Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up trial

In the treatment of de-novo coronary small vessel disease, drug-coated balloons (DCBs) are non-inferior to drug-eluting stents (DESs) regarding clinical outcome up to 12 months, but data beyond 1 year is sparse. We aimed to test the long-term efficacy and safety of DCBs regarding clinical endpoints in an all-comer population undergoing percutaneous coronary intervention.

In this study, Between April 10, 2012, and Feb 1, 2017, of 883 patients assessed, 758 (86%) patients were randomly assigned to the DCB group (n=382) or the DES group (n=376). The Kaplan-Meier estimate of the rate of major adverse cardiac events was 15% in both the DCB and DES groups (hazard ratio [HR] 0·99, 95% CI 0·68–1·45; p=0·95). The two groups were also very similar concerning the single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate 5% vs 4%, HR 1·29, 95% CI 0·63–2·66; p=0·49), non-fatal myocardial infarction (both Kaplan-Meier estimate 6%, HR 0·82, 95% CI 0·45–1·51; p=0·52), and TVR (both Kaplan-Meier estimate 9%, HR 0·95, 95% CI 0·58–1·56; p=0·83). Rates of all-cause death were very similar in DCB versus DES patients (both Kaplan-Meier estimate 8%, HR 1·05, 95% CI 0·62–1·77; p=0·87). Rates of probable or definite stent thrombosis (Kaplan-Meier estimate 1% vs 2%; HR 0·33, 95% CI 0·07–1·64; p=0·18) and major bleeding (Kaplan-Meier estimate 2% vs 4%, HR 0·43, 95% CI 0·17–1·13; p=0·088) were numerically lower in DCB versus DES, however without reaching significance.

Interpretation

There is maintained efficacy and safety of DCB versus DES in the treatment of de-novo coronary small vessel disease up to 3 years.

Does it mean there will be a shift towards to DCBs., less need for DES?

Did we understand the total picture of the COVID-19?

Did we understand the total picture of the COVID-19? Is there something more to unfold in the coming months?

Multisystem inflammatory syndrome in children (MIS-C) is a newly described condition associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure that is reminiscent of both Kawasaki disease and toxic shock syndrome. There is recent surge in this disease. It has prompted us to increase the awareness of MIS-C.  The number of reported cases continues to increase. Kawasaki-like multisystem inflammatory condition is a possibility in adults. The first case is reported in USA.

A constellation of signs 1)fever for more than 5 days, 2)erythema multiforme-like rash, 3)bilateral non-exudative conjunctivitis, 4)erythema or cracking of the lips, 5)unilateral cervical lymphadenopathy measuring more than 1·5 cm in diameter), the American Heart Association (AHA) criteria for Kawasaki disease were noted in a man. So, based on these criteria he was diagnosed with Kawasaki-like multisystem inflammatory syndrome associated with COVID-19. It was notable that he did not experience the hypoxic respiratory failure most frequently associated with moderate to severe COVID-19, despite his abnormal chest x-ray findings. He exhibited many MIS-C-related features such as a predominance of gastrointestinal symptoms, generalised extremity pain, and prominent cardiac dysfunction, and his cardiac findings (elevated cardiac enzymes and left ventricular hypokinesis with a reduction in ejection fraction) resemble findings of myocarditis recently described in MIS-C. This patient's palmar lesions are distinct from the acral erythema and swelling with subsequent desquamation typically seen in Kawasaki disease, and his diffuse conjunctivitis was not limbic-sparing. Biochemically, he demonstrated markedly elevated C-reactive protein, neutrophilia, and lymphopenia, which are more consistent with MIS-C than with classic Kawasaki disease. Emerging reports depict the phenotype of MIS-C as a combination of Kawasaki disease, toxic shock syndrome, and macrophage activation syndrome (or haemophagocytic lymphohistiocytosis), these are all syndromes of dysregulated immune responses. Diagnostic distinction from classic Kawasaki disease might have meaningful implications: whereas treatments targeting IL-6 are currently being investigated among therapeutic options for COVID-19-associated hyperinflammation, the IL-6 inhibitor tocilizumab might provoke the development of coronary artery aneurysms in patients with classic Kawasaki disease. Though this is a rare presentation of one case in association with COVID19, we should be aware of such can be associated and we vigilant in the future.