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Asian cardiovascular & thoracic annals 153p264-269

Myocardial Revascularization: Surgery or Stenting?
Sunny H Wong, Song Wan and Malcolm J Underwood Asian Cardiovasc Thorac Ann 2007;15:264-269 This information is current as of August 30, 2010
The online version of this article, along with updated information and services, is located on the World Wide Web at: The Asian Cardiovascular & Thoracic Annals is the official journal of The Asian Society forCardiovascular Surgery and affiliated journal of The Association of Thoracic and Cardiovascular Surgeons of Asia. Myocardial Revascularization: Surgery or Stenting? Sunny H Wong, MBChB, Song Wan, FRCS, Malcolm J Underwood, FRCS Division of Cardiothoracic SurgeryDepartment of SurgeryPrince of Wales HospitalThe Chinese University of Hong KongHong Kong, China There is current debate regarding the relative merits and roles of surgical revascularization and percutaneous revascularization for patients with obstructive coronary artery disease. This article reviews the current literature relating to this subject.
(Asian Cardiovasc Thorac Ann 2007;15:264–9) CABG VS BARE-METAL STENTS Since the introduction of coronary artery bypass The endothelial response to injury during PCI may result grafting (CABG) in 1967, and percutaneous in extensive proliferation of smooth muscle cells and transluminal coronary angioplasty (PTCA) 10 years extracellular matrix around the angioplasty site, leading later, several major clinical trials have compared the two to neointimal hyperplasia and restenosis, which in turn therapeutic strategies, including the Bypass Angioplasty may result in recurrent angina and necessitate repeat Revascularization Investigation (BARI) and the revascularization.4–6 Various measures have been proposed Coronary Angioplasty versus Bypass Revascularization to limit this process, such as directional atherectomy, Investigation (CABRI) trials.1,2 The 7-year outcome data rotablators, or lasers. However, clinical results following of the BARI trial (involving 1,829 patients) demonstrated these interventions have been largely disappointing as that CABG carried a signifi cant survival benefi t over they may cause further damage to the vessel and lead PTCA, and this was particularly pronounced in diabetic to more severe neointimal hyperplasia.7–10 The use of patients.1 In addition, nearly 60% of the patients treated stents following PTCA has been suggested as a method with PTCA had to undergo repeat revascularization of improving the long-term outcome of PCI by reducing procedures, and half of them relied on CABG as a the incidence of restenosis and the need for repeat subsequent therapy.1 Nevertheless, the past decade has witnessed a rapid progression of PTCA technology; in particular, the development of intracoronary stents. Several randomized controlled trials have been conducted Drug-eluting stents (DES), especially, appear to have to compare CABG and PCI with stenting. The Arterial impacted signifi cantly on the daily practice of treating Revascularization Therapies Study (ARTS) is one of patients with coronary artery disease.3 These advances the largest, and it evaluated the clinical outcomes of and their immediate clinical application provide a good 1,205 patients over a 5-year period.11 Although the example of how technology may shift the paradigm 5-year mortality rate of the PCI group (8.0%) was of medicine. As a consequence of this, it is believed comparable to that of the CABG group (7.6%), the by many that the role of surgical revascularization need for repeat revascularization was significantly needs to be redefi ned, despite its success over the more frequent in the former group (30.3% vs 8.8%).11 past 4 decades. To clarify this important issue, we In terms of symptomatic relief, angina persisted in 21.2% appraised the available evidence comparing CABG of patients after PCI, compared to a signifi cantly lower and percutaneous coronary intervention (PCI) in the incidence of 15.5% in the CABG group.11 Similar modern era of stenting.
fi ndings have been reported by other investigators. The For reprint information contact:Malcolm J Underwood, FRCS Tel: 852 2632 2629 Fax: 852 2637 7974 Email: mjunderwood@surgery.cuhk.edu.hkDivision of Cardiothoracic Surgery, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China.
