Self-expandable sirolimus-eluting stents compared to second-generation drug-eluting stents for the treatment of the left main: A propensity score analysis from the SPARTA and the FAILS-2 registries.

OBJECTIVES: To compare the effectiveness and safety of self-expandable, sirolimus-eluting Stentys stents (SES) and second-generation drug-eluting stents (DES-II) for the treatment of the unprotected left main (ULM). BACKGROUND: SES may provide a valuable option to treat distal ULM, particularly when significant caliber gaps with side branches are observed. METHODS: Patients from the multicenter SPARTA (clinicaltrials.gov: NCT02784405) and FAILS2 registries were included. Propensity-score with matching was performed to account for the lack of randomization. Primary end-point was the rate of major adverse cardiovascular events (MACE, a composite of all cause death, myocardial infarction, target lesion revascularization [TLR], unstable angina and definite stent thrombosis [ST]). Single components of MACE were the secondary end-points. RESULTS: Overall, 151 patients treated with SES and 1270 with DES-II were included; no differences in MACE rate at 250 days were observed (9.8% vs. 11.5%, P = 0.54). After propensity score with matching, 129 patients treated with SES and 258 with DES-II, of which about a third of female gender, were compared. After a follow-up of 250 days, MACE rate did not differ between the two groups (9.9% vs. 8.5%, P = 0.66), as well as the rate of ULM TLR (1.6% vs. 3.1%, P = 0.36) and definite ST (0.8% vs. 1.2%, P = 0.78). These results were consistent also when controlling for the treatment with provisional vs. 2-stents strategies for the ULM bifurcation. CONCLUSION: SES use for ULM treatment was associated with a similar MACE rate compared to DES-II at an intermediate-term follow-up. SES might represent a potential option in this setting.

Safety and efficacy profile of bioresorbable-polylactide-polymer-biolimus-A9-eluting stents versus durable-polymer-everolimus- and zotarolimus-eluting stents in patients with acute coronary syndrome.

BACKGROUND: Comparative data on long-term safety and efficacy of bioresorbable-polymer-BES versus durable-polymer-EES/ZES in ACS setting have hitherto been lacking. We sought to assess the safety and efficacy of bioresorbable-polymer-biolimus-A9-eluting stents (BES) compared with thin-strut-durable-polymer-everolimus- and zotarolimus-eluting stents (EES/ZES) in patients with acute coronary syndrome (ACS) undergoing PCI. METHODS AND RESULTS: Between 2007 and 2012, 1,547 patients were implanted with new-generation drug-eluting stents (DES). Out of these, 369 received BES and 1,178 EES/ZES. The primary endpoint was probable/definite stent thrombosis (ST) while the secondary endpoint was a composite of all-cause death, myocardial infarction (MI), target vessel revascularization (TVR) and definite ST up to 5 years. As stent assignment was not random, we performed a propensity score matching (PSM), with 1:3 ratio, to account for potential confounders. Primary analysis demonstrated no significant differences between both groups for the primary endpoint of ST (BES vs. EES/ZES: 1.6% vs. 1.9%; mean-event-time = 1,797 days vs. 1,795 days, respectively; P = 0.75) and composite safety endpoint (BES vs. EES/ZES: 12.5% vs. 12.9%; mean-event-time = 1,631 days vs. 1,620 days, respectively; P = 0.88). Results regarding the 5-year-ST- and safety endpoint remained non-significant after PSM (P = 0.85, P = 0.56; respectively). After stratification based on cardiovascular risk, no difference regarding ST and composite outcome measure has been documented between both stent groups in high-risk- and low-risk patients. The type of stent did neither predict ST (HR 1.11, 95%CI 0.45-2.74, P = 0.82) nor composite safety endpoint (HR 0.93, 95%CI 0.67-1.30, P = 0.69). CONCLUSIONS: Long-term safety and efficacy of bioresorbable-polymer-BES and durable-polymer-EES/ZES appear comparable in patients with ACS. © 2016 Wiley Periodicals, Inc.

Long-term outcomes following drug-eluting balloons vs. thin-strut drug-eluting stents for treatment of recurrent restenosis in drug-eluting stents.

