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Stent - Remedica
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This web
site (and its accompanying journal) has been developed to provide a guide to
developments in the rapidly expanding field of coronary stenting. Contents:
up-to-date review articles on important topics by opinion leaders from around
the world. The Portfolio section comprising case reports accompanied by detailed
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TCT 2002 Abstracts
Indications for stenting Archive 1996-2001
Review
Coronary
artery stenting
Ashby DT, et al.
Catheter Cardiovasc Interv 2002;56:83-102.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=11979540
Comparison
of clinical outcomes using stents versus no stents after percutaneous coronary
intervention for proximal left anterior descending versus proximal right and
left circumflex coronary arteries
Ashby DT, et al.
Am J Cardiol 2002;89:1162-6.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=12008168
Patients with proximal LAD stenoses treated with non-stenting strategies have
lower procedural success than those treated with stenting strategies; the
patients with proximal LAD non-stent PCI have significantly higher rates of
clinical restenosis than patients with proximal right and circumflex stenoses.
Stenting
for coronary artery spasm
Khatri S, et al.
Catheter Cardiovasc Interv
2002;56:16-20.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=11979526
In the rare,
carefully selected patient, stents may represent an adjunct in the management of
focal coronary artery spasm, although currently medical therapy remains the
standard initial approach.
TCT 2002 Expert Presentations
TRENDS:
Large trial puts direct stenting on solid ground
with slides / A randomized 1000-patient trial has shown that direct
stenting and stenting with predilatation yield comparable angiographic and
clinical results. The direct approach, as proponents consistently say and
hospital accountants have hoped, also cuts procedure time and uses less contrast
agent.
TRENDS:
Tetra Randomized European Direct Stenting Study
Direct stenting yields similar clinical and angiographic outcomes compared
with predilatation, but also offers some advantages with respect to resource
utilization.
Clinical and angiographic outcome after
conventional angioplasty with optional stent implantation compared with direct
stenting without predilatation
Miketic S, et al.
Heart 2002;88:622-6
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12433894
Direct stent implantation without predilatation significantly reduced late
luminal loss, giving a better improvement in minimal luminal diameter and
restenosis rate than with optional stenting. The procedure may help to reduce
the cost of coronary interventions by reducing overall procedure and fluoroscopy
times, the amount of contrast medium used, and the number of angiography
catheters needed.
Editorial
Direct stenting: safe with advantages for
the patient and for the doctor (less fluoroscopy and procedural time)
Colombo A.
Eur Heart J 2002;23:592-5.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=11969271
A randomized comparison of direct stenting
versus stenting with predilatation in native coronary artery disease: results
from the multicentric crosscut study
Airoldi F, et al.
J Invasive Cardiol 2003;15:1-5
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12499519
Direct stenting is safe and feasible for
the treatment of lesions in native coronary arteries and obtains a significant
reduction in procedural cost, mainly due to the lower number of balloons used.
Clinical and angiographic results at 6 months are comparable to those obtained
after a conventional predilatation-stenting strategy
Direct stent implantation in acute coronary
syndrome
Atmaca Y, et al.
J Invasive Cardiol 2002;14:308-12.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=12042621
Direct stenting is a feasible and safe technique. It is equivalent to
single-vessel conventional stent implantation techniques with respect to MACE
rate in-hospital, at 1 month, and at 6 month follow-up in selected patients with
ACS.
Free full text
Myocardial injury after apparently successful
coronary stenting with or without balloon dilation: direct versus conventional
stenting
Timurkaynak T, et al.
J Invasive Cardiol 2002;14:167-70
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11923567
Cardiac enzymes (troponin T, CK and CKMB) were measured to determine which
stenting approach causes less vessel trauma.
Full
Text
Full text journal article Jun 2002
Acute Coronary Syndrome:
Direct Stent for All?
There should be unrestricted use of direct stenting in ACS, but enhancements
in stenting strategy are still necessary.
Full text journal article Sep 2002
Sidebranch Occlusion
After Coronary Stenting With or Without Balloon Predilation: Direct Versus
Conventional Stenting
Sidebranch occlusion (SBO) is a challenging problem during interventional
procedures.
Full text journal article Aug 2002
Effect of Direct Stent
Implantation on Minor Myocardial Injury
Minor myocardial injury occurs less frequently following direct stenting
compared to stenting plus predilatation.
Direct coronary stenting through left and
right internal mammary artery grafts
Bouki KP, et al.
