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TITLE:TITLE:TITLE:TITLE: Percutaneous Coronary InterventionPercutaneous Coronary InterventionPercutaneous Coronary InterventionPercutaneous Coronary Intervention as an Alternative as an Alternative as an Alternative as an Alternative
to Coronary Artery Bypass Graftingto Coronary Artery Bypass Graftingto Coronary Artery Bypass Graftingto Coronary Artery Bypass Grafting in Patients with in Patients with in Patients with in Patients with
Diabetes MellitusDiabetes MellitusDiabetes MellitusDiabetes Mellitus and Multiand Multiand Multiand Multi----vessel Disease vessel Disease vessel Disease vessel Disease
AUTHOR:AUTHOR:AUTHOR:AUTHOR: Judith Walsh, MD,Judith Walsh, MD,Judith Walsh, MD,Judith Walsh, MD, MPHMPHMPHMPH
Professor of MedicineProfessor of MedicineProfessor of MedicineProfessor of Medicine
Division of General Internal MedicineDivision of General Internal MedicineDivision of General Internal MedicineDivision of General Internal Medicine
Department of MedicineDepartment of MedicineDepartment of MedicineDepartment of Medicine
University of California San FranciscoUniversity of California San FranciscoUniversity of California San FranciscoUniversity of California San Francisco
PUBLISHER:PUBLISHER:PUBLISHER:PUBLISHER: California Technology Assessment ForumCalifornia Technology Assessment ForumCalifornia Technology Assessment ForumCalifornia Technology Assessment Forum
DATE OF DATE OF DATE OF DATE OF
PUBLICATION:PUBLICATION:PUBLICATION:PUBLICATION: March March March March 6666, 2013, 2013, 2013, 2013
PLACE OF PLACE OF PLACE OF PLACE OF
PUBLICATION:PUBLICATION:PUBLICATION:PUBLICATION: San Francisco, CASan Francisco, CASan Francisco, CASan Francisco, CA
PERCUTANEOUS CORONARPERCUTANEOUS CORONARPERCUTANEOUS CORONARPERCUTANEOUS CORONARY INTERVENTION AS ANY INTERVENTION AS ANY INTERVENTION AS ANY INTERVENTION AS AN ALTERNATIVE TO CORONALTERNATIVE TO CORONALTERNATIVE TO CORONALTERNATIVE TO CORONARY ARY ARY ARY
ARTERY BYPASS GRAFTIARTERY BYPASS GRAFTIARTERY BYPASS GRAFTIARTERY BYPASS GRAFTING IN PATIENTS WITH NG IN PATIENTS WITH NG IN PATIENTS WITH NG IN PATIENTS WITH DIABETES MELLITUS ANDIABETES MELLITUS ANDIABETES MELLITUS ANDIABETES MELLITUS AND MULTID MULTID MULTID MULTI----
VESSEL DISEASEVESSEL DISEASEVESSEL DISEASEVESSEL DISEASE
A Technology Assessment
IntroductionIntroductionIntroductionIntroduction
The California Technology Assessment Forum is requested to review the
scientific evidence for the use of percutaneous coronary intervention as an
alternative to coronary artery bypass grafting in patients with diabetes mellitus.
This topic is being addressed because of recent publication of the Future
Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal
Management of Multi-Vessel Disease (FREEDOM) trial. This is the first time that
CTAF has addressed this topic.
BackgroundBackgroundBackgroundBackground
Coronary heart disease (CHD) is the number one cause of death in both men
and women in the U.S. Untreated CHD typically leads to progressive angina,
myocardial infarction, left ventricular (LV) dysfunction and congestive heart failure
(CHF) and sudden death. The goals of therapy in CHD are alleviation of anginal
symptoms, to delay or prevent progression of CHD and to prevent myocardial
infarction (MI) or death.
CHD treatment typically starts with medical therapy, including aggressive risk
factor reduction. Therapy includes aspirin, reaching treatment goals for
hypertension and hyperlipidemia, smoking cessation, and for diabetics, control of
serum glucose.
Coronary heart disease is a significant contributor to morbidity and mortality
in patients with diabetes mellitus. CHD is more common in diabetics than in non-
diabetics, and it is more likely to be multi-vessel. Diabetics are more likely to have
silent ischemia compared to patients without diabetes. In addition, diabetics with
CHD have lower survival rates than patients with CHD who do not have diabetes.
Diabetic and non-diabetic patients with multi-vessel coronary artery disease
are often considered for revascularization. In the U.S., approximately 700,000
patients undergo revascularization each year.1,2 The two main indications for
revascularization are 1) unacceptable angina and 2) where a survival benefit might
be expected from revascularization.
RevascularizationRevascularizationRevascularizationRevascularization: Coronary Artery Bypass Graft: Coronary Artery Bypass Graft: Coronary Artery Bypass Graft: Coronary Artery Bypass Grafting ing ing ing
The first revascularization treatment developed and used was coronary
artery bypass grafting (CABG). CABG relieves symptoms and improves survival
compared with medical management in some patients with stable angina. The
Coronary Artery Surgery Study (CASS) which was done in the late 1970s and early
1980s showed that more patients remained symptom free after CABG than with
medical therapy at one year (66% vs 30%) and at five years (63% vs 38%).3
Although for many patients with coronary artery disease (CAD) who undergo
CABG, there is no mortality benefit,4-7 certain subgroups do have a mortality benefit
from CABG. Patients who have a mortality benefit from CABG compared with
medical therapy include those with left main disease or left main equivalent disease,
three vessel coronary disease especially in the presence of reduced ejection fraction
(EF) and two vessel disease when there is a <75% stenosis in the left anterior
descending artery (LAD) proximal to the first septal artery.6,8-11
The 2011 Recommendations of the American College of Cardiology
Foundation/American Heart Association ACCF/AHA on CABG recommend a strong
preference for CABG in the following groups of patients:
• Unprotected left main coronary artery stenosis (≥50%);
• Significant (>70% stenosis) three vessel disease with or without proximal LAD
disease;
• Two vessel disease with proximal LAD disease (>75% stenosis in the LAD
proximal to the first major septal artery); and
• Patients with one or more significant coronary artery stenosis amenable to
revascularization and disabling angina while on maximal medical therapy12
A weak recommendation for CABG is made for the following groups:
• Two vessel disease without significant proximal LAD disease but with
extensive ischemia;
• Significant proximal LAD disease and evidence of extensive ischemia if a left
internal mammary artery bypass graft can be placed; and
• Mild to moderate left ventricular systolic dysfunction (EF: 35 - 50%) and
significant multi-vessel CAD or proximal LAD stenosis when viable
myocardium is present in the region of intended revascularization.12
Revascularization recommendations for patients with diabetes are essentially
the same as for those patients who do not have diabetes. However the short term
and long term results with either PCI or CABG are typically worse in diabetics than
in nondiabetics.13
Revascularization: Percutaneous Coronary InterventionsRevascularization: Percutaneous Coronary InterventionsRevascularization: Percutaneous Coronary InterventionsRevascularization: Percutaneous Coronary Interventions
Percutaneous coronary interventions (PCIs) are therapeutic procedures
where a balloon or catheter is inserted into a coronary artery. PCIs are non-surgical
treatments and are potentially less invasive options for the treatment of CAD when
compared with CABG. PCI is typically preferred to CABG for single vessel disease,
but its role in more severe forms of CAD has been less clear.