ASIAN CARDIOVASCULAR & THORACIC ANNALS 264 VOL. 15, NO. 3 Surgery or Stenting Argentine randomized trial of PCI vs CABG (ERACI-II, or CABG suffer from diabetes, as recorded in various n = 450, with a 5-year follow-up) and the Medicine, registry data. The BARI trial showed a sustained survival Angioplasty or Surgery Study (MASS-II, n = 611, with benefi t of more than 20% in patients treated with CABG 1-year follow-up) both revealed signifi cantly higher rates at 7 years, adding strong evidence that CABG should of repeat revascularization in patients receiving PCI, be the preferred method of revascularization in diabetic despite similar mortality to CABG in these selected patients.1 The ARTS trial also attempted to address this patients.12,13 Among all the major trials comparing stenting issue in a subgroup analysis of 211 diabetic patients; and surgery, the Stent or Surgery (SoS) trial was the one diabetic patients in the PCI group had a higher (though to report differences in mid-term (as opposed to early) statistically not signifi cant) 5-year mortality (13.5%) than survival. The trial involved 988 patients with multivessel those treated with CABG (8.3%), and a signifi cantly disease from 11 European countries and Canada.14 In higher repeat revascularization rate than would be contrast to previous studies, a signifi cant and more than expected considering the results of previous trials.11 2-fold increase in death in the PCI group was found at Moreover, comparisons of diabetic and non-diabetic 2-year follow-up (5% in the PCI group vs 2% in the patients in this trial revealed that those with diabetes were more likely to die when treated with PCI rather than CABG.11 This fi nding was echoed by the ERACI-II Although randomized controlled trials are considered trial.12 A meta-analysis by Hoffman and colleagues15 to represent the highest level of evidence, helping to confi rmed a signifi cant survival benefi t for CABG over determine the place of therapeutic interventions, registry PCI at 4 years, but not at 6.5 years, in diabetic patients. data and meta-analyses are also pivotal in refl ecting the Another meta-analysis by Mercado and colleagues17 true effi cacy of various treatments in the "real world", suggested higher (though statistically not signifi cant) involving the full spectrum of patients. In a meta-analysis 1-year mortality in diabetic patients after stenting. More comparing CABG to PTCA with (4 studies), or without recently, the report of the New York cardiac registries, (9 studies) stents in 7,964 patients, Hoffman and which included 37,212 patients undergoing CABG and colleagues15 found a 1.9% absolute survival advantage 22,102 having PCI with stenting from 1997 to 2000, favoring CABG over PTCA at 5 years, although the confi rmed that risk-adjusted survival rates in the PCI signifi cance may not be maintained at 8 years. In patients group were signifi cantly lower, whereas the repeat with multivessel disease, CABG provided signifi cant revascularization rate was signifi cantly higher than that survival advantages at both 5 and 8 years. Patients in the CABG group at 3 years.18 In particular, the adjusted randomized to PTCA had more repeat revascularizations hazard ratio for the risk of death after CABG relative to at all time points; and with stents, this risk difference was PCI was 0.64 (95% confi dence interval: 0.56–0.74) for still 15% at 3 years.15 In addition, patients treated with patients with triple-vessel disease.18 Although without CABG also had a signifi cantly lower risk of recurrent risk-stratifi cation, Mack and colleagues19 recorded lower angina than those receiving PTCA, with a risk difference mortality after PCI; the proportion of multivessel disease of 10% at 3 years.15 was greater in the CABG group in their database. It is noteworthy that the risk-adjusted survival benefi t of A recent propensity analysis involving 6,033 consecutive CABG over stenting has been repeatedly demonstrated patients over a 5-year period at the Cleveland Clinic not only in North America but also in Europe.15,16,18,20 (86% of them received CABG) indicated that in those patients with multivessel coronary artery disease and The Angina With Extremely Serious Operative Mortality many high-risk characteristics, CABG was associated (AWESOME) trial was conducted to compare PCI and with better survival than PCI with stenting after CABG in 454 patients with refractory myocardial adjustment for risk profi les.16 In fact, it was found that ischemia and one or more risk factors for an adverse PCI