From November 4 to 6, 2021, the Annual Conference of Transcatheter Cardiovascular Therapeutics (TCT 2021) was successfully held in the form of online+offline. The Late-Breaking Clinical Trials and Science session of this conference, Atlanta, USA
Professor David E. Kandzari of the Monte Heart Institute announced the early results of the OPTIMUM study, and this journal invites him to conduct in-depth discussions on related issues.
International Circulation: At this TCT conference, you will announce the early results of the OPTIMUM study. Would you please introduce the characteristics of the patients enrolled in this study and what progress has been made in the study?
Professor David E. Kandzari: Thank you. And thanks for the opportunity to be with you and to share the results of the OPTIMUM study. The OPTIMUM study was a prospective investigator-initiated study of 750 patients with complex coronary artery disease (i.e. left main or multivessel coronary artery disease) who were deemed ineligible by the site-specific heart team, specifically the site cardiothoracic surgeon, for coronary artery bypass surgery. The study was performed at 22 centers in the United States, and we examined the outcomes of patients undergoing high-risk PCI after determination of ineligibility for bypass surgeries. Specifically, we compared the actual or observed mortality either in hospital or through 30 days, with that predicted by surgical risk models of the STS (Society of Thoracic Surgery). As secondary objectives, we also compared the actual mortality with the EuroScore II model, and also the site surgeons’ own estimate or prediction of mortality by 30 days. As a key secondary objective, we also examined patient reported health status measured by the Seattle Angina Questionnaire (SAQ) and the Kansas City Cardiomyopathy Questionnaire (KCCQ). In other words, we examined quality of life, patient reported angina status and heart failure symptoms.
International Circulation: In clinical practice, what are the common management strategies for patients with CABG contraindications?
Professor David E. Kandzari: This is a terrific question because, just as background, these patients with complex coronary disease are of increasing prevalence across the world in cardiac catheterization laboratories. It is estimated that patients with complex coronary disease, left main or multivessel disease who are not eligible for bypass surgery represent at least one-in-five such patients. These are patients who are not routinely addressed in societal guidelines. They are not included in clinical trials. So, we really don’t have much information with regard to the outcomes, especially with contemporary PCI. The purpose of this study was to not only characterize this population, but secondly to examine reasons why these patients were turned down for bypass surgery, and perhaps most importantly, to examine the clinical outcomes with high-risk PCI and to provide information that would guide decision-making for these patients in the future with regard to whether they should undergo PCI or not versus medical therapy alone perhaps. And secondly, to determine what benefits could be observed with PCI, not only with regard to survival, but with regard to health status. And finally, to help inform shared decision-making with patients and their family to be able to provide them an estimate of what the likelihood or prediction of adverse outcomes would be in this specific patient population.
International Circulation: For patients with complicated coronary artery disease (such as multivessel disease, left main disease), what are the clinical benefits of CABG and PCI?
Professor David E. Kandzari: We know from randomized clinical trials that are quite dated in the medical literature, for example, with left main disease, that bypass surgery is a lifesaving endeavor. We certainly know now from a succession of comparative trials of PCI versus bypass surgery that there are selected instances of severe disease burden where bypass surgery may have an advantage, especially with regard to non-fatal myocardial infarction, compared to percutaneous revascularization. There are some studies, for example in diabetes, suggesting the advantage with regard to survival of bypass surgery over PCI, again, at least in selected patients. But here, these are patients who have been determined by the surgeon to not be eligible for bypass surgery, so we don’t have good information with regard to the outcomes when surgery is not an option. That was the purpose of this study.
International Circulation: Could you please introduce the research direction of the next stage of this research?
Professor David E. Kandzari: We have a wealth of information from the study. The first key finding was that the mortality rate of 5.6%, which is certainly higher than other contemporary studies of less complex patients, was actually predicted uniquely well with the surgical risk models. It was 42% lower than predicted by the site surgeons’ estimates. We also observed significant improvements in patient reported health status, quality of life, physical function and angina frequency - all were significantly improved with percutaneous revascularization. In fact, by 6 months, >80% of the patients were free of angina by their own reporting. As next steps, we are going to dive further into this wealth of information from this trial to, for example, determine risk models or models to help inform decision-making with regard to which patients do benefit, and how much completeness of revascularization is needed to improve both outcomes and health status. And moreover, to provide information that we can share with patients when surgery is not an option, so that they can make an informed decision with regard to either medical therapy alone, or PCI with medical therapy.
