IN.PACT Outcomes at 5 Years

Over time, percutaneous coronary intervention (PCI) with drug coated balloons (DCB) have been shown more beneficial than conventional PCI. However, in many cases, stenting is required to treat suboptimal results. 

Resultados a 2 años de los stents liberadores de Zotarolimus vs stents libres de polímero liberadores de Biolimus. ¿Son seguros en pacientes con alto riesgo de sangrado?

Even though several studies have looked into this scenario, long term durability still calls for research.

This was a 5 year thorough analysis of the IN.PACT which looked at 1,397 patients with severe lesions in femoropopliteal territory. 353 of these patients were treated with DCB + bare metal stent (DCB BMS) and 1,044 with DCB alone. 

The safety primary outcome was ischemia driven target lesion revascularization (TLR); it looked at the cumulative incidence of ischemia driven TLR at 5 years.  

Participant mean age was 68, and there were no differences in the presence of diabetes, hypertension, dyslipidemia, obesity, kidney function deterioration, heart disease or carotid disease. Neither were there differences in Rutherford functional class, even though ABI index was lower in patients receiving DCB BMS.

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There was no variation in the number of lesions or reference diameter. However, DCB BMS patients showed higher incidence of de novo lesions, length, total occlusions, length of total occlusion, calcification and pre and post dilation occlusion percentage. Also, restenosis was more frequent in patients treated with DCB. 

At 5 years, there were no significant differences in primary outcome per Kaplan Meier curve (68.8% vs. 70%, p=0.219 for DCB BMS vs. DCB), neither in major adverse events (49.1% vs. 45%, p=0.17), mortality, or amputation.

Conclusion

In a real world context, complex revascularization in femoropopliteal territory with PCI with DCB alone or followed by provisional BM stenting in certain lesions was shown comparable in terms of clinical safety and efficacy.

Dr. Carlos Fava - Consejo Editorial SOLACI

Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.

Original Title: Five-Year Safety and Effectiveness of Paclitaxel Drug-Coated Balloons Alone or With Provisional Bare Metal Stenting for Real-World Femoropopliteal Lesions: IN.PACT Global Study Subgroup Analysis.

Reference: Gary M. Ansel et al. Circ Cardiovasc Interv. 2024;17:e013084. DOI: 10.1161/CIRCINTERVENTIONS.123.013084.


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