with stenting was associated with a more than surgical outcome.21 These risk factors included prior 2-fold increase in death (hazard ratio 2.3, p < 0.0001), open-heart surgery, age > 70 years, left ventricular ejection and this difference was observed across all categories fraction < 35%, myocardial infarction within 7 days, or of propensity.16 In 2,319 diabetic patients, a higher pre-revascularization use of an intra-aortic balloon pump. mortality rate was observed in the PCI group and the A variable proportion of patients received stenting in the most signifi cant difference occurred among insulin-treated PCI group (26% in 1995 rising to 88% in 1999/2000). diabetics in whom the adjusted hazard ratio reached 2.6 Although survival rates in the CABG (79%) and (95% confi dence interval: 1.7–3.9) in the PCI group.16 PCI (80%) groups were not signifi cantly different at 36 months, the need for subsequent repeat revascularization Treatment options for diabetic patients with a bare-metal was higher in the PCI group.21 The Stenting vs Internal stent (BMS) have always been of concern in clinical Mammary Artery (SIMA) study compared CABG with practice, as up to one third of patients receiving PCI stenting in 123 patients with proximal, isolated, de 2007, VOL. 15, NO. 3 ASIAN CARDIOVASCULAR & THORACIC ANNALS Surgery or Stenting novo left anterior descending coronary artery disease.22 in more complicated coronary lesions have also shown Although 2-year mortality was not signifi cantly different positive results. These include the Sirolimus-Eluting in this particular study, a signifi cantly higher incidence vs Uncoated Stents for Prevention of Restenosis in of repeat revascularization was documented in the stent Small Coronary Arteries (SES-SMART) trial on small group. In contrast, the event-free survival rate in the coronary vessels, and the Stenting of Coronary Arteries in ARTS trial was signifi cantly higher after CABG than Non-Stress/Benestent Disease (SCANDSTENT) trial on after PCI for patients with triple-vessel disease.11 It was bifurcation, ostial, angulated, and occlusive lesions.27,28 acknowledged that in the ARTS trial, patients with left ventricular dysfunction, a left main lesion, or concomitant PACLITAXEL-ELUTING STENTS hepatic or renal diseases were excluded.11 These criteria Recently, large clinical series, such as TAXUS-IV have provided a framework that may magnify the apparent (n = 1,314) and TAXUS-V (n = 1,156), have investigated effi cacy of PCI. As an example to put this in context, the Taxus slow-release stent for longer coronary lesions in the New York cardiac surgery registry, up to 24% of in smaller coronary vessels.29,30 Signifi cant reductions patients receiving CABG had an ejection fraction < 40%; in target lesion revascularization for up to 2 years in these patients are often excluded in controlled trials, the TAXUS-IV trial and 1 year in the TAXUS-V trial yet they are known to have a survival advantage with have been reported. The TAXUS-VI (n = 446) study surgical revascularization.18 Excluding such patients may also demonstrated a lower repeat revascularization unfairly reduce the potential survival benefi ts for surgery rate following the use of the TAXUS moderate-release and introduce a bias in favor of PCI. Hence, it must be stent compared to the BMS.31 More recent studies recognized that patients in clinical trials do not necessarily suggest, however, that there are serious concerns accurately represent those in the "real world".
aside from restenosis or repeat intervention following DES implantation, which may occur at a higher rate CABG VS DRUG-ELUTING STENTS than usually thought. For instance, several groups of Although BMS implantation has signifi cantly reduced investigators have observed the development of subacute the incidence of repeat revascularization following PCI, or late stent thrombosis.32–35 Such complications could the rate of restenosis remains high and comparable to lead to fatal myocardial infarction even a few years after CABG. It was not until the emergence of drug-eluting DES implantation.35 stents (DES) that a true reduction in the restenosis rate following percutaneous intervention was reported, marking a new era in PCI development. However, to With the encouraging results from various trials date there are no published data from randomized trials comparing DES and BMS, it is believed that the comparing DES with CABG. We may gain a better insight new technology of DES has the potential to further by looking into trials comparing DES and BMS.
