Clnical Practice Dissociated from Study Outcomes: Bad News for Our Patients?

Differences in patient characteristics, changes in treatment algorithms, and advances in device technology, together or separately, might limit the applicability of older randomized trials to contemporary clinical practice.

Práctica clínica disociada de los estudios ¿malas noticias para nuestros pacientes?

In this case, we look at patients and devices used in the contemporary clinical practice vs. those in the EXTEND DAPT. These differences were associated with attenuated benefits and great harm attributable to unnecessarily prolonged DAPT duration. 

The EXTEND DAPT (Dual Antiplatelet Therapy) had concluded that prolonged DAPT reduced ischemic events at the expense of greater bleeding. 

However, since the DAPT was release, new devices with very different instent thrombosis rates have changed the game completely. In other words, at present, the beneficial effect in bleeding is maintained, but ischemic risk has significantly dropped. In this regard, if the EXTEND DAPT were carried out today, its conclusions would be radically different.


Read also: Is the Booster Dose Against COVID-19 Effective for All Ages?


The study compared patient characteristics of those receiving contemporary DES between 2016 and 2017. After multiple adjustments, researchers estimated the effects of receiving 30-month DAPT vs. 12 months after DES stenting in the “real world”. 

The randomized cohort receiving DES was 8,864 patients and the registry included 568,540 patients. Compared with the trial population, registry patients had more comorbidities and were more likely to present myocardial infarction and receive 2nd-generation drug-eluting stents. 

A new analysis looked at the same data and found prolonged DAPT no longer reduced thrombosis (OR 0.40; CI 95%, 0.99% to 0.15%), combined cardiovascular and cerebrovascular events (OR 0.52; CI 95%, 2.62% to 1.03%) or MI (OR 0.52; CI 95%, 2.62% to 1.03%) significantly. 


Read also: Melody: One of the Pioneers in Transcatheter Pulmonary Valve Replacement with Long Term Outcomes.


All of the above in the context of prolonged DAPT and a two-fold increased risk in bleeding (OR 2.42%; CI 95%, 0.79% to 3.91%).

Conclusion

The differences between patients and devices used in the contemporary clinical practice compared with those used in the DAPT trial were associated with attenuated benefits of prolonged DAPT and the same damage associated to bleeding. 

These findings limit the applicability of older study outcomes to the contemporary clinical practice. 

CIRCULATIONAHA-121-056878

Original Title: Estimation of DAPT Study Treatment Effects in Contemporary Clinical Practice: Findings From the EXTEND-DAPT Study.

Reference: Neel M. Butala et al. Circulation. 2022 Jan 11;145(2):97-106. doi: 10.1161/CIRCULATIONAHA.121.056878.


Subscribe to our weekly newsletter

Get the latest scientific articles on interventional cardiology

More articles by this author

TCT 2024 | FAVOR III EUROPA

The study FAVOR III EUROPA, a randomized trial, included 2,000 patients with chronic coronary syndrome, or stabilized acute coronary syndrome, and intermediate lesions. 1,008...

TCT 2024 – ECLIPSE: Randomized Study of Orbital Atherectomy vs Conventional PCI in Severely Calcified Lesions

Coronary calcification is associated with stent under-expansion and increased risk of both early and late adverse events. Atherectomy is an essential tool for uncrossable...

TCT 2024 | Use of Drug-Coated Balloons for Side Branch Treatment in Provisional Stenting

In some cases, treating coronary bifurcations with provisional stenting requires side branch stenting, which may lead to suboptimal outcomes. Drug-coated balloons (DCBs) have emerged...

TCT 2024 | Use of Artificial Intelligence for Patients with Suspected Coronary Artery Disease

The current approach to chest pain mainly focuses on symptom characteristics, conducting functional tests for ischemia assessment. However, several randomized clinical trials have shown...

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Related Articles

SOLACI Sessionsspot_img

Recent Articles

TCT 2024 | FAVOR III EUROPA

The study FAVOR III EUROPA, a randomized trial, included 2,000 patients with chronic coronary syndrome, or stabilized acute coronary syndrome, and intermediate lesions. 1,008...

TCT 2024 | TRISCEND II

This randomized study included 400 patients; 267 were treated with EVOQUE valve and 133 with optimal medical treatment (OMT). After one-year follow-up, there were no...

TCT 2024 – ACCESS-TAVI: Comparing Percutaneous Access Closure Strategies After TAVI

Vascular access complications following transcatheter aortic valve implantation (TAVI) remain common. However, few studies compare vascular access closure methods.  Based on the CHOICE-CLOSURE and MASH...