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Drug-eluting balloon is as good as drug-eluting stent for in-stent restenosis
DENVER – Treatment of coronary in-stent restenosis using a paclitaxel-eluting balloon proved noninferior to an everolimus-eluting stent in terms of minimal lumen diameter at 6 months in the DARE trial, Jose P.S. Henriques, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The two forms of device therapy also yielded similar rates of adverse clinical events, including target vessel revascularization, at 12 months, he said.
The DARE (Drug-Eluting Balloon for In-Stent Restenosis) trial included 278 patients with in-stent restenosis (ISR) randomized to the SeQuent Please paclitaxel-eluting balloon or Xience everolimus-eluting stent at high-volume Dutch percutaneous coronary intervention centers. The trial was unique in that it included a mix of patients with in-stent restenosis involving DES and bare-metal stents. Indeed, 44% of participants had ISR in a bare-metal stent. These older-model stents are still used in patients who require a shorter duration of dual-antiplatelet therapy, so the DARE population reflects real-world clinical practice better than do prior studies restricted to ISR in only one stent type or the other, according to the cardiologist.
The primary outcome in this noninferiority trial was the in-segment minimal lumen diameter at 6-month angiographic follow-up. The mean diameter was 1.71 mm in the drug-eluting balloon (DEB) group and closely similar at 1.74 mm in the DES group. There was greater acute gain with the drug-eluting stent, but it was canceled out by greater late loss by 6 months.
Moreover, the 12-month composite clinical event rate composed of death, target vessel MI, and target vessel revascularization was 10.9% in the DEB recipients and 9.2% with the DES, a nonsignificant difference. Of note, target vessel revascularization occurred in 8.8% of the DEB group and was similar at 7.1% in the DES recipients, although the DARE trial wasn’t powered to detect differences in clinical events.
These results confirm the European Society of Cardiology’s class 1A recommendation for DEB as well as DES for ISR, Dr. Henriques said at the meeting sponsored by the Cardiovascular Research Foundation.
U.S. guidelines don’t address DEB for the treatment of coronary ISR. That’s because the devices, which have long been available in Europe, aren’t approved for use in the coronary tree in the United States. They are available in the United States only for treatment of peripheral vascular disease. And no U.S. clinical trials of DEBs in the coronary tree are planned.
“I wish the U.S. Food and Drug Administration was listening to the DARE results because we really would like to see this technology in the U.S.,” said Roxana Mehran, MD, who moderated a press conference where the DARE findings were highlighted.
David J. Cohen, MD, director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City, Mo., commented, “This type of device, obviously with it being similar in performance to drug-eluting stents, would be a very welcome addition to our armamentarium, because one of the things I don’t like to do as a coronary interventionalist is to line up multiple stents inside each other.”
“Making club sandwiches out of patients’ arteries with stent after stent is not a good idea. We know that,” added Dr. Mehran, professor of medicine and director of interventional cardiovascular research and clinical trials at Mount Sinai School of Medicine in New York.
Cindy L. Grines, MD, chair of cardiology at the Hofstra Northwell School of Medicine in Hempstead, N.Y., said DEBs “would absolutely be welcome” if they were available to cardiologists in the United States.
“When you have repeated episodes of in-stent restenosis, you can start with a vessel that’s 3 mm in diameter; then when it restenoses and you place a second stent inside there, all of a sudden – even if you have a great stent result – you can be down to 2.25 mm. And then the next time you need to treat it for restenosis, you’re down to a very tiny lumen. That’s the big problem with trying to treat in-stent restenosis with more stents,” she explained.
The DEBs are expensive, and ISR has become so uncommon with the use of the current generation of drug-eluting stents that the device companies have little incentive to do the studies required to be able to market DEBs in the United States.
“I think the FDA should consider in-stent restenosis as an orphan disease. We really should be able to get a drug-eluting balloon approved in this country based on the data over in Europe,” Dr. Grines said.
Dr. Henriques reported receiving research grants from B. Braun, which markets the paclitaxel-eluting stent in Europe, as well as from Abbott Vascular.
DENVER – Treatment of coronary in-stent restenosis using a paclitaxel-eluting balloon proved noninferior to an everolimus-eluting stent in terms of minimal lumen diameter at 6 months in the DARE trial, Jose P.S. Henriques, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The two forms of device therapy also yielded similar rates of adverse clinical events, including target vessel revascularization, at 12 months, he said.
