Coronary artery bypass graft versus percutaneous coronary intervention with drug-eluting stent implantation for diabetic patients with unprotected left main coronary artery disease: the D-DELTA registry

Meliga, Emanuele; Benedictis, Mauro De; Chieffo, Alaide; Latib, Azeem; Park, Seung Jung; Kim, Young Hak; Onuma, Yoshinobu; Capranzano, Piera; Jēgere, Sanda; Makkar, Raj; Palacios, Igor F.; Bande, Marta; Chakravarty, Tarun; Mehran, Roxana; Naber, Christoph; Scrocca, Innocenzo; Margey, Ronan; Leon, Martin B.; Moses, Jeffrey W.; Fajadet, Jean; Lefèvre, Thierry; Morice, Marie Claude; Ērglis, Andrejs; Tamburino, Corrado; Alfieri, Ottavio; Conte, Maria Rosa; Serruys, Patrick W.; Colombo, Antonio

doi:10.4244/eijv9i7a133

Cited by 2 publications

(3 citation statements)

References 23 publications

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“…Furthermore, a total of 6 observational studies, including 9360 patients with a mean weighted follow-up of 5.2 years were analyzed [24][25][26][27][28][29]. Of these total patients, 4237 patients (45.3%) were treated by DES-based PCI, and 3669 (39.2%) had DM.…”

Section: Resultsmentioning

confidence: 99%

“…While much information is available regarding outcome definitions for RCTs, observational studies provided less detail and may have been a source of heterogeneity for outcomes other than all-cause mortality. Third, several observational studies had violations of the proportional hazards assumption as CABG may provide more significant benefit during longer follow-ups [24,25,27,29]. However, calculating the restricted mean survival time was not possible without the published adjusted survival curves or individual participant data [43].…”

Section: Discussionmentioning

confidence: 99%

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The effect of diabetes on surgical versus percutaneous left main revascularization outcomes: a systematic review and meta-analysis

d’Entremont

Yagi

Salia

et al. 2022

J Cardiothorac Surg

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Background The optimal method of coronary revascularization for diabetes mellitus (DM) patients with left main coronary artery disease (LMCAD) is controversial in the drug-eluting stent (DES) era. Methods We performed a systematic review and meta-analysis comparing DES-based percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) for LMCAD in DM patients and tested for effect measure modification (EMM) by diabetes for adverse events. We included all randomized controlled trials (RCTs) and observational studies comparing CABG to DES-based PCI including DM patients with LMCAD published up to March 1, 2021. We completed separate random-effects meta-analyses for four RCTs (4356 patients, mean follow-up of 4.9 years) and six observational studies (9360 patients, mean follow-up of 5.2 years). Results In RCTs among DM patients, DES-based PCI, compared to CABG, was associated with a 30% increased relative risk (RR) (RR 1.30, 95% CI 1.09–1.56, I2 = 0%), while among non-DM patients, there was a 25% increased relative risk (RR 1.25, 95% CI 1.07–1.44, I2 = 0%) for the composite endpoint of all-cause mortality, myocardial infarction, stroke, and unplanned revascularization (MACCE). There was no evidence of EMM (p-value for interaction = 0.70). The mean weighted SYNTAX score was 25.7. In observational studies, there was no difference between DES-based PCI and CABG for all-cause mortality in patients with DM (RR 1.13, 95% CI 0.91–1.40, I2 = 0%). Conclusions CABG was superior to PCI for LMCAD in RCTs in DM patients for MACCE. Heart teams may consider DM as one of the many components in the clinical decision-making process, but may not want to consider DM as a primary deciding factor between DES-based PCI and CABG for LMCAD with low to intermediate anatomical complexity in the other coronary arteries. Study registration CRD42021246931 (PROSPERO).

