Rotablation or Balloon Immediate and 6 month results of a trial in patients with chronic total coronary occlusion Layth A. Mimish, M. Bakhshi, J. Buraiki, F. Nozha, K. Niazi, B. Dunn, B. Dajani, M.E. Fawzy

The Goal of the Study u PTCA of chronic total occlusion carries high restenosis rate u Main mechanism of GOBA is controlled dissection/++Trauma u Smoother lumen is created by debulking with rotablation u Does that reflect on restenosis rates?

Study Patients/Design u All patients undergoing percutaneous revascularization of occluded coronary artery of more than 3 months duration u Informed Consent u After crossing the lesion with the wire patients are randomized to one limb of the study

Study Patient/Design u For rotablator patients the wire is exchanged to Rota wire using Buchbinder exchange catheter u All rotablations are chased with low atmospheric inflations to achieve residual stenosis of less than 20%

Study Patient/Design u Multiple angiographic views with assessment of collaterals, length of lesion, LVEF, Segmental analysis u 10,000 U I.V. Heparin followed by check of ACT u I.C. NTG and/or Verapamil as required

Study Patient/Design u Balloon size is judged by the size of the artery in the immediate proximity of the lesion u Preferably single balloon of matching size is used u Only if failure to cross with deep throating with the guider, a pre dilation with 1.5 mm balloon is used

Study Patient/Design u Smallest Burr size available is used followed by larger size/s Burrs aiming to achieve at least 30% residual stenosis u All rotablated cases are chased with balloon dilatation u Stenting is used only for dissection or for residual narrowing of more than 30%

Demographic/Clinical Data u No. of patients u Males/females u Mean Age u Hypertension u Diabetes u Smokers u Duration/m PTCA Rota P value NS NS 16/6 17/4 NS 16/6 17/4 NS NS NS 7/22 8/21 NS 7/22 8/21 NS 6/22 12/21 NS 6/22 12/21 NS 9 15 NS 9 15 NS NS NS

Angiographic/Clinical Data u LVEF u Collaterals u Vessel Size u Length u Dissection u Stenosis/Post u Floro Time PTCA Rota P value NS NS NS NS NS NS 10 8 NS 10 8 NS NS NS

Shortcomings & Pitfalls u Small number of patients u Visual assessment u Contamination with stenting u Ballooning post rotablations

6 Months Follow Up u Angiographic follow up showed significant restenosis in 10 patients in each group i.e. 45% Vs 47% ( P=N.S.) u Stenting ( 1 in PTCA group and 7 in Rotablator group ) did not affect the restenosis rates

Conclusions u Rotablation does not significantly decrease the rate of restenosis u It definitely increases the cost and the time of the procedure u It exposes the team and the patient to higher dose of radiation