The DARE (Drug-Eluting Balloon for In-Stent Restenosis) trial included 278 patients with in-stent restenosis (ISR) randomized to the SeQuent Please paclitaxel-eluting balloon or Xience everolimus-eluting stent at high-volume Dutch percutaneous coronary intervention centers. The trial was unique in that it included a mix of patients with in-stent restenosis involving DES and bare-metal stents. Indeed, 44% of participants had ISR in a bare-metal stent. These older-model stents are still used in patients who require a shorter duration of dual-antiplatelet therapy, so the DARE population reflects real-world clinical practice better than do prior studies restricted to ISR in only one stent type or the other, according to the cardiologist.
The primary outcome in this noninferiority trial was the in-segment minimal lumen diameter at 6-month angiographic follow-up. The mean diameter was 1.71 mm in the drug-eluting balloon (DEB) group and closely similar at 1.74 mm in the DES group. There was greater acute gain with the drug-eluting stent, but it was canceled out by greater late loss by 6 months.
Moreover, the 12-month composite clinical event rate composed of death, target vessel MI, and target vessel revascularization was 10.9% in the DEB recipients and 9.2% with the DES, a nonsignificant difference. Of note, target vessel revascularization occurred in 8.8% of the DEB group and was similar at 7.1% in the DES recipients, although the DARE trial wasn’t powered to detect differences in clinical events.
These results confirm the European Society of Cardiology’s class 1A recommendation for DEB as well as DES for ISR, Dr. Henriques said at the meeting sponsored by the Cardiovascular Research Foundation.
U.S. guidelines don’t address DEB for the treatment of coronary ISR. That’s because the devices, which have long been available in Europe, aren’t approved for use in the coronary tree in the United States. They are available in the United States only for treatment of peripheral vascular disease. And no U.S. clinical trials of DEBs in the coronary tree are planned.
“I wish the U.S. Food and Drug Administration was listening to the DARE results because we really would like to see this technology in the U.S.,” said Roxana Mehran, MD, who moderated a press conference where the DARE findings were highlighted.
David J. Cohen, MD, director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City, Mo., commented, “This type of device, obviously with it being similar in performance to drug-eluting stents, would be a very welcome addition to our armamentarium, because one of the things I don’t like to do as a coronary interventionalist is to line up multiple stents inside each other.”
“Making club sandwiches out of patients’ arteries with stent after stent is not a good idea. We know that,” added Dr. Mehran, professor of medicine and director of interventional cardiovascular research and clinical trials at Mount Sinai School of Medicine in New York.
Cindy L. Grines, MD, chair of cardiology at the Hofstra Northwell School of Medicine in Hempstead, N.Y., said DEBs “would absolutely be welcome” if they were available to cardiologists in the United States.
“When you have repeated episodes of in-stent restenosis, you can start with a vessel that’s 3 mm in diameter; then when it restenoses and you place a second stent inside there, all of a sudden – even if you have a great stent result – you can be down to 2.25 mm. And then the next time you need to treat it for restenosis, you’re down to a very tiny lumen. That’s the big problem with trying to treat in-stent restenosis with more stents,” she explained.
The DEBs are expensive, and ISR has become so uncommon with the use of the current generation of drug-eluting stents that the device companies have little incentive to do the studies required to be able to market DEBs in the United States.
“I think the FDA should consider in-stent restenosis as an orphan disease. We really should be able to get a drug-eluting balloon approved in this country based on the data over in Europe,” Dr. Grines said.
Dr. Henriques reported receiving research grants from B. Braun, which markets the paclitaxel-eluting stent in Europe, as well as from Abbott Vascular.
DENVER – Treatment of coronary in-stent restenosis using a paclitaxel-eluting balloon proved noninferior to an everolimus-eluting stent in terms of minimal lumen diameter at 6 months in the DARE trial, Jose P.S. Henriques, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The two forms of device therapy also yielded similar rates of adverse clinical events, including target vessel revascularization, at 12 months, he said.
