Final 5-Year Results in Unselected Patients Implanted With a Thin-Strut, Platinum-Chromium, Everolimus-Eluting Stent (from the PROMUS Element Plus US Post-Approval Study).

PROMUS Element (PE) Plus post-approval study was a large prospective, observational, all-comers study designed to evaluate the safety and performance of a thin-strut platinum chromium everolimus-eluting PE Plus stent in everyday clinical practice. A total of 2,683 "real-world" patients with limited clinical or anatomic exclusion criteria were enrolled at 52 clinical sites in the United States. The study met its primary end point of 12-month cardiac death or myocardial infarction (CD/MI) compared with a prespecified performance goal (p <0.0001). Five-year clinical outcomes were evaluated in overall PE Plus post-approval study patients and high-risk subgroups. During the 5-year follow-up period, CD/MI and stent thrombosis related to the PE Plus stent occurred in 9% and 2.2% overall patients, respectively. The reported all-cause mortality rate was 15%, with 7% classified as cardiac-related. A total of 18% patients underwent target vessel revascularization, and 11% were reported as target lesion revascularization. The rates of PE Plus stent-related CD/MI remained low in patients with medically treated diabetes (13%), small vessels (9%), and long stents (10%). PE Plus stent-related thrombosis through 5 years in patients with diabetes, small vessels and long stents was 4.2%, 2.2%, and 2.6%, respectively. The occurrence of target lesion revascularization was numerically higher in patients with diabetes (16%) and long lesions (18%) than the small vessels subgroup (11%). In conclusion, the final 5-year results establish the long-term safety and efficacy of the PE Plus stent in a broad, unselected patient population representative of "real-world" clinical practice.

Long-term follow-up of the platinum chromium TAXUS Element (ION) stent: The PERSEUS Workhorse and Small Vessel trial five-year results.

BACKGROUND: The TAXUS Element (ION) platinum chromium paclitaxel-eluting stent (PtCr-PES) incorporates a thin (81 µm) strut design with a similar polymer and drug dose density as prior PES. The pivotal PERSEUS trial program consisted of two studies: PERSEUS Workhorse (WH) and PERSEUS Small Vessel (SV). The PERSEUS WH trial demonstrated the PtCr-PES to be non-inferior to the predicate TAXUS Express PES (TE-PES) for target lesion failure (TLF) at 1 year and in-segment angiographic percent diameter stenosis at 9 months. The PERSEUS SV trial demonstrated the PtCr-PES to be superior to a historical bare metal stent (BMS) for angiographic late lumen loss at 9 months. Long-term (5-year) clinical outcomes following PtCr-PES have not been previously reported. METHODS: PERSEUS WH was a prospective, Bayesian, 3:1 randomized (PtCr-PES vs. TE-PES) trial in patients with lesion length ≤28 mm and vessel diameter ≥2.75 to ≤4.0 mm. PERSEUS SV was a prospective, single-arm trial in patients with lesion length ≤20 mm and vessel diameter ≥2.25 to <2.75 mm comparing PtCr-PES to a matched historical BMS control. RESULTS: Among randomized subjects in the PERSEUS WH study, clinical event rates at 5 years were similar between treatment groups, including TLF (12.9% TE-PES vs. 12.1% PtCr-PES; P = 0.66). In the PERSEUS SV study, 5-year rates of MACE, and TLF were significantly lower for PtCr-PES (vs. BMS) following adjustment for baseline characteristics and were primarily due to lower target lesion revascularization rates (27.2% BMS vs. 14.9% PtCr-PES; P = 0.049). CONCLUSIONS: At 5 years, the PtCr-PES provides efficacy and safety that is comparable to the TE-PES and superior efficacy with similar safety when compared with BMS in smaller caliber vessels. Cumulative stent thrombosis rates remained low and similar through 5 years for both DES platforms.

One-year outcomes in 1,010 unselected patients treated with the PROMUS Element everolimus-eluting stent: the multicentre PROMUS Element European Post-Approval Surveillance Study.