J Invasive Cardiol 2002;14:417-9.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=12082197
This is the first reported case of successful direct stent implantation through
the LIMA and RIMA.
Insertion of Self-Expandable Nitinol Stents
Without Previous Balloon Angioplasty Reduces Restenosis Compared with PTA Prior
to Stenting
Harnek J, et al.
Cardiovasc Intervent Radiol 2002;25:3
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=12042993
Insertion of a self-expandable nitinol stent without previous PTA results in
less intimal hyperplasia than if PTA is performed prior to stenting, suggesting
that direct stenting can be used in angioplasty sessions with a favorable
outcome
A randomized comparison of direct stenting
with conventional stent implantation in selected patients with acute myocardial
infarction
Loubeyre C, et al.
J Am Coll Cardiol 2002;39:15-21.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=11755281
In selected patients with AMI, direct stenting can be applied safely and
effectively. This strategy may result in a significant reduction of
microvascular injury, as suggested by improved ST-segment resolution after
reperfusion with major potential clinical consequences.
Direct coronary stenting versus stenting
with balloon pre-dilation: immediate and follow-up results of a multicentre,
prospective, randomized study. The DISCO trial
Martinez-Elbal L, et al.
Eur Heart J 2002;23:633-40.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=11969278
Direct stenting is as safe as pre-dilated stenting in selected coronary lesions.
Acute angiographic results are similar but procedural costs, duration of the
procedure and radiation exposure are lower in direct stenting. Overall success
rate, mid-term clinical outcome and restenosis are similar with both techniques
Could direct stenting reduce no-reflow in
acute coronary syndromes? A randomized pilot study
Sabatier R, et al.
Am Heart J 2002;143:1027-32.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=12075259
http://www.mosby.com/scripts/om.dll/serve?action=searchDB&searchDBfor=art&artType=abs&id=a122509&target=
This randomized study confirms the promising results of previous studies that
show the feasibility and the safety of direct coronary stenting in highly
selected acute coronary syndrome-related lesions. The major impact of this
strategy is the improvement of the cost-benefit ratio, with no major influence
on the acute complications and especially on the occurrence of no-reflow in this
high-risk population.
Conventional Versus Direct Stenting in AMI:
Effect on Immediate Coronary Blood Flow
Timurkaynak T, et al.
J Invasive Cardiol 2002;14:372-7.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=12082189
Direct stenting strategy in thrombus containing lesions seems to be a safe and
feasible approach in avoiding no re-flow.
Stenting
vs. balloon angioplasty with provisional stenting for the treatment of vessels
with small reference diameter
Lemos
PA, et al.
Catheter Cardiovasc Interv
2002;55:309-14.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=11870933
Treatment of small vessels with balloon dilatation and provisional stenting or
with primary stenting yielded similar late outcomes. Operators' choice of
treatment strategy was based on particular angiographic characteristics.
A
stepwise strategy for the stent treatment of bifurcated coronary lesions
Pan M, et al.
Catheter Cardiovasc Interv
2002;55:50-7.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=11793495
Patients with coronary stenosis at major bifurcations may be treated following
an unitary stepwise approach. In the first step, balloon angioplasty of the side
branch followed by stenting of the parent vessel; in the second, balloon
redilation of the side-branch origin across the metallic structure of the stent;
in the third, stenting of the side-branch origin. Progression through each phase
was triggered by the failure of one procedure to achieve a <50% residual
stenosis at the side branch. This attitude may avoid side-branch stent
implantation in most patients, providing good immediate and long-term results.
A
randomized comparison of the value of additional stenting after optimal balloon
angioplasty for long coronary lesions: final results of the additional value of
NIR stents for treatment of long coronary lesions (ADVANCE) study
Serruys PW, et al.
J Am Coll Cardiol
2002;39:393-9.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=11823075
A strategy of provisional stenting for long coronary lesions led to bailout
stenting in one-third of patients, with a threefold increase in peri-procedural
infarction. Additional stenting yielded a lower angiographic restenosis rate,
but no reduction in MACE at nine months.
