Long-term clinical results following stenting of the left main stem: insights from RESEARCH (Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital) and T-SEARCH (Taxus-Stent Evaluated at Rotterdam Cardiology Hospital) Registries.

We investigated the long-term clinical outcomes and independent predictors of major cardiac events in unprotected left main coronary artery disease (ULMCA) patients treated by percutaneous coronary intervention with drug-eluting stent (DES). There is limited information on long-term (>3 years) outcomes after DES implantation for ULMCA. Furthermore, bifurcation angle and SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) score are emerging as parameters for patient risk stratification, and their prognostic implications have still to be elucidated. One hundred forty-eight patients with ULMCA treated with DES were analyzed and compared with a historical cohort of 79 patients who received bare-metal stents for the treatment of ULMCA. Patient-oriented composite end point was defined as the occurrence of all-cause death, any myocardial infarction, or any revascularization. The 4-year cumulative incidence of all-cause death, any myocardial infarction, any revascularization, and patient-oriented composite were 35.6%, 3.8%, 25.2%, and 54.4%, respectively. These end points had relatively increased from 1 year to 4 years by Delta70%, Delta5%, Delta50%, and Delta68%, respectively. When compared with a historical cohort who received bare-metal stents for ULMCA treatment, landmark analysis performed after the first 2 years of follow-up demonstrated that the DES cohort had significantly higher patient-oriented composite end point over the last 2 years of follow-up (26% vs. 8%, p = 0.02). EuroSCORE (European System for Cardiac Operative Risk Evaluation), cardiogenic shock, and SYNTAX score were identified as independent predictors for the 4-year patient-oriented composite, whereas bifurcation angle was not. Late increase in patient-oriented composite end points after DES implantation for ULMCA warrants careful and long-term follow-up. SYNTAX score and EuroSCORE appear to have a significant prognostic value in long-term patient risk.

Onuma Y ，Girasis C ，Piazza N ，Garcia-Garcia HM ，Kukreja N ，Garg S ，Eindhoven J ，Cheng JM ，Valgimigli M ，van Domburg R ，Serruys PW ，Interventional Cardiologists at Thoraxcenter 2000-2005 ... -  《-》

Impact of coronary anatomy and stenting technique on long-term outcome after drug-eluting stent implantation for unprotected left main coronary artery disease.

This study sought to evaluate the impact of anatomic and procedural variables on the outcome of the unprotected left main coronary artery (uLMCA) itself after drug-eluting stent (DES) implantation. There is a controversial debate regarding when and how to perform percutaneous coronary intervention (PCI) for an uLMCA stenosis. This analysis is based on a randomized study of 607 patients undergoing PCI for uLMCA, randomized 1:1 to receive paclitaxel- or sirolimus-eluting stents. We evaluated the impact of the SYNTAX score, uLMCA anatomy, and stenting technique on in-stent restenosis (ISR), target lesion revascularization (TLR), and the 3-year outcomes. The 3-year cardiac mortality rate was 5.8%; 235 (39%) patients had a true bifurcation lesion (TBL), and the median SYNTAX score was 27. TBL was associated with a higher need for multiple stents (72% vs. 37%, p < 0.001). TBL was a significant predictor of ISR (23% vs. 14%, p = 0.008) and for TLR (18% vs. 9%, p < 0.001). The need for multiple stents was a predictor of ISR (22% vs. 13%, p = 0.005) and for TLR (16% vs. 9%, p = 0.005). Culotte stenting showed better results compared with T-stenting for ISR (21% vs. 56%, p = 0.02) and for TLR (15% vs. 56%, p < 0.001). We observed a significant association between uLMCA-TLR and SYNTAX scores (9.2% for scores ≤ 22, 14.9% for scores 23 to 32, and 13.0% for scores ≥ 33, p = 0.008). PCI of uLMCA lesions with DES is safe and effective out to 3 years. TBL and multiple stents were independent predictors for ISR. In the multivariate analysis, independent predictors for TLR were TBL, age, and EuroSCORE (European System for Cardiac Operative Risk Evaluation). (Drug-Eluting-Stents for Unprotected Left Main Stem Disease [ISAR-LEFT-MAIN]; NCT00133237).

