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(Circulation. 1999;100:236-242.)
© 1999 American Heart Association, Inc.
Clinical Investigation and Reports |
Primary Stenting Versus Balloon Angioplasty in Occluded Coronary Arteries
The Total Occlusion Study of Canada (TOSCA)
From Vancouver General Hospital, Vancouver, BC (C.E.B., R.S.F.); the University of Alberta, Edmonton (V.D., K.K.T.); St Paul's Hospital, Vancouver (R.G.C.); the University of British Columbia, Vancouver (G.B.J.M.); Hôpital Laval, Quebec City, Quebec (G.B.); The Toronto Hospital (C.L.), Toronto, Ont; Foothills Hospital, Calgary, Alta (T.J.A., M.L.K.); Ottawa Heart Institute (J.F.M.), Ottawa, Ont; Toyohashi National Hospital, Japan (T.S.); and Sunnybrook Health Sciences Centre, Toronto (E.A.C.)
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Abstract |
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 Top Abstract IntroductionMethodsResultsDiscussionAppendix 1Appendix 2References |
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Background—Balloon angioplasty (PTCA) of occluded coronary arteries is limited by high rates of restenosis and reocclusion. Although stenting improves results in anatomically simple occlusions, its effect on patency and clinical outcome in a broadly selected population with occluded coronary arteries is unknown.
Methods and Results—Eighteen centers randomized 410 patients with nonacute native coronary occlusions to PTCA or primary stenting with the heparin-coated Palmaz-Schatz stent. The primary end point, failure of sustained patency, was determined at 6-month angiography. Repeat target-vessel revascularization, adverse cardiovascular events, and angiographic restenosis (>50% diameter stenosis) constituted secondary end points. Sixty percent of patients had occlusions of >6 weeks' duration, baseline flow was TIMI grade 0 in 64%, and median treated segment length was 30.5 mm. With 95.6% angiographic follow-up, primary stenting resulted in a 44% reduction in failed patency (10.9% versus 19.5%, P=0.024) and a 45% reduction in clinically driven target-vessel revascularization at 6 months (15.4% versus 8.4%, P=0.03). The incidence of adverse cardiovascular events was similar for both strategies (PTCA, 23.6%; stent, 23.3%; P=NS). Stenting resulted in a larger mean 6-month minimum lumen dimension (1.48 versus 1.23 mm, P<0.01) and a reduced binary restenosis rate (55% versus 70%, P<0.01).
Conclusions—Primary stenting of broadly selected nonacute coronary occlusions is superior to PTCA alone, improving late patency and reducing restenosis and target-vessel revascularization.
Key Words: trials • stents • angioplasty • occlusion
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1Appendix 2References |
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Primary use of coronary stents to reduce restenosis after coronary angioplasty in simple lesions is well supported by major clinical trials.1 2 Use of stents in complex lesions, although now routine, has not been subjected to equal scrutiny.
Nonacute occlusions are complex not only from the occlusion itself but also from the frequent coexistence of extended length, contiguous diffuse disease, and thrombus. The late results of balloon angioplasty (PTCA) for coronary occlusions are poor.3 Their tendency to reocclude may prompt selection of surgical revascularization or medical therapy as initial treatment. Importantly, the failure of angioplasty to provide a high rate of sustained patency has hindered trials testing routine late recanalization of infarct-related arteries (the "open-artery" hypothesis).4
Although stenting of highly selected simple coronary occlusions can improve results, it is untested in larger, broadly selected cohorts.5 6 We report final angiographic and 6-month clinical outcomes from a controlled randomized trial testing the heparin-coated Palmaz-Schatz stent (Cordis, Johnson & Johnson) in a diverse spectrum of patients with nonacute coronary occlusions.
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Methods |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1Appendix 2References |
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Participating Centers and Sponsorship
The Total Occlusion Study of Canada (TOSCA) was a multicenter prospective randomized controlled trial of primary stenting in native coronary artery occlusions conducted at 18 centers in accordance with local institutional guidelines after review board approval (Appendix 1). Study design and rationale have been reported previously.7 The primary purpose was to determine whether routine stent placement improves late complete patency (TIMI flow grade 3) of recanalized coronary artery occlusions. The protocol was developed and implemented by the investigators and supported by a grant from Cordis, Johnson & Johnson.
