2
Editorial Comment Opportunities for Improvement—The Disappearing Stent David R. Holmes, Jr., MD Consultant in Cardiovascular Medicine Mayo Clinic, Rochester, MN The field of interventional cardiology continues to evolve having followed the path of balloon angioplasty alone to a variety of ablative devices to bare metal stent-based procedures and now drug-eluting stent pro- cedures which dominate the landscape. At each turn, new technology was developed to meet both the real as well as the perceived problems present at that time. Techniques that were found to be both safe and effi- cacious in randomized trials and registry experiences became dominant; those that were not were marginalized and sometime disappeared. Drug-eluting stents have undergone intense scrutiny and have become predicate devices. They have dramatically decreased both angiogra- phic and clinical restenosis rates compared to either bare metal stents or to angioplasty alone. Problems (or better-stated opportunities) for improvement remain. Drug-eluting stents have not completely eliminated restenosis. While in selected patients restenosis rates are single digit, in other patients with higher risk lesions, for example, bifurcation disease and diffuse small vessel disease, restenosis rates remain increased. The etiology of the restenosis varies from strut fracture to inadequate drug concentration, to excess drug concentration, and to inflammation from the polymer. The potential for delayed subacute thrombosis has been well documented. While this occurs with both bare metal and drug-eluting stents, its timing may be differ- ent. With drug-eluting stents, it may be delayed. The etiology of this event varies from inflammation to de- layed endothelialization, to side branch involvement, and to penetration of the necrotic arthrosclerotic core. The most important hazard for this catastrophic event is premature discontinuation of dual antiplatelet therapy. This has important implications for performance of non cardiac surgery after stent placement. There are other potential issues. There is increasing use of non invasive screening in patients with coronary artery disease. The presence of the stent makes this problematic because of artifact. In addition, the pres- ence of the stent may change the possibility of having subsequent cardiac surgery because it may exclude a graft touchdown site. For these as well as other reasons, there continues to be interest in stents that may not be permanent. The article by Waksman et al is an early foray into the field with a bioabsorbable magnesium alloy stent. Although this stent is currently being implanted in European patients with coronary artery disease, animal data is still required to learn more about basic issues. The current paper addresses some of these issues par- ticularly safety and efficacy in an animal model. What can we learn from this experience? 1. The magnesium alloy stents can be safely deployed and can achieve a good initial angiographic result that is comparable to bare metal stents. 2. At 28 days, there is already initial bioabsorption of these stents, so the concept of metal bioabsorption is real and can be documented. 3. At three months, the percent area of stenosis and percent diameter stenosis are improved when mea- sured by angiographic analysis in the magnesium alloy stent group, and in addition, neointimal is less than with bare metal stents. 4. There was no excess of inflammation in the histo- logic segments compared with the bare metal stent. 5. The authors do point out an at least interesting and perhaps concerning finding although there was a reduction in neointimal formation when assessing the results with histologic morphometry, this did not translate into ‘‘a larger vessel lumen and the overall stented segment was significantly smaller when com- pared to the stainless steel stent’’. That finding is diffi- cult to explain in that the quantitative coronary angiography at three months documents that the diam- eter stenosis was actually less and minimal lumen diameter was greater in the animals treated with the magnesium alloy stent. While there are a number of Correspondence to: David R. Holmes, Jr. E-mail: [email protected] Received 14 March 2006; Revision accepted 14 March 2006 DOI 10.1002/ccd.20923 Published online 12 September 2006 in Wiley InterScience (www. interscience.wiley.com). ' 2006 Wiley-Liss, Inc. Catheterization and Cardiovascular Interventions 68:618–619 (2006)

Opportunities for improvement—The disappearing stent

Embed Size (px)

