Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk.

BACKGROUND: Polymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited. METHODS: In an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus-coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority. RESULTS: A total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P = 0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P = 0.007 for noninferiority). CONCLUSIONS: Among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.).

Paravalvular leak closure for persisting aortic regurgitation after implantation of the CoreValve transcatheter valve.

Significant aortic regurgitation after TAVI results in lack of symptomatic and prognostic benefit from the procedure and generally requires intervention. While most of the regurgitations can be successfully targeted with standard techniques, occasional patients have restrictive calcification resistant to post-dilatation and significant regurgitation persists. We present a case of refractory aortic regurgitation successfully treated with percutaneous paravalvular leak closure. An 81-year-old man with symptomatic severe aortic stenosis underwent a transfemoral CoreValve TAVI in December 2009. He had significant aortic regurgitation refractory to medical and interventional therapy including balloon post-dilatation, valve repositioning and valve-in-valve reimplantation. Aortic regurgitation remained severe and therefore in early 2013, we proceeded with an attempted percutaneous closure of the residual paraprosthetic leak. Using 6-French femoral access and a Terumo wire, the defect was successfully crossed with a 4-French Multipurpose catheter and an 8 mm Amplatzer Vascular Plug 4 device (St. Jude Medical) was deployed through this catheter, resulting in abolition of aortic regurgitation on aortography and TOE, with associated excellent clinical response. Refractory paravalvular aortic regurgitation post CoreValve implantation can be successfully treated using the Amplatzer Vascular Plug 4 device.

Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE.

BACKGROUND: Resolute Onyx polymer-based zotarolimus-eluting stents (ZES) were noninferior in safety and effectiveness to BioFreedom polymer-free biolimus A9-coated stents (DCS) in high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) at 1 year. OBJECTIVES: This study reports the final 2-year results of the randomized Onyx ONE trial. METHODS: The Onyx ONE (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients) trial randomly assigned HBR patients to treatment with ZES or DCS. Following 1-month DAPT, event-free patients received SAPT (either aspirin or a P2Y12 inhibitor at physician discretion). The primary safety endpoint, a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year, was determined at 1 year. Rates of primary and secondary endpoints were calculated after final follow-up at 2 years. RESULTS: A total of 1,003 patients were randomly allocated to ZES and 993 patients to DCS. Follow-up was complete in 980 (97.7%) ZES patients and 962 (96.9%) DCS patients at 2 years. The primary safety endpoint occurred in 208 (21.2%) patients in the ZES group and 199 (20.7%) patients in the DCS group (risk difference: 0.5%; 95% CI: -3.1% to 4.2%; P = 0.78) at 2 years without significant differences in individual components of the composite endpoint. The secondary effectiveness endpoint occurred in 217 (22.1%) patients in the ZES group and 202 (21.0%) patients in the DCS group (risk difference: 1.1%; 95% CI: -2.5% to 4.8%; P = 0.54). CONCLUSIONS: Among patients at HBR treated with 1-month DAPT followed by SAPT, the Resolute Onyx polymer-based ZES had similar 2-year outcomes for the primary safety and secondary effectiveness endpoint compared with the BioFreedom polymer-free DCS. (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy [DAPT] for High-Bleeding Risk Patients [Onyx ONE]; NCT03344653).

Antiplatelet therapy following transcatheter aortic valve implantation.

OBJECTIVE: There is limited evidence to support decision making on antiplatelet therapy following transcatheter aortic valve implantation (TAVI). Our aim was to assess the efficacy and safety of aspirin-only (ASA) versus dual antiplatelet therapy (DAPT) following TAVI. METHODS: We performed a systematic review and pooled analysis of individual patient data from 672 participants comparing single versus DAPT following TAVI. Primary endpoint was defined as the composite of net adverse clinical and cerebral events (NACE) at 1 month, including all-cause mortality, acute coronary syndrome (ACS), stroke, life-threatening and major bleeding. RESULTS: At 30 days a NACE rate of 13% was observed in the ASA-only and in 15% of the DAPT group (OR 0.83, 95% CI 0.48 to 1.43, p=0.50). A tendency towards less life-threatening and major bleeding was observed in patients treated with ASA (OR 0.56, 95% CI 0.28 to 1.11, p=0.09). Also, ASA was not associated with an increased all-cause mortality (OR 0.91, 95% CI 0.36 to 2.27, p=0.83), ACS (OR 0.5, 95% CI 0.05 to 5.51, p=0.57) or stroke (OR 1.21; 95% CI 0.36 to 4.03, p=0.75). CONCLUSIONS: No difference in 30-day NACE rate was observed between ASA-only or DAPT following TAVI. Moreover, a trend towards less life-threatening and major bleeding was observed in favour of ASA. Consequently the additive value of clopidogrel warrants further investigation.

Clinical outcomes with 6 months dual antiplatelet therapy after implantation of biolimus-A9 drug eluting coronary stents.