Stent design, Covered and coated stents
TCT 2002 Abstracts
TCT 2002 Expert
Presentations
Summer in Seattle 2002
| A Rush to Judgment on Drug Eluting Stents? | A. E. Raizner |
| Cardiology in the Drug Eluting Stent World | R. E. Kuntz |
| The Economic Impact of Drug Eluting Stents | D. J. Cohen |
ACC 2002 Meeting Coverage
| Stent Design Matters - Results from ISAR STEREO II | H. Schuhlen |
Strut
thickness, direct stenting and atherectomy featured in Atlanta late-breakers
Among the late-breaking sessions here today came confirmation that the
narrower a stent is, the lower the restenosis rate will be, as well as evidence
that direct stenting is feasible in the majority of patients. But atherectomy
guru Antonio Colombo was unable to show that this procedure was superior to
stenting alone. American College of Cardiology 51st Annual Scientific Session. [ Mar 17, 2002 ]
American
College of Cardiology 51st Annual Scientific Session
Read about the latest advances in stenting.
Full text journal article Oct
2002
Could
Stent Design Affect Platelet Activation? Results of the Platelet Activation in
STenting (PAST) STudy
The activation of platelets following coronary stent implantation has been
reported by measuring platelet aggregation and surface receptor expression in
circulating blood.
Early
and late clinical and angiographic outcomes following terumo coronary stent
implantation
Mak KH, et al.
J Invasive Cardiol 2002;14:239-42.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=11983943
The Terumo stent appears to be safe and effective in patients with unfavorable
clinical conditions and complex lesions.
Full text
Role
of the "dogbone" effect of balloon-expandable stents: quantitative
coronary analysis of DUET and NIR stent implantation introducing a novel
indexing system
Hehrlein C, et al.
J Invasive Cardiol 2002;14:59-65.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=11818639
The second-generation DUET and NIR stents and their respective delivery
systems show angiographically different acute performance characteristics.
Insufficient deployment of stents visualized by the "dogbone" effect
plays a role in the extent of residual stenosis after stenting. The introduced
angiographic indexes require further validation.
New
stent design for autologous venous graft-covered stent preparation: first human
application for sealing of a coronary aneurysm
Stefanadis C, et al.
Catheter Cardiovasc Interv 2002;55:222-7.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=11835652
Case report on the first clinical application of a new stent design for
autologous venous graft-covered stent preparation. This stent consists of a main
body, resembling the configuration of conventional stents, and two connecting
arms at the edges of the stent for the stabilization of the venous graft on the
external surface of the stent.
Stent
struts and articulations: their impact on balloon-expandable stents' hoop
strength, pushability, and radiopacity in an experimental setting
Wiskirchen J, et al.
Invest Radiol 2002;37:356-62.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=12021593
The ideal stent-having high hoop strength, a low profile, a good pushability,
and a good radiopacity-still does not exist. However, by changing strut design (from
rectangular to arch-like struts) and by inserting articulations, hoop strength
and pushability can be improved without reducing radiopacity.
Special Review
Coated stents for the prevention of
restenosis: Part I
Babapulle MN, et al.
Circulation 2002;106:2734-40
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12438301
Animal studies investigating coated stents have shown variable results. Stents
coated with diamond-like carbon have not shown an inhibitory effect on
restenosis. Although phosphorylcholine-coated stents do not seem to inhibit
neointimal hyperplasia, they are well tolerated in vivo and have drug-eluting
potential. Animal studies have also demonstrated encouraging results with
respect to the efficacy of stent-based drug delivery. Stents coated with heparin
do not appear to have a major effect on neointimal hyperplasia. Stents coated
with corticosteroids may have an effect on the inflammatory response, but do not
exhibit a significant antiproliferative effect. Stents eluting antimitotic
agents such as paclitaxel and sirolimus show the most promise, with significant
inhibitory effects on neointimal hyperplasia.
Special Review
Coated Stents for the Prevention of
Restenosis: Part II
Mohan N. Babapulle and Mark J. Eisenberg
Circulation 2002;106 2859-2866
http://circ.ahajournals.org/cgi/content/full/106/22/2859?etoc
In-stent restenosis is a common problem, affecting 20% to 40% of patients by
6 months after PCI, with neointimal hyperplasia being the primary cause. The
systemic administration of various pharmacological agents has had little effect
on the occurrence of restenosis. Stents coated with biocompatible materials,
anticoagulants, and corticosteroids have been examined in both animal and human
studies. These studies suggest that stents coated with these agents do not have
a significant inhibitory effect on neointimal hyperplasia. Stents eluting
antimitotic agents such as sirolimus and paclitaxel seem to be the most
beneficial in this regard. Results of observational studies in animals and
humans investigating these antimitotic agents are promising, with extremely low
rates of clinical events and restenosis over the short and mid-term. The
preliminary results of several clinical trials evaluating stents eluting these
agents in de novo lesions at a low risk for restenosis are also encouraging.