Initial PCI procedures included balloon angioplasty where a balloon was
used to open up the stenotic artery. Although balloon angioplasty was the initial
type of PCI, high rates of restenosis led to adding a stent after the artery was
opened. The initial stents that were used were bare metal stents (BMS), but BMS
were still associated with a significant restenosis risk.
The current standard for PCI is angioplasty with the addition of a drug
eluting stent (DES). DES have been shown to reduce the rate of restenosis
compared with BMS. They inhibit neointimal hyperplasia, a response that may be
stimulated by BMS. DES include a standard metallic stent, which has a polymer
coating and an anti-restenotic drug. The drug is mixed within the polymer and is
released over a period of days for up to a year after the procedure. There are
currently four types of approved DES. They include sirolimus-eluting, paclitaxel-
eluting, zotarolimus-eluting and everolimus-stents. Sirolimus is a macrocyclic triene
antibiotic with immunosuppressive and anti-proliferative properties They were
developed to prevent the proliferation of smooth muscle cells. Paclitaxel interferes
with microtubule function that are responsible for chromosome segregation during
cell division. They also prevent smooth muscle proliferation. Everolimus is a
sirolimus derivate as is zotarolimus. DES have similar safety profiles when
compared with BMS. In terms of efficacy, DES are preferred given that they
significantly lower the rate of target lesion revascularization when compared with
BMS.
Currently the standard of care when performing PCI is to use a DES rather
than a BMS in most patients given the evidence for increased efficacy with DES.
When comparing CABG to PCI, many of the earlier studies compared CABG to
balloon angioplasty or BMS, whereas the more recent studies compare CABG to
DES.
RevascularRevascularRevascularRevascularization in Diabeticsization in Diabeticsization in Diabeticsization in Diabetics
Among patients undergoing revascularization, approximately 25-30% have
diabetes. The indications for revascularization are similar in diabetics and non-
diabetics, although the outcomes in patients with diabetes are typically worse.
Most of the studies in diabetics comparing PCI with CABG have been
subgroup analyses of larger studies. Given that diabetics have worse short and
long term outcomes with any revascularization, it is important to compare the
efficacy of CABG with the efficacy of PCI specifically in diabetic populations. The
goal of this assessment is to evaluate PCI as an alternative to CABG in diabetics with
multi-vessel CAD.
TECHNOLOGY ASSESSMENT (TA)TECHNOLOGY ASSESSMENT (TA)TECHNOLOGY ASSESSMENT (TA)TECHNOLOGY ASSESSMENT (TA)
TA Criterion 1:TA Criterion 1:TA Criterion 1:TA Criterion 1: The technology must have final approval from the The technology must have final approval from the The technology must have final approval from the The technology must have final approval from the appropriate appropriate appropriate appropriate
government regulatory bodies.government regulatory bodies.government regulatory bodies.government regulatory bodies.
The U.S. Food and Drug Administration (FDA) defines a coronary stent as a
device made of a metal scaffold placed via a delivery catheter during PCI into the
coronary artery or saphenous vein graft to widen or maintain the opening of the
narrowed coronary vessels. Coronary artery stents are classified as Class III devices
and approved only via the pre-market approval (PMA) process. Manufacturers with
FDA approved coronary artery stents and systems include Cordis Corporation, - a
subsidiary of Johnson & Johnson, Co., Abbot Vascular, Boston Scientific
Corporation, Medtronic, and Medinol, Ltd.
TA Criterion 1 is met.
TA Criterion 2:TA Criterion 2:TA Criterion 2:TA Criterion 2: The scientific evidence must permit conclusions concerning The scientific evidence must permit conclusions concerning The scientific evidence must permit conclusions concerning The scientific evidence must permit conclusions concerning
the effectiveness of ththe effectiveness of ththe effectiveness of ththe effectiveness of the technology regarding health e technology regarding health e technology regarding health e technology regarding health
outcomes.outcomes.outcomes.outcomes.
The Medline database, Cochrane clinical trials database, Cochrane reviews
database and Database of Abstracts of Reviews of Effects (DARE) were searched
using the search terms coronary artery bypass, CABG, percutaneous coronary
intervention, PCI stents and coronary artery disease, and diabetes mellitus or
diabetes. The search was performed for the period from database inception
through December, 2012. The bibliographies of systematic reviews and key articles
were manually searched for additional references and references were requested
form the device manufacturer. The abstracts of citations were reviewed for
relevance and all potentially relevant articles were reviewed in full.
Inclusion criteria were:
• Study had to evaluate PCI and CABG in patients with diabetes and multi-
vessel disease;
• Study had to measure clinical outcomes;
• Included only humans; and
• Published in English as a peer reviewed article
Studies were excluded if they only focused on non-clinical outcomes.
A total of 373 potentially relevant articles were identified. These 373
abstracts were evaluated and 331 were excluded. Reasons for exclusion included
not addressing the study question, not reporting clinical outcomes, not comparing
PCI to CABG. After evaluation of the remaining 42 abstracts, exclusion of duplicate
publications and review of articles, a total of fourteen published clinical trials are
included in this evaluation.
Details of the clinical trials are described in Table 1. There were five trials
comparing CABG to balloon angioplasty.14-18 These five trials included a total of 640
diabetic patients. In all these studies, diabetics were a subgroup of the total
number of patients. An additional five studies compared BMS with CABG.19-23
These studies included a total of 684 diabetic patients who were again a subgroup
of all patients. Four trials compared DES with CABG.22,24-32 These studies included
3,021 patients, 1,900 of whom came from one study, the FREEDOM trial.27,32 In two
of the studies, diabetics were a subgroup of the total number of patients
included.22,26,29-31 Two of the studies included only diabetics.27,28,32
Study outcomes included mortality, non-fatal MI, Q wave MI, CVA and rates
of revascularization. Composite endpoints were frequently used. Typical
composite endpoints included MACCE (major cardiovascular and cerebrovascular
events) defined as death, CVA, MI and repeat revascularization, and MACE (major
cardiovascular events) defined as death, MI and repeat revascularization. Other
included outcomes were angina class at one year and freedom from angina
pectoris at one year.
Level of Evidence: 1,2
TA Criterion 2 is met.
Table 1: Description of Studies of PCI vs CABG in Patients with DiabetesTable 1: Description of Studies of PCI vs CABG in Patients with DiabetesTable 1: Description of Studies of PCI vs CABG in Patients with DiabetesTable 1: Description of Studies of PCI vs CABG in Patients with Diabetes MellitusMellitusMellitusMellitus
NameNameNameName of of of of
studystudystudystudy
Diabetics are a Diabetics are a Diabetics are a Diabetics are a
subgroup?subgroup?subgroup?subgroup?