Professor David E. Kandzari of the Monte Heart Institute announced the early results of the OPTIMUM study, and this journal invites him to conduct in-depth discussions on related issues.
Professor David E. Kandzari: Thank you. And thanks for the opportunity to be with you and to share the results of the OPTIMUM study. The OPTIMUM study was a prospective investigator-initiated study of 750 patients with complex coronary artery disease (i.e. left main or multivessel coronary artery disease) who were deemed ineligible by the site-specific heart team, specifically the site cardiothoracic surgeon, for coronary artery bypass surgery. The study was performed at 22 centers in the United States, and we examined the outcomes of patients undergoing high-risk PCI after determination of ineligibility for bypass surgeries. Specifically, we compared the actual or observed mortality either in hospital or through 30 days, with that predicted by surgical risk models of the STS (Society of Thoracic Surgery). As secondary objectives, we also compared the actual mortality with the EuroScore II model, and also the site surgeons’ own estimate or prediction of mortality by 30 days. As a key secondary objective, we also examined patient reported health status measured by the Seattle Angina Questionnaire (SAQ) and the Kansas City Cardiomyopathy Questionnaire (KCCQ). In other words, we examined quality of life, patient reported angina status and heart failure symptoms.
International Circulation: In clinical practice, what are the common management strategies for patients with CABG contraindications?
Professor David E. Kandzari: This is a terrific question because, just as background, these patients with complex coronary disease are of increasing prevalence across the world in cardiac catheterization laboratories. It is estimated that patients with complex coronary disease, left main or multivessel disease who are not eligible for bypass surgery represent at least one-in-five such patients. These are patients who are not routinely addressed in societal guidelines. They are not included in clinical trials. So, we really don’t have much information with regard to the outcomes, especially with contemporary PCI. The purpose of this study was to not only characterize this population, but secondly to examine reasons why these patients were turned down for bypass surgery, and perhaps most importantly, to examine the clinical outcomes with high-risk PCI and to provide information that would guide decision-making for these patients in the future with regard to whether they should undergo PCI or not versus medical therapy alone perhaps. And secondly, to determine what benefits could be observed with PCI, not only with regard to survival, but with regard to health status. And finally, to help inform shared decision-making with patients and their family to be able to provide them an estimate of what the likelihood or prediction of adverse outcomes would be in this specific patient population.
International Circulation: For patients with complicated coronary artery disease (such as multivessel disease, left main disease), what are the clinical benefits of CABG and PCI?
Professor David E. Kandzari: We know from randomized clinical trials that are quite dated in the medical literature, for example, with left main disease, that bypass surgery is a lifesaving endeavor. We certainly know now from a succession of comparative trials of PCI versus bypass surgery that there are selected instances of severe disease burden where bypass surgery may have an advantage, especially with regard to non-fatal myocardial infarction, compared to percutaneous revascularization. There are some studies, for example in diabetes, suggesting the advantage with regard to survival of bypass surgery over PCI, again, at least in selected patients. But here, these are patients who have been determined by the surgeon to not be eligible for bypass surgery, so we don’t have good information with regard to the outcomes when surgery is not an option. That was the purpose of this study.
International Circulation: Could you please introduce the research direction of the next stage of this research?
Professor David E. Kandzari: We have a wealth of information from the study. The first key finding was that the mortality rate of 5.6%, which is certainly higher than other contemporary studies of less complex patients, was actually predicted uniquely well with the surgical risk models. It was 42% lower than predicted by the site surgeons’ estimates. We also observed significant improvements in patient reported health status, quality of life, physical function and angina frequency - all were significantly improved with percutaneous revascularization. In fact, by 6 months, >80% of the patients were free of angina by their own reporting. As next steps, we are going to dive further into this wealth of information from this trial to, for example, determine risk models or models to help inform decision-making with regard to which patients do benefit, and how much completeness of revascularization is needed to improve both outcomes and health status. And moreover, to provide information that we can share with patients when surgery is not an option, so that they can make an informed decision with regard to either medical therapy alone, or PCI with medical therapy.
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