t-stenting with drug-eluting stents for the treatment of bifurcation in-stent restenosis

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IT FITS! (IntelligenceTransfer: From Images to Solutions) Edited by Steven B.H. Timmis T- Stenting with Drug-Eluting Stents for the Treatment of Bifurcation In-Stent Restenosis DAVID G. RIZIK, M.D.,* NEIL C. BARMAN, M.D.,* ANDRE BOUHASIN, M.D., and BERNARD J. VILLEGAS, M.D.* *Sconsdale Heart Group, Scottsdale, A~~zoM, and St. Louis University, St. Louis, Missouri A 52-year-old female with documented coronary disease presented to the emergency room with unsta- ble angina. She had multiple previous coronary inter- ventions, including bifurcation stenting of the LAD and diagonal branch. In-stent restenosis had been treated three times over a 6-month period. Despite the application of previous brachytherapy, diagnostic an- giography revealed the recurrence of in-stent resteno- sis involving both the culprit LAD and diagonal branches. Under intravascular ultrasound (IVUS) guidance, sirolimus-eluting Bx VELOCITY stents (Cordis, a Johnson & Johnson Company) were placed using a T-stenting technique (Fig. 1). Figure 2 demonstrates the results of 5-month anniversary angiography re- vealing wide patency of both stented segments. These results suggest that antiproliferative therapies may be a reasonable alternative for complex in-stent resteno- sis. Editor’s Comments Interventional cardiology stands at the edge of a revolution. As sirolimus-coated intracoronary stents are being considered for approval in the United States by the Federal Drug Administration, industry is revving up for their broad use. Initial trials investigat- ing sirolimus-coated stents in coronary arteries, in- Address for reprints: David G. Rizik, M.D., Scottsdale Heart Group, 9755 North 90th St., Suite A100, Scottsdale, AZ 85258. Fax: (480) 860 1580 e-mail: [email protected] cluding the landmark RAVEL trial, have evaluated their application in single, primary lesions in native coronary vessels.’-3 The results have been striking. Late lumen loss has ranged from -0.01 to 0.09 mm by quantitative coronary angiography .’” Measurement of neointimal hyperplasia by quantitative intravascular ultrasonography has likewise been minimal, ranging from 1.8% to 1.0% luminal ~ o l u m e . ~ . ~ These findings have produced binary angiographic rates of restenosis (250% lumen diameter) of O%!’ That this compares favorably to the 28% rate of restenosis reported for control arteries treated with uncoated stents is a vast understatement. However, it is expected that these stents will be ap- proved and marketed only for use in coronary lesions similar to those evaluated by these early studies. Nev- ertheless, no one doubts that they will immediately be applied to the total spectrum of lesions treated in the cath lab. These vessels will include such complex and high-risk features as chronic total occlusions, bifurcat- ing, highly-calcified, and long lesions, all of which were excluded from the existing trials. Another untested application is restenotic lesions such as the current and compelling case study presented by Rizik et al. This case is particularly interesting because the patient had radiation therapy for in-stent restenosis. The patient clearly benefited from an untested applica- tion of the sirolimus-coated stent. As we move forward, it is easy to predict that the cardiovascular literature will be flooded with a series of studies and case reports evaluating off-label use of these stents. Tremendous results are expected. How- ever, success will likely not be universal. As Sousa et Vol. 15, No. 6,2002 Journal of Interventional Cardiology 519

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Page 1: T-Stenting with Drug-Eluting Stents for the Treatment of Bifurcation In-Stent Restenosis

IT FITS! (Intelligence Transfer: From Images to Solutions) Edited by Steven B.H. Timmis

T- Stenting with Drug-Eluting Stents for the Treatment of Bifurcation In-Stent Restenosis

DAVID G. RIZIK, M.D.,* NEIL C. BARMAN, M.D.,* ANDRE BOUHASIN, M.D., and BERNARD J. VILLEGAS, M.D.*

*Sconsdale Heart Group, Scottsdale, A ~ ~ z o M , and St. Louis University, St. Louis, Missouri

A 52-year-old female with documented coronary disease presented to the emergency room with unsta- ble angina. She had multiple previous coronary inter- ventions, including bifurcation stenting of the LAD and diagonal branch. In-stent restenosis had been treated three times over a 6-month period. Despite the application of previous brachytherapy, diagnostic an- giography revealed the recurrence of in-stent resteno- sis involving both the culprit LAD and diagonal branches.