AIMS: The PROMUS™ Element™ European Post-Approval Surveillance Study (PE-Prove) is a prospective, open-label, multicentre observational study designed to assess outcomes following PROMUS Element everolimus-eluting stent implantation in an unselected patient population. METHODS AND RESULTS: A total of 1,010 patients were enrolled at 40 clinical sites in Europe, including 24.9% with medically treated diabetes, 50.0% with Type B2/C lesions, 6.1% with chronic total occlusion, 17.8% with acute myocardial infarction (MI ≤24 hours pre-procedure), and 20.1% with unstable angina. The target lesion was the culprit for ST-segment elevation MI in 7.3% of patients. The one-year, per patient target vessel failure rate was 6.2% (60/975), 3.4% (33) being related to the PROMUS Element stent. Rates of cardiac death, MI, and Academic Research Consortium (ARC) definite/probable stent thrombosis were 1.7%, 3.5%, and 0.6%, respectively. The target vessel revascularisation rate was 3.2% (31/975), 2.1% (20) being related to the PROMUS Element stent. CONCLUSIONS: In a large and relatively complex group of "real-world" patients, coronary artery revascularisation with the PROMUS Element everolimus-eluting stent provides favourable results with low event rates consistent with those reported for other contemporary drug-eluting stents.

Final 5-year results of the TAXUS ATLAS, TAXUS ATLAS Small Vessel, and TAXUS ATLAS Long Lesion clinical trials of the TAXUS Liberté paclitaxel-eluting stent in de-novo coronary artery lesions.

OBJECTIVE: To report the final, cumulative, 5-year outcomes from the TAXUS ATLAS program, which studied the use of the TAXUS Liberté paclitaxel-eluting stent in de-novo coronary artery lesions. METHODS: TAXUS ATLAS Workhorse, Small Vessel, and Long Lesion are nonrandomized studies comparing TAXUS Liberté (N=871), TAXUS Liberté 2.25 mm (N=261), and TAXUS Liberté 38 mm (N=150) stents, respectively, with case-matched TAXUS Express historical controls. RESULTS: In the unadjusted analysis, TAXUS Liberté showed comparable 5-year rates of major adverse cardiac events (27.1% TAXUS Express vs. 26.2% TAXUS Liberté, P=0.70) in workhorse lesions and greater 5-year cumulative freedom from target lesion revascularization (78.4 vs. 87.3%, P=0.03) in small vessels. In addition, a lower periprocedural myocardial infarction rate (MI, 4.1 vs. 0.0%; P=0.01) was observed in long lesions versus TAXUS Express. After propensity score adjustment, no statistically significant effect of TAXUS Liberté on the 5-year rates of TLR in small vessels (17.9 vs. 13.3%, P=0.36) or MI in long lesions (9.1 vs. 7.0%, P=0.53) was found, although the rates remained numerically lower with TAXUS Liberté. CONCLUSION: Cumulative 5-year results of the TAXUS ATLAS studies suggest that the TAXUS Liberté stent provides similar safety and effectiveness in workhorse lesions, and may provide lower revascularization rates in small vessels and lower periprocedural MI rates in long lesions compared with the TAXUS Express stent, although no statistically significant differences were found following propensity adjustment.

Racial differences in long-term outcomes after percutaneous coronary intervention with paclitaxel-eluting coronary stents.

OBJECTIVES: To assess the influence of race on long-term outcomes following percutaneous coronary intervention (PCI) with paclitaxel-eluting stents (PES). BACKGROUND: Data on the influence of race on long-term outcomes following PCI with drug-eluting stents are limited because of severe underrepresentation of minority populations in randomized trials. METHODS: We compared 5-year outcomes of 2,301 whites, 127 blacks, and 169 Asians treated with PES in the TAXUS IV, V, and ATLAS trials. Outcomes were adjusted using a propensity score logistic regression model with 1:4 matching. RESULTS: Blacks were more likely than whites to be female, have a history of hypertension, diabetes mellitus, congestive heart failure, and stroke, but were less likely to have prior coronary artery disease. Compared with whites, Asians were younger, more likely to be male, have stable angina, and left anterior descending disease, and less likely to have silent ischemia, previous coronary artery bypass surgery, prior coronary artery disease, diabetes mellitus, peripheral vascular disease, and to receive glycoprotein IIb/IIIa inhibitors. Despite higher antiplatelet compliance, the adjusted 5-year rates of myocardial infarction (15.4% vs. 5.4%, P < 0.001) and stent thrombosis (5.6% vs. 1.1%, P = 0.002) were higher in blacks than whites. Despite lower antiplatelet compliance, Asians had no differences in myocardial infarction and stent thrombosis compared with whites. Mortality and revascularization rates were similar between the three groups. CONCLUSIONS: The long-term risk of major thrombotic events after PCI with PES was higher in blacks, but not Asians, compared with whites. The mechanisms underlying these racial differences warrant further investigation.

