared to medical therapy, percutaneous coronary intervention (PCI) has been associated with lower mortality or MI rates in patients with STEMI and in high-risk patients with ACS

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PCI has been shown to improve symptoms compared with conservative medical treatment in patients with stable CAD

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Effect of PCI on the risk of death, MI, and subsequent revascularization in patients with stable CAD is controversial

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A total of 2950 patients (1476 received PCI, and 1474 received conservative treatment).

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There was no significant difference between the 2 treatment strategies with regard to mortality, cardiac death or myocardial infarction, nonfatal myocardial infarction, CABG, or PCI during follow-up.

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CONCLUSION: In patients with chronic stable CAD, in the absence of a recent myocardial infarction, PCI does not offer any benefit in terms of death, myocardial infarction, or the need for subsequent revascularization compared with conservative medical treatment.

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•Katritsis DG, Ioannidis JP. Circulation. 2005 Jun 7;111(22):2906-12. Epub 2005 May 31.

COURAGE: Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation AHA/ACC Class I/II indications for PCI, suitable coronary artery anatomy and ≥70% stenosis in ≥1 proximal epicardial vessel + objective evidence of ischemia or ≥80% stenosis + class III angina without provocation testing

Optimal medical therapy* + PCI (n = 1149)

Randomized

Optimal medical therapy (n = 1138)

Primary outcome: All-cause mortality, nonfatal MI Follow-up: Median 4.6 years

*Intensive pharmacologic therapy + lifestyle intervention Boden WE et al. N Engl J Med. 2007;356.

COURAGE: Treatment effect on primary outcome All-cause death, MI 1.0 0.9 Survival free of primary outcome

HR 1.05* (0.87-1.27) P = 0.62

0.8 0.7 0.6 0.5 0 0

No. at risk Medical therapy PCI

1138 1149

1 1017 1013

Medical therapy

2

3

4 Years

959 952

834 833

638 637

5

6

7

408 417

192 200

30 35

PCI + medical therapy

*Unadjusted Boden WE et al. N Engl J Med. 2007;356.

BARI 2D: Enrollment, randomization, and treatments

BARI 2D: All-cause Death for Medical Therapy Vs. Type of Revascularization

BARI 2D: Death, MI, Stroke for Medical Therapy VS. Type of Revascularization

ď‚Ž BARI 2D provides evidence that patients

with type 2 diabetes and moderate CAD can be treated safely with medical therapy but with careful follow-up and subsequent revascularization if needed.

Stich Important Inclusion Criteria 

LVEF ≤ 0.35 within 3 months of trial entry

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CAD suitable for CABG

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MED eligible  Absence of left main CAD as defined by an intraluminal stenosis of ≥ 50%  Absence of CCS III angina or greater (angina markedly limiting ordinary activity)

Surgical Treatment for Ischemic Heart Failure Trial (STICH) 1212

Randomized MED only

602

610

• 99 clinical sites in 22 countries • Enrollment: July 2002 – May 2007

Randomized CABG

HR HR 0.86 0.86 (0.72, (0.72, 1.04) 1.04) PP == 0.123 0.123

0.46 0.41

HR HR0.86 0.86(0.72, (0.72,1.04) 1.04) PP==0.123 0.123 Adjusted AdjustedHR HR0.82 0.82(0.68, (0.68,0.99) 0.99) Adjusted P = 0.039 Adjusted P = 0.039

0.46 0.41

Cardiovascular Mortality— As Randomized HR HR 0.81 0.81 (0.66, (0.66, 1.00) 1.00) PP == 0.050 0.050 Adjusted Adjusted HR HR 0.77 0.77 (0.62, (0.62, 0.94) 0.94) Adjusted Adjusted PP == 0.012 0.012

0.39 0.32

Death or Cardiovascular Hospitalization —

0.68 0.58

HR HR 0.74 0.74 (0.64, (0.64, 0.85) 0.85) PP << 0.001 0.001 Adjusted Adjusted HR HR 0.70 0.70 (0.61, (0.61, 0.81) 0.81) PP << 0.001 0.001

Conclusions of Stich 

In patients randomized to STICH, there was no statistically significant difference in all-cause mortality between medical therapy alone and medical therapy with CABG

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Medical therapy with CABG reduces cardiovascular mortality and morbidity compared to medical therapy alone

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When randomized to CABG, patients are exposed to an early risk

Conclusions of OAT Trial 

Regardless of the excellent 1-year patency of the IRA and modest attenuation of left ventricular remodeling, PCI did not reduce clinical events

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There was a trend toward excess reinfarction with PCI, not driven by periprocedural MI

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These results support the routine use of aggressive secondary prevention without revascularization as the preferred therapy for OAT-eligible patients.

Methodology of Our Study Retrospectively  2697 adult patients with stable IHD  Cardiovascular disease management program (CVDMP) at King Abdul Aziz Medical CityRiyadh  Between April 2000 and Oct. 2011.  Data of enrollment and the last follow up visits to the clinic was collected from the electronic database, and analyzed by using the SPSS. 

Patients who had no follow up visits (n= 65) Or  Had non obstructive CAD (n= 280) 

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Total excluded 345 patients

Our Study Design All CAD patients F/U in CVDMP from 2000-2011 (n = 2697)

Excluded 345 patients All eligible patients after exclusion (n = 2352)

Retrospectively Reviewed

Optimal medical therapy* + Revascularization (OMTR) (n = 2031)

Optimal medical therapy (OMT) (n = 321)

Primary outcome: All-cause mortality

Follow-up: Mean 40 months

*Intensive pharmacologic therapy + lifestyle reinforcement

Excluded from Study

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All patients were receiving optimal medical therapy as part of the regular care of the CVDMP

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Intensive pharmacologic therapy to achieve targets

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Lifestyle interventions were encouraged but not directly supervised ( cardiac rehabilitation program was not yet established)

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Established in the year 2000 Nurse Led, target oriented, cardiologist supervised Implementing up to date and evidence based international recommendations Open door system Emphasis on adherence

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CHF program Atherosclerosis secondary prevention Cardiac diabetes program Life style modification program ( under construction) Anticoagulation program ( under construction) Hypertension program ( under construction)

Baseline characteristics:

* The mean EF of OMTR minus OMT equals 7.53 95% confidence interval of this difference: (6.20 to 8.87)

Baseline characteristics:

Changes in LVEF

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LVEF improved by 1.6% in OMTR (from 46% to 47.6%) and by 2.8% in OMTO groups (from 38.2% to 41%) (P value…)

Conclusion

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Mortality was higher in OMT group, in which patients were more sick as represented by higher incidence of CHF and lower baseline LVEF Those who refused revascularization did not increase their risk of death significantly Patients declined by the treating team because of their poor target vessels or non viable myocardium, had the worst outcomes

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Retrospective study Life style interventions were not optimal as compared to the landmark related studies Covariant analysis and sub group and detailed analysis to explore predictors of mortality