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. Author manuscript; available in PMC: 2011 Apr 8.
Published in final edited form as: JACC Cardiovasc Interv. 2010 Jun;3(6):602–611. doi: 10.1016/j.jcin.2010.03.019

Drug-Eluting Stents versus Bare Metal Stents in Unprotected Left Main Coronary Artery Stenosis: a Meta-Analysis

Sanjay B Pandya §, Young-Hak Kim †, Sheridan N Meyers §, Charles J Davidson §, James D Flaherty §, Duk-Woo Park †, Anuj Mediratta §, Karen Pieper , Eric Reyes , Robert O Bonow §, Seung-Jung Park †, Nirat Beohar §
PMCID: PMC3072800  NIHMSID: NIHMS278767  PMID: 20630453

Abstract

Objectives

We undertook a meta-analysis to assess outcomes for drug-eluting (DES) and bare metal stents (BMS) in percutaneous coronary intervention (PCI) for unprotected left main coronary stenosis (LMCA).

Background

Uncertainty exits regarding the relative performance of DES versus BMS in unprotected LMCA PCI.

Methods

Of a total of 838 studies, 44 met inclusion criteria (N=10,342). The co-primary endpoints were mortality, myocardial infarction (MI), target vessel/target lesion revascularization (TVR/TLR), and major adverse cardiac events (MACE: mortality, MI, TVR/TLR).

Results

Event rates for DES and BMS were calculated at 6–12 months, at 2 years and at 3 years. Crude event rates at 3 years were: mortality (8.8% and 12.7%), MI (4.0% and 3.4%), TVR/TLR (8.0% and 16.4%), and MACE (21.4% and 31.6%). Nine studies were included in a comparative analysis (N=5,081). At 6–12 months the adjusted odds ratio (OR) for DES vs. BMS were: mortality 0.94 (95% confidence interval [CI] 0.06–15.48; p=0.97), MI 0.64 (95% CI 0.19–2.17; p=0.47), TVR/TLR 0.10 (95% CI 0.01–0.84; p=0.01) and MACE 0.34 (95% CI 0.15–0.78; p=0.01). At 2 years the OR were: mortality 0.42 (95% CI 0.28–0.62; p<0.01), MI 0.16 (95% CI 0.01–3.53; p=0.13), and MACE 0.31 (95% CI 0.15–0.66; p<0.01). At 3 years the OR were: mortality 0.70 (95% CI 0.53–0.92; p=0.01), MI 0.49 (95% CI 0.26–0.92; p=0.03), TVR/TLR 0.46 (95% CI 0.30–0.69; p<0.01), and MACE 0.78 (95% CI 0.57–1.07; p=0.12).

Conclusion

Our meta-analysis suggests that DES is associated with favorable outcomes for mortality, MI, TVR/TLR, and MACE as compared to BMS in unprotected LMCA PCI.

Introduction

Unprotected left main coronary artery stenosis (LMCA) is associated with poor clinical outcomes. Studies have shown improved long-term outcomes in those who undergo surgical revascularization as compared to optimal medical therapy alone (1,2). This is the basis for the ACC/AHA class I recommendation for coronary artery bypass surgery (CABG) in patients with ≥ 50% left main stenosis (3).

Early percutaneous attempts at revascularization with balloon-only angioplasty were associated with suboptimal clinical outcomes (4). This led to an ACC/AHA class III (contraindicated) guidelines recommendation for percutaneous coronary intervention (PCI) in CABG-eligible patients (5). The subsequent advent of coronary stents, which reduced peri-procedural risks and improved clinical outcomes, renewed interest in unprotected LMCA PCI. This interest was further fueled by the subsequent introduction of drug-eluting stents (DES), which led to substantially lower rates of restenosis in coronary lesions (6,7). On the basis of improved clinical outcomes, the most recent ACC/AHA guidelines have given unprotected LMCA PCI a class IIb recommendation (8).

However, there remains some clinical uncertainty over the ideal stent type for unprotected LMCA PCI. The use of DES in the left main position is considered an off-label application; prior studies have identified increased adverse events for such off-label applications (9). Additionally, although the reduction in restenosis seen with DES use is particularly attractive for unprotected LMCA PCI, the large caliber of most left main arteries could attenuate this benefit. Finally, concern exists over potentially increased rates of late stent thrombosis with DES, which has serious implications in unprotected LMCA PCI (10).