NNNN
DDDDiabeticsiabeticsiabeticsiabetics
Inclusion CriteriaInclusion CriteriaInclusion CriteriaInclusion Criteria InterventionInterventionInterventionIntervention Main OutcomesMain OutcomesMain OutcomesMain Outcomes
Balloon Angioplasty vs CABGBalloon Angioplasty vs CABGBalloon Angioplasty vs CABGBalloon Angioplasty vs CABG
BARI18
Yes 353 Multi-vessel CAD and
candidates for PTCA or
CABG
Balloon angioplasty
vs CABG
All cause mortality
New MI
CABRI17
Yes 124 Multi-vessel CAD and
eligible for revascularization
PTCA vs CABG Mortality and angina class at one
year
EAST14 Yes 90 Multi-vessel CAD who could
undergo either procedure
PTCA vs CABG Composite: death, Q wave MI or
major ischemic thallium defect at
three year follow-up
GABI15
Yes 41 Symptomatic multi-vessel
disease
PTCA vs CABG Freedom from angina pectoris at
one year
RITA-116 Yes 62 Single or multi-vessel
disease and
revascularization
appropriate
PTCA vs CABG Death or non-fatal MI
Bare Metal Stenting vs CABG Bare Metal Stenting vs CABG Bare Metal Stenting vs CABG Bare Metal Stenting vs CABG
ARTS-I22 Yes 208 Multi-vessel CAD including
LAD and at least one other
lesion in another major
epicardial artery
BMS vs CABG Composite: MACCE -death, CVA, MI
and repeat revascularization
AWESOME20 Yes 144 Medically refractory
unstable angina and at high
risk for CABG
BMS vs CABG 30 day, six month and 36 month
survival
SOS23 Yes 142 Revascularization clinically PCI (any Mortality
NameNameNameName of of of of
studystudystudystudy
Diabetics are a Diabetics are a Diabetics are a Diabetics are a
subgroup?subgroup?subgroup?subgroup?
NNNN
DDDDiabeticsiabeticsiabeticsiabetics
Inclusion CriteriaInclusion CriteriaInclusion CriteriaInclusion Criteria InterventionInterventionInterventionIntervention Main OutcomesMain OutcomesMain OutcomesMain Outcomes
indicated and appropriate
by either strategy
commercially
available BMS) vs
CABG
Rate of repeat revascularization
ERACI II19
Yes 78 Multi-vessel CHD and
clinical indication for
revascularization
PCI with stent
placement vs CABG
Freedom from major adverse
cardiovascular events (MACE) at 30
days, one year, three years and five
years
MASS II21 Yes 115 Multi-vessel CAD and
eligible for each strategy
PCI with stent vs
CABG
Composite: Mortality, Q wave MI,
and refractory angina requiring
revascularization
Drug eluting stents vs CABGDrug eluting stents vs CABGDrug eluting stents vs CABGDrug eluting stents vs CABG
ARTS-II22,24,25
Yes 159 Multi-vessel CAD including
LAD and at least one other
lesion in another major
epicardial artery
Sirolimus eluting
stent single arm
compare with
historical controls
Composite: MACCE -death, CVA, MI
and repeat revascularization
CARDia28
No 510 Diabetic patients with multi-
vessel or complex single
vessel CAD
PCI plus stenting
(69% sirolimus and
31% BMS) vs CABG
Composite: all cause mortality, MI
and stroke
SYNTAX26,29-31
Yes:
prespecified
452 Left main and or three
vessel disease
TAXUS express DES
(paclitaxel) vs
CABG
Composite: all cause mortality, CVA,
MI or repeat revascularization
FREEDOM27,32
No 1,900 Multi-vessel coronary
disease suitable for either
PCI or CABG
Drug eluting stent
(sirolimus or
paclitaxel)
Composite: all cause mortality, non-
fatal MI and non-fatal stroke
ARTS-I: Arterial Revascularization Study I
AWESOME: Angina With Extremely Serious Operative Mortality Evaluation
BARI: Bypass Angioplasty Revascularization Investigation
CABG: Coronary Artery Bypass Graft
CABRI: Coronary Angioplasty versus Bypass Revascularization
CAD: Coronary Artery Disease
CARDia: Coronary Artery Revascularization in Diabetes
CHD: Coronary Heart Disease
EAST: Emory Angioplasty vs Surgery Trial
ERACI II: Argentine Randomized Study-Coronary Angioplasty with Stenting Versus Coronary Bypass Surgery in Multi-
Vessel Disease
FREEDOM: Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multi-Vessel
Disease
GABI: German Angioplasty Bypass Surgery Investigation
MACCE: Major Adverse Cardiac and Cerebrovascular Events
MACE: Major Adverse Cardiac Events
MASS II: Medicine, Angioplasty or Surgery Study
MI: Myocardial Infarction
PCI: Percutaneous Coronary Intervention
PTCA: Percutaneous Transluminal Coronary Angioplasty
RITA-1: Randomized Intervention Treatment of Angina
SOS: Surgery or Stent Study
SYNTAX: Synergy between PCI with Taxus and Cardiac Surgery
Table 2: Outcomes of Studies of PCI vs CABG in Patients with Diabetes MellitusTable 2: Outcomes of Studies of PCI vs CABG in Patients with Diabetes MellitusTable 2: Outcomes of Studies of PCI vs CABG in Patients with Diabetes MellitusTable 2: Outcomes of Studies of PCI vs CABG in Patients with Diabetes Mellitus
NameNameNameName Length of Length of Length of Length of
followfollowfollowfollow----upupupup
ResultsResultsResultsResults CommentsCommentsCommentsComments
Balloon Balloon Balloon Balloon AAAAngioplasty vs CABGngioplasty vs CABGngioplasty vs CABGngioplasty vs CABG
BARI18
5.4 years Five year survival 80.6% for CABG and 65.5% for PTCA
(p=0.003)
CABRI One year Overall mortality at one year follow-up similar in both groups
(2.7% CABG and 3.9% PTCA: NS)
Diabetics not analyzed separately
EAST Three years Overall composite: 27.3% CABG vs 28.8% PTCA; NS
Diabetics not analyzed separately
GABI Overall freedom from angina: 74% CABG vs 71% PTCA; NS Diabetics not analyzed separately
RITA-1 6.5 years Primary outcome: 5/29 PTCA vs 12/33 CABG: p=.055
Bare Bare Bare Bare MMMMetal etal etal etal SSSStententententttting vs CABG ing vs CABG ing vs CABG ing vs CABG
ARTS-I Five years MACCE higher in patients with BMS compared with CABG
(53.8% vs 23.4%:
p= 0.001)
AWESOME20 Three years
(36
months)
Survival at 36 months: 72% CABG vs 81% PCI: NS
SOS23 Six year 17.6% of PCI patients died vs 5.4% in CABG group (HR 3.53:
95% C.I. 1.14 to 10.95)
No difference in treatment effect
between diabetic and non-diabetic
subgroups
ERACI-II Five years PCI mortality 10% vs CABG mortality 10.2%: NS)
MASS-II Five years Overall composite: 21.2% in CABG group vs 32.7% in PCI
(p=0.0026)
Diabetics not analyzed separately
Drug Drug Drug Drug EEEEluting luting luting luting SSSStents vs CABGtents vs CABGtents vs CABGtents vs CABG
NameNameNameName Length of Length of Length of Length of
followfollowfollowfollow----upupupup
ResultsResultsResultsResults CommentsCommentsCommentsComments
ARTS-II24,25
Onuma, 2010;
Five years MACCE lower in CABG than DES (23.4% vs 40.5%: p<0.001) Comparison with historical control
CARDia28
One year No difference in composite outcome (death/MI/stroke) 10.5%
CABG vs 13.0% PCI (HR 1.25: 95% C.I. 0.75,2.09: p=0.39)
Secondary outcome: death, MI stroke or revascularization
11.3% CABG vs 19.3% PCI (HR 1.77:95% C.I. 1.11-2.82: p=0.02)
When subgroup that received DES
(69%) compared with CABG, still
no difference
SYNTAX26,29-31
Three years No difference in composite safety endpoint at one
year(death/stroke/MI) between two groups
(10.3% CABG vs 10.1% DES; p=0.96)
Repeat revascularization rates higher with DES (20.3% vs
6.4%;p<0.0010
At three years, composite endpoint 22.9% CABG vs 27.0%
DES: p=0.002
FREEDOM32
3.8 years Composite outcome at five years more common in PCI
group: 26.6% in PCI and 18.7% in CABG: p=0.005
Stroke rate at five years more common in CABG group (5.2%
vs 2.4%: p=0.030)
