(Circulation. 1996;93:1803-1808.)
© 1996 American Heart Association, Inc.
Articles |
Utilization of the Coronary Balloon-Expandable Coil Stent Without Anticoagulation or Intravascular Ultrasound
From the Division of Cardiovascular Diseases, University of Alabama at Birmingham.
Correspondence to Gary S. Roubin, MD, PhD, Division of Cardiovascular Diseases, University of Alabama at Birmingham, 1808 7th Ave S, 383 BDB, Birmingham, AL 35294.
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Abstract |
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Background The balloon-expandable coil stent has been proved effective in the management of acute and threatened closure after coronary balloon angioplasty and has been shown to reduce restenosis in patients with suboptimal results after coronary balloon angioplasty. Coronary artery stenting has been limited by the occurrence of stent thrombosis and comorbidity related to anticoagulation. This study was undertaken to determine whether anticoagulation may be removed from poststenting protocols, thus reducing comorbidity without increasing stent thrombosis.
Methods and Results Between September 1994 and May 1995, 369 patients received balloon-expandable coil stents in native coronary arteries at our institution. Of these patients, 216 were selected for a protocol of aspirin and ticlopidine (for 1 month) without anticoagulation. Eligibility for this protocol followed satisfaction of certain procedural and angiographic criteria. These criteria included adequate coverage of intimal dissections, absence of residual filling defects, and normal (TIMI grade 3) flow in the stented vessel after high-pressure balloon inflations. Intravascular ultrasound was not used to guide stent deployment. The stenting procedure was planned in 37% of patients and unplanned in 63% of patients, including 25 (12%) for acute or threatened closure. During the 30-day follow-up period, stent thrombosis occurred in 2 patients (0.9%), there was 1 death (0.5%), and 2 patients (0.9%) underwent coronary bypass surgery. Vascular access-site complications occurred in 4 patients (1.9%), and bleeding that required blood transfusion occurred in 4 patients (1.9%).
Conclusions Patients who receive the coronary balloon-expandable coil stent with optimal angiographic results without intravascular ultrasound guidance can be managed safely with a combination of aspirin and ticlopidine without anticoagulation.
Key Words: stents • angioplasty • angiography • balloon
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Introduction |
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The coronary balloon-expandable coil stent has proved effective in the management of acute or threatened closure complicating percutaneous coronary balloon angioplasty (PTCA).1 2 Recently,3 this device was shown to reduce late restenosis in patients who had suboptimal angiographic results after PTCA. Although long-term anticoagulation was not used during initial clinical work with this stent design, prolonged intravenous heparin administration and anticoagulation with warfarin were adopted as reports of subacute thrombosis emerged from other investigators.4 5 6 During the last 8 years of experience with coronary stents, a variety of extensive anticoagulation regimens have been used. Patients have required prolonged hospitalization while they received intravenous heparin and were stabilized on warfarin therapy. In addition to the increased cost of prolonged hospitalization, extensive anticoagulation has been associated with a substantial incidence of hemorrhagic and vascular access-site complications.1 2
The first reports of extensive coronary stent use without anticoagulation after intravascular ultrasound–guided stent deployment appeared in 1994.7 8 Using intravascular ultrasound, Colombo et al7 8 demonstrated that intracoronary stents were frequently suboptimally deployed and that high-pressure inflations with noncompliant balloons were required to optimize stent deployment. Subsequently, poststenting anticoagulation was successfully omitted in this group of patients. Other investigators9 10 who adopted this strategy of poststenting high-pressure balloon dilation reported similar results using both slotted, tubular stents and coil stents with a combination of aspirin and ticlopidine, without intravascular ultrasound guidance. These studies demonstrated that coronary stents can be placed without the use of anticoagulants and raised questions about the necessity of intravascular ultrasound–guided stent deployment. The present study reports our prospective observational experience using the balloon-expandable coil stent in native coronary arteries guided by angiography alone without subsequent anticoagulation.