We performed a meta-analysis of the current literature to assess outcomes of PCI in unprotected LMCA and to compare the relative performance of DES and BMS in this application.

Methods

Search strategy

Pubmed, clinicaltrials.gov, and BioMedCentral databases were searched from January 2000 to September 2009; there were no language restrictions. Search terms included “left main”, “coronary”, “intervention”, and “stenting”. Citations were screened and evaluated using the established inclusion/exclusion criteria at the abstract level by two operators (SP and NB), and relevant studies were retrieved as full manuscripts. Inclusion criteria were: a) involving unprotected left main disease, b) involving bare metal or drug eluting stents, and c) involving at least 20 patients in the overall study cohort. Exclusion criteria were defined as: a) unpublished studies, b) abstract only, c) angioplasty without stenting d) ST elevation myocardial infarction, e) cardiogenic shock, f) experimental devices, g) non-English studies, h) studies not reporting relevant clinical outcomes. Data regarding patient demographics and clinical outcomes were then entered into a database.

Endpoints

The co-primary endpoints were mortality, myocardial infarction (MI), target vessel/target lesion revascularization (TVR/TLR), and major adverse cardiovascular events (MACE, defined as mortality, MI, and TVR/TLR). These endpoints were reported for the following time periods post-PCI: 6–12 months, 2 years, and 3 years. Data for all endpoints at each time period were not available for every study.

Statistical analysis

Crude event rates were reported for mortality, MI, and TVR/TLR for both DES and BMS. Since these estimates were based, in part, on studies for which a causal link between stent type and outcome was not established, direct comparison of rates is not appropriate, and rates can only be seen as descriptive in nature. Subsequent comparative analysis was performed evaluating studies that provided adjusted outcomes on relevant endpoints or were randomized according to stent types; odds ratios (OR) were reported for this analysis. When both hazard ratios (HR) and OR were reported as endpoints across trials they were combined, assuming that the follow-up was fairly complete (and thus the HR would be similar to the expected OR). Similarly, Kaplan-Meier rates and percentages were combined when one of the two was not available for an endpoint. Several endpoints did not meet the assumption of homogeneity of rates across studies, and thus random effects modeling techniques were used to combine rates and calculate confidence intervals. Comprehensive Meta Analysis software version 2.2.048 was used for all analyses (Comprehensive Meta Analysis, www.Meta-Analysis.com)(11).

Results

Database searches retrieved an initial 838 studies, of which 76 were deemed relevant; 32 of these studies were eventually excluded. A final 44 studies meeting inclusion/exclusion criteria were included in the analysis, consisting of 10,342 patients (see Figure 1). Studies fell into general categories involving a) use of only BMS, b) use of only DES, c) comparative studies of BMS versus DES, or d) comparison studies of PCI versus CABG (see Table 1).

Figure 1.

Figure 1

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Methods

Table 1.

