A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: Results from the multi-center randomized controlled PATENT-C first in human trial.

BACKGROUND: Scoring balloons produce excellent acute results in the treatment of in-stent restenosis (ISR), fibro-calcific and bifurcation lesions but have not been shown to affect the restenosis rate. A novel paclitaxel-coated scoring balloon (SB) was developed and tested to overcome this limitation. METHODS AND RESULTS: SB were coated with paclitaxel admixed with a specific excipient. Patients at four clinical sites in Germany and one in Brazil with ISR of coronary bare metal stent (BMS) were randomized 1:1 to treatment with either a drug-coated or uncoated SB. Baseline and 6-month follow-up quantitative coronary angiography was performed by an independent blinded core lab and all patients will be evaluated clinically for up to one year. The primary endpoint was angiographic in-segment late lumen loss (LLL). Secondary endpoints included the rate of clinically driven target lesion revascularization (TLR), composite of major adverse cardiovascular events (MACE), stent thrombosis and other variables. Sixty-one patients were randomized (28 uncoated and 33 drug-coated SB); mean age 65 years, males 72%, and presence of diabetes 39%. At 6-month angiography, in-segment LLL was 0.48 ± 0.51 mm in the uncoated SB group versus 0.17 ± 0.40 mm in the drug-coated SB group (P = 0.01; ITT analysis). The rate of binary restenosis was 41% in the uncoated SB group versus 7% in the drug-coated SB group (P = 0.004). The MACE rate was 32% with the uncoated SB vs. 6% in the drug-coated SB group (P = 0.016). This difference was primarily due to the reduced need for clinically driven TLR in the coated SB group (3% vs. 32% P = 0.004). CONCLUSIONS: A novel paclitaxel-coated coronary SB has been developed and successfully used in a first-in-human randomized controlled trial [ClinicalTrials.gov Identifier: NCT01495533]. © 2015 Wiley Periodicals, Inc.

A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: Results from the multi-center randomized controlled PATENT-C first in human trial

Scoring balloons produce excellent acute results in the treatment of instentrestenosis (ISR), fibro-calcific and bifurcation lesions but have not been shown toaffect the restenosis rate. A novel paclitaxel-coated scoring balloon (SB) was developedand tested to overcome this limitation. Methods and Results: SB were coatedwith paclitaxel admixed with a specific excipient. Patients at four clinical sites inGermany and one in Brazil with ISR of coronary bare metal stent (BMS) were randomized1:1 to treatment with either a drug-coated or uncoated SB. Baseline and 6-monthfollow-up quantitative coronary angiography was performed by an independent blindedcore lab and all patients will be evaluated clinically for up to one year. The primaryendpoint was angiographic in-segment late lumen loss (LLL). Secondary endpoints included the rate of clinically driven target lesion revascularization (TLR), composite ofmajor adverse cardiovascular events (MACE), stent thrombosis and other variables.Sixty-one patients were randomized (28 uncoated and 33 drug-coated SB); mean age65 years, males 72%, and presence of diabetes 39%. At 6-month angiography, insegmentLLL was 0.48 6 0.51 mm in the uncoated SB group versus 0.17 6 0.40 mm inthe drug-coated SB group (P 5 0.01; ITT analysis). The rate of binary restenosis was41% in the uncoated SB group versus 7% in the drug-coated SB group (P 5 0.004). TheMACE rate was 32% with the uncoated SB vs. 6% in the drug-coated SB group(P 5 0.016). This difference was primarily due to the reduced need for clinically drivenTLR in the coated SB group (3% vs. 32% P 5 0.004). Conclusions: A novel paclitaxelcoatedcoronary SB has been developed and successfully used in a first-in-human randomized controlled trial...

Experiência Inicial de Dois Centros Nacionais no Implante de Prótese Aórtica Transcateter / Initial Experience of Two National Centers in Transcatheter Aortic Prosthesis Implantation

Fundamento: O implante de prótese aórtica transcateter é uma alternativa efetiva para o tratamento cirúrgico para a correção de estenose aórtica grave em pacientes inoperáveis ou de alto risco cirúrgico. Objetivos: Apresentar os resultados clínicos e ecocardiográficos imediatos e no médio prazo da experiência inicial do implante de prótese aórtica transcateter. Métodos: Entre junho de 2009 e fevereiro de 2013, 112 pacientes foram submetidos a implante de prótese aórtica transcateter. Resultados: A idade média foi 82,5 ± 6,5 anos e o Euro SCORE logístico foi 23,6 ± 13,5. O sucesso do procedimento foi de 84%. Após o implante, houve queda do gradiente sistólico médio (pré = 54,7 ± 15,3 mmHg vs. pós = 11,7 ± 4,0 mmHg; p < 0,01). Acidente vascular cerebral ocorreu em 3,6% dos pacientes, complicações vasculares em 19%, e foi necessário o implante de marca-passo definitivo em 13% dos pacientes nos primeiros 30 dias pós-implante. A mortalidade aos 30 dias e no seguimento médio de 16 ± 11 meses foi, respectivamente, de 14 e de 8,9%. A presença de doença pulmonar obstrutiva crônica foi o único preditor de mortalidade em 30 dias e no seguimento. A área valvar aórtica e o gradiente sistólico médio não apresentaram variações significativas durante o seguimento. Conclusões: O implante de prótese aórtica transcateter é um procedimento eficaz e seguro para o tratamento da estenose aórtica em pacientes de alto risco cirúrgico ou inoperáveis. A presença de doença pulmonar obstrutiva crônica foi o único preditor independente de mortalidade identificado, tanto no primeiro mês pós-intervenção quanto no seguimento mais tardio. .

Background: Transcatheter aortic valve implantation is an effective alternative to surgical treatment of severe aortic stenosis in patients who are inoperable or at high surgical risk. Objectives: To report the immediate and follow-up clinical and echocardiographic results of the initial experience of transcatheter aortic valve implantation. Methods: From 2009 June to 2013 February, 112 patients underwent transcatheter aortic valve implantation. Results: Mean age was 82.5 ± 6.5 years, and the logistic EuroSCORE was 23.6 ± 13.5. Procedural success was 84%. After the intervention, a reduction in the mean systolic gradient was observed (pre: 54.7 ± 15.3 vs. post: 11.7 ± 4.0 mmHg; p < 0.01). Cerebrovascular accidents occurred in 3.6%, vascular complications in 19% and permanent pacemaker was required by 13% of the patients. Thirty-day mortality and at follow-up of 16 ± 11 months was 14% and 8.9% respectively. The presence of chronic obstructive pulmonary disease was the only predictor of mortality at 30 days and at follow-up. During follow up, aortic valve area and mean systolic gradient did not change significantly. Conclusions: Transcatheter aortic valve implantation is an effective and safe procedure for the treatment of aortic stenosis in high-surgical risk or inoperable patients. The presence of chronic obstructive pulmonary disease was the only independent predictor of mortality identified both in the first month post-intervention and at follow-up. .