decrease the morbidity and repeat revascularization rate after PCI. However, many of these trials involved SIROLIMUS-ELUTING STENTS relatively simple coronary lesions. Even the SES-SMART, The RAVEL study was the fi rst randomized double-blind SCANDSTENT, and TAXUS-V trials did not truly trial that compared the Cypher sirolimus-coated eluting represent the un-selected patient population routinely stent (SES) with a BMS in 238 patients with relatively presenting for CABG. Moreover, the longest follow-up simple, single de novo coronary lesions.23 Encouraging period in these studies was only 4 years. There have results were reported, with an angiographic restenosis rate been concerns over the long-term effi cacy of DES, and of 0% in the SES group and 26% in the BMS group at some authors have postulated that DES might merely be 6 months. The 4-year results of the study also revealed delaying rather than reducing restenosis, since there may sustained and signifi cant reductions in major adverse be stent dilapidation following total elution of the drug. cardiac events and repeat target lesion revascularization Thus it would be unwise to extrapolate data comparing in the DES group. While the RAVEL trial was criticized DES and BMS and apply the fi ndings to a comparison for the simple nature of the lesions treated, the larger of DES with CABG. Ongoing clinical trials, such as sirolimus-coated stent had been developed and a the Synergy between PCI with TAXUS and Cardiac subsequent clinical trial (SIRIUS) involving 1,058 patients Surgery (SYNTAX) trial, are primarily designed to with longer coronary lesions was instigated.24 The 3-year compare the 1-year outcomes of PCI with the TAXUS follow-up data showed a signifi cant reduction in target stent and CABG in patients with triple-vessel and/or lesion revascularization and angiographic stenosis in the left main coronary artery disease.36 This study aims to SES group. The NEW-SIRIUS study, which comprised recruit over 4,250 patients at 90 centers in Europe and Canadian and European data involving 452 patients, also the United States. Attempting to refl ect the "real world", showed signifi cant reductions in major adverse cardiac the study includes not only the randomized arms but events at 9 months in the SES group.25,26 Other trials also the 2 ineligible registries and a "preference registry" ASIAN CARDIOVASCULAR & THORACIC ANNALS 266 VOL. 15, NO. 3 Surgery or Stenting (refusal of treatment allocation). It will address some It has been well recognized that CABG provides better important issues on the relative roles of DES and CABG protection against repeat revascularization than PCI in the treatment of patients with complex coronary artery with stenting. The high rate of repeat revascularization disease, the short- and long-term cost-effectiveness, as following PCI should not be overlooked. Although the well as quality of life. With respect to the previous data use of stents has substantially reduced this, the fi gure of the CABG arm of the ARTS trial, an ARTS II trial still remains high (30.3% in the ARTS trial and 28.4% in the ERACI-II trial at 5 years). Indeed, in these two was started in 2003 at 45–50 centers across Europe to studies, a signifi cant percentage of patients (34.7% assess the "non-inferiority" of SES implantation.11,37 in ARTS and 29.6% in ERACI-II) treated with PCI However, based on the patient population enrolled in eventually required subsequent revascularization with ARTS I, the ARTS II trial has been limited to include CABG, a fact disguising to some extent ‘real' differences 1/3 of patients with 3-vessel disease vs 2/3 with 2-vessel in reported survival rates as the trial was conducted and disease.37 Another Future Revascularization Evaluation in analyzed on an intention-to-treat principle. This high patients with Diabetes Mellitus: Optimal Management of rate of repeat revascularization with the need to resort Multivessel Disease (FREEDOM) trial was also carried to CABG therefore questions the applicability of the out to compare 5-year mortality in diabetic patients treated survival data because up to 10.5% and 8.6% of all PCI with either DES or CABG.38 Obviously, more large-scale patients eventually required CABG.11,12 Perhaps more prospective studies will be needed to elucidate and defi ne important than restenosis is the issue of the completeness the accurate role of the currently available treatment of revascularization potentially achieved by the two strategies in patients with ischemic heart disease.
treatment options.39–42 By placing grafts distal to the diseased coronary segment, CABG deals not only with the immediate culprit lesion but with future lesions, Coronary artery bypass grafting has stood the test of time whereas PCI only addresses the existing lesions.42 for 4 decades with excellent success as measured by a For this reason, surgery has been considered to carry variety of clinical outcome markers, and patency rates an intrinsic advantage that makes it superior to PCI, of the left internal mammary artery grafted to the left irrespective of the type of stent used.