Included studies

Study Year Design Stent
Type		 N DES
(N)		 BMS
(N)		 Location Follow-up
(months)
BMS only studies: 5
Black (50) 2001 Retrospective Cohort study BMS 92 0 92 Europe 7+/−5
Kelley (51) 2003 Retrospective cohort study BMS 43 0 43 US/Europe 12
Lee BK (52) 2007 Propective cohort study BMS 187 0 187 Asia 71+/26
Silvestri (53) 2000 Prospective cohort study BMS 140 0 140 Europe 12
Takagi (54) 2002 Prospective cohort study BMS 64 0 64 Europe 31+/−23
DES only studies: 21
Agostini (55) 2005 Retrospective cohort study DES 58 58 0 Europe 15
Arampatzis (56) 2003 Retrospective cohort study DES 31 31 0 Europe 5.1+/−1.8
Chieffo (57) 2007 Retrospective cohort study DES 147 147 0 US/Asia/Europe 30+/−10
Chieffo (58) 2008 Retrospective cohort study DES 731 731 0 US/Asia/Europe 29+/−13
Cherradi (59) 2008 Prospective cohort study DES 101 101 0 Europe 12+/−3
de Lezo(60) 2004 Prospective cohort study DES 52 52 0 Europe 12
Ge L (61) 2007 Retrospective cohort study DES 70 70 0 Asia/Europe 12
Khattab (62) 2007 Prospective cohort study DES 82 82 0 Europe 36
Kim (63) 2006 Retrospective cohort study DES 116 116 0 Asia 18
Kim (64) 2008 Retrospective cohort study DES 63 63 0 US 12+/−8
Lee, SH (65) 2005 Nonrandomized study (SES vs PES) DES 54 54 0 Asia 6
Lozano (66) 2004 Prospective cohort study DES 42 42 0 Europe 11
Mehilli (67) 2009 Randomized controlled trial (SES vs PES) DES 607 607 0 Europe 24
Meliga (68) 2008 Retrospective cohort study DES 358 358 0 US/Europe 36
Migliorini (69) 2006 Prospective cohort study DES 101 101 0 Europe 10+/−6
Price (70) 2006 Prospective cohort study DES 50 50 0 US 9
Sanmartin (71) 2007 Prospective cohort study DES 100 100 0 Europe 12
Sheiban (72) 2007 Prospective cohort study DES 85 85 0 Europe 20+/−7
Vaquerizo (73) 2009 Prospective cohort study DES 291 291 0 Europe 24
Vecchio (74) 2007 Prospective cohort study DES 114 114 0 Europe 17+/−9
Wood (75) 2008 Retrospective cohort study DES 100 100 0 US 28
BMS and DES studies: 12
Cheiffo (76) 2005 Nonrandomized study DES vs BMS 149 85 64 Europe 6
Erglis (12) 2007 Randomized Controlled Trial DES vs BMS 103 53 50 Australia 6
Gao (77) 2008 Nonrandomized study DES vs BMS 424 220 224 Asia 15
Han (78) 2009 Nonrandomized study DES vs BMS 287 178 109 Asia 35+/−14
Hertting (79) 2008 Nonrandomized study DES vs BMS 54 16 38 Europe 24
Kim (80) 2009 Nonrandomized study DES vs BMS 1217 864 353 Asia 36
Palmerini (81) 2008 Nonrandomized study DES vs BMS 1453 1111 342 Europe 24
Park (63) 2005 Nonrandomized study DES vs BMS 123 102 121 Asia 12
Schrale (82) 2008 Retrospective cohort study DES and BMS 100 55 45 Europe 21+/−14
Tamburino (83) 2009 Nonrandomized study DES vs BMS 849 611 238 Europe 36
Tamburino (84) 2009 Nonrandomized study DES vs BMS 479 334 145 Europe 36
Wood (85) 2005 Nonrandomized study DES vs BMS 161 61 100 US 12
PCI/CABG studies: 6
Buszman (86) 2008 Randomized controlled trial CABG vs PCI 52 18 34 Europe 28+/−10
Chieffo (87) 2006 Nonrandomized study CABG vs DES 107 107 0 Europe 12
Makikallo (88) 2008 Nonrandomized study CABG vs DES 49 49 0 Europe 12+/−6
Palmerini (89) 2006 Nonrandomized study CABG vs PCI 157 94 63 Europe 14
Sanmartin (90) 2007 Nonrandomized study CABG vs DES 96 96 0 Europe 13+/−8
Seung (91) 2008 Randomized Controlled Trial CABG vs PCI 603 396 207 Asia 34
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Patient demographics in the group undergoing BMS placement were generally similar to those undergoing DES placement (see Table 2). There was incomplete reporting of baseline demographics across studies. Medication profiles – including duration of antiplatelet drug therapy – were inconsistently reported.

Table 2.

Baseline Patient Demographics for Studies Included in the Overall Analysis

DES BMS
n n
Age (years) 4768 67.5 (65.8 – 69.3) 1621 67.8 (66.0 – 69.7)
Percent (95% CI) Percent (95% CI)
Male 6464 74 (73 – 75) 2091 61 (69 – 73)
Diabetes Mellitus (DM) 6691 28 (27 – 29) 2170 22 (20 – 23)
    Insulin dependent DM 85 11.0 (4.2 – 17.8) 63 8.9 (1.9 – 15.9)
Hypertension 6297 65 (64 – 67) 2032 53 (51 – 55)
Hypercholesterolemia 6111 57 (57 – 59) 1892 39 (36 – 41)
History of Prior MI 3036 23 (21 – 24) 1165 12 (10 – 14)
History of PCI 1912 19 (18 – 21) 794 13 (10 – 15)
COPD 1962 9.4 (7.9 – 10.9) 996 1.6 (0.8 – 2.4)
Renal Insufficiency 3570 7.7 (6.8 – 5.5) 1241 4.5 (3.4 – 5.6)
Peripheral Arterial Disease 1168 6.8 (5.5 – 8.2) 560 0.9 (0.03– 1.9)
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*

n refers to the number of patients within the studies who contributed to the estimate of interest. Rates are the estimated percent of patients with the characteristic, and associated 95% confidence intervals.

