EU must step up response to COVID-19, Commission warns as infections spike

By Francesco Guarascio



a flag flying in front of a building: FILE PHOTO: European Union flags flutter outside the European Commission headquarters in Brussels, Belgium


© Reuters/YVES HERMAN
FILE PHOTO: European Union flags flutter outside the European Commission headquarters in Brussels, Belgium

BRUSSELS (Reuters) – The European Commission proposed on Wednesday a series of new measures to fight the COVID-19 pandemic in the European Union, saying the new spike in infections on the continent was “alarming”.

As Europe again becomes the world’s epicentre of the pandemic, the EU executive urged the 27 EU governments to do more and in a more coordinated fashion against the virus.

“The relaxation of applied measures during the summer months was not always accompanied by steps to build up sufficient response capacity,” the Commission warned in a statement as part of its formal proposal to EU governments for action.

To better trace the spread of infections, Brussels said EU governments should coordinate their testing strategies and make a larger use of rapid antigen tests, despite the global supply for these kits is now tightening.

It warned the “current shortfalls in testing capacity” required swift action.

Last week, European Commission President Ursula von der Leyen said the EU executive would direct 100 million euros ($118 million) to buy up to 22 million antigen tests to meet EU countries’ “immediate needs”. It is now urging states to buy more through a joint procurement scheme.

It also said states should have common testing requirements for incoming travellers, including tests at arrival if tests were not available in the country of departure. It called for coordinated rules on quarantines.

AVOIDING SHORTAGES

To avoid risks of new shortages of medical equipment, which dogged the bloc at the beginning of the pandemic in spring, the Commission said it had launched a joint procurement for gear needed to inoculate people, such as syringes and disinfectants.

It also extended to April a temporary suspension of customs duties and sales tax on import of medical equipment.

EU countries could also exempt COVID-19 testing kits and vaccines from sales tax, the Commission said.

The Commission also repeated its call on EU governments to quickly devise vaccination strategies so that the most vulnerable people could quickly access COVID-19 vaccines if and when effective shots will be available.

(Reporting by Francesco Guarascio @fraguarascio, editing by Robin Emmott)

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Step in the Right Direction for DCB in Below-Knee CLI

An investigational drug-coated balloon (DCB) may offer clinical benefit in critical limb ischemia patients with below-the-knee (BTK) chronic total occlusions, preliminary results from the IN.PACT BTK study suggest.

Use of the IN.PACT 0.014 DCB (Medtronic) was associated with a numerically lower rate of late lumen loss than percutaneous transluminal angioplasty (PTA) at 9 months (mean, 0.89 vs 1.31 mm; P = .070).

The investigators, however, took a page from coronary studies, also assessing late lumen loss along the entirety of the lesion, rather than just at the single narrowest segment in the lesion, as is classically done.

Subsegmental late lumen loss proved significantly lower with the DCB than with PTA (mean, 0.59 vs 1.26 mm; P = .017).

“The subsegmental measurements are more rigorous,” lead investigator Antonio Micari, MD, University of Messina, Italy, said at the virtual meeting of Transcatheter Cardiovascular Therapeutics (TCT) 2020. “This can provide more detail on how the lesion fails over time.”

There is a relative paucity of DCB technology for BTK lesions, with three earlier DCB trials failing to meet their primary end point. Medtronic also withdrew its earlier-generation paclitaxel-coated IN.PACT Amphirion DCB from the global market in 2013 based on results from the IN.PACT DEEP trial showing a lack of treatment effect and trend toward more major amputations at 12 months.

The present results showed no safety concerns among the 50 participants, including no major amputations in either group and a low all-cause death rate of 4.3% for DCB and 8.0% for PTA (P = 1.0), Micari said.

The safety end point — a composite of freedom from device- and procedure-related death through 30 days, freedom from major target limb amputation within 270 days, and freedom from clinically driven target lesion revascularization within 270 days — was met by 91.3% of the DCB group and 87.5% of the angioplasty group (P = 1.0).

“That was a very interesting presentation with very promising results, but I’m not convinced,” session comoderator and limb salvage pioneer Frank J. Veith, MD, said. “Are you planning to add more patients, and what about longer follow-up?

“I would be more convinced if you had 2-year follow-up and at least double or triple the number of patients in each arm,” added Veith, professor of surgery at NYU Langone Health, New York City, and at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University.

Micari said they are planning longer follow-up, possibly out to 5 years. “This is a feasibility study and we are happy to show that, even in a small population, we have a difference. This is a new design of the study that we can apply to a larger trial and we are definitely looking for a bigger trial.”

During a press briefing, discussant Peter A. Schneider, MD, University of California, San Francisco, said IN.PACT BTK is notable for several reasons: every person had a CTO and the mean lesion length was over 20 centimeters (DCB 21.5 cm vs PTA 21.8 cm). “So this is

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