Under intravascular ultrasound (IVUS) guidance, sirolimus-eluting Bx VELOCITY stents (Cordis, a Johnson & Johnson Company) were placed using a T-stenting technique (Fig. 1). Figure 2 demonstrates the results of 5-month anniversary angiography re- vealing wide patency of both stented segments. These results suggest that antiproliferative therapies may be a reasonable alternative for complex in-stent resteno- sis.

Editor’s Comments

Interventional cardiology stands at the edge of a revolution. As sirolimus-coated intracoronary stents are being considered for approval in the United States by the Federal Drug Administration, industry is revving up for their broad use. Initial trials investigat- ing sirolimus-coated stents in coronary arteries, in-

Address for reprints: David G. Rizik, M.D., Scottsdale Heart Group, 9755 North 90th St., Suite A100, Scottsdale, AZ 85258. Fax: (480) 860 1580 e-mail: [email protected]

cluding the landmark RAVEL trial, have evaluated their application in single, primary lesions in native coronary vessels.’-3 The results have been striking. Late lumen loss has ranged from -0.01 to 0.09 mm by quantitative coronary angiography .’” Measurement of neointimal hyperplasia by quantitative intravascular ultrasonography has likewise been minimal, ranging from 1.8% to 1.0% luminal ~ o l u m e . ~ . ~ These findings have produced binary angiographic rates of restenosis (250% lumen diameter) of O%!’ That this compares favorably to the 28% rate of restenosis reported for control arteries treated with uncoated stents is a vast understatement.

However, it is expected that these stents will be ap- proved and marketed only for use in coronary lesions similar to those evaluated by these early studies. Nev- ertheless, no one doubts that they will immediately be applied to the total spectrum of lesions treated in the cath lab. These vessels will include such complex and high-risk features as chronic total occlusions, bifurcat- ing, highly-calcified, and long lesions, all of which were excluded from the existing trials. Another untested application is restenotic lesions such as the current and compelling case study presented by Rizik et al. This case is particularly interesting because the patient had radiation therapy for in-stent restenosis. The patient clearly benefited from an untested applica- tion of the sirolimus-coated stent.

As we move forward, it is easy to predict that the cardiovascular literature will be flooded with a series of studies and case reports evaluating off-label use of these stents. Tremendous results are expected. How- ever, success will likely not be universal. As Sousa et

Vol. 15, No. 6,2002 Journal of Interventional Cardiology 519

Page 2: T-Stenting with Drug-Eluting Stents for the Treatment of Bifurcation In-Stent Restenosis

A

RIZIK, ET AL.

Figure 2. 5-month anniversary angiogram.

B

Figure 1. A. Preintervention. B. Immediately following implanta- tion of sirolimus-eluting stents.

al. point out, restenosis will likely occur and be more dependent on technical and operator-dependent char- acteristics such as geographic miss, gaps between un- overlapped stents, stent underdeployment, e t ~ . ~ Lessons will obviously need to be learned. I hope and

expect that the field will push the envelope with cau- tion. Progress in the use of these stents will depend less on taking diminutive steps toward their evolving ap- plication and more on honest reporting of failures along with successes. That said, I expect that success will predominate. Bring on the revolution!

References

Morice MC, Sermys PW. Sousa JE, et al. A randomized com- parison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002;346:

Sousa JE, Costa MA, Abizaid A, et al. Lack of neointimal pro- liferation after implantation of sirolimus-coated stents in hu- man coronary arteries: A quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circ

Rensing BJ, Vos J, Smits PC, et al. Coronary restenosis elimi- nation with a sirolimus eluting stent: first European human ex- perience with 6-month angiographic and intravascular ultra- sonic follow-up. Eur Heart J 2001;22125-130. Sousa JE, Costa MA, Sousa AGMR. What is “the matter” with restenosis in 2002? Circulation 2002; 105:2932-2933.

1773- 1780.

2001 ;103: 192-195.

520 Journal of Interventional Cardiology Vol. 15, No. 6,2002