Estimates of rates for mortality, MI, and TVR/ TLR at each of the three recorded time points are displayed in Table 3. The rates of events are numerically higher for patients treated with BMS for most endpoints, at most timepoints. However, without adjustment, the significance and/or relevance of the differences noted cannot be fully determined. As expected, the overall rates of events are higher in patients undergoing unprotected LMCA PCI than in conventional PCI patients.

Table 3.

Estimated Cumulative Event Rates by Stent Type in the Overall Analysis

Stent
Type		 6–12 Months 2 years 3 years
Mortality DES 5.94%
(4.73% – 7.44%)
n = 2691		 7.89%
(6.07% – 10.20%)
n = 4430		 8.80%
(6.20% – 12.34%)
n = 2912
BMS 7.24%
(3.51% – 14.33%)
n = 763		 14.14%
(8.96% – 21.62%)
n = 1266		 12.71%
(6.94% – 22.15%)
n = 959
MI DES 6.26%
(4.71% – 8.27%)
n = 2356		 3.90%
(1.98% – 7.55%)
n = 2182		 4.04%
(2.33% – 6.91%)
n = 2516
BMS 9.97%
(6.09% – 15.90%)
n = 157		 3.06%
(1.18% – 7.69%)
n = 607		 3.43%
(1.87% – 6.21%)
n = 752
TVR/TLR DES 7.83%
(5.95% – 10.24%)
n = 2257		 10.20%
(8.55% – 12.13%)
n = 4772		 8.03%
(5.62% – 11.37%)
n = 2912
BMS 16.95%
(12.92% – 21.92%)
n = 985		 16.15%
(13.93% – 18.66%)
n = 1241		 16.40%
(12.23% – 21.64%)
n = 959
MACE DES 15.87%
(12.93%-19.32%)
n=2593		 18.99%
(14.92%-23.86%)
n=2623		 21.43%
(14.85%-29.91%)
n=1652
BMS 39.31%
(31.68%-47.50%)
n=554		 32.69%
(17.72%-52.26%)
n=441		 31.60%
(23.15%-41.47%)
n=399
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*

n refers to the number of patients within the studies who contributed to the estimate of interest. Rates are the estimated percent of patients with the event and associated 95% confidence intervals.

Subsequent analysis was performed on those studies comparing DES and BMS and providing either adjusted event rates, or randomization according to stent type. Of the 12 comparative studies, 9 studies reported relevant endpoints, consisting of 5,081 patients (see Table 4). Most utilized propensity scoring for adjustment. Comparative event estimates for DES versus BMS were calculated (see Table 5). At 6–12 months, the OR for mortality was 0.94 (95%CI 0.06 – 15.48, p=0.97) and for MI was (0.64, 95%CI 0.19 – 2.17, p = 0.47). The OR clearly favored DES for TVR/TLR (0.10, 95%CI 0.01 – 0.84, p=0.01) and MACE (0.34, 95%CI 0.15 – 0.78, p=0.01) at 6–12 months. At 2 years the OR favored DES for mortality (0.42, 95%CI 0.28 – 0.62, p<0.01) and MACE (0.31, 95%CI 0.15 – 0.66, p<0.01); the OR for MI did not reach statistical significance (0.16, 95%CI 0.01 – 3.53, p=0.13). The OR for TVR/TLR at 2 years could not be estimated due to a lack of reported data. Findings at 3 years favored DES for mortality (0.70, 95%CI 0.53 – 0.92, p=0.01), MI (0.49, 95%CI 0.26 – 0.92, p=0.03), and TVR/TLR (0.46, 95%CI 0.30 – 0.69, p<0.01); the OR for MACE did not reach statistical significance (0.78, 95%CI 0.57 – 1.07, p=0.12).

Table 4.