anterior descending coronary artery are consistently over 90% at 10 years. No similar claim can currently be made Last, but not least, every patient deserves to make their for any catheter-based intervention. The longest trial of own decision regarding treatment, based on updated BMS has not reached 10-year follow-up. Moreover, as far evidence and a balance of clinical opinion. This, by as patient survival is concerned, no solid evidence from defi nition, would require multi-disciplinary input into previous trials comparing BMS and CABG supported the this important process.41,42 Only with unprejudiced superiority of PCI over CABG. Registry data with much interpretation of published literature and information disclosure can we provide holistic and comprehensive larger patient numbers have also unequivocally indicated care to patients with coronary artery disease.
survival benefi ts for patients treated with CABG rather than PCI. A recent report involving 14,493 BARI-like Over the past decade, the techniques and outcomes patients with multivessel coronary disease once again of both CABG and PCI have substantially advanced. confi rmed the signifi cant survival advantage of CABG Nevertheless, as a majority of the previous clinical trials over PCI in a 7-year period (1994–2001; mean follow-up, comparing these two therapeutic strategies have been 3.6 years).39 It is noteworthy that such therapeutic benefi t limited to selected patient populations, optimal treatment was mainly driven by the superior survival after CABG modalities for high-risk patients with complex coronary in patients with 3-vessel disease.39 On the contrary, the lesions and multiple comorbidities remain undetermined. 30-day mortality in the SHOCK trial (302 patients with Although the rapid growth of the PCI industry and the cardiogenic shock after acute myocardial infarction for consequent decline in the caseload for CABG has emergency revascularization) was similar between the generated much speculation about the future role of CABG (57.4%) and PCI (55.6%) groups, although in each type of intervention, so far no valid data exist to indicate that PCI plus DES could replace CABG the former group there was a much greater prevalence entirely. Fortunately, such an opinion is largely shared of diabetes, 3-vessel, and left main disease.40 It must by both surgeons and cardiologists.41–44 While eager to be acknowledged that while PCI has been changing, gain scientifi c knowledge from some on-going important advances in many aspects of the CABG technique have clinical trials, we must bear in mind that the patient with been remarkable. As a result, CABG has been consistently complex coronary disease demands safe and cost-effective regarded as the "gold standard" for treatment of coronary treatment that provides good long-term quality of life. disease worldwide.41 Therefore, the choice of myocardial revascularization 2007, VOL. 15, NO. 3 ASIAN CARDIOVASCULAR & THORACIC ANNALS Surgery or Stenting for an individual patient should not be based simply on the 6. Serruys PW, van Hout B, Bonnier H, Legrand V, Garcia E, anatomical fi ndings. Each patient should be advised by a Macaya C, et al. Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected multidisciplinary team that can present in the most balanced patients with coronary artery disease (Benestent II). Lancet way the advantages and limitations of PCI and CABG.
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some recent randomized and observational studies have 8. Bertrand ME, Lablanche JM, Leroy F, Bauters C, De Jaegere P, documented a consistent and disturbing small increase in Serruys PW, et al. Percutaneous transluminal coronary rotary the absolute risk for late stent-related thrombotic events ablation with Rotablator (European experience). Am J Cardiol with DES. Compared DES (47% sirolimus-eluting, 53% paclitaxel-eluting) with BMS using data from 9. Ramsdale DR, Morris JL. If Rotablator is useful, why don't we 14 randomized trials (involving 6,675 patients), it was use it? Heart 1997;78 Suppl 2:36–7.
found that when stent thromboses occurred more than 10. Stone GW, de Marchena E, Dageforde D, Foschi A, Muhlestein JB, McIvor M, et al. Prospective, randomized, multicenter comparison 30 days after implantation they tended to appear much later of laser-facilitated balloon angioplasty versus stand-alone balloon with DES than with BMS.45 In particular, the thrombosis angioplasty in patients with obstructive coronary artery disease. The incidence was signifi cantly greater with DES than with Laser Angioplasty Versus Angioplasty (LAVA) Trial Investigators. BMS more than 6 months and 1 year after implantation. 45 J Am Coll Cardiol 1997;30:1714–21.
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Sunny H Wong, Song Wan and Malcolm J Underwood Asian Cardiovasc Thorac Ann 2007;15:264-269 This information is current as of August 30, 2010
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