Optimal medical therapy in patients with stable coronary artery disease in Poland. The ISCHEMIA Trial experience

Background. Today, a number of unresolved issues remain regarding vulnerable coronary plaques, one of which is the need for preventive revascularization.Aim. Evaluation of the appropriateness of preventive revascularization of functionally insignificant lesions of the coronary arteries with signs of vulnerability according to the virtual histology of intravascular ultrasound in patients with stable coronary artery disease.Methods. The prospective randomized study includes patients with stable coronary artery disease and isolated intermediate-grade coronary stenosis. The first step in patients is measured fractional flow reserve to confirm the hemodynamic insignificance of stenosis. Then an intravascular ultrasound is performed to verify signs of plaque vulnerability: a thin-cap fibroatheroma and / or minimum lumen area <4 mm2 and/or plaque burden >70%. After that, patients are randomized into two groups: preventive revascularization or optimal medical therapy. After 12 months, patients undergo repeated intravascular ultrasound and end-point analysis.Results. So far, 10 patients have been included in the study (6 in the preventive revascularization group and 4 in the optimal medical therapy group). No endpoints and complications were recorded in both groups in 30-days follow-up.Conclusion. Intravascular imaging methods can identify vulnerable coronary plaques, which allows you to use a personalized approach in determining treatment tactics, one of which can be preventive revascularization.

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ISCHEMIA trial: a win for the optimal medical therapy in the management of stable coronary artery disease?

REC: interventional cardiology (English Edition) ◽

10.24875/recice.m20000134 ◽

2020 ◽

Author(s):

Luciano Consuegra-Sánchez ◽

Daniel Fernández-Bergés ◽

Ramón López-Palop

Keyword(s):

Coronary Artery Disease ◽

Coronary Artery ◽

Medical Therapy ◽

Stable Coronary Artery Disease ◽

Optimal Medical Therapy ◽

Artery Disease

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A meta-analysis of optimal medical therapy with or without percutaneous coronary intervention in patients with stable coronary artery disease

Coronary Artery Disease ◽

10.1097/mca.0000000000001041 ◽

2021 ◽

Vol Publish Ahead of Print ◽

Author(s):

Rahman Shah ◽

Mannu Nayyar ◽

Francis K Le ◽

Ajay Labroo ◽

Abrar Nasr ◽

...

Keyword(s):

Coronary Artery Disease ◽

Percutaneous Coronary Intervention ◽

Coronary Artery ◽

Medical Therapy ◽

Meta Analysis ◽

Stable Coronary Artery Disease ◽

Coronary Intervention ◽

Optimal Medical Therapy ◽

Percutaneous Coronary ◽

Artery Disease

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Abstract 3506: Cost Effectiveness of Adding PCI to Optimal Medical Therapy in Patients with Stable Coronary Artery Disease: Economic Outcomes from the COURAGE Trial

Circulation ◽

10.1161/circ.116.suppl_16.ii_794 ◽

2007 ◽

Vol 116 (suppl_16) ◽

Author(s):

William S Weintraub ◽

Ron Goeree ◽

Zefeng Zhang ◽

Koon Teo ◽

Paul Kolm ◽

...

Keyword(s):

Coronary Artery Disease ◽

Cost Effectiveness ◽

Coronary Artery ◽

Medical Therapy ◽

Management Strategy ◽

Stable Coronary Artery Disease ◽

Optimal Medical Therapy ◽

Initial Management ◽

Artery Disease

Background: The main results of COURAGE showed no differences in all-cause mortality or non-fatal MI (primary endpoint), the composite of death, MI or stroke, or hospitalization for ACS (secondary endpoints) during 4.6 year median follow-up in the 2,287 patients with stable coronary artery disease (CAD) randomized to optimal medical therapy (OMT) with or without percutaneous coronary intervention (PCI). There was a benefit to PCI in quality of life measured with the Seattle Angina Questionnaire. This study focuses on cost-effectiveness of PCI. Methods: Resource utilization including initial and follow-up hospitalizations were assigned a DRG and then costs assigned from Medicare reimbursement. Medication costs were assessed from Redbook average wholesale price. Survival was estimated for patients from Framingham data. Survival was quality adjusted from utility measured by standard gamble. Cost and outcome were discounted 3%. Costs after the trial period are Medicare average costs. Cost-effectiveness is expressed as an incremental cost effectiveness ratio (ICER), of cost per life year (LY) or quality adjusted life year (QALY) gained. The distribution of the ICER was assessed by bootstrap. Results: The added cost of PCI is approximately $10,000, without significant gain in LY or QALYs. The ICER varied from just over $150,000 to just under $300,000 per LY or QALY gained with PCI. A large minority of the distributions of the ICERs found PCI to be dominated by OMT, that is OMT offering better outcome at lower cost. Conclusions: The addition of PCI to OMT as an initial management strategy costs significantly more without offering an advantage in survival or QALYs. The ICER is high compared to conventional benchmarks, and the distribution includes infinity and low probability of being below $50,000/QALY gained. PCI in addition to OMT is not a cost-effective initial management strategy for symptomatic, chronic coronary artery disease.

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Abstract 2449: Clinical Outcomes in Women with Stable Coronary Artery Disease Randomized to Optimal Medical Therapy With or Without PCI: Pre-Specified Subset Analysis of the COURAGE Trial

Circulation ◽

10.1161/circ.116.suppl_16.ii_538-b ◽

2007 ◽

Vol 116 (suppl_16) ◽

Author(s):

William E Boden ◽

Alice K Jacobs ◽

Koon K Teo ◽

Pamela M Hartigan ◽

David J Maron ◽

...

Keyword(s):

Coronary Artery Disease ◽

Coronary Artery ◽

Clinical Outcomes ◽

Medical Therapy ◽

Stable Coronary Artery Disease ◽

Optimal Medical Therapy ◽

P Value ◽

Subset Analysis ◽

Artery Disease

Background: The main results of the COURAGE Trial showed no significant differences in the primary outcome of all-cause mortality or non-fatal MI, or in major secondary outcomes (the composites of death, MI or stroke, and hospitalization for ACS) in the 2,287 patients with stable coronary artery disease randomized to optimal medical therapy (OMT) with or without percutaneous coronary intervention (PCI). In a pre-specified subset analysis, women who received an initial strategy of PCI during a median 4.6 year follow-up appeared to benefit for death or MI, but the interaction P value for this comparison (0.03) exceeded the nominal pre-specified value for all trial subgroup interactions (P<0.01) . Methods: We explored various pre-specified clinical endpoints in the 338 women (15%) of the COURAGE cohort who were randomized to PCI + OMT vs. OMT alone. Chi-Square analyses were conducted for the following outcomes between groups (time to first event): death or MI; death; MI; the composite of death, MI or stroke; death, MI or hospitalization (Hosp) for ACS; and Hosp for CHF. Results: There were no significant differences between treatment arms for major pre-specified cardiovascular events in men, but there was apparent benefit for many clinical outcomes in women randomized to PCI + OMT vs. OMT alone, although in all but one comparison (i.e., CHF), the P values exceeded the pre-specified value for interaction (P < 0.01) during long-term follow-up (Table ): Conclusions: Although the primary endpoint and death alone were not significantly different between groups, women randomized to PCI appeared to fare better than those randomized to OMT alone for selected clinical outcomes. However, because women comprised only 15% of the COURAGE population, it is unclear whether these findings indicative true clinical benefit for PCI in women, or alternatively may represent a statistical play of chance or type II error. These important findings may warrant additional investigation and analysis.

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