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– A planned two-stent, double-kissing crush PCI technique proved superior to the widely utilized provisional stenting strategy for treatment of unprotected distal left main bifurcation lesions in the randomized DKCRUSH-V trial, Shao-Liang Chen, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.

The study randomized 482 patients with unprotected true distal left main bifurcation lesions to one of the two PCI strategies at 26 centers in five countries, including the United States. Roughly 80% of the left main lesions were categorized as Medina 1,1,1.

The primary outcome was the 1-year composite rate of target lesion failure (TLF), defined as cardiac death, target vessel MI, or clinically driven target lesion revascularization. The rate was 10.7% in patients assigned to provisional stenting and 5.0% with double kissing (DK) crush. This clinically and statistically significant difference was driven by a sharp reduction in target vessel MI in the DK crush group: 0.4%, compared with 2.9% in the provisional stenting group.

Dr. Shao-Liang Chen, professor of internal medicine and cardiology at Nanjing (China) Medical University and vice president of Nanjing First Hospital
Dr. Shao-Liang Chen
Also noteworthy were the DK crush group’s lower rate of definite or probable stent thrombosis – 0.4% versus 3.3% – and an absence of cardiac deaths in the first 30 days, versus a 1.7% rate in the provisional stenting group, according to Dr. Chen, professor of internal medicine and cardiology at Nanjing (China) Medical University and vice president of Nanjing First Hospital.

Moreover, the DK crush group’s 3.8% rate of clinically driven target lesion revascularization and 7.1% rate of angiographic restenosis within the left main complex were both less than half the rates in the provisional stenting group, he added at the meeting, which was sponsored by the Cardiovascular Research Foundation.

The absolute benefit for the DK crush strategy was greatest in the roughly 30% of patients with complex bifurcations, defined as those with an ostial side branch lesion length of at least 10 mm and 70% diameter stenosis while meeting at least two of six minor criteria. The 1-year TLF rate in such patients was 18.2% with provisional stenting versus 7% with DK crush. For simple bifurcations, the TLF rates were 8% versus 1.9%.

The results favored DK crush in all examined subgroups, including those based upon age, gender, SYNTAX score, distal angle, and diabetes status.

Forty-seven percent of patients in the provisional stenting arm received a second stent, typically needed as a bailout for the side branch. Most of the excess target vessel MIs and other TLF events in the provisional stenting group occurred in patients who got a second stent.

The DK crush is an advanced technique with numerous steps involving multiple vessel wirings, rewirings, and stent crushing. It can be challenging to perform. It took an average of 82 minutes, 16 minutes longer than provisional stenting – a difference in procedural time that interventional cardiologists don’t take lightly. It also entailed an average of 36 mL more contrast media than the 191 mL for provisional stenting.

In an earlier multicenter, randomized, prospective trial – DKCRUSH-III – Dr. Chen and his coinvestigators showed that the DK crush technique provides superior outcomes compared with culotte stenting, another widely used treatment strategy for distal left main bifurcation lesions (J Am Coll Cardiol. 2013 Apr 9;61[14]:1482-8).

“The take home message on the surface of the data would be that we should consider this particular two-stent bifurcation technique as perhaps the treatment of choice for true distal bifurcation lesions,” said Gregg W. Stone, MD, who was a coinvestigator in DKCRUSH-V and chaired the late-breaking clinical trial session where Dr. Chen presented the results.

“This technique theoretically gives you the largest amount of laminar flow both in the main vessel and the side branch,” added Dr. Stone, professor of medicine and director of cardiovascular research and education at Columbia University Medical Center in New York.

Simultaneously with Dr. Chen’s presentation at TCT 2017, the DKCRUSH-V results were published online (J Am Coll Cardiol. 2017 Oct 30. doi: 10.1016/j.jacc.2017.09.1066). In an accompanying editorial, Emmanouil S. Brilakis, MD, declared that DK crush should become the preferred strategy for treating unprotected left main bifurcation lesions.

It’s not a technique for the average interventionalist, though. It should be performed in high-volume centers of excellence accustomed to performing complex PCIs. Indeed, the DKCRUSH-V trial required the primary operators to have performed at least 300 PCIs per year for 5 years, including 20 left main PCIs per year or more. To put that in perspective, the median annual PCI volume in the United States is 59 cases, noted Dr. Brilakis of the Minneapolis Heart Institute (J Am Coll Cardiol. 2017 Oct. 30. doi: 10.1016/j.jacc.2017.09.1083).