Patient Selection
Patients 18 to 80 years old undergoing clinically indicated
coronary interventions were eligible provided that 1 target
segment met the study definition of occlusion: a high-grade native
coronary stenosis accompanied by TIMI grade 0 or 1
antegrade flow. The target segment was required to be able to
accommodate a balloon of 
3.0-mm diameter and to be suitable for stent
placement. Exclusion criteria were (1) <72 hours since onset of
ST-segment elevation, (2) extensive lesion-related thrombus (TIMI
thrombus grade 3 or 4, Appendix 2), (3) occlusions previously
revascularized by patent bypass grafts, (4) uncontrolled heart failure
or shock, (5) patient unwilling or unsuitable for protocol-required
6-month angiography, (6) patient of child-bearing potential, and (7)
inability to cross occlusion with guidewire. All patients provided
written informed consent.
Age of occlusion was determined by the interval from the last episode
of acute coronary syndrome or infarction consistent
with the location of the occlusion. Randomization, stratified by center
and age of occlusion (
6 weeks or >6 weeks/uncertain) occurred after
the occlusion was crossed with a guidewire but before initial dilation.
Patients undergoing attempted recanalization of
coronary occlusions but not enrolled were entered into a
previously reported registry.7
Clinical Care and Monitoring
Operators were instructed to optimize PTCA results using a
balloon of 3.0-mm nominal diameter and a balloon-to-artery ratio of
1. Prolonged inflations of 15 minutes' duration were required
before crossover to stent. However, because significant residual
stenosis and dissection frequently characterize initial PTCA
results in occlusions but seldom result in acute ischemic
events, crossover was recommended only if a 70% visual
stenosis or major dissection causing impaired flow or
ischemia (chest pain or ECG changes) was
present.7 8
The stent arm used the Carmeda process heparin-coated 15-mm-long PS-153
Palmaz-Schatz coronary stent premounted on a sheathed delivery
system.9 Complete coverage of the occluded segment and
adjacent lesion was required, using as many contiguous stents as
necessary. Stent expansion at 14 bar was recommended.
Treatment of lesions in major segments proximal or distal to the occlusion with >50% visual stenosis was required in both arms. Use of stents in noncontiguous lesions or other vessels was not determined by protocol. All patients received aspirin 325 mg/d beginning before the procedure. Ticlopidine administration was left to operator discretion.
Clinical events and ECGs were routinely recorded at 24 hours, hospital discharge, 1 month, and final angiography. Creatine kinase (CK) and CK-MB were obtained at baseline, 8 hours, and 18 to 24 hours after the procedure.
Angiographic Analysis
After intracoronary nitroglycerine, 2
orthogonal views were reproduced at baseline, after the initial
procedure, and at final 6-month angiography. Angiograms performed
before 6 months qualified as final if (1) failure of patency was
present, (2) the interval from enrollment to angiography was >16
weeks, or (3) the findings led to target-vessel bypass grafting.
Analysis of lumen dimensions and flow was performed independently in a dedicated core laboratory using the ImageCom system (Quinton). Target lesion work length, defined as the length of contiguous target segment exposed to balloon inflation, was measured by use of images recorded throughout the procedure.7 Minimum lumen diameter (MLD) was derived from analysis of the entire treated segment. With rigorously selected disease-free proximal-only reference segments used, restenosis was defined as >50% diameter stenosis at the point of MLD. Reference values were deemed unmeasurable in ostial and near-ostial occlusions.
End Points
Failure of sustained complete target-vessel patency at final
angiography, defined as TIMI flow <3 as determined by the Core
Angiographic Laboratory, was the primary end point. To prevent counting
of nonepicardial causes of reduced flow, an accompanying target-vessel
stenosis of >70% was also required. Target segment MLDs and
restenosis rates were secondary end points.
Clinical end points were (1) repeat target-vessel
revascularization (TVR, defined as any attempted
percutaneous or surgical
revascularization of the target vessel after the
initial procedure) and (2) a composite end point composed of any
revascularization (of any coronary vessel),
myocardial infarction (MI), or death. MI was defined as any CK-MB
elevation above local laboratory normal range and was classified
according to the magnitude of peak CK-MB elevation (5 times or >5
times normal). A 3-member committee adjudicated all events.
Data Analysis
All end-point analyses were performed on an
intention-to-treat basis. Prespecified subgroups included patients with
age of occlusion 6 weeks versus >6 weeks (or uncertain) and baseline
TIMI flow grade 0 versus 1. Discrete variables are provided as
counts and percentages and compared by 2-tailed Fisher's exact test.