Small sample sizes and short follow-up periods remain important limitations of
these trials. If these preliminary results are borne out in larger trials with
extended follow-up periods, drug-eluting stents may resolve the long-standing
issue of post-PCI restenosis.
Note Added in Proof
After this article went into publication, preliminary results of SIRIUS and
TAXUS II were released at a AHA 2002 interventional cardiology conference. The
results are available at http://www.clinicaltrialresults.com
AHA 2002 Meeting Coverage
Longer-term
data on sirolimus and paclitaxel stents, plus newcomer to the stent: Estrogen
Longer-term data on several of the first sirolimus- and paclitaxel-eluting stent
trials were released in a special session here, as well as early data from the
TAXUS IV-SR trial and preliminary results on a new approach: estrogen-eluting
stents.
American Heart Association Scientific Sessions 2002. [ Nov 18, 2002 ]
Controversy:
Should We Use Drug-eluting Stents in All Patients and for All Lesions?
Patrick Serruys and Ron Waksman go head-to-head to debate the current status
and future of drug-eluting stents.
Italian
Controversie
in cardiologia: dobbiamo usare stent a rilascio di farmaci in tutti i pazienti e
in tutte le lesioni?
Luis Gruberg, MD
TCT 2002 Meeting Coverage
Drug-Eluting
Stent Euphoria: A Revolutionary Step or Misguided Euphoria?
A debate featuring Martin B. Leon and Renu Virmani on whether drug-eluting
stents mark a turning point in the practice of cardiology.
European
Approval of Drug-Eluting Stents: Implications for US Practice and What?s to Come
Penetration of drug-eluting stents in the European market and clinical
practice have been hindered by a number of obstacles. Will the US face the same?
SIRIUS
subgroup analyses: further insights
Subgroup analyses of the SIRIUS study show a "remarkable consistency"
of the effect of sirolimus-eluting stents seen in the overall study results, the
researchers say. More information is provided on cases of late incomplete
apposition, seen only with the sirolimus-eluting stents.
SIRIUS
final results show 3.2% in-stent, 8.9% in-segment restenosis rates with
sirolimus-eluting stents
with slides / Use of the drug-eluting stent reduced restenosis within
the stent by 91% and by 75% in the segment, in addition to cutting clinical
events in a population purposely "enriched" with those patients prone
to restenosis. The findings will change practice in the field, researchers say.
SIRIUS:
Clinical and Angiographic Outcomes
Overall and final 9-month results of the 1101-patient SIRIUS trial
demonstrate that a sirolimus-eluting stent yields superior benefit compared to a
bare metal stent.
SIRIUS:
IVUS Results and Subset Analysis
A number of subset analyses, including diabetic patients, LAD lesions, and
IVUS analysis from the SIRIUS trial, confirm the overwhelming clinical benefit
of sirolimus-eluting stents.
TAXUS
II: 6-month data show significant benefits of paclitaxel-eluting stents
with slides / A new study comparing bare stents with either slow- or
moderate-release paclitaxel stents shows the drug-eluting stents reduced
restenosis, as well as clinical end points, without any significant advantage of
one formulation over the other.
TAXUS
II: Slow- and Moderate-Release Formulations
Both the slow- and moderate-release formulations of a paclitaxel-eluting
stent show significant benefit in the reduction of in-stent net volume
obstruction, in-stent restenosis, TLR, and MACE at 6 months.
TCT 2002 Abstracts
TCT 2002 Expert Presentations
Sirolimus Drug-Eluting Stents
Taxol: Nonpolymer-Based Delivery
Beyond Rapamycin & Taxol
Coronary State of the Art
ESC 2002 Meeting Coverage
Drug-Eluting
Stents: Impact on Management of Coronary Artery Disease
Luis Gruberg, MD
Experts
Convene to Discuss the Latest on Drug-Eluting Stents
David Good
High
cost preventing extensive use of sirolimus stent in Europe
Interventional cardiologists in Europe would like to use the new
sirolimus-eluting stent in the majority of PCIs, but few are doing so because of
cost constraints. The new stent, the only drug-eluting stent so far available,
costs about €2300 compared with about €500 for a regular stent.
European
Society of Cardiology Congress 2002 [ Sep 10, 2002 ]
PCR 2002 Meeting Coverage
Updates
on TAXUS III and ELUTES paclitaxel-coated stent trials
With sirolimus threatening to steal the show yet again, results from two
paclitaxel-coated stent trials were also presented at the Paris Course on
Revascularization, providing longer-term data on both de novo and in-stent
lesions: TAXUS III and ELUTES. [ May 23, 2002 ]
Drug-coated
stents: A revolution-in-waiting?