Comparative studies of DES versus BMS

Design Method of
Adjustment		 DES
(n)		 BMS
(n)		 F/u
(months)		 Adjusted
Point
Estimate
Mortality at
f/u		 Adjusted
Point
Estimate
MI at f/u		 Adjusted
Point
Estimate
TVR/TLR at
f/u		 Adjusted
Point
Estimate
MACE at
f/u
Chieffo 2005 (76) Nonrandomized study Propensity score matching 85 64 6 N/A N/A OR 0.28
(0.09–0.81)
p=0.01		 OR 0.27
(0.09–0.73)
p=0.007
Erglis 2007 (12) Randomized Controlled trial Randomization 53 50 6 OR 0.94
(0.06–15.48)
p=1.00		 OR 0.64
(0.19–2.17)
p= 0.47		 OR 0.10
(0.01–0.84)
p=0.01		 OR 0.36
(0.13–0.96)
p=0.04
Gao 2008 (77) Prospective Cohort study (DES compared to historical BMS cohort) Propensity score matching 220 224 15 N/A N/A N/A OR 0.49
(0.26–0.94)
p=0.032
Han 2009 (78) Prospective Cohort study Propensity score matching 178 109 35+/−14 OR 0.25
(0.08–0.81)
p<0.01		 OR 0.16
(0.01–3.53)
p=0.13		 OR 0.26
(0.08–0.83)
p<0.001		 OR 0.23
0.09–0.56)
p<0.001
Kim 2009 (80) Prospective Cohort study Weighting with propensity score 864 353 36 HR 0.86
(0.50–1.47)
p=0.569		 N/A HR 0.32
(0.17–0.61)
P<0.001		 HR 0.81
(0.54–1.21)
p=0.31
Palmerini 2007 (40) Nonrandomized study Propensity score as a covariate 1111 342 24 HR 0.48
(0.32–0.74)
p=0.002		 N/A N/A N/A
Schrale 2008 Retrospective Cohort study Multivariate Cox regression 55 45 21+/14 HR 0.23
(0.06–0.91)
p=0.034		 N/A N/A N/A
Tamburino 2009 (83) Nonrandomized study Propensity score matching 611 238 36 HR 0.75
(0.52–1.12)
p=0.17		 HR 0.49
(0.26–0.92)
p=0.03		 HR 0.46
(0.29–0.74)
p=0.001		 N/A
Tamburino 2009 (84) Nonrandomized study Propensity score matching 334 145 36 HR 0.51
(0.30–0.86)
p=0.01		 N/A HR 0.79
(0.33–1.90)
p=0.39		 HR 0.73
(0.44–1.21)
p=0.22
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*

n refers to the number of patients within the studies who contributed to the estimate of interest. Odds ratios (OR) and Hazard ratios (HR) are reported with 95% confidence intervals.

Table 5.

Cumulative Odds Ratios for Comparative Studies (DES versus BMS)

Time Contributing studies DES
(n)		 BMS
(n)		 OR
(95% CI)		 P value
Mortality 6–12months Erglis 2007(12) 53 50 0.94
(0.06–15.48)		 p=0.97
2 years Han 2009 (78)
Palmerini 2007 (40)
Schrale 2008 (82)		 1344 496 0.42
(0.28–0.62)		 p<0.01
3 years Kim 2009 (80)
Tamburino 2009 (83)
Tamburino 2009 (84)		 1809 736 0.70
(0.53–0.92)		 p=0.01
MI 6–12 months Erglis 2007(12) 53 50 0.64
(0.19–2.17)		 p= 0.47
2 years Han 2009 (78) 178 109 0.16
(0.01–3.53)		 p=0.13
3 years Tamburino 2009 (83) 611 238 0.49
(0.26–0.92)		 p=0.03
TVR/TLR 6–12 months Erglis 2007(12) 53 50 0.10
(0.01–0.84)		 p=0.01
2 years No studies -- -- -- --
3 years Kim 2009 (80)
Tamburino 2009 (83)
Tamburino 2009 (84)		 1809 736 0.46
(0.30–0.69)		 p<0.01
MACE 6–12 months Chieffo 2005 (76)
Erglis 2007(12)		 138 114 0.34
(0.15–0.78)		 P=0.01
2 years Gao 2008 (77)
Han 2009 (78)		 398 333 0.31
(0.15–0.66)		 P<0.01
3 years Kim 2009 (80)
Tamburino 2009 (84)		 1198 498 0.78
(0.57–1.07)		 P=0.12
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*

n refers to the number of patients within the studies who contributed to the estimate of interest. OR are reported with 95% confidence intervals.

Discussion

PCI is increasingly being performed for lesions previously considered contraindicated, such as unprotected LMCA. Given the lower rates of restenosis reported with DES in PCI of standard coronary lesions, there has been a trend towards their use in unprotected LMCA PCI. However, the superiority of DES over BMS for unprotected LMCA has not been clearly established.