Normally distributed continuous variables are expressed as
mean±SD, and abnormally distributed continuous variables as
medians with interquartile ranges.
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Results |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1Appendix 2References |
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From March 1996 through May 1997, 1118 patients were screened for inclusion.7 Of these, 380 (34%) did not meet eligibility criteria (including 101 excluded for inability to cross with a guidewire), 328 (29%) were eligible but not enrolled, and 410 were enrolled. Baseline characteristics of the treatment groups were well matched (Tables 1
and 2).
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Treatment Variables
Median target lesion work length was 30.5 mm (range, 20.9 to
43.7 mm) (Table 3). Crossover during
the initial procedure occurred in 20 patients (9.6%) assigned to PTCA
and 8 (4.0%) assigned to stent. On average, 2.0 contiguous target
lesion stents were deployed per stent-assigned patient. Both
operator-estimated reference vessel diameter and mean nominal balloon
size were similar in the 2 groups, although maximum inflation pressures
were higher in stent patients. Use of abciximab was infrequent (3%).
Apart from ticlopidine, which was administered more frequently to stent
patients (93% versus 57%, P<0.01), discharge medications
were similar.
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Clinical Outcome
By final angiography, TVR had occurred in 15.4% of patients
assigned to PTCA and 8.4% assigned to stent, a relative reduction of
45% (P=0.03, Figure 1, Tables 4 and 5).
TVR rates diverged early after the index procedures. No instances of
acute or subacute stent thrombosis were apparent. Composite adverse
cardiac event rates were similar (23.6% PTCA versus 23.3% stent,
P=NS). Although a trend toward reduced
revascularization of any vessel was seen in the
stent group, more MIs occurred in this group. The majority of
infarctions, however, were characterized by peak CK-MB elevations of
5 times normal, and none resulted in new Q waves. None of the 20
patients who experienced MI in the periprocedural period (4 PTCA, 16
stent) suffered recurrent MI or death during follow-up. No cardiac
deaths occurred.
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Patency and Quantitative Angiography
Angiographic follow-up was obtained in 392 patients (95.6%),
refused in 15 (6 PTCA, 9 stent), and not possible in 3 (1 PTCA, 2
stent). At final angiography, each reduced TIMI flow grade (0, 1, or 2)
was observed less frequently in the stent group than in the PTCA group
(Table 6). Therefore, failure to sustain
patency was present in 21 of 191 patients assigned to stent
(10.9%) versus 39 of 201 patients assigned to PTCA (19.5%), a 44%
relative reduction (Figure 2).
Although operator-estimated mean vessel size, target-segment location,
and final mean balloon size were very similar in PTCA and stent
patients, core laboratory–determined mean baseline proximal reference
diameters were 0.16 mm larger in stent patients. However, no
relationship between this variable and failed patency was
present on univariate or multivariate
logistic modeling.
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Initial postprocedural and final follow-up MLDs were significantly
larger in the stent group, despite greater late loss (Table 7, Figure 3). Angiographic restenosis
(>50% diameter stenosis) derived by use of proximal reference
segments was present in 55% of patients assigned to stent and 70%
assigned to PTCA (P<0.01).
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1Appendix 2References |
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Reocclusion after PTCA of symptomatic coronary occlusions is reported in 16% to 34% and restenosis in 45% to 72%.3 5 6 10 11 Results in asymptomatic patients from preliminary open-artery trials have been equally discouraging. In the Total Occlusion Post-MI Intervention Study (TOMIIS), for example, sustained patency was achieved in just 43% of the intervention arm.12
In the wake of nonrandomized reports,13 14 15 2 randomized
trials of stents in coronary occlusions with 100 patients
have been published. Both the Stents in Chronic Coronary
Occlusion (SICCO) and Gruppo Italiano di Studio sullo Stent nelle
Occlusioni Coronariche (GISSOC) trials evaluated stents in highly
selected populations excluding long lesions, other complex features,
and patients with recent infarction.5 6 Both demonstrated
that stents reduce restenosis (32% versus 72% and 32% versus
68%, respectively). GISSOC also demonstrated reduced reocclusion with
stents (8% versus 34%), although only stent patients received routine
warfarin therapy.
