Clinical findings after bioresorbable vascular scaffold implantation in an unrestricted cohort of patients with ST-segment elevation myocardial infarction (from the RAI registry).

BACKGROUND: The bioresorbable vascular scaffold (BVS) technology may be an appealing option in ST-segment elevation myocardial infarction (STEMI) patients. However, the available evidence on its use in this challenging subset is limited. METHODS: Registro Absorb Italiano (RAI) is a multicenter, prospective registry that aims to assess BVS performance through a 5-year follow-up of all consecutive patients who undergone at least 1 successful BVS implantation. As a part of it, a subgroup analysis in STEMI patients was performed and the outcomes of this cohort compared to the remaining population (defined as "non-STEMI") are reported here. RESULTS: Among the 1505 patients enrolled, 317 (21.1%) had STEMI on admission. Among those, 232 (73.2%) underwent primary percutaneous coronary intervention (PCI) within 12 h from symptom onset; 64 (20.2%) were late-comers (>12 h); 16 (5%) underwent PCI after successful thrombolysis while 5 (1.6%) underwent rescue-PCI. At a median follow-up time of 12 months (IQR 6-20 months) no differences were noticed between STEMI and "non-STEMI" groups in terms of device-oriented composite endpoint (4.1% vs. 5.6%; p = 0.3) and its singular components: ischemia-driven target lesion revascularization (3.2% vs. 3.6%; p = 0.7), target-vessel myocardial infarction (3.2% vs. 2.8%; p = 0.7) and cardiac death (0.6% vs. 0.6%; p = 0.9). The rate of definite/probable scaffold thrombosis (ScT) was numerically higher but not significant in the STEMI group (2.5% vs. 1.3%; p = 0.1). CONCLUSIONS: BVS implantation in an unrestricted cohort of STEMI patients is associated with a numerically higher rate of ScT compared to the non-STEMI group. Further studies exploring the potential clinical impact of a pre-specified BVS implantation strategy in this high-risk clinical setting are needed.

Outcomes in Patients With Transcatheter Aortic Valve Replacement and Left Main Stenting: The TAVR-LM Registry.

BACKGROUND: A percutaneous approach with transcatheter aortic valve replacement (TAVR) and percutaneous coronary intervention (PCI) of the left main coronary artery (LM) is frequently used in high-risk patients with coexisting aortic stenosis and LM disease. Outcomes of TAVR plus LM PCI have not been previously reported. OBJECTIVES: The primary objective of the TAVR-LM registry is to evaluate clinical outcomes in patients undergoing TAVR plus LM PCI. METHODS: Clinical, echocardiographic, computed tomographic, and angiographic characteristics were retrospectively collected in 204 patients undergoing TAVR plus LM PCI. In total, 128 matched patient pairs were generated by performing 1:1 case-control matching between 167 patients with pre-existing LM stents undergoing TAVR and 1,188 control patients undergoing TAVR without LM revascularization. RESULTS: One-year mortality (9.4% vs. 10.2%, p = 0.83) was similar between the TAVR plus LM PCI cohort and matched controls. One-year mortality after TAVR plus LM PCI was not different in patients with unprotected compared with protected LMs (7.8% vs. 8.1%, p = 0.88), those undergoing LM PCI within 3 months compared with those with LM PCI greater than 3 months before TAVR (7.4% vs. 8.6%, p = 0.61), and those with ostial versus nonostial LM stents (10.3% vs. 15.6%, p = 0.20). Unplanned LM PCI performed because of TAVR-related coronary complication, compared with planned LM PCI performed for pre-existing LM disease, resulted in increased 30-day (15.8% vs. 3.4%, p = 0.013) and 1-year (21.1% vs. 8.0%, p = 0.071) mortality. CONCLUSIONS: Despite the anatomic proximity of the aortic annulus to the LM, TAVR plus LM PCI is safe and technically feasible, with short- and intermediate-term clinical outcomes comparable with those in patients undergoing TAVR alone. These results suggest that TAVR plus LM PCI is a reasonable option for patients who are at high risk for surgery.

Intermediate Clinical and Hemodynamic Outcomes After Transcatheter Aortic Valve Implantation.

