British Bifurcation Coronary study: Old, New, and Evolving strategies - BBC ONE

Description:

The current trial sought to determine if a simple stepwise provisional T-stent strategy is superior to a more complex total lesion coverage with crush or culotte techniques for bifurcation lesions.

Contribution to the Literature: The BBC ONE trial showed that simple stepwise provisional T-stent strategy is superior to a more complex total lesion coverage with crush or culotte techniques for periprocedural outcomes and long-term mortality.

Study Design

Patients Enrolled: 500
Mean Follow-Up: 9 months
Mean Patient Age: 64 years
Female: 23%
Mean Ejection Fraction (EF): EF >50% in about 87% of the patients; only 0.5% had an EF <30%

Patient Populations:

  • Bifurcation coronary artery disease requiring stenting
  • Vessel diameters: ≥2.25 mm side and ≥2.5 mm main

Exclusions:

  • Unprotected left main stem narrowing ≥50%
  • Primary angioplasty
  • Cardiogenic shock
  • Chronic total occlusion of either bifurcation-related vessel
  • Additional type C or bifurcation lesions requiring percutaneous coronary intervention (PCI)
  • Left ventricular EF ≤20%

Primary Endpoints:

  • Death at 9 months
  • Target vessel failure (TVF) at 9 months
  • Myocardial infarction (MI) at 9 months

Secondary Endpoints:

Clinical:
  • Death
  • MI
  • TVF
  • Angina status—Canadian Cardiovascular Society and Angina index
  • Quality of Life Seattle questionnaires
  • Repeat angiography—with/without treatment

Procedural:
  • Procedural success
  • TIMI 3 flow and <30% stenosis main vessel, and
  • TIMI 3 flow side branch
  • Kissing balloons success
  • Periprocedural (within 24 hours) major adverse cardiac events (MACE)
  • In-hospital MACE
  • In-hospital major complications
  • Procedure duration, fluoroscopy, cGy · cm2, contrast
  • Procedural consumables (wires, balloons, stents)

Drug/Procedures Used:

In the simple strategy, the operator would proceed with stenting of the main vessel, followed by kissing inflation, and then T-stenting. In the complex strategy arm, either culotte (wire both vessels, stent first vessel, then rewire main vessel, and then stent the second vessel, with mandatory kissing) or crush (stent side vessel, crush with balloon/stent, then stent the main vessel, then recross the side vessel, with mandatory kissing) techniques were employed.

Concomitant Medications:

Paclitaxel-eluting stent in all patients, dual antiplatelet therapy for 9 months; glycoprotein IIb/IIIa use (36%)

Principal Findings:

A total of 500 patients were randomized, 250 to the complex strategy, and 250 to the simple strategy. The majority of the patients had the bifurcation lesion at the left anterior descending artery/D1 (82%). A true bifurcation was noted in about 83% of the patients, and about 10% had at least moderate calcification, 11% had at least moderate tortuosity, and 14% had an angle of >60 degrees.

Baseline characteristics were fairly similar between the two groups, other than glycoprotein IIb/IIIa inhibitor use, which was more frequent in the complex strategy arm. About 12% of the patients had diabetes. More than two-thirds of the patients (67%) underwent PCI for stable angina, 28% for unstable coronary syndromes, and 5% for ST-segment elevation MI (STEMI).

The mean total stent length was 21.5 mm in the main vessel, and in the complex strategy arm, 16 mm in the side arm. Total stented length was thus significantly higher in the complex strategy arm (41 mm vs. 24 mm, p < 0.0001). All operators performed at least 150 PCI procedures annually, and 96% of the procedures took place at centers with emergency surgical backup.

In the simple strategy arm, stent to the main vessel, with no kissing, was employed in the majority of the patients (68%); 27% required kissing balloons in addition to stenting in the main vessel. Of the 75 patients in whom the culotte technique was employed, stents to both vessels with failed kissing balloons occurred in 4% of the patients, and in 7% of the patients, more than one vessel was not stented. Of the 169 patients in whom the crush technique was employed, stents to both vessels with failed kissing balloons occurred in 18% of the patients, and in 9% of the patients, more than one vessel was not stented.

The composite endpoint of death, MI, orTVF was noted more frequently in the complex strategy arm compared with the simple strategy arm (15.2% vs. 8.0%, hazard ratio [HR] 2.0, 95% confidence interval [CI] 1.2-3.5, p = 0.009). Similarly, MI was significantly higher in the complex strategy arm (11.2% vs. 3.6%, p = 0.001). The incidences of mortality (0.8% vs. 0.4%), TVF (7.2% vs. 5.6%), and stent thrombosis (2.0% vs. 0.4%) were all higher with the complex strategy, but not statistically significant.

Periprocedural MACE was also higher in the complex strategy arm (7.6% vs. 2.0%, RR 3.8, 95% CI 1.5-10.0, p = 0.003). TIMI major bleeding was also higher with the complex strategy. Procedure time (78 vs. 57 minutes), radiation exposure (7900 vs. 6140 cGy · cm2), and number of stents used (2.21 vs. 1.17) were all higher with the complex strategy as well (p < 0.001 for all comparisons).

Five-year clinical outcomes (combined NORDIC I and BBC ONE data sets): All-cause mortality for complex vs. simple strategy: 7.0% vs. 3.8%, p = 0.04 (BBC ONE: 5.9% vs. 2.9%; NORDIC I: 10.4% vs. 5.9%, p = 0.1).

Interpretation:

The results of the BBC ONE trial indicate that a simple stepwise T-stent strategy is superior to a complex strategy with culotte or crush techniques in patients with bifurcation lesions in reducing MACE, MI, bleeding, as well as procedural parameters such as procedure time and number of stents used. Long-term mortality also appears to be lower, although the mechanism for this (lower TLR, lower TV-MI) is unknown.

References:

Behan MW, Holm NR, de Belder AJ, et al. Coronary bifurcation lesions treated with simple or complex stenting: 5-year survival from patient-level pooled analysis of the Nordic Bifurcation Study and the British Bifurcation Coronary Study. Eur Heart J 2016;37:1923-8.

Presented by Dr. David J. Hildick-Smith at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2008), Washington, DC, October 2008.

Hildick-Smith D, de Belder AJ, Cooter N, et al. Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesions: the British Bifurcation Coronary Study: old, new, and evolving strategies. Circulation 2010;121:1235-43

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Interventions and Imaging, Angiography, Nuclear Imaging, Chronic Angina

Keywords: Angiography, Myocardial Infarction, Coronary Stenosis, Angina, Stable, Thrombosis, Stents, Percutaneous Coronary Intervention


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