By Will Boggs MD
NEW YORK (Reuters Health) - The double kissing (DK) crush two-stent technique is better than provisional stenting (PS) for treating left main (LM) bifurcation lesions in patients with unprotected LM coronary artery disease (ULMCAD), according to results from the DKCRUSH-V randomized trial.
Guidelines generally favor coronary artery bypass graft (CABG) surgery over percutaneous coronary intervention (PCI) for patients with ULMCAD. But recent studies have suggested that PCI using the latest generation of stents might offer outcomes comparable to those of CABG. Which stent technique should be used for these patients remains unclear.
Dr. Shao-Liang Chen from Nanjing Medical University, in Nanjing, China, and colleagues from 26 centers in China, Indonesia, Thailand, Italy and the U.S. compared outcomes of DK crush and PS in 482 patients with true distal LM bifurcation lesions undergoing PCI.
Biomarker release at the time of the procedure occurred in 11.3% of DK-crushed patients versus 4.1% of PS patients, but the rates of protocol-defined periprocedural myocardial infarction (MI) did not differ significantly between the groups (0% vs. 1.2%, respectively; p=0.33), the researchers report in the Journal of the American College of Cardiology, online October 30.
At 30 days, target lesion failure (TLF) had occurred significantly more frequently in the PS group (2.9%) than in the DK-crush group (0.4%), at least partly due to a higher stent thrombosis rate in the PS group (2.5% vs. 0.4% in the DK-crush group, p=0.09).
TLF at one year, the composite of cardiac death, target-vessel MI (TVMI), or clinically driven target lesion revascularization (TLR), occurred in 26 of 242 patients assigned to PS versus 12 of 240 patients assigned to DK crush (Kaplan-Meier estimated rates, 10.7% vs. 5.0%; p=0.02).
TVMI and stent thrombosis rates were significantly lower with DK crush, and clinically driven TLR and angina tended to be lower with DK crush, whereas cardiac and all-cause mortality did not differ significantly between the groups.
At follow-up angiography, minimal luminal diameter was larger and diameter stenosis was smaller in the side branch (SB) after DK crush stenting. But there were no significant quantitative coronary-analysis differences between the two techniques in the main vessel at follow-up.
“Learning the DK crush technique, although not overly complicated, requires training, experience, and attention to procedural detail, including carefully rewiring the SB, sequential post-dilatation with noncompliant balloons at high pressure before each kissing inflation, and final POT (proximal optimization technique) after KBI (kissing balloon inflation)," the researchers note. “The operators participating in the DKCRUSH-V trial were relatively high-volume proceduralists, were familiar with the DK crush technique, and had to submit roll-in cases demonstrating their technical competence with this approach. The results of the present trial may not be replicated by less experienced operators.”
Dr. Emmanouil S. Brilakis from Minneapolis Heart Institute, in Minnesota, who co-authored a linked editorial entitled "DK crush should become preferred strategy for treating unprotected LM bifurcation lesions," told Reuters Health by email, "In my opinion, the most interesting part of the study is that more complex stenting (DK crush) is superior to a simpler provisional technique. This reinforces the point that ‘things should be as simple as possible, but not simpler.’”
“Left main PCI is part of the increasing trend for creating ‘complex PCI centers’ that do complex interventions, including CTOs (chronic total occlusions) and left main PCIs,” he said. “Complex PCIs should be performed by high-volume operators, and in the future we are likely to see increasing numbers of advanced fellowships in complex PCI.”
Dr. Brilakis concluded, “If you are doing left-main stenting, you should learn and become proficient in the DK-crush technique if you want to offer the best possible outcomes to your patients.”
Dr. Sheldon Goldberg from the University of Pennsylvania Perelman School of Medicine in Philadelphia, who recently reviewed the management of unprotected LM disease, told Reuters Health by email, "It should be emphasized that the site operators were highly experienced - a requirement for being a trial investigator was performance of at least 300 PCIs per year for 5 years, including 20 LM procedures per year. This is far above the number of procedures performed by the average U.S. interventional cardiologist.”
“So, to achieve comparable results, operators should be well versed in advanced bifurcation stenting techniques before tackling this challenging patient population,” said Dr. Goldberg, who was not involved in the study. “In many centers, CABG might be the better long-term option.”
Dr. Antonio Colombo from IRCCS Ospedale San Raffaele, in Milan, Italy, who recently reported a substudy that compared PS with an elective two-stent strategy for ULMCAD, said of the new trial, “My main surprise is the relatively high number of adverse events occurring in the provisional arm. The high thrombosis rate in the provisional group is at discordance with a number of prior publications and, in my opinion, is just a play of chance and does not mean that the provisional approach is inferior.”
“I believe that the DK crush may be appropriate in complex bifurcations,” Dr. Colombo, who also was not involved in the new study, told Reuters Health by email. “Nevertheless, I would assume that PS should be suitable for simple bifurcations.”
Publication of the paper coincided with a presentation at the Transcatheter Cardiovascular Therapeutics (TCT) 2017 scientific symposium in Denver, Colorado.
Microport, Abbott Vascular, and Medtronic provided funding for this trial. The authors declared no relationships relevant to the content of their report.
Dr. Chen did not respond to a request for comments.
SOURCE: http://bit.ly/2zYMc2G and http://bit.ly/2hUPKfA
J Am Coll Cardiol 2017.
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