Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesions. The British bifurcation coronary study: old, new, and evolving strategies

Hildick-Smith, David, De Belder, Adam, Cooter, Nina, Curzen, Nick, Clayton, Tim C., Oldroyd, Keith G., Bennett, Lorraine, Holmberg, Steve, Cotton, James M., Glennon, Peter E., Thomas, Martyn R., MacCarthy, Philip A., Baumbach, Andreas, Mulvihill, Niall T., Henderson, Robert A., Redwood, Simon R., Starkey, Ian R. and Stables, Rodney H. (2010) Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesions. The British bifurcation coronary study: old, new, and evolving strategies. Circulation, 121 (10), 1235-1243. (doi:10.1161/CIRCULATIONAHA.109.888297).

Abstract

Background— The optimal strategy for treating coronary bifurcation lesions remains a subject of debate. With bare-metal stents, single-stent approaches appear to be superior to systematic 2-stent strategies. Drug-eluting stents, however, have low rates of restenosis and might offer improved outcomes with complex stenting techniques.

Methods and Results— Patients with significant coronary bifurcation lesions were randomized to either a simple or complex stenting strategy with drug-eluting stents. In the simple strategy, the main vessel was stented, followed by optional kissing balloon dilatation/T-stent. In the complex strategy, both vessels were systematically stented (culotte or crush techniques) with mandatory kissing balloon dilatation. Five hundred patients 64±10 years old were randomized; 77% were male. Eighty-two percent of lesions were true bifurcations (>50% narrowing in both vessels). In the simple group (n=250), 66 patients (26%) had kissing balloons in addition to main-vessel stenting, and 7 (3%) had T stenting. In the complex group (n=250), 89% of culotte (n=75) and 72% of crush (n=169) cases were completed successfully with final kissing balloon inflations. The primary end point (a composite at 9 months of death, myocardial infarction, and target-vessel failure) occurred in 8.0% of the simple group versus 15.2% of the complex group (hazard ratio 2.02, 95% confidence interval 1.17 to 3.47, P=0.009). Myocardial infarction occurred in 3.6% versus 11.2%, respectively (P=0.001), and in-hospital major adverse cardiovascular events occurred in 2.0% versus 8.0% (P=0.002), respectively. Procedure duration and x-ray dose favored the simple approach.

Conclusions— When coronary bifurcation lesions are treated, a systematic 2-stent technique results in higher rates of in-hospital and 9-month major adverse cardiovascular events. This difference is largely driven by periprocedural myocardial infarction. Procedure duration is longer, and x-ray dose is higher. The provisional technique should remain the preferred strategy in the majority of cases.

Clinical Trial Registration Information— URL: http://www.clinicaltrials.gov. Unique identifier: NCT 00351260.

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Contributors

Author: Nick Curzen

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