ARTS-I: Arterial Revascularization Study I
AWESOME: Angina With Extremely Serious Operative Mortality Evaluation
BARI: Bypass Angioplasty Revascularization Investigation
CABG: Coronary Artery Bypass Graft
CABRI: Coronary Angioplasty versus Bypass Revascularization
CAD: Coronary Artery Disease
CARDia: Coronary Artery Revascularization in Diabetes
CHD: Coronary Heart Disease
EAST: Emory Angioplasty vs Surgery Trial
ERACI II: Argentine Randomized Study-Coronary Angioplasty with Stenting Versus Coronary Bypass Surgery in Multi-
Vessel Disease
FREEDOM: Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multi-Vessel
Disease
GABI: German Angioplasty Bypass Surgery Investigation
MACCE: Major Adverse Cardiac and Cerebrovascular Events
MACE: Major Adverse Cardiac Events
MASS II: Medicine, Angioplasty or Surgery Study
MI: Myocardial Infarction
PCI: Percutaneous Coronary Intervention
PTCA: Percutaneous Transluminal Coronary Angioplasty
RITA-1: Randomized Intervention Treatment of Angina
SOS: Surgery or Stent Study
SYNTAX: Synergy between PCI with Taxus and Cardiac Surgery
TA Criterion 3:TA Criterion 3:TA Criterion 3:TA Criterion 3: The technology must improve net health outcomes.The technology must improve net health outcomes.The technology must improve net health outcomes.The technology must improve net health outcomes.
In order to determine whether PCI improves net health outcomes, the
potential benefits and potential risks must be assessed.
Potential BenefitsPotential BenefitsPotential BenefitsPotential Benefits
CABG has been the standard technique used to treat obstructions in
coronary arteries. In order to get the blood to the myocardium, either veins
(typically the saphenous) or arteries (internal mammary) are used to bypass the
diseased vessels. CABG can relieve symptoms and can prolong life for some
individuals but is a major surgical procedure, requiring sternotomy and associated
with surgical morbidity and mortality as well as a prolonged convalesence. The
main potential benefits of PCI are the ability to open a stenotic artery while
avoiding the need for a major operation with a sternotomy. The procedure
requires a groin incision using local anaesthetic and so avoids the need for major
surgery. Patients can often go home on the same day as the procedure.33 Thus the
main potential benefit is that revascularizaiton can be achieved without the patient
needing to undergo major cardiac surgery.
Potential RisksPotential RisksPotential RisksPotential Risks
1. 1. 1. 1. Long TermLong TermLong TermLong Term
The main long term risk with PCI is restsnosis, stent failure and the need for
revascularization. In the era of balloon angioplasty, the rate of restenosis was
significantly higher than it is currently in the DES era. The main reason for the
current use of DES is to reduce the risk of restenosis. Although restenosis can still
happen, the rates are lower than with BMS or PTCA. One large meta-analysis of 38
studies showed a reduction in target lesion revascularization with DES as compared
with BMS by about 12% at four year folllow-up.34 In a large registry study that
included patients with complex coronary lesions, the rate of target vessel
revascularization at two years was 7.4% for those who received DES compared with
10.7% for those who received BMS (p<0.001).35 In the FREEDOM trial, the
randomized controlled trial (RCT) of PCI with DES versus CABG in diabetics, the rate
of repeat revascularization events at one year was 12.6% in the PCI group vs 4.8% in
the CABG group (HR 2.74: 95% C.I. 1.91-3.89). Thus, although the rate of restenosis
requiring revascularization has decreased with the use of DES, it still remains a
significant long term risk associated with PCI.
2. 2. 2. 2. PeriPeriPeriPeri----ProceduralProceduralProceduralProcedural
PCI risks include those that are related to cardiac catheterization and
diagnostic angiography as well as those that are related to the particular stent
and/or wires that are used. Since the current standard of PCI includes the use of
stents rather than balloon angioplasty alone, the complications that are currently
seen are more likely to be stent related than those related to balloon angioplasty.
The risk of peri-procedural complications has decreased over time as devices
have improved, stents have been used and the use of anti-platelet therapy has
become more standard. In general rates of major peri-procedural complications
are low.
3. 3. 3. 3. Major complicationsMajor complicationsMajor complicationsMajor complications
An important complication which is frequently monitored is the need for
emergent CABG after PCI, if the PCI was not successful. The rate of emergent PCI
after CABG has been decreasing over time. In one study, it decreased from 2.95%
in 1979 to 1994 to 0.3% in 2000-2003.36 In the American College of Cardiology
National Cardiovascular Data registry, which includes over 100,000 PCI procedures,
performed between 1998 and 2000 of which 77% received stents, low rates of peri-
procedural complications, including in-hospital MI (0.4%), urgent CABG (1.9%) or
death (1.4%) were reported37.
4. 4. 4. 4. Coronary Artery CompCoronary Artery CompCoronary Artery CompCoronary Artery Compllllicationsicationsicationsications
Coronary artery complications include dissection, perforation, intramural
hematoma and occlusion of branch vessels. Dissection and resulting abrupt closure
are much less common in the DES era than they were with PTCA. Coronary artery
perforation is similarly much less common in the stent era but can still occur. In a
large series of over 10,000 PCIs performed from 1993-2001 (of which 6,836 received
stents ) the risk of perforation was 0.84%.38 The mortality rate after coronary artery
perforation is five to ten percent.39,40
5.5.5.5. Vascular ComplicationsVascular ComplicationsVascular ComplicationsVascular Complications
Vascular complications at the femoral artery insertion site can occur in about
six percent of patients41,42 Peripheral vascular complictaions after conventional and
complex percutaneous coronary interventional procedures42. include hematomas,
formation of pseudoaneurysms, occlusion, creation of AV fistulas and
retroperitoneal hematomas. Use of the radial artery (which is more compressible)
for access as compared with the femoral artery was associated with a reduced risk
of major bleeding in a 2009 meta-analysis,43 but not overall in a large RCT – Radial
vs Femoral Access for Coronary Angiography and Intervention in Patients with
Acute Coronary Syndromes (RIVAL), although there were some subgroups who did
achieve a bleeding reduction in RIVAL.44
6. 6. 6. 6. StrokStrokStrokStrokeeee
Stroke is a relatively rare complication of PCI with a rate of approximately
0.07% to 0.4% of procedures.45-47 Since stroke also occurs with the main alternative
to PCI, CABG, it is important to compare the risk of the two procedures. Most
individual trials have not shown a signfiicant difference in risk between the two
procedures, but most did not have adequate power to detect differences in that
relatively rare outcome. A recent meta-analysis compared the risk of stroke with
CABG to the risk with PCI.47 The meta-analysis included 10,944 patients in 19 trials.
