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– A completely noninvasive method of identifying functionally significant lesions in patients with triple-vessel coronary artery disease yielded results comparable to conventional invasive angiographic assessment accompanied by an intracoronary pressure wire, in a prespecified secondary analysis of the SYNTAX II study.

That noninvasive method uses fractional flow reserve calculated from computed tomographic angiography, Carlos Collet, MD, said at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

Bruce Jancin/MDedge News
Dr. Carlos Collet
Moreover, the fully noninvasive evaluation was considerably more informative than was conventional invasive angiography alone, which is the dominant diagnostic strategy utilized in contemporary clinical practice despite persuasive evidence of the added clinical value provided by invasive measurement of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR). Indeed, the noninvasive approach evaluated in SYNTAX II reclassified 30% of patients from the high- and intermediate-risk tertiles based on invasive angiography to the low-risk tertile, a result with important implications for patient management because it renders them stronger candidates for PCI, observed Dr. Collet, a cardiologist at the Academic Medical Center of Amsterdam.

The results were hailed as a harbinger of a coming era in which interventional decision making will be based entirely upon noninvasively acquired anatomic and physiologic data. Conventional diagnostic angiography is predicted to fall by the wayside, with resultant savings in time and cost as well as avoidance of the risks of percutaneous diagnostic angiography, which entails considerably more radiation exposure than does noninvasive CT angiography (CTA).

“We are on the verge of a major change,” said Patrick W. Serruys, MD, PhD, professor of cardiology at Imperial College London, who was the senior coinvestigator in the study. “I think that the next disruptive moment in cardiology will be the introduction of the new generation of multislice CT scans replacing conventional cineangiography in the next 5-10 years. For the interventional cardiologist, to have the results of a multislice CT scan the day before a procedure is a wonderful bonus. You know in advance what you’re going to see, you can develop your treatment strategy, and you can spare contrast.”

Bruce Jancin/MDedge News
Dr. Patrick W. Serruys
This was a relatively small proof-of-concept study involving 77 patients with three-vessel CAD who underwent both CTA with noninvasive calculation of FFR and conventional invasive angiography with invasive physiologic assessment as part of the larger previously reported SYNTAX II (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery II) study.

Compared with conventional invasive angiographic assessment with the use of an intracoronary pressure wire to measure iFR, the noninvasively calculated SYNTAX II score had 95% sensitivity and 61% specificity for detection of functionally significant stenosis, with a positive predictive value of 81% and a negative predictive value of 87%. And this was achieved using older scanners and software considerably less accurate than today’s rapidly evolving state of the art, Dr. Collet noted.

 

 

Background

The original landmark SYNTAX trial led to development of an anatomically based SYNTAX score for use in stratifying risk and guiding treatment planning – coronary artery bypass grafting versus PCI – in patients with multivessel CAD. Both the U.S. and European guidelines recommend the use of this score, based on invasive angiography, giving it a Class IIa and I recommendation, respectively. Patients with a low-risk SYNTAX score of 22 or less were shown to have similar outcomes with PCI and coronary artery bypass grafting, while those with a score of 23 or more had better outcomes at 5-year follow-up with CABG.

Subsequently, incorporation of clinical characteristics formed the basis of the updated SYNTAX II score, with enhanced predictive accuracy allowing for projections of 4-year all-cause mortality with CABG versus PCI in a given patient (www.syntaxscore.com). The new SYNTAX II substudy takes things a giant step further by rendering the coronary imaging and physiology assessment noninvasive.

Simultaneous with Dr. Collet’s presentation at EuroPCR 2018, the study results were published in the Journal of the American College of Cardiology.

In an accompanying editorial, Bjarne L. Norgaard, MD, PhD, of Aarhus (Denmark) University and coauthors enthused, “These data suggest that we may be entering a new era in the management of CAD. The days of having patients entering the catheterization laboratory with nothing more than symptoms and a positive stress test result may be coming to an end. This study may be signaling a shifting paradigm in which CAD is diagnosed and thoroughly characterized noninvasively, and revascularization planning made in a collaborative fashion integrating the heart team, and a wealth of noninvasive data that will hopefully lead to more effective and cost-efficient revascularization strategies.”