To nobody's surprise, the much-prophesied transformation of cardiology
practice promised by drug-eluting stents dominated the opening of the Paris
Course on Revascularization, but not everyone was convinced that the revolution
was well on its way. [ May 22, 2002 ]
More
glowing reports on drug-eluting stents
Drug-eluting stents remained center stage at the Paris Course on
Revascularization, with further details emerging on the SIRIUS Trial and
in-stent restenosis pilot studies in São Paulo and Rotterdam. Researchers
involved in these trial also addressed concerns raised earlier in this meeting
about possible long-term injurious effects attributed to this new technology.
[ May 23, 2002 ]
ACC 2002 Meeting Coverage
| Promising Results With Tacrolimus - The PRESENT and EVIDENT Trials | E. Grube |
| The ELUTES Trial | B. R. Chevalier |
Long-term
sirolimus results dominate day 1, while preliminary tacrolimus data shows early
promise
The longest-term follow-up data available to date for drug-eluting stents in
de novo lesions were presented here today, while very preliminary data using a
tacrolimus-coated stent shows no MACE at 30 days. American College of
Cardiology 51st Annual Scientific Session.
[ Mar 17, 2002 ]
STRIDE
results show "promise" for dexamethasone-eluting stents: Abbott Labs
buys Biocompatibles' stent business
Results of STRIDE indicate that the Biocompatibles Inc
dexamethasone-eluting stent tested in the trial is a 'promising' means of
preventing restenosis in de novo lesions, although STRIDE's 13.3% restenosis
rate does not match other drug-eluting stent trials. The day after STRIDE was
presented, Abbott Labs announced it is buying Biocompatibles cardiovascular
stent business.
American College of Cardiology 51st Annual Scientific Session. [ Mar 29, 2002 ]
Six-month
follow-up in batimastat-eluting stent trial disappoints: BRILLIANT II enrollment
stopped
Less than 24 hours after the news that Guidant's ACTION stent trial
had been halted, the UK's Biocompatibles Inc (Farnham, UK) has announced
that enrollment in its BRILLIANT II trial evaluating the
batimastat-eluting BiodivYsio stent has been suspended.
[ Mar 08, 2002 ]
ACTION
trial of actinomycin-D eluting stents scrapped for "unacceptably high"
restenosis rates
Guidant's ACTION trial of an actinomycin-D coated stent has been halted
because of unacceptably high rates of restenosis in an early review of treated
patients. The company insists that it has other compounds in the pipeline should
its lead program with paclitaxel also disappoint.
[ Mar 07, 2002 ]
Zero
restenosis with paclitaxel-coated stent at nine months
Boston Scientific Corporation is reporting zero restenosis after nine months
of use of their paclitaxel-eluting stent. The positive result from the TAXUS
I clinical trial has prompted the company to submit an Investigational
Device Exemption application to the FDA so that it can conduct another clinical
trial this year.
[ Jan 17, 2002 ]
Summaries of important articles from major peer-reviewed journals
| Perspective: Sirolimus-Eluting Coronary Stents | G. Curfman | NEJM 2002; 346:1770-1771 |
| What Is "The Matter" With Restenosis in 2002? | J. M. Sousa | Circulation. 2002;105:2932 |
| Paclitaxel Derivate-Eluting Polymer Stent System Implantation for In-Stent Restenosis | f. liistro | Circulation 2002;105:1883 |
| RAVEL Trial Update | M. Morice | NEJM 2002;346:1773-1780. |
| IVUS Findings from the RAVEL Trial | P. W. Serruys | Circulation 2002;106:798-803 |
Sirolimus-Eluting Stent for the Treatment of
In-Stent Restenosis: A Quantitative Coronary Angiography and Three-Dimensional
Intravascular Ultrasound Study
J. Eduardo Sousa, et al
Circulation 2003;107 24-27
http://circ.ahajournals.org/cgi/content/abstract/107/1/24?etoc
Twenty-five patients with in-stent restenosis were successfully treated with
the implantation of 1 or 2 sirolimus-eluting Bx VELOCITY stents in São Paulo,
Brazil (1.4 stents per lesion). All vessels were patent at the time of 12-month
angiography. No patient had in-stent or stent margin restenosis at 4 months, and
only one patient developed in-stent restenosis at 1-year follow-up. There was no
evidence of stent malapposition either acutely or in the follow-up IVUS images,
and there were no deaths, stent thromboses, or repeat revascularizations.This
study demonstrates the safety and the potential utility of sirolimus-eluting Bx
VELOCITY stents for the treatment of in-stent restenosis.