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Methods |
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Study Patients
From September 1994 through May 1995, 1207 patients underwent PTCA at the University of Alabama at Birmingham. Balloon-expandable coil stents (Cook, Inc) were successfully implanted in the native coronary arteries of 369 patients for various indications, including acute or threatened closure1 2 and elective use3 for suboptimal results after PTCA. Of these patients, 216 were selected for a new drug regimen of antiplatelet therapy without anticoagulation. These patients were selected on the basis of the satisfaction of certain procedural and angiographic criteria. These criteria included adequate coverage of intimal dissections, normal (TIMI grade 3) flow, and absence of residual filling defects in the stented vessel after high-pressure balloon inflations. Some patients were excluded from this new regimen because concurrent medical conditions necessitated chronic anticoagulation (ie, atrial fibrillation or history of thromboembolism). The remaining patients received either the standard poststent anticoagulation therapy1 or anticoagulation with subcutaneous heparin for a period of 14 days. Early in the study, only patients who received single stents as an elective treatment with good angiographic results were selected for this protocol. As experience with this regimen increased, patients who received multiple stents, those who were undergoing multiple-vessel stenting, and those with stenting of infarct-related arteries and stenting after reconstitution of chronic total occlusions were included. During the second half of the study period, 79% of stented patients were selected for this protocol. The proportion of patients who received anticoagulation versus antiplatelet agents during the study period is shown in Fig 1
and represents increasing confidence by the
investigators in the new regimen.
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Antiplatelet Protocol
All patients received soluble aspirin 325 mg and ticlopidine 250
mg before the angioplasty procedure. When patients were admitted the
day before the procedure, they received at least two doses of each of
these medications. Patients admitted on the day of the procedure (n=92)
received a single dose of each of these drugs. During the procedure,
heparin was administered by intra-arterial injection
and the dose was adjusted to achieve an activated clotting time
between 250 and 350 seconds. Dextran 40 solution was administered in 92
patients. This preparation was removed from the protocol in February
1995, and the last 124 patients in the series received no dextran. All
patients received intravenous nitroglycerin
during the procedure. Generally, heparin was not administered after the
procedure. Sheaths were removed the same day with compression applied
with a mechanical device. Patients (n=23) who had their procedure
performed late in the day were maintained on intravenous
heparin at approximately 1000 U/h overnight, and sheaths were removed
early the next morning. Early in the study, 34 patients (16%) received
intravenous heparin for a period of 24 to 48 hours after
the procedure. No patient received warfarin. Aspirin 325 mg twice daily
and ticlopidine 250 mg twice daily were administered during
hospitalization and continued for 4 weeks. White blood cell counts were
performed after 2 weeks of therapy with ticlopidine. After 4 weeks,
patients were managed with aspirin alone.
PTCA and Stenting Procedure
Coronary angioplasty was performed by use of
conventional techniques with 8F (ID, 0.086 in) guide catheters via the
femoral approach. Coronary lesions were dilated by use of
balloon catheters equivalent to the target-vessel size. When a
decision was made to proceed with coronary artery stenting,
vessel sizing was performed by use of on-line quantitative
coronary angiography or visual estimation, and stent size was
selected for a stent-to-artery ratio of 1.1:1 to 1.2:1
according to current recommendations.11 Stents were
deployed by use of stent balloon-inflation pressures of 4 to 6 atm.
After initial deployment, high-pressure balloon inflations were
then performed in all patients within the stent by use of a
noncompliant balloon equivalent in size to the nominal size of the
stent. Adequacy of stent placement was assessed angiographically. The
result was considered inadequate if dissection flaps were not
completely covered by stent struts, if residual filling defects were
present within the stented segment, or if flow was less than TIMI
grade 3 in the stented vessel. In these cases, additional
high-pressure balloon inflations were performed and/or additional
stents were deployed. If optimal results were not achieved, the patient
was treated with anticoagulation. Intravascular ultrasound was not used
in any patient to ascertain adequacy of stent deployment. Patients were
allowed to mobilize 10 to 12 hours after removal of the
arterial sheath. If they remained stable, they were
generally discharged from the hospital 2 days after the procedure.
Definitions
In-hospital stent thrombosis was defined as angiographic
TIMI grade 0 to 1 flow in the stented vessel or myocardial infarction
with the development of new Q waves on the ECG. Non–Q-wave myocardial
infarction was defined as creatine kinase (CK) elevation more than
twice 250 IU/L with a positive CK-MB isoenzyme. Out-of-hospital
stent thrombosis was defined as any unexplained sudden death or
myocardial infarction within the 30-day period after the procedure or
readmission to the hospital with symptoms and ECG or laboratory
evidence of myocardial infarction in the distribution of the stented
vessel. Vascular access-site complications were categorized as
pseudoaneurysm, arteriovenous fistula, or hematoma
requiring blood transfusion. Pseudoaneurysm was clinically
identified as an expansile groin mass and was confirmed by an
ultrasound examination. Major bleeding was defined as that which
required a blood transfusion.