 

 


What’s next

Elsewhere at EuroPCR 2018, Dr. Serruys presented the results of the SYNTAX III Revolution Trial, which randomized six pairs of heart teams – each comprising an interventional cardiologist, surgeon, and radiologist – to collectively assess and plan revascularization strategies for 223 patients with left main or triple-vessel CAD. One heart team in each pair was provided with a patient’s noninvasive CTA and FFR results, while the other team was given only the results of conventional angiography.

“There was almost perfect agreement between the heart teams on their decisions,” according to Dr. Serruys. “We were impressed that the surgeons were enthusiastic about the prospect of operating based on multislice CT alone.

On the basis of this evidence that heart teams found, the noninvasive assessment to be acceptable, he and his coinvestigators are organizing a multicenter trial to assess the feasibility and safety of the fully noninvasive stratification, compared with conventional angiography and invasive physiologic assessment of lesions. The primary safety endpoint will be the 1-month patency of bypass grafts.

The multislice scanner used in the SYNTAX III Revolution trial was the General Electric Revolution CT scanner, which enables imaging of the heart during a single heart beat. But Dr. Serruys said most of the big medical imaging companies with an eye to the near future are now developing multislice scanners specifically for the heart.

 

 


“They cost half the price and take only half the space of conventional scanners. I think these small units – which are not used for the brain, the abdomen, and all the rest – are going to play a big role in cardiology,” he predicted.

William Wijns, MD, codirector of EuroPCR, called the results of the SYNTAX II and SYNTAX III Revolution studies “transformative.” He and the other meeting organizers highlighted the studies in a special “deep-dive” session, which he urged younger interventionalists in particular to attend because he believes it’s likely they will be relying on these noninvasive assessments in the near future.

The SYNTAX III Revolution trial was sponsored by the European Cardiovascular Research Institute with support from GE Healthcare and HeartFlow. Dr. Serruys reported having no financial relationship with either company.

SOURCE: Collet C. EuroPCR 2018, Simultaneous publication (J Am Coll Cardiol 2018;71:40-53).

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– A completely noninvasive method of identifying functionally significant lesions in patients with triple-vessel coronary artery disease yielded results comparable to conventional invasive angiographic assessment accompanied by an intracoronary pressure wire, in a prespecified secondary analysis of the SYNTAX II study.

That noninvasive method uses fractional flow reserve calculated from computed tomographic angiography, Carlos Collet, MD, said at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

Bruce Jancin/MDedge News
Dr. Carlos Collet
Moreover, the fully noninvasive evaluation was considerably more informative than was conventional invasive angiography alone, which is the dominant diagnostic strategy utilized in contemporary clinical practice despite persuasive evidence of the added clinical value provided by invasive measurement of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR). Indeed, the noninvasive approach evaluated in SYNTAX II reclassified 30% of patients from the high- and intermediate-risk tertiles based on invasive angiography to the low-risk tertile, a result with important implications for patient management because it renders them stronger candidates for PCI, observed Dr. Collet, a cardiologist at the Academic Medical Center of Amsterdam.

The results were hailed as a harbinger of a coming era in which interventional decision making will be based entirely upon noninvasively acquired anatomic and physiologic data. Conventional diagnostic angiography is predicted to fall by the wayside, with resultant savings in time and cost as well as avoidance of the risks of percutaneous diagnostic angiography, which entails considerably more radiation exposure than does noninvasive CT angiography (CTA).

