Real-world outcome of coronary bifurcation lesions in the drug-eluting stent era: results from the 4,314-patient Italian Society of Invasive Cardiology (SICI-GISE) Italian Multicenter Registry on Bifurcations (I-BIGIS).

BACKGROUND: Drug-eluting stents (DESs) introduction has somewhat renewed the issues of strategy and stenting technique for treatment of bifurcation lesions. In particular, concerns remain on extensive use of DESs, especially in the side branch, and on time of dual antiplatelet therapy (DAT) discontinuation, reflecting lack of pertinent long-term data. This study aimed to evaluate clinical safety and efficacy of different strategies for bifurcations treatment in a large observational real-world registry. METHODS: A multicenter, retrospective Italian study of consecutive patients undergoing bifurcation percutaneous coronary intervention between January 2002 and December 2006 was performed. The primary end point was the long-term rate of major adverse cardiac events (MACEs). The role of DAT length on outcome was also analyzed. RESULTS: A total of 4,314 patients (4,487 lesions) were enrolled at 22 independent centers. In-hospital procedural success rate was 98.7%. After median follow-up of 24 months, MACEs occurred in 17.7%, with cardiac death in 3.4%, myocardial infarction in 4.0%, target lesion revascularization in 13.2%, and stent thrombosis in 2.9%. Extensive multivariable analysis showed that MACEs were independently predicted by age, diabetes, renal failure, systolic dysfunction, multivessel disease, myocardial infarction at admission, restenotic lesion, bare-metal stent implantation, complex stenting strategy, and short duration of DAT. CONCLUSIONS: This large study based on current clinical practice in an unselected patient population presenting with bifurcation disease and submitted to percutaneous coronary intervention demonstrated favorable long-term clinical results in this challenging patient setting, especially when DESs, simple stenting strategy, and DAT for at least 6 months are used.

Are drug-eluting stents superior to bare-metal stents in patients with unprotected non-bifurcational left main disease? Insights from a multicentre registry.

AIMS: To compare long-term clinical outcome following drug-eluting stents (DES) or bare-metal stents (BMS) implantation on lesions located at the ostium or the shaft of the left main in a large real-world population. The advent of DES decreased the risk of unprotected left main coronary artery (ULMCA) restenosis when compared with BMS, but it is unclear if this advantage continues when non-bifurcational lesions are considered. METHODS AND RESULTS: The GISE-SICI registry is a retrospective, observational multicentre registry promoted by the Italian Society of Invasive Cardiology in which 19 high-volume participating centres enrolled 1453 consecutive patients who underwent percutaneous coronary intervention on ULMCA between January 2002 and December 2006. From the registry, a total of 479 consecutive patients with ostial and shaft lesions who underwent DES (n = 334) or BMS (n = 145) implantation were analysed with extensive multivariable and propensity score adjustments. At 3-year follow-up, risk-adjusted survival rates were higher in patients treated with DES than in those treated with BMS. The adjusted hazard ratio (HR) for the risk of mortality after DES implantation relative to BMS implantation was 0.37 (95% CI: 0.15-0.96, P = 0.04). The adjusted HR for the risk of cardiac mortality was 0.31 (95% CI: 0.09-1.04, P = 0.06). The adjusted 3-year rates of target lesion revascularization (TLR) were not significantly lower in the DES group than in the BMS group (P = 0.60). CONCLUSION: In a large population of patients with lesions located at the ostium or the shaft of the left main in a real-world setting, DES were associated with favourable clinical outcomes when compared with BMS, although there was no evidence of a significant reduction in TLR with DES vs. BMS.

Early and long-term outlook of percutaneous coronary intervention for bifurcation lesions in young patients.

BACKGROUND: Coronary artery disease is most common in older patients, but may occur in younger subjects. The outlook of young patients after percutaneous coronary intervention (PCI) of challenging lesion subsets such as coronary bifurcations, is not established. We thus aimed to appraise the early and long-term results of PCI for bifurcations in young patients. METHODS: A multicenter, retrospective study was conducted enrolling consecutive patients undergoing bifurcation PCI between 2002 and 2006 in 22 Italian centers. Patients were divided in 2 groups: age ≤ 45 years, and age > 45 years. The primary end-point was long-term rate of major adverse cardiac events (MACE). RESULTS: 4,314 patients were included: 195 (4.5%) in the younger group, and 4119 (95.5%) in the older group. 30-day outcomes did not show significant differences in MACE rates, with 1.0% in the ≤ 45 years group and 2.1% in the >45 years group (p=0.439), with death in 0.5% and 1.2% (p=0.388). At long-term follow-up (24.4 ± 15.1 months), younger patients showed similar rates of MACE, (12.8% vs. 16.6%, p=0.161), myocardial infarction (3.1% vs. 3.7%, p=0.633), target lesion revascularization (11.3% vs. 12.5%, p=0.627), or stent thrombosis (1.5% vs. 2.8%, p=0.294), despite an increased risk of death in older patients (1.0% vs. 5.0%, p=0.012). Even at extensive multivariable analysis, younger patients still faced a similar risk of MACE (HR=0.78 [0.48-1.27], p=0.318). CONCLUSIONS: Despite their low age, young patients undergoing PCI for bifurcation face a significant risk of early and late non-fatal adverse events. Thus, they should not be denied careful medical management and follow-up.