At TCT 2017 in Denver, not everyone found the DKCRUSH-V findings persuasive.

“I’m quite surprised by the results,” said panel discussant David Hildick-Smith, MD.

“There’s something we have yet to understand about the divergence between the results that are coming out of China and the results coming out of Europe. Almost everything coming out of Europe tends to suggest that provisional stenting is better, while in Chinese hands the DK crush technique has proved to be an extremely successful strategy,” said Dr. Hildick-Smith, professor of interventional cardiology and director of the cardiac research unit at the Brighton and Sussex (England) Medical School.

He added that he intends to reserve judgment as to the preferred strategy until the results of the ongoing European Bifurcation Club Left Main Study (EBC MAIN) become available late in 2018. EBC MAIN is comparing the DK crush, culotte, and other strategies, with the choice of technique left to the operator’s discretion.

The DKCRUSH-V trial was supported by the National Science Foundation of China, the Nanjing Municipal Medical Development Project, Microport, Abbott Vascular, and Medtronic. Dr. Chen and Dr. Stone reported having no financial conflicts of interest regarding the study.

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– A planned two-stent, double-kissing crush PCI technique proved superior to the widely utilized provisional stenting strategy for treatment of unprotected distal left main bifurcation lesions in the randomized DKCRUSH-V trial, Shao-Liang Chen, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.

The study randomized 482 patients with unprotected true distal left main bifurcation lesions to one of the two PCI strategies at 26 centers in five countries, including the United States. Roughly 80% of the left main lesions were categorized as Medina 1,1,1.

The primary outcome was the 1-year composite rate of target lesion failure (TLF), defined as cardiac death, target vessel MI, or clinically driven target lesion revascularization. The rate was 10.7% in patients assigned to provisional stenting and 5.0% with double kissing (DK) crush. This clinically and statistically significant difference was driven by a sharp reduction in target vessel MI in the DK crush group: 0.4%, compared with 2.9% in the provisional stenting group.

Dr. Shao-Liang Chen, professor of internal medicine and cardiology at Nanjing (China) Medical University and vice president of Nanjing First Hospital
Dr. Shao-Liang Chen
Also noteworthy were the DK crush group’s lower rate of definite or probable stent thrombosis – 0.4% versus 3.3% – and an absence of cardiac deaths in the first 30 days, versus a 1.7% rate in the provisional stenting group, according to Dr. Chen, professor of internal medicine and cardiology at Nanjing (China) Medical University and vice president of Nanjing First Hospital.

Moreover, the DK crush group’s 3.8% rate of clinically driven target lesion revascularization and 7.1% rate of angiographic restenosis within the left main complex were both less than half the rates in the provisional stenting group, he added at the meeting, which was sponsored by the Cardiovascular Research Foundation.

The absolute benefit for the DK crush strategy was greatest in the roughly 30% of patients with complex bifurcations, defined as those with an ostial side branch lesion length of at least 10 mm and 70% diameter stenosis while meeting at least two of six minor criteria. The 1-year TLF rate in such patients was 18.2% with provisional stenting versus 7% with DK crush. For simple bifurcations, the TLF rates were 8% versus 1.9%.

The results favored DK crush in all examined subgroups, including those based upon age, gender, SYNTAX score, distal angle, and diabetes status.

Forty-seven percent of patients in the provisional stenting arm received a second stent, typically needed as a bailout for the side branch. Most of the excess target vessel MIs and other TLF events in the provisional stenting group occurred in patients who got a second stent.

The DK crush is an advanced technique with numerous steps involving multiple vessel wirings, rewirings, and stent crushing. It can be challenging to perform. It took an average of 82 minutes, 16 minutes longer than provisional stenting – a difference in procedural time that interventional cardiologists don’t take lightly. It also entailed an average of 36 mL more contrast media than the 191 mL for provisional stenting.

In an earlier multicenter, randomized, prospective trial – DKCRUSH-III – Dr. Chen and his coinvestigators showed that the DK crush technique provides superior outcomes compared with culotte stenting, another widely used treatment strategy for distal left main bifurcation lesions (J Am Coll Cardiol. 2013 Apr 9;61[14]:1482-8).

