Theodosios Bisdas, Department of Vascular Surgery, University Clinic & St Franziskus Hospital of Munster, presented in-hopsital outcome results from the real-world, critical limb ischaemia CRITISCH registry at the Leipzig Interventional Congress (LINC, 27–30 January, Leipzig, Germany). In the study, more than 50% of patients treated for critical limb ischaemia in Germany underwent endovascular therapy.
The CRITISCH registry aimed to assess the current limb ischaemia practice at 27 German centres. It was a multicentre, prospective, interdisciplinary, externally-monitored registry of 1,200 patients (Rutherford class 4–6) enrolled between January 2013 and September 2014. The first-line treatment strategies that were assessed were endovascular first, bypass surgery first, common or deep femoral artery patchplasty only, and no vascular intervention (primary amputation or conservative treatment). The endpoints were in line with the reporting standards of Society for Vascular Surgery: major amputation/death (composite endpoint), major amputation, death, haemodynamic failure, major adverse cerebrocardiovascular events and reintervention.
In the study, Bisdas told delegates, 53.5% patients underwent an endovascular intervention, 23.7% bypass surgery, 10.5% patchplasty, 9.8% conservative approach and 2.5% primary amputation. He noted that characteristics and demographics were similar amongst patient groups but highlighted that the primary amputation group had a larger number of diabetic patients (63%) and a larger number of patients with previous stroke or transient ischaemic attack (30%); he also added that across the five groups a large number of patients had had a previous vascular intervention.
In relation to anatomical characteristics, the investigators noted that the primary amputation group presented with a larger percentage of Rutherford class 6 patients (83%) in comparison to the other groups studied (20–25%), and that the number of TASC D lesions was high (70%) in the bypass surgery group (in comparison to 29–57% in the other cohorts). The primary amputation group also presented with the largest number of patients with no run-off vessels (60% vs. 11–27% in the other groups).
“Another important point is that in a considerable number of patients in all groups of patients could not be classified according to the TASC classification. This shows the drawback of this classification, especially in diabetic patients,” Bisdas said.
Presenting the results for the endovascular group, Bisdas noted that in the femoral vessels (n=347) the majority of patients were treated with plain angioplasty only (36%), angioplasty plus stenting (40.6%) or drug-coated balloons (18.2%). In the popliteal vessels, 38.2% were treated with angioplasty only, 33.1% with angioplasty plus stenting and 19.5% with drug-coated balloons. “It is interesting to note that 33.1% of the operators used a stent in the popliteal vessel despite the challenges related to this segment,” he said. In the tibial vessels, 70.4% of patients were treated with angioplasty only, followed by drug-coated balloons at 9.8% and stenting at 6.5%.
With regards to bypass surgery, the material of choice was leg vein in 53.2% of cases, PTFE in 25%, Dacron in 11.3% and arm vein in 3.9%.
The results of an unmatched analysis showed no difference between the groups in relation to the composite endpoint of amputation/death (Table 1). However, the investigators observed higher in-hospital mortality rates in the primary amputation group (p=0.003) and high haemodynamic failure (91%) in patients undergoing conservative treatment. Bisdas stated that an unexpected result was a high reinterveniton rate in the bypass surgery group (14%).
He commented: “We tried to adjust all the differences to find the risk factors for critical limb ischaemia patients. We found that for the composite endpoint, coronary artery disease and previous myocardial infarction (within six months) were risk factors. In addition, patients undergoing dialysis and with previous myocardial infarction were more prone to amputation. For the endpoint of death, the risk factors were bypass surgery, renal insufficiency and previous myocardial infarction. For haemodynamic failure the main risk factors were renal insufficiency, dialysis and previous vascular intervention. For major adverse cerebrocardiovascular events, the risk factors were renal insufficiency, coronary artery disease and previous myocardial infarction. The only risk factor for reintervention was bypass surgery.”
In conclusion, Bisdas stated, in-hospital outcomes in this real-world critical limb ischaemia study show that in Germany the first-line treatment of choice remains endovascular therapy (54%). “Primary amputation showed the highest mortality rate, at 10%; bypass surgery led to higher mortality and reintervention rates in comparison to endovascular therapy; and coronary artery disease and previous myocardial infarction were risk factors for the composite endpoint of amputation/ death. We also found that renal insufficiency without dialysis was an independent risk factor for poor in-hospital outcomes,” he said.