Enrollment criteria for TOSCA were much broader. Patients with long occlusions, occlusions contained within diffuse segments of disease, moderate lesion-related thrombus, recent infarction, and other complex features that might diminish the effectiveness of stents were not excluded. Unlike SICCO and GISSOC, randomization occurred immediately after the guidewire was advanced across the occlusion. Thus, operators were committed to enrollment and treatment assignment before initial dilation permitted detailed assessment of target segment length, distal vessel quality or dissection, or unrecognized thrombus.
The choice of failed patency as the primary end point was based on several considerations. First, because failed patency occurs less frequently than restenosis, only a study powered to detect improved patency would be adequately powered to examine both. Second, the significance of angiographic restenosis in vessels previously occluded is unclear, given the inevitability of previous downstream infarction, developed collaterals, or both. Third, because strong circumstantial evidence links patency (but not restenosis) to improved post-MI outcome, prospective trials testing the open-artery hypothesis await therapies proven to enhance sustained patency.4 16
Our primary end-point results are clear. Compared with PTCA, stenting of occluded coronary arteries results in a marked improvement in sustained patency. Primary end-point results in the 4 prespecified subgroups, although they demonstrate heterogeneity of the point estimate, are compatible with general benefit. CIs cross unity only in subgroups with <150 patients.
Stenting, however, did not eliminate patency failures. Nearly 11% of patients assigned to stenting demonstrated failed patency, and 8.3% (versus 13.5% of PTCA patients, P=0.15) developed complete reocclusion (TIMI 0 or 1 flow). New stent designs and periprocedural or long-term glycoprotein IIb/IIIa antagonists may have roles yet to be defined. Interestingly, patients assigned to PTCA had lower rates of failed patency than previously reported, despite inclusion of complex lesions, rigorous crossover rules, and low crossover rates.
Restenosis
Our convention of using disease-free proximal reference segments
as the sole denominator for all quantitative analyses was
driven by the inability to obtain distal reference segments in occluded
vessels. Given the natural taper of coronary arteries, this
approach would be expected to increase percent stenosis values
compared with analyses using interpolated references.
Nevertheless, we observed large values of absolute late loss in both
arms attributable to the additive effects of large initial gain,
extended lesion length, thrombus, and frequent use of multiple
stents.17 18 19 Furthermore, although PTCA
restenosis rates in TOSCA, SICCO, and GISSOC were remarkably
similar, we found less difference in stent and PTCA restenosis
rates in our complex population, despite the possible advantage
conveyed by slightly larger proximal reference segments in the stent
arm. As with patency, stents with greater length and improved
uniformity of radial support may prove particularly effective in this
challenging setting.17 20
Target-Vessel Revascularization
In contrast to previous studies, stenting reduced TVR before the
confounding effect of protocol-specified angiography.1 2 6
The immediate divergence of the curves is consistent with
previous observations that early reocclusion is
common.8
Overall, TVR was infrequent (11.9%), despite frequent angiographic restenosis. However, some stable patients may have had repeat revascularization deliberately delayed pending protocol angiography. Continued follow-up is therefore essential to determine the durability of our 6-month findings.
Adverse Cardiovascular Events
Although composite adverse cardiac event rates were similar in the
stent and PTCA groups, certain patterns emerged.
Revascularization procedures in any vessel tended
to be more frequent in the PTCA group. This trend, however, was driven
entirely by procedures involving the target segment (Table 5
).
As defined in the protocol, MI was more frequent in the stent group (11.9% versus 3.8%, P=0.01). We screened for periprocedural MI with routine sequential enzyme samples and used a very inclusive definition (any elevation of CK-MB, regardless of total CK). Most MIs were indeed periprocedural and small. The mechanisms for periprocedural infarction after coronary occlusion angioplasty are enigmatic. Early closure of the target lesion is probably not responsible; both early TVR and late failed patency were more common in the treatment group with fewer MIs. More likely, distal thromboembolism or obstruction of side branches arising near target occlusions accounts for this phenomenon. The significance of small periprocedural CK-MB elevations after stent placement is controversial.21 22 23 Regardless, recent data suggest that routine use of abciximab would have largely abolished group differences in rates of periprocedural infarction.24
Other Limitations
Although our angiographic follow-up rate was high, 4.4% of the
study population was not reevaluated angiographically. A conservative
remedy would be to impute the overall combined rate of failed patency
(15.3%) to all patients without final angiography. This approach does
not, however, materially affect our results (P=0.03).
