At 30 days, culprit lesion–only PCI was associated with fewer cases of death or renal replacement therapy than immediate multivessel PCI.
However, not all the news was good for culprit lesion–only PCI: At 1 year, it was associated with a higher frequency of rehospitalization for heart failure and of repeat vascularization, according to, of the Heart Center Leipzig at the University of Leipzig (Germany) and his colleagues.
These results from the Culprit Only Lesion PCI versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK) study were presented at the annual congress of the European Society of Cardiology and published simultaneously in the.
The 30-day results from the study,last year, were enough to convince the creators of the European revascularization guidelines to downgrade immediate multivessel PCI in cardiogenic shock to a class III B recommendation, which indicates that it is not effective and may cause harm.
However, the results also caused controversy because complete revascularization via immediate multivessel PCI in cardiogenic shock patients might lead to long-term benefits. In fact, evidence from nonrandomized trials and a registry study had suggested that immediate multivessel PCI may reduce mortality at 1 year.
But the new 1-year data don’t support that hypothesis of long-term benefit, Dr. Thiele and his colleagues found.
The CULPRIT-SHOCK trial randomized 684 patients at 83 centers to culprit lesion–only PCI or multivessel PCI. At 30 days, death or renal replacement therapy occurred at a lower frequency in the culprit lesion–only group (45.9% vs. 55.4%; relative risk, 0.83; P = .01).
At 1 year, all-cause mortality was 50.0% in the group that underwent culprit lesion–only PCI, compared with 56.9% in the group that underwent multivessel PCI, a result that was not statistically significant (RR, 0.88; 95% CI, 0.76-1.01). There was also no significant difference in death from cardiovascular causes, 46.2% in culprit lesion–only patients, compared with 52.8% in multivessel patients (RR, 0.88; 95% CI, 0.75-1.02).
Mortality rates between baseline and 1 year were similar in the intention-to-treat, per-protocol, and as-treated populations.
The researchers conducted a post hoc analysis of the original primary endpoint – death or renal replacement therapy – at 1 year, and they found results similar to those seen at 30 days: 52.0% in the culprit lesion–only group and 59.5% in the multivessel group (RR, 0.87; 95% CI, 0.76-0.99).
Some results favored multivessel PCI: 32.3% of the culprit lesion–only group underwent repeat revascularization, compared with 9.4% of multivessel PCI (RR, 3.44; 95% CI, 2.39-4.95). Rehospitalizations for congestive heart failure were rare, but occurred in 5.2% of the culprit lesion–only group, compared with 1.2% of the multivessel group (RR, 4.46; 95% CI, 1.53-13.04).
The study was funded by the European Union Seventh Framework Programme, the German Heart Research Foundation, and the German Centre for Cardiovascular Research. Dr. Thiele had no relevant conflicts of interest.
SOURCE: Thiele H et al. N Engl J Med. 2018 Aug 25. .