The DARE (Drug-Eluting Balloon for In-Stent Restenosis) trial included 278 patients with in-stent restenosis (ISR) randomized to the SeQuent Please paclitaxel-eluting balloon or Xience everolimus-eluting stent at high-volume Dutch percutaneous coronary intervention centers. The trial was unique in that it included a mix of patients with in-stent restenosis involving DES and bare-metal stents. Indeed, 44% of participants had ISR in a bare-metal stent. These older-model stents are still used in patients who require a shorter duration of dual-antiplatelet therapy, so the DARE population reflects real-world clinical practice better than do prior studies restricted to ISR in only one stent type or the other, according to the cardiologist.
The primary outcome in this noninferiority trial was the in-segment minimal lumen diameter at 6-month angiographic follow-up. The mean diameter was 1.71 mm in the drug-eluting balloon (DEB) group and closely similar at 1.74 mm in the DES group. There was greater acute gain with the drug-eluting stent, but it was canceled out by greater late loss by 6 months.
Moreover, the 12-month composite clinical event rate composed of death, target vessel MI, and target vessel revascularization was 10.9% in the DEB recipients and 9.2% with the DES, a nonsignificant difference. Of note, target vessel revascularization occurred in 8.8% of the DEB group and was similar at 7.1% in the DES recipients, although the DARE trial wasn’t powered to detect differences in clinical events.
These results confirm the European Society of Cardiology’s class 1A recommendation for DEB as well as DES for ISR, Dr. Henriques said at the meeting sponsored by the Cardiovascular Research Foundation.
U.S. guidelines don’t address DEB for the treatment of coronary ISR. That’s because the devices, which have long been available in Europe, aren’t approved for use in the coronary tree in the United States. They are available in the United States only for treatment of peripheral vascular disease. And no U.S. clinical trials of DEBs in the coronary tree are planned.
“I wish the U.S. Food and Drug Administration was listening to the DARE results because we really would like to see this technology in the U.S.,” said Roxana Mehran, MD, who moderated a press conference where the DARE findings were highlighted.
David J. Cohen, MD, director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City, Mo., commented, “This type of device, obviously with it being similar in performance to drug-eluting stents, would be a very welcome addition to our armamentarium, because one of the things I don’t like to do as a coronary interventionalist is to line up multiple stents inside each other.”
“Making club sandwiches out of patients’ arteries with stent after stent is not a good idea. We know that,” added Dr. Mehran, professor of medicine and director of interventional cardiovascular research and clinical trials at Mount Sinai School of Medicine in New York.
Cindy L. Grines, MD, chair of cardiology at the Hofstra Northwell School of Medicine in Hempstead, N.Y., said DEBs “would absolutely be welcome” if they were available to cardiologists in the United States.
“When you have repeated episodes of in-stent restenosis, you can start with a vessel that’s 3 mm in diameter; then when it restenoses and you place a second stent inside there, all of a sudden – even if you have a great stent result – you can be down to 2.25 mm. And then the next time you need to treat it for restenosis, you’re down to a very tiny lumen. That’s the big problem with trying to treat in-stent restenosis with more stents,” she explained.
The DEBs are expensive, and ISR has become so uncommon with the use of the current generation of drug-eluting stents that the device companies have little incentive to do the studies required to be able to market DEBs in the United States.
“I think the FDA should consider in-stent restenosis as an orphan disease. We really should be able to get a drug-eluting balloon approved in this country based on the data over in Europe,” Dr. Grines said.
Dr. Henriques reported receiving research grants from B. Braun, which markets the paclitaxel-eluting stent in Europe, as well as from Abbott Vascular.
AT TCT 2017
Key clinical point:
Major finding: The mean 6-month in-segment minimal lumen diameter following treatment of in-stent restenosis with a paclitaxel-eluting balloon was 1.71 mm and was similar at 1.74 mm in patients treated using an everolimus-eluting stent.
Data source: A prospective, multicenter Dutch randomized trial including 278 patients with in-stent restenosis.
Disclosures: The study was sponsored by the University of Amsterdam and financially supported by a research grant from B. Braun. The presenter reported receiving research grants from that company and Abbott Vascular.
In MI with cardiogenic shock, PCI of only culprit lesions is safer
In patients with acute myocardial infarction and multivessel coronary artery disease with cardiogenic shock, 30-day rates of death and renal-replacement therapy were lower when patients underwent percutaneous coronary intervention (PCI) of the culprit lesion as opposed to multivessel PCI.
