CULPRIT-SHOCK, EXCEL and DKCRUSH-V: TCT 2017 Late Breaking Trial Results
Reported from the TCT 2017 Scientific Sessions in Denver, United States
Two potentially impactful clinical trials were in the limelight during day 2 of TCT 2017, as well as the quality of life analysis of a trial comparing revascularization strategies for left main disease. Let’s take a look at the results and see what their potential could be for daily practice.
CULPRIT-SHOCK: keep it simple in cardiogenic shock
In the recent 2017 STEMI guidelines, complete revascularization of multivessel disease in patients presenting with cardiogenic shock is currently given a Class IIa grade recommendation, with a C level of evidence. It seems that this recommendation will need to be re-written, and the level of evidence upgraded.
In CULPRIT SHOCK, a strategy of culprit-only revascularization yielded better outcomes at 30 days compared with a complete revascularization strategy in cardiogenic shock patients with STEMI or NSTEMI, driven by lower mortality but also by a trend towards the reduction in the need of renal replacement therapy. From a trial interpretation standpoint, the treatment effect was large (27%) and the reduction was dominated by the most important of all endpoints (ie, mortality). From my perspective, this can be considered a practice-changing trial.
EXCEL Quality of life: early benefit, no later penalty for PCI
Patient-reported outcomes are more and more disclosed in clinical trials: what we and our surgical colleagues try to do with revascularization is to decrease the burden of hard clinical outcomes, but what really matters to patients?
The EXCEL investigators looked at that issue in their trial of PCI vs. CABG for low-to-intermediate risk left main disease, and reported that both procedures improve disease-specific and generic health outcomes, with no differences at long term (a novel finding) and some advantage of PCI at 1 month. Also, importantly, PCI was found to reduce the rates of depression at 1 year, a finding that should not be overlooked.
Putting these results into perspective of previous revascularization trials conducted in the era of POBA, BMS and first-generation DES, it is notable to observe that this is possibly the first time we see no difference in long-term angina favoring CABG, yet in a population with less complex coronary artery disease than in SYNTAX and FREEDOM. Is it the stent? Is it better patient selection? Is it because of the long-term follow-up available at only 3 years? Hard to tell but thought-provoking.
DKCRUSH-V: keep it… complex in distal left main PCI?
A randomized trial of the DK-CRUSH technique vs. provisional stenting in true left main bifurcation lesions, found a large reduction in target lesion failure with the upfront 2-stent technique, driven by less target-vessel myocardial infarction and a trend towards less target lesion revascularization. Also there was less thrombosis with the routine 2-stent strategy. The rate of crossover stenting in the provisional group was surprisingly high at 47%, and experts advocate that this may be a contributing explanation for these results.
In perspective, the DK-crush technique was previously found in another trial from the same investigators to achieve better outcomes that the culotte technique in patients with complex distal bifurcation lesions. These new results are provocative and extend those findings to candidates of the provisional strategy, suggesting that interventional cardiologists should try to become more familiar with this relatively complex technique to be able to offer it to selected patients with distal left main disease. Further insights on the topic of stenting strategies for left main disease will come from the ongoing EBC Main study.