Data Collection
All demographic, clinical, and technical data were collected
prospectively on standard forms and entered into a computerized
database. Subsequently, all hospital charts were audited for accuracy
and completeness of the database information. All patients were
contacted by telephone at least 30 days after hospital discharge. This
follow-up information was also entered on standard forms for
analysis. Follow-up information was 99% complete. ECGs
were recorded immediately after the procedure, then daily before
discharge. CK levels were measured immediately after the procedure and
twice thereafter at 8-hour intervals. If the patient had recurrent
symptoms after the procedure, additional ECGs and CK estimations were
performed. Quantitative angiographic measurements were performed by use
of electronic calipers. Data are expressed as mean±1 SD.
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Results |
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Study Patients
The study group consisted of 158 men and 58 women. The mean age was 61±11 years (range, 32 to 92 years); 50 (23%) of the patients were older than 70 years. Forty-two (19%) of the patients had undergone previous bypass surgery, and 73 (34%) of them had undergone previous PTCA. Sixty-nine (32%) of the patients had single-vessel disease, 90 (42%) had two-vessel disease, and 57 (26%) had three-vessel disease. Other demographic data are shown in Table 1
. The indication for PTCA was stable angina in
26% of patients, unstable angina in 48%, ischemia after
myocardial infarction in 14%, and other indications in 12%.
Coronary artery stenting was performed as a planned procedure
in 80 (37%) of the patients and was unplanned in 136 (63%). Of the
planned stenting procedures, 46 (58%) were de novo lesions, 24 (30%)
were restenotic lesions, and 10 (12%) were ostial lesions.
The unplanned stenting procedures were performed for suboptimal results
in 111 (82%) of the patients, threatened closure in 22 (16%), and
acute closure in 3 (2%) (Fig 2).
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Lesion and Stent Characteristics
There were a total of 346 balloon-expandable coil stents
implanted in 240 vessels. Thirteen patients had additional single,
slotted, tubular stents implanted during the same procedure. One
hundred twenty (56%) of the patients received a single stent, 68
(31%) received two stents, and 28 (13%) received three or more
stents. Twenty-four (11%) of the patients underwent
double-vessel stenting. The mean number of stents per vessel was
1.5±0.7 (range, 1 to 4), and the mean number of stents per patient was
1.6±0.9 (range, 1 to 6). The left anterior descending coronary
artery was stented in 38% of patients, the right coronary
artery in 39%, and the left circumflex coronary artery in
30%. One patient underwent stenting of a protected left main
coronary artery. Two patients had concurrent balloon
angioplasty and stenting of vein grafts. Nineteen patients (9%) had
stents deployed after reconstitution of chronic total occlusions.
Thirty patients (14%) with recent myocardial infarction (<10 days
before the procedure) underwent stenting of the infarct-related
artery. Twenty-five patients (12%) had conventional balloon
angioplasty performed of one or more additional vessels during the same
procedure.
Quantitative Data
Average reference-vessel diameter was 2.97±0.52 mm. Of the
240 vessels stented, 38 (16%) were 2.0 to 2.5 mm in diameter, 98
(41%) were 2.5 to 3.0 mm, 67 (28%) were 3.0 to 3.5 mm, 28 (12%) were
3.5 to 4.0 mm, and 9 (4%) were 4.0 to 4.5 mm (Table 2).
Minimal luminal diameter before PTCA was 0.69±0.44 mm, and the
percentage diameter stenosis was 77±14%. Lesion length was
12.9±8.4 mm. Final minimal luminal diameter after stenting was
2.99±0.56 mm, with a final percent stenosis of 5±12%.
Average nominal stent size was 3.44±0.4 mm. Of the 359 stents
deployed, 5 (1%) were 2.5 mm in diameter, 125 (35%) were 3.0 mm, 138
(38%) were 3.5 mm, and 91 (25%) were 4.0 mm. Final balloon size was
equivalent to nominal stent size in 91% of stents, 0.5 mm larger in
8%, and 0.5 mm smaller in 1%. The mean final balloon-inflation
pressure was 15.3±2.1 atm (range, 12 to 22 atm). The nominal stent
size–to–vessel diameter ratio was 1.17±0.17 (Table 3).