“We are on the verge of a major change,” said Patrick W. Serruys, MD, PhD, professor of cardiology at Imperial College London, who was the senior coinvestigator in the study. “I think that the next disruptive moment in cardiology will be the introduction of the new generation of multislice CT scans replacing conventional cineangiography in the next 5-10 years. For the interventional cardiologist, to have the results of a multislice CT scan the day before a procedure is a wonderful bonus. You know in advance what you’re going to see, you can develop your treatment strategy, and you can spare contrast.”

Bruce Jancin/MDedge News
Dr. Patrick W. Serruys
This was a relatively small proof-of-concept study involving 77 patients with three-vessel CAD who underwent both CTA with noninvasive calculation of FFR and conventional invasive angiography with invasive physiologic assessment as part of the larger previously reported SYNTAX II (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery II) study.

Compared with conventional invasive angiographic assessment with the use of an intracoronary pressure wire to measure iFR, the noninvasively calculated SYNTAX II score had 95% sensitivity and 61% specificity for detection of functionally significant stenosis, with a positive predictive value of 81% and a negative predictive value of 87%. And this was achieved using older scanners and software considerably less accurate than today’s rapidly evolving state of the art, Dr. Collet noted.

 

 

Background

The original landmark SYNTAX trial led to development of an anatomically based SYNTAX score for use in stratifying risk and guiding treatment planning – coronary artery bypass grafting versus PCI – in patients with multivessel CAD. Both the U.S. and European guidelines recommend the use of this score, based on invasive angiography, giving it a Class IIa and I recommendation, respectively. Patients with a low-risk SYNTAX score of 22 or less were shown to have similar outcomes with PCI and coronary artery bypass grafting, while those with a score of 23 or more had better outcomes at 5-year follow-up with CABG.

Subsequently, incorporation of clinical characteristics formed the basis of the updated SYNTAX II score, with enhanced predictive accuracy allowing for projections of 4-year all-cause mortality with CABG versus PCI in a given patient (www.syntaxscore.com). The new SYNTAX II substudy takes things a giant step further by rendering the coronary imaging and physiology assessment noninvasive.

Simultaneous with Dr. Collet’s presentation at EuroPCR 2018, the study results were published in the Journal of the American College of Cardiology.

In an accompanying editorial, Bjarne L. Norgaard, MD, PhD, of Aarhus (Denmark) University and coauthors enthused, “These data suggest that we may be entering a new era in the management of CAD. The days of having patients entering the catheterization laboratory with nothing more than symptoms and a positive stress test result may be coming to an end. This study may be signaling a shifting paradigm in which CAD is diagnosed and thoroughly characterized noninvasively, and revascularization planning made in a collaborative fashion integrating the heart team, and a wealth of noninvasive data that will hopefully lead to more effective and cost-efficient revascularization strategies.”

 

 


What’s next

Elsewhere at EuroPCR 2018, Dr. Serruys presented the results of the SYNTAX III Revolution Trial, which randomized six pairs of heart teams – each comprising an interventional cardiologist, surgeon, and radiologist – to collectively assess and plan revascularization strategies for 223 patients with left main or triple-vessel CAD. One heart team in each pair was provided with a patient’s noninvasive CTA and FFR results, while the other team was given only the results of conventional angiography.

“There was almost perfect agreement between the heart teams on their decisions,” according to Dr. Serruys. “We were impressed that the surgeons were enthusiastic about the prospect of operating based on multislice CT alone.

On the basis of this evidence that heart teams found, the noninvasive assessment to be acceptable, he and his coinvestigators are organizing a multicenter trial to assess the feasibility and safety of the fully noninvasive stratification, compared with conventional angiography and invasive physiologic assessment of lesions. The primary safety endpoint will be the 1-month patency of bypass grafts.

The multislice scanner used in the SYNTAX III Revolution trial was the General Electric Revolution CT scanner, which enables imaging of the heart during a single heart beat. But Dr. Serruys said most of the big medical imaging companies with an eye to the near future are now developing multislice scanners specifically for the heart.

 

 


“They cost half the price and take only half the space of conventional scanners. I think these small units – which are not used for the brain, the abdomen, and all the rest – are going to play a big role in cardiology,” he predicted.