TAXUS I: Six- and Twelve-Month Results From
a Randomized, Double-Blind Trial on a Slow-Release Paclitaxel-Eluting Stent for
De Novo Coronary Lesions
Eberhard Grube et al
Circulation 2003;107 38-42
http://circ.ahajournals.org/cgi/content/abstract/107/1/38?etoc
The TAXUS I trial was a prospective, double-blind, three-center study
randomizing 61 patients with de novo or restenotic lesions (12 mm) to receive a
TAXUS (n=31) versus control (n=30) stent (diameter 3.0 or 3.5 mm). No stent
thromboses were reported at 1, 6, 9, or 12 months. At 12 months, the MACE rate
was 3% (1 event) in the TAXUS group and 10% (4 events in 3 patients) in the
control group (P=NS). Six-month angiographic restenosis rates were 0% for TAXUS
versus 10% for control (P=NS) patients. No evidence of edge restenosis was seen
in either group. In this feasibility trial, the TAXUS slow-release stent was
well tolerated and showed promise for treatment of coronary lesions, with
significant reductions in angiographic and intravascular ultrasound measures of
restenosis.
One
of the first drug-eluting stent studies for in-stent restenosis disappoints at
12 months
Liistro F et al.
Circulation 2002; 105: published online before print April 1, 2002.
Don't get excited about drug-eluting stents until the 12-month results are
in, researchers say. Their promising 6-month results with one of the first
clinical studies of a paclitaxel derivative-eluting stent for in-stent
restenosis were not maintained at 12 months. The stent used in their study was
the ill-fated QuaDS-QP2 stent of the aborted SCORE trial.
Mechanism of late in-stent restenosis after
implantation of a paclitaxel derivate-eluting polymer stent system in humans
Virmani R, et al.
Circulation 2002;106:2649-51
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12438288
Restenotic lesions from QuaDS-QP2-eluting stents at 12 months show persistent
fibrin deposition with varying degrees of inflammation. These pathological
changes, representing delayed healing, are usually observed up to only 3 months
in human coronary arteries with stainless steel balloon-expandable stents. The
nonreabsorbable polymer alone may have induced chronic inflammation.
Six-month
QCA and 12-month MACE for RAVEL published in New England Journal of Medicine
with slide / Nine months after a European Society of Cardiology
audience stood to applaud the good news from the RAVEL study, results on this
first major randomized trial of a sirolimus-eluting stent have been published in
the New England Journal of Medicine.
Morice M-C et al. N Engl J Med 2002: 346:1773-80. [ Jun 05, 2002 ]
Editorial
Drug eluting coronary stents
Jenkins NP, et al.
Bmj 2002;325:1315-6
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12468460
A
randomized comparison of a sirolimus-eluting stent with a standard stent for
coronary revascularization
(RAVEL Study)
Morice MC, et al.
N Engl J Med
2002;346:1773-80.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=12050336
http://content.nejm.org/cgi/content/full/346/23/1773
http://content.nejm.org/cgi/content/abstract/346/23/1773
As compared with a standard coronary stent, a sirolimus-eluting stent shows
considerable promise for the prevention of neointimal proliferation, restenosis,
and associated clinical events.
Selected Abstracts Accepted for CRT 2003
New Onset Rest Angina: A Potential Short-Term Complication of
Sirolimus-Eluting Stent Implantation
by Dr. Nicoletta De Cesare
Images in Cardiovascular Medicine
True Three-Dimensional Reconstructed Images Showing Lumen Enlargement After
Sirolimus-Eluting Stent Implantation
Kengo Tanabe, et al
Circulation 2002;106 179-180
http://circ.ahajournals.org/cgi/content/full/106/22/e179?etoc
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.
Angiopeptin-eluting
stents: observations in human vessels and pig coronary arteries
Armstrong J, et al.
J Invasive Cardiol 2002;14:230-8.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=11983942
Delivery of angiopeptin from drug delivery PC-coated stents is safe, but
does not lead to a significant reduction in neointimal growth at 28 days within
the parameters of this study.
Full text
Outcome of Treatment of
Aorto-ostial Lesions Involving the Right Coronary Artery or a Saphenous Vein
Graft With a Polytetrafluoroethylene-Covered Stent
Toutouzas K, Stankovich G, Takagi T, et al.
