Coated and covered stents 2000-2001

'The potential of coated stents' Live Netcast 
View Drs Jean-Pierre Bassand, Edoardo Camenzind, Carlo Di Mario, Karl Karsch, Campbell Rogers, and an invited guest panel in their discussion on 'The potential of coated stents'. This Medical CyberSession, features the ESC Working Group on Interventional Cardiology, and was broadcast via the Internet on Thursday, March 15, 2001. 
View the webcast at: http://www.cybersessions.com/ESC-Series

Review 
Update on Coated and Covered Stents
Hofma SH || van der Giessen WJ
Click here to view the full article
See also Current Interventioanl Cardiology Reports 2001;Vol 3 Issue 1 
http://www.current-reports.com/cr_contents.cfm?Volume=3&Issue=1&JournalID=IC 
Excellent and updated review 

Coated stents: a new era 
Recorded October 3, 2001
The stunning results of the RAVEL trial have galvanized the cardiology community's interest in coated stents. Dr Ulrich Sigwart leads a panel discussion about this powerful new technology, its promise, its limitations, and its future
http://www.theheart.org/documents/page.cfm?from=590001383&doc_id=25974

ESC 2001 Meeting Coverage

• RAVEL (Randomized double-blind study with the Sirolimus-eluting Bx VElocity balloon expandable stent in the treatment of patients with de novo native coronary artery Lesions)
  Click here
  PowerPoint Presentation: http://www.radiationonline.com/ppt/ravel.ppt

• The TRUST Study: Antiplatelet Therapy Plus Stent Placement
  Multicenter randomized trial comparing the effect of a silicon-carbide (SiC:H) coated stent to conventional stents in reduction of restenosis and subacute thrombosis
  Comment -1    Comment - 2

AHA 2001 Meeting Coverage

• New Data, New Era, With Drug-Eluting Stents?
  RAVEL, SIRIUS, ASPECT, ACTION, HOPE
  by Tim A. Fischell, MD 
  Click here
  
• State of the Art: Are Stent Coatings the Ultimate Cure for Restenosis?
  by J. Eduardo Sousa, MD
  At two major meetings recent data has been presented on the subject of drug coated stents for the prevention of restenosis. Dr. Sousa looks at the promising preliminary results of these drug coated stents and also discusses the controversy surrounding radiated stents.
  Click here
  

• The ELUTES Trial: European Evaluation of Paclitaxel Eluting Stent 
  Presenter: Anthony H. Gershlick, Leicester, United Kingdom
  Click here

TCT 2001 Meeting Coverage

• Studies with Actinomycin D: From ACTION to U.S. OPEN Pivotal Study

• RAVEL Update

• Six-Month Results of ASPECT

• TAXUS-1 Trial 
  Webcast o the first presentation of the TAXUS-1 Trial on Sept 24 2001
  Eberhard Grube, M.D. and Gregg W. Stone, M.D.
  http://www.tctmd.com/industry-news/one.html?news_id=2362 
  Professor Eberhard Grube presents the results of TAXUS 1- NIRx Coronary Stent Clinical Safety and Performance Study: Interim 6-month analysis.
  PowerPoint Presentation: http://www.radiationonline.com/ppt/Taxus1.ppt

TCTMD Slide Set

• Drug-Eluting Stent Symposium: Clinical Imperatives and Device Design Considerations, by M.B. Leon

• Effect of a Carbon Coating on Subacute Thrombosis and Restenosis: The ANTARES Study by A.Bartorelli

TCTMD - Euro-PCR Slide Sets

• Heparin Coated Stents, by M.B. Leon and R. Mehran

TCT 2001 Abstracts

TCT 2001 Expert Presentation Slides - First in Man Experience

• Paclitaxel-coated V-Flex Plus Coronary Stent for Treatment of Recurrent In-stent Restenosis
• Rapamycin Coated Stent for In-Stent Restenosis
• Rapamycin: 4 and 12 Month Data
• Rapamycin: IVUS Insights Into Patterns and Degree of Proliferation, and the Edge Effect
• Studies with Actinomycin-D: From ACTION to U.S. OPEN PIVOTAL Study
• Study of Anti-restenosis With the Biodivysio Dexamethasone Eluting Stent (STRIDE)
• TAXUS I - IV: Trial Designs, Goals and Enrollment Status
• Taxane Coated Stents for Recurrent In-Stent Restenosis
• Taxol - Preliminary Results of the ELUTES Study
• The RAVEL Trial
• The SIRIUS Trial and Rapamycin Registries: Design and Status