BACKGROUND: Concerns still exist regarding long-term results and freedom from valve-related adverse events in transcatheter aortic valve implantation (TAVI). The aim of this single-center retrospective study was to assess intermediate-term (up to 5-year) clinical and hemodynamic outcomes in patients undergoing TAVI. METHODS: From 2007 through 2013, 338 consecutive patients underwent TAVI at our institution. Preoperative variables were defined according to the European System for Cardiac Operative Risk Evaluation (EuroSCORE) definitions, and outcomes were reported according to the Valve Academic Research Consortium (VARC)-2 definitions. Multivariate logistic regression analysis was performed to identify independent predictors of mortality at follow-up. RESULTS: transfemoral (TF) and transapical (TA) TAVI were performed in 233 (69%) and 105 (31%) patients, respectively. All-cause 30-day mortality was 4.4%, with no differences between TA and TF procedures. Thirty-day cardiovascular death, stroke, and myocardial infarction were not different between groups. The acute kidney injury (AKI) rate was higher in the TA group (30.5% versus 11.2%; p < 0.001). Access-related complications were more frequent in the TF group (36.1% versus 11.4%; p < 0.001). Mean follow-up was 22.3 ± 17.8 months (range, 1-74 months). Overall survival rates at 1, 3, and 5 years were 85.5% ± 2.1%, 69.9% ± 3.2%, and 61% ± 4.3%, respectively. Independent predictors of all-cause mortality at follow-up were previous myocardial infarction (odds ratio [OR], 2.7), any grade of paravalvular leak (PVL) (OR, 2.5), and AKI (OR, 3.1). Mean gradient and effective orifice area at follow-up were 10.7 ± 12.0 mm Hg and 1.1 ± 0.9 cm(2)/m(2), respectively. CONCLUSIONS: Our data show that TAVI has good early and intermediate-term clinical and hemodynamic outcomes in high-risk or inoperable patients with severe symptomatic aortic valve stenosis. PVL of any grade has a significant impact on survival.

Registro Absorb Italiano (BVS-RAI): an investigators-owned and -directed, open, prospective registry of consecutive patients treated with the Absorb™ BVS: study design.

BACKGROUND: The Absorb™ BVS is a bioresorbable, everolimus-eluting scaffold approved and marketed for coronary use. Published data on long-term results after treatment are limited to a small number of patients, most of them with elective PCI of simple lesions. The importance of scaffold resorption is variably appreciated among cardiologists, and indications for use from health technology assessment bodies or guidelines are missing. Instruments are needed to collect, share and assess the experience being accumulated with this new device in several centres. METHODS/DESIGN: The BVS-RAI Registry is a spontaneous initiative of a group of Italian interventional cardiologists in cooperation with Centro di Ricerche Farmacologiche e Biomediche "Mario Negri" Institute, and is not recipient of funding or benefits originating from the BVS manufacturer. It is a prospective registry with 5-year follow-up of all consecutive patients who have undergone successful implantation of 1 or more coronary BVS following the indications, techniques and protocols used in each of the participating institutions. Outcome measures are BVS target lesion failure within one year and device-oriented major adverse cardiac events within 5years. The registry started in October 2012 and will extend enrolment throughout 2015, with the aim to include about 1000 patients. ClinicalTrials.gov identifier is CT02298413. CONCLUSIONS: The BVS-RAI Registry will contribute observational knowledge on the long-term safety and efficacy of the Absorb™ BVS as used in a number of Italian interventional centres in a broad spectrum of settings. Unrewarded and undirected consecutive patient enrolments are key-features of this observation, which is therefore likely to reflect common clinical practice in those centres.

Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve.

AIMS: Early data on the Edwards SAPIEN 3 valve (S3-THV) have shown low rates of paravalvular leaks and vascular complications but relatively high 30-day permanent pacemaker implantation (PPMI) rates. No direct comparisons on clinical outcomes including PPMI rates are available for the S3-THV and the Edwards SAPIEN XT (XT-THV). We aimed to compare the 30-day PPMI rates in patients treated with the two prostheses and to assess the interplay among valve type, depth of implantation and PPMI rate. METHODS AND RESULTS: Two hundred and nine patients treated by TAVI were considered. The S3-THV was associated with higher PPMI rates compared to the XT-THV, both overall and in subgroups matched for several predictors of PPMI. However, in the S3-THV group, 30-day PPMI was strictly associated with deep valve implantation, and PPMI risk of high-implanted S3-THVs was similar to that of the overall XT-THV matched group. No cases of significant paravalvular leak were observed in the S3-THV group. CONCLUSIONS: The S3-THV was associated with a higher incidence of PPMI compared to the XT-THV. In the S3-THV group, pacemaker implantation was strictly associated with deep valve implantation. An implantation technique involving higher initial placement of the central marker (from 0 to 3 mm above the base of the aortic cusps) and, as a consequence, higher final valve depth might help in preventing post-TAVI PPMI with the S3-THV, without affecting the risk of paravalvular leak.