The difference appeared to be driven by mortality, as the renal endpoint alone was not significant.
As many as 80% of patients with cardiogenic shock also present with multivessel coronary artery disease, and this is associated with worse mortality. It is unclear whether immediate PCI of clinically important stenoses of major nonculprit coronary arteries is of benefit, and previous randomized trials comparing the procedures did not look at patients with cardiogenic shock, Holger Thiele, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
European guidelines suggest that PCI of nonculprit lesions should be considered in patients with cardiogenic shock, while U.S. guidelines offer no opinion, but recent appropriate use criteria recommend revascularization of a nonculprit artery if cardiogenic shock continues after the culprit artery has been repaired. It is thought that immediate revascularization of all coronary arteries with clinically important stenoses might improve overall myocardial perfusion and function in patients with cardiogenic shock, but the procedure could also have drawbacks, including additional ischemia, volume overload, and renal impairment from higher doses of contrast material.
To better understand outcomes in these patients, the Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK) trial randomized 706 patients to culprit-only PCI or multivessel PCI, in which PCI was performed on all major coronary arteries with more than 70% stenosis. Patients receiving culprit-only PCI could also undergo optional staged revascularization due to residual ischemic lesions, symptoms, or clinical or neurologic status.
At 30 days, death and/or renal-replacement therapy occurred in 45.9% of the culprit-only group, compared to 55.4% in the multivessel group (relative risk, 0.83; 95% confidence interval, 0.71-0.96; P = .01). A per-protocol analysis showed similar results (RR, 0.81; 95% CI, 0.69-0.96; P =.01), as did an analysis of the as-treated population (RR, 0.83; 95% CI, 0.72-0.97; P = .02).
All-cause mortality was lower in the culprit-only group (43.3% versus 51.6%; RR, 0.84; 95% CI, 0.72-0.98; P=.03). The rate of renal-replacement therapy was higher in the multivessel group (16.4% versus 11.6%), but this did not reach statistical significance (P = .07).
There were no statistically significant differences between the two groups with respect to recurrent myocardial infarction, rehospitalization for heart failure, bleeding, or stroke, Dr. Thiele reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
Some limitations of the study included its unblinded nature, and the fact that 75 patients originally assigned to one treatment category crossed over to the other, including 14 in the culprit-lesion only category who underwent immediate multivessel PCI. This suggests that treatment strategy may need to be adopted to a patient’s clinical circumstances.
The CULPRIT-SHOCK results were published online at the time of Dr. Thiele’s presentation (N Engl J Med. 2017 Oct 30. doi:10/056/NEJMoa1710261).
Several of the study’s authors reported financial ties to the pharmaceutical industry.
This study’s findings reinforce those of previous trials that had suggested that multivessel percutaneous coronary intervention has higher early mortality than culprit-lesion-only PCI.
The study provides compelling evidence that culprit-lesion-only PCI should be the preferred treatment choice over multivessel PCI in patients with cardiogenic shock.
A previous meta-analysis of patients with uncomplicated ST-segment elevation myocardial infarction showed lower rates of mortality or MI with initial multivessel PCI. The disagreement between the two studies suggests that patients with cardiogenic shock may experience greater risk of these adverse outcomes during multivessel PCI procedures.
Future clinical trials should test individual multivessel revascularization strategies to reduce mortality in MI patients with cardiogenic shock, such as coronary artery bypass grafting (CABG) and venoarterial extracorporeal membrane oxygenation (ECMO).
Judith Hochman, MD, and Stuart Katz, MD, of New York University Langone Health, made these comments in an accompanying editorial (N Engl J Med. 2017 Oct 30. doi: 10.1056/nejme1713341). Dr. Hochman had no relevant disclosures. Dr. Katz has consulted for Novartis, Amgen, and Regeneron, and has received funding from Amgen, American Regent, and Janssen.
This study’s findings reinforce those of previous trials that had suggested that multivessel percutaneous coronary intervention has higher early mortality than culprit-lesion-only PCI.
The study provides compelling evidence that culprit-lesion-only PCI should be the preferred treatment choice over multivessel PCI in patients with cardiogenic shock.
