Safety and Efficacy of Low Temperature Rota-flush Solution in Patients With Severe Calcified Lesion (LOTA-II)
Condition: Myocardial Injury
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Calcified lesions related to coronary artery are a type of atherosclerosis, accompanied by
      severe calcified lesions of the stenosis, which is a difficult point for PCI interventional
      therapy. Calcified lesions have poor response to balloon dilatation and the device can not be
      successfully placed, which reduce the success rate of operation. Furthermore, the stent is
      under-expanded and the adherence is poor, which significantly increases the incidence of
      major adverse cardiovascular events (MACEs).

      Intracoronary rotational atherectomy (RA) was developed by David Auth in the early 1980s. In
      1988, Bertrand has completed the first case of coronary RA. RA was recommended for treatment
      of severe calcified lesions in ACC/AHA Guidelines for Coronary Interventional Therapy in 2011
      (IIa, C). However, many studies have found that the incidence of RA-related myocardial injury
      is relatively high, and affect the efficacy of RA and prognosis in patients with severe
      calcified lesions. It has been reported that 58 consecutive patients with stable angina
      requiring PCI with RA to a calcified coronary lesion have 68% 5-fold increase in high
      sensitivity troponin after RA. The objective of this randomized control trial is to gain a
      clinical insight on the use of low temperature rota-flush solution for the treatment of
      RA-related myocardial injury in patients with heavy calcified lesions. The primary objective
      is assess efficacy and safety of low temperature rota-flush solution for the treatment of
      RA-related myocardial injury in patients with severe calcified lesions.
    

Detailed description: 
      The current study is designed as a multicenter, randomized and prospective study aiming to
      compare the incidence rate of RA-related myocardial injury indicated by change in levels of
      myocardial injury biomarkers (such as TNI and CK-MB) between low temperature rota-flush
      solution group and room temperature rota-flush solution group. Based on previous study, the
      incidence rate of RA-related myocardial injury is 68.0 % in patients with severe calcified
      lesions undergoing PCI. And in our study the expected incidence rate of RA-related myocardial
      injury is up to 34.0 % in patients with severe calcified lesions undergoing PCI after
      treatment with low temperature rota-flush solution. Moreover, the investigators estimated 10%
      loss follow-up of these patients in each arm. As a result, a total of 132 patients with heavy
      calcified lesions were required, and with 66 patients per group as a ratio of 1:1
      randomization.
    

Intervention name(s): low temperature rota-flush solution
Intervention type(s): Other
Intervention description(s): Patients with severe calcified lesions undergoing RA were performed with low temperature rota-flush solution. The investigators used thermal insulation equipment to keep rota-flush solution at 0～5℃. The EKG and blood pressure were monitored during the RA procedure. After RA, the investigators monitored levels of myocardial injury biomarkers for 3 days every 8 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: low temperature; rota-flush solution; RA-related myocardial injury; severe calcified lesion