Causes and timing of death during long-term follow-up after transcatheter aortic valve replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an effective therapeutic option for patients with severe aortic stenosis at high risk for surgery. Identification of causes of death after TAVR may help improve patient selection and outcome. METHODS: We enrolled 874 consecutive patients who underwent TAVR at 3 centers using all approved bioprostheses and different access routes. Clinical outcomes during follow-up were defined according to the Valve Academic Research Consortium 2 definitions. Causes of deaths were carefully investigated. RESULTS: Mean logistic European System for Cardiac Operative Risk Evaluation was 23.5% ± 15.3%; Society of Thoracic Surgery score, 9.0% ± 8.2%. The Corevalve (Medtronic, Minneapolis, MN) was used in 41.3%; the Edwards Sapien (Edwards Lifesciences Inc., Irvine, CA) in 57.3%. Vascular access was transfemoral in 75.7%. In-hospital mortality was 5.0%. Cumulative mortality rates at 1 to 3 years were 12.4%, 23.4%, and 31.5%, respectively. Landmark analysis showed a significantly higher incidence of cardiovascular (CV) death in the first 6 months of follow-up and a significantly higher incidence of non-CV death thereafter. At Cox regression analysis, the independent predictors of in-hospital mortality were acute kidney injury grades 2 to 3 (hazard ratio [HR] 3.41) life-threatening bleeding (HR 4.26), major bleeding (HR 4.61), and myocardial infarction (HR 3.89). The independent predictors of postdischarge mortality were chronic obstructive pulmonary disease (HR 1.48), left ventricular ejection fraction at discharge (HR 0.98), and glomerular filtration rate <30 mL/min per 1.73 m(2) (HR 1.64). CONCLUSIONS: Around a third of patients treated with TAVR in daily practice die within the first 3 years of follow-up. Early mortality is predominantly CV, whereas late mortality is mainly non-CV, and it is often due to preexisting comorbidity.

Six-year clinical outcomes of first-generation drug-eluting stents: a propensity-matched analysis.

OBJECTIVE: Drug-eluting stents are more effective in reducing restenosis than bare-metal stents. Paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) are the most widely used first-generation drug-eluting stents, but long-term comparative data on these are scant. The aim of the present report is to investigate the 6-year clinical outcomes of PES versus SES in a matched cohort of single-center registry patients. MATERIALS AND METHODS: Data were obtained from the observational, monocentric registry of 632 consecutive patients who underwent percutaneous coronary intervention between September 2002 and September 2005 with PES or SES. We assessed the composite and separate occurrence of the major adverse cardiac events (MACE), including death, nonfatal myocardial infarction, and target lesion revascularization (TLR). RESULTS: After a propensity 1 : 1 matching analysis, baseline clinical, procedural, and angiographic characteristics were well balanced between the two groups. Throughout the 6 years of follow-up, there were no significant differences between PES and SES in terms of MACE (P=0.52), all-cause death (P=0.24), myocardial infarction (P=0.25), stent thrombosis (P=0.38), and TLR (P=0.68). The sensitivity analysis on the total unmatched population confirmed this result, the stent type not being predictive of MACE (PES vs. SES group, hazard ratio 0.97, 95% confidence interval 0.66-1.41, P=0.87) or TLR (PES vs. the SES group, hazard ratio 1.35, 95% confidence interval 0.69-2.64, P=0.38). CONCLUSION: In this 'real-life' registry, PES and SES showed a comparable safety and efficacy profile throughout the 6 years of follow-up. The increase in the rate of TLR was slow and comparable between the two groups, even though the 'late catch-up' phenomenon showed a different temporal pattern between PES and SES.

Gender-related differences of diabetic patients undergoing percutaneous coronary intervention with drug-eluting stents: a real-life multicenter experience.

BACKGROUND: Gender-based differences in diabetic patients are understudied in the field of percutaneous coronary intervention (PCI) with drug-eluting stents. METHODS: Data were obtained from a multicenter registry of 2420 consecutive patients with diabetes mellitus (DM) who underwent PCI with paclitaxel- or sirolimus-eluting stents between 2003 and 2009. Among them, 679 (28.1%) women were compared to 1741 (71.9%) men in terms of clinical aspects and major adverse cardiac events (MACE), including all-cause death, myocardial infarction (MI) and target lesion revascularization (TLR). Target vessel revascularization (TVR) and any revascularization were also reported. RESULTS: Women were less numerous, older, used more insulin and showed more tortuous coronary arteries, while men were more frequently smokers and received larger stents. At the median follow-up of 24.3 months (interquartile range 12.3-39.7), MACE, TVR and any revascularization did not significantly differ between females and males (19.9% vs 18.7%, 12.2% vs 13.4%, 14.1% vs 15.1%, respectively). At multivariable analysis of the overall cohort, female gender was not a predictor of MACE (hazard ratio [HR] 1.02, 95% confidence interval [CI] 0.92-2.36, p=0.11), death (HR 1.04, 95% CI 0.84-1.24, p=0.86), MI (HR 1.48, 95% CI 0.92-2.36, p=0.11), and TLR (HR 1.14, 95% CI 0.85-1.52, p=0.38). CONCLUSION: In this registry of diabetic patients treated by drug-eluting stents, women were less represented, older and needed more insulin compared to men who, on the other hand, received larger stents. Gender-related outcomes were similar and female sex did not predict MACE.