The primary end point was 30 day risk of stroke. The 30 day risk of stroke was
signficantly higher in those who underwent CABG compared with those who
underwent PCI (1.20% vs 0.34%: OR 2.94: 95% C.I. 1.69 to 5.09: p = 0.0001). Similar
results were seen after a median follow-up of 12.1 months (1.83% vs 0.99%: OR
1.67:95% C.I. 1.09 to 2.56: p = 0.02). Thus although stroke remains a risk with PCI,
the risk is significantly lower than it would be with the main alternative, CABG.
7. 7. 7. 7. Other ComplicationsOther ComplicationsOther ComplicationsOther Complications
Other complications that can rarely occur as a result of PCI are
atheroembolic disease, acute kidney injury and anticoagulation associated bleeding.
SummarySummarySummarySummary
In summary, PCI has several potential benefits, especially in the current era
of PCI with DES. These benefits include revascularization without the need for a
major surgical procedure and its associated morbidity and mortality and need for
recuperation. The major risk is the potential need for revasascularizaiton after the
procedure. Although procedural complications can occur, overall the risks are
relatively low. Although stroke is a potentially important complication of PCI, the
risk of stroke is significantly lower than the risk seen with CABG. Thus, overall, net
health outcomes are improved with PCI, especially in the current era of DES.
TA Criterion 3 is TA Criterion 3 is TA Criterion 3 is TA Criterion 3 is metmetmetmet
TA Criterion 4:TA Criterion 4:TA Criterion 4:TA Criterion 4: The technology must be as beneficial as any established The technology must be as beneficial as any established The technology must be as beneficial as any established The technology must be as beneficial as any established
alternatives.alternatives.alternatives.alternatives.
The main established alternative to PCI is CABG. PCI treatments have
evolved over time. Initial studies compared balloon angioplasty with CABG. After
the introduction of stents, studies began to compare BMS with CABG. Finally, with
the introduction of DES, most recent studies have compared DES with CABG.
Early studies of Early studies of Early studies of Early studies of balloon angioplasty vs CABGballoon angioplasty vs CABGballoon angioplasty vs CABGballoon angioplasty vs CABG: subgroup analysis: subgroup analysis: subgroup analysis: subgroup analysis
Percutaneous transluminal coronary angioplasty (PTCA) was first introduced
in 1977.48 Initially it was used in patients with single vessel disease but over time
also began to be used in those with multi-vessel disease. In 1987, the NIH Heart,
Lung, and Blood Institute (NHLBI) initiated the Bypass Angioplasty Revascularization
Investigation (BARI). The goal of BARI was to test the hypothesis that a
revascularization strategy involving PTCA did not result in poorer clnical outcomes
than CABG at five year follow-up.49 BARI prespecified some subgroup analyses,
although evaluation of the impact on patients with diabetes was not prespecified.
A total of 1,829 patients with multi-vessel disease were randomized to either CABG
or PTCA and were followed for an average of 5.4 years. Of these, 353 had treated
diabetes at baseline. Overall, in the entire study cohort, the five year survival rate
was 89.3% for those assigned to CABG and 86.3% for those assigned to PTCA (p =
0.19). Among diabetics who were receiving diabetic treatment at baseline, the five
year survial was 80.6% for CABG and 65.5% for PTCA (p = 0.003). The results of this
study suggest that five year survival in diabetics may be better after CABG than
after PTCA, but since the analysis in diabetics was not a prespecified subgroup
analysis, these results should be seen as hypothesis generating rather than clearly
causal.
Four other studies of balloon angioplasty vs CABG all included some
diabetics.14-17 The number of diabetics in each study ranged from 41-124. However,
in only one of the studies - RITA-I: Randomized Intervention Treatment of Angina -
were diabetics analyzed separately. The primary outcome (death or MI) was not
statistically significantly different between the two groups although the numbers
were very small, given tht there were only 62 diabetic patients in the RITA-1 study.16
Bare Metal Stents Bare Metal Stents Bare Metal Stents Bare Metal Stents vvvvs CABGs CABGs CABGs CABG
The development of BMS was a significant advance over balloon angioplasty
in the treatment of coronary artery diseaes. Adding the BMS could reduce the
chance of restenosis by minimizing early arterial recoil and contraction. A total of
five studies have compared BMS to CABG. Four of these five studies reported
results in diabetics separately. The Medicine, Angioplasty or SMedicine, Angioplasty or SMedicine, Angioplasty or SMedicine, Angioplasty or Surgery Studyurgery Studyurgery Studyurgery Study IIIIIIII
((((MASS-II) included 115 diabetics but did not report the results in diabetics
separately.21
1. Arterial Revascularization Study I (ARTS1. Arterial Revascularization Study I (ARTS1. Arterial Revascularization Study I (ARTS1. Arterial Revascularization Study I (ARTS----I)I)I)I)
In ARTS-I, patients with multi-vessel CAD including the LAD and at least one
other lesion in another major epicardial artery were randomized to receive BMS vs
CABG. The main endpoint was a composite endpoint- death, MI and repeat
revascularizaiton or MACCE (major adverse cardiac and cerebrovascular events). In
the subgroup analysis of 208 diabetic patients, at five years the rate of MACCE was
higher in patients treated with BMS than in those treated with CABG (53.8% vs
23.4%: p = 0.001).
2. Angina With Extrememly Serious Operative Mortalit2. Angina With Extrememly Serious Operative Mortalit2. Angina With Extrememly Serious Operative Mortalit2. Angina With Extrememly Serious Operative Mortality Evaluationy Evaluationy Evaluationy Evaluation (AWESOME)(AWESOME)(AWESOME)(AWESOME)
In the AWESOME trial, patients with medically refractory unstable angina and
at high risk for CABG were randomized to either BMS vs CABG. Study outcomes
included 30 day, six month and 36 month survival. Among the 144 included
diabetics, 36 month survival was similar in the two groups (72% CABG vs 81% PCI:
NS).
3. Surgery or Stent (SOS) Trial 3. Surgery or Stent (SOS) Trial 3. Surgery or Stent (SOS) Trial 3. Surgery or Stent (SOS) Trial
The SOS trial randomized patients in whom revascularization was clinically
indicated and appropriate by either strategy to receive PCI with any commercially
available BMS vs CABG. The main study outcome was rate of repeat
revascularizaiton. A total of 142 diabetics were included in this study. At six year
follow-up, a total of 17/65 of the PCI patients had died vs 5.4% of those in the
CABG group (HR 3.53: 95% C.I. 1.14 to 10.95). There was no difference in treatment
effect between diabetic and non-diabetic subgroups.
4.4.4.4. Argentine Randomized StudyArgentine Randomized StudyArgentine Randomized StudyArgentine Randomized Study----coronary Angioplasty with Stentingcoronary Angioplasty with Stentingcoronary Angioplasty with Stentingcoronary Angioplasty with Stenting IIIIIIII (ERACI II)(ERACI II)(ERACI II)(ERACI II)
In the ERACI II trial, patients with multi-vessel CHD and clinical indications for
revascularization were randomized to either receive PCI with stent placement or
CABG. The main outcome was freedom from major adverse cardiovascular events
(MACE) at 30 days, one year, three years and five years. At five year follow-up,
mortaltiy among the 78 included diabetics was 10% in the PCI group vs 10.2% in the
CABG group, not significantly different between the two groups.