A previous meta-analysis of patients with uncomplicated ST-segment elevation myocardial infarction showed lower rates of mortality or MI with initial multivessel PCI. The disagreement between the two studies suggests that patients with cardiogenic shock may experience greater risk of these adverse outcomes during multivessel PCI procedures.
Future clinical trials should test individual multivessel revascularization strategies to reduce mortality in MI patients with cardiogenic shock, such as coronary artery bypass grafting (CABG) and venoarterial extracorporeal membrane oxygenation (ECMO).
Judith Hochman, MD, and Stuart Katz, MD, of New York University Langone Health, made these comments in an accompanying editorial (N Engl J Med. 2017 Oct 30. doi: 10.1056/nejme1713341). Dr. Hochman had no relevant disclosures. Dr. Katz has consulted for Novartis, Amgen, and Regeneron, and has received funding from Amgen, American Regent, and Janssen.
This study’s findings reinforce those of previous trials that had suggested that multivessel percutaneous coronary intervention has higher early mortality than culprit-lesion-only PCI.
The study provides compelling evidence that culprit-lesion-only PCI should be the preferred treatment choice over multivessel PCI in patients with cardiogenic shock.
A previous meta-analysis of patients with uncomplicated ST-segment elevation myocardial infarction showed lower rates of mortality or MI with initial multivessel PCI. The disagreement between the two studies suggests that patients with cardiogenic shock may experience greater risk of these adverse outcomes during multivessel PCI procedures.
Future clinical trials should test individual multivessel revascularization strategies to reduce mortality in MI patients with cardiogenic shock, such as coronary artery bypass grafting (CABG) and venoarterial extracorporeal membrane oxygenation (ECMO).
Judith Hochman, MD, and Stuart Katz, MD, of New York University Langone Health, made these comments in an accompanying editorial (N Engl J Med. 2017 Oct 30. doi: 10.1056/nejme1713341). Dr. Hochman had no relevant disclosures. Dr. Katz has consulted for Novartis, Amgen, and Regeneron, and has received funding from Amgen, American Regent, and Janssen.
In patients with acute myocardial infarction and multivessel coronary artery disease with cardiogenic shock, 30-day rates of death and renal-replacement therapy were lower when patients underwent percutaneous coronary intervention (PCI) of the culprit lesion as opposed to multivessel PCI.
The difference appeared to be driven by mortality, as the renal endpoint alone was not significant.
As many as 80% of patients with cardiogenic shock also present with multivessel coronary artery disease, and this is associated with worse mortality. It is unclear whether immediate PCI of clinically important stenoses of major nonculprit coronary arteries is of benefit, and previous randomized trials comparing the procedures did not look at patients with cardiogenic shock, Holger Thiele, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
European guidelines suggest that PCI of nonculprit lesions should be considered in patients with cardiogenic shock, while U.S. guidelines offer no opinion, but recent appropriate use criteria recommend revascularization of a nonculprit artery if cardiogenic shock continues after the culprit artery has been repaired. It is thought that immediate revascularization of all coronary arteries with clinically important stenoses might improve overall myocardial perfusion and function in patients with cardiogenic shock, but the procedure could also have drawbacks, including additional ischemia, volume overload, and renal impairment from higher doses of contrast material.
To better understand outcomes in these patients, the Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK) trial randomized 706 patients to culprit-only PCI or multivessel PCI, in which PCI was performed on all major coronary arteries with more than 70% stenosis. Patients receiving culprit-only PCI could also undergo optional staged revascularization due to residual ischemic lesions, symptoms, or clinical or neurologic status.
At 30 days, death and/or renal-replacement therapy occurred in 45.9% of the culprit-only group, compared to 55.4% in the multivessel group (relative risk, 0.83; 95% confidence interval, 0.71-0.96; P = .01). A per-protocol analysis showed similar results (RR, 0.81; 95% CI, 0.69-0.96; P =.01), as did an analysis of the as-treated population (RR, 0.83; 95% CI, 0.72-0.97; P = .02).
All-cause mortality was lower in the culprit-only group (43.3% versus 51.6%; RR, 0.84; 95% CI, 0.72-0.98; P=.03). The rate of renal-replacement therapy was higher in the multivessel group (16.4% versus 11.6%), but this did not reach statistical significance (P = .07).