“The take home message on the surface of the data would be that we should consider this particular two-stent bifurcation technique as perhaps the treatment of choice for true distal bifurcation lesions,” said Gregg W. Stone, MD, who was a coinvestigator in DKCRUSH-V and chaired the late-breaking clinical trial session where Dr. Chen presented the results.

“This technique theoretically gives you the largest amount of laminar flow both in the main vessel and the side branch,” added Dr. Stone, professor of medicine and director of cardiovascular research and education at Columbia University Medical Center in New York.

Simultaneously with Dr. Chen’s presentation at TCT 2017, the DKCRUSH-V results were published online (J Am Coll Cardiol. 2017 Oct 30. doi: 10.1016/j.jacc.2017.09.1066). In an accompanying editorial, Emmanouil S. Brilakis, MD, declared that DK crush should become the preferred strategy for treating unprotected left main bifurcation lesions.

It’s not a technique for the average interventionalist, though. It should be performed in high-volume centers of excellence accustomed to performing complex PCIs. Indeed, the DKCRUSH-V trial required the primary operators to have performed at least 300 PCIs per year for 5 years, including 20 left main PCIs per year or more. To put that in perspective, the median annual PCI volume in the United States is 59 cases, noted Dr. Brilakis of the Minneapolis Heart Institute (J Am Coll Cardiol. 2017 Oct. 30. doi: 10.1016/j.jacc.2017.09.1083).

At TCT 2017 in Denver, not everyone found the DKCRUSH-V findings persuasive.

“I’m quite surprised by the results,” said panel discussant David Hildick-Smith, MD.

“There’s something we have yet to understand about the divergence between the results that are coming out of China and the results coming out of Europe. Almost everything coming out of Europe tends to suggest that provisional stenting is better, while in Chinese hands the DK crush technique has proved to be an extremely successful strategy,” said Dr. Hildick-Smith, professor of interventional cardiology and director of the cardiac research unit at the Brighton and Sussex (England) Medical School.

He added that he intends to reserve judgment as to the preferred strategy until the results of the ongoing European Bifurcation Club Left Main Study (EBC MAIN) become available late in 2018. EBC MAIN is comparing the DK crush, culotte, and other strategies, with the choice of technique left to the operator’s discretion.

The DKCRUSH-V trial was supported by the National Science Foundation of China, the Nanjing Municipal Medical Development Project, Microport, Abbott Vascular, and Medtronic. Dr. Chen and Dr. Stone reported having no financial conflicts of interest regarding the study.

 

– A planned two-stent, double-kissing crush PCI technique proved superior to the widely utilized provisional stenting strategy for treatment of unprotected distal left main bifurcation lesions in the randomized DKCRUSH-V trial, Shao-Liang Chen, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.

The study randomized 482 patients with unprotected true distal left main bifurcation lesions to one of the two PCI strategies at 26 centers in five countries, including the United States. Roughly 80% of the left main lesions were categorized as Medina 1,1,1.

The primary outcome was the 1-year composite rate of target lesion failure (TLF), defined as cardiac death, target vessel MI, or clinically driven target lesion revascularization. The rate was 10.7% in patients assigned to provisional stenting and 5.0% with double kissing (DK) crush. This clinically and statistically significant difference was driven by a sharp reduction in target vessel MI in the DK crush group: 0.4%, compared with 2.9% in the provisional stenting group.

Dr. Shao-Liang Chen, professor of internal medicine and cardiology at Nanjing (China) Medical University and vice president of Nanjing First Hospital
Dr. Shao-Liang Chen
Also noteworthy were the DK crush group’s lower rate of definite or probable stent thrombosis – 0.4% versus 3.3% – and an absence of cardiac deaths in the first 30 days, versus a 1.7% rate in the provisional stenting group, according to Dr. Chen, professor of internal medicine and cardiology at Nanjing (China) Medical University and vice president of Nanjing First Hospital.

Moreover, the DK crush group’s 3.8% rate of clinically driven target lesion revascularization and 7.1% rate of angiographic restenosis within the left main complex were both less than half the rates in the provisional stenting group, he added at the meeting, which was sponsored by the Cardiovascular Research Foundation.

The absolute benefit for the DK crush strategy was greatest in the roughly 30% of patients with complex bifurcations, defined as those with an ostial side branch lesion length of at least 10 mm and 70% diameter stenosis while meeting at least two of six minor criteria. The 1-year TLF rate in such patients was 18.2% with provisional stenting versus 7% with DK crush. For simple bifurcations, the TLF rates were 8% versus 1.9%.