Drug Eluting Stents vs Drug Eluting Stents vs Drug Eluting Stents vs Drug Eluting Stents vs CABGCABGCABGCABG
Many of the earlier studies using either balloon angioplasty or BMS were
done before the current era where the standard for PCI to use DES. Four studies
have compared drug eluting stents and CABG for the treatment of multi-vessel
disease in patients with diabetes. A total of 3,021 patients have been included in
these four studies- 1,900 of the patients came from the FREEDOM study. Two of
the studies were subgroup analyses of larger studies22,24-26,29-31, and the other two
studies included only diabetics.32
1. ARTS1. ARTS1. ARTS1. ARTS----IIIIIIII
The ARTS-II study was a single arm study. All participants received DES.
ARTS I was a randomized controlled trial comparing surgery and BMS. Patients in
the ARTS-II trial were compared to the surgical arm of the ARTS-I as a historical
control. In order to be sure that the population was comparable to the ARTS-I trial,
patients were stratified by clinical site with the goal of ensuring that at least 1/3 of
patients had three vessel disease. Among the 607 patients included in ARTS-II
study, 159 of them had diabetes. Investigators compared DES with BMS and also
compared DES with CABG. At three year follow-up, there was no significant
difference in the main outcome (MACCE) between those who received DES and
those who received CABG. However at five year follow-up, the rate of MACCE was
lower in CABG than in DES (23.4% vs 40.5%: p< 0.001). Thus, CABG appeared safer
at five year follow up. Caution should be used in drawing conclusions, since this
was a subgroup analysis using a group of historical controls.
2. Synergy 2. Synergy 2. Synergy 2. Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX)between PCI with Taxus and Cardiac Surgery (SYNTAX)between PCI with Taxus and Cardiac Surgery (SYNTAX)between PCI with Taxus and Cardiac Surgery (SYNTAX)
SYNTAX was a large randomized controlled trial including 1,800 patients and
conducted at 85 sites.26 The study was designed to compare CABG and DES
(paclitaxel) in patients with three vessel or left main coronary disease. The main
outcome was major adverse cardiac and cerebrovascular events (MACCE). Overall,
rates of MACCE were significantly higher in those who received DES than those who
received CABG. This study was designed as a non-inferiority trial but because of
the significant difference in MACCE between groups, the criteria for noninferiority
were not met.
A subgroup analysis of SYNTAX in patients with diabetes was prespecified. A
total of 452 of the trial participants had diabetes. At one year follow-up there was
no difference between the two groups, but at three year follow-up diabetics who
received CABG had a 22.9% rate of MACCE and diabetics who received DES had a
rate of 37.0% (p = 002).29,31 Thus, in this prespecified subgroup analysis, the rate of
adverse events was lower in those who received CABG than in those who received
DES.
3. 3. 3. 3. Coronary Artery Revascularization in Diabetes Study (CARDia)Coronary Artery Revascularization in Diabetes Study (CARDia)Coronary Artery Revascularization in Diabetes Study (CARDia)Coronary Artery Revascularization in Diabetes Study (CARDia)
The CARDia study was the first randomized controlled trial that specifically
focused on the role of PCI with DES and CABG in diabetic patients with multi-vessel
coronary artery disease.28 This was a non-inferiority trial designed to show whether
or not PCI was or was not non-inferior to CABG. Patients were included if they had
diabetes and either multi-vessel coronary artery disease or complex single vessel
disease (ostial or proximal left anterior descending artery disease). Patients had to
be eligible to receive either PCI or CABG in order to be included. Patients were
randomized to either receive PCI or CABG. The trial started out with patients
receiving BMS, but when DES became available, patients received DES. The primary
endpoint was a composite end point assessed at one year after randomization. The
composite end point included death, MI and stroke. A major secondary endpoint
was repeat revascularization at one-year follow-up.
Among those who received stents, 69% received DES and 31% received BMS.
At one-year follow-up there was a trend toward a reduction in the composite end
point in those who received CABG compared with PCI, but this reduction was not
statistically significant. (10.5% CABG vs 13.0% PCI: HR 1.25: 95% C.I. 0.75-2.09: p =
0.39) The rate of all cause mortality was 3.2% in each group. The combined
endpoint of MACCE was 11.3% in the CABG group and 19.3% in the PCI group (HR
1.77: 95% C.I. 1.11-2.82: p = 0.02). When the patients who received CABG were
compared with the subset of patients who received DES, there were still no
statistically significant differences.
These results at one year did not show that PCI was non-inferior to CABG.
Although there was a trend toward a reduction in the composite outcome among
those treated with CABG compared with those treated with PCI, this was not
statistically significant. This could be because there truly is no difference or could
be because of inadequate power of the trial to detect a true difference. Regardless,
the CARDia study alone did not answer the question of whether PCI or CABG
should be preferred in patients with diabetes.
4. Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal 4. Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal 4. Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal 4. Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal
MaMaMaManagement of Multinagement of Multinagement of Multinagement of Multi----Vessel Disease Study (FREEDOM)Vessel Disease Study (FREEDOM)Vessel Disease Study (FREEDOM)Vessel Disease Study (FREEDOM)
The major study that addresses the role of PCI plus stenting vs CABG in
diabetics is the FREEDOM study. The FREEDOM study was a large multi-center RCT
that compared DES to CABG in patients with multi-vessel coronary artery disease.32
A total of 1,900 diabetic patients at a total of 140 centers around the world were
randomized to receive PCI with DES or CABG. Patients were included if they had
Type I or Type 2 diabetes and had angiographically confirmed multi-vessel
coronary artery disease with stenosis of more than 70% in two or more major
epicardial vessels involving at least two separate coronary artery territories and
without left main disease. Among those receiving DES, sirolimus-eluting and
paclitaxel-eluting stents were most commonly used. A newer generation of drug
eluting stent could be used as long as it was FDA approved. Abciximab was
recommended for patients undergoing PCI. Dual antiplatelet therapy with aspirin
and clopidrogel was recommended for at least 12 months after stent implantation.
For CABG surgery, arterial revascularization was encouraged. Risk factor
modification was encouraged in all patients, and recommended targets were set.
These included a goal low density lipoprotein (LDL) of <70 mg/deciliter, a goal
blood pressure of <130/80 and a goal glycosylated hemoglobin of <7%.
The primary study outcome was a composite of all cause mortality, nonfatal
MI and nonfatal stroke. Secondary outcomes included rate of MACCE at 30 days
and 12 months after the procedure (including some components of the primary
outcome and repeat revascularization).
Mean patient age was 63.1 years, 29% were women and 83% had triple
vessel disease. The primary composite outcome was more common at five year
follow-up in the PCI group (26.6% PCI vs 18.7% CABG: p =0.005). When outcomes
were analyzed individually, at five year follow-up, MI was lower in CABG group
(6.0% vs 13.9%: p < 0.001) and all cause mortality was also lower in the CABG group
(10.9% vs 16.3%: p = 0.049). Stroke at five year follow up was higher in the CABG
group than in the PCI group (5.2% vs 2.4%: p = 0.03).