Simplifying clinical risk prediction for percutaneous coronary intervention of bifurcation lesions: the case for the ACEF (age, creatinine, ejection fraction) score.

AIMS: We aimed to appraise the predictive accuracy of a novel and user-friendly risk score, the ACEF (age, creatinine, ejection fraction), in patients undergoing PCI for coronary bifurcations. METHODS AND RESULTS: A multicentre, retrospective study was conducted enrolling consecutive patients undergoing bifurcation PCI between January 2002 and December 2006 in 22 Italian centres. Patients with complete data to enable computation of the ACEF score were divided into three groups according to tertiles of ACEF score. The primary endpoint was 30-day mortality. The discrimination of the ACEF score as a continuous variable was also appraised with area under the curve (AUC) of the receiver-operating characteristic. A total of 3,535 patients were included: 1,119 in the lowest tertile of ACEF score, 1,190 in the mid tertile, and 1,153 in the highest tertile. Increased ACEF score was associated with significantly different rates of 30-day mortality (0.1% in the lowest tertile vs. 0.5% in the mid tertile and 3.0% in the highest tertile, p<0.001), with similar differences in myocardial infarction (0.3% vs. 0.7% and 1.8%, p<0.001) and major adverse cardiac events (MACE, 0.5% vs. 1.2% and 4.3%, p<0.001). After an average follow-up of 24.4±15.1 months, increased ACEF score was still associated with a higher rate of all-cause death (1.3% vs. 2.4% and 11.0%, p<0.001), cardiac death (0.9% vs. 1.4% and 7.2%, p<0.001), myocardial infarction (3.4% vs. 2.7% and 5.7%, p<0.001), MACE (13.6% vs. 15.9% and 22.3%, p<0.001), and stent thrombosis (2.3% vs. 1.8% and 5.0%, p<0.001). Discrimination of ACEF score was satisfactory for 30-day mortality (AUC=0.82 [0.77-0.87], p<0.001), 30-day MACE (AUC=0.73 [0.67-0.78], p<0.001), long-term mortality (AUC=0.77 [0.74-0.81], p<0.001), and moderate for long-term MACE (AUC=0.60 [0.57-0.62], p<0.001). CONCLUSIONS: The simple and extremely user-friendly ACEF score can accurately identify patients undergoing PCI for coronary bifurcation lesions at high risk of early fatal or non-fatal complications, as well as long-term fatality.

Impact of drug-eluting stents and diabetes mellitus in patients with coronary bifurcation lesions: a survey from the Italian Society of Invasive Cardiology.

BACKGROUND: We investigated the long-term impact of different stent types and diabetes mellitus (DM) in patients undergoing percutaneous coronary intervention (PCI) of bifurcation lesions, based on a large multicenter survey endorsed by the Italian Society of Invasive Cardiology. METHODS AND RESULTS: Relative benefits of drug eluting stent (DES) over bare metal stent (BMS) in patients with (n=1049) and without (n=3020) DM were analyzed with extensive multivariable adjustment. At 3 years, stenting with DES was associated with lower adjusted risk of major adverse cardiac events (MACE, adjusted hazard ratio [HR] 0.27, 95% confidence interval [CI] 0.15 to 0.49, P<0.001), cardiac death, and target lesion revascularization in DM patients but failed to demonstrate any significant benefit in patients without DM. CONCLUSIONS: In a large observational registry with admitted potential for selection bias and residual confounding, DES in DM patients with coronary bifurcation lesions were associated with improved outcomes in terms of MACE, cardiac death, and repeat revascularization at long-term follow up. These figures were not replicated in non-DM subjects.

Sicilian DES Registry: prospective in-hospital and 9-month clinical and angiographic follow-up in selected high restenosis risk patients.

OBJECTIVE: This is a multicentre, open label, prospective non-randomized registry, with 9-month angiographic follow-up, conducted to evaluate the safety and effectiveness of drug-eluting stents (DES) when used in high restenosis risk patients from the real world. METHODS: From June 2004 to February 2005, a total of 1622 consecutive patients were enrolled to the Sicilian DES Registry, according to specific inclusion criteria. Both paclitaxel-eluting and sirolimus-eluting stents were used. The analysis was performed on 1472 patients because 150 patients were excluded from the study. The primary endpoint was to evaluate the rate of major adverse cardiac events (MACE) within 9 months after DES implantation. Major adverse cardiac events were defined as cardiac death, non-Q-wave or Q-wave myocardial infarction (MI) and target vessel revascularization (TVR). The secondary endpoints were procedural success, angiographic binary restenosis and stent thrombosis within 9 months post-procedure. RESULTS: Patients were more frequently male; 472 (32.1%) were diabetics, of whom 130 (27.5%) were treated with insulin. Mean ejection fraction of the left ventricle was 51.5 +/- 8.7%. Multivessel disease was found and treated in 627 patients (42.6%). A total of 2439 lesions were treated with DES. Final angiographic success was achieved in 2422 (99.3%) lesions. Procedural success was achieved in 1422 (96.6%) patients. The 9-month cumulative incidence of MACE was 7.3% with 0.8% of cardiac deaths, 0.8% non-fatal MI, 7.9% TVR. Binary restenosis was observed in 101 patients (8.3%). Stent thrombosis was documented in 11 patients (0.8%). CONCLUSIONS: Drug-eluting stents appear to be safe and associated with a low incidence of MACE at 9-month follow-up, even in patients selected for their complexity.