News
BIOCOMPATIBLES AND BRITISH BIOTECH BEGIN KEY STENT TRIALS
UK medical devices company Biocompatibles and British Biotech announced on Jan 2002 the start of a pivotal European trial to secure approval of their drug-coated stent for reducing restenosis after coronary angioplasty.
http://cardiology.medscape.com/46764.rhtml?srcmp=card-010402

Late acute thrombosis after paclitaxel eluting stent implantation
Liistro F, et al.
Heart 2001;86:262-4
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11514475 

Novel drug-delivery stent: intravascular ultrasound observations from the first human experience with the QP2-eluting polymer stent system
Honda Y, et al.
Circulation 2001;104:380-3
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11468196 

Initial results of the Quanam drug eluting stent (QuaDS-QP-2) Registry (BARDDS) in human subjects
de la Fuente LM, et al.
Catheter Cardiovasc Interv 2001;53:480-8
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11514998 

SCORE coated stent trial stopped early: company claims implications for other trials are limited
Boston Scientific inherited the SCORE trial of paclitaxel-eluting stents when it acquired Quanam Medical. Last month it stopped the trial due to major adverse cardiac events. Its own trials continue with a different stent and a different formulation of paclitaxel. [May 18 2001]

Pathological analysis of local delivery of paclitaxel via a polymer-coated stent
Farb A, et al.
Circulation 2001;104:473-9
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11468212 
Paclitaxel polymer-coated stents implanted in iliac arteries of New Zealand White rabbits reduce neointima formation but are associated with evidence of incomplete healing at 28 days. However, neointimal suppression was not maintained at 90 days.

Paclitaxel-coated stent: is there a light at the end of the tunnel?
Kipshidze N, et al.
J Am Coll Cardiol 2001;38:292-3
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11451292 

Lack of Neointimal Proliferation After Implantation of Sirolimus-Coated Stents in Human Coronary Arteries : A Quantitative Coronary Angiography and Three-Dimensional Intravascular Ultrasound Study
Sousa JE, et al.
Circulation 2001;103:192-195
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11208675 

Sirolimus-coated Stent Prevents Neointimal Proliferation
Abizaid A, et al.
Current interventional cardiology reports 2001;3:1-4
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=11177714 

Long-term clinical safety and efficacy of NIROYAL vs. NIR intracoronary stent
Harding SA, et al.
Catheter Cardiovasc Interv 2001;54:141-5
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11590672 

Increased risk of restenosis after placement of gold-coated stents
Gehman S.
Circulation 2001;104:E23
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11479268 

Biodegradable Polymeric Stents
Tsuji T || Uehata H
Current Interventioanl Cardiology Reports 2001;Vol 3 Issue 1 
http://www.current-reports.com/cr_contents.cfm?Volume=3&Issue=1&JournalID=IC 

Comparison of the heparin coated vs the uncoated Jostent((R)) - no influence on restenosis or clinical outcome
Wohrle J, et al.
Eur Heart J 2001;22:1808-16
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11549303 

Acute and mid-term results of phosphorylcholine-coated stents in primary coronary stenting for acute myocardial infarction
Galli M, et al.
Catheter Cardiovasc Interv 2001;53:182-7
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11387601 

Patients with high-risk ACS can benefit from silicon-coated stent in absence of GP IIb/IIIa antagonist
http://www.theheart.org/index.cfm?doc_id=25039 
Results from the TRUST study show that high-risk ACS patients may benefit from a silicon-coated stent to reduce MACE. Researchers suggest that in this modern stent era, costly GP IIb/IIIa inhibitors may no longer be necessary in all ACS patients. [Sept 3]

Efficacy of heparin-coated stent in early setting of acute myocardial infarction
Shin EK, et al.
Catheter Cardiovasc Interv 2001;52:306-12
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11246241 

Images in cardiology
Transcatheter closure of coronary artery to pulmonary artery fistula using covered stents
A S Mullasari, C V Umesan, and K Jagadeesh Kumar
Heart 2002;87 60
http://www.heartjnl.com/cgi/content/full/87/1/60-a 
Coronary fistulas most commonly originate from the right coronary artery and the majority are asymptomatic. The related problems that occur usually are myocardial ischaemia and angina (the result of a "coronary steal"), congestive heart failure, bacterial endocarditis, cardiac arrhythmia or rupture of an aneurysmal fistula. Current treatment options include surgical ligation and coil embolisation. Recently covered stents have been successfully employed for the closure of coronary fistulas.