BACKGROUND: There is limited data on the optimal revascularization strategy in patients with recurrent in-stent restenosis (R-ISR). AIMS: To compare the long-term outcomes of patients treated with either a thin-strut drug-eluting stent (thin-DES) or a drug-eluting balloon (DEB) for R-ISR in a drug-eluting stent (DES). METHODS: A multicenter DEB-DRAGON registry was used to retrospectively identify patients with R-ISR who received either a thin-DES or a DEB. Propensity score matching was applied to adjust for baseline differences. The primary outcome was target lesion revascularization (TLR). RESULTS: Out of 311 patients (mean age, 67 years; 63% male) with R-ISR, 86 (27.7%) were treated with a thin-DES and 225 (72.3%) with a DEB. Median follow-up was 2.6 years. TLR occurred in 18 (20.9%) patients who received thin-DES and 61 (27.1%) patients treated with DEB (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.33-0.98; log-rank P = 0.04). The difference remained significant in a propensity score-matched cohort of 57 patients treated with thin-DES and 57 patients treated with a DEB (17.5 vs. 33.3%, respectively; HR, 0.38; 95% CI, 0.17-0.86; P = 0.01). The risks of device-oriented adverse cardiac events and all-cause mortality were similar after thin-DES or DEB in both unadjusted and propensity score-matched cohorts. In a multivariable Cox proportional hazard model, the treatment with a thin-DES was an independent predictor of a TLR-free survival (HR, 0.33; 95% CI 0.13-0.84; P = 0.02). CONCLUSIONS: In patients with R-ISR implantation of a thin-DES is associated with a lower risk of repeated revascularization compared with angioplasty with a DEB.

Polymer-Free Biolimus-Eluting Stents or Polymer-Based Zotarolimus-Eluting Stents for Coronary Bifurcation Lesions.

BACKGROUND: A polymer-free biolimus-eluting stent (PF-BES) and a zotarolimus-eluting stent (ZES) recently showed similar clinical profiles and appear to be competing options in specific clinical settings of patients undergoing percutaneous coronary intervention (PCI). Whether they perform similarly also in complex procedural settings as coronary bifurcation lesions remains unaddressed. METHODS: All consecutive patients undergoing coronary bifurcation PCI with PF-BES or the new iteration of the ZES from three large multicenter real-world registries were included. The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis (ST). Multiple analyses to adjust for baseline differences were carried out including propensity-score matching, propensity-score stratification and inverse-probability-weighting. Outcomes are reported according to Cox proportional hazard models censored at 400-day follow-up. RESULTS: 1169 patients treated with PF-BES (n = 440) or ZES (n = 729) on the main branch of a coronary bifurcation lesion were included (mean age 69 ± 11 years, 75.4% male, 53.8% acute coronary syndrome at presentation, 26.6% left main bifurcation, median dual antiplatelet therapy duration 12 [range 12-12] months). MACE, all-cause death, TLR and ST tended towards non-statistically higher rates with the PF-BES as compared to the ZES. Higher MI and target vessel revascularization occurrence was observed with PF-BES. CONCLUSIONS: In this large contemporary cohort of patients undergoing coronary bifurcation PCI, the occurrence of MACE was non-statistically different with the use of PF-BES and ZES devices. However, differences favoring the ZES device that may entail clinical relevance were observed. Further studies are needed to confirm these findings and explore whether they remain valid when a short dual antiplatelet therapy is adopted.

Dual antiplatelet therapy strategies and clinical outcomes in patients treated with polymer-free biolimus A9-coated stents.

AIMS: A large trial established the favourable clinical profile of a new polymer-free biolimus A9-eluting stent (PF-BES) with a one-month dual antiplatelet therapy (DAPT) regimen in patients at high bleeding risk (HBR). We aimed to evaluate the real-world patterns of indications, DAPT strategies and outcomes for the PF-BES following this evidence. METHODS AND RESULTS: CHANCE is a multicentre registry including all patients who underwent percutaneous coronary intervention (PCI) with at least one PF-BES. The reasons for the PF-BES PCI and planned antithrombotic regimens were collected. Primary outcomes were the 390-day Kaplan-Meier estimates of patient-oriented and device-oriented composite endpoints (POCE: death, myocardial infarction [MI] or target vessel revascularisation [TVR]; DOCE: cardiac death, target vessel MI or ischaemia-driven target lesion revascularisation [ID-TLR]). Between January 2016 and July 2018, 858 patients (age 74±10 years, 64.6% male, 58.7% acute coronary syndrome presentation) underwent PF-BES PCI. The main reasons for the physicians' choice of PF-BES reflected a perceived HBR in 77.7% of patients. One-month DAPT was planned in 40.3% of patients. At 390-day follow-up (median 340 days, interquartile range: 187-390 days), the estimated incidence of POCE was 13.1% (any MI 3.7%, any TVR 3.4%) and of DOCE was 7.1% (TV-MI 3.6%, ID-TLR 1.4%), while the 390-day estimate of any bleeding event was 11.1% (BARC 3-5 bleeding 3.0%). CONCLUSIONS: In a large all-comers registry, PF-BES was used mostly in HBR patients, frequently followed by a very short DAPT regimen. The reported outcomes suggest a favourable safety and efficacy profile for the PF-BES in a real-world clinical setting. ClinicalTrials.gov identifier: NCT03622203.