This large trial with adequate power has answered the question of whether
CABG or PCI with DES is superior in patients with diabetes. This study has clearly
shown that for patients with diabetes and multi-vessel coronary artery disease,
CABG is superior to PCI. It significantly reduced the rate of the composite endpoint
(mortality, MI and stroke). In addition, overall mortality and MI were both reduced,
although there was a small increased risk of stroke in those who received CABG.
Thus, this study clearly shows that in diabetics, PCI using the current
technology of DES is inferior to CABG. PCI does not show an improvement in
clinical outcomes compared with the established alternative of CABG in diabetic
patients with multi-vessel disease who are undergoing revascularization.
Summary Summary Summary Summary
In summary, the current standard for PCI procedure uses DES. Among the
trials comparing PCI with DES to CABG, two were subgroup analyses - one showed
no difference between the interventions and one showed worse outcome with PCI.
Two trials evaluated PCI with DES vs CABG exclusively in diabetics - one was small
and underpowered. The large FREEDOM trial included 1,900 diabetics and
definitively showed a significant reduction in mortality and myocardial infarction
with CABG compared with PCI, although was associated with a small increased risk
of stroke. This study has shown us that CABG is superior to PCI for diabetics with
multi-vessel disease requiring revascularization. PCI when compared with the
established alternative of CABG does not result in an improvement in health
outcomes.
TA Criterion 4 is TA Criterion 4 is TA Criterion 4 is TA Criterion 4 is not metnot metnot metnot met for PCI as an alternative to CABGfor PCI as an alternative to CABGfor PCI as an alternative to CABGfor PCI as an alternative to CABG for diabetics with multifor diabetics with multifor diabetics with multifor diabetics with multi----
vessel disease. vessel disease. vessel disease. vessel disease.
TA Criterion 5:TA Criterion 5:TA Criterion 5:TA Criterion 5: The improvement must be attainable outside of the The improvement must be attainable outside of the The improvement must be attainable outside of the The improvement must be attainable outside of the
investigational investigational investigational investigational setting.setting.setting.setting.
Since the improvement has not been shown in the investigational setting, an
improvement cannot be obtained outside of the investigational setting.
TA Criterion 5 is notTA Criterion 5 is notTA Criterion 5 is notTA Criterion 5 is not met.met.met.met.
CONCLUSIONCONCLUSIONCONCLUSIONCONCLUSION
In summary, PCI is being compared to CABG in diabetics with multi-vessel
disease. Many studies have compared PCI and CABG in patients with coronary
disease. The majority of the early studies conducted subgroup analyses of
diabetics, most suggesting at least a trend toward improvement with CABG. In
addition, PCI technology has progressed from balloon angioplasty to BMS and now
to the current standardly used technology of DES. However, even using the
currently used PCI technology of DES, PCI compared with CABG does not lead to an
improvement in health outcomes.
DRAFT DRAFT DRAFT DRAFT RECRECRECRECOMMENDATIONOMMENDATIONOMMENDATIONOMMENDATION
It is recommended that PCI as an alternative to CABG in patients with
diabetes mellitus does not meet CTAF criteria 4 or 5 for safety, efficacy and
improvement in health outcomes.
March 6, 2013
RECOMMENDATIONS OF OTHERSRECOMMENDATIONS OF OTHERSRECOMMENDATIONS OF OTHERSRECOMMENDATIONS OF OTHERS
American CollegeAmerican CollegeAmerican CollegeAmerican College of Cardiologyof Cardiologyof Cardiologyof Cardiology
In 2011, the American College of Cardiology released two practice guidelines.
1) In partnership with the American Heart Association (AHA) and the Society for
Cardiovascular Angiography and Interventions (SCAI): 2011 ACCF/AHA/SCAI 2011 ACCF/AHA/SCAI 2011 ACCF/AHA/SCAI 2011 ACCF/AHA/SCAI
guideline foguideline foguideline foguideline for percutaneous coronary artery intervention. A Report of the r percutaneous coronary artery intervention. A Report of the r percutaneous coronary artery intervention. A Report of the r percutaneous coronary artery intervention. A Report of the
American College of Cardiology Foundation/American Heart Association Task American College of Cardiology Foundation/American Heart Association Task American College of Cardiology Foundation/American Heart Association Task American College of Cardiology Foundation/American Heart Association Task
Force on Practice Guidelines and the Society for Cardiovascular Angiography Force on Practice Guidelines and the Society for Cardiovascular Angiography Force on Practice Guidelines and the Society for Cardiovascular Angiography Force on Practice Guidelines and the Society for Cardiovascular Angiography
and Interventions; and Interventions; and Interventions; and Interventions; and
2) In partnership with the American Heart Association: 2011 ACCF/AHA Guideline 2011 ACCF/AHA Guideline 2011 ACCF/AHA Guideline 2011 ACCF/AHA Guideline
for Coronary Artery Bypass Graft Surgery: A Report of the American College of for Coronary Artery Bypass Graft Surgery: A Report of the American College of for Coronary Artery Bypass Graft Surgery: A Report of the American College of for Coronary Artery Bypass Graft Surgery: A Report of the American College of
Cardiology Foundation/American Heart Association Task Force on Practice Cardiology Foundation/American Heart Association Task Force on Practice Cardiology Foundation/American Heart Association Task Force on Practice Cardiology Foundation/American Heart Association Task Force on Practice
GuidelinesGuidelinesGuidelinesGuidelines....
Both sets of guidelines make the following recommendation under sections titled:
Revascularization to Improve Survival: Recommendations; Non-Left Main CAD
Revascularization, Class IIa:
CABG is probably recommended in preference to PCI to improve survival in
patients with multivessel CAD and diabetes mellitus, particularly if a LIMA
graft can be anastomosed to the LAD artery. (Level of Evidence: B)
The ACC was invited to send an opinion on this technology and invited to
send a representative to the meeting.
American Heart American Heart American Heart American Heart Association (AHA)Association (AHA)Association (AHA)Association (AHA)
The AHA was invited to send an opinion on this technology and invited to
send a representative to the meeting. See above for guideline(s).
Society for Cardiovascular Angiography and InterventionsSociety for Cardiovascular Angiography and InterventionsSociety for Cardiovascular Angiography and InterventionsSociety for Cardiovascular Angiography and Interventions (SCAI)(SCAI)(SCAI)(SCAI)
SCAI was invited to send an opinion on this technology and invited to send a
representative to the meeting. See above for guideline(s).
Agency for Healthcare Research and Quality (AHRQ)Agency for Healthcare Research and Quality (AHRQ)Agency for Healthcare Research and Quality (AHRQ)Agency for Healthcare Research and Quality (AHRQ)
AHRQ’s Effective Health Care Program published in 2007 its report:
Comparative Effectiveness of Percutaneous Coronary Interventions and Coronary Comparative Effectiveness of Percutaneous Coronary Interventions and Coronary Comparative Effectiveness of Percutaneous Coronary Interventions and Coronary Comparative Effectiveness of Percutaneous Coronary Interventions and Coronary
Artery Bypass Grafting for Coronary Artery Disease.Artery Bypass Grafting for Coronary Artery Disease.Artery Bypass Grafting for Coronary Artery Disease.Artery Bypass Grafting for Coronary Artery Disease. One of the key questions in the
report was to determine the evidence of comparative effectiveness of PCI and
CABG based on coronary diseases risk factors, diabetes or other comorbid disease.