The results favored DK crush in all examined subgroups, including those based upon age, gender, SYNTAX score, distal angle, and diabetes status.

Forty-seven percent of patients in the provisional stenting arm received a second stent, typically needed as a bailout for the side branch. Most of the excess target vessel MIs and other TLF events in the provisional stenting group occurred in patients who got a second stent.

The DK crush is an advanced technique with numerous steps involving multiple vessel wirings, rewirings, and stent crushing. It can be challenging to perform. It took an average of 82 minutes, 16 minutes longer than provisional stenting – a difference in procedural time that interventional cardiologists don’t take lightly. It also entailed an average of 36 mL more contrast media than the 191 mL for provisional stenting.

In an earlier multicenter, randomized, prospective trial – DKCRUSH-III – Dr. Chen and his coinvestigators showed that the DK crush technique provides superior outcomes compared with culotte stenting, another widely used treatment strategy for distal left main bifurcation lesions (J Am Coll Cardiol. 2013 Apr 9;61[14]:1482-8).

“The take home message on the surface of the data would be that we should consider this particular two-stent bifurcation technique as perhaps the treatment of choice for true distal bifurcation lesions,” said Gregg W. Stone, MD, who was a coinvestigator in DKCRUSH-V and chaired the late-breaking clinical trial session where Dr. Chen presented the results.

“This technique theoretically gives you the largest amount of laminar flow both in the main vessel and the side branch,” added Dr. Stone, professor of medicine and director of cardiovascular research and education at Columbia University Medical Center in New York.

Simultaneously with Dr. Chen’s presentation at TCT 2017, the DKCRUSH-V results were published online (J Am Coll Cardiol. 2017 Oct 30. doi: 10.1016/j.jacc.2017.09.1066). In an accompanying editorial, Emmanouil S. Brilakis, MD, declared that DK crush should become the preferred strategy for treating unprotected left main bifurcation lesions.

It’s not a technique for the average interventionalist, though. It should be performed in high-volume centers of excellence accustomed to performing complex PCIs. Indeed, the DKCRUSH-V trial required the primary operators to have performed at least 300 PCIs per year for 5 years, including 20 left main PCIs per year or more. To put that in perspective, the median annual PCI volume in the United States is 59 cases, noted Dr. Brilakis of the Minneapolis Heart Institute (J Am Coll Cardiol. 2017 Oct. 30. doi: 10.1016/j.jacc.2017.09.1083).

At TCT 2017 in Denver, not everyone found the DKCRUSH-V findings persuasive.

“I’m quite surprised by the results,” said panel discussant David Hildick-Smith, MD.

“There’s something we have yet to understand about the divergence between the results that are coming out of China and the results coming out of Europe. Almost everything coming out of Europe tends to suggest that provisional stenting is better, while in Chinese hands the DK crush technique has proved to be an extremely successful strategy,” said Dr. Hildick-Smith, professor of interventional cardiology and director of the cardiac research unit at the Brighton and Sussex (England) Medical School.

He added that he intends to reserve judgment as to the preferred strategy until the results of the ongoing European Bifurcation Club Left Main Study (EBC MAIN) become available late in 2018. EBC MAIN is comparing the DK crush, culotte, and other strategies, with the choice of technique left to the operator’s discretion.

The DKCRUSH-V trial was supported by the National Science Foundation of China, the Nanjing Municipal Medical Development Project, Microport, Abbott Vascular, and Medtronic. Dr. Chen and Dr. Stone reported having no financial conflicts of interest regarding the study.

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Key clinical point: A PCI technique known as the double-kissing crush proved superior to a provisional stenting strategy for treatment of unprotected distal left main bifurcation lesions.

Major finding: The 1-year composite rate of target lesion failure in patients treated with the planned two-stent double-kissing crush strategy was 5%, significantly less than the 10.7% rate with provisional stenting.

Data source: The DKCRUSH-V study randomized 482 patients with unprotected true distal left main bifurcation lesions to one of the two PCI strategies at 26 centers in five countries.

Disclosures: The study was supported by the National Science Foundation of China, the Nanjing Municipal Medical Development Project, Microport, Abbott Vascular, and Medtronic. The presenter reported having no financial conflicts of interest.

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