Treatment of coronary artery disease with a new-generation drug-coated balloon: final results of the Italian Elutax SV rEgistry-DCB-RISE.

AIMS: Drug-coated balloons (DCBs) are a recognized alternative to stents for the treatment of in-stent restenosis (ISR), and there is some initial clinical evidence about their efficacy for the treatment of small coronary vessels. Newer-generation DCBs were developed to overcome the reduced deliverability of the previous generation, also warranting a more effective drug delivery to vessel wall. However, the vast majority of new-generation DCBs still lack of reliability due to paucity of clinical data. METHODS: Between 2012 and 2015, all patients treated with Elutax SV DCB (Aachen Resonance, Germany) at nine Italian centers were enrolled in this retrospective registry. Primary outcome was the occurrence of target-lesion revascularization (TLR) at the longest available follow-up. Secondary endpoints were procedural success and occurrence of device-oriented adverse cardiovascular events including cardiac death, target-vessel myocardial infarction, stroke, and TLR. A minimum 6-month clinical follow-up was required. RESULTS: We enrolled 544 consecutive patients treated at 583 sites. Fifty-three per cent of the patients had ISR, and the rest native vessel coronary artery disease. Procedural success occurred in 97.5%. At the longest available clinical follow-up (average 13.3 ±â€Š7.4 months), 5.9% of the patients suffered a TLR and 7.1% a device-oriented adverse cardiovascular event. We did not register cases of target-vessel abrupt occlusion. At multivariate analysis, severe calcification at the lesion site was the first determinant for the occurrence of TLR. CONCLUSION: This registry on the performance of a new-generation DCB shows an adequate profile of safety and efficacy at mid-term clinical follow-up.

Clinical outcomes with bioabsorbable polymer- versus durable polymer-based drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis.

OBJECTIVES: This study sought to investigate the relative safety and efficacy of bioabsorbable polymer (BP)-based biolimus-eluting stents (BES) versus durable-polymer (DP)-drug-eluting stents (DES) and bare-metal stents (BMS) by means of a network meta-analysis. BACKGROUND: Studies have suggested that BP-BES might reduce the risk of stent thrombosis (ST) and late adverse outcomes compared with first-generation DES. However, the relative safety and efficacy of BP-BES versus newer-generation DES coated with more biocompatible DP have not been investigated in depth. METHODS: Randomized controlled trials comparing BP-BES versus currently U.S.-approved DES or BMS were searched through MEDLINE, EMBASE, and Cochrane databases. Information on study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. RESULTS: Data from 89 trials including 85,490 patients were analyzed. At 1-year follow-up, BP-BES were associated with lower rates of cardiac death/myocardial infarction (MI), MI, and target vessel revascularization (TVR) than BMS and lower rates of TVR than fast-release zotarolimus-eluting stents. The BP-BES had similar rates of cardiac death/MI, MI, and TVR compared with other second-generation DP-DES but higher rates of 1-year ST than cobalt-chromium everolimus-eluting stents (CoCr-EES). The BP-BES were associated with improved late outcomes compared with BMS and paclitaxel-eluting stents, considering the latest follow-up data available, with nonsignificantly different outcomes compared with other DP-DES although higher rates of definite ST compared with CoCr-EES. CONCLUSIONS: In this large-scale network meta-analysis, BP-BES were associated with superior clinical outcomes compared with BMS and first-generation DES and similar rates of cardiac death/MI, MI, and TVR compared with second-generation DP-DES but higher rates of definite ST than CoCr-EES.