As in other device trials, treatment assignment could not readily be blinded. Thus, a bias influencing subsequent patient management could have existed. The study design does not permit conclusions regarding the importance of the heparin coating of the investigational stents. Similarly, our study did not address occlusions that cannot be crossed with a guidewire, a difficulty encountered in 9% of patients screened for TOSCA.
Summary
We have demonstrated that primary stent placement improves late
patency and reduces restenosis in a broadly selected population
with occluded coronary arteries. Stenting resulted in a reduced
need for repeat TVR but no net difference in overall adverse cardiac
events. Although continued clinical follow-up is necessary, these data
support routine stenting when occluded coronary arteries are
reopened. In contrast to previous stent trials, TOSCA had few criteria
to exclude lesions perceived as unfavorable. These data, therefore,
provide new insights regarding the utility of stents in the treatment
of complex lesions frequently encountered in current practice.
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Acknowledgments |
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Funding was provided through an unrestricted grant from Cordis, Johnson & Johnson, Miami Lakes, Fla.
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Footnotes |
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Reprint requests to Christopher E. Buller, MD, FRCPC, FACC, 865 W 10th Ave, Vancouver, BC, Canada V5Z 1L7.
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Appendix 1 |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1Appendix 2References |
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Study chair: Dr Christopher Buller. Executive committee: Dr Christopher Buller, Dr Vladimir Dzavik (cochair), Dr Merrill Knudtson, Dr Jean-François Marquis. Coordinating center: Interventional Cardiology Research, Vancouver General Hospital, Rebecca Fox, MSc. Data center: EPICORE Center, University of Alberta: Dr Koon Teo, director; Paula Priest, data coordinator; Diane Catellier, PhD, biostatistician. Angiographic core laboratory: Dr G.B. John Mancini, director; Joseph Li, senior technician. Events committee: Dr Ronald Carere, chair; Dr Koon Teo; Dr Anoop Chauhan. Data Safety and Monitoring Committee: Ruth Milner, chair; Dr Christopher Granger; Dr Paul Armstrong.
Participating centers: Vancouver General Hospital: Dr Christopher Buller, Rebecca Fox. Toronto Hospital: Dr Charles Lazzam, Arlene Carter. Hôpital Laval, Ste-Foy: Dr Gerald Barbeau, Marie-Mai Lariviere. St Paul's Hospital, Vancouver: Dr Ronald Carere, Margot Wilson. Kokuryo Toyohashi Higashi Hospital, Japan: Dr Takahiko Suzuki, Dr Hiroaki Hosokawa. University of Alberta Hospital, Edmonton: Dr Vladimir Dzavik, Cheryl Kee. Foothills Hospital, Calgary: Dr Todd Anderson, Lana Shewchuk. Royal Columbian Hospital, New Westminster: Dr Robert I.G. Brown, Marjorie Colclough. Royal Alexandra Hospital, Edmonton: Dr Neil Brass, Donna Daniec. Green Lane Hospital, New Zealand: Dr James Stewart, Sarah Heath. Queen Elizabeth II Health Sciences Center, Halifax: Dr Lawrence Title, Kim Foshay. University of Ottawa Heart Institute, Ottawa: Dr Jean-François Marquis, Sharon Kearns. Sunnybrook Health Science Center, Toronto: Dr Eric Cohen, Lynn Balleza. Winnipeg Health Sciences Center: Dr John Ducas, Usha Schick. New Brunswick Heart Center, Saint John: Dr Robert MacDonald, Hallie Bass. London Health Sciences Center, London: Dr David Almond, Joanne White. Duke Medical Center, Durham, NC: Dr James Zidar, Steve Sawchak. Mayo Clinic, Rochester, Minn: Dr Peter Berger, Jeanette Ramaker.
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Appendix 2 |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1Appendix 2References |
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TIMI Thrombus Grades
Grade 0: No cineangiographic characteristics suggestive of thrombus.
Grade 1: Angiography demonstrates characteristics such as reduced contrast density, haziness, irregular lesion contour, or a smooth convex meniscus at the site of total occlusion suggestive but not diagnostic of thrombus.
Grade 2: Definite thrombus with greatest dimensions 1/2
vessel diameter.
Grade 3: Definite thrombus with greatest linear dimension >1/2 but <2 vessel diameters.
Grade 4: As in grade 3 but with largest dimension 2 vessel
diameters.
Received December 31, 1998; revision received April 19, 1999; accepted April 22, 1999.
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