Randomized Trial on Routine vs. Provisional T-Stenting in the Treatment of De Novo Coronary Bifurcation Lesions - Randomized Trial on Routine vs. Provisional T-Stenting in the Treatment of De Novo Coronary Bifurcation Lesions

Oct 14, 2008
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Trial Sponsor:
Cordis
Date Published:
01/01/2008
Date Updated:
10/14/2008
Original Posted Date:
10/14/2008
References

Description:

The goal of the trial was to evaluate a strategy of routine T-stenting compared with provisional T-stenting in the treatment of de novo bifurcation lesions.

Hypothesis:

Routine T-stenting will improve angiographic outcomes of side branch.

Study Design

Study Design:

Patients Screened: 479
Patients Enrolled: 202
Mean Follow Up: 2 years
Mean Patient Age: 67 years
Female: 21
Mean Ejection Fraction: 60

Patient Populations:

  • Patients with stable angina or a positive stress test due to a coronary lesion involving a bifurcation

Exclusions:

  • Side branch size less than 2.25 mm
  • Main branch size more than 4.0 mm
  • Left main artery stenosis
  • Thrombus or calcification
  • Severe tortuosity
  • Contraindication to any of the study medications
  • History of bleeding disorder or coagulopathy

Primary Endpoints:

  • In-segment percent diameter stenosis at 9 months

Secondary Endpoints:

  • All-cause mortality at 1 and 2 years
  • Non-fatal myocardial infarction at 1 and 2 years
  • Stent thrombosis at 1 and 2 years
  • Target lesion revascularization of the main and side branch
  • Major adverse cardiac events

Drug/Procedures Used:

Patients with stable angina due to a bifurcation lesion were randomized to routine T-stenting (n = 101) versus provisional T-stenting (n = 101) with sirolimus-eluting stents. In both groups, kissing balloon technique was used.

Concomitant Medications:

Patients were loaded with 600 mg of clopidogrel at least 2 hours prior to the intervention. Intravenous aspirin was administered to aspirin-naïve patients. Intra-arterial heparin was administered at a dose of 70-140 U/kg. Glycoprotein IIb/IIIa inhibitors were available for bailout. Aspirin was administered for life and clopidogrel for 6 months.

Principal Findings:

Overall, 202 patients were randomized. There was no difference in the baseline characteristics between the groups. Diabetes was present in 18.8% of the routine T-stent group versus 25.7% of the provisional T-stent group (p = 0.16). The location of the bifurcation was left anterior descending/diagonal in 73.3% of the routine T-stent group versus 75.2% of the provisional T-stent group. There were three patients in the routine group where a side branch stent was unable to be placed. There were 19 patients in the provisional group who required a side branch stent due to poor flow.

The primary outcome, percent diameter stenosis of the side branch at 9 months, was 27.7% in the routine T-stenting group versus 23.0% in the provisional T-stenting group (p = 0.15). Binary restenosis was 12.5% versus 9.4% (p = 0.32), respectively.

At 1 year: mortality was 1.0% versus 2.0% (p = 1.0), non-fatal myocardial infarction was 2.0% versus 1.0% (p = 1.0), target lesion revascularization of the main branch was 3.0% versus 6.9% (p = 0.19), target lesion revascularization of the side branch was 7.9% versus 5.0% (p = 0.39), any major adverse cardiac event was 11.9% versus 12.9% (p = 0.83), and definite stent thrombosis was 2.0% versus 1.0% (p = 1.0), respectively for routine versus provisional T-stenting.

Interpretation:

Among patients with stable angina due to a bifurcation lesion, routine T-stenting of the side branch with a sirolimus stent is not superior to provisional T-stenting of the side branch. Routine T-stenting of the side branch is associated with similar in-segment percent diameter and binary restenosis compared with provisional T-stenting. There is also similar incidence of death, non-fatal myocardial infarction, stent thrombosis, and target lesion revascularization between these two strategies. Specifically, target lesion revascularization of the side branch was only 5.0% with provisional stenting. Two-year clinical outcomes will be reported at a later date.

Side branch revascularization remains a difficult lesion subset for interventional cardiology with a high risk of procedural complications and restenosis. This trial complements the NORDIC trial, which also documented similar angiographic and clinical outcomes from provisional side branch stenting compared with routine side branch stenting; however, with less fluoroscopy time and biomarker elevation. Until future technology is developed, a strategy of main branch only stenting appears warranted in most bifurcation lesions unless poor flow occurs in the side branch.

References:

Ferenc M, Gick M, Kienzle RP, et al. Randomized trial on routine vs. provisional T-stenting in the treatment of de novo coronary bifurcation lesions. Eur Heart J 2008;Oct 9:[Epub ahead of print].

Keywords: Complement System Proteins, Coronary Artery Disease, Myocardial Infarction, Fluoroscopy, Biomarkers, Angina, Stable, Thrombosis, Constriction, Pathologic, Sirolimus, Diabetes Mellitus, Stents, Exercise Test


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