William Wijns, MD, codirector of EuroPCR, called the results of the SYNTAX II and SYNTAX III Revolution studies “transformative.” He and the other meeting organizers highlighted the studies in a special “deep-dive” session, which he urged younger interventionalists in particular to attend because he believes it’s likely they will be relying on these noninvasive assessments in the near future.

The SYNTAX III Revolution trial was sponsored by the European Cardiovascular Research Institute with support from GE Healthcare and HeartFlow. Dr. Serruys reported having no financial relationship with either company.

SOURCE: Collet C. EuroPCR 2018, Simultaneous publication (J Am Coll Cardiol 2018;71:40-53).

 

– A completely noninvasive method of identifying functionally significant lesions in patients with triple-vessel coronary artery disease yielded results comparable to conventional invasive angiographic assessment accompanied by an intracoronary pressure wire, in a prespecified secondary analysis of the SYNTAX II study.

That noninvasive method uses fractional flow reserve calculated from computed tomographic angiography, Carlos Collet, MD, said at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

Bruce Jancin/MDedge News
Dr. Carlos Collet
Moreover, the fully noninvasive evaluation was considerably more informative than was conventional invasive angiography alone, which is the dominant diagnostic strategy utilized in contemporary clinical practice despite persuasive evidence of the added clinical value provided by invasive measurement of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR). Indeed, the noninvasive approach evaluated in SYNTAX II reclassified 30% of patients from the high- and intermediate-risk tertiles based on invasive angiography to the low-risk tertile, a result with important implications for patient management because it renders them stronger candidates for PCI, observed Dr. Collet, a cardiologist at the Academic Medical Center of Amsterdam.

The results were hailed as a harbinger of a coming era in which interventional decision making will be based entirely upon noninvasively acquired anatomic and physiologic data. Conventional diagnostic angiography is predicted to fall by the wayside, with resultant savings in time and cost as well as avoidance of the risks of percutaneous diagnostic angiography, which entails considerably more radiation exposure than does noninvasive CT angiography (CTA).

“We are on the verge of a major change,” said Patrick W. Serruys, MD, PhD, professor of cardiology at Imperial College London, who was the senior coinvestigator in the study. “I think that the next disruptive moment in cardiology will be the introduction of the new generation of multislice CT scans replacing conventional cineangiography in the next 5-10 years. For the interventional cardiologist, to have the results of a multislice CT scan the day before a procedure is a wonderful bonus. You know in advance what you’re going to see, you can develop your treatment strategy, and you can spare contrast.”

Bruce Jancin/MDedge News
Dr. Patrick W. Serruys
This was a relatively small proof-of-concept study involving 77 patients with three-vessel CAD who underwent both CTA with noninvasive calculation of FFR and conventional invasive angiography with invasive physiologic assessment as part of the larger previously reported SYNTAX II (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery II) study.

Compared with conventional invasive angiographic assessment with the use of an intracoronary pressure wire to measure iFR, the noninvasively calculated SYNTAX II score had 95% sensitivity and 61% specificity for detection of functionally significant stenosis, with a positive predictive value of 81% and a negative predictive value of 87%. And this was achieved using older scanners and software considerably less accurate than today’s rapidly evolving state of the art, Dr. Collet noted.

 

 

Background

The original landmark SYNTAX trial led to development of an anatomically based SYNTAX score for use in stratifying risk and guiding treatment planning – coronary artery bypass grafting versus PCI – in patients with multivessel CAD. Both the U.S. and European guidelines recommend the use of this score, based on invasive angiography, giving it a Class IIa and I recommendation, respectively. Patients with a low-risk SYNTAX score of 22 or less were shown to have similar outcomes with PCI and coronary artery bypass grafting, while those with a score of 23 or more had better outcomes at 5-year follow-up with CABG.

