Evaluation of the safety and efficacy of the Cobra PzF NanoCoated coronary stent in routine, consecutive, prospective, and high-risk patients: The e-Cobra study.

BACKGROUND: The Cobra PzF coronary stent is cobalt chromium with flat thin struts, nano-coated with Polyzene-F that enhance rapid reendothelialization and reduce the risk of stent thrombosis and restenosis. It is designed to overcome shortfalls of BMS and DES in patients requiring short DAPT duration. AIMS: To report procedural and 1-year clinical outcomes following Cobra PzF stent implantation in routine practice PCI. METHODS: e-Cobra registry is a multicenter prospective study to evaluate Cobra PzF stent in routine practice in patients deemed appropriate for short DAPT after PCI. The primary endpoint was MACE rate at 12 months (Cardiac death, MI, TLR). The secondary endpoint was definite stent thrombosis at 12 months. RESULTS: Among 940 patients (72% men, 72.8 ± 13.4 years) with multiple co-morbidities, 47% had acute coronary syndromes, and 62% were defined as high bleeding risk. A total of 1,229 lesions were treated with 1,314 stents. 36% of patients had lesion type B2 or C classification. Angiographic success was achieved in all cases. One-year follow-up was available for 97% of patients. The primary endpoint occurred in 9.0% of patients, including cardiac death 3.7%, MI 4.8%, and TLR 4.3%. Definite stent thrombosis occurred in six out of 915 (0.7%). CONCLUSION: The Cobra PzF stent was safe and effective in routine practice patients and seems feasible in situations when short DAPT or Mono Antiplatelet Therapy (MAPT) is needed. One-year follow-up was associated with satisfactory clinical outcomes and validate previously reported data.

The mortality rates in registries of patients with STEMI are highly affected by inclusion criteria and population characteristics.

BACKGROUND: Different mortality rates are reported in registries of patients with ST-segment elevation myocardial infarction (STEMI), but comparisons between registries are challenging. AIMS: To determine whether the higher mortality rate in our regional French registry (SCALIM) is related to different inclusion criteria and demographic characteristics. METHODS: The SCALIM registry included all patients with STEMI within the first 24 h in the region of Limousin, France (06/2011-01/2015). To compare mortality rates with other contemporary registries in France and European neighbouring countries, the others' inclusion criteria were applied to the SCALIM registry. RESULTS: Among 1501 patients included, in-hospital and 1-month mortality were 8.2% and 8.8% respectively, significantly higher than many other registries. The use of inclusion criteria from EMUST (France), MINAP (UK) or LOMBARDIMA (Italy) markedly decreased the number of enrolled patients by 64%, 36%, and 21%, respectively. When those inclusion criteria were applied to the SCALIM registry, difference in in-hospital and 1-month mortality rates between other registries and ours remained significant. In the multivariate analysis, age, initial acute pulmonary oedema (Killip class ≥2), complication occurring before percutaneous coronary intervention, absence of transfer to an interventional cardiology centre for primary angioplasty and lack of reperfusion therapy within 12 h were associated with higher risk of 1-month mortality (all p < 0.05). Age (65 versus 63.3 years, p < 0.001) was higher and reperfusion rate (84.2 versus 74.7%, p < 0.001) was significantly lower in SCALIM than FAST-MI, the national French registry on STEMI patients. Interestingly, the 3% of patients included in SCALIM who would be excluded from FAST-MI registry had 91% mortality at one month. CONCLUSION: Higher mortality rate in our regional SCALIM registry is in part due to differences in inclusion criteria and demographic data. Consensus should be made to harmonise inclusion criteria in STEMI registries for the sake of comparability.