TCT 2000 Meeting Coverage

• Thrombosis Prevented by Passive Stent Coatings
    by David Antoniucci MD Click here

TCT 2000 Expert Presentation Slides 

• The Sorin CARBOSTENT
    by Bartorelli A Click here

AHA 2000 Meeting Coverage

• Perfect Early Results with Drug-Eluting Stent
    by Popma J and Grube E Click here
• Biodegradable Stent Safe and Effective
    by Hidenori Komori Click here
• New Generation Interventional Approaches: Ringing Out the Old? 
    by Serruys P Click here

Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries
  Sousa JE
  Circulation 2000; 102: r54
  Click here for comment from TCTMD  
These early results indicate that the implantation of sirolimus-coated BX Velocity stents is feasible and safe. The cytostatic effects of sirolimus seem effective in the prevention of neointimal formation at 4 months after stent implantation in de novo lesions. Twelve-month angiographic and IVUS follow-up will be performed in all patients to assess whether this effect is sustained.

Increased risk of restenosis after placement of gold-coated stents: results of a randomized trial comparing gold-coated with uncoated steel stents in patients with coronary artery disease
  Kastrati A || Neumann FJ
  Circulation 2000;101:2478-83 
  http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=0010831521
Gold-coated Inflow stents were associated with a considerable higer angiographic restenosis over the first year after stenting compared with uncoated Inflow stents of identical design (49.7% vs 38.1%; P = 0.003)

Italian BiodivYsio open registry (BiodivYsio PC-coated stent): study of clinical outcomes of the implant of a PC-coated coronary stent [see Editorial]
  Galli M || Lanteri G
  J Invasive Cardiol 2000;12:452-8
  http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=0010973369
  Click here to see the slide
BiodivYsio stent implantation was safe in clinical situations with a high risk of complications (50% unstable angina and 13% acute myocardial infarction) confirming the hypothesis that PC may have non-thrombogenic properties

BiodivYsio stent - Multicenter evaluation of the phosphorylcholinecoated biodivYsio stent in short de novo coronary lesions: The SOPHOS study
  Boland JL || Kyriakides ZS
  International Journal of Cardiovascular Interventions 2000; 3(4) Page  215
Boland et al present a multicenter evaluation of the phosphorylcholine-coated stent. Stent coating for passivation of the vascular proliferative response is a major active research line in interventional cardiology today. In the next 10 years, the passive and active coating of stents will become one of the major research topics in our fast-moving field.

Late-Breaking Clinical Trial 
Distinct trial 
  Moses JW Presented at AHA 2000 Meeting
  Comment from http://www.theheart.org/index.cfm?doc_id=19458
Multicenter prospective trial comparing the BiodivYsio (Biocompatibles) PC-coated vs ACS Multilink Duet (Guidant) noncoated coronary stent. BiodivYsio stent is equivalent to the Multilink Duet stent. In addition, the hydrophilic polymer coating can release drugs at various controlled rates and  retard thrombus formation.

Stents covered by autologous venous grafts: feasibility and immediate and long-term results
  Stefanadis C || Toutouzas P
  Am Heart J 2000;139:437-45
  http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=0010689258
Stents covered by autologous venous grafts may be safely prepared without complications. This technique may prove to be a useful means, especially in patients with ACS

Intrapericardial paclitaxel delivery inhibits neointimal proliferation and promotes arterial enlargement after porcine coronary overstretch
  Hou D et al.
  Circulation 2000;102:1575-81
  http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=0011004150 
Catheter-based intrapericardial (IPC) space delivery of a single dose of paclitaxel significantly reduces vessel narrowing in this balloon-overstretch model. This effect is mediated by reduction of neointimal mass as well as positive vascular remodeling.

MENTOR trial - Heparin-coated Wiktor stents in human coronary arteries
  Vrolix MC || Brachman J for the MENTOR Trial Investigators
  Am J Cardiol 2000;86:385-9
  http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=0010946029
In this multicenter international trial performed from 1996 to 1997, were included 132 patients. The subacute thrombosis rate was 0.8%. At 6 months, event-free survival was 85% and angiographic restenosis rate was 22%.

Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans [see Editorial below]
  Tamai H || Uehata H
  Circulation 2000;102:399-404 
  http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=0010908211
  Figures & table
In this safety and feasibility trial, 25 PLLA Igaki-Tamai stents were implantated in 19 lesions of 15 patients. After 6 months, both angiographic restenosis and TLR rates were 10.5%.

Editorial 
Biodegradable stents : "fulfilling the mission and stepping away"
  Colombo A and Karvouni E
  Circulation 2000;102:371-3
  http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=0010908206
  Click here to view the full article
The biodegradable stent represents the first move toward a new concept of coronary stenting: "fulfill the mission (with possible local drug or gene delivery) and step away."