Am J Cardiol 2002;90(1):63-66
http://www.medscape.com/viewarticle/440839_2
The present study shows once more that not all coronary artery lesions are
the same. The disappointing results obtained with the PTFE-covered stent add to
the long and frustrating list of devices that have failed to give a definitive
answer to aorto-ostial lesions.
TCT 2002 Meeting Coverage
| The RESCUT Trial | R. Albiero |
Meeting Coverage
RESCUT:
Restenosis Cutting Balloon Evaluation
Cutting balloon angioplasty yields similar rates of in-stent restenosis
compared with conventional PTCA; however, the procedure requires fewer devices
and is associated with a lower incidence of balloon slippage.
http://www.medscape.com/viewarticle/442507
Review
Cutting balloon angioplasty
Lee MS, et al.
J Invasive Cardiol 2002;14:552-6
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12205358
Studies thus far have shown that the cutting balloon is equivalent in safety and
efficacy to POBA in the overall PCI population, and may afford an advantage over
POBA in decreasing the incidence of restenosis and TLR in particular groups of
interventional patients, although this has yet to be proven
- Full Text
Impact of deep vessel wall injury on acute
response and remodeling of coronary artery segments after cutting balloon
angioplasty
Nakamura M, et al.
Am J Cardiol 2003;91:6-11
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12505563
Deep vessel wall injury tends to occur in lesions with relatively small size and
such lesions show favorable vessel response after cutting balloon angioplasty.
Mechanism of cutting balloon angioplasty for
in-stent restenosis: an intravascular ultrasound study
Montorsi P, et al.
Catheter Cardiovasc Interv 2002;56:166-73
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12112907
CB enlarges coronary lumen mainly by in-stent tissue reduction associated with a
moderate degree of additional stent expansion. Favorable QCA and IVUS acute
results are maintained at 24 hr.
Different types of coronary artery wall
injury following cutting balloon angioplasty
Montorsi P, Galli S, Fabbiocchi F,
Trabattoni D, Grancini L, Ravagnani P, Bartorelli AL
Ital Heart J 2002;3:676-681
Abstract
Full text PDF
This study showed that the coexistence of many, rather than a single, anatomical
and proceduralcharacteristics may increase the risk of vascular complications
following CB angioplasty. The lesion eccentricityis probably the most important
factor, followed by vessel calcification and a large balloon-to-artery ratio.IVUS
evaluation is superior to angiography in identifying both the type and mechanism
of complications after CB angioplasty. Interestingly, the appearance, at
angiography, of an overdilated vessel after CB angioplasty should raise
suspicion of an excessively deep cut of the device
Cutting balloon angioplasty for the prevention
of restenosis: results of the Cutting Balloon Global Randomized Trial
Mauri L, et al.
Am J Cardiol 2002;90:1079-83
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12423707
This multicenter, randomized trial compared the incidence of restenosis after CB
angioplasty versus conventional balloon angioplasty in 1,238 patients. The
primary end point, the 6-month binary angiographic restenosis rate, was 31.4%
for CB and 30.4% for PTCA (p = 0.75). Five coronary perforations occurred in the
CB arm only (0.8% vs 0%, p = 0.03). The proposed mechanism of controlled
dilatation did not reduce the rate of angiographic restenosis for the CB
compared with conventional balloon angioplasty. CB angioplasty should be
reserved for difficult lesions in which controlled dilatation is believed to
provide a better acute result compared with balloon angioplasty alone.
Intravascular
ultrasonic comparisons of mechanisms of vasodilatation of cutting balloon
angioplasty versus conventional balloon angioplasty
Hara H, et al.
Am J Cardiol 2002;89:1253-6.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=12031723
The findings of this study suggest that the predominant mechanism of
dilatation after CBA is plaque compression or shift rather than vessel expansion,
unlike conventional angioplasty.
Comparison
of volumetric intravascular ultrasound analysis of acute results and underlying
mechanisms from cutting balloon and conventional balloon angioplasty for the
treatment of coronary in-stent restenotic lesions
Schiele TM, et al.
Am J Cardiol 2002;90:539-42.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=12208420
Combined
cutting balloon angioplasty and intracoronary beta radiation for treatment of
in-stent restenosis: Clinical outcomes and effect of pullback radiation for long
lesions
Moustapha A, et al.
Catheter Cardiovasc Interv 2002;57:325-9.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=12410508
A combination of CB angioplasty and intracoronay beta radiation for ISR seems to
yield low rates of subsequent target vessel revascularization and adverse
cardiac events.