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Clinical Outcome and Ischemic Complications
During the 30-day follow-up period, stent thrombosis occurred
in 2 (0.9%) of the patients, and there was 1 death (0.5%). Of the 2
patients with stent thrombosis, one underwent salvage PTCA for acute
myocardial infarction after failed thrombolytic
therapy, and the dilated segment was stented because of threatened
closure. This patient underwent urgent bypass grafting on day 5 for
subacute thrombosis. The other patient developed severe bleeding
from the large bowel and hypotension 14 days after stenting that
required cessation of antiplatelet agents and subsequently a
colectomy. The patient died suddenly with ventricular
fibrillation in the postoperative period and was found at postmortem to
have stent thrombosis. There were no Q-wave myocardial infarctions.
Non–Q-wave myocardial infarction occurred in 8 patients (3.7%) and
was associated with side-branch occlusion in 7. In 1 patient,
non–Q-wave myocardial infarction was attributed to embolization during
concurrent PTCA of a vein graft. Repeat angiography was performed on
only 19 patients (9%) during the follow-up period; in all cases,
stent patency and TIMI grade 3 flow were demonstrated. One patient who
underwent repeat angiography because of recurrent ischemic
chest pain was found to have a suboptimal angiographic result, with
tissue prolapse between the stent struts. A decision was made to send
this patient for bypass surgery in view of multiple previous
interventions and multivessel coronary disease. The average
hospital stay from procedure to hospital discharge was 2.5±1.5
days (range, 1 to 10 days); 48 (22%) patients were discharged
from the hospital the day after the procedure.
Hemorrhagic and Vascular Access-Site Complications
Pseudoaneurysm of the cannulated femoral artery
occurred in two patients. Both patients were in the early phase of the
study and had received postprocedural heparin infusions. One
pseudoaneurysm was closed by mechanical compression; the
other required surgical closure. One patient developed transient
femoral neuropathy related to groin compression with a
mechanical device. Bleeding that required blood transfusion occurred in
four (1.9%) of the patients.
Adverse Drug Reactions
During the 30-day follow-up period, five (2%) of the patients
had adverse reactions attributed to ticlopidine, which required its
cessation. Two patients developed gastrointestinal upset, one developed
a decrease in hematocrit attributed to gastrointestinal blood loss, and
two developed a rash. Neutropenia was not documented in any patient
during the follow-up period.
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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The present study demonstrates that patients who receive the balloon-expandable coil stent with optimal angiographic results without intravascular ultrasound guidance may be managed safely with a combination of the antiplatelet agents aspirin and ticlopidine without anticoagulation. Outcomes observed in the present study were stent thrombosis (0.9%), vascular access-site complications (1.9%), and major bleeding (1.9%). This protocol simplifies patient management after stenting and reduces the morbidity, length, and cost of hospitalization.
Comparison With Other Studies
Studies that incorporated standard anticoagulation regimens after
coronary stenting for acute or threatened closure reported
stent thrombosis rates of 8%1 2 to 16%.12
Other adverse outcomes reported were myocardial infarction in
6%2 to 20%, urgent coronary bypass surgery in
4%1 2 to 13%,12 and death in
2%1 2 to 4%.12 Adverse event rates were
lower in studies that incorporated standard anticoagulation in patients
undergoing elective coronary artery stenting, with stent
thrombosis rates of 3% to 4%, myocardial infarction in 5% to 6%,
and coronary bypass surgery in 2% to 3%.13 14
Standard anticoagulation regimens were associated with vascular
access-site complications in 6% to 16%1 6 15 and
bleeding that necessitated blood transfusion in 5% to
20%.1 2 15 The current study, which incorporated both
"bailout" and elective stenting, compares favorably with respect
to the incidence of stent thrombosis and vascular access-site and
bleeding complications.
Recently, Colombo et al8 reported the results of 338
patients who received slotted, tubular stents without postprocedural
anticoagulation. The incidence of stent thrombosis was 0.9%. That
study differed from the present study in that the majority of
patients had intravascular ultrasound–guided stent deployment,
whereas in the present study, stent deployment was guided by
angiography alone. In addition, the present study had an increased
number of patients with bailout as the indication for stenting (12%
versus 5%), stenting of an infarct-related artery (14% versus
1%), and stenting after reconstitution of a chronic total occlusion
(9% versus 5%). Multiple stents were deployed in 44% of patients in
the present study, and 57% of vessels stented were 
3.0 mm in
diameter. Despite the unfavorable profile of the present study
population,16 the incidences of stent thrombosis,
myocardial infarction, and coronary artery bypass surgery were
comparable to the study reported by Colombo et al.8 These
favorable results were achieved with careful selection of stent size
relative to reference-artery size (ratio of 1.1:1 to 1.2:1) and
with supplementary high-pressure balloon inflations after stent
deployment. Meticulous care was taken to cover all intimal dissections.