Citation preview

Page 1: Opportunities for improvement—The disappearing stent

Editorial Comment

Opportunities forImprovement—TheDisappearing Stent

David R. Holmes, Jr., MD

Consultant in Cardiovascular MedicineMayo Clinic, Rochester, MN

The field of interventional cardiology continues toevolve having followed the path of balloon angioplastyalone to a variety of ablative devices to bare metalstent-based procedures and now drug-eluting stent pro-cedures which dominate the landscape. At each turn,new technology was developed to meet both the real aswell as the perceived problems present at that time.Techniques that were found to be both safe and effi-cacious in randomized trials and registry experiencesbecame dominant; those that were not were marginalizedand sometime disappeared. Drug-eluting stents haveundergone intense scrutiny and have become predicatedevices. They have dramatically decreased both angiogra-phic and clinical restenosis rates compared to either baremetal stents or to angioplasty alone. Problems (orbetter-stated opportunities) for improvement remain.Drug-eluting stents have not completely eliminated

restenosis. While in selected patients restenosis rates aresingle digit, in other patients with higher risk lesions,for example, bifurcation disease and diffuse small vesseldisease, restenosis rates remain increased. The etiologyof the restenosis varies from strut fracture to inadequatedrug concentration, to excess drug concentration, and toinflammation from the polymer.The potential for delayed subacute thrombosis has

been well documented. While this occurs with both baremetal and drug-eluting stents, its timing may be differ-ent. With drug-eluting stents, it may be delayed. Theetiology of this event varies from inflammation to de-layed endothelialization, to side branch involvement,and to penetration of the necrotic arthrosclerotic core.The most important hazard for this catastrophic event ispremature discontinuation of dual antiplatelet therapy.This has important implications for performance of noncardiac surgery after stent placement.There are other potential issues. There is increasing

use of non invasive screening in patients with coronaryartery disease. The presence of the stent makes thisproblematic because of artifact. In addition, the pres-

ence of the stent may change the possibility of havingsubsequent cardiac surgery because it may exclude agraft touchdown site.For these as well as other reasons, there continues to

be interest in stents that may not be permanent. Thearticle by Waksman et al is an early foray into the fieldwith a bioabsorbable magnesium alloy stent. Althoughthis stent is currently being implanted in Europeanpatients with coronary artery disease, animal data is stillrequired to learn more about basic issues.The current paper addresses some of these issues par-

ticularly safety and efficacy in an animal model. Whatcan we learn from this experience?

1. The magnesium alloy stents can be safely deployedand can achieve a good initial angiographic resultthat is comparable to bare metal stents.

2. At 28 days, there is already initial bioabsorption ofthese stents, so the concept of metal bioabsorption isreal and can be documented.

3. At three months, the percent area of stenosis andpercent diameter stenosis are improved when mea-sured by angiographic analysis in the magnesiumalloy stent group, and in addition, neointimal is lessthan with bare metal stents.

4. There was no excess of inflammation in the histo-logic segments compared with the bare metal stent.

5. The authors do point out an at least interesting andperhaps concerning finding although there was areduction in neointimal formation when assessing theresults with histologic morphometry, this did nottranslate into ‘‘a larger vessel lumen and the overallstented segment was significantly smaller when com-pared to the stainless steel stent’’. That finding is diffi-cult to explain in that the quantitative coronaryangiography at three months documents that the diam-eter stenosis was actually less and minimal lumendiameter was greater in the animals treated with themagnesium alloy stent. While there are a number of

Correspondence to: David R. Holmes, Jr.

E-mail: [email protected]

Received 14 March 2006; Revision accepted 14 March 2006

DOI 10.1002/ccd.20923

Published online 12 September 2006 in Wiley InterScience (www.

interscience.wiley.com).

' 2006 Wiley-Liss, Inc.

Catheterization and Cardiovascular Interventions 68:618–619 (2006)

Page 2: Opportunities for improvement—The disappearing stent

potential reasons for this, as the authors point out, thismight just be related to processing artifact.

This study does not answer all of the questions,including, will a longer-term follow up be required,information on eventual restenosis rates, will a drug berequired along with the bioabsorbable metal, and the

potential late effects of the process of bioabsorption.Additional areas of investigation will be the effect oneventual remodeling, and the relative merits of bioab-sorbable metals versus bioabsorbable polymers.Will this become a predicate group of devices or will

this type of stent go away like the metal itself goes away?Only time will tell, but this concept and the problems thatit potentially solves is an important venture.

The Disappearing Stent 619