Clinical Impact of Intraprocedural Stent Thrombosis During Percutaneous Coronary Intervention in Patients Treated With Potent P2Y12 inhibitors ‐ a VALIDATE‐SWEDEHEART Substudy

Abstract

Background The clinical importance of intraprocedural stent thrombosis (IPST) during percutaneous coronary intervention in the contemporary era of potent oral P2Y12 inhibitors is not established. The aim of this study was to assess IPST and its association with clinical outcome in patients with myocardial infarction undergoing percutaneous coronary intervention with contemporary antithromboticmedications. Methods and Results The VALIDATE‐SWEDEHEART study (Bivalirudin Versus Heparin in ST‐Segment and Non–ST‐Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence‐Based Care in Heart Disease Evaluated According to Recommended Therapies Registry Trial) included 6006 patients with myocardial infarction, treated with potent P2Y12 inhibitors during percutaneous coronary intervention. IPST, defined as a new or worsening thrombus related to a stent deployed during the procedure, was reported by the interventional cardiologist in 55 patients (0.9%) and was significantly associated with ST‐segment elevation myocardial infarction presentation, longer stents, bailout glycoprotein IIb/IIIa inhibitors, and final Thrombolysis in Myocardial Infarction flow <3. The primary composite end point included cardiovascular death, myocardial infarction, out‐of‐laboratory definite stent thrombosis and target vessel revascularization within 30 days. Secondary end points were major bleeding and the individual components of the primary composite end point. Patients with versus without IPST had significantly higher rates of the primary composite end point (20.0% versus 4.4%), including higher rates of cardiovascular death, target vessel revascularization, and definite stent thrombosis, but not myocardial infarction or major bleeding. By multivariable analysis, IPST was independently associated with the primary composite end point (hazard ratio, 3.82; 95% CI, 2.05–7.12; P <0.001). Conclusions IPST is a rare but dangerous complication during percutaneous coronary intervention, independently associated with poor prognosis, even in the current era of potent antiplatelet agents. Future treatment studies are needed to reduce the rate of IPST and to improve the poor outcome among these patients. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02311231.

Outcome of Primary Percutaneous Coronary Intervention for STEMI due to Stent Thrombosis

“…Despite these advancements, the pathophysiological underpinnings of ST remain elusive, with factors such as lesion morphology, adherence to dual antiplatelet therapy (DAPT), diabetes prevalence, and stent design emerging as significant contributors. The heterogeneity observed in histopathological analyses of thrombus specimens further complicates the understanding of ST, with a diverse array of components such as platelet-rich clots and fibrin/fibrinogen fragments being implicated (2,3,14). Our investigation aligns with existing literature, highlighting a mortality rate of 24% in patients undergoing primary PCI for STEMI attributed to ST, a figure that resonates with findings from other studies within the Pakistani context, which have reported similar mortality rates post-PCI.…”

“…This adverse event can occur at any point following stent deployment, ranging from the immediate peri-procedural period to several years post-implantation. The rising prevalence of PCI as a therapeutic strategy has shifted the focus from procedural success towards the prevention of in-stent thrombosis (3,4). The advent of drug-eluting stents (DES) was initially heralded as a breakthrough in reducing the rate of restenosis observed with bare metal stents (BMS).…”