Paclitaxel- and sirolimus-eluting stents in older patients with diabetes mellitus: results of a real-life multicenter registry.

BACKGROUND: Older patients and diabetes mellitus (DM) are rapidly increasing in Western world populations. The treatment of coronary artery disease in these patients is challenging because they are complex and at high risk. Performance of the two widely used drug-eluting stents (DES), i.e. sirolimus- (SES) and paclitaxel-eluting stent (PES), is understudied in this subset. AIM: We aimed to explore the impact of the first generation DES choice on mid term outcome in a large and unselected population of diabetic patients older than 65 years. METHODS AND RESULTS: From a multicenter registry of 2,429 diabetic patients treated with sirolimus- (SES) or paclitaxel-eluting stent (PES), 1,417 patients ≥65 years old were analyzed overall and separately for groups aged 65-74 (67%) and ≥75 (33%) years old. SES (55%) were compared to PES (45%) in terms of major adverse cardiac events, including all-cause death, myocardial infarction (MI) and target lesion revascularization (TLR) throughout 1-to-5 year follow-up (median time 24 months). We failed to find at the unadjusted and adjusted analyses statistically significant differences in term of outcome between the two DES, both in the overall cohort and in the two different aged subgroups, also regardless of the insulin treatment. CONCLUSIONS: In this real-life multicenter registry, PES and SES showed a comparable safety and efficacy profile in diabetic patients older than 65 years throughout 1-to-5 years follow-up.

Paclitaxel versus sirolimus eluting stents in diabetic patients: does stent type and/or stent diameter matter?: long-term clinical outcome of 2,429-patient multicenter registry.

BACKGROUND: Drug-eluting stents (DES) are more effective in reducing restenosis than bare-metal stents. Less certain is the relative performance of the two widely used DES-sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES)-in diabetic patients undergoing percutaneous coronary intervention (PCI). OBJECTIVES: We studied the long-term effectiveness and safety of SES versus PES in diabetic patients, overall and grouped by the size of the stent placed in the native-stented vessel. METHODS: Data were obtained from an observational, multicenter registry of 2,429 consecutive patients with DM who underwent PCI between August 2003 and August 2009 with SES (n = 1,370) or PES (n = 1,059). Data were analyzed separately for patients with small stents (<3.0 mm, n = 1,274) vs. only large (≥3.0 mm, n = 1,155). RESULTS: At Cox-adjusted analysis of the overall cohort, there was no significant difference between SES and PES with regard to death/myocardial infarction (D/MI) (P = 0.6) or target lesion revascularization (TLR) (P = 0.3) either in "small-stent" (D/MI, P = 0.8; TLR, P = 0.2) or "large stent" group (D/MI, P = 0.8; TLR, P = 0.4) throughout 1 to 5-year follow-up. These results were confirmed by sensitivity, propensity-score matched analysis (717 matched pairs) that failed to find differences in the safety and efficacy between SES and PES. CONCLUSIONS: In this large observational study, PES and SES were equally safe and efficacious in diabetic patients undergoing PCI in clinical practice, regardless of the stent size.

Comparison of impact of mortality risk on the survival benefit of primary percutaneous coronary intervention versus facilitated percutaneous coronary intervention.

Available data suggest that thrombolytic therapy facilitated percutaneous coronary intervention (FPCI) is not beneficial, and recent analyses have shown a correlation between mortality risk and outcomes of patients with ST elevation myocardial infarctions treated with FPCI. The aim of this study was to analyze the impact of the mortality risk on the survival benefit of primary percutaneous coronary intervention (PPCI) compared to FPCI. A total of 13 trials enrolling 5,789 patients were pooled for analyses. PPCI survival benefit was calculated as the 30-day mortality after FPCI minus the 30-day mortality after PPCI, and the mortality rate of FPCI was interpreted as a proxy for mortality risk. A weighted metaregression was used to test the relation between mortality risk and explanatory variables. A fixed-effect linear regression analysis modeling the log odds ratio (PPCI/FPCI) as a linear function of the log odds of FPCI mortality was used to estimate the mortality risk that nullified the 30-day survival benefit of PPCI over FPCI. Across all studies, the absolute survival benefit ranged from -5.6 (favoring FPCI) to +7.2 (favoring PPCI). According to the slope of the regression line (-0.7, x-axis intercept -2.1) for the patients with baseline mortality risk > 4.2%, it is unlikely to obtain a survival benefit by FPCI compared to PPCI. In conclusion, the higher the mortality risk of patients with ST elevation myocardial infarctions, the higher the likelihood of a survival advantage of PPCI over FPCI.