Coronary
stent strut avulsion in aorto-ostial in-stent restenosis: potential complication
after cutting balloon angioplasty
Wang HJ, et al.
Catheter Cardiovasc Interv 2002;56:215-9.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=12112916
Case report of stent strut avulsion by the cutting balloon during the withdrawal
of the deflated balloon catheter in aorto-ostial in- stent restenosis, which was
managed successfully by another stent. The proposed mechanisms and
recommendations to avoid this rare complication are provided.
"Cutting
Balloon and the Three Burrs": treatment for ostial left anterior descending
artery in-stent restenosis
Osula S, et al.
J Invasive Cardiol 2002;14:93-5.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=11818646
Ostial in-stent restenosis of the LAD was treated with rotational atherectomy
and a cutting balloon PTCA. Combining two useful technologies for treating
in-stent restenosis may prove to yield better results than using either
technique alone.
Case Report
Extensive right coronary artery
dissection following cutting balloon treatment of in-stent restenosis
Niccoli G, et al.
J Invasive Cardiol 2002;14:209-11
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11923578
- Full text
Case Report
Extraction of previously deployed
stent by an entrapped cutting balloon due to the blade fracture
Kawamura A, et al.
Catheter Cardiovasc Interv 2002;57:239-43.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=12357529
During treatment for in-stent restenosis, entrapment of cutting balloon occurred
because of the blade fracture. Removal of the balloon caused stent extraction,
inducing acute occlusion of the coronary artery. Application of cutting balloon
for in-stent restenosis requires every caution against such type of
complications.
Effectiveness
of cutting balloon angioplasty for small vessels less than 3.0 mm in diameter
Muramatsu T, et al.
J Interv Cardiol 2002;15:281-6
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12238423
A group of 166 patients (175 lesions) were treated with CBA (CBA group), and 215
patients (240 lesions) were treated with plain old balloon angioplasty (POBA
group). The restenosis rate was 37.5% in CBA group versus 48.1% in the POBA
group; in vessels < 2.75 mm, restenosis was significantly lower in the CBA
group than in the POBA group (36.9% vs 62.7%, P < 0.05). CBA may be a useful
therapeutic strategy for small vessels, given the absence of severe coronary
dissection and the significantly lower rate of restenosis compared to POBA.
Reduction
of early elastic recoil by cutting balloon angioplasty as compared to
conventional balloon angioplasty
Kawaguchi K, et al.
J Invasive Cardiol 2002;14:515-9
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12205350
There is significantly less early elastic recoil in the cutting balloon
angioplasty than in the conventional balloon angioplasty group. The efficacy of
cutting balloon continues 24 hours after angioplasty.
Cutting
balloon angioplasty through stent struts of a jailed sidebranch ostial lesion
Hongo RH, et al.
J Invasive Cardiol 2002;14:558-60
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12205359
The treatment of sidebranch ostial lesions jailed after stent implantation is
challenging. This paper reports a case of successful Cutting Balloon angioplasty
through stent struts of a severe, elastic sidebranch ostial lesion. Cutting
Balloon angioplasty may be an optimal strategy for the treatment of elastic
ostial lesions in smaller vessels that are suboptimal for stenting.
Cutting
and stenting in a heavily calcified left anterior descending artery lesion
Meerkin D, et al.
J Invasive Cardiol 2002;14:547-51
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12205357
The significance of heavily calcified proximal left anterior descending coronary
artery stenosis in a 57-year-old man was assessed physiologically using a
Doppler flow wire. Intravascular ultrasound guidance allowed for adequate
dilatation with a cutting balloon and optimization of stent deployment. The
cutting balloon offers an effective alternative in this challenging scenario.
Cutting
balloon angioplasty for underexpanded stent deployed through struts of
previously implanted stent
Balan O, et al.
J Invasive Cardiol 2002;14:697-701.
http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&dopt=r&uid=12403903
Report of a case in which stenting through the struts of a previously deployed
stent resulted in stent underexpansion despite 25 atm inflation pressure. Four
months later, follow-up angiography demonstrated in-stent restenosis. It was
successfully expanded with a Cutting Balloon.
Rotablator
versus cutting balloon for the treatment of long in-stent restenoses
Braun P, et al.
J Invasive Cardiol 2002;14:291-6
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12042616
The study data indicate that treating diffuse ISR with the CB results in an
acceptable long-term outcome and a low complication rate, results which make
this method appear superior to RA