Patients were excluded from the present study if there was reduced
flow, residual dissection, or filling defects within the stented
vessel.
Role of Intravascular Ultrasound
The role of intravascular ultrasound–guided stent deployment
and selection of patients for poststenting protocols without
anticoagulation remains uncertain. Optimal stent deployment guided by
intravascular ultrasound has been defined as achieving a
cross-sectional area within the stent equal to or greater than the
cross-sectional area of the distal reference lumen. In addition,
ultrasound should demonstrate symmetrical stent expansion with good
apposition of the stent wires against the vessel wall and no
significant residual luminal narrowing. This has been postulated to be
the critical element in the reduction of stent thrombosis and the
removal of anticoagulation from poststenting protocols.8
Although a low incidence of stent thrombosis was reported in a study
that used ultrasound guidance,8 a comparable outcome has
been achieved in studies in which angiography was used to guide stent
deployment.9 10 17 Complete stent expansion can be
confirmed more accurately with intravascular ultrasound than with
angiography.18 19 20 Likewise, the full extent of intimal
dissections and their subsequent management may be better defined with
intravascular ultrasound than with angiography.21
Nonetheless, in the present study with routine use of
high-pressure balloon inflations within the coil stent, absence of
ultrasound guidance does not appear to have adversely affected early
clinical outcomes. Routine use of intravascular ultrasound increases
procedural time and cost and on occasion has been reported to cause
complications.8 18 19 Given the excellent outcomes
achieved with angiography-guided stent deployment and no
postprocedural anticoagulation, it would appear that the coil stent can
be deployed safely and effectively without intravascular ultrasound
guidance. It currently is not known whether angiographically guided
stent deployment will have similar late outcomes and
restenosis rates compared with intravascular
ultrasound–guided stent deployment.
Role of Ticlopidine
Although ticlopidine was used in the present study, its value
as an adjunct to aspirin after coronary artery stenting is
unproved. Ticlopidine has been demonstrated to reduce ischemic
outcomes in patients after thromboembolic stroke compared with
placebo.22 One study23 demonstrated reduced
acute closure after coronary angioplasty in patients who
received ticlopidine compared with placebo. However, another
study24 demonstrated equivalent efficacy between
ticlopidine and aspirin for this indication. Others8 have
reported equivalent poststenting outcomes in patients who received
aspirin compared with patients who received the combination of aspirin
and ticlopidine. The role of ticlopidine after coronary artery
stenting needs to be defined further.
Study Limitations
This study was a nonrandomized, prospective, observational study,
and the criteria for patient selection changed during the period of the
study. Initially, only elective patients who were having single stents
deployed were selected. As physician confidence with the regimen
increased, the selection criteria broadened to include patients who
were receiving multiple stents, patients undergoing multivessel
stenting, and patients who presented with acute
ischemic syndromes or who required bailout stenting. Although
not all stented patients were eligible for the study, this series
does represent a consecutive series of patients assigned to
this new regimen. The relative importance of the factors responsible
for the results achieved, that is, the use of ticlopidine, disuse of
warfarin and dipyridamole, or use of high-pressure
inflations with noncompliant balloons, cannot be determined from the
present study. Physicians involved in the present study
represented a group of experienced operators who perform
large numbers of stenting procedures.
Conclusions
This observational study indicates that patients who receive the
balloon-expandable coil stent in native coronary arteries
can be managed safely with a combination of aspirin and ticlopidine
without anticoagulation provided that certain procedural and
angiographic criteria are satisfied. These criteria include adequate
coverage of intimal dissections, absence of residual filling defects,
and TIMI grade 3 flow in the stented vessel after high-pressure
balloon inflations. Intravascular ultrasound–guided stent
deployment was not used in achieving these results.
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Acknowledgments |
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We wish to thank Anne Cameron, RN, Cynthia Sutor, RN, MPH, and Phyllis Slaughter for their assistance with data management and patient follow-up.
Received July 31, 1995; revision received November 16, 1995; accepted November 21, 1995.
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