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A randomized comparison of balloon angioplasty versus rotational atherectomy in complex coronary lesions (COBRA
1Department of Cardiology, University Hospital Eppendorf, Hamburg, Germany.
Insights
Rotablation and percutaneous transluminal coronary angioplasty (PTCA) with stenting show comparable long-term outcomes for complex coronary lesions. Rotablation offers higher procedural success rates, while both methods have similar complication rates and restenosis.
Area of Science:
- Cardiology
- Interventional Cardiology
Background:
- Rotablation is a common treatment for complex coronary artery lesions.
- Controlled studies supporting its efficacy are limited.
Purpose of the Study:
- To compare the short- and long-term effects of percutaneous transluminal coronary angioplasty (PTCA) versus rotablation.
- To evaluate outcomes in patients with angiographically defined complex coronary artery lesions.
Main Methods:
- A multicentre, prospective, randomized trial (COBRA study) involving 502 patients.
- Patients were assigned to either PTCA (n=250) or rotablation (n=252).
- Primary endpoints included procedural success, 6-month restenosis, and major cardiac events.
Main Results:
- Rotablation achieved higher procedural success (85%) compared to PTCA (78%) (P=0.038).
- More stents were needed after PTCA (14.9%) versus rotablation (6.4%) (P<0.002).
- No significant differences were observed in restenosis rates (49% vs. 51%) or major cardiac events at 6 months.
Conclusions:
- Both PTCA with stenting and rotablation are effective for complex coronary lesions with high success and low complication rates.
- Long-term clinical and angiographic outcomes are comparable between the two procedures.
Aims:
Rotablation is a widely used technique for the treatment of complex coronary artery lesions but is so far only poorly supported by controlled studies. The Comparison of Balloon-Angioplasty versus Rotational Atherectomy study (COBRA) is a multicentre, prospective, randomized trial to compare short- and long-term effects of percutaneous transluminal coronary angioplasty (PTCA) and rotablation in patients with angiographically pre-defined complex coronary artery lesions.
Methods And Results:
At seven clinical sites 502 patients with pre-defined complex coronary artery lesions were assigned to either PTCA (n=250) or rotablation (n=252). Primary end-points were procedural success, 6-month restenosis rates in the treated segments, and major cardiac events during follow-up. Procedural success was achieved in 78% (PTCA), and 85% (rotablation) (P=0.038) of cases. Crossover from PTCA to rotablation was 4% and 10% vice versa (P=0.019). There was no difference between PTCA and rotablation with respect to procedure-related complications such as Q wave infarctions (2.4% each), emergency bypass surgery (1.2% versus 2.4%), and death (1.6% versus 0.4%). However, more stents were required after PTCA (14.9% versus 6.4%, P<0.002), predominantly for bailout or unsatisfactory results. Including bail-out stents as an end-point, the procedural success rates were 73% for angioplasty and 84% for rotablation (P=0.006). At 6 months, symptomatic outcome, target vessel reinterventions and restenosis rates (PTCA 51% versus rotablation 49%, P=0.33) were not different.
Conclusion:
Complex coronary artery lesions can be treated with a high level of success and low complication rates either by PTCA with adjunctive stenting or rotablation. The long-term clinical and angiographic outcome is comparable.
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