INTRODUCTION: Duration of dual antiplatelet therapy (DAPT) following drug eluting stent (DES) implantation remains poorly defined. Endothelialisation of biodegradable polymer biolimus-eluting stents occurs early, and 6 months DAPT may be adequate. AIMS: We evaluated long term outcome in patients treated with biolimus-eluting stents who were treated with 6 months DAPT. Endpoints included cardiac death and non-fatal stent thrombosis occurring 6 to 12 months after stent implantation. METHODS: 692 patients (77.2% male), aged 65.6 ± 12.5 years received biolimus-eluting DES (March 2008 -November 2011). Vital status was tracked through the Medical Research Information Service. Episodes of non-fatal stent thrombosis, (Academic Research Consortium definition) between months 6 and 12 were tracked via systematic database searches (5 PCI centres). RESULTS: Presentations included acute coronary syndrome (47.2%) and stable coronary disease (52.8%). Vessels treated included left main stem (6.8%), left anterior descending (37.4%), circumflex (19.1%), right coronary artery (34.5%) and saphenous vein graft (2.1%) respectively. High-risk subsets included diabetes (15.6%); AHA type C lesions (35.1%) and chronic total occlusions (12.8%). During median follow-up of 700 days (0 to 1392) there were 42 deaths (6.1%); 4.2% at 0-6 months, 1.0% at 6-12 months and 0.9% at >12 months. Of the 7 deaths between 6 and 12 months, one death was adjudicated as possible stent thrombosis. There were no cases of non-fatal known stent thrombosis. All cause mortality accrued with smooth decremental incidence. Statistical examination showed no evidence of event clustering between 6 and 12 months. CONCLUSIONS: After implantation of biodegradable polymer biolimus-eluting coronary stents, 6 months DAPT appears to be adequate, safe and effective.

Antiplatelet and antithrombotic treatment after transcatheter aortic valve implantation - comparison of regimes.

OBJECTIVES: We compared procedural and follow-up complications of TAVI patients based on the type of antithrombotic treatment used (single-antiplatelet [SAPT] vs dual-antiplatelet [DAPT] vs warfarin). BACKGROUND: Despite growing operator experience and device development, vascular complications following transcatheter aortic valve implantation (TAVI) remain problematic. Bleeding complications and stroke are two of the main disadvantages compared with surgical aortic valve replacement. Correct choice of antiplatelet or antithrombotic treatment is therefore crucial, but remains empirical. METHODS: We analyzed a cohort of 171 patients with symptomatic severe aortic stenosis who underwent TAVI using the CoreValve (Medtronic, Inc) in our center between December 2007 and June 2012. We assessed both procedural, in-hospital, and follow-up outcomes for vascular complications, stroke, myocardial infarction, bleeding complications, and death. RESULTS: Patients were aged 81.6 ± 6.4 years; 47% were male. Treatment regimes were DAPT (34%), SAPT (53%), or warfarin (13%). When analyzing the combined endpoint of all-cause death, acute coronary events, stroke, or bleeding, the outcome was significantly worse in the DAPT group (in-hospital P=.01, 30-day follow-up P=.02). This difference was driven mainly by bleeding complications, with a trend toward higher rates of major bleeding events in the DAPT group vs SAPT group (P=.07 for both in-hospital and 30-day bleeding). The occurrence of major adverse cardiac and cerebrovascular events was statistically similar in all groups. CONCLUSION: This relatively small series suggests that DAPT does not protect patients from stroke, but may expose them to higher bleeding risk. Further study of this area is warranted.

Prognostic impact of pre-existing right ventricular dysfunction on the outcome of transcatheter aortic valve implantation.

AIMS: Right ventricular dysfunction is a well recognized adverse prognostic factor in patients undergoing surgical aortic valve replacement. The prognostic significance of right ventricular dysfunction in the context of transcatheter aortic valve implantation (TAVI) has not been established. We evaluated the relationship between preprocedural right ventricular impairment and the outcome of TAVI. METHODS AND RESULTS: Between December 2007 and December 2011, a total of 155 patients with severe aortic stenosis underwent TAVI at the Sussex Cardiac Centre, of whom 83%-91% had prospective analysis of right ventricular function prior to TAVI using two different standard echocardiographic methods. We identified patients with preserved and impaired ventricular function and compared their all-cause mortality during follow-up. Right ventricular dysfunction was defined as tricuspid annular plane systolic excursion (TAPSE) <15 mm or right ventricular peak systolic velocity (RVPSV) <9 cm/s and was identified in 11% of patients. Vital status was established from the Office of National Statistics. Average follow-up was 628 ± 392 days. A total of 107 patients were followed for at least 1 year and 63 patients for at least 2 years. Cumulative total mortality was 17.4%. In-hospital mortality was 2.6%, death within 30 days was 5.8%, 1-year mortality was 14.0%, and 2-year mortality was 15.9%. There was no statistically significant difference in outcome between patients with and without right ventricular dysfunction. This finding was consistent between the two methods used to determine right ventricular function (TAPSE: hazard ratio [HR] 1.57 and P=.42; RVPSV: HR 1.28 and P=.71). CONCLUSIONS: Preprocedural right ventricular dysfunction does not adversely impair immediate or follow-up survival during medium-term follow-up after TAVI.

Coronary stent implantation technique: prolonged inflation time maximizes stent expansion.

OBJECTIVES: To determine whether longer periods of stent balloon inflation result in greater minimal luminal diameter (MLD) as measured by quantitative coronary analysis (QCA), and to determine whether measured size correlated with that predicted by pressure-diameter nomograms. METHODS: Seventy-four stents were implanted in 52 patients. Stent acquisitions at a steady inflation pressure were taken at 10 s, 30 s, and 60 s. The stent MLD at each of these intervals was measured by QCA. Comparisons were made between (1) stent diameter obtained at these time intervals; and (2) nomogram-predicted pressure-related stent diameters. RESULTS: Measured stent size increased significantly between each time point measured, with the most marked increment in size (0.15 ± 0.02 mm) observed between 10 s and 30 s (P<.0001), with a smaller but still significant increment between 30 s and 60 s (0.06 ± 0.02 mm; P=.0034). Although there was good correlation between measured size and expected size at 10 s and 30 s (r² = 0.60 and 0.58, respectively), the correlation at 60 s inflation was strongest (r² = 0.65). CONCLUSIONS: Longer durations of stent inflation increase MLD. A minimum duration of 30 seconds is recommended. However, even after 60 s, the MLD does not match the nomogram-derived expected diameter.