Subsequently, incorporation of clinical characteristics formed the basis of the updated SYNTAX II score, with enhanced predictive accuracy allowing for projections of 4-year all-cause mortality with CABG versus PCI in a given patient (www.syntaxscore.com). The new SYNTAX II substudy takes things a giant step further by rendering the coronary imaging and physiology assessment noninvasive.

Simultaneous with Dr. Collet’s presentation at EuroPCR 2018, the study results were published in the Journal of the American College of Cardiology.

In an accompanying editorial, Bjarne L. Norgaard, MD, PhD, of Aarhus (Denmark) University and coauthors enthused, “These data suggest that we may be entering a new era in the management of CAD. The days of having patients entering the catheterization laboratory with nothing more than symptoms and a positive stress test result may be coming to an end. This study may be signaling a shifting paradigm in which CAD is diagnosed and thoroughly characterized noninvasively, and revascularization planning made in a collaborative fashion integrating the heart team, and a wealth of noninvasive data that will hopefully lead to more effective and cost-efficient revascularization strategies.”

 

 


What’s next

Elsewhere at EuroPCR 2018, Dr. Serruys presented the results of the SYNTAX III Revolution Trial, which randomized six pairs of heart teams – each comprising an interventional cardiologist, surgeon, and radiologist – to collectively assess and plan revascularization strategies for 223 patients with left main or triple-vessel CAD. One heart team in each pair was provided with a patient’s noninvasive CTA and FFR results, while the other team was given only the results of conventional angiography.

“There was almost perfect agreement between the heart teams on their decisions,” according to Dr. Serruys. “We were impressed that the surgeons were enthusiastic about the prospect of operating based on multislice CT alone.

On the basis of this evidence that heart teams found, the noninvasive assessment to be acceptable, he and his coinvestigators are organizing a multicenter trial to assess the feasibility and safety of the fully noninvasive stratification, compared with conventional angiography and invasive physiologic assessment of lesions. The primary safety endpoint will be the 1-month patency of bypass grafts.

The multislice scanner used in the SYNTAX III Revolution trial was the General Electric Revolution CT scanner, which enables imaging of the heart during a single heart beat. But Dr. Serruys said most of the big medical imaging companies with an eye to the near future are now developing multislice scanners specifically for the heart.

 

 


“They cost half the price and take only half the space of conventional scanners. I think these small units – which are not used for the brain, the abdomen, and all the rest – are going to play a big role in cardiology,” he predicted.

William Wijns, MD, codirector of EuroPCR, called the results of the SYNTAX II and SYNTAX III Revolution studies “transformative.” He and the other meeting organizers highlighted the studies in a special “deep-dive” session, which he urged younger interventionalists in particular to attend because he believes it’s likely they will be relying on these noninvasive assessments in the near future.

The SYNTAX III Revolution trial was sponsored by the European Cardiovascular Research Institute with support from GE Healthcare and HeartFlow. Dr. Serruys reported having no financial relationship with either company.

SOURCE: Collet C. EuroPCR 2018, Simultaneous publication (J Am Coll Cardiol 2018;71:40-53).

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Key clinical point: Noninvasive assessment of lesions in triple-vessel CAD may replace invasive diagnostic coronary angiography.

Major finding: A completely noninvasive method of identifying functionally significant lesions in patients with triple-vessel CAD by means of fractional flow reserve calculated from CT angiography yielded results comparable to conventional pressure-wire-based invasive angiographic assessment.

Study details: This prespecified secondary analysis of the SYNTAX II trial compared the results of noninvasive assessment of patients with triple-vessel CAD using FFR calculated from CT angiography with conventional angiography plus an invasive pressure wire.

Disclosures: The study was sponsored by the European Cardiovascular Research Institute with research grant support from Volcano and Boston Scientific. The presenter reported financial relationships with half a dozen medical device companies, but neither of those two.

Source: Collet C. EuroPCR 2018, simultaneous publication (J Am Coll Cardiol 2018;71:40-53).
 

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