There were no statistically significant differences between the two groups with respect to recurrent myocardial infarction, rehospitalization for heart failure, bleeding, or stroke, Dr. Thiele reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
Some limitations of the study included its unblinded nature, and the fact that 75 patients originally assigned to one treatment category crossed over to the other, including 14 in the culprit-lesion only category who underwent immediate multivessel PCI. This suggests that treatment strategy may need to be adopted to a patient’s clinical circumstances.
The CULPRIT-SHOCK results were published online at the time of Dr. Thiele’s presentation (N Engl J Med. 2017 Oct 30. doi:10/056/NEJMoa1710261).
Several of the study’s authors reported financial ties to the pharmaceutical industry.
In patients with acute myocardial infarction and multivessel coronary artery disease with cardiogenic shock, 30-day rates of death and renal-replacement therapy were lower when patients underwent percutaneous coronary intervention (PCI) of the culprit lesion as opposed to multivessel PCI.
The difference appeared to be driven by mortality, as the renal endpoint alone was not significant.
As many as 80% of patients with cardiogenic shock also present with multivessel coronary artery disease, and this is associated with worse mortality. It is unclear whether immediate PCI of clinically important stenoses of major nonculprit coronary arteries is of benefit, and previous randomized trials comparing the procedures did not look at patients with cardiogenic shock, Holger Thiele, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
European guidelines suggest that PCI of nonculprit lesions should be considered in patients with cardiogenic shock, while U.S. guidelines offer no opinion, but recent appropriate use criteria recommend revascularization of a nonculprit artery if cardiogenic shock continues after the culprit artery has been repaired. It is thought that immediate revascularization of all coronary arteries with clinically important stenoses might improve overall myocardial perfusion and function in patients with cardiogenic shock, but the procedure could also have drawbacks, including additional ischemia, volume overload, and renal impairment from higher doses of contrast material.
To better understand outcomes in these patients, the Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK) trial randomized 706 patients to culprit-only PCI or multivessel PCI, in which PCI was performed on all major coronary arteries with more than 70% stenosis. Patients receiving culprit-only PCI could also undergo optional staged revascularization due to residual ischemic lesions, symptoms, or clinical or neurologic status.
At 30 days, death and/or renal-replacement therapy occurred in 45.9% of the culprit-only group, compared to 55.4% in the multivessel group (relative risk, 0.83; 95% confidence interval, 0.71-0.96; P = .01). A per-protocol analysis showed similar results (RR, 0.81; 95% CI, 0.69-0.96; P =.01), as did an analysis of the as-treated population (RR, 0.83; 95% CI, 0.72-0.97; P = .02).
All-cause mortality was lower in the culprit-only group (43.3% versus 51.6%; RR, 0.84; 95% CI, 0.72-0.98; P=.03). The rate of renal-replacement therapy was higher in the multivessel group (16.4% versus 11.6%), but this did not reach statistical significance (P = .07).
There were no statistically significant differences between the two groups with respect to recurrent myocardial infarction, rehospitalization for heart failure, bleeding, or stroke, Dr. Thiele reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
Some limitations of the study included its unblinded nature, and the fact that 75 patients originally assigned to one treatment category crossed over to the other, including 14 in the culprit-lesion only category who underwent immediate multivessel PCI. This suggests that treatment strategy may need to be adopted to a patient’s clinical circumstances.
The CULPRIT-SHOCK results were published online at the time of Dr. Thiele’s presentation (N Engl J Med. 2017 Oct 30. doi:10/056/NEJMoa1710261).
Several of the study’s authors reported financial ties to the pharmaceutical industry.
FROM TCT 2017
Key clinical point: The combined rate of 30-day mortality and renal-replacement therapy was lower when the culprit lesion alone was treated.
Major finding: The culprit-only PCI group had a relative risk of death or renal-replacement therapy of 0.83.
Data source: CULPRIT-SHOCK, a randomized, controlled trial of 706 patients.
Disclosures: Some of the study’s authors reported financial ties to the pharmaceutical industry. Dr. Katz has consulted for Novartis, Amgen, and Regeneron, and has received funding from Amgen, American Regent, and Janssen.
Left main distal bifurcation? Double kiss and crush it
DENVER – 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.
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.
DENVER – 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.
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.
DENVER – 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.
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.
AT TCT 2017
Key clinical point:
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.