The report notes the following:
“…six RCTs reporting survival of diabetic patients at one and five years. One
RCT - Bypass Angioplasty Revascularization Investigation (BARI) trial - found
significantly better survival for diabetic patients assigned to CABG while
none of the other five trials found significant differences in survival between
diabetic patients with PCI vs. CABG. However, the pooled data from all the
trials showed no significant difference in survival after PCI or CABG.”
Blue Cross Blue Shield Association (BCBSA)Blue Cross Blue Shield Association (BCBSA)Blue Cross Blue Shield Association (BCBSA)Blue Cross Blue Shield Association (BCBSA)
No assessments on this technology were found on the BCBSA TEC website.
Canadian Agency for Drugs and Technologies in Health (CADTH)Canadian Agency for Drugs and Technologies in Health (CADTH)Canadian Agency for Drugs and Technologies in Health (CADTH)Canadian Agency for Drugs and Technologies in Health (CADTH)
On October, 2012, CADTH issued its Rapid Response Report: Rapid Response Report: Rapid Response Report: Rapid Response Report: Drug Eluting Drug Eluting Drug Eluting Drug Eluting
Stents for Patients with Diabetes and Coronary Artery Disease: A Review of the Stents for Patients with Diabetes and Coronary Artery Disease: A Review of the Stents for Patients with Diabetes and Coronary Artery Disease: A Review of the Stents for Patients with Diabetes and Coronary Artery Disease: A Review of the
Clinical EvidenceClinical EvidenceClinical EvidenceClinical Evidence and Guidelinesand Guidelinesand Guidelinesand Guidelines to determine the clinical effectiveness and drug
safety of drug eluting stents in adults with both diabetes and coronary artery
disease and to find any evidence guidelines on this topic. Based on its findings,
CADTH wrote the following:
“In adults with diabetes and coronary artery disease, findings from both
randomized and non- randomized controlled trials showed consistently that
the clinical effectiveness, as measured by the need for a repeat
revascularization of the target vessel, is the best with CABG, followed by DES
(drug eluting stents), then BMS (bare metal stents). Findings on safety
outcomes such as risk of death and myocardial infarction are similar
between DES and BMS up to 2.5 years follow-up and in favour of DES with
longer follow-up times. Findings on comparisons between DES and CABG
are inconsistent on safety outcomes. There was no evidence found on
guidelines for the use of DES in adult patients with both diabetes and
coronary artery disease.”
National Institute for Health and Clinical Excellence (NICE)National Institute for Health and Clinical Excellence (NICE)National Institute for Health and Clinical Excellence (NICE)National Institute for Health and Clinical Excellence (NICE)
NICE clinical guideline 126: Management of Stable AnginaNICE clinical guideline 126: Management of Stable AnginaNICE clinical guideline 126: Management of Stable AnginaNICE clinical guideline 126: Management of Stable Angina (issued on July
2011 and last modified on December 2012) noted the following in the section: Key
Priorities for Implementation:
When either procedure would be appropriate, take into account the
potential survival advantage of CABG over PCI for people with multivessel
disease whose symptoms are not satisfactorily controlled with optimal
medical treatment and who:
• have diabetes or or or or
• are over 65 years orororor
• have anatomically complex three-vessel disease, with or without
involvement of the left main stem.
Centers Centers Centers Centers for Medicare and Medicaid Services (CMS)for Medicare and Medicaid Services (CMS)for Medicare and Medicaid Services (CMS)for Medicare and Medicaid Services (CMS)
National Coverage Determination (NCD) guidelines are available for
Percutaneous Transluminal Angioplasty (PTA) procedures under Section 20.7 in the
Medicare National Determination Coverage Manual. However, there is no NCD for
drug eluting coronary stents themselves used in PTA or PCI.. Local Medicare
carriers have discretion on coverage decisions of coronary stents.
American College of Cardiology (ACS), CA ChapterAmerican College of Cardiology (ACS), CA ChapterAmerican College of Cardiology (ACS), CA ChapterAmerican College of Cardiology (ACS), CA Chapter
ACS – CA Chapter was invited to provide an opinion on this technology and
to send a representative to the CTAF public meeting.
American Association for Thoracic Surgery (AATS)American Association for Thoracic Surgery (AATS)American Association for Thoracic Surgery (AATS)American Association for Thoracic Surgery (AATS)
AATS was invited to provide an opinion on this technology and to send a
representative to the CTAF public meeting.
Society of Thoracic Surgeons (STS)Society of Thoracic Surgeons (STS)Society of Thoracic Surgeons (STS)Society of Thoracic Surgeons (STS)
STS was invited to provide an opinion on this technology and to send a
representative to the CTAF public meeting.
ABBREVIATIONS ABBREVIATIONS ABBREVIATIONS ABBREVIATIONS
ARTS-I: Arterial Revascularization Study I
AV: Arterio Venous
AWESOME: Angina With Extremely Serious Operative Mortality Evaluation
BARI: Bypass Angioplasty Revascularization Investigation
BMS: Bare Metal Stents
CABG: Coronary Artery Bypass Graft
CABRI: Coronary Angioplasty versus Bypass Revascularization
CAD: Coronary Artery Disease
CARdia: Coronary Artery Revascularization in Diabetes
CASS: Coronary Artery Surgery Study
CVA: Cerebrovascular Accident
CHD: Coronary Heart Disease
CHF: Congestive Heart Failure
C.I.: Confidence Interval
DARE: Database of Abstracts of Reviews of Effects
DES: Drug Eluting Stent(s)
EAST: Emory Angioplasty vs Surgery Trial
EF: Ejection Fraction
ERACI II: Argentine Randomized Study-coronary Angioplasty with Stenting
Versus coronary Bypass surgery in Multi-Vessel Disease
FDA: Food and Drug Administration
FREEDOM: Future Revascularization Evaluation in Patients with Diabetes Mellitus:
Optimal Management of Multi-Vessel Disease
GABI: German Angioplasty Bypass Surgery Investigation
HR: Hazard Ratio
LAD: Left Anterior Descending
LDL: Low Density Lipoprotein
LV: Left Ventricle or Ventricular
MACCE: Major Adverse Cardiovascular and Cerebrovascular Events (Death,
CVA, MI and repeat revascularization)
MACE: Major Adverse Cardiovascular Events (death, MI and repeat
revascularization)
MASS II: Medicine, Angioplasty or Surgery Study
MI: Myocardial Infarction
NHLBI: National Institutes of Health (NIH) Heart, Lung, and Blood Institute
OR: Odds Ratio
PCI: Percutaneous Coronary Intervention
PTCA: Percutaneous Transluminal Coronary Angioplasty
RCT: Randomized Controlled Trial
RITA: Randomized Intervention Treatment of Angina
RIVAL: Radial vs Femoral Access for Coronary Angiography and Intervention
in Patients with Acute Coronary Syndromes
SOS: Surgery or Stent Study
SYNTAX: Synergy between PCI with Taxus and Cardiac Surgery
ATTACHMENTATTACHMENTATTACHMENTATTACHMENT
Farkouh ME, Domanski M, Sleeper LA, et al. Strategies for multivessel
revascularization in patients with diabetes. N Engl J Med. Dec 20 2012;367(25):2375-
2384
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