We reviewed the literature on unprotected LMCA PCI to compare outcomes between DES vs. BMS. We identified 44 studies involving PCI for unprotected LMCA as a source for crude event rates. Crude event rates were lower for DES than BMS for mortality, TVR/TLR and MACE at 6–12 months, 2 years, and 3 years, but appeared equivalent for MI at these same timeponts. However, these rates are unadjusted, rendering them prone to selection bias and confounding.

To address this, we performed a subsequent analysis involving studies that provided adjusted event rates or randomized patients according to stent type (DES vs. BMS). Although event rates at 6–12 months favored DES, the sample size was small, involving predominantly one study (12). At 2 and 3 years post-PCI, the sample size was larger and improved outcomes with DES over BMS were observed for mortality, MI, TVR/TLR, and MACE. Statistically significance differences were observed in most cases.

Although the finding of lower TVR/TLR rates is consistent with the known performance of DES, no study to date has shown a consistent mortality benefit with DES over BMS in unprotected LMCA PCI. The reason for the lower mortality rate in the DES group seen in our meta-analysis is unclear. It may be that DES, with known lower rates of restenosis, provides a true advantage over BMS. In the critical left main position a small or moderate degree of restenosis could theoretically precipitate critical ischemia. Alternatively, this finding could be due to methodological issues. Selection bias may have favored DES: patients with fewer medical comorbidities may have preferentially undergone DES placement. A review of overall patient demographics in our analysis does not support this, as similar rates of cardiac risk factors were found between both groups (see Table 2). An alternative explanation may relate to a procedural learning curve, as operators may have become more technically proficient at unprotected LMCA PCI by the time DES were favored. Finally, as medication profiles at baseline and follow-up were not consistently reported, it is possible that the benefit seen with DES could be due, in part, to a longer duration of dual antiplatelet drug therapy as compared to BMS. Similarly, patients deemed to be poor candidates for long-term dual or triple antiplatelet therapy may have been denied treatment with DES.

A recent meta-analysis of patients undergoing DES for unprotected LMCA by Biondi-Zoccai et al noted similar findings, reporting an adjusted OR of 0.34 for both MACE and TVR, favoring DES over BMS (13). This meta-analysis was performed through 2006 and included far fewer patients than our analysis (206 DES patients, 190 BMS patients). Since our analysis was performed, Buszman et al have reported on the long-term follow-up of a group of 252 patients from the LE-MANS registry (14). Their results mirror ours. Unmatched analysis showed a significantly lower rate of major adverse cardiovascular or cerebral events (MACCE) with DES as compared to BMS at four-year follow-up (14.9% vs. 25.9%, p=0.039); subsequent propensity matched analysis showed similar results. They noted that mortality rates favored DES, although this did not reach statistical significance (9.6% vs. 13.3%, p=NS). In a subgroup of patients with distal unprotected LMCA, however, DES was associated with a statistically significant lower mortality rate as compared to BMS (p=0.03). Results from the left main subset of the SYNTAX trial (15) were presented at TCT 2008. Reported 12 month DES event rates were similar to our cumulative crude estimates, with a rate of 4.2% for mortality, 4.3% for MI, and 15.8% for major cardiac or cerebrovascular adverse events (MACCE) (16). As these results have yet to be published they were not included in our analysis. SYNTAX did not include a BMS arm and thus would not impact our comparative analysis.

Currently there are no large, randomized controlled clinical trials comparing DES to BMS in unprotected LMCA. Two ongoing studies comparing PCI with DES to CABG for unprotected LMCA (PRE-COMBAT and REVASCULARIZE) do not include a comparison with BMS. Therefore our meta-analysis may offer evidence to guide clinical practice.

Study limitations

Our study has clear limitations. The limitations of the meta-analytical approach are well known and documented (17); the meta-analytical approach with observational data is even more fraught with limitations (18). The inclusion of only published studies makes our analysis prone to publication bias. Our results, particularly the crude event rates, are prone to confounding and selection bias and thus direct comparison of these overall rates was not performed. We did not have data for all studies at each time period; therefore this limits comparison of rates across time within a specific endpoint. Finally, we were unable to control for the specific type of DES or BMS used, as some studies suggest heterogenous outcomes within the stent types.

Conclusions

The results of this meta-analysis suggest that DES is associated with favorable outcomes as compared to BMS in unprotected LMCA PCI. The improved outcomes observed with DES compared to BMS support a continued re-evaluation of the role of PCI for the treatment of unprotected LMCA.

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