Tiroch K ，Mehilli J ，Byrne RA ，Schulz S ，Massberg S ，Laugwitz KL ，Vorpahl M ，Seyfarth M ，Kastrati A ，ISAR-LEFT MAIN Study Investigators ... -  《-》

The unrestricted use of sirolimus- and paclitaxel-eluting stents results in better clinical outcomes during 6-year follow-up than bare-metal stents: an analysis of the RESEARCH (Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital) and T-SEA

The aim of this study was to assess the 6-year clinical outcome after unrestricted use of sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) as compared with bare-metal stents (BMS) in consecutive de novo patients undergoing percutaneous coronary intervention (PCI). SES and PES have been shown to significantly decrease target vessel revascularization (TVR) rates compared with BMS in "real-world" registries. However, possible higher rates of very-late stent thrombosis and a restenosis "catch-up" trend might jeopardize the benefit. Three PCI cohorts, each with exclusive use of 1 stent type (BMS = 450; SES = 508; PES = 576), were systematically followed for the occurrence of major adverse cardiac events (MACE). Very-late stent thrombosis was more common in SES and PES patients than BMS patients (2.4% vs. 0.9% vs. 0.4%, respectively; p = 0.02); however, there were no significant differences between the stent types for all-cause mortality and all-cause mortality/myocardial infarction at 6-year follow-up. Sixty-nine SES patients (Kaplan-Meier estimate 14%) and 72 PES patients (14%) had a TVR, as compared with 79 BMS patients (18%; log-rank p = 0.02), which maintained significance after adjustment for (potential) confounders. Multivariate analysis showed that DES implantation is associated with lower incidence of TVR and MACE than BMS implantation (hazard ratio: 0.65, 95% confidence interval: 0.49 to 0.86; p = 0.003; hazard ratio: 0.79, 95% confidence interval: 0.65 to 0.97; p = 0.02, respectively). Incidence of MACE was also lower in SES and PES patients (30% and 30%, respectively) than in BMS patients (34%); however, significance was borderline. The unrestricted use of both DES resulted in a sustained advantage in decreasing TVR and, to a lesser extent, MACE compared with BMS at 6 years. The SES and PES are equally safe and effective in the treatment of coronary lesions.

Simsek C ，Magro M ，Boersma E ，Onuma Y ，Nauta ST ，Gaspersz MP ，van der Giessen WJ ，van Domburg RT ，Serruys PW ，Interventional Cardiologists of the Thoraxcenter ... -  《-》

Validation of SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) score for prediction of outcomes after unprotected left main coronary revascularization.

This study aimed to validate the SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) score representing angiographic complexity after unprotected left main coronary artery (ULMCA) revascularization. The validity of the SYNTAX score has been adequately evaluated. The SYNTAX scores were calculated for 1,580 patients in a large multicenter registry who underwent percutaneous coronary intervention (PCI) (n = 819) or coronary artery bypass graft (CABG) (n = 761) for ULMCA stenosis. The outcomes of interests were 3-year incidences of major adverse vascular events (MAVE), including death, Q-wave myocardial infarction, and stroke and major adverse cardiac and cerebrovascular events (MACCE), including MAVE and target vessel revascularization of ULMCA. The incidence of 3-year MAVE was 6.2% in the lowest (< or =23), 7.1% in the intermediate (23 to approximately 36), and 17.4% in the highest (>36) SYNTAX score tertile groups after PCI (p = 0.010). However, the incidences of MAVE in the CABG group and MACCE in the PCI and CABG groups did not differ among the SYNTAX tertiles. In subgroups, the MAVE (p = 0.005) and MACCE (p = 0.007) rates according to the SYNTAX score tertiles were significantly different in patients receiving drug-eluting stent, not in those receiving bare-metal stent. When compared with the clinical EuroSCORE (European System for Cardiac Operative Risk Evaluation), the C-indexes of SYNTAX score and EuroSCORE were 0.59 and 0.67, respectively, for discrimination of MAVE and 0.53 and 0.57, respectively, for MACCE. The angiographic SYNTAX score seems to play a partial role in predicting long-term adverse events after PCI for ULMCA stenosis. A complementary consideration of patient's clinical risk might improve the predictive ability of risk score.

Kim YH ，Park DW ，Kim WJ ，Lee JY ，Yun SC ，Kang SJ ，Lee SW ，Lee CW ，Park SW ，Park SJ ... -  《-》

Impact of sex on 3-year outcome after percutaneous coronary intervention using bare-metal and drug-eluting stents in previously untreated coronary artery disease: insights from the RESEARCH (Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospit

Onuma Y ，Kukreja N ，Daemen J ，Garcia-Garcia HM ，Gonzalo N ，Cheng JM ，van Twisk PH ，van Domburg R ，Serruys PW ，Interventional Cardiologists of Thoraxcenter ... -  《-》