Economic modeling of new stent platforms to evaluate cost effectiveness: analysis of the TAXUS Liberté versus TAXUS express stents.

BACKGROUND: With the changing health care environment, cost effectiveness is an important adjunct to clinical investigation when assessing new medical devices. This study presents an economic model to evaluate cost effectiveness of coronary stents. METHODS: Markov modeling was developed comparing total costs (Medicare payer perspective) between TAXUS Liberté and TAXUS Express based on 3-year clinical outcomes from the TAXUS ATLAS Small Vessel and Long Lesion trials. RESULTS: The TAXUS Liberté 2.25-mm stent provided cost savings relative to TAXUS Express from a payer perspective ($17,605 vs. $20,281), driven by reduced target vessel revascularization (0.16 events/patient vs. 0.33 events/patient). In probabilistic sensitivity analyses, TAXUS Liberté was less costly with fewer major adverse cardiac events in over 99% of parameter sets. The TAXUS Liberté Long (38 mm) stent was cost neutral relative to TAXUS Express from a payer perspective ($18,545 vs. $18,551) with fewer myocardial infarctions and cardiac deaths. Accounting for angiography-driven revascularizations, TAXUS Liberté 2.25 mm still provided cost savings relative to TAXUS Express ($16,822 vs. $19,139), although TAXUS Liberté Long was more expensive than TAXUS Express ($17,886 vs. $17,652). From a hospital perspective, TAXUS Liberté Long provided cost savings up to a price premium of $671/stent, driven by fewer stents employed per patient. CONCLUSIONS: This analysis confirms the utility of economic modeling in assessing new stent platforms. TAXUS Liberté 2.25 mm is economically dominant relative to TAXUS Express when treating small vessels. TAXUS Liberté Long is cost neutral to modestly more costly than TAXUS Express 2.25 mm from a payer perspective.

Long-term benefit of the TAXUS Liberté stent in small vessels and long lesions. TAXUS ATLAS program.

BACKGROUND: The long-term impact of treating de novo coronary lesions in native vessels and challenging small vessel and long lesion subsets with TAXUS Liberté stents is unknown. This report examines the 3-year efficacy and safety from the TAXUS ATLAS program. METHODS AND RESULTS: TAXUS ATLAS WH, Small Vessel, and Long Lesion are non-randomized studies comparing TAXUS Liberté (n = 871), TAXUS Liberté 2.25 mm (n = 261), and TAXUS Liberté 38 mm (n = 150) stents, respectively, to case-matched TAXUS Express historical controls. TAXUS Liberté demonstrated comparable 3-year rates of major adverse cardiac events (19.0% vs. 20.2%, P = 0.51) in de novo lesions, reduced target lesion revascularization (TLR, 10.0% vs. 22.1%, P = 0.008) in small vessels, and reduced myocardial infarction (MI, 2.9% vs. 10.4%; P = 0.01) and stent thrombosis (ST, 0.0% vs. 3.9%, P = 0.03) in long lesions vs. TAXUS Express. After propensity score adjustment, no statistically significant effect of TAXUS Liberté on TLR (9.7% vs. 16.9%, P = 0.12) in small vessels or MI (2.9% vs. 7.9%, P = 0.05) in long lesions was noted, although reduced ST (0.0% vs. 2.7%, P = 0.02) remained in long lesions. Multivariate analyses demonstrated that TAXUS Liberté treatment significantly reduced TLR by 66% in small vessels, and MI by 75% in long lesions, vs. TAXUS Express. CONCLUSIONS: TAXUS Liberté suggests durable 3-year effectiveness in reducing restenosis and improved clinical outcomes in small vessels and long lesions compared with TAXUS Express.