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

The effect of diabetes on surgical versus percutaneous left main revascularization outcomes: a systematic review and meta-analysis

d’Entremont

Yagi

Salia

et al. 2022

J Cardiothorac Surg

View full text Add to dashboard Cite

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“…Although previous subgroup studies of individual randomized trials have attempted to address this issue, they have had limited power in isolation. [3][4][5] Moreover, registry-based studies have been constrained by a high risk of bias and confounding, [6][7][8][9] and no randomized controlled trials have specifically explored this key clinical question. Previous trials comparing PCI and CABG in patients with multivessel disease without left main involvement have suggested that diabetes might be a modulating factor for clinical outcomes, as evidenced by a lower 5-year mortality rate in patients with diabetes after CABG but similar 5-year mortality rate after PCI and CABG in patients without diabetes.…”

mentioning

confidence: 99%

Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Left Main Disease With and Without Diabetes: Findings From a Pooled Analysis of 4 Randomized Clinical Trials

Gaba,

Sabik,

Murphy

et al. 2024

Circulation

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BACKGROUND: Diabetes may be associated with differential outcomes in patients undergoing left main coronary revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). The aim of this study was to investigate outcomes in patients with left main disease with and without diabetes undergoing PCI versus CABG. METHODS: Individual patient data were pooled from 4 trials (SYNTAX [TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries], PRECOMBAT [Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease], NOBLE [PCI vs. CABG in the Treatment of Unprotected Left Main Stenosis], and EXCEL [Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization]) that randomized patients with left main disease to PCI or CABG. Patients were considered suitable for either approach. Patients were categorized by diabetes status. Kaplan-Meier event rates, Cox model hazard ratios, and interactions were assessed. RESULTS: Among 4393 patients, 1104 (25.1%) had diabetes. Patients with diabetes experienced higher rates of 5-year death (158/1104 [Kaplan-Meier rate, 14.7%] versus 297/3289 [9.3%]; P <0.001), spontaneous myocardial infarction (MI; 67/1104 [6.7%] versus 114/3289 [3.7%]; P <0.001), and repeat revascularization (189/1104 [18.5%] versus 410/3289 [13.2%]; P <0.001). Rates of all-cause mortality did not differ after PCI versus CABG in those with (84/563 [15.3%] versus 74/541 [14.1%]; hazard ratio, 1.11 [95% CI, 0.82–1.52]) or without (155/1634 [9.7%] versus 142/1655 [8.9%]; hazard ratio, 1.08 [95% CI, 0.86–1.36; P intHR =0.87) diabetes. Rates of stroke within 1 year were lower with PCI versus CABG in the entire population, with no heterogeneity based on diabetes status ( P intHR =0.51). The 5-year rates of spontaneous MI and repeat coronary revascularization were higher after PCI regardless of diabetes status (spontaneous MI: 45/563 [8.9%] versus 22/541 [4.4%] in diabetes and 82/1634 [5.3%] versus 32/1655 [2.1%] in no diabetes, P intHR =0.47; repeat revascularization: 127/563 [24.5%] versus 62/541 [12.4%] in diabetes and 254/1634 [16.3%] versus 156/1655 [10.1%] in no diabetes, P intHR =0.18). For spontaneous MI and repeat revascularization, there were greater absolute excess risks beyond 1 year in patients with diabetes (4.9% and 9.9%) compared with those without (2.1% and 4.3%; P intARD =0.047 and 0.016). CONCLUSIONS: In patients with left main disease considered equally suitable for PCI or CABG and with largely low to intermediate SYNTAX scores, diabetes was associated with higher rates of death and cardiovascular events through 5 years. Compared with CABG, PCI resulted in no difference in the risk of death, a lower risk of early stroke regardless of diabetes status, and a higher risk of spontaneous MI and repeat coronary revascularization, with larger late absolute excess risks in patients with diabetes. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT01205776, NCT0146651, NCT00422968, and NCT00114972

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Coronary artery bypass graft versus percutaneous coronary intervention with drug-eluting stent implantation for diabetic patients with unprotected left main coronary artery disease: the D-DELTA registry

Abstract: In diabetic patients with ULMCA disease with/without concomitant multivessel disease, PCI and CABG led to similar results in terms of death, MI and CVA. However, CABG was associated with less MACCE at long-term follow-up, primarily due to the higher repeat revascularisation rate with DES.

Cited by 2 publications

References 23 publications

The effect of diabetes on surgical versus percutaneous left main revascularization outcomes: a systematic review and meta-analysis

The effect of diabetes on surgical versus percutaneous left main revascularization outcomes: a systematic review and meta-analysis

Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Left Main Disease With and Without Diabetes: Findings